Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up.

PubMed

Irgens, Audun C; Hoffart, Asle; Nysæter, Tor E; Haaland, Vegard Ø; Borge, Finn-Magnus; Pripp, Are H; Martinsen, Egil W; Dammen, Toril

2017-01-01

Background: Thought field therapy (TFT) is used for many psychiatric conditions, but its efficacy has not been sufficiently documented. Hence, there is a need for studies comparing TFT to well-established treatments. This study compares the efficacy of TFT and cognitive behavioral therapy (CBT) for patients with agoraphobia. Methods: Seventy-two patients were randomized to CBT ( N = 24), TFT ( N = 24) or a wait-list condition (WLC) ( N = 24) after a diagnostic procedure including the MINI PLUS that was performed before treatment or WLC. Following a 3 months waiting period, the WL patients were randomized to CBT ( n = 12) or TFT ( n = 12), and all patients were reassessed after treatment or waiting period and at 12 months follow-up. At first we compared the three groups CBT, TFT, and WL. After the post WL randomization, we compared CBT ( N = 12 + 24 = 36) to TFT ( N = 12 + 24 = 36), applying the pre-treatment scores as baseline for all patients. The primary outcome measure was a symptom score from the Anxiety Disorders Interview Scale that was performed by an interviewer blinded to the treatment condition. For statistical comparisons, we used the independent sample's t -test, the Fisher's exact test and the ANOVA and ANCOVA tests. Results: Both CBT and TFT showed better results than the WLC ( p < 0.001) at post-treatment. Post-treatment and at the 12-month follow-up, there were not significant differences between CBT and TFT ( p = 0.33 and p = 0.90, respectively). Conclusion: This paper reports the first study comparing TFT to CBT for any disorder. The study indicated that TFT may be an efficient treatment for patients with agoraphobia. Trial Registration: https://clinicaltrials.gov/, identifier NCT00932919.

Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up

PubMed Central

Irgens, Audun C.; Hoffart, Asle; Nysæter, Tor E.; Haaland, Vegard Ø.; Borge, Finn-Magnus; Pripp, Are H.; Martinsen, Egil W.; Dammen, Toril

2017-01-01

Background: Thought field therapy (TFT) is used for many psychiatric conditions, but its efficacy has not been sufficiently documented. Hence, there is a need for studies comparing TFT to well-established treatments. This study compares the efficacy of TFT and cognitive behavioral therapy (CBT) for patients with agoraphobia. Methods: Seventy-two patients were randomized to CBT (N = 24), TFT (N = 24) or a wait-list condition (WLC) (N = 24) after a diagnostic procedure including the MINI PLUS that was performed before treatment or WLC. Following a 3 months waiting period, the WL patients were randomized to CBT (n = 12) or TFT (n = 12), and all patients were reassessed after treatment or waiting period and at 12 months follow-up. At first we compared the three groups CBT, TFT, and WL. After the post WL randomization, we compared CBT (N = 12 + 24 = 36) to TFT (N = 12 + 24 = 36), applying the pre-treatment scores as baseline for all patients. The primary outcome measure was a symptom score from the Anxiety Disorders Interview Scale that was performed by an interviewer blinded to the treatment condition. For statistical comparisons, we used the independent sample’s t-test, the Fisher’s exact test and the ANOVA and ANCOVA tests. Results: Both CBT and TFT showed better results than the WLC (p < 0.001) at post-treatment. Post-treatment and at the 12-month follow-up, there were not significant differences between CBT and TFT (p = 0.33 and p = 0.90, respectively). Conclusion: This paper reports the first study comparing TFT to CBT for any disorder. The study indicated that TFT may be an efficient treatment for patients with agoraphobia. Trial Registration: https://clinicaltrials.gov/, identifier NCT00932919. PMID:28676782

Mindfulness training and stress reactivity in substance abuse: results from a randomized, controlled stage I pilot study.

PubMed

Brewer, Judson A; Sinha, Rajita; Chen, Justin A; Michalsen, Ravenna N; Babuscio, Theresa A; Nich, Charla; Grier, Aleesha; Bergquist, Keri L; Reis, Deidre L; Potenza, Marc N; Carroll, Kathleen M; Rounsaville, Bruce J

2009-01-01

Stress is important in substance use disorders (SUDs). Mindfulness training (MT) has shown promise for stress-related maladies. No studies have compared MT to empirically validated treatments for SUDs. The goals of this study were to assess MT compared to cognitive behavioral therapy (CBT) in substance use and treatment acceptability, and specificity of MT compared to CBT in targeting stress reactivity. Thirty-six individuals with alcohol and/or cocaine use disorders were randomly assigned to receive group MT or CBT in an outpatient setting. Drug use was assessed weekly. After treatment, responses to personalized stress provocation were measured. Fourteen individuals completed treatment. There were no differences in treatment satisfaction or drug use between groups. The laboratory paradigm suggested reduced psychological and physiological indices of stress during provocation in MT compared to CBT. This pilot study provides evidence of the feasibility of MT in treating SUDs and suggests that MT may be efficacious in targeting stress.

Study protocol for the dabigatran, apixaban, rivaroxaban, edoxaban, warfarin comparative effectiveness research study.

PubMed

Krumme, Alexis A; Pawar, Ajinkya; Schneeweiss, Sebastian; Glynn, Robert J; Choudhry, Niteesh K; Kulldorff, Martin; Ortiz, Adrian Santiago; Avorn, Jerome; Gagne, Joshua J

2018-01-01

Since 2010, four oral anticoagulants have been approved for marketing in addition to warfarin for treatment of thromboembolic disease. Limited head-to-head data exist comparing these treatments, leaving patients and clinicians with little guidance for selecting a strategy that balances recurrence reduction with bleeding risk. In the dabigatran, apixaban, rivaroxban, edoxaban and warfarin comparative effectiveness research study, we compare all five currently available oral anticoagulant agents for the extended treatment of deep venous thrombosis and pulmonary embolism, as well as no extended treatment, and evaluate whether results differ in specific sub-populations. As our population includes Medicare novel anticoagulant users and large numbers of commercially insured and Medicaid patients, our results will likely be transportable to the majority of US patients experiencing a DVT or pulmonary embolism. NCT03271450.

Comparing Offenders against Women and Offenders against Children on Treatment Outcome in Offenders with Intellectual Disability

ERIC Educational Resources Information Center

Lindsay, William R.; Michie, Amanda M.; Steptoe, Lesley; Moore, Fhionna; Haut, Fabian

2011-01-01

Background: Several studies have shown the positive effects of sex offender treatment for men with intellectual disabilities who have perpetrated sex offences or inappropriate sexual behaviour. The present study investigates the process of treatment change and compares two groups of offenders against adults and offenders against children. Method:…

A Comprehensive Comparison of the Efficacy and Tolerability of Racecadotril with Other Treatments of Acute Diarrhea in Adults

PubMed Central

Fischbach, Wolfgang; Andresen, Viola; Eberlin, Marion; Mueck, Tobias; Layer, Peter

2016-01-01

Racecadotril is a guideline-recommended treatment to alleviate symptoms of acute diarrhea. A systematic review of randomized studies was performed comparing efficacy and safety of treatment with racecadotril to that with placebo or active treatments in adults. In five double-blind studies, racecadotril and placebo had comparable tolerability, but racecadotril was more effective. This was consistent across multiple efficacy parameters including duration of diarrhea, number of diarrheic stools, abdominal pain, and meteorism; it was also consistent across countries in Africa, Asia, and Europe. In six randomized studies in outpatients comparing racecadotril to loperamide, resolution of symptoms occurred with similar speed and efficacy; however, racecadotril treatment was associated with less rebound constipation and less abdominal discomfort. The seventh comparative study performed in geriatric nursing home residents reported a superior efficacy of racecadotril. In direct comparison with Saccharomyces boulardii treatment, racecadotril exhibited similar tolerability but was more efficacious. One study compared racecadotril to octreotide in patients with acute diarrhea requiring hospitalization, rehydration, and antibiotic treatment; in this cohort, octreotide was more efficacious than racecadotril. In conclusion, in adults with acute diarrhea, racecadotril is more efficacious than placebo or S. boulardii, similarly efficacious as loperamide and, in patients with moderate to severe disease as add-on to antibiotics, less than octreotide. The tolerability of racecadotril is similar to that of placebo or S. boulardii and better than that of loperamide, particularly with regard to risk of rebound constipation. Taken together, these data demonstrate that racecadotril is a suitable treatment to alleviate symptoms of acute diarrhea in adults. PMID:27790616

Massage therapy has short-term benefits for people with common musculoskeletal disorders compared to no treatment: a systematic review.

PubMed

Bervoets, Diederik C; Luijsterburg, Pim A J; Alessie, Jeroen J N; Buijs, Martijn J; Verhagen, Arianne P

2015-07-01

Is massage therapy effective for people with musculoskeletal disorders compared to any other treatment or no treatment? Systematic review of randomised clinical trials. People with musculoskeletal disorders. Massage therapy (manual manipulation of the soft tissues) as a stand-alone intervention. The primary outcomes were pain and function. The 26 eligible randomised trials involved 2565 participants. The mean sample size was 95 participants (range 16 to 579) per study; 10 studies were considered to be at low risk of bias. Overall, low-to-moderate-level evidence indicated that massage reduces pain in the short term compared to no treatment in people with shoulder pain and osteoarthritis of the knee, but not in those with low back pain or neck pain. Furthermore, low-to-moderate-level evidence indicated that massage improves function in the short term compared to no treatment in people with low back pain, knee arthritis or shoulder pain. Low-to-very-low-level evidence from single studies indicated no clear benefits of massage over acupuncture, joint mobilisation, manipulation or relaxation therapy in people with fibromyalgia, low back pain and general musculoskeletal pain. Massage therapy, as a stand-alone treatment, reduces pain and improves function compared to no treatment in some musculoskeletal conditions. When massage is compared to another active treatment, no clear benefit was evident. Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Subjective response to antipsychotic treatment and compliance in schizophrenia. A naturalistic study comparing olanzapine, risperidone and haloperidol (EFESO Study)

PubMed Central

García-Cabeza, Ignacio; Gómez, Juan-Carlos; Sacristán, Jose A; Edgell, Eric; González de Chavez, Manuel

2001-01-01

Background In order to compare the effectiveness of different antipsychotic drugs in the treatment of schizophrenia it is very important to evaluate subjective response and compliance in patient cohorts treated according to routine clinical practice. Method Outpatients with schizophrenia entered this prospective, naturalistic study when they received a new prescription for an antipsychotic drug. Treatment assignment was based on purely clinical criteria, as the study did not include any experimental intervention. Patients treated with olanzapine, risperidone or haloperidol were included in the analysis. Subjective response was measured using the 10-item version of the Drug Attitude Inventory (DAI-10), and treatment compliance was measured using a physician-rated 4 point categorical scale. Results A total of 2128 patients initiated treatment (as monotherapy) with olanzapine, 417 with risperidone, and 112 with haloperidol. Olanzapine-treated patients had significantly higher DAI-10 scores and significantly better treatment compliance compared to both risperidone- and haloperidol-treated patients. Risperidone-treated patients had a significantly higher DAI-10 score compared to haloperidol-treated patients. Conclusion Subjective response and compliance were superior in olanzapine-treated patients, compared to patients treated with risperidone and haloperidol, in routine clinical practice. Differences in subjective response were explained largely, but not completely, by differences in incidence of EPS. PMID:11835695

Prospective, open-label, rater-blinded and self-controlled pilot study of the treatment of proliferating superficial infantile hemangiomas with 0.5% topical timolol cream versus 595-nm pulsed dye laser.

PubMed

Ying, Hanru; Zou, Yun; Yu, Wenxin; Qiu, Yajing; Ma, Gang; Chang, Lei; Gu, Yifei; Lyu, Dongze; Lin, Xiaoxi

2017-06-01

Topical timolol and 595-nm pulsed dye laser (PDL) are both widely used in the treatment of superficial infantile hemangiomas (IH). However, to date, there is no reliable study comparing the therapeutic outcomes between the two treatment options. We designed the present study to evaluate and compare the efficacy and safety of timolol cream and PDL in the treatment of superficial proliferating IH. Twenty-one patients with superficial IH were included in the study. Each lesion was divided into two regions; one part was treated with 0.5% topical timolol cream four times daily, and the other part was treated monthly with PDL. Both treatments were continued for 2-6 months. Five independent and blinded assessors were asked to judge the results in both the topical timolol-treated and PDL-treated parts by comparing photographs taken before and after treatment. Both treatments resulted in significant clinical improvements after 3.39 sessions in the 2-month follow up. The average visual evaluation showed that PDL had significantly better results than topical timolol (6.55 ± 2.26 to 4.98 ± 2.92, P < 0.01). No patients experienced permanent side-effects during the treatment. Our short-term study revealed that PDL had better results compared with topical timolol cream application in the treatment of superficial proliferating IH. Further studies with longer follow-up time and larger sample size are required to validate our findings. © 2017 Japanese Dermatological Association.

Causal Inference and the Comparative Interrupted Time Series Design: Findings from Within-Study Comparisons

ERIC Educational Resources Information Center

St. Clair, Travis; Hallberg, Kelly; Cook, Thomas D.

2014-01-01

Researchers are increasingly using comparative interrupted time series (CITS) designs to estimate the effects of programs and policies when randomized controlled trials are not feasible. In a simple interrupted time series design, researchers compare the pre-treatment values of a treatment group time series to post-treatment values in order to…

Laser treatment of infantile hemangioma: A systematic review.

PubMed

Chinnadurai, Sivakumar; Sathe, Nila A; Surawicz, Tanya

2016-03-01

To systematically review studies of laser treatment of infantile hemangioma (IH). We searched multiple databases including MEDLINE® and EMBASE from 1982 to June 2015. Two investigators independently screened studies against predetermined criteria and extracted key data. Investigators independently assessed study risk of bias and the strength of the evidence of the body of literature. We identified 29 studies addressing lasers: 4 randomized controlled trials, 8 retrospective cohort studies, and 17 case series. Lasers varied across studies in type, pulse width, or cooling materials. Most comparative studies (n = 9) assessed variations of pulsed dye laser (PDL) and examined heterogeneous endpoints. Most studies reported on treatment of cutaneous lesions. Overall, longer pulse PDL with epidermal cooling was the most commonly used laser for cutaneous lesions; Nd:YAG was the most commonly used intralesionally. Most studies reported a higher success rate with longer pulse PDL compared with observation in managing the size of IH, although the magnitude of effect differed substantially. CO2 laser was used for subglottic IH in a single study, and was noted to have a higher success rate and lower complication rate than both Nd:YAG and observation. Studies comparing laser with β-blockers or in combination with β-blockers reported greater improvements in lesion size in combination arms versus β-blockers alone and greater effects of lasers on mixed superficial and deep IH. Strength of the evidence for outcomes after laser treatments ranged from insufficient to low for effectiveness outcomes. Strength of the evidence was insufficient for the effects of laser compared with β-blockers or in combination with β-blockers as studies evaluated different agents and laser types. Studies assessing outcomes after CO2 and Nd:YAG lasers typically reported some resolution of lesion size, but heterogeneity among studies limits our abilities to draw conclusions. Studies of laser treatment of IH primarily addressed different laser modalities compared with observation or other laser modalities. PDL was the most commonly studied laser type, but multiple variations in treatment protocols did not allow for demonstration of superiority of a single method. Most studies reported a higher success rate with longer pulse PDL compared to observation in managing the size of IH, although the magnitude of effect differed substantially. Studies generally found PDL more effective than other types of lasers for cutaneous lesions. When first introduced as a primary treatment for IH, various laser modalities generally offered superior outcomes compared with steroid therapy and observation. In the era of β-blocker therapy, laser treatment may retain an important role in the treatment of residual and refractory lesions. © 2015 Wiley Periodicals, Inc.

Challenges of hepatitis C treatment in Native Americans in two North Dakota medical facilities.

PubMed

Hossain, S; Jalil, S; Guerrero, D M; Sahmoun, A E

2014-01-01

The prevalence of chronic liver disease (CLD) in the Aboriginal North American population is disproportionately higher than that of the non-indigenous population. Hepatitis C virus (HCV) is the second leading cause of CLD in American Indians or Alaska Natives (AIANs). This study described the experience of two teaching community medical centers in North Dakota in treating HCV infection among AIANs and compared treatment outcomes to a cohort of Caucasian patients. The retrospective study described the characteristics and proportion of AIAN patients with HCV who received treatment. Documented reasons for not receiving treatment were analyzed. For those AIAN patients treated for HCV infection, responses to treatment, including rapid, early and sustained virological responses (SVRs), were compared with those of Caucasians. Only 22 (18%) of 124 AIANs with HCV infection received treatment. Common reasons for not receiving treatment include lack of access to specialists, concomitant or decompensated liver disease, alcohol and drug abuse and cost. There were no significant differences in the baseline characteristics and key predictors of SVR in AIANs compared to Caucasian controls. Most AIAN patients with HCV infection do not receive treatment despite comparable treatment response rates to Caucasians. Further population-based studies, addressing access to specialized hepatitis C treatment and public health concerns are warranted, as it is crucial to treat chronic HCV infection to decrease the burden of disease in the AIAN community.

Managing attention deficit hyperactivity disorder in adults using illicit psychostimulants: A systematic review.

PubMed

Cook, Jon; Lloyd-Jones, Martyn; Arunogiri, Shalini; Ogden, Edward; Bonomo, Yvonne

2017-09-01

Attention deficit hyperactivity disorder and stimulant use disorder commonly co-exist, and appropriate treatments have not been well established. To provide guidance for treatment of co-existing attention deficit hyperactivity disorder and stimulant use disorder. A systematic review of published English articles using MEDLINE, EMBASE, CINAHL, PsycINFO and Cochrane, utilising consistent search terms. Randomised controlled trials, comparing any treatment arm with a control group, for participants meeting Diagnostic and Statistical Manual of Mental Disorders or equivalent criteria for both attention deficit hyperactivity disorder and stimulant use disorder. Eight trials were identified for inclusion in this review. Four of eight studies showed improvement in attention deficit hyperactivity disorder outcome measures compared with placebo. Two of six studies that reported substance use outcomes showed improvement in treatment arms compared with placebo. Studies to show effect tended to be those with the highest treatment dosage. Evidence for the efficacy of treatment of patients with comorbid stimulant use disorder and attention deficit hyperactivity disorder is limited. Promising outcomes need replication in further studies utilising higher treatment dosage.

Surgical versus injection treatment for injection-confirmed chronic sacroiliac joint pain

PubMed Central

Spiker, William Ryan; Lawrence, Brandon D.; Raich, Annie L.; Skelly, Andrea C.; Brodke, Darrel S.

2012-01-01

Study design: Systematic review. Study rationale: Chronic sacroiliac joint pain (CSJP) is a common clinical entity with highly controversial treatment options. A recent systematic review compared surgery with denervation, but the current systematic review compares outcomes of surgical intervention with therapeutic injection for the treatment of CSJP and serves as the next step for evaluating current evidence on the comparative effectiveness of treatments for non-traumatic sacroiliac joint pain. Objective or clinical question: In adult patients with injection-confirmed CSJP, does surgical treatment lead to better outcomes and fewer complications than injection therapy? Methods: A systematic review of the English-language literature was undertaken for articles published between 1970 and June 2012. Electronic databases and reference lists of key articles were searched to identify studies evaluating surgery or injection treatment for injection-confirmed CSJP. Studies involving traumatic onset or non-injection–confirmed CSJP were excluded. Two independent reviewers assessed the level of evidence quality using the grading of recommendations assessment, development and evaluation (GRADE) system, and disagreements were resolved by consensus. Results: We identified twelve articles (seven surgical and five injection treatment) meeting our inclusion criteria. Regardless of the type of treatment, most studies reported over 40% improvement in pain as measured by Visual Analog Scale or Numeric rating Scale score. Regardless of the type of treatment, most studies reported over 20% improvement in functionality. Most complications were reported in the surgical studies. Conclusion: Surgical fusion and therapeutic injections can likely provide pain relief, improve quality of life, and improve work status. The comparative effectiveness of these interventions cannot be evaluated with the current literature. PMID:23526911

A pilot comparative study of topical latanoprost and tacrolimus in combination with narrow-band ultraviolet B phototherapy and microneedling for the treatment of nonsegmental vitiligo.

PubMed

Korobko, Igor V; Lomonosov, Konstantin M

2016-11-01

Prostaglandins and their analogues are beneficial as topical agents in vitiligo treatment, yet neither of the previous study addressed their comparative efficiency with conventional topical agents used in vitiligo treatment. In this pilot (24 patients) left-right comparative study we addressed efficiency of prostaglandin F2α analogue latanoprost versus tacrolimus when combined with narrow-band ultraviolet B and microneedling in repigmentation of nonsegmental vitiligo lesions. Our results confirm potency of prostaglandins, in particular, that of latanoprost, in inducing repigmentation, with the efficiency being at least comparable to that of tacrolimus, while contribution of microneedling remains unclear. In summary, results of our study provide further evidences for justified use of prostaglandins, in particular, latanoprost, in vitiligo treatment. In turn, this warrants future studies on the topic aiming to conclusively introduce prostaglandin-based formulations as conventional agents for vitiligo management. © 2016 Wiley Periodicals, Inc.

Meta-analysis of Dropout in Treatments for Post-traumatic Stress Disorder

PubMed Central

Imel, Zac E.; Laska, Kevin; Jakcupcak, Matthew; Simpson, Tracy L.

2013-01-01

Objective Many patients dropout of treatments for Post-traumatic stress disorder (PTSD) and some clinicians believe that ‘trauma focused’ treatments increase dropout. Method We conducted a meta-analysis of dropout among active treatments in clinical trials for PTSD (42 studies; 17 direct comparisons). Results The average dropout rate was 18%, but it varied significantly across studies. Group modality and greater number of sessions, but not trauma focus, predicted increased dropout. When the meta-analysis was restricted to direct comparisons of active treatments, there were no differences in dropout. Differences in trauma focus between treatments in the same study did not predict dropout. However, trauma focused treatments resulted in higher dropout as compared to Present Centered Therapy (PCT) – a treatment originally designed as a control, but now listed as a research supported intervention for PTSD. Conclusion Dropout varies between active interventions for PTSD across studies, but differences are primarily driven by differences between studies. There do not appear to be systematic differences across active interventions when they are directly compared in the same study. The degree of clinical attention placed on the traumatic event does not appear to be a primary cause of dropout from active treatments. However comparisons of PCT may be an exception to this general pattern, perhaps due to a restriction of variability in trauma focus among comparisons of active treatments. More research is needed comparing trauma focused interventions to trauma avoidant treatments such as PCT. PMID:23339535

Telerehabilitation in poststroke anomia.

PubMed

Agostini, Michela; Garzon, Martina; Benavides-Varela, Silvia; De Pellegrin, Serena; Bencini, Giulia; Rossi, Giulia; Rosadoni, Sara; Mancuso, Mauro; Turolla, Andrea; Meneghello, Francesca; Tonin, Paolo

2014-01-01

Anomia, a word-finding difficulty, is a frequent consequence of poststroke linguistic disturbance, associated with fluent and nonfluent aphasia that needs long-term specific and intensive speech rehabilitation. The present study explored the feasibility of telerehabilitation as compared to a conventional face-to-face treatment of naming, in patients with poststroke anomia. Five aphasic chronic patients participated in this study characterized by: strictly controlled crossover design; well-balanced lists of words in picture-naming tasks where progressive phonological cues were provided; same kind of the treatment in the two ways of administration. ANOVA was used to compare naming accuracy in the two types of treatment, at three time points: baseline, after treatment, and followup. The results revealed no main effect of treatment type (P = 0.844) indicating that face-to-face and tele-treatment yielded comparable results. Moreover, there was a significant main effect of time (P = 0.0004) due to a better performance immediately after treatment and in the followup when comparing them to baseline. These preliminary results show the feasibility of teletreatment applied to lexical deficits in chronic stroke patients, extending previous work on telerehabilitation and opening new vistas for future studies on teletreatment of language functions.

Mindfulness Training and Stress Reactivity in Substance Abuse: Results from A Randomized, Controlled Stage I Pilot Study

PubMed Central

Brewer, Judson A.; Sinha, Rajita; Chen, Justin A.; Michalsen, Ravenna N.; Babuscio, Theresa A.; Nich, Charla; Grier, Aleesha; Bergquist, Keri L.; Reis, Deidre L.; Potenza, Marc N.; Carroll, Kathleen M.; Rounsaville, Bruce J.

2011-01-01

Background Stress is important in substance use disorders (SUDs). Mindfulness training (MT) has shown promise for stress-related maladies. No studies have compared MT to empirically-validated treatments for SUDs. Goals to assess MT compared to cognitive behavioral therapy (CBT) in substance use and treatment acceptability, and specificity of MT compared to CBT in targeting stress reactivity. Methods 36 individuals with alcohol and/or cocaine use disorders were randomly assigned to receive group MT or CBT in an outpatient setting. Drug use was assessed weekly. After treatment, responses to personalized stress provocation were measured. Results Fourteen individuals completed treatment. There were no differences in treatment satisfaction, or drug use between groups. The laboratory paradigm suggested reduced psychological and physiological indices of stress during provocation in MT compared to CBT. Conclusions This pilot study provides evidence of the feasibility of MT in treating SUDs and suggests that MT may be efficacious in targeting stress. PMID:19904666

Endoscopic treatments for Barrett's esophagus: a systematic review of safety and effectiveness compared to esophagectomy

PubMed Central

2010-01-01

Background Recently, several new endoscopic treatments have been used to treat patients with Barrett's esophagus with high grade dysplasia. This systematic review aimed to determine the safety and effectiveness of these treatments compared with esophagectomy. Methods A comprehensive literature search was undertaken to identify studies of endoscopic treatments for Barrett's esophagus or early stage esophageal cancer. Information from the selected studies was extracted by two independent reviewers. Study quality was assessed and information was tabulated to identify trends or patterns. Results were pooled across studies for each outcome. Safety (occurrence of adverse events) and effectiveness (complete eradication of dysplasia) were compared across different treatments. Results The 101 studies that met the selection criteria included 8 endoscopic techniques and esophagectomy; only 12 were comparative studies. The quality of evidence was generally low. Methods and outcomes were inconsistently reported. Protocols, outcomes measured, follow-up times and numbers of treatment sessions varied, making it difficult to calculate pooled estimates. The surgical mortality rate was 1.2%, compared to 0.04% in 2831 patients treated endoscopically (1 death). Adverse events were more severe and frequent with esophagectomy, and included anastomotic leaks (9.4%), wound infections (4.1%) and pulmonary complications (4.1%). Four patients (0.1%) treated endoscopically experienced bleeding requiring transfusions. The stricture rate with esophagectomy (5.3%) was lower than with porfimer sodium photodynamic therapy (18.5%), but higher than aminolevulinic acid (ALA) 60 mg/kg PDT (1.4%). Dysphagia and odynophagia varied in frequency across modalities, with the highest rates reported for multipolar electrocoagulation (MPEC). Photosensitivity, an adverse event that occurs only with photodynamic therapy, was experienced by 26.4% of patients who received porfimer sodium. Some radiofrequency ablation (RFA) or argon plasma coagulation (APC) studies (used in multiple sessions) reported rates of almost 100% for complete eradication of dysplasia. But the study methods and findings were not adequately described. The other studies of endoscopic treatments reported similarly high rates of complete eradication. Conclusions Endoscopic treatments offer safe and effective alternatives to esophagectomy for patients with Barrett's esophagus and high grade dysplasia. Unfortunately, shortcomings in the published studies make it impossible to determine the comparative effectiveness of each of the endoscopic treatments. PMID:20875123

Cultured allogeneic keratinocyte sheets accelerate healing compared to Op-site treatment of donor sites in burns.

PubMed

Duinslaeger, L A; Verbeken, G; Vanhalle, S; Vanderkelen, A

1997-01-01

Donor site treatment is a crucial issue in the treatment of extensive burns. In this single-blind, randomized study treatment of donor sites with a polyurethane dressing, Op-Site (Smith & Nephew, York, U.K.) is compared to treatment with allogeneic cultured keratinocyte sheets. Results show a mean healing time of 6.7 days with use of cultured keratinocyte sheets compared to mean healing time of 13.6 days with Op-Site treatment. Also, improvement in the comfort of patients as the result of less exudate formation and pain attenuation was noted.

Risk of pneumonia with budesonide-containing treatments in COPD: an individual patient-level pooled analysis of interventional studies

PubMed Central

Hollis, Sally; Jorup, Carin; Lythgoe, Dan; Martensson, Gunnar; Regnell, Pontus; Eckerwall, Göran

2017-01-01

Background Concerns have been raised that treatment of COPD with inhaled corticosteroids may increase pneumonia risk. Responding to a request from the European Medicines Agency Pharmacovigilance Risk Assessment Committee, a pooled analysis of interventional studies compared pneumonia risk with inhaled budesonide-containing versus non-budesonide-containing treatments and the impact of other clinically relevant factors. Methods AstraZeneca-sponsored, parallel-group, double-blind, randomized controlled trials meeting the following criteria were included: >8 weeks’ duration; ≥60 patients with COPD; inhaled budesonide treatment arm (budesonide/formoterol or budesonide); and non-budesonide-containing comparator arm (formoterol or placebo). Primary and secondary outcomes were time to first pneumonia treatment-emergent serious adverse event (TESAE) and treatment-emergent adverse event (TEAEs), respectively, analyzed using Cox regression models stratified by study. Results Eleven studies were identified; 10,570 out of 10,574 randomized patients receiving ≥1 dose of study treatment were included for safety analysis (budesonide-containing, n=5,750; non-budesonide-containing, n=4,820). Maximum exposure to treatment was 48 months. The overall pooled hazard ratio (HR), comparing budesonide versus non-budesonide-containing treatments, was 1.15 for pneumonia TESAEs (95% confidence interval [CI]: 0.83, 1.57) and 1.13 for pneumonia TEAEs (95% CI: 0.94, 1.36). The annual incidence of pneumonia TESAEs was 1.9% and 1.5% for budesonide-containing and non-budesonide-containing treatments, respectively. Comparing budesonide/formoterol with non-budesonide-containing treatment, the HRs for pneumonia TESAEs and TEAEs were 1.00 (95% CI: 0.69, 1.44) and 1.21 (95% CI: 0.93, 1.57), respectively. For budesonide versus placebo, HRs were 1.57 for pneumonia TESAEs (95% CI: 0.90, 2.74) and 1.07 for pneumonia TEAEs (95% CI: 0.83, 1.38). Conclusion This pooled analysis found no statistically significant increase in overall risk for pneumonia TESAEs or TEAEs with budesonide-containing versus non-budesonide-containing treatments. However, a small increase in risk with budesonide-containing treatment cannot be ruled out; there is considerable heterogeneity in study designs and patient characteristics, particularly in the early budesonide studies, and each study contributes <40 pneumonia TESAEs. PMID:28435240

Risk of pneumonia with budesonide-containing treatments in COPD: an individual patient-level pooled analysis of interventional studies.

PubMed

Hollis, Sally; Jorup, Carin; Lythgoe, Dan; Martensson, Gunnar; Regnell, Pontus; Eckerwall, Göran

2017-01-01

Concerns have been raised that treatment of COPD with inhaled corticosteroids may increase pneumonia risk. Responding to a request from the European Medicines Agency Pharmacovigilance Risk Assessment Committee, a pooled analysis of interventional studies compared pneumonia risk with inhaled budesonide-containing versus non-budesonide-containing treatments and the impact of other clinically relevant factors. AstraZeneca-sponsored, parallel-group, double-blind, randomized controlled trials meeting the following criteria were included: >8 weeks' duration; ≥60 patients with COPD; inhaled budesonide treatment arm (budesonide/formoterol or budesonide); and non-budesonide-containing comparator arm (formoterol or placebo). Primary and secondary outcomes were time to first pneumonia treatment-emergent serious adverse event (TESAE) and treatment-emergent adverse event (TEAEs), respectively, analyzed using Cox regression models stratified by study. Eleven studies were identified; 10,570 out of 10,574 randomized patients receiving ≥1 dose of study treatment were included for safety analysis (budesonide-containing, n=5,750; non-budesonide-containing, n=4,820). Maximum exposure to treatment was 48 months. The overall pooled hazard ratio (HR), comparing budesonide versus non-budesonide-containing treatments, was 1.15 for pneumonia TESAEs (95% confidence interval [CI]: 0.83, 1.57) and 1.13 for pneumonia TEAEs (95% CI: 0.94, 1.36). The annual incidence of pneumonia TESAEs was 1.9% and 1.5% for budesonide-containing and non-budesonide-containing treatments, respectively. Comparing budesonide/formoterol with non-budesonide-containing treatment, the HRs for pneumonia TESAEs and TEAEs were 1.00 (95% CI: 0.69, 1.44) and 1.21 (95% CI: 0.93, 1.57), respectively. For budesonide versus placebo, HRs were 1.57 for pneumonia TESAEs (95% CI: 0.90, 2.74) and 1.07 for pneumonia TEAEs (95% CI: 0.83, 1.38). This pooled analysis found no statistically significant increase in overall risk for pneumonia TESAEs or TEAEs with budesonide-containing versus non-budesonide-containing treatments. However, a small increase in risk with budesonide-containing treatment cannot be ruled out; there is considerable heterogeneity in study designs and patient characteristics, particularly in the early budesonide studies, and each study contributes <40 pneumonia TESAEs.

A Systematic Review of the Effectiveness of Psychological Treatments for IBS in Gastroenterology Settings: Promising but in Need of Further Study.

PubMed

Thakur, Elyse R; Shapiro, Jordan; Chan, Johanna; Lumley, Mark A; Cully, Jeffrey A; Bradford, Andrea; El-Serag, Hashem B

2018-05-10

Psychological treatments are efficacious for irritable bowel syndrome (IBS) in clinical trials; however, their effectiveness when conducted in gastroenterology practice settings is unclear. To perform a systematic review of the types and effects of psychological treatments for IBS conducted in gastroenterology clinics. We searched PubMed, EMBASE, and Cochrane central register. Studies conducted in gastroenterology clinic settings with IBS patients who were clinically referred from gastroenterology were included. We identified 3078 citations, of which only eight studies were eligible. Seven studies compared psychological treatments (average n = 25.7; range 12-43) to controls (average n = 25.4 patients; range 12-47), whereas one study compared two active "bonafide" interventions. Psychological treatments varied (cognitive-behavioral therapy, guided affective imagery, mindfulness, hypnosis, biofeedback, emotional awareness training). However, across approaches, short-term benefits were seen. IBS symptoms improved significantly among patients in cognitive and behavioral therapies, mindfulness-based stress reduction, guided affective imagery, and emotional awareness training compared with controls; there was a similar trend for gut-directed hypnotherapy. Similarly, IBS symptoms improved in a study of two active biofeedback and hypnosis treatments. Evidence for the effectiveness of psychological treatment in gastroenterology practice is promising but limited. Study designs that involve a blending of efficacy and effectiveness components are needed.

Cyclosporine and ketoconazole for the treatment of perianal fistulas in dogs.

PubMed

Patricelli, Alison J; Hardie, Robert J; McAnulty, Jonathan E

2002-04-01

To evaluate efficacy and cost of using cyclosporine and ketoconazole for the treatment of perianal fistulas in dogs. Clinical trial. 12 dogs with perianal fistulas. Dogs received cyclosporine and ketoconazole orally (target whole blood trough cyclosporine concentrations of 400 to 600 ng/ml). Study endpoints were resolution of clinical signs, remission, and recurrence of disease. Adverse effects and cost of medications were reported. Results were compared with those from previous studies in humans and in dogs in which single agent cyclosporine treatment for perianal fistulas was used. All dogs had resolution of clinical signs. Eight dogs went into remission; however, 5 of those 8 had recurrence of fistulas. Adverse effects of treatment were minimal and well tolerated. Cost of treatment was comparable to traditional surgical options and less than single agent cyclosporine treatment. Administration of cyclosporine with ketoconazole is an effective and cost-comparable treatment for perianal fistulas in dogs.

Assessing treatment effects in older breast cancer patients: systematic review of observational research methods.

PubMed

de Glas, N A; Kiderlen, M; de Craen, A J M; Hamaker, M E; Portielje, J E A; van de Velde, C J H; Liefers, G J; Bastiaannet, E

2015-03-01

Solid evidence of treatment effects in older women with breast cancer is lacking, as they are generally underrepresented in randomized clinical trials on which guideline recommendations are based. An alternative way to study treatment effects in older patients could be to use data from observational studies. However, using appropriate methods in analyzing observational data is a key condition in order to draw valid conclusions, as directly comparing treatments generally results in biased estimates due to confounding by indication. The aim of this systematic review was to investigate the methods that have been used in observational studies that assessed the effects of breast cancer treatment on survival, breast cancer survival and recurrence in older patients (aged 65 years and older). Studies were identified through systematic review of the literature published between January 1st 2009 and December 13th 2013 in the PubMed database and EMBASe. Finally, 31 studies fulfilled the inclusion criteria. Of these, 22 studies directly compared two treatments. Fifteen out of these 22 studies addressed the problem of confounding by indication, while seven studies did not. Nine studies used some form of instrumental variable analysis. In conclusion, the vast majority of observational studies that investigate treatment effects in older breast cancer patients compared treatments directly. These studies are therefore likely to be biased. Observational research will be essential to improve treatment and outcome of older breast cancer patients, but the use of accurate methods is essential to draw valid conclusions from this type of data. Copyright © 2015 Elsevier Ltd. All rights reserved.

Azelaic acid in the treatment of papulopustular rosacea: a systematic review of randomized controlled trials.

PubMed

Liu, Rosemarie H; Smith, Molly K; Basta, Sameh A; Farmer, Evan R

2006-08-01

To evaluate the clinical efficacy of topical 20% azelaic acid cream and 15% azelaic acid gel compared with their respective vehicles and metronidazole gel in the treatment of papulopustular rosacea. Electronic searches of MEDLINE, EMBASE, BIOSIS, and SciSearch through July or August 2004 and the Cochrane Central Register of Controlled Trials through 2004 (issue 3). We performed hand searches of reference lists, conference proceedings, and clinical trial databases. Experts in rosacea and azelaic acid were contacted. Randomized controlled trials involving topical azelaic acid (cream or gel) for the treatment of rosacea compared with placebo or other topical treatments. Two authors independently examined the studies identified by the searches. Ten studies were identified, of which 5 were included (873 patients). Two authors independently extracted data from the included studies, then jointly assessed methodological quality using a quality assessment scale. Because standard deviation data were not available for 4 of the 5 studies, a meta-analysis could not be conducted. Four of the 5 studies demonstrated significant decreases in mean inflammatory lesion count and erythema severity after treatment with azelaic acid compared with vehicle. None of the studies showed any significant decrease in telangiectasia severity. Azelaic acid in 20% cream and 15% gel formulations appears to be effective in the treatment of papulopustular rosacea, particularly in regard to decreases in mean inflammatory lesion count and erythema severity. Compared with metronidazole, azelaic acid appears to be an equally effective, if not better, treatment option.

Design of the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study (NC ProCESS).

PubMed

Chen, Ronald C; Carpenter, William R; Kim, Mimi; Hendrix, Laura H; Agans, Robert P; Meyer, Anne-Marie; Hoffmeyer, Anna; Reeve, Bryce B; Nielsen, Matthew E; Usinger, Deborah S; Strigo, Tara S; Jackman, Anne M; Anderson, Mary; Godley, Paul A

2015-01-01

The North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS) was designed in collaboration with stakeholders to compare the effectiveness of different treatment options for localized prostate cancer. Using the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry, 1,419 patients (57% of eligible) with newly-diagnosed localized prostate cancer were enrolled from January 2011 to June 2013, on average 5 weeks after diagnosis. All participants were enrolled prior to treatment and this population-based cohort is sociodemographically diverse. Prospective follow-up continues to collect data on treatments received, disease control, survival and patient-reported outcomes. This study highlights several important considerations regarding stakeholder involvement, study design and generalizability regarding comparative effectiveness research in prostate cancer.

Bibliotherapy Treatment for Children with Adjustment Difficulties: A Comparison of Affective and Cognitive Bibliotherapy

ERIC Educational Resources Information Center

Betzalel, Nurit; Shechtman, Zipora

2010-01-01

This study compared outcomes following cognitive and affective bibliotherapy treatment with 79 children and adolescents in a residential home in Israel. Treatment children were compared to a control-no treatment group from the same home. Anxiety was measured through a self-report measure (Revised Children's Manifest Anxiety Scale; Reynolds &…

A comparative study of symptoms and quality of life among patients with breast cancer receiving target, chemotherapy, or combined therapy.

PubMed

Huang, Sheng-Miauh; Tai, Chen-Jei; Lin, Kuan-Chia; Tai, Cheng-Jeng; Tseng, Ling-Ming; Chien, Li-Yin

2013-01-01

Studies have rarely compared health outcomes for patients with breast cancer at different treatment stages. The purpose of the study was to compare symptoms and quality of life among patients with breast carcinoma receiving target, chemotherapy, or combined therapy. A longitudinal study was carried out with 57 patients receiving chemotherapy, 30 receiving target therapy, and 34 receiving combined therapy. Data were collected before the start of treatment, at 4 weeks, and at 12 weeks following the start of treatment. Symptom severity and interference were assessed by the M. D. Anderson Symptom Inventory. The physical and mental components of quality of life (physical component score [PCS] and mental component score [MCS]) were assessed using SF-36. There were no significant differences in symptom severity and interference for patients in the 3 therapy groups. The PCSs did not differ significantly according to the therapy group but did decrease significantly after each treatment. Patients receiving target therapy had significantly higher MCSs than did patients receiving chemotherapy, but the MCSs did not differ significantly before and after the treatment. Patients with higher symptom severity and interference had worse PCS and MCS. Patients at all treatment groups had worse physical components quality of life after treatment as compared with before treatment. Patients receiving target therapy had better mental components of quality of life. The mental components of quality of life remained stable during treatment. Nurses should assess the patients' symptoms during treatment and provide timely intervention to optimize their quality of life.

Informing hot flash treatment decisions for breast cancer survivors: a systematic review of randomized trials comparing active interventions.

PubMed

Johns, Claire; Seav, Susan M; Dominick, Sally A; Gorman, Jessica R; Li, Hongying; Natarajan, Loki; Mao, Jun James; Irene Su, H

2016-04-01

Patient-centered decision making about hot flash treatments often incorporates a balance of efficacy and side effects in addition to patient preference. This systematic review examines randomized controlled trials (RCTs) comparing at least two non-hormonal hot flash treatments in breast cancer survivors. In July 2015, PubMed, SCOPUS, CINAHL, Cochrane, and Web of Science databases were searched for RCTs comparing active, non-hormonal hot flash treatments in female breast cancer survivors. Thirteen trials were included after identifying 906 potential studies. Four trials were dose comparison studies of pharmacologic treatments citalopram, venlafaxine, gabapentin, and paroxetine. Hot flash reduction did not differ by tamoxifen or aromatase inhibitor use. Citalopram 10, 20, and 30 mg daily had comparable outcomes. Venlafaxine 75 mg daily improved hot flashes without additional side effects from higher dosing. Gabapentin 900 mg daily improved hot flashes more than 300 mg. Paroxetine 10 mg daily had fewer side effects than 20 mg. Among four trials comparing different pharmacologic treatments, venlafaxine alleviated hot flash symptoms faster than clonidine; participants preferred venlafaxine over gabapentin. Five trials compared pharmacologic to non-pharmacologic treatments. Acupuncture had similar efficacy to venlafaxine and gabapentin but may have longer durability after completing treatment and fewer side effects. We could not perform a pooled meta-analysis because outcomes were not reported in comparable formats. Clinical trial data on non-hormonal hot flash treatments provide comparisons of hot flash efficacy and other patient important outcomes to guide clinical management. Clinicians can use the information to help patients select hot flash interventions.

Prospective cohort studies of newly marketed medications: using covariate data to inform the design of large-scale studies.

PubMed

Franklin, Jessica M; Rassen, Jeremy A; Bartels, Dorothee B; Schneeweiss, Sebastian

2014-01-01

Nonrandomized safety and effectiveness studies are often initiated immediately after the approval of a new medication, but patients prescribed the new medication during this period may be substantially different from those receiving an existing comparator treatment. Restricting the study to comparable patients after data have been collected is inefficient in prospective studies with primary collection of outcomes. We discuss design and methods for evaluating covariate data to assess the comparability of treatment groups, identify patient subgroups that are not comparable, and decide when to transition to a large-scale comparative study. We demonstrate methods in an example study comparing Cox-2 inhibitors during their postmarketing period (1999-2005) with nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). Graphical checks of propensity score distributions in each treatment group showed substantial problems with overlap in the initial cohorts. In the first half of 1999, >40% of patients were in the region of nonoverlap on the propensity score, and across the study period this fraction never dropped below 10% (the a priori decision threshold for transitioning to the large-scale study). After restricting to patients with no prior NSAID use, <1% of patients were in the region of nonoverlap, indicating that a large-scale study could be initiated in this subgroup and few patients would need to be trimmed from analysis. A sequential study design that uses pilot data to evaluate treatment selection can guide the efficient design of large-scale outcome studies with primary data collection by focusing on comparable patients.

Chronic Hepatitis C Treatment with Daclatasvir Plus Asunaprevir Does Not Lead to a Decreased Quality of Life.

PubMed

Kawakubo, Megumi; Eguchi, Yuichiro; Okada, Michiaki; Iwane, Shinji; Oeda, Satoshi; Otsuka, Taiga; Nakashita, Syunya; Araki, Norimasa; Koga, Akemi

2018-03-09

Objective The aim of this study was to determine if direct-acting antiviral (DAA) treatment with daclatasvir (DCV) plus asunaprevir (ASV) for 24 weeks influenced the health-related quality of life (HRQOL) at 12 and 24 weeks after treatment initiation (end of treatment [EOT]). Methods This was a prospective, longitudinal study comparing the HRQOL of patients receiving DAA treatment at 12 weeks after treatment initiation and EOT with the HRQOL at baseline. We used a Japanese-validated version of the 8-item Short Form Health Survey (SF-8) to assess the HRQOL of patients. This score can be compared to the Japanese normative sample scores of SF-8. Wilcoxon signed-rank tests were used to compare the HRQOL before treatment, 12 weeks after treatment initiation, and at EOT. Patients We enrolled patients who received 24-week combination therapy using DCV and ASV for HCV at Saga University Hospital between November 2014 and July 2015. Those who discontinued treatment due to relapse or adverse reactions during the treatment period were excluded from the study. Results There were no significant changes in any of the SF-8 subscales, Physical component scores (PCS) or mental component scores (MCS) during the treatment period for both males and females. Conclusion Our study makes a significant contribution to the literature because 24-week DAA treatment with DCV plus ASV did not decrease the HRQOL at 12 or 24 weeks after treatment initiation.

Comparative clinical effectiveness of management strategies for sciatica: systematic review and network meta-analyses.

PubMed

Lewis, Ruth A; Williams, Nefyn H; Sutton, Alex J; Burton, Kim; Din, Nafees Ud; Matar, Hosam E; Hendry, Maggie; Phillips, Ceri J; Nafees, Sadia; Fitzsimmons, Deborah; Rickard, Ian; Wilkinson, Clare

2015-06-01

There are numerous treatment approaches for sciatica. Previous systematic reviews have not compared all these strategies together. To compare the clinical effectiveness of different treatment strategies for sciatica simultaneously. Systematic review and network meta-analysis. We searched 28 electronic databases and online trial registries, along with bibliographies of previous reviews for comparative studies evaluating any intervention to treat sciatica in adults, with outcome data on global effect or pain intensity. Network meta-analysis methods were used to simultaneously compare all treatment strategies and allow indirect comparisons of treatments between studies. The study was funded by the UK National Institute for Health Research Health Technology Assessment program; there are no potential conflict of interests. We identified 122 relevant studies; 90 were randomized controlled trials (RCTs) or quasi-RCTs. Interventions were grouped into 21 treatment strategies. Internal and external validity of included studies was very low. For overall recovery as the outcome, compared with inactive control or conventional care, there was a statistically significant improvement following disc surgery, epidural injections, nonopioid analgesia, manipulation, and acupuncture. Traction, percutaneous discectomy, and exercise therapy were significantly inferior to epidural injections or surgery. For pain as the outcome, epidural injections and biological agents were significantly better than inactive control, but similar findings for disc surgery were not statistically significant. Biological agents were significantly better for pain reduction than bed rest, nonopioids, and opioids. Opioids, education/advice alone, bed rest, and percutaneous discectomy were inferior to most other treatment strategies; although these findings represented large effects, they were statistically equivocal. For the first time, many different treatment strategies for sciatica have been compared in the same systematic review and meta-analysis. This approach has provided new data to assist shared decision-making. The findings support the effectiveness of nonopioid medication, epidural injections, and disc surgery. They also suggest that spinal manipulation, acupuncture, and experimental treatments, such as anti-inflammatory biological agents, may be considered. The findings do not provide support for the effectiveness of opioid analgesia, bed rest, exercise therapy, education/advice (when used alone), percutaneous discectomy, or traction. The issue of how best to estimate the effectiveness of treatment approaches according to their order within a sequential treatment pathway remains an important challenge. Copyright © 2015 Elsevier Inc. All rights reserved.

Under-treatment of elderly patients with ovarian cancer: a population based study.

PubMed

Fourcadier, Elisabeth; Trétarre, Brigitte; Gras-Aygon, Claudine; Ecarnot, Fiona; Daurès, Jean-Pierre; Bessaoud, Faïza

2015-11-26

Ovarian cancer is the fourth most common cancer among women in France, and mainly affects the elderly. The primary objective of this study was to compare treatment of ovarian cancer according to age. All patients with invasive cancer (n=1151) diagnosed between 1997 and 2011 in the Herault Department of southern France were included. Demographic data (age, area of residence), cancer characteristics (stage, histology, grade) and treatment modality (type, period and location of treatment) were analysed. Univariate and multivariate logistic regression was used to compare treatment by age. Ovarian cancer was less treated in elderly compared to younger patients, regardless of the type of treatment. This difference was more pronounced for chemotherapy, and was maximal for surgery followed by chemotherapy (odds ratio (OR) for surgery for patients aged >70 vs those aged <70 years=0.47 [0.24-0.91], OR for chemotherapy, age>70 vs <70=0.30 [0.16-0.55] and OR for surgery plus chemotherapy, age>70 vs <70=0.14 [0.08-0.28]). This effect of age was independent of other variables, including stage and grade. The probability of receiving standard treatment, in accordance with recommendations, was reduced by 50% in elderly patients compared to their younger counterparts. Overall and net survival of elderly patients with standard treatment was similar to those of younger patients treated outside standard treatment. Elderly women with ovarian cancer were therapeutically disadvantaged compared to younger women. Further studies including co morbidities are necessary to refine these results and to improve therapeutic management of elderly patients with ovarian cancer.

Local and systemic innate immunity in broiler chickens supplemented with yeast-derived carbohydrates.

PubMed

Munyaka, P M; Echeverry, H; Yitbarek, A; Camelo-Jaimes, G; Sharif, S; Guenter, W; House, J D; Rodriguez-Lecompte, J C

2012-09-01

A study was conducted to assess the effect of yeast-derived carbohydrates (YDC) on performance and innate immune responses of broiler chickens. In total, 1,080 one-day-old birds were randomly assigned to one of 3 dietary treatments (n = 360): a standard broiler diet containing monensin (control), control + bacitracin methylene disalycylate (BMD), and YDC treatment (control + YDC at 0.02%, 0.01%, and 0.005% for starter, grower, and finisher, respectively). Weekly BW, feed intake (FI), and feed conversion ratio (FCR) were recorded. Immune organ weights, gut morphology, gene expression, heterophil:lymphocyte (H:L), and serum IgG were determined at d 42. No significant difference in FCR, FI, and mortality was observed among treatments. However, BW gain in starter phase was higher in control and YDC treatments compared with BMD treatment. Ileal villi height, crypt depth, and their ratio were not significantly different among treatments, whereas villi width was lower in control and YDC treatments compared with BMD treatment. The number of goblet cells per unit area in the ileum was lower in BMD treatment compared with control and YDC treatments. Expression of TLR2b and IL-6 in the ileum and cecal tonsils was not significantly different among treatments (P > 0.05). Expression of TLR4 was downregulated in YDC treatment compared with control in the ileum. Expression of IL-12p35 and IFN-γ were downregulated in the YDC treatment only in the cecal tonsils. Compared with the control, the expression of IL-10 in both the ileum and the cecal tonsils was downregulated in YDC treatment. Serum IgG and H:L ratio were lower and higher, respectively, in the YDC treatment compared with control and BMD treatments. In conclusion, dietary inclusion of YDC affected intestinal cytokines anti-inflammatory profile on a gut location associated immune pathways manner, suggesting different immune pathways that require further studies in this field.

Behavior in children with Prader-Willi syndrome before and during growth hormone treatment: a randomized controlled trial and 8-year longitudinal study.

PubMed

Lo, Sin T; Siemensma, Elbrich P C; Festen, Dederieke A M; Collin, Philippe J L; Hokken-Koelega, Anita C S

2015-09-01

Information on behavior of children with Prader-Willi syndrome (PWS) and the effect of growth hormone (GH) treatment is scarce. Parents report less problem behavior during GH treatment. Forty-two pre-pubertal children, aged 3.5-14 years were studied in a randomized controlled GH trial (RCT) during 2 years, followed by a longitudinal study during 8 years of GH treatment. Behavior was measured annually by the Developmental Behavior Checklist for children with intellectual disability (DBC) and a Dutch questionnaire to evaluate social behavioral problems in children, the Children's Social Behavior Questionnaire (CSBQ). Problem behavior measured by the DBC in children with PWS was similar compared to peers with comparable intellectual disability. Scores on 'Social disabilities' subscale were however significantly higher compared to the DBC total score (p < 0.01). A lower IQ was associated with more self-absorbed behavior, more communication problems and more problem behavior in general. Problem behavior measured by the CSBQ was similar compared to peers with a comparable intellectual disability, but children with PWS scored significantly higher on the 'Not tuned', 'Understanding', and 'Stereotyped' subscales than the CSBQ total score (p < 0.05 for all subscales and p = 0.001 for the 'Not tuned'-subscale). There were no significant effects of GH treatment during the RCT and 8 years of GH treatment. Children with PWS showed similar problem behavior as a reference population with a comparable intellectual disability. Social problems were the most pronounced within-problem behavior in PWS. In contrast to our expectations and parents reports, our study shows no improvement but also no deterioration of behavioral problems in children with PWS during long-term GH treatment.

Quality of Diagnosis and Treatment Plans After Using the 'Diagnostic Guideline for Anxiety and Challenging Behaviours' in People with Intellectual Disabilities: A Comparative Multiple Case Study Design.

PubMed

Pruijssers, Addy; van Meijel, Berno; Maaskant, Marian; Keeman, Noortje; van Achterberg, Theo

2016-07-01

People with intellectual disabilities often have a multitude of concurrent problems due to the combination of cognitive impairments, psychiatric disorders (particularly anxiety) and related challenging behaviours. Diagnoses in people with intellectual disabilities are complicated. This study evaluates the quality of the diagnoses and treatment plans after using a guideline that was developed to support professionals in their diagnostic tasks. A comparative multiple case study with an experimental and control condition, applying deductive analyses of diagnoses and treatment plans. The analyses revealed that the number of diagnostic statements and planned treatment actions in the experimental group was significantly larger and more differentiated than in the control condition. In the control group, consequential harm and protective factors were hardly mentioned in diagnoses and treatment plans. Working with the 'Diagnostic Guideline for Anxiety and CB' leads to improved diagnoses and treatment plans compared with care as usual. © 2015 John Wiley & Sons Ltd.

Comparing the Effects of Commercially Available and Custom-Made Video Prompting for Teaching Cooking Skills to High School Students with Autism

ERIC Educational Resources Information Center

Mechling, Linda C.; Ayres, Kevin M.; Foster, Ashley L.; Bryant, Kathryn J.

2013-01-01

The study compared the effects of using commercially available and custom-made video prompts on the completion of cooking recipes by four high school age males with a diagnosis of autism. An adapted alternating treatments design with continuous baseline, comparison, final treatment, and best treatment condition was used to compare the two…

Treatment effectiveness and fidelity of manual therapy to the knee: A systematic review and meta-analysis.

PubMed

Salamh, Paul; Cook, Chad; Reiman, Michael P; Sheets, Charles

2017-09-01

Manual therapy (MT) is a commonly used treatment for knee osteoarthritis (OA) but to date only one systematic review has explored its effectiveness. The purpos e of the present study was to perform a systematic review and meta-analysis of the literature, to determine the effectiveness and fidelity of studies using MT techniques in individuals with knee OA. Relevant studies were assessed for inclusion. Effectiveness was measured using effect sizes, and methodological bias and treatment fidelity were both explored. Effect sizes were calculated using standardized mean differences (SMD) based on pooled data depending on statistical and clinical heterogeneity, as well as risk of bias. The search captured 2,969 studies; after screening, 12 were included. Four had a low risk of bias and high treatment fidelity. For self-reported function, comparing MT with no treatment resulted in a large effect size (standardized mean difference [SMD] 0.84), as did adding MT to a comparator treatment (SMD 0.78). A significant difference was found for pain when adding MT to a comparator treatment (SMD 0.73). The findings in the present meta-analytical review support the use of MT versus a number of different comparators for improvement in self-reported knee function. Lesser support is present for pain reduction, and no endorsement of functional performance can be made at this time. Copyright © 2016 John Wiley & Sons, Ltd.

Displaced intra-articular calcaneal fractures.

PubMed

Bajammal, Sohail; Tornetta, Paul; Sanders, David; Bhandari, Mohit

2005-01-01

Calcaneal fractures comprise 1 to 2 percent of all fractures. Approximately 75% of calcaneal fractures are intra-articular. The management of intra-articular calcaneal fractures remains controversial. Nonoperative treatment options include elevation, ice, early mobilization, and cyclic compression of the plantar arch. Operative treatment options include closed reduction and percutaneous pin fixation, open reduction and internal fixation, and arthrodesis. The effect of operative versus nonoperative treatment has been the focus of several comparative studies. This study was designed to determine the effect of operative treatment compared with nonoperative treatment on the rate of union, complications, and functional outcome after intra-articular calcaneal fracture in adults.

Experimental Treatment of Early Stuttering: A Preliminary Study

ERIC Educational Resources Information Center

Franken, Marie-Christine J.; Kielstra-Van der Schalk, Carine J.; Boelens, Harrie

2005-01-01

This pilot study compared two treatments for stuttering in preschool-age children. Thirty children were randomly assigned to either a Lidcombe Program (LP) treatment or a Demands and Capacities Model (DCM) treatment. Stuttering frequencies and severity ratings were obtained immediately before and after treatment (12 weeks). The stuttering…

A comparative study of renal care in Brazil and Mexico: hemodialysis treatment from the perspective of ESRD sufferers.

PubMed

Mercado-Martinez, Francisco J; da Silva, Denise Guerreiro V; Correa-Mauricio, Mauricio E

2017-04-01

Renal replacement therapy is the indicated treatment for individuals with chronic kidney disease (CKD) to survive. However, not all sick people have access to the same treatment. This study compares renal care in two developing countries with different health systems. Specifically, it explores hemodialysis treatment from the perspective of low-income individuals. A qualitative, comparative study was performed in Brazil and Mexico. Using purposive sampling, the research was based on open-ended interviews with nineteen participants with kidney failure undergoing hemodialysis treatment in public hospitals and ten relatives. According to our results, Brazilian participants perceived hemodialysis care as satisfactory because of health personnel courtesy as well as free access to dialysis treatment, prescription drugs, hospitalization and transportation. However, they reported deficiencies in the care they were receiving due to shortages of specialists, prescription drugs, laboratory tests and transportation. Mexican participants, in contrast, highlighted the catastrophic costs of medical care because they had no free access to renal therapy, nor adequate financial resources. Our findings suggest that low-income Brazilian CKD sufferers experience renal care differently, as they are more satisfied and face less obstacles with hemodialysis compared with those of Mexico. More studies on the topic are needed. © 2016 John Wiley & Sons Ltd.

Adjuvant therapy with carboplatin and pamidronate for canine appendicular osteosarcoma.

PubMed

Kozicki, A R; Robat, C; Chun, R; Kurzman, I D

2015-09-01

Amputation and chemotherapy are the mainstay of treatment for canine appendicular osteosarcoma (OSA). In vitro studies have demonstrated anti-tumour activity of pamidronate against canine OSA. The purpose of this study was to assess the safety of adding pamidronate to standard post-operative carboplatin chemotherapy in 17 dogs with appendicular OSA treated with limb amputation. Median disease-free interval (DFI) and median survival time (MST) were evaluated as secondary endpoints. Incidence of side effects and treatment outcomes were compared to 14 contemporary control patients treated with carboplatin alone. There were no identified side effects to the pamidronate treatment. The median DFI for the study group was 185 days compared to 172 days for the control group (P = 0.90). The MST of the study group was 311 days compared to 294 days for the control group (P = 0.89). Addition of pamidronate to carboplatin chemotherapy for the treatment of canine appendicular OSA is safe and does not impair efficacy of standard carboplatin treatment. © 2013 Blackwell Publishing Ltd.

Clinical Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A Pragmatic Trial of Complex Treatment for a Complex Disorder

PubMed Central

Nierenberg, Andrew A.; Sylvia, Louisa G.; Leon, Andrew C.; Reilly-Harrington, Noreen; Shesler, Leah W.; McElroy, Susan L.; Friedman, Edward S.; Thase, Michael E.; Shelton, Richard C.; Bowden, Charles; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence; Kocsis, James; McInnis, Melvin G.; Schoenfeld, David; Bobo, William V.; Calabrese, Joseph R.

2015-01-01

Background Classic and second generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the “real-world” advantages and disadvantages of these medications Purpose We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This paper outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Methods Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments. The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool. Results The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus adjunctive personalized treatment (APT), across ten sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. 482 participants were randomized to the study and 364 completed. Limitations The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants’ ability to pay for study medications. Conclusion We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second generation antipsychotic with broad-spectrum activity in bipolar disorder and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial. PMID:24346608

Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison.

PubMed

Cameron, Chris; Zummo, Jacqueline; Desai, Dharmik N; Drake, Christine; Hutton, Brian; Kotb, Ahmed; Weiden, Peter J

Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic recently approved for treatment of schizophrenia on the basis of a large-scale trial of two doses of AL versus placebo. There are no direct-comparison studies with paliperidone palmitate (PP; long-acting antipsychotic used most often in acute settings) for the acute psychotic episode. To indirectly compare efficacy and safety of the pivotal AL study with all PP studies meeting indirect comparison criteria. Systematic searches of MEDLINE, Embase, Cochrane CENTRAL, PsycINFO, ClinicalTrials.gov, International Clinical Trials Registry Platform, and gray literature were performed to identify randomized controlled trials of PP with similar designs to the AL trial. Bayesian network meta-analysis compared treatments with respect to symptom response and tolerability issues including weight gain, akathisia, parkinsonism, and likelihood of treatment-emergent adverse events. Three appropriate PP studies were identified for indirect comparison. Both doses of AL (441 mg and 882 mg monthly) were used and compared with two efficacious doses of PP (156 mg and 234 mg monthly). All four active-treatment conditions were associated with comparable reductions in acute symptoms (Positive and Negative Syndrome Scale) versus placebo and were of similar magnitude (range of mean difference -8.12 to -12.01, with overlapping 95% credible intervals). Between-group comparisons of active-treatment arms were associated with summary estimates of magnitude near 0. No clinically meaningful differences in selected safety or tolerability parameter incidence were found between active treatments. These results suggest that both AL and PP are effective for treatment of adults experiencing acute exacerbation of schizophrenia. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Two Double-Blind, Multicenter, Randomized, Placebo-Controlled, Single-Dose Studies of Sumatriptan/Naproxen Sodium in the Acute Treatment of Migraine: Function, Productivity, and Satisfaction Outcomes

PubMed Central

Landy, Stephen; DeRossett, Sarah E.; Rapoport, Alan; Rothrock, John; Ames, Michael H.; McDonald, Susan A.; Burch, Steven P.

2007-01-01

Objective To describe return to normal function, productivity, and satisfaction of patients with moderate or severe migraine attacks treated with combined sumatriptan/naproxen sodium, sumatriptan alone, naproxen sodium alone, or placebo. Patients, design, and setting Patients in 2 identical, US, phase 3, randomized, double-blind, parallel-group, placebo-controlled, single-dose, multicenter studies treated a single moderate or severe migraine attack with sumatriptan/naproxen sodium (85 mg sumatriptan formulated with RT Technology and 500 mg naproxen sodium in a single-tablet formulation), sumatriptan, naproxen sodium, or placebo. Main outcome measures Ability to function (not impaired, mildly impaired, severely impaired, or required bed rest) was collected in diary cards completed immediately prior to treatment, every 30 minutes for the first 2 hours, and hourly from 2 to 24 hours while awake. Patients completed the Productivity Assessment Questionnaire (PAQ) 24 hours after study drug administration. The Patient Perception of Migraine Questionnaire (PPMQ) was administered at screening and 24 hours post treatment to capture patient satisfaction. Results Compared with the other groups, the sumatriptan/naproxen sodium group reported significantly higher levels of normal or mildly impaired functioning as early as 2 and 4 hours after dosing. They also demonstrated greater reductions in workplace productivity loss compared with placebo in both studies, and were consistently more satisfied with their treatment compared with patients in other treatment groups and compared with their usual medications. Conclusions Treatment with sumatriptan/naproxen sodium allowed significantly more subjects to return to normal or mildly impaired functioning more quickly, and sumatriptan/naproxen sodium patients were significantly more satisfied with their treatment compared with other treatment groups. Overall productivity loss was significantly reduced following use of sumatriptan/naproxen sodium. PMID:17955107

Treatment of Adolescent Panic Disorder: A Nonrandomized Comparison of Intensive versus Weekly CBT

ERIC Educational Resources Information Center

Chase, Rhea M.; Whitton, Sarah W.; Pincus, Donna B.

2012-01-01

This study compared the relative efficacy of intensive versus weekly panic control treatment (PCT) for adolescent panic disorder with agoraphobia (PDA). Twenty-six adolescents participated in weekly sessions and 25 received intensive treatment involving daily sessions. Both groups demonstrated significant and comparable reductions in panic…

Effect of Foot Manipulation on Pregnancy-Related Pelvic Girdle Pain: A Feasibility Study.

PubMed

Melkersson, Camilla; Nasic, Salmir; Starzmann, Karin; Bengtsson Boström, Kristina

2017-09-01

The objective of this study was to investigate if the research process to evaluate the effect of foot manipulation on pregnancy-related pelvic girdle pain (PPGP) is feasible. A randomized, single-blind (patients and evaluators) pilot trial was performed to compare foot manipulation to a comparative group at 6-weekly treatment sessions at 5 physiotherapy outpatient clinics in Skaraborg primary care (Skövde, Sweden). Women at 12 to 31 weeks of pregnancy with well-defined PPGP (n = 97) and joint dysfunction or decreased range of movement in the feet were included. Women with a twin pregnancy, low back pain, rheumatoid arthritis, or other serious diseases and those who had previous foot manipulation were excluded. Visual analog scale scores were recorded before study start, before and after each treatment session, and 3 months after delivery. One-hundred and two women were eligible, and 97 were included (group 1: foot manipulation, n = 47; group 2: comparative treatment, n = 50); 40 and 36 in the foot manipulation and comparative treatment groups, respectively, completed the study. The foot manipulation group had a nonsignificant pain relief score compared with that of the comparative group, which had higher pain relief scores. The difference was most pronounced at the first and second treatment sessions. A power analysis showed that at least 250 individuals would be needed in each group to confirm the effect of foot manipulation. This study showed that it is feasible to assess the effect of foot manipulation on PPGP in a multicenter physical therapy outpatient clinic setting. A new larger study should choose a different comparative method and test this hypothesis in a full-scale trial.

Depression drug treatment outcomes in pregnancy and the postpartum period: a systematic review and meta-analysis.

PubMed

McDonagh, Marian S; Matthews, Annette; Phillipi, Carrie; Romm, Jillian; Peterson, Kim; Thakurta, Sujata; Guise, Jeanne-Marie

2014-09-01

To evaluate the comparative benefits and harms in both mother and child of antidepressant treatment for depression in pregnant or postpartum women. MEDLINE, the Cochrane Library, CINAHL, Scopus, ClinicalTrials.gov (inception to July 2013), manufacturers, and reference lists. Two reviewers independently selected studies of pregnant women with depression comparing antidepressants with each other, placebo or no treatment, or nondrug treatments. Studies making comparisons among women taking antidepressants for any reason and those not taking antidepressants (depression status unknown) were used to fill gaps in the evidence. Dual study data extraction and quality assessment were used. Six randomized controlled trials and 15 observational studies provided evidence. Low-strength evidence suggested neonates of pregnant women with depression taking selective serotonin reuptake inhibitors had higher risk of respiratory distress than did neonates of untreated women (13.9% compared with 7.8%; P<.001) but no difference in risk of neonatal convulsions (0.14% compared with 0.11%; P=.64) or preterm birth (17% compared with 10%; P=.07). Indirect evidence from studies of pregnant women receiving antidepressants for mixed or unreported reasons compared with pregnant women not taking antidepressants (depression status unknown) suggested future research should focus on congenital anomalies and autism spectrum and attention deficit disorders in the child. In postpartum depression, low-strength evidence suggested symptom response was not improved when sertraline was added to psychotherapy or when cognitive-behavioral therapy was added to paroxetine. Evidence was insufficient for other outcomes, including depression symptoms, functional capacity, breastfeeding, and infant and child development. A serious limitation is the lack of study populations of exclusively depressed pregnant and postpartum women. Evidence about the comparative benefits and harms of pharmacologic treatment of depression in pregnant and postpartum women was largely inadequate to allow informed decisions about treatment. Considering the prevalence of depression, filling this gap is essential.

Very long-term sequelae of craniopharyngioma.

PubMed

Wijnen, Mark; van den Heuvel-Eibrink, Marry M; Janssen, Joseph A M J L; Catsman-Berrevoets, Coriene E; Michiels, Erna M C; van Veelen-Vincent, Marie-Lise C; Dallenga, Alof H G; van den Berge, J Herbert; van Rij, Carolien M; van der Lely, Aart-Jan; Neggers, Sebastian J C M M

2017-06-01

Studies investigating long-term health conditions in patients with craniopharyngioma are limited by short follow-up durations and generally do not compare long-term health effects according to initial craniopharyngioma treatment approach. In addition, studies comparing long-term health conditions between patients with childhood- and adult-onset craniopharyngioma report conflicting results. The objective of this study was to analyse a full spectrum of long-term health effects in patients with craniopharyngioma according to initial treatment approach and age group at craniopharyngioma presentation. Cross-sectional study based on retrospective data. We studied a single-centre cohort of 128 patients with craniopharyngioma treated from 1980 onwards (63 patients with childhood-onset disease). Median follow-up since craniopharyngioma presentation was 13 years (interquartile range: 5-23 years). Initial craniopharyngioma treatment approaches included gross total resection ( n  = 25), subtotal resection without radiotherapy ( n  = 44), subtotal resection with radiotherapy ( n  = 25), cyst aspiration without radiotherapy ( n  = 8), and 90 Yttrium brachytherapy ( n  = 21). Pituitary hormone deficiencies (98%), visual disturbances (75%) and obesity (56%) were the most common long-term health conditions observed. Different initial craniopharyngioma treatment approaches resulted in similar long-term health effects. Patients with childhood-onset craniopharyngioma experienced significantly more growth hormone deficiency, diabetes insipidus, panhypopituitarism, morbid obesity, epilepsy and psychiatric conditions compared with patients with adult-onset disease. Recurrence-/progression-free survival was significantly lower after initial craniopharyngioma treatment with cyst aspiration compared with other therapeutic approaches. Survival was similar between patients with childhood- and adult-onset craniopharyngioma. Long-term health conditions were comparable after different initial craniopharyngioma treatment approaches and were generally more frequent in patients with childhood- compared with adult-onset disease. © 2017 European Society of Endocrinology.

Prospective and Retrospective Studies of Substance Abuse Treatment Outcomes: Methods and Results of Four Large-Scale Follow-Up Studies.

ERIC Educational Resources Information Center

Gerstein, Dean R.; Johnson, Robert A.

This report compares the research methods, provider and patient characteristics, and outcome results from four large-scale followup studies of drug treatment during the 1990s: (1) the California Drug and Alcohol Treatment Assessment (CALDATA); (2) Services Research Outcomes Study (SROS); (3) National Treatment Improvement Evaluation Study (NTIES);…

Baseline Body Mass Index and the Efficacy of Hypoglycemic Treatment in Type 2 Diabetes: A Meta-Analysis.

PubMed

Cai, Xiaoling; Yang, Wenjia; Gao, Xueying; Zhou, Lingli; Han, Xueyao; Ji, Linong

2016-01-01

The aim of this study is to compare the effects of hypoglycemic treatments in groups of patients categorized according to the mean baseline body mass indexes (BMIs). Studies were identified by a literature search and all the studies were double blind, placebo-controlled randomized trials in type 2 diabetes patients; study length of ≥12 weeks with the efficacy evaluated by changes in HbA1c from baseline in groups. The electronic search was first conducted in January 2015 and repeated in June 2015. 227 studies were included. Treatment with sulfonylureas was compared with placebo in overweight patients and resulted in a significantly greater change in the HbA1c levels (weighted mean difference (WMD), -1.39%) compared to obese patients (WMD, -0.77%)(p<0.05). Treatment with metformin in overweight patients resulted in a comparable change in the HbA1c levels (WMD, -0.99%) compared to obese patients (WMD, -1.06%)(p>0.05). Treatment with alpha glucosidase inhibitors in normal weight patients was associated with a HbA1c change (WMD, -0.94%) that was comparable that in overweight (WMD, -0.72%) and obese patients (WMD, -0.56%)(p>0.05). Treatment with thiazolidinediones in normal weight patients was associated with a HbA1c change (WMD, -1.04%) that was comparable with that in overweight (WMD, -1.02%) and obese patients (WMD, -0.88%)(p>0.05). Treatment with DPP-4 inhibitors in normal weight patients was associated with a HbA1c change (WMD, -0.93%) that was comparable with that in overweight (WMD, -0.66%) and obese patients (WMD, -0.61%)(p>0.05). In total, of the seven hypoglycemic agents, regression analysis indicated that the mean baseline BMI was not associated with the mean HbA1c changes from baseline. In each kind of hypoglycemic therapy in type 2 diabetes, the baseline BMI was not associated with the efficacy of HbA1c changes from baseline.

Baseline Body Mass Index and the Efficacy of Hypoglycemic Treatment in Type 2 Diabetes: A Meta-Analysis

PubMed Central

Cai, Xiaoling; Yang, Wenjia; Gao, Xueying; Zhou, Lingli; Han, Xueyao; Ji, Linong

2016-01-01

Aim The aim of this study is to compare the effects of hypoglycemic treatments in groups of patients categorized according to the mean baseline body mass indexes (BMIs). Methods Studies were identified by a literature search and all the studies were double blind, placebo-controlled randomized trials in type 2 diabetes patients; study length of ≥12 weeks with the efficacy evaluated by changes in HbA1c from baseline in groups. The electronic search was first conducted in January 2015 and repeated in June 2015. Results 227 studies were included. Treatment with sulfonylureas was compared with placebo in overweight patients and resulted in a significantly greater change in the HbA1c levels (weighted mean difference (WMD), −1.39%) compared to obese patients (WMD, −0.77%)(p<0.05). Treatment with metformin in overweight patients resulted in a comparable change in the HbA1c levels (WMD, −0.99%) compared to obese patients (WMD, −1.06%)(p>0.05). Treatment with alpha glucosidase inhibitors in normal weight patients was associated with a HbA1c change (WMD, −0.94%) that was comparable that in overweight (WMD, −0.72%) and obese patients (WMD, −0.56%)(p>0.05). Treatment with thiazolidinediones in normal weight patients was associated with a HbA1c change (WMD, −1.04%) that was comparable with that in overweight (WMD, −1.02%) and obese patients (WMD, −0.88%)(p>0.05). Treatment with DPP-4 inhibitors in normal weight patients was associated with a HbA1c change (WMD, −0.93%) that was comparable with that in overweight (WMD, −0.66%) and obese patients (WMD, −0.61%)(p>0.05). In total, of the seven hypoglycemic agents, regression analysis indicated that the mean baseline BMI was not associated with the mean HbA1c changes from baseline. Conclusion In each kind of hypoglycemic therapy in type 2 diabetes, the baseline BMI was not associated with the efficacy of HbA1c changes from baseline. PMID:27935975

Comparative Evaluation of Pediatric Patients with Mental Retardation undergoing Dental Treatment under General Anesthesia: A Retrospective Analysis.

PubMed

Ahuja, Ravish; Jyoti, Bhuvan; Shewale, Vinod; Shetty, Shridhar; Subudhi, Santosh Kumar; Kaur, Manpreet

2016-08-01

Behavioral management of patients forms one of the foremost components of pediatric dental treatment. Some children readily cooperate with dental treatment, while others require general anesthesia as a part of treatment protocol for carrying out various dental procedures. Hence, we evaluated the pediatric patients with and without mental retardation, who underwent dental treatment under general anesthesia. The present study analyzed the record of 480 pediatric patients reporting in the department of pedodontics from 2008 to 2014. Analysis of the records of the patients who underwent dental treatment under general anesthesia was done and all the patients were divided into two study groups depending upon their mental level. For the purpose of evaluation, the patients were also grouped according to their age; 4 to 7 years, 8 to 12 years, and 13 to 18 years. Measurement of decayed, missing, and filled teeth and scores for both deciduous and permanent dentition was done before and after the commencement of the dental treatment. Chi-square test and independent t-test were used for evaluating the level of significance. While comparing the patients in the two groups, maximum number of patients is present in the age group of 13 to 18 years. While comparing the indices' score between the two study groups in various age intervals, no statistically significant results were obtained. Restorative treatment and dental extractions were the most common dental treatments that were seen at a higher frequency in the intellectual disability study group. In patients with mental retardation, a higher frequency of restorative treatment and extractions occurs as compared to healthy subjects of similar age group. Therefore, they require special attention regarding maintenance of their oral health. Special attention should be given for maintaining the oral health of patients with special health care needs as compared to their physically and mentally normal counterparts.

Nonpharmacologic Treatments for Attention-Deficit/Hyperactivity Disorder: A Systematic Review.

PubMed

Goode, Adam P; Coeytaux, Remy R; Maslow, Gary R; Davis, Naomi; Hill, Sherika; Namdari, Behrouz; LaPointe, Nancy M Allen; Befus, Deanna; Lallinger, Kathryn R; Bowen, Samantha E; Kosinski, Andrzej; McBroom, Amanda J; Sanders, Gillian D; Kemper, Alex R

2018-06-01

Nonpharmacologic treatments for attention-deficit/hyperactivity disorder (ADHD) encompass a range of care approaches from structured behavioral interventions to complementary medicines. To assess the comparative effectiveness of nonpharmacologic treatments for ADHD among individuals 17 years of age and younger. PubMed, Embase, PsycINFO, and Cochrane Database of Systematic Reviews for relevant English-language studies published from January 1, 2009 through November 7, 2016. We included studies that compared any ADHD nonpharmacologic treatment strategy with placebo, pharmacologic, or another nonpharmacologic treatment. Study design, patient characteristics, intervention approaches, follow-up times, and outcomes were abstracted. For comparisons with at least 3 similar studies, random-effects meta-analysis was used to generate pooled estimates. We identified 54 studies of nonpharmacologic treatments, including neurofeedback, cognitive training, cognitive behavioral therapy, child or parent training, dietary omega fatty acid supplementation, and herbal and/or dietary approaches. No new guidance was identified regarding the comparative effectiveness of nonpharmacologic treatments. Pooled results for omega fatty acids found no significant effects for parent rating of ADHD total symptoms ( n = 411; standardized mean difference -0.32; 95% confidence interval -0.80 to 0.15; I 2 = 52.4%; P = .10) or teacher-rated total ADHD symptoms ( n = 287; standardized mean difference -0.08; 95% confidence interval -0.47 to 0.32; I 2 = 0.0%; P = .56). Studies often did not reflect the primary care setting and had short follow-up periods, small sample sizes, variations in outcomes, and inconsistent reporting of comparative statistical analyses. Despite wide use, there are significant gaps in knowledge regarding the effectiveness of ADHD nonpharmacologic treatments. Copyright © 2018 by the American Academy of Pediatrics.

A systematic review of dosing frequency with bone-targeted agents for patients with bone metastases from breast cancer

PubMed Central

Hutton, Brian; Addison, Christina L.; Campbell, Kaitryn; Fergusson, Dean; Mazarello, Sasha; Clemons, Mark

2013-01-01

Background Bone-targeted agents are usually administered to breast cancer patients with bone metastases every 3–4 weeks. Less frequent (‘de-escalated’) treatment may provide similar benefits with improved safety and reduced cost. Methods To systematically review randomised trials comparing de-escalated treatment with bone-targeted agents (i.e. every 12–16 weeks) to standard treatment (i.e. every 3–4 weeks), a formal systematic review of the literature was performed. Two individuals independently screened citations and full text articles. Random effects meta-analyses of clinically important outcomes were planned provided homogeneous studies were identified. Results Five relevant studies (n=1287 patients) were identified. Sample size ranged from 38 to 425. Information on outcomes including occurrence of SREs, bone pain, urinary N-telopeptide concentrations, serum C-telopeptide concentrations, pain medication use and safety outcomes was not consistently available. Two trials were non-inferiority studies, two dose-response evaluations and one was a pilot study. Bone-targeted agents use varied between studies, as did duration of prior therapy. Patient populations were considered heterogeneous in several ways, and thus no meta-analyses were performed. Observations from the included studies suggest there is potential that 3 month de-escalated treatment may provide similar benefits compared to 3–4 weekly treatment and that lower doses of zoledronic acid and denosumab might be equally effective. Conclusions Studies comparing standard and de-escalated treatment with bone-targeted agents in breast cancer are rare. The benefits of standard treatment compared to de-escalated therapy on important clinical outcomes remain unclear. Future pragmatic studies must be conducted to determine the merits of this approach. PMID:26909282

Add-on deep Transcranial Magnetic Stimulation (dTMS) for the treatment of chronic migraine: A preliminary study.

PubMed

Rapinesi, Chiara; Del Casale, Antonio; Scatena, Paola; Kotzalidis, Georgios D; Di Pietro, Simone; Ferri, Vittoria Rachele; Bersani, Francesco Saverio; Brugnoli, Roberto; Raccah, Ruggero Nessim; Zangen, Abraham; Ferracuti, Stefano; Orzi, Francesco; Girardi, Paolo; Sette, Giuliano

2016-06-03

Deep Transcranial Magnetic Stimulation (dTMS) can be an alternative treatment to relieve pain in chronic migraine (CM). The aim of this study was to evaluate the effect of high-frequency dTMS in add-on to standard treatment for CM in patients not responding to effective abortive or preventive drug treatment. We randomized 14 patients with International Classification of Headache Disorders, 3rd Edition (ICHD-3) treatment-resistant CM to add-on dTMS (n=7) or standard abortive or preventive antimigraine treatment (n=7). Three sessions of alternate day 10Hz dTMS consisting of 600 pulses in 10 trains were delivered to the dorsolateral prefrontal cortex (DLPFC), bilaterally, but with left hemisphere prevalence, for 12 sessions spread over one month. The add-on dTMS treatment was well tolerated. Patients treated with dTMS showed significant reduction of pain intensity, frequency of attacks, analgesic overuse, and depressive symptoms during treatment and one month later, compared to the month preceding treatment and at the same time-points compared to the control group. As compared to standard pharmacological treatment alone, add-on high-frequency dTMS of the bilateral DLPFC reduced the frequency and intensity of migraine attack, drug overuse, and depressive symptoms. This study supports the add-on dTMS treatment in treatment-resistant CM. Copyright © 2016. Published by Elsevier Ireland Ltd.

Antibiotics versus no treatment for toxoplasma retinochoroiditis.

PubMed

Pradhan, Eli; Bhandari, Sanjeeb; Gilbert, Ruth E; Stanford, Miles

2016-05-20

Acute toxoplasma retinochoroiditis causes transient symptoms of ocular discomfort and may lead to permanent visual loss. Antibiotic treatment aims primarily to reduce the risk of permanent visual loss, recurrent retinochoroiditis, and the severity and duration of acute symptoms. There is uncertainty about the effectiveness of antibiotic treatment. To compare the effects of antibiotic treatment versus placebo or no treatment for toxoplasma retinochoroiditis. We searched CENTRAL (which contains the Cochrane Eyes and Vision group Trials Register) (2016, Issue 1), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to February 2016), EMBASE (January 1980 to February 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to February 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 22 February 2016. We searched the reference lists of identified articles and contacted pharmaceutical companies for unpublished trials. We included randomised controlled trials that compared any antibiotic treatment against placebo or no treatment. We excluded trials that included immunocompromised participants. We considered any antibiotic treatment known to be active against Toxoplasma gondii. Antibiotic treatment could be given in any dose orally, by intramuscular injection, by intravenous infusion, or by intravitreal injection. The primary outcomes for this review were visual acuity at least three months after treatment and risk of recurrent retinochoroiditis. Secondary outcomes were improvement in symptoms and signs of intraocular inflammation, size of lesion, and adverse events. We used standard methodological procedures expected by Cochrane. Four trials that randomised a total of 268 participants met the inclusion criteria. In all four studies antibiotic was administered orally.One study conducted in Brazil in both adults and children compared trimethoprim-sulfamexacocol over 20 months to no treatment and was judged to be at high risk of performance, detection, and attrition bias. The other three studies compared antibiotic treatment to placebo. We judged these three studies to be at a mixture of low or unclear risk of bias due to poor reporting. One study conducted in the US in adults studied pyrimethamine-trisulfapyrimidine for eight weeks; one study conducted in the UK in children and adults evaluated pyrimethamine for four weeks; and one study conducted in Brazil in adults investigated trimethoprim-sulfamethoxazole for 12 months. In the last study, all participants had active retinochoroiditis and were treated with antibiotics for 45 days prior to randomisation to trimethoprim-sulfamethoxazole versus placebo.Only the study in Brazil of trimethoprim-sulfamethoxazole over 12 months, in participants with healed lesions, reported the effect of treatment on visual acuity. People treated with antibiotics may have a similar change in visual acuity compared with people treated with placebo at one year (mean difference -1.00 letters, 95% confidence interval (CI) -7.93 to 5.93 letters; 93 participants; low-quality evidence).Treatment with antibiotics probably reduces the risk of recurrent retinochoroiditis compared with placebo (risk ratio (RR) 0.26, 95% CI 0.11 to 0.63; 227 participants; 3 studies; I(2) = 0%; moderate-quality evidence); similar results were seen for acute and chronic retinochoroiditis.The UK study of pyrimethamine for four weeks reported an improvement in intraocular inflammation in treated compared with control participants (RR 1.76, 95% CI 0.98 to 3.19; 29 participants; low-quality evidence). The study in Brazil of trimethoprim-sulfamethoxazole for 12 months stated that the severity of inflammation was higher in the comparator group when compared to the antibiotic-treated group but did not provide further details. In the US study of pyrimethamine-trisulfapyrimidine for eight weeks intraocular inflammation had almost completely resolved by eight weeks in all participants, however in this study all participants received steroid treatment.Two studies (UK and US studies) reported an increased risk of adverse events in treated participants. These were a fall in haemoglobin, leucocyte, and platelet count, nausea, loss of appetite, rash, and arthralgia. Treatment with antibiotics probably reduces the risk of recurrent toxoplasma retinochoroiditis, but there is currently no good evidence that this leads to better visual outcomes. However, absence of evidence of effect is not the same as evidence of no effect. Further trials of people with acute and chronic toxoplasma retinochoroiditis affecting any part of the retina are required to determine the effects of antibiotic treatment on visual outcomes.

Indirect Treatment Comparison of Talimogene Laherparepvec Compared with Ipilimumab and Vemurafenib for the Treatment of Patients with Metastatic Melanoma.

PubMed

Quinn, Casey; Ma, Qiufei; Kudlac, Amber; Palmer, Stephen; Barber, Beth; Zhao, Zhongyun

2016-04-01

Few randomized controlled trials have compared new treatments for metastatic melanoma. We sought to examine the relative treatment effect of talimogene laherparepvec compared with ipilimumab and vemurafenib. A systematic literature review of treatments for metastatic melanoma was undertaken but a valid network of evidence could not be established because of a lack of comparative data or studies with sufficient common comparators. A conventional adjusted indirect treatment comparison via network meta-analysis was, therefore, not feasible. Instead, a meta-analysis of absolute efficacy was undertaken, adjusting overall survival (OS) data for differences in prognostic factors between studies using a published algorithm. Four trials were included in the final indirect treatment comparison: two of ipilimumab, one of vemurafenib, and one of talimogene laherparepvec. Median OS for ipilimumab and vemurafenib increased significantly when adjustment was applied, demonstrating that variation in disease and patient characteristics was biasing OS estimates; adjusting for this made the survival data more comparable. For both ipilimumab and vemurafenib, the adjustments improved Kaplan-Meier OS curves; the observed talimogene laherparepvec OS curve remained above the adjusted OS curves for ipilimumab and vemurafenib, showing that long-term survival could differ from the observed medians. Even with limited data, talimogene laherparepvec, ipilimumab, and vemurafenib could be compared following adjustments, thereby providing a more reliable understanding of the relative effect of treatment on survival in a more comparable patient population. The results of this analysis suggest that OS with talimogene laherparepvec is at least as good as with ipilimumab and vemurafenib and improvement was more pronounced in patients with no bone, brain, lung or other visceral metastases. Amgen Inc.

Comparative Effectiveness of Transarterial Embolization and Sorafenib for Hepatocellular Carcinoma: A Population-Based Study.

PubMed

Kwan, Sharon W; Harris, William P; Gold, Laura S; Hebert, Paul L

2018-06-01

The purpose of this study was to compare the clinical effectiveness of embolization with that of sorafenib in the management of hepatocellular carcinoma as practiced in real-world settings. This population-based observational study was conducted with the Surveillance, Epidemiology, and End Results-Medicare linked database. Patients 65 years old and older with a diagnosis of primary liver cancer between 2007 and 2011 who underwent embolization or sorafenib treatment were identified. Patients were excluded if they had insufficient claims records, a diagnosis of intrahepatic cholangiocarcinoma, or other primary cancer or had undergone liver transplant or combination therapy. The primary outcome of interest was overall survival. Inverse probability of treatment weighting models were used to control for selection bias. The inclusion and exclusion criteria were met by 1017 patients. Models showed good balance between treatment groups. Compared with those who underwent embolization, patients treated with sorafenib had significantly higher hazard of earlier death from time of treatment (hazard ratio, 1.87; 95% CI, 1.46-2.37; p < 0.0001) and from time of cancer diagnosis (hazard ratio, 1.87; 95% CI, 1.46-2.39; p < 0.0001). The survival advantage after embolization was seen in both intermediate- and advanced-stage disease. This comparative effectiveness study of Medicare patients with hepatocellular carcinoma showed significantly longer overall survival after treatment with embolization than with sorafenib. Because these findings conflict with expert opinion-based guidelines for treatment of advanced-stage disease, prospective randomized comparative trials in this subpopulation would be justified.

A comparative study of combined periodontal and orthodontic treatment with fixed appliances and clear aligners in patients with periodontitis.

PubMed

Han, Ji-Young

2015-12-01

With the increasing prevalence of orthodontic treatment in adults, clear aligner treatments are becoming more popular. The aim of this study was to evaluate the effect of orthodontic treatment on periodontal tissue and to compare orthodontic treatment with fixed appliances (FA) to clear aligner treatment (CAT) in periodontitis patients. A total of 35 patients who underwent orthodontic treatment in the Department of Periodontology were included in this study. After periodontal treatment with meticulous oral hygiene education, patients underwent treatment with FA or CAT, and this study analyzed patient outcomes depending on the treatment strategy. Clinical parameters were assessed at baseline and after orthodontic treatment, and the duration of treatment was compared between these two groups. The overall plaque index, the gingival index, and probing depth improved after orthodontic treatment (P<0.01). The overall bone level also improved (P=0.045). However, the bone level changes in the FA and CAT groups were not significantly different. Significant differences were found between the FA and CAT groups in probing depth, change in probing depth, and duration of treatment (P<0.05). However, no significant differences were found between the FA and CAT groups regarding the plaque index, changes in the plaque index, the gingival index, changes in the gingival index, or changes in the alveolar bone level. The percentage of females in the CAT group (88%) was significantly greater than in the FA group (37%) (P<0.01). After orthodontic treatment, clinical parameters were improved in the FA and CAT groups with meticulous oral hygiene education and plaque control. Regarding plaque index and gingival index, no significant differences were found between these two groups. We suggest that combined periodontal and orthodontic treatment can improve patients' periodontal health irrespective of orthodontic techniques.

Comparative effectiveness of exercise, acupuncture, and spinal manipulation for low back pain.

PubMed

Standaert, Christopher J; Friedly, Janna; Erwin, Mark W; Lee, Michael J; Rechtine, Glenn; Henrikson, Nora B; Norvell, Daniel C

2011-10-01

Systematic review. We sought to answer the following clinical questions: (1) Is structured exercise more effective in the treatment of chronic low back pain (LBP) than spinal manipulative therapy (SMT)? (2) Is structured exercise more effective in the treatment of chronic LBP than acupuncture? (3) Is SMT more effective in the treatment of chronic LBP than acupuncture? (4) Do certain subgroups respond more favorably to specific treatments? (5) Are any of these treatments more cost-effective than the others? Exercise, SMT, and acupuncture are widely used interventions in the treatment of chronic LBP. There is evidence that all of these approaches may offer some benefit for patients with chronic LBP when compared with usual care or no treatment. The relative benefits or cost-effectiveness of any one of these treatments when compared with the others are less well-defined, and it is difficult to identify specific subgroups of those with chronic LBP who may preferentially respond to a particular treatment modality. A systematic review of the literature was performed to identify randomized controlled trials comparing a structured exercise program, SMT, or acupuncture with one another in patients with chronic LBP. Two studies were identified comparing the use of structured exercise with SMT that met our inclusion criteria. Although these studies utilized different approaches for the exercise and SMT treatment groups, patients in both groups improved in terms of pain and function in both studies. Using random-effects modeling, there was no difference between the exercise and SMT groups when the data from these studies were pooled. We identified no studies meeting our inclusion criteria that compared acupuncture with either structured exercise or SMT or that addressed the relative cost-effectiveness of these approaches in the treatment of patients with chronic LBP. The studies identified indicate that structured exercise and SMT appear to offer equivalent benefits in terms of pain and functional improvement for those with chronic LBP with clinical benefits evident within 8 weeks of care. However, the level of evidence is low. There is insufficient evidence to comment on the relative benefit of acupuncture compared with either structured exercise or SMT or to address the differential effects of structured exercise, SMT, or acupuncture for specific subgroups of individuals with chronic LBP. There is also insufficient evidence regarding the relative cost-effectiveness of structured exercise, SMT, or acupuncture in the treatment of chronic LBP. Structured exercise and SMT appear to offer equivalent benefits in the management of pain and function for patients with nonspecific chronic LBP. If no clinical benefit is appreciated after using one of these approaches for 8 weeks, then the treatment plan should be reevaluated and consideration should be given to modifying the treatment approach or using alternate forms of care. Strength of recommendation: Weak.There is insufficient evidence regarding the relative benefits of the acupuncture compared with either structured exercise or SMT in the treatment of chronic LBP.There is insufficient evidence to address differential effects of structured exercise, SMT, or acupuncture for specific subgroups of individuals with chronic LBP. There is insufficient evidence regarding the relative cost-effectiveness of structured exercise, SMT, or acupuncture in the treatment of chronic LBP.

Prevention praised, cure preferred: results of between-subjects experimental studies comparing (monetary) appreciation for preventive and curative interventions

PubMed Central

2013-01-01

Background 'An ounce of prevention is worth a pound of cure’ is a common saying, and indeed, most health economic studies conclude that people are more willing to pay for preventive measures than for treatment activities. This may be because most health economic studies ask respondents to compare preventive measures with treatment, and thus prompt respondents to consider other uses of resources. However, psychological theorizing suggests that, when methods do not challenge subjects to consider other uses of resources, curative treatment is favored over prevention. Could it be that while prevention is praised, cure is preferred? Methods In two experimental studies, we investigated, from a psychological perspective and using a between-subjects design, whether prevention or treatment is preferred and why. In both studies, participants first read a lung cancer prevention or treatment intervention scenario that varied on the prevention-treatment dimension, but that were the same on factors like 'costs per saved life’ and kind of disease. Then participants completed a survey measuring appreciation (general and monetary) as well as a number of potential mediating variables. Results Both studies clearly demonstrated that, when the design was between-subjects, participants had greater (general and monetary) appreciation for treatment interventions than for preventive interventions with perceived urgency of the intervention quite consistently mediating this effect. Differences in appreciation of treatment over preventive treatment were shown to be .59 (Study 1) and .45 (Study 2) on a 5-point scale. Furthermore, participants thought that health insurance should compensate more for the treatment than for preventive measures, differences of 16% (Study 1), and 22% (Study 2). When participants were asked to directly compare both interventions on the basis of a short description, they preferred the preventive intervention. Conclusion It appears that people claim to prefer prevention when they are asked to consider other use of resources, but otherwise they prefer treatment. This preference is related to perceived urgency. The preference for treatment may be related to the prevention-treatment dimension itself, but also to variations on other dimensions that are inherently linked to prevention and treatment (like different efficacy rates and costs per treatment). PMID:24344779

Is Operative Treatment of Achilles Tendon Ruptures Superior to Nonoperative Treatment?

PubMed Central

Erickson, Brandon J.; Mascarenhas, Randy; Saltzman, Bryan M.; Walton, David; Lee, Simon; Cole, Brian J.; Bach, Bernard R.

2015-01-01

Background: Multiple meta-analyses have been published in efforts to determine whether operative or nonoperative treatment of Achilles tendon ruptures affords superior outcomes. Purpose: To perform a systematic review of overlapping meta-analyses comparing operative and nonoperative treatment of Achilles tendon ruptures to determine which meta-analyses provide the highest level of evidence for treatment recommendations. Study Design: Systematic review; Level of evidence, 3. Methods: A systematic review of the literature was performed to identify meta-analyses that fit the study inclusion criteria. Data were extracted from these meta-analyses regarding patient outcomes and reruptures. Meta-analysis quality was assessed using the Oxman-Guyatt and QUOROM (Quality of Reporting of Meta-analyses) systems. The Jadad algorithm was applied to determine the meta-analyses with the highest level of evidence. Results: Nine meta-analyses met the eligibility criteria, with all but 1 study including level 1 evidence. A total of 5842 patients were included. Seven studies found a higher rate of rerupture in the nonoperative group but a higher rate of complications in the operative group. One study found no differences in rerupture or complication rates, and 1 study found surgery decreased rerupture rates only when compared with nonoperative treatment without a functional brace. Three studies also identified an earlier return to work in the operative group. Almost all (8 of 9) of the meta-analyses had Oxman-Guyatt scores >3, indicating no major flaws. Conclusion: Operative treatment of Achilles tendon ruptures decreases rerupture rates but increases the risk for minor complications when compared with nonoperative treatment. Additionally, surgical treatment may allow earlier return to work. PMID:26665055

THE EFFECTIVENESS OF COMPULSORY DRUG TREATMENT: A SYSTEMATIC REVIEW

PubMed Central

Werb, D; Kamarulzaman, A; Meacham, MC; Rafful, C; Fisher, B; Strathdee, SA; Wood, E

2016-01-01

Background Despite widespread implementation of compulsory treatment modalities for drug dependence, there has been no systematic evaluation of the scientific evidence on the effectiveness of compulsory drug treatment. Methods We conducted a systematic review of studies assessing the outcomes of compulsory treatment. We conducted a search in duplicate of all relevant peer-reviewed scientific literature evaluating compulsory treatment modalities. The following academic databases were searched: PubMed, PAIS International, Proquest, PsycINFO, Web of Science, Soc Abstracts, JSTOR, EBSCO/Academic Search Complete, REDALYC, SciELO Brazil. We also searched the Internet, and article reference lists, from database inception to July 15th, 2015. Eligibility criteria are as follows: peer-reviewed scientific studies presenting original data. Primary outcome of interest was post-treatment drug use. Secondary outcome of interest was post-treatment criminal recidivism. Results Of an initial 430 potential studies identified, nine quantitative studies met the inclusion criteria. Studies evaluated compulsory treatment options including drug detention facilities, short (i.e. 21-day) and long-term (i.e., 6 months) inpatient treatment, community-based treatment, group-based outpatient treatment, and prison-based treatment. Three studies (33%) reported no significant impacts of compulsory treatment compared with control interventions. Two studies (22%) found equivocal results but did not compare against a control condition. Two studies (22%) observed negative impacts of compulsory treatment on criminal recidivism. Two studies (22%) observed positive impacts of compulsory inpatient treatment on criminal recidivism and drug use. Conclusion There is limited scientific literature evaluating compulsory drug treatment. Evidence does not, on the whole, suggest improved outcomes related to compulsory treatment approaches, with some studies suggesting potential harms. Given the potential for human rights abuses within compulsory treatment settings, non-compulsory treatment modalities should be prioritized by policymakers seeking to reduce drug-related harms. PMID:26790691

[Comparative Cost Effectiveness of Clostridium Histolyticum Collagenase (Xiapex®) and Partial Fasciectomy for the Treatment of Dupuytren's Contracture in Austria].

PubMed

Neuwirth, M; Binter, A; Pipam, W; Rab, M

2016-08-01

Since Dupuytren's contracture is a common disorder, the costs for its surgical treatment impose a considerable burden on the healthcare system. For the first time in the German-speaking area, this study aimed to provide a comparative cost-effectiveness analysis for partial fasciectomy vs. treatment with Clostridium histolyticum collagenase (CCH). A retrospective monocentric study of the period from 2012 to 2014 comprised 40 patients with previously untreated Dupuytren's contracture of one finger. 20 outpatients received one CCH treatment (Group 1), while 20 inpatients underwent partial fasciectomy (Group 2). The direct pre-interventional treatment and post-interventional costs were compared. The direct post-interventional and postoperative results were comparable. Group 1 (CCH) showed a mean reduction in contracture of 96.4%; in Group 2 (partial fasciectomy), this was 97.7%. There were fewer complications in Group 1 than in Group 2. Mean treatment costs in Group 1 were € 1 458.60 and in Group 2, € 5 315.20. Treatment with CCH is more cost effective than with partial fasciectomy. This is due to greater costs for personnel, time and surgical material, as well as the treatment of the more frequent complications in Group 2. Despite the limited comparability, our findings are consistent with the present international literature. © Georg Thieme Verlag KG Stuttgart · New York.

A retrospective analysis of the clinical efficacies of Q-switched Alexandrite and Q-switched Nd:YAG lasers in the treatment of nevus of Ota in Korean patients.

PubMed

Choi, Jae Eun; Lee, Joo Bong; Park, Ki Beom; Kim, Bang Soon; Yeo, Un-Cheol; Huh, Chang Hun; Kim, Jie Hoon; Kye, Young Chul

2015-06-01

While the Q-switched Alexandrite laser (QSAL) and the Q-switched neodymium: yttrium-aluminum-garnet (QSNY) laser have been widely used in treating nevus of Ota, few studies compared them. To compare the efficacies of the QSAL and the QSNY laser in the treatment of nevus of Ota in Korean patients. A retrospective multicenter study was conducted in 76 patients with nevus of Ota. Thirty-one patients were treated with a QSAL (5.5-8.0 J/cm(2), 4-mm spot size) and 45 patients were treated with QSNY laser (6.0-12.0 J/cm(2), 2-mm spot size). Treatment outcomes were categorized into five grades and the results were compared with the relevant variables taken into account using multivariate logistic regression analysis. QSAL treatment was more likely to achieve a better response compared with that with QSNY laser treatment. The odds ratio of achieving an excellent response, compared with the odds ratio of having a poor response, was 12.213-times more likely when a QSAL was used than when a QSNY laser was used (p = 0.026). The QSAL tends to be more efficient than the QSNY laser in the treatment of nevus of Ota in Korean patients. Further controlled, prospective comparison studies are needed.

Interventions for actinic keratoses.

PubMed

Gupta, Aditya K; Paquet, Maryse; Villanueva, Elmer; Brintnell, William

2012-12-12

Actinic keratoses are a skin disease caused by long-term sun exposure, and their lesions have the potential to develop into squamous cell carcinoma. Treatments for actinic keratoses are sought for cosmetic reasons, for the relief of associated symptoms, or for the prevention of skin cancer development. Detectable lesions are often associated with alteration of the surrounding skin (field) where subclinical lesions might be present. The interventions available for the treatment of actinic keratoses include individual lesion-based (e.g. cryotherapy) or field-directed (e.g. topical) treatments. These might vary in terms of efficacy, safety, and cosmetic outcomes. To assess the effects of topical, oral, mechanical, and chemical interventions for actinic keratosis. We searched the following databases up to March 2011: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 2005), EMBASE (from 2010), and LILACS (from 1982). We also searched trials registers, conference proceedings, and grey literature sources. Randomised controlled trials (RCTs) comparing the treatment of actinic keratoses with either placebo, vehicle, or another active therapy. At least two authors independently abstracted data, which included adverse events, and assessed the quality of evidence. We performed meta-analysis to calculate a weighted treatment effect across trials, and we expressed the results as risk ratios (RR) and 95% confidence intervals (CI) for dichotomous outcomes (e.g. participant complete clearance rates), and mean difference (MD) and 95% CI for continuous outcomes (e.g. mean reduction in lesion counts). We included 83 RCTs in this review, with a total of 10,036 participants. The RCTs covered 18 topical treatments, 1 oral treatment, 2 mechanical interventions, and 3 chemical interventions, including photodynamic therapy (PDT). Most of the studies lacked descriptions of some methodological details, such as the generation of the randomisation sequence or allocation concealment, and half of the studies had a high risk of reporting bias. Study comparison was difficult because of the multiple parameters used to report efficacy and safety outcomes, as well as statistical limitations. We found no data on the possible reduction of squamous cell carcinoma.The primary outcome 'participant complete clearance' significantly favoured four field-directed treatments compared to vehicle or placebo: 3% diclofenac in 2.5% hyaluronic acid (RR 2.46, 95% CI 1.66 to 3.66; 3 studies with 420 participants), 0.5% 5-fluorouracil (RR 8.86, 95% CI: 3.67 to 21.44; 3 studies with 522 participants), 5% imiquimod (RR 7.70, 95% CI 4.63 to 12.79; 9 studies with1871 participants), and 0.025% to 0.05% ingenol mebutate (RR 4.50, 95% CI 2.61 to 7.74; 2 studies with 456 participants).It also significantly favoured the treatment of individual lesions with photodynamic therapy (PDT) compared to placebo-PDT with the following photosensitisers: aminolevulinic acid (ALA) (blue light: RR 6.22, 95% CI 2.88 to 13.43; 1 study with 243 participants, aminolevulinic acid (ALA) (red light: RR 5.94, 95% CI 3.35 to 10.54; 3 studies with 422 participants), and methyl aminolevulinate (MAL) (red light: RR 4.46, 95% CI 3.17 to 6.28; 5 studies with 482 participants). ALA-PDT was also significantly favoured compared to cryotherapy (RR 1.31, 95% CI 1.05 to 1.64).The corresponding comparative risks in terms of number of participants completely cleared per 1000 were as follows: 313 with 3% diclofenac compared to 127 with 2.5% hyaluronic acid; 136 with 0.5% 5-fluorouracil compared to 15 with placebo; 371 with 5% imiquimod compared to 48 with placebo; 331 with ingenol mebutate compared to 73 with vehicle; 527 to 656 with ALA/MAL-PDT treatment compared to 89 to 147 for placebo-PDT; and 580 with ALA-PDT compared to 443 with cryotherapy.5% 5-fluorouracil efficacy was not compared to placebo, but it was comparable to 5% imiquimod (RR 1.85, 95% Cl 0.41 to 8.33).A significant number of participants withdrew because of adverse events with 144 participants affected out of 1000 taking 3% diclofenac in 2.5% hyaluronic acid, compared to 40 participants affected out of 1000 taking 2.5% hyaluronic acid alone, and 56 participants affected out of 1000 taking 5% imiquimod compared to 21 participants affected out of 1000 taking placebo.Based on investigator and participant evaluation, imiquimod treatment and photodynamic therapy resulted in better cosmetic outcomes than cryotherapy and 5-fluorouracil. For individual lesions, photodynamic therapy appears more effective and has a better cosmetic outcome than cryotherapy. For field-directed treatments, diclofenac, 5-fluorouracil, imiquimod, and ingenol mebutate had similar efficacy, but their associated adverse events and cosmetic outcomes are different. More direct comparisons between these treatments are needed to determine the best therapeutic approach.

Doing Anger Differently: Two Controlled Trials of Percussion Group Psychotherapy for Adolescent Reactive Aggression

ERIC Educational Resources Information Center

Currie, Michael; Startup, Mike

2012-01-01

This study evaluates efficacy and effectiveness of "Doing Anger Differently" (DAD), a group treatment for reactively aggressive 12-15 year old males. DAD uses percussion exercises to aid treatment. Study 1 compared a ten-week treatment with a waitlist control at pre, post and 6 month (treatment group only) follow-up. Study 2 replicated Study 1,…

Clinician-delivered contingency management increases engagement and attendance in drug and alcohol treatment.

PubMed

Fitzsimons, Heather; Tuten, Michelle; Borsuk, Courtney; Lookatch, Samantha; Hanks, Lisa

2015-07-01

This study examined the impact of a low-cost contingency management (CM) delivered by program clinicians on treatment attendance and utilization for patients enrolled in outpatient psychosocial substance abuse treatment. The study used a pre-posttest design to compare substance abuse patients who received Reinforcement-Based Treatment (RBT) plus low cost CM (n=130; RBT+CM) to patients who received RBT only (n=132, RBT). RBT+CM participants received a $10 incentive for returning to treatment the day following intake assessment (day one), and a $15 incentive for attending treatment on day five following admission. RBT clients received standard care intervention without the addition of the CM procedures. Groups were compared on proportion of participants who returned to treatment on day one, mean days of treatment attendance, individual sessions attended, and treatment utilization during the first week and the first month following treatment admission. Both the RBT+CM and RBT group participants returned to the clinic on day one at high rates (95% versus 89%, respectively). However, the RBT group participants were more likely to attend the intake assessment only (i.e., never return to treatment) compared to the RBT+CM participants. Additionally, the RBT+CM participants attended significantly more treatment days, attended more individual counseling sessions, and had higher rates of overall treatment utilization compared to the RBT participants during the one week and one month following treatment admission. Findings support the feasibility and effectiveness of a CM intervention delivered by clinicians for increasing treatment attendance and utilization in a community substance abuse program. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Random versus Blocked Practice in Treatment for Childhood Apraxia of Speech

ERIC Educational Resources Information Center

Maas, Edwin; Farinella, Kimberly A.

2012-01-01

Purpose: To compare the relative effects of random vs. blocked practice schedules in treatment for childhood apraxia of speech (CAS). Although there have been repeated suggestions in the literature to use random practice in CAS treatment, no systematic studies exist that have directly compared random with blocked practice in this population.…

Rapid Syllable Transitions (ReST) treatment for Childhood Apraxia of Speech: the effect of lower dose-frequency.

PubMed

Thomas, Donna C; McCabe, Patricia; Ballard, Kirrie J

2014-01-01

This study investigated the effectiveness of twice-weekly Rapid Syllable Transitions (ReST) treatment for Childhood Apraxia of Speech (CAS). ReST is an effective treatment at a frequency of four sessions a week for three consecutive weeks. In this study we used a multiple-baselines across participants design to examine treatment efficacy for four children with CAS, aged four to eight years, who received ReST treatment twice a week for six weeks. The children's ability to acquire new skills, generalize these skills to untreated items and maintain the skills after treatment was examined. All four children improved their production of the target items. Two of the four children generalized the treatment effects to similar untreated pseudo words and all children generalized to untreated real words. During the maintenance phase, all four participants maintained their skills to four months post-treatment, with a stable rather than rising profile. This study shows that ReST treatment delivered twice-weekly results in significant retention of treatment effects to four months post-treatment and generalization to untrained but related speech behaviors. Compared to ReST therapy four times per week, the twice-weekly frequency produces similar treatment gains but no ongoing improvement after the cessation of treatment. This implies that there may be a small but significant benefit of four times weekly therapy compared with twice-weekly ReST therapy. Readers will be able to define dose-frequency, and describe how this relates to overall intervention intensity. Readers will be able to explain the acquisition, generalization and maintenance effects in the study and describe how these compare to higher dose frequency treatments. Readers will recognize that the current findings give preliminary support for high dose-frequency CAS treatment. Copyright © 2014 Elsevier Inc. All rights reserved.

[Basic concepts for network meta-analysis].

PubMed

Catalá-López, Ferrán; Tobías, Aurelio; Roqué, Marta

2014-12-01

Systematic reviews and meta-analyses have long been fundamental tools for evidence-based clinical practice. Initially, meta-analyses were proposed as a technique that could improve the accuracy and the statistical power of previous research from individual studies with small sample size. However, one of its main limitations has been the fact of being able to compare no more than two treatments in an analysis, even when the clinical research question necessitates that we compare multiple interventions. Network meta-analysis (NMA) uses novel statistical methods that incorporate information from both direct and indirect treatment comparisons in a network of studies examining the effects of various competing treatments, estimating comparisons between many treatments in a single analysis. Despite its potential limitations, NMA applications in clinical epidemiology can be of great value in situations where there are several treatments that have been compared against a common comparator. Also, NMA can be relevant to a research or clinical question when many treatments must be considered or when there is a mix of both direct and indirect information in the body of evidence. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

Remission induction and maintenance effect of probiotics on ulcerative colitis: A meta-analysis

PubMed Central

Sang, Li-Xuan; Chang, Bing; Zhang, Wen-Liang; Wu, Xiao-Mei; Li, Xiao-Hang; Jiang, Min

2010-01-01

AIM: To evaluate the induction of remission and maintenance effects of probiotics for ulcerative colitis. METHODS: Information was retrieved from MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The induction of remission and promotion of maintenance were compared between probiotics treatment and non-probiotics treatment in ulcerative colitis. RESULTS: Thirteen randomized controlled studies met the selection criteria. Seven studies evaluated the remission rate, and eight studies estimated the recurrence rate; two studies evaluated both remission and recurrence rates. Compared with the non-probiotics group, the remission rate for ulcerative colitis patients who received probiotics was 1.35 (95% CI: 0.98-1.85). Compared with the placebo group, the remission rate of ulcerative colitis who received probiotics was 2.00 (95% CI: 1.35-2.96). During the course of treatment, in patients who received probiotics for less than 12 mo compared with the group treated by non-probiotics, the remission rate of ulcerative colitis was 1.36 (95% CI: 1.07-1.73). Compared with the non-probiotics group, the recurrence rate of ulcerative colitis patients who received probiotics was 0.69 (95% CI: 2.47-1.01). In the mild to moderate group who received probiotics, compared to the group who did not receive probiotics, the recurrence rate was 0.25 (95% CI: 0.12-0.51). The group who received Bifidobacterium bifidum treatment had a recurrence rate of 0.25 (95% CI: 0.12-0.50) compared with the non-probiotics group. CONCLUSION: Probiotic treatment was more effective than placebo in maintaining remission in ulcerative colitis. PMID:20397271

Remission induction and maintenance effect of probiotics on ulcerative colitis: a meta-analysis.

PubMed

Sang, Li-Xuan; Chang, Bing; Zhang, Wen-Liang; Wu, Xiao-Mei; Li, Xiao-Hang; Jiang, Min

2010-04-21

To evaluate the induction of remission and maintenance effects of probiotics for ulcerative colitis. Information was retrieved from MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The induction of remission and promotion of maintenance were compared between probiotics treatment and non-probiotics treatment in ulcerative colitis. Thirteen randomized controlled studies met the selection criteria. Seven studies evaluated the remission rate, and eight studies estimated the recurrence rate; two studies evaluated both remission and recurrence rates. Compared with the non-probiotics group, the remission rate for ulcerative colitis patients who received probiotics was 1.35 (95% CI: 0.98-1.85). Compared with the placebo group, the remission rate of ulcerative colitis who received probiotics was 2.00 (95% CI: 1.35-2.96). During the course of treatment, in patients who received probiotics for less than 12 mo compared with the group treated by non-probiotics, the remission rate of ulcerative colitis was 1.36 (95% CI: 1.07-1.73). Compared with the non-probiotics group, the recurrence rate of ulcerative colitis patients who received probiotics was 0.69 (95% CI: 2.47-1.01). In the mild to moderate group who received probiotics, compared to the group who did not receive probiotics, the recurrence rate was 0.25 (95% CI: 0.12-0.51). The group who received Bifidobacterium bifidum treatment had a recurrence rate of 0.25 (95% CI: 0.12-0.50) compared with the non-probiotics group. Probiotic treatment was more effective than placebo in maintaining remission in ulcerative colitis.

A multi-site randomized study to compare the effects of Eye Movement Desensitization and Reprocessing (EMDR) added to TAU versus TAU to reduce craving and drinking behavior in alcohol dependent outpatients: study protocol.

PubMed

Markus, Wiebren; de Weert-van Oene, Gerdien H; Becker, Eni S; DeJong, Cor A J

2015-03-18

Addiction constitutes a major public health problem, and despite treatment, relapse rates remain very high. Preliminary findings suggest that Eye Movement Desensitization and Reprocessing (EMDR), an evidence-based treatment for PTSD, may also reduce craving and relapse rates when applied in substance abuse. This study aims to determine the feasibility, efficacy and effectiveness of EMDR when added to treatment as usual (TAU) for addiction in alcohol dependent outpatients, compared to TAU only. A single blinded study in which 100 adult patients with a primary DSM-IV-TR diagnosis of alcohol dependence or abuse receiving treatment in one of six Dutch outpatient addiction care facility sites, will be enrolled. After baseline assessment participants will be allocated to one of two treatment conditions (allocation ratio of 1:1) using a stratified (per site, per care pathway), blocked randomization procedure. The intervention consists of EMDR (seven weekly 90 minute sessions) + TAU or TAU only. Assessments are scheduled pre-treatment (t0), post-treatment (t0 + eight weeks), and one and six months post treatment. The effects of both treatment arms are compared on indices of (a) drinking behavior, (b) mediators, moderators and predictors of treatment outcome, (c) quality of life and d) safety, acceptability and feasibility of treatment. Repeated measures ANOVA's will be conducted using an intention-to-treat and per-protocol approach. Multiple imputation will be used to deal with missing values when possible. This study adapts and extends the standard EMDR treatment for traumatized patients for use with patients with alcohol use disorders without psychological trauma. ClinicalTrial.gov: NCT01828866.

A comparative study of a new food supplement, ViviScal, with fish extract for the treatment of hereditary androgenic alopecia in young males.

PubMed

Lassus, A; Eskelinen, E

1992-11-01

A controlled, randomized, double-blind, parallel-group study compared the effects of ViviScal (a new food supplement incorporating special marine extracts and a silica compound) with those of a fish extract in the treatment of young males with hereditary androgenic alopecia. The pretreatment histological diagnosis was alopecia with a mild to moderate perifollicular inflammation zone. The study consisted of 20 subjects who received two tablets of ViviScal once daily and 20 who received two tablets of fish extract once daily for 6 months. The mean patient age and mean duration and severity of baldness compared well between the two groups. Most patients had been treated with long-term topical 2% minoxidil for 1 year or more prior to the study. At baseline and after 6 months' treatment, a biopsy was taken for histological examination. A non-vellus hair count was performed at baseline and after 2, 4 and 6 months. In the fish extract treatment group three patients withdrew from the study before the fourth month due to lack of therapeutic effect. After 6 months' treatment, patients receiving ViviScal showed a mean increase in non-vellus hair of 38% compared with a 2% increase in the fish extract treatment group (P < 0.0001). In the ViviScal group, 19 (95%) subjects showed both clinical and histological cure, whereas none treated with fish extract showed any clinical or histological difference after 6 months' treatment (P < 0.0001). In both groups, a minimal decrease in the erythemal index was observed. In conclusion, ViviScal appears to be the first highly active treatment for androgenic alopecia in young males.

[Myasthenia gravis: clinical and surgical treatment].

PubMed

Werneck, L C; Moreira, P R

1991-12-01

The indication for thymectomy in myasthenia gravis still is controversial, and it is uncommon to find in the present days studies comparing conservative treatments, due to the widespread surgical treatment adopted in most centers. We studied 65 cases divided into three groups of patients: (1) 15 thymectomized patients and 50 with conservative treatment; (2) 15 thymectomized patients paired with 15 on conservative treatment; (3) 49 patients treated with corticosteroids against 16 without corticosteroids. These three groups where compared regarding age, age when the symptoms began, disease duration, clinical severity and functional scale, studying remission, stability or worsening of the symptoms and death rate after several years of treatment. It was found a reduction of the symptoms (p < 0.05) in the thymectomized patients of group 1; the remaining parameters of all three groups did not show any statistical significance. These results suggest that the type of treatment did not interfere with evolution of myasthenia gravis in this group of patients.

Observational studies using propensity score analysis underestimated the effect sizes in critical care medicine.

PubMed

Zhang, Zhongheng; Ni, Hongying; Xu, Xiao

2014-08-01

Propensity score (PS) analysis has been increasingly used in critical care medicine; however, its validation has not been systematically investigated. The present study aimed to compare effect sizes in PS-based observational studies vs. randomized controlled trials (RCTs) (or meta-analysis of RCTs). Critical care observational studies using PS were systematically searched in PubMed from inception to April 2013. Identified PS-based studies were matched to one or more RCTs in terms of population, intervention, comparison, and outcome. The effect sizes of experimental treatments were compared for PS-based studies vs. RCTs (or meta-analysis of RCTs) with sign test. Furthermore, ratio of odds ratio (ROR) was calculated from the interaction term of treatment × study type in a logistic regression model. A ROR < 1 indicates greater benefit for experimental treatment in RCTs compared with PS-based studies. RORs of each comparison were pooled by using meta-analytic approach with random-effects model. A total of 20 PS-based studies were identified and matched to RCTs. Twelve of the 20 comparisons showed greater beneficial effect for experimental treatment in RCTs than that in PS-based studies (sign test P = 0.503). The difference was statistically significant in four comparisons. ROR can be calculated from 13 comparisons, of which four showed significantly greater beneficial effect for experimental treatment in RCTs. The pooled ROR was 0.71 (95% CI: 0.63, 0.79; P = 0.002), suggesting that RCTs (or meta-analysis of RCTs) were more likely to report beneficial effect for the experimental treatment than PS-based studies. The result remained unchanged in sensitivity analysis and meta-regression. In critical care literature, PS-based observational study is likely to report less beneficial effect of experimental treatment compared with RCTs (or meta-analysis of RCTs). Copyright © 2014 Elsevier Inc. All rights reserved.

Effects of pay-for-performance system on tuberculosis default cases control and treatment in Taiwan.

PubMed

Tsai, Wen-Chen; Kung, Pei-Tseng; Khan, Mahmud; Campbell, Claudia; Yang, Wen-Ta; Lee, Tsuey-Fong; Li, Ya-Hsin

2010-09-01

In order to make tuberculosis (TB) treatment more effective and to lower the default rate of the disease, the Bureau of National Health Insurance (BNHI) in Taiwan implemented the "pay-for-performance on Tuberculosis" program (P4P on TB) in 2004. The purpose of this study is to investigate the effectiveness of the P4P system in terms of default rate. This is a retrospective study. National Health Insurance Research Datasets in Taiwan from 2002 to 2005 has been used for the study. The study compared the differences of TB default rate before and after the implementation of P4P program, between participating and non-participating hospitals, and between P4P hospitals with and without case managers. Furthermore, logistic regression analysis was conducted to explore the related factors influencing TB patients default treatment after TB detected. The treatment default rate after "P4P on TB" was 11.37% compared with the 15.56% before "P4P on TB" implementation. The treatment default rate in P4P hospitals was 10.67% compared to 12.7% in non-P4P hospitals. In addition, the default rate was 10.4% in hospitals with case managers compared with 12.68% in hospitals without case managers. The results of the study showed that "P4P on TB" program improved the treatment default rate for TB patients. In addition, case managers improved the treatment outcome in controlling patients' default rate. Copyright 2010 The British Infection Society. Published by Elsevier Ltd. All rights reserved.

Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice.

PubMed

Williams, Cylie M; Skinner, Elizabeth H; James, Alicia M; Cook, Jill L; McPhail, Steven M; Haines, Terry P

2016-08-17

Comparative effectiveness research compares two active forms of treatment or usual care in comparison with usual care with an additional intervention element. These types of study are commonly conducted following a placebo or no active treatment trial. Research designs with a placebo or non-active treatment arm can be challenging for the clinician researcher when conducted within the healthcare environment with patients attending for treatment.A framework for conducting comparative effectiveness research is needed, particularly for interventions for which there are no strong regulatory requirements that must be met prior to their introduction into usual care. We argue for a broader use of comparative effectiveness research to achieve translatable real-world clinical research. These types of research design also affect the rapid uptake of evidence-based clinical practice within the healthcare setting.This framework includes questions to guide the clinician researcher into the most appropriate trial design to measure treatment effect. These questions include consideration given to current treatment provision during usual care, known treatment effectiveness, side effects of treatments, economic impact, and the setting in which the research is being undertaken.

The benefit of heart rate variability biofeedback and relaxation training in reducing trait anxiety.

PubMed

Lee, Jieun; Kim, Jung K; Wachholtz, Amy

Previous research studies have indicated that biofeedback treatment and relaxation techniques are effective in reducing psychological and physical symptoms (Hammond, 2005; Manzoni, G. M., Pagnini, F., Castelnuovo, G., & Molinari, E., 2008). However, dearth of studies has compared heart rate variability (HRV) biofeedback treatment and relaxation training to reduce trait anxiety. The objective of this study was to determine the effect of HRV biofeedback treatment and relaxation training in reducing trait anxiety compared to control group without any treatment using students in a science and engineering university of South Korea. For the present study, a total of 15 graduate students with moderate level of trait anxiety were recruited for 4 individual sessions every two weeks. They were randomly assigned into three groups: biofeedback treatment (n = 5), relaxation training (n = 5), and no treatment control group (n = 5). Our results revealed significant difference in change score of trait anxiety between the HRV biofeedback treatment and the no treatment control group. However, no significant difference was found between the relaxation training group and the no treatment control group. In addition, there was no significant difference between the HRV biofeedback treatment and the relaxation training. Results of the present study indicate that there is potential benefit in utilizing HRV biofeedback treatment for stress management programs and/or anxiety reduction treatment.

Efficacy and safety of fractional CO2 laser versus fractional Er:YAG laser in the treatment of facial skin wrinkles.

PubMed

Robati, Reza M; Asadi, Elmira

2017-02-01

Ablative fractional lasers were introduced for treating facial rhytides. Few studies have compared fractional CO 2 and Er:YAG lasers on cutaneous photodamages by a split trial. The aim of the present study was to compare these modalities in a randomized controlled double-blind split-face design with multiple sessions and larger sample size compared to previous studies done before. Forty patients with facial wrinkles were enrolled. Patients were randomly assigned to receive three monthly treatments on each side of the face, one with a fractional CO 2 and one with a fractional Er:YAG laser. The evaluations included investigating clinical outcome determined by two independent dermatologists not enrolled in the treatment along with measuring skin biomechanical property of cheeks using a sensitive biometrologic device with the assessment of cutaneous resonance running time (CRRT). Moreover, possible side effects and patients' satisfaction have been recorded at baseline, 1 month after each treatment, and 3 months after the last treatment session. Clinical assessment showed both modalities significantly reduce facial wrinkles (p value < 0.05), with no appreciable difference between two lasers. Mean CRRT values also decreased significantly after the laser treatment compared to the baseline in both laser groups. There was no serious long-standing adverse effect after both laser treatments, but the discomfort was more pronounced by the participants after CO 2 laser treatment. According to the present study, both fractional CO 2 and fractional Er:YAG lasers show considerable clinical improvement of facial skin wrinkles with no serious adverse effects, but post-treatment discomfort seems to be lower with Er:YAG laser.

Incorporating bazedoxifene into the treatment paradigm for postmenopausal osteoporosis in Japan.

PubMed

Ohta, H; Solanki, J

2015-03-01

The incidence of osteoporosis-related fractures in Asian countries is steadily increasing. Optimizing osteoporosis treatment is especially important in Japan, where the rate of aging is increasing rapidlyelderly population is increasing rapidly and life expectancy is among the longest in the world. There are several therapies currently available in Japan for the treatment of postmenopausal osteoporosis, each with a unique risk/benefit profile. A novel selective estrogen receptor modulator, bazedoxifene (BZA), was recently approved for the treatment of postmenopausal osteoporosis in Japan. Results from a 2-year, phase 2 trial in postmenopausal Japanese women showed that BZA significantly improved lumbar spine and total hip bone mineral density compared with placebo, while maintaining endometrial and breast safety, consistent with results from 2 global, phase 3 trials including a 2-year osteoporosis prevention study and a 3-year osteoporosis treatment study. In the pivotal 3-year treatment study, BZA significantly reduced the incidence of new vertebral fractures compared with placebo; in a post hoc analysis of a subgroup of women at higher risk of fractures, BZA significantly reduced the risk of nonvertebral fractures compared with placebo and raloxifene. A 2-year extension of the 3-year treatment study demonstrated the sustained efficacy of BZA over 5 years of treatment. BZA was generally safe and well tolerated in these studies. In a "super-aging" society such as Japan, long-term treatment for postmenopausal osteoporosis is a considerable need. BZA may be considered as a first choice for younger women anticipating long-term treatment, and also an appropriate option for older women who are unable or unwilling to take bisphosphonates.

Do Stimulants Reduce the Risk for Alcohol and Substance Use in Youth With ADHD? A Secondary Analysis of a Prospective, 24-Month Open-Label Study of Osmotic-Release Methylphenidate.

PubMed

Hammerness, Paul; Petty, Carter; Faraone, Stephen V; Biederman, Joseph

2017-01-01

The purpose of this study was to examine the impact of stimulant treatment on risk for alcohol and illicit drug use in adolescents with ADHD. Analysis of data derived from a prospective open-label treatment study of adolescent ADHD ( n = 115, 76% male), and a historical, naturalistic sample of ADHD ( n = 44, 68% male) and non-ADHD youth ( n = 52, 73% male) of similar age and sex. Treatment consisted of extended-release methylphenidate in the clinical trial or naturalistic stimulant treatment. Self-report of alcohol and drug use was derived from a modified version of the Drug Use Screening Inventory. Rates of alcohol and drug use in the past year were significantly lower in the clinical trial compared with untreated and treated naturalistic ADHD comparators, and similar to rates in non-ADHD comparators. Well-monitored stimulant treatment may reduce the risk for alcohol and substance use in adolescent ADHD.

Rutosides for treatment of post-thrombotic syndrome.

PubMed

Morling, Joanne R; Yeoh, Su Ern; Kolbach, Dinanda N

2013-04-30

Post-thrombotic syndrome (PTS) is a long-term complication of deep venous thrombosis (DVT) that is characterised by pain, swelling, and skin changes in the affected limb. One in three patients with DVT will develop post-thrombotic sequelae within five years. Rutosides are a group of compounds derived from horse chestnut (Aesculus hippocastanum), a traditional herbal remedy for treating oedema formation in chronic venous insufficiency (CVI). However, it is not known whether rutosides are effective and safe in the treatment of PTS. To determine the effectiveness and safety of rutosides for treatment of PTS in patients with DVT compared to placebo, no intervention, elastic compression stockings (ECS) or any other treatment. The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched October 2012) and CENTRAL (2012, Issue 9). Clinical trials databases were searched for details of ongoing and unpublished studies. Two authors (JM and DNK) independently assessed studies for inclusion. Studies were included to allow the comparison of rutosides versus placebo or no treatment, rutosides versus ECS, and rutosides versus any other treatment. Two authors (JM and SEY) extracted information from the trials. Disagreements were resolved by discussion. Data were extracted using designated data extraction forms. The Cochrane risk of bias tool was used for all included studies to assist in the assessment of quality. Primary outcome measures were the occurrence of leg ulceration over time (yes or no) and any improvement or deterioration of post-thrombotic syndrome (yes or no). Secondary outcomes included reduction of oedema, pain, recurrence of deep venous thrombosis or pulmonary embolism, compliance with therapy, and adverse effects. All of the outcome measures were analysed using Mantel-Haenzel fixed-effect model odds ratios. The unit of analysis was the number of patients. Ten reports of nine studies were identified following searching and three studies with a total of 233 participants met the inclusion criteria. One study compared rutoside with placebo, one study compared rutosides with ECS and rutosides plus ECS versus ECS alone, and one study compared rutosides with an alternative venoactive remedy. Occurrence of leg ulceration was not reported in any of the included studies. There was a 29% odds of an improvement in PTS in the rutoside treated group versus placebo or no treatment, and lower rates of improvement in PTS in the rutoside treated group when compared with ECS, however these were statistically non-significant. Lower rates of improvement in PTS were shown in the rutoside treated group when compared with an alternative venoactive remedy. More PTS deterioration was shown in the placebo or no treatment group when compared with rutosides but this was not statistically significant. Compared with ECS, rutosides showed higher odds of PTS deterioration but this was also not statistically significant. One study reported on adverse effects showing higher odds of mild adverse effects in the rutoside treated group compared to placebo but this was not statistically significant. There was no evidence that rutosides were superior to the use of placebo or ECS. Overall, there is currently limited evidence that 'venoactive' or 'phlebotonic' remedies such as rutosides reduce symptoms of PTS. Mild side effects were noted in one study. The three studies included in this review provide no evidence for the use of rutosides in the treatment of PTS.

Cost-effectiveness of several atypical antipsychotics in orally disintegrating tablets compared with standard oral tablets in the treatment of schizophrenia in the United States.

PubMed

Ascher-Svanum, Haya; Furiak, Nicolas M; Lawson, Anthony H; Klein, Timothy M; Smolen, Lee J; Conley, Robert R; Culler, Steven D

2012-01-01

Although the use of innovative drug delivery systems, like orally disintegrating antipsychotic tablets (ODT), may facilitate medication adherence and help reduce the risk of relapse and hospitalization, no information is available about the comparative cost-effectiveness of standard oral tablets (SOT) vs ODT formulations in the treatment of schizophrenia. This study compared the cost-effectiveness of olanzapine ODT and olanzapine SOT in the usual treatment of outpatients with schizophrenia from a US healthcare perspective. The study also compared olanzapine ODT with risperidone and aripiprazole, two other atypical antipsychotics available in both ODT and SOT formulations. Published medical literature and a clinical expert panel were used to populate a 1-year Monte Carlo Micro-simulation model. The model captures clinical and cost parameters including adherence levels, treatment discontinuation by reason, relapse with and without inpatient hospitalization, quality-adjusted life years (QALYs), treatment-emergent adverse events, healthcare resource utilization, and associated costs. Key outcomes were total annual direct cost per treatment, QALY, and incremental cost-effectiveness (ICER) per 1 QALY gained. Based on model projections, olanzapine ODT therapy was more costly ($9808 vs $9533), but more effective in terms of a lower hospitalization rate (15% vs 16%) and better QALYs (0.747 vs 0.733) than olanzapine SOT therapy. Olanzapine ODT was more cost-effective than olanzapine SOT (ICER: $19,643), more cost-effective than risperidone SOT therapy (ICER: $39,966), and dominant (meaning less costly and more effective) than risperidone ODT and aripiprazole in ODT or SOT formulations. Lack of head-to-head randomized studies comparing the three studied atypical antipsychotics required making input assumptions that need further study. This micro-simulation found that the utilization of olanzapine ODT for the treatment of schizophrenia is predicted to be more cost-effective than any other ODT or SOT formulations of the studied atypical antipsychotic medications.

Cost-Effectiveness Models in Age-Related Macular Degeneration: Issues and Challenges.

PubMed

Schmier, Jordana K; Hulme-Lowe, Carolyn K

2016-03-01

Age-related macular degeneration (AMD) is a common ophthalmic condition that can have few symptoms in its early stage but can progress to major visual impairment. While there are no treatments for early-stage AMD, there are multiple modalities of treatment for advanced disease. Given the increasing prevalence of the disease, there are dozens of analyses of cost effectiveness of AMD treatments, but methods and approaches vary broadly. The goal of this review was to identify, characterize, and critique published models in AMD and provide guidance for their interpretation. After a literature review was performed to identify studies, and exclusion criteria applied to limit the review to studies comparing treatments for AMD, we compared methods across the 36 studies meeting the review criteria. To some extent, variation was related to targeting different audiences or acknowledging the most appropriate population for a given treatment. However, the review identified potential areas of uncertainty and difficulty in interpretation, particularly regarding duration of observation periods and the importance of visual acuity as an endpoint or a proxy for patient-reported utilities. We urge thoughtful consideration of these study characteristics when comparing results.

Midstory hardwood species respond differently to chainsaw girdle method and herbicide treatment

Treesearch

Ronald A. Rathfon; Michael R. Saunders

2013-01-01

Foresters in the Central Hardwoods Region commonly fell or girdle interfering trees and apply herbicide to the cut surface when performing intermediate silvicultural treatments. The objective of this study was to compare the use of single and double chainsaw girdle methods in combination with a herbicide treatment and, within the double girdle method, compare herbicide...

Comparative experimental pharmacokinetics of benzimidazole derivatives.

PubMed

Sergeeva, S A; Gulyaeva, I L

2008-12-01

Comparative study of experimental kinetics of distribution of benzimidazole derivatives (bemithyl, etomerzole, and thietazole) in organs and tissues was carried out after single and course treatment. The drugs intensely passed into organs and tissues from the blood after treatment by all protocols. Specific features of drug distribution were detected; for example, splenic tissue selectively accumulated thietazole during course treatment.

Concentrated ERP Delivered in a Group Setting: A Replication Study.

PubMed

Havnen, Audun; Hansen, Bjarne; Öst, Lars-Göran; Kvale, Gerd

2017-09-01

In a previous effectiveness study (Havnen et al., 2014), 35 obsessive compulsive disorder (OCD) patients underwent Concentrated Exposure Treatment (cET), which is a newly developed group treatment format delivered over four consecutive days. The primary aims of the present study were to evaluate the treatment results for a new sample of OCD patients receiving the cET treatment approach and to replicate the effectiveness study described in Havnen et al. (2014). Forty-two OCD patients underwent cET treatment. Treatment was delivered by different therapists than in Havnen et al. (2014), except for two groups led by the developers of the treatment. Assessments of OCD symptom severity, treatment satisfaction, and occupational impairment were included. The results showed a significant reduction in Yale-Brown Obsessive Compulsive Scale scores from pre-treatment to post-treatment, which was maintained at 6-month follow-up. At post-treatment, 74% of the sample was remitted; at 6-month follow-up, 60% were recovered. The sample showed a very high degree of overall treatment satisfaction. The results from the present study were statistically compared with those obtained in the previous study. The analyses showed that the study samples had comparable demographic data and equal application of treatment. The outcome of the present and original study did not differ significantly on primary and secondary outcome measures. This study shows that cET was successfully replicated in a new patient sample treated by different therapists than the original study. The results indicate that cET is well accepted by the patients, and the potential for dissemination is discussed.

Comparison of single and combination treatments of Phytoseiulus persimilis, Neoseiulus californicus, and Acramite (bifenazate) for control of twospotted spider mites in strawberries.

PubMed

Rhodes, Elena M; Liburd, Oscar E; Kelts, Crystal; Rondon, Silvia I; Francis, Roger R

2006-01-01

Greenhouse and field experiments were conducted from 2003 to 2005 to determine the effectiveness of combining releases of two predatory mite species, Phytoseiulus persimilis Athias-Henriot and Neoseiulus californicus (McGregor), and a reduced-risk miticide, Acramite (bifenazate), for control of twospotted spider mite (TSSM) (Tetranychus urticae Koch) in strawberries. In the greenhouse experiment, a combination treatment of P. persimilis and N. californicus was compared with single treatments of each species, Acramite application, and untreated control. All treatments significantly reduced TSSM numbers compared with the control. Field studies employed two approaches: one investigating the same five treatments as the greenhouse experiment and a second, comparing combination treatments of P. persimilis/N. californicus, Acramite/N. californicus, and Acramite/P. persimilis to single treatments of each and to control plots. Among the combination treatments, the P. persimilis/N. californicus treatment significantly reduced TSSM numbers compared with the control, but was not as effective as N. californicus alone during the 2003-2004 field season. Also, combination treatments of Acramite/N. californicus, and Acramite/P. persimilis significantly reduced TSSM populations compared with the control. These findings indicate that all three combination treatments are promising options for TSSM control in strawberries for growers in northern Florida and other strawberry producing areas of the world.

Regenerative therapies increase survivorship of avascular necrosis of the femoral head: a systematic review and meta-analysis.

PubMed

Andriolo, Luca; Merli, Giulia; Tobar, Carlos; Altamura, Sante Alessandro; Kon, Elizaveta; Filardo, Giuseppe

2018-02-06

The aim of this study was to document the available evidence on the use of regenerative techniques for the treatment of femoral head osteonecrosis (or avascular necrosis of femoral head, AVN) and to understand their benefit compared to core decompression (CD) alone in avoiding failure and the need for total hip replacement (THR). The search was conducted on three medical electronic databases according to PRISMA guidelines. The studies reporting number and timing of failures were included in a meta-analysis calculating cumulative survivorship with a Kaplan-Mayer curve. Moreover, the results on failures in treatment groups reported in RCT were compared with those documented in control groups, in order to understand the benefit of biological therapies compared to CD for the treatment of AVN. Forty-eight studies were included in this systematic review, reporting results of different types of regenerative techniques: mesenchymal stem cell implantation in the osteonecrotic area, intra-arterial infiltration with mesenchymal stem cells, implantation of bioactive molecules, or platelet-rich plasma. Overall, reported results were good, with a cumulative survivorship of 80% after ten year follow-up, and better results when regenerative treatments were combined to CD compared to CD alone (89.9% vs 70.6%, p < 0.0001). Regenerative therapies offer good clinical results for the treatment of AVN. The combination of CD with regenerative techniques provides a significant improvement in terms of survivorship over time compared with CD alone. Further studies are needed to identify the best procedure and the most suitable patients to benefit from regenerative treatments for AVN.

Childhood Obesity, Obesity Treatment Outcome, and Achieved Education: A Prospective Cohort Study.

PubMed

Hagman, Emilia; Danielsson, Pernilla; Brandt, Lena; Svensson, Viktoria; Ekbom, Anders; Marcus, Claude

2017-10-01

Childhood obesity represents a social burden. This study aims to investigate whether achieved educational level differs in young adults who have suffered obesity in childhood compared with the general population and to determine how obesity treatment influences achieved educational level. This prospective cohort study includes subjects from the Swedish Childhood Obesity Treatment Registry (BORIS, n = 1,465) who were followed up after 20 years of age. They were compared with a randomly selected matched population-based group (n = 6,979). Achieved educational level was defined as ≥12 years in school (completers). Covariates include sex, migration background, and attention deficit disorders for both groups. Furthermore, age and degree of obesity at start of obesity treatment, treatment duration, and efficacy were analyzed in the obese cohort. In the obese cohort, 55.4% were school completers, compared with 76.2% in the comparison group (adjusted odds ratio [OR] = .42, p < .0001). Subjects with moderate obesity had a completion rate of 64.4%, compared with 50.9% among subjects with morbid obesity (adjusted OR = .57, p < .0001). Successful obesity treatment was associated with increased future educational level, compared with those experiencing no treatment effect (61.9% vs. 51.3% completers; adjusted OR = 1.4, p < .05). In children with attention deficit disorder, obesity was not an extra risk for not completing 12 or more years of schooling, p = .11. Obesity in childhood was associated with low educational level in early adulthood. Children and adolescents with obesity may require special support at school in addition to health care treatment to lose weight. Copyright © 2017 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Health economic evaluation of patients treated for nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: secondary analysis of a multicenter randomized clinical trial of vancomycin and linezolid.

PubMed

Niederman, Michael S; Chastre, Jean; Solem, Caitlyn T; Wan, Yin; Gao, Xin; Myers, Daniela E; Haider, Seema; Li, Jim Z; Stephens, Jennifer M

2014-09-01

Results from studies comparing health care resource use (HCRU), costs of treatment, and cost-effectiveness of linezolid compared with vancomycin therapy in the treatment of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA) nosocomial pneumonia are limited in the published literature. We therefore conducted an analysis to compare the HCRU, costs of treatment, and cost-effectiveness of linezolid compared with vancomycin in the treatment of hospitalized patients with MRSA nosocomial pneumonia using data from a Phase IV clinical trial. The economic effect of moderate to severe adverse events (MSAEs) and the development of renal failure were also evaluated. We performed a post hoc analysis of data from a Phase IV, double-blind, randomized, comparator-controlled, multicenter trial that compared linezolid and vancomycin treatment in patients with MRSA nosocomial pneumonia. HCRU and costs were compared based on treatment, development of MSAEs, and development of renal failure using data from the modified intent-to-treat population. Predictors of costs were evaluated using generalized linear models. A piggyback cost-effectiveness analysis was conducted to assess the incremental cost-effectiveness ratio of linezolid versus vancomycin, given the significantly higher clinical success of linezolid compared with vancomycin found in the trial. Overall, HCRU and costs were similar between the linezolid and vancomycin treatment groups; drug costs were significantly higher and dialysis costs significantly lower for linezolid- compared with vancomycin-treated patients. Total treatment costs were approximately $8000 higher (P = .046) for patients who developed renal failure compared with those who did not. Renal failure occurred more commonly in patients randomized to receive vancomycin (15%) compared with linezolid (4%; P < .001). Region, ventilator-associated pneumonia, clinical failure, and development of renal failure were associated with significantly higher total costs. The point estimate incremental cost-effectiveness ratio for linezolid compared with vancomycin was $16,516 per treatment success, with linezolid dominant in 24% and dominated in <2% of bootstrapped samples. This phase 4 clinical trial conducted in patients with MRSA-confirmed nosocomial pneumonia reveals that linezolid- compared with vancomycin-treated patients had similar HCRU and total overall costs. Fewer patients developed renal failure during the study while taking linezolid compared with vancomycin, and patients with a documented MSAE or renal failure had increased HCRU and costs. In summary, linezolid may be a cost-effective treatment strategy in MRSA-confirmed nosocomial pneumonia. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Comparing Treatment Policies with Assistance from the Structural Nested Mean Model

PubMed Central

Lu, Xi; Lynch, Kevin G.; Oslin, David W.; Murphy, Susan

2015-01-01

Summary Treatment policies, also known as dynamic treatment regimes, are sequences of decision rules that link the observed patient history with treatment recommendations. Multiple, plausible, treatment policies are frequently constructed by researchers using expert opinion, theories and reviews of the literature. Often these different policies represent competing approaches to managing an illness. Here we develop an “assisted estimator” that can be used to compare the mean outcome of competing treatment policies. The term “assisted” refers to the fact estimators from the Structural Nested Mean Model, a parametric model for the causal effect of treatment at each time point, are used in the process of estimating the mean outcome. This work is motivated by our work on comparing the mean outcome of two competing treatment policies using data from the ExTENd study in alcohol dependence. PMID:26363892

A review of dosimetric and toxicity modeling of proton versus photon craniospinal irradiation for pediatrics medulloblastoma.

PubMed

Ho, Evangeline S Q; Barrett, Sarah A; Mullaney, Laura M

2017-08-01

Craniospinal irradiation (CSI) is the standard radiation therapy treatment for medulloblastoma. Conventional CSI photon therapy (Photon-CSI) delivers significant dose to surrounding normal tissue (NT). Research into pediatric CSI with proton therapy (Proton-CSI) has increased, with the aim of exploiting the potential to reduce NT dose and associated post-treatment complications. This review aims to compare treatment outcomes of pediatric medulloblastoma patients between Proton- and Photon-CSI treatments. A search and review of studies published between 1990 and 2016 comparing pediatric (2-18 years) medulloblastoma Proton- and Photon-CSI in three aspects - normal organ sparing and target coverage; normal organ dysfunction and second malignancy risks - was completed. Fifteen studies were selected for review and the results were directly compared. Proton-CSI reported improved out-of-field organ sparing while target coverage improvements were inconsistent. Normal organ dysfunction risks were predicted to be lower following Proton-CSI. Secondary malignancy risks (SMRs) were generally lower with Proton-CSI based on several different risk models. Proton-CSI conferred better treatment outcomes than Photon-CSI for pediatric medulloblastoma patients. This review serves to compare the current literature in the absence of long-term data from prospective studies.

Comparative cost analysis of inpatient integrative medicine-Results of a pilot study.

PubMed

Ostermann, Thomas; Lauche, Romy; Cramer, Holger; Dobos, Gustav

2017-06-01

Costs of integrative treatment alone and in comparison with other treatment approaches have scarcely been reported in the past. This study presents results of a comparative cost analysis of an inpatient integrative medicine treatment costs. Data from 2006 for inpatients referred to a Department of Integrative Medicine in Germany were used. Case-related treatment costs were calculated, and transformed into Casemix-Indices and revenues per DRG. Costs were compared between departments at the same hospital and between different hospitals using univariate statistics and Chi-Square tests. In total 1253 inpatients (81.4% female, 61.1±14.4years) were included in the current analysis. Most patients were treated for diseases of the musculoskeletal system (57.2%), followed by diseases of the digestive system (11.4%), and diseases of the nervous system (10.4%). The department received an additional payment for most of the patients (88.0%), which led to an effective appreciation of 10.8% per case compared to the standardized Casemix-Index. In-house comparisons with other departments found the department in close vicinity to the departments of Internal medicine with regards to CMI and mean revenue, however the Patient Clinical Complexity Level was significantly lower in the Integrative medicine department. The interhospital comparison revealed comparable Casemix-Index and DRG-revenue, however the additional payment increased the mean revenue significantly. Modern integrative in-patient treatment is mostly cost-equivalent to conventional treatment. Cost effectiveness studies should be considered to further investigate the potential of integrative in patient treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

Plasma Rich in Growth Factors for the Treatment of Dry Eye after LASIK Surgery.

PubMed

Sanchez-Avila, Ronald Mauricio; Merayo-Lloves, Jesus; Fernandez, Maria Laura; Rodriguez-Gutierrez, Luis Alberto; Jurado, Nancy; Muruzabal, Francisco; Orive, Gorka; Anitua, Eduardo

2018-06-08

The aim of this study was to evaluate the use of plasma rich in growth factors (PRGF) eye drops in patients with dry eye disease after laser-assisted in situ keratomileusis (LASIK) surgery. This is a longitudinal, retrospective, comparative, and descriptive study of 77 eyes of 42 patients with dry eye disease following LASIK surgery. This study was designed to evaluate the efficacy of PRGF treatment compared to conventional therapy (control group). Outcome measures including signs and symptoms of dry eye disease were evaluated before and after treatment. The percentage of change before and after treatment for each clinical variable measured was compared between both groups. There were 1-4 treatment cycles with PRGF eye drops (1 cycle = 6 weeks). Results showed a statistically significant improvement in the Ocular Surface Disease Index (38.12%), visual analogue scale scores for frequency (41.89%) and severity (42.47%), and the Schirmer test scores (88.98%) after PRGF treatment (p < 0.05). No adverse events were reported after PRGF treatment. These results suggest that PRGF eye drops are effective for the improvement of dry eye symptoms in patients who underwent LASIK surgery in comparison to the conventional therapy. The treatment with PRGF is an alternative for patients who suffer from postoperative dry eye. © 2018 S. Karger AG, Basel.

Comparing Effectiveness of Treatments for Borderline Personality Disorder in Communal Mental Health Care: The Oulu BPD Study.

PubMed

Leppänen, V; Hakko, H; Sintonen, H; Lindeman, S

2016-02-01

The implementation of effective psychotherapies in community mental health care is challenging. This study aimed to create a well-structured and easily applicable treatment model for patients with severe borderline personality disorder (BPD). We integrated a schema therapy based psycho-educational group into an available individual therapy. Two groups were formed: (1) community treatment by experts (CTBE) patients (n = 24) receiving new treatment and (2) treatment as usual (TAU) patients (n = 47). Changes in symptoms were measured by Borderline Personality Disorder Severity Index-IV interview and quality of life by the 15D health-related quality of life questionnaire. After 1 year the CTBE patients showed a significant reduction in a wider range of BPD symptoms and better quality of life than TAU patients. The results of this study are encouraging. A well-structured treatment model was successfully implemented into community mental health care with improved patient adherence to treatment and superior treatment outcomes compared to TAU patients.

Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.

PubMed

Nierenberg, Andrew A; Sylvia, Louisa G; Leon, Andrew C; Reilly-Harrington, Noreen A; Shesler, Leah W; McElroy, Susan L; Friedman, Edward S; Thase, Michael E; Shelton, Richard C; Bowden, Charles L; Tohen, Mauricio; Singh, Vivek; Deckersbach, Thilo; Ketter, Terence A; Kocsis, James H; McInnis, Melvin G; Schoenfeld, David; Bobo, William V; Calabrese, Joseph R

2014-02-01

Classic and second-generation antipsychotic mood stabilizers are recommended for treatment of bipolar disorder, yet there are no randomized comparative effectiveness studies that have examined the 'real-world' advantages and disadvantages of these medications. We describe the strategic decisions in the design of the Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE). This article outlines the key issues and solutions the investigators faced in designing a clinical trial that would maximize generalizability and inform real-world clinical treatment of bipolar disorder. Bipolar CHOICE was a 6-month, multi-site, prospective, randomized clinical trial of outpatients with bipolar disorder. This study compares the effectiveness of quetiapine versus lithium, each with adjunctive personalized treatments (APTs). The co-primary outcomes selected are the overall benefits and harms of the study medications (as measured by the Clinical Global Impression-Efficacy Index) and the Necessary Clinical Adjustments (a measure of the number of medication changes). Secondary outcomes are continuous measures of mood, the Framingham General Cardiovascular Risk Score, and the Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT). The final study design consisted of a single-blind, randomized comparative effectiveness trial of quetiapine versus lithium, plus APT, across 10 sites. Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan. In all, 482 participants were randomized to the study, and 364 completed the study. The potential limitations of the study include the heterogeneity of APT, selection of study medications, lack of a placebo-control group, and participants' ability to pay for study medications. We expect that this study will inform our understanding of the benefits and harms of lithium, a classic mood stabilizer, compared to quetiapine, a second-generation antipsychotic with broad-spectrum activity in bipolar disorder, and will provide an example of a well-designed and well-conducted randomized comparative effectiveness clinical trial.

Impact of a Comparative Study on the Management of Scoliosis in Duchenne Muscular Dystrophy: Are Corticosteroids Decreasing the Rate of Scoliosis Surgery in the United States?

PubMed

Raudenbush, Brandon L; Thirukumaran, Caroline P; Li, Yue; Sanders, James O; Rubery, Paul T; Mesfin, Addisu

2016-09-01

A cross-sectional analysis. The aim of this study was to determine whether the surgical treatment for scoliosis due to Duchenne muscular dystrophy (DMD) has decreased over a recent 11-year period, specifically, after the wide acceptance of glucocorticoid treatment for DMD. DMD can result in a flaccid neuromuscular scoliosis that has been traditionally treated surgically. In 2004, a comparative study demonstrated that glucocorticoid treatment decreased the progression of scoliosis in DMD. We used the Nationwide Inpatient Sample from 2001 to 2012 to identify patients with DMD undergoing spinal fusion. Demographic information (age, hospital size, location, geographic status) was collected. We examined the distribution of patient and hospital characteristics among cohorts undergoing spinal fusion from 2001 to 2004 (period 1; before publication of the comparative study), 2005 to 2008 (period 2; immediately following publication of the comparative study), and 2009 to 2012 (period 3; moderate duration following publication of the comparative study). We identified 1874 males undergoing spinal fusion. During this period, the overall rate of DMD surgeries declined by 48%-from 1.87 surgeries in 2001 to 0.97 surgeries in 2012 per million US males per year. This decline was significantly pronounced following the publication of the comparative study [periods 2 and 3; For period 2 vs. period 1: incidence rate ratio (IRR) = 0.71, 95% confidence interval (95% CI) = 0.56-0.91, P = 0.01; For period 3 vs. period 1: IRR = 0.77, 95% CI = 0.61-0.97, P = 0.03]. Our study demonstrates a significant decrease in the rate of scoliosis surgery for DMD from 2001 to 2012. It appears that the decline in surgical treatment could be related to the publication and landmark study demonstrating decreased progression of scoliosis with glucocorticoid treatment. 3.

Comparisons of the efficacy of alpha glucosidase inhibitors on type 2 diabetes patients between Asian and Caucasian.

PubMed

Cai, Xiaoling; Han, Xueyao; Luo, Yingying; Ji, Linong

2013-01-01

To compare the efficacy of glycemic control and insulin secretion of alpha glucosidase inhibitors (AGI) on type 2 diabetes patients between Asian and Caucasian. The MEDLINE®, EMBASE®, CENTRAL were searched and qualified studies in Asian and Caucasian population comparing AGI treatment with placebo or other oral anti-diabetic drugs in type 2 diabetic patients were included. Totally 58 qualified studies were included. When AGI treatment was compared with placebo, a significant difference in HbA1c decline from baseline favoring AGI treatment was found in Asian (weighted mean difference (WMD), -0.50%; 95% CI, -0.66% to -0.34%) and in Caucasian a significant difference in HbA1c decline favoring AGI treatment was also found (WMD, -0.68%; 95% CI, -0.76% to -0.60%). In Asian, fasting plasma glucose was reduced with AGI treatment compared with placebo (WMD, -0.53 mmol/L; 95% CI, -0.91 to -0.14 mmol/L) and in Caucasian there was also a significant difference in FPG changes favoring AGI therapy (WMD, -0.88 mmol/L; 95% CI, -1.00 to -0.77 mmol/L). Studies in Asian showed a significant difference in fasting insulin changes favoring AGI treatment (WMD, -0.78 uU/ml; 95% CI, -0.96 to -0.59 uU/ml). While in Caucasian fasting insulin was decreased without significance with AGI treatment (WMD-1.24 uU/ml; 95% CI, -2.51 to 0.04 uU/ml). Body weight was decreased with AGI treatment in Asian (WMD, -1.00 kg; 95% CI, -1.69 to -0.31 kg) and was also decreased with AGI treatment in Caucasian (WMD, -0.73 kg; 95% CI, -1.13 to -0.33 kg). According to results from this meta-analysis, the efficacy in glucose lowering, body weight reduction and insulin secretion decreasing of AGI treatment in Asian were comparable with those in Caucasian.

The effects of pay-for-performance on tuberculosis treatment in Taiwan.

PubMed

Li, Ya-Hsin; Tsai, Wen-Chen; Khan, Mahmud; Yang, Wen-Ta; Lee, Tsuey-Fong; Wu, Yi-Chun; Kung, Pei-Tseng

2010-07-01

In order to make tuberculosis (TB) treatment more effective and to lower the transmission rate of the disease, the Bureau of National Health Insurance (BNHI) in Taiwan implemented the 'Pay-for-Performance on Tuberculosis' programme (P4P on TB) in 2004. This study investigates the effectiveness of the P4P system in terms of cure rate and length of treatment. This retrospective study obtained information on all TB cases in the national data sets of Taiwan for the years 2002 to 2005. The number of cases in pre-P4P years (2002 and 2003) was 25 754, compared with 33 536 in the post-P4P implementation years (2004 and 2005). The effectiveness of the programme was evaluated by comparing the TB cure rate and length of treatment before and after the implementation of the P4P programme, and between participating and non-participating hospitals. Logistic regression analysis was conducted to explore the factors affecting TB patients' cure rate within a 12-month treatment period. The cure rate and the average length of treatment before the implementation of P4P were 46.9% and 256.24 days, respectively, compared with 63.0% and 249.74 days after implementation of P4P. The cure rate and length of treatment in P4P hospitals were 68.1% and 249.13 days, respectively, compared with 42.4% and 53.71 days in non-P4P hospitals. This study found that both the cure rate and average length of treatment for cured cases improved significantly after the implementation of the P4P on TB programme in Taiwan. Compared with non-P4P hospitals, P4P hospitals had significantly better treatment outcomes. Patients' age, income level, the physician density of a patient's place of residence, and whether the hospital has joined the P4P on TB programme are factors affecting the treatment outcomes of TB patients in Taiwan.

What Sex Abusers Say about Their Treatment: Results from a Qualitative Study on Pedophiles in Treatment at a Canadian Penitentiary Clinic

ERIC Educational Resources Information Center

Drapeau, Martin; Korner, Annett C.; Granger, Luc; Brunet, Louis

2005-01-01

This exploratory study used qualitative methodology to examine what pedophiles think about treatment, as well as their daily experience of a treatment program. To this end, twenty-three offenders receiving treatment from the La Macaza federal penitentiary clinic were interviewed using non-directive semi-structured interviews. Comparative analysis…

Associations Between Medication Class and Subsequent Augmentation of Depression Treatment in Privately Insured US Adults.

PubMed

Ameli, Omid; Soria-Saucedo, Rene; Smith, Eric G; Cabral, Howard J; Soley-Bori, Marina; Kazis, Lewis E

2017-06-01

Treatment augmentation is an important clinical decision in the pharmacotherapy for depression, yet few studies have examined the rates of treatment augmentation by medication class. The aim of this study was to examine which initial pharmacotherapies for depression are more likely than others to result in subsequent treatment augmentation. This study is a retrospective cohort analysis of administrative data of 214,705 privately insured US adults between the age of 18 and 64 years who were diagnosed with a new episode of depression in 2009. Propensity score-adjusted logistic regression and Cox regression were used to model the effect of the class of initial monotherapy on treatment augmentation. Risk adjustors included depression severity, comorbidities, provider type, insurance, and demographic characteristics. The class of initial monotherapy and the health care provider type were the main independent variables of interest. The outcome was the augmentation of monotherapy. Thirty-four percent of individuals received treatment augmentation. Compared with selective serotonin reuptake inhibitor monotherapy, second-generation antipsychotics as the initial treatment were associated with significant increase in the likelihood of augmentation compared with the other classes (hazards ratio, 2.59; 95% confidence interval [CI], 2.51-2.68). This result was corroborated after propensity score adjustment (odds ratio, 2.85; 95% CI, 2.70-3.00) when comparing second-generation antipsychotics to the other classes of pharmacotherapy. The other significant predictor of treatment augmentation was the provider type. Mental health specialists were 27% more likely to augment a treatment compared with generalists (hazards ratio, 1.27; 95% CI, 1.25-1.30). The type of initial antidepressant therapy is associated with the chances of treatment augmentation. Second-generation antipsychotics progressed to augmentation more rapidly than the other classes.

Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children.

PubMed

Watkinson, Simon; Harrison, Jayne E; Furness, Susan; Worthington, Helen V

2013-09-30

Prominent lower front teeth (termed reverse bite; under bite; Class III malocclusion) may be due to a combination of the jaw or tooth positions or both. The upper jaw (maxilla) can be too far back or the lower jaw (mandible) too far forward, or both. Prominent lower front teeth can also occur if the upper front teeth (incisors) are tipped back or the lower front teeth are tipped forwards, or both. Various treatment approaches have been described to correct prominent lower front teeth in children and adolescents. To assess the effects of orthodontic treatment for prominent lower front teeth in children and adolescents. We searched the following databases: Cochrane Oral Health Group's Trials Register (to 7 January 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 12), MEDLINE via OVID (1946 to 7 January 2013), and EMBASE via OVID (1980 to 7 January 2013). Randomised controlled trials (RCTs) recruiting children or adolescents or both (aged 16 years or less) receiving any type of orthodontic treatment to correct prominent lower front teeth (Class III malocclusion). Orthodontic treatments were compared with control groups who received either no treatment, delayed treatment or a different active intervention. Screening of references, identification of included and excluded studies, data extraction and assessment of the risk of bias of the included studies was performed independently and in duplicate by two review authors. The mean differences with 95% confidence intervals were calculated for continuous data. Meta-analysis was only undertaken when studies of similar comparisons reported comparable outcome measures. A fixed-effect model was used. The I2 statistic was used as a measure of statistical heterogeneity. Seven RCTs with a total of 339 participants were included in this review. One study was assessed as at low risk of bias, three studies were at high risk of bias, and in the remaining three studies risk of bias was unclear. Four studies reported on the use of a facemask, two on the chin cup, one on the tandem traction bow appliance, and one on mandibular headgear. One study reported on both the chin cup and mandibular headgear appliances.One study (n = 73, low quality evidence), comparing a facemask to no treatment, reported a mean difference (MD) in overjet of 4.10 mm (95% confidence interval (CI) 3.04 to 5.16; P value < 0.0001) favouring the facemask treatment. Two studies comparing facemasks to untreated control did not report the outcome of overjet. Three studies (n = 155, low quality evidence) reported ANB (an angular measurement relating the positions of the top and bottom jaws) differences immediately after treatment with a facemask when compared to an untreated control. The pooled data showed a statistically significant MD in ANB in favour of the facemask of 3.93 ° (95% CI 3.46 to 4.39; P value < 0.0001). There was significant heterogeneity between these studies (I2 = 82%). This is likely to have been caused by the different populations studied and the different ages at the time of treatment.One study (n = 73, low quality evidence) reported outcomes of the use of the facemask compared to an untreated control at three years follow-up. This study showed that improvements in overjet and ANB were still present three years post-treatment. In this study, adverse effects were reported but due to the low prevalence of temporomandibular (TMJ) signs and symptoms no analysis was undertaken.Two studies (n = 90, low quality evidence) compared the chin cup with an untreated control. Both studies found a statistically significant improvement in ANB, and one study also found an improvement in the Wits appraisal. Data from these two studies were not suitable for pooling.A single study of the tandem traction bow appliance compared to untreated control (n = 30, very low quality evidence) showed a statistically significant difference in both overjet and ANB favouring the intervention group.The remaining two studies did not report the primary outcome of this review. There is some evidence that the use of a facemask to correct prominent lower front teeth in children is effective when compared to no treatment on a short-term basis. However, in view of the general poor quality of the included studies, these results should be viewed with caution. Further randomised controlled trials with long follow-up are required.

Trismus following different treatment modalities for head and neck cancer: a systematic review of subjective measures.

PubMed

Loh, Sook Y; Mcleod, Robert W J; Elhassan, Hassan A

2017-07-01

The aim of this review was to compare systematically the subjective measure of trismus between different interventions to treat head and neck cancer, particularly those of the oropharynx. Using The Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) Guidelines, Six databases were searched for the text using various terms which include "oropharyngeal/head and neck cancer", "trismus/mouth opening" and the various treatment modalities. Included in the review were clinical studies (> or =10 patients). Three observers independently assessed the papers identified. Among the six studies reviewed, five showed a significantly worst outcome with regard to the quality-of-life questionnaire scores for a radiotherapy or surgery and radiotherapy (RT) ± chemotherapy or chemoradiotherapy when compared to surgery alone. Only one study showed no significant difference between surgery alone and other treatment modalities. Subjective quality-of-life measures are a concurrent part of modern surgical practice. Although subjective measures were utilised to measure post operative trismus successfully, there was no consensus as to which treatment modality had overall better outcomes, with conflicting studies in keeping with the current debate in this field. Larger and higher quality studies are needed to compare all three treatment modalities.

Utility of Boron in Dermatology.

PubMed

Jackson, David G; Cardwell, Leah A; Oussedik, Elias; Feldman, Steven R

2017-08-09

Boron compounds are being investigated as therapies for dermatologic conditions. Several features of boron chemistry make this element an ideal component in dermatologic treatments. We review the published dermatologically-relevant clinical trials and case studies pertaining to boron compounds. PubMed was utilized to query terms boron, chemistry, drug, development, dermatology, atopic dermatitis, psoriasis, onychomycosis, tavaborole, AN 2690, crisaborole, and AN 2728. Clinical trials, case studies, animal studies and in vitro studies. pertaining to atopic dermatitis, psoriasis and onychomycosis were included. Crisaborole 2% topical solution reduced atopic dermatitis lesions by approximately 60% when compared to pre-treatment baseline. Crisaborole maintains its dose-dependent effect in treatment of psoriasis and significantly reduces psoriatic plaques when compared to controls. Adverse effects were mild, frequency of events varied between studies. Crisaborole was well tolerated when applied to sensitive skin. Topical tavaborole significantly reduced or eliminated onychomycosis with minimal side effects compared to placebo. Tavaborole was effective in treating recalcitrant onychomycosis. Boron-based compounds form stable interactions with enzyme targets and are safe medications for the treatment of atopic dermatitis, psoriasis, and onychomycosis. The mild and rare side effects of topical boron-based compounds may make them ideal treatments for individuals with sensitive skin and pediatric populations.

Effect of Botulinum Toxin and Surgery among Spasmodic Dysphonia Patients.

PubMed

van Esch, Babette F; Wegner, Inge; Stegeman, Inge; Grolman, Wilko

2017-02-01

Objective The effect of botulinum toxin among patients with adductor spasmodic dysphonia (AdSD) is temporary. To optimize long-term treatment outcome, other therapy options should be evaluated. Alternative treatment options for AdSD comprise several surgical treatments, such as thyroarytenoid myotomy, thyroplasty, selective laryngeal adductor denervation-reinnervation, laryngeal nerve crush, and recurrent laryngeal nerve resection. Here, we present the first systematic review comparing the effect of botulinum toxin with surgical treatment among patients diagnosed with AdSD. Data Sources MEDLINE (PubMed), EMBASE, and the Cochrane Library. Methods Articles were reviewed by 2 independent authors, and data were compiled in tables for analysis of the objective outcome (voice expert evaluation after voice recording), the subjective outcome (patient self-assessment scores), and voice-related quality of life (Voice Health Index scores). Results No clinical trials comparing both treatment modalities were identified. Single-armed studies evaluated either the effect of botulinum toxin or surgical treatment. Thirteen studies reported outcomes after botulinum toxin treatment (n = 419), and 9 studies reported outcomes after surgical treatment (n = 585 patients). A positive effect of bilateral botulinum toxin injections was found for the objective voice outcome, subjective voice outcome, and quality of life. The duration of the beneficial effect ranged from 15 to 18 weeks. Surgical treatment had an overall positive effect on objective voice improvement, subjective voice improvement, and quality of live. Conclusion No preference for one treatment could be demonstrated. Prospective clinical trials comparing treatment modalities are recommended to delineate the optimal outcomes by direct comparison.

Study quality on groin injury management remains low: a systematic review on treatment of groin pain in athletes

PubMed Central

Serner, Andreas; van Eijck, Casper H; Beumer, Berend R; Hölmich, Per; Weir, Adam; de Vos, Robert-Jan

2015-01-01

Background Groin pain in athletes is frequent and many different treatment options have been proposed. The current level of evidence for the efficacy of these treatments is unknown. Objective Systematically review the literature on the efficacy of treatments for groin pain in athletes. Methods Nine medical databases were searched in May 2014. Inclusion criteria: treatment studies in athletes with groin pain; randomised controlled trials, controlled clinical trials or case series; n>10; outcome measures describing number of recovered athletes, patient satisfaction, pain scores or functional outcome scores. One author screened search results, and two authors independently assessed study quality. A best evidence synthesis was performed. Relationships between quality score and outcomes were evaluated. Review registration number CRD42014010262. Results 72 studies were included for quality analysis. Four studies were high quality. There is moderate evidence that, for adductor-related groin pain, active exercises compared with passive treatments improve success, multimodal treatment with a manual therapy technique shortens the time to return to sports compared with active exercises and adductor tenotomy improves treatment success over time. There is moderate evidence that for athletes with sportsman's hernia, surgery results in better treatment success then conservative treatment. There was a moderate and inverse correlation between study quality and treatment success (p<0.001, r=−0.41), but not between study quality and publication year (p=0.09, r=0.20). Conclusions Only 6% of publications were high quality. Low-quality studies showed significantly higher treatment success and study quality has not improved since 1985. There is moderate evidence for the efficacy of conservative treatment (active exercises and multimodal treatments) and for surgery in patients with adductor-related groin pain. There is moderate evidence for efficacy of surgical treatment in sportsman's hernia. PMID:25633830

Ablative fractional lasers (CO(2) and Er:YAG): a randomized controlled double-blind split-face trial of the treatment of peri-orbital rhytides.

PubMed

Karsai, Syrus; Czarnecka, Agnieszka; Jünger, Michael; Raulin, Christian

2010-02-01

Ablative fractional lasers were introduced for treating facial rhytides in an attempt to achieve results comparable to traditional ablative resurfacing but with fewer side effects. However, there is conflicting evidence on how well this goal has generally been achieved as well as on the comparative value of fractional CO(2) and Er:YAG lasers. The present study compares these modalities in a randomized controlled double-blind split-face study design. Twenty-eight patients were enrolled and completed the entire study. Patients were randomly assigned to receive a single treatment on each side of the peri-orbital region, one with a fractional CO(2) and one with a fractional Er:YAG laser. The evaluation included the profilometric measurement of wrinkle depth, the Fitzpatrick wrinkle score (both before and 3 months after treatment) as well as the assessment of side effects and patient satisfaction (1, 3, 6 days and 3 months after treatment). Both modalities showed a roughly equivalent effect. Wrinkle depth and Fitzpatrick score were reduced by approximately 20% and 10%, respectively, with no appreciable difference between lasers. Side effects and discomfort were slightly more pronounced after Er:YAG treatment in the first few days, but in the later course there were more complaints following CO(2) laser treatment. Patient satisfaction was fair and the majority of patients would have undergone the treatment again without a clear preference for either method. According to the present study, a single ablative fractional treatment session has an appreciable yet limited effect on peri-orbital rhytides. When fractional CO(2) and Er:YAG lasers are used in such a manner that there are comparable post-operative healing periods, comparable cosmetic improvement occurs. Multiple sessions may be required for full effect, which cancels out the proposed advantage of fractional methods, that is, fewer side effects and less down time.

Clinical efficacy and safety of topical versus oral ivermectin in treatment of uncomplicated scabies.

PubMed

Ahmad, Hesham M; Abdel-Azim, Eman S; Abdel-Aziz, Rasha T

2016-01-01

Many medications are available for scabies treatment including oral and topical ivermectin. However, studies comparing these two forms as a scabies treatment are few. This study compares efficacy and safety of topical versus oral ivermectin as scabies treatment. The study included 62 confirmed uncomplicated scabies patients, divided into: Group I (32 patients, received topical ivermectin) and Group II (30 patients, received oral ivermectin). Patients were assessed, clinically and by KOH smear at 1, 2 and 4 weeks. Treatment was repeated after one week in patients with persistent infection. Adverse events were recorded. Most patients (87.5% and 73.5% in group I and group II respectively) were symptom free after a single treatment. A second treatment was required in 4 patients of group I and 8 patients of group II. However, 2 weeks after treatment symptoms and signs completely resolved in all cases with no recurrence at 4 weeks. This study suggests that both topical and oral ivermectin are safe and equally effective in treatment of uncomplicated scabies. Single treatment, whether topical or oral, is associated with high cure rate in a week post treatment. However, repeating treatment after one week may be required to achieve 100% cure. © 2015 Wiley Periodicals, Inc.

Repeated addiction treatment use in Sweden: a National Register Database study.

PubMed

Grahn, Robert; Chassler, Deborah; Lundgren, Lena

2014-11-01

Sweden has a free, universal addiction treatment system, yet few studies exist examining utilization of treatment in this country. This study identified predisposing, enabling, and need factors associated with history of number of voluntary addiction treatment episodes for a national sample of 12,009 individuals assessed for an alcohol and/or drug use disorder in Sweden. On average, people reported 4.3 prior treatment episodes. Linear regression methods identified that predisposing factors such as older age and being male were associated with more voluntary addiction treatment episodes compared to younger and female clients; a higher Addiction Severity Index (ASI) employment score (an enabling factor) was associated with more voluntary addiction treatment episodes; and need factors including a history of inpatient mental health treatment, a higher ASI psychiatric score, a higher ASI alcohol score, higher levels of illicit drug use, more compulsory addiction treatment episodes, a lower ASI legal score, and a history of criminal justice involvement were all associated with more voluntary addiction treatment episodes compared to their counterparts.. There were no differences in the number of treatment episodes by education or immigrant status. (1) Need is a key factor associated with more treatment use. (2) Further studies are needed to identify gender differences in access/use of treatment. (3) Given multiple treatment histories, Swedish addiction treatment policy should reflect a chronic care model rather than an acute care model.

Effectiveness of Mindfulness-Based Group Therapy Compared to the Usual Opioid Dependence Treatment.

PubMed

Imani, Saeed; Atef Vahid, Mohammad Kazem; Gharraee, Banafsheh; Noroozi, Alireza; Habibi, Mojtaba; Bowen, Sarah

2015-06-01

This study investigated the effectiveness of mindfulness-based group therapy (MBGT) compared to the usual opioid dependence treatment (TAU).Thirty outpatients meeting the DSM-IV-TR criteria for opioid dependence from Iranian National Center for Addiction Studies (INCAS) were randomly assigned into experimental (Mindfulness-Based Group Therapy) and control groups (the Usual Treatment).The experimental group undertook eight weeks of intervention, but the control group received the usual treatment according to the INCAS program. The Five Factor Mindfulness Questionnaire (FFMQ) and the Addiction Sevier Index (ASI) were administered at pre-treatment and post-treatment assessment periods. Thirteen patients from the experimental group and 15 from the control group completed post-test assessments. The results of MANCOVA revealed an increase in mean scores in observing, describing, acting with awareness, non-judging, non-reacting, and decrease in mean scores of alcohol and opium in MBGT patient group. The effectiveness of MBGT, compared to the usual treatment, was discussed in this paper as a selective protocol in the health care setting for substance use disorders.

Effectiveness of Mindfulness-Based Group Therapy Compared to the Usual Opioid Dependence Treatment

PubMed Central

Imani, Saeed; Atef Vahid, Mohammad Kazem; Gharraee, Banafsheh; Noroozi, Alireza; Habibi, Mojtaba; Bowen, Sarah

2015-01-01

Objective: This study investigated the effectiveness of mindfulness-based group therapy (MBGT) compared to the usual opioid dependence treatment (TAU).Thirty outpatients meeting the DSM-IV-TR criteria for opioid dependence from Iranian National Center for Addiction Studies (INCAS) were randomly assigned into experimental (Mindfulness-Based Group Therapy) and control groups (the Usual Treatment).The experimental group undertook eight weeks of intervention, but the control group received the usual treatment according to the INCAS program. Methods: The Five Factor Mindfulness Questionnaire (FFMQ) and the Addiction Sevier Index (ASI) were administered at pre-treatment and post-treatment assessment periods. Thirteen patients from the experimental group and 15 from the control group completed post-test assessments. Results: The results of MANCOVA revealed an increase in mean scores in observing, describing, acting with awareness, non-judging, non-reacting, and decrease in mean scores of alcohol and opium in MBGT patient group. Conclusion: The effectiveness of MBGT, compared to the usual treatment, was discussed in this paper as a selective protocol in the health care setting for substance use disorders. PMID:26877751

Intravenous versus intramuscular cobinamide compared to intravenous saline (control) in the treatment of acute, survivable, mitochondrial toxins in swine (Sus Scrofa): a pilot study

DTIC Science & Technology

2018-04-10

Type of Research: Animal Research 3. Title: Intravenous versus intramuscular cobinamide compared to intravenous saline ( control ) in the treatment...the hyperkalemia under control and in our upcoming protocol we feel we will finally be able to induce apnea with the toxin and calcium channel...intramuscular cobinamide compared to intravenous saline ( control ) in the treatment of acute, survivable, mitochondrial toxins in swine (Sus Scrofa): a pilot

Long-term effect of diode laser irradiation compared to sodium fluoride varnish in the treatment of dentine hypersensitivity in periodontal maintenance patients: a randomized controlled clinical study.

PubMed

Yilmaz, Hasan Guney; Kurtulmus-Yilmaz, Sevcan; Cengiz, Esra

2011-11-01

The aim of this clinical study was to evaluate and compare the desensitizing effects of a gallium?aluminum?arsenide (GaAlAs) laser and sodium fluoride (NaF) varnish on dentine hypersensitivity (DH) in periodontal maintenance patients. The use of lasers opens a new dimension in the treatment of DH. Forty-eight patients with 244 teeth affected by DH were included in the trial. To be included in the study, the subjects had to have 4 or more hypersensitive teeth at different quadrants. Selected teeth were randomly assigned to a GaAlAs laser group, placebo laser group, NaF varnish group, or a placebo NaF varnish group. Laser therapy was performed at 8.5?J/cm(2) energy density. In the placebo laser group, the same laser without laser emission was used. In the NaF varnish group, the varnish was painted at the cervical region of the teeth. In the placebo NaF varnish group, the same treatment procedures were performed with a saline solution. DH was assessed with a visual analog scale (VAS); immediately, at 1 week, and at 1, 3, and 6 months after treatments. Intra-group time-dependent data were analyzed by Friedman's test, and Wilcoxon's rank sum test was used to evaluate the differences within groups. GaAlAs laser and NaF varnish treatments resulted in a significant reduction in the VAS scores immediately after treatments that were maintained throughout the study when compared to the baseline and placebo treatments. In the NaF group, there was a significant increase in the VAS scores at 3 and 6 months compared to at 1 week and 1 month. The placebo treatments showed no significant changes in VAS scores throughout the study period. Within the limits of the study, GaAlAs laser irradiation was effective in the treatment of DH, and it is a more comfortable and faster procedure than traditional DH treatment.

Blending Face-to-Face and Internet-Based Interventions for the Treatment of Mental Disorders in Adults: Systematic Review.

PubMed

Erbe, Doris; Eichert, Hans-Christoph; Riper, Heleen; Ebert, David Daniel

2017-09-15

Many studies have provided evidence for the effectiveness of Internet-based stand-alone interventions for mental disorders. A newer form of intervention combines the strengths of face-to-face (f2f) and Internet approaches (blended interventions). The aim of this review was to provide an overview of (1) the different formats of blended treatments for adults, (2) the stage of treatment in which these are applied, (3) their objective in combining face-to-face and Internet-based approaches, and (4) their effectiveness. Studies on blended concepts were identified through systematic searches in the MEDLINE, PsycINFO, Cochrane, and PubMed databases. Keywords included terms indicating face-to-face interventions ("inpatient," "outpatient," "face-to-face," or "residential treatment"), which were combined with terms indicating Internet treatment ("internet," "online," or "web") and terms indicating mental disorders ("mental health," "depression," "anxiety," or "substance abuse"). We focused on three of the most common mental disorders (depression, anxiety, and substance abuse). We identified 64 publications describing 44 studies, 27 of which were randomized controlled trials (RCTs). Results suggest that, compared with stand-alone face-to-face therapy, blended therapy may save clinician time, lead to lower dropout rates and greater abstinence rates of patients with substance abuse, or help maintain initially achieved changes within psychotherapy in the long-term effects of inpatient therapy. However, there is a lack of comparative outcome studies investigating the superiority of the outcomes of blended treatments in comparison with classic face-to-face or Internet-based treatments, as well as of studies identifying the optimal ratio of face-to-face and Internet sessions. Several studies have shown that, for common mental health disorders, blended interventions are feasible and can be more effective compared with no treatment controls. However, more RCTs on effectiveness and cost-effectiveness of blended treatments, especially compared with nonblended treatments are necessary. ©Doris Erbe, Hans-Christoph Eichert, Heleen Riper, David Daniel Ebert. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 15.09.2017.

Comparative effectiveness of lipid-lowering treatments to reduce cardiovascular disease.

PubMed

Suh, Dong-Churl; Griggs, Scott K; Henderson, Emmett R; Lee, Seung-Mi; Park, Taehwan

2018-02-01

The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor is a new treatment option for patients with hypercholesterolemia. The objective of this study was to systematically review the cost-effectiveness of lipid-lowering agents. Areas covered: Based on Pubmed, Embase, and Cochrane Database of Systematic Reviews, we identified 29 relevant articles. Studies found statins were cost-effective compared with placebo or no treatment in general. Atorvastatin was reported to be cost-effective against simvastatin. In most cases, rosuvastatin was more cost-effective than atorvastatin or simvastatin. Additionally, ezetimibe was considered to be cost-effective compared with no treatment for statin intolerant patients. For patients not meeting treatment goals with their statins, switching to ezetimibe plus simvastatin was consistently reported cost-effective. The cost-effectiveness of ezetimibe plus a hybrid of a statin varied by the source of clinical data and cost of ezetimibe. Finally, the cost-effectiveness of PCSK9 inhibitor plus a statin against statin monotherapy was uncertain. The PCSK9 inhibitor plus a stain was cost-ineffective compared with ezetimibe plus a statin. Expert commentary: Drug costs and treatment efficacy were the key drivers of the cost-effectiveness results in prior analyses. Future evaluations are warranted to reflect the decreasing drug prices and the long-term treatment effects of PCSK9 inhibitors.

The benefit of heart rate variability biofeedback and relaxation training in reducing trait anxiety†

PubMed Central

Lee, Jieun; Kim, Jung K; Wachholtz, Amy

2016-01-01

Previous research studies have indicated that biofeedback treatment and relaxation techniques are effective in reducing psychological and physical symptoms (Hammond, 2005; Manzoni, G. M., Pagnini, F., Castelnuovo, G., & Molinari, E., 2008). However, dearth of studies has compared heart rate variability (HRV) biofeedback treatment and relaxation training to reduce trait anxiety. The objective of this study was to determine the effect of HRV biofeedback treatment and relaxation training in reducing trait anxiety compared to control group without any treatment using students in a science and engineering university of South Korea. For the present study, a total of 15 graduate students with moderate level of trait anxiety were recruited for 4 individual sessions every two weeks. They were randomly assigned into three groups: biofeedback treatment (n = 5), relaxation training (n = 5), and no treatment control group (n = 5). Our results revealed significant difference in change score of trait anxiety between the HRV biofeedback treatment and the no treatment control group. However, no significant difference was found between the relaxation training group and the no treatment control group. In addition, there was no significant difference between the HRV biofeedback treatment and the relaxation training. Results of the present study indicate that there is potential benefit in utilizing HRV biofeedback treatment for stress management programs and/or anxiety reduction treatment PMID:27099546

Editorial--Avoiding Unethical Helicobacter pylori Clinical Trials: Susceptibility-Based Studies and Probiotics as Adjuvants.

PubMed

Graham, David Y

2015-10-01

As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g., in a population with known clarithromycin resistance) is unethical. As susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance >0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies, and studies of adjuvants and probiotics. However, the journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors, we provide examples and suggestions regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. © 2015 John Wiley & Sons Ltd.

A comparative study of combined periodontal and orthodontic treatment with fixed appliances and clear aligners in patients with periodontitis

PubMed Central

2015-01-01

Purpose With the increasing prevalence of orthodontic treatment in adults, clear aligner treatments are becoming more popular. The aim of this study was to evaluate the effect of orthodontic treatment on periodontal tissue and to compare orthodontic treatment with fixed appliances (FA) to clear aligner treatment (CAT) in periodontitis patients. Methods A total of 35 patients who underwent orthodontic treatment in the Department of Periodontology were included in this study. After periodontal treatment with meticulous oral hygiene education, patients underwent treatment with FA or CAT, and this study analyzed patient outcomes depending on the treatment strategy. Clinical parameters were assessed at baseline and after orthodontic treatment, and the duration of treatment was compared between these two groups. Results The overall plaque index, the gingival index, and probing depth improved after orthodontic treatment (P<0.01). The overall bone level also improved (P=0.045). However, the bone level changes in the FA and CAT groups were not significantly different. Significant differences were found between the FA and CAT groups in probing depth, change in probing depth, and duration of treatment (P<0.05). However, no significant differences were found between the FA and CAT groups regarding the plaque index, changes in the plaque index, the gingival index, changes in the gingival index, or changes in the alveolar bone level. The percentage of females in the CAT group (88%) was significantly greater than in the FA group (37%) (P<0.01). Conclusions After orthodontic treatment, clinical parameters were improved in the FA and CAT groups with meticulous oral hygiene education and plaque control. Regarding plaque index and gingival index, no significant differences were found between these two groups. We suggest that combined periodontal and orthodontic treatment can improve patients’ periodontal health irrespective of orthodontic techniques. PMID:26734489

Intralesional tuberculin (PPD) versus measles, mumps, rubella (MMR) vaccine in treatment of multiple warts: a comparative clinical and immunological study.

PubMed

Shaheen, Maha Adel; Salem, Samar Abdallah M; Fouad, Dina Adel; El-Fatah, Abeer Aly Abd

2015-01-01

Intralesional purified protein derivative (PPD) or mumps, measles, rubella (MMR) were not previously compared regarding their efficacy or mechanism of action in treatment of warts. We aimed to compare their efficacy in treatment of multiple warts and investigate their effect on serum interleukin (IL)-4 and IL-12. Thirty patients with multiple warts were included (10 treated with PPD, 10 with MMR, and 10 with normal saline (control)). Injection was done every 3 weeks until clearance or maximum of three treatments. Clinical response of target and distant warts was evaluated. Serum ILs-4 and -12 were assessed before and after treatment. A significantly higher rate of complete response was found in target and distant warts with PPD (60% each) and MMR (80%, 40%, respectively) compared with controls (0%), with no significant difference between both treatments. After treatment, the control group showed the lowest serum IL-12 and IL-4 levels compared with the MMR- and PPD-treated groups with statistically significant difference in between. MMR resulted in a significantly higher serum IL-12 than PPD. With PPD, IL-4 was increased with statistically significant change compared with pretreat-ment level. Intralesional PPD and MMR show comparable efficacy and safety in treatment of multiple warts. Serum ILs-4 and-12 increase following antigen injection. © 2015 Wiley Periodicals, Inc.

The Cost-Effectiveness of an Intensive Treatment Protocol for Severe Dyslexia in Children

ERIC Educational Resources Information Center

Hakkaart-van Roijen, Leona; Goettsch, Wim G.; Ekkebus, Michel; Gerretsen, Patty; Stolk, Elly A.

2011-01-01

Studies of interventions for dyslexia have focused entirely on outcomes related to literacy. In this study, we considered a broader picture assessing improved quality of life compared with costs. A model served as a tool to compare costs and effects of treatment according to a new protocol and care as usual. Quality of life was measured and valued…

Treatment of Focal Articular Cartilage Defects in the Knee

PubMed Central

Magnussen, Robert A.; Dunn, Warren R.; Carey, James L.

2008-01-01

We asked whether autologous chondrocyte implantation or osteochondral autograft transfer yields better clinical outcomes compared with one another or with traditional abrasive techniques for treatment of isolated articular cartilage defects and whether lesion size influences this clinical outcome. We performed a literature search and identified five randomized, controlled trials and one prospective comparative trial evaluating these treatment techniques in 421 patients. The operative procedures included autologous chondrocyte implantation, osteochondral autograft transfer, matrix-induced autologous chondrocyte implantation, and microfracture. Minimum followup was 1 year (mean, 1.7 years; range, 1–3 years). All studies documented greater than 95% followup for clinical outcome measures. No technique consistently had superior results compared with the others. Outcomes for microfracture tended to be worse in larger lesions. All studies reported improvement in clinical outcome measures in all treatment groups when compared with preoperative assessment; however, no control (nonoperative) groups were used in any of the studies. A large prospective trial investigating these techniques with the addition of a control group would be the best way to definitively address the clinical questions. Level of Evidence: Level II, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18196358

Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial

PubMed Central

Rossignol, Daniel A; Rossignol, Lanier W; Smith, Scott; Schneider, Cindy; Logerquist, Sally; Usman, Anju; Neubrander, Jim; Madren, Eric M; Hintz, Gregg; Grushkin, Barry; Mumper, Elizabeth A

2009-01-01

Background Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. Methods 62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21), were randomly assigned to 40 hourly treatments of either hyperbaric treatment at 1.3 atmosphere (atm) and 24% oxygen ("treatment group", n = 33) or slightly pressurized room air at 1.03 atm and 21% oxygen ("control group", n = 29). Outcome measures included Clinical Global Impression (CGI) scale, Aberrant Behavior Checklist (ABC), and Autism Treatment Evaluation Checklist (ATEC). Results After 40 sessions, mean physician CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0008), receptive language (p < 0.0001), social interaction (p = 0.0473), and eye contact (p = 0.0102); 9/30 children (30%) in the treatment group were rated as "very much improved" or "much improved" compared to 2/26 (8%) of controls (p = 0.0471); 24/30 (80%) in the treatment group improved compared to 10/26 (38%) of controls (p = 0.0024). Mean parental CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0336), receptive language (p = 0.0168), and eye contact (p = 0.0322). On the ABC, significant improvements were observed in the treatment group in total score, irritability, stereotypy, hyperactivity, and speech (p < 0.03 for each), but not in the control group. In the treatment group compared to the control group, mean changes on the ABC total score and subscales were similar except a greater number of children improved in irritability (p = 0.0311). On the ATEC, sensory/cognitive awareness significantly improved (p = 0.0367) in the treatment group compared to the control group. Post-hoc analysis indicated that children over age 5 and children with lower initial autism severity had the most robust improvements. Hyperbaric treatment was safe and well-tolerated. Conclusion Children with autism who received hyperbaric treatment at 1.3 atm and 24% oxygen for 40 hourly sessions had significant improvements in overall functioning, receptive language, social interaction, eye contact, and sensory/cognitive awareness compared to children who received slightly pressurized room air. Trial Registration clinicaltrials.gov NCT00335790 PMID:19284641

Editorial - Avoiding unethical Helicobacter pylori clinical trials: Susceptibility-based studies and probiotics as adjuvants

PubMed Central

Graham, David Y.

2016-01-01

As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g. in a population with known clarithromycin resistance) is unethical. Since susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance greater than 0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies and of adjuvants and probiotics. However, the Journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors we provide examples and suggestion regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. PMID:26123529

The Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adults Who Have Experienced Complex Childhood Trauma: A Systematic Review of Randomized Controlled Trials.

PubMed

Chen, Runsen; Gillespie, Amy; Zhao, Yanhui; Xi, Yingjun; Ren, Yanping; McLean, Loyola

2018-01-01

Background: Survivors of complex childhood trauma (CT) such as sexual abuse show poorer outcomes compared to single event trauma survivors. A growing number of studies investigate Eye Movement Desensitization and Reprocessing (EMDR) treatment for posttraumatic stress disorder (PTSD), but no systematic reviews have focused on EMDR treatment for CT as an intervention for both adults and children. This study therefore systematically reviewed all randomized controlled trials (RCTs) evaluating the effect of EMDR on PTSD symptoms in adults and children exposed to CT. Methods: Databases including PubMed, Web of Science, and PsycINFO were searched in October 2017. Randomized controlled trials which recruited adult and children with experience of CT, which compared EMDR to alternative treatments or control conditions, and which measured PTSD symptoms were included. Study methodology quality was evaluated with Platinum Standard scale. Results: Six eligible RCTs of 251 participants were included in this systematic review. The results indicated that EMDR was associated with reductions in PTSD symptoms, depression and/or anxiety both post-treatment and at follow-up compared with all other alternative therapies (cognitive behavior therapy, individual/group therapy and fluoxetine) and control treatment (pill placebo, active listening, EMDR delayed treatment, and treatment as usual). However, studies suffered from significant heterogeneity in study populations, length of EMDR treatment, length of follow-up, comparison groups, and outcome measures. One study had a high risk of bias. Discussion: This systematic review suggests that there is growing evidence to support the clinical efficacy of EMDR in treating CT in both children and adults. However, conclusions are limited by the small number of heterogenous trials. Further RCTs with standardized methodologies, as well as studies addressing real world challenges in treating CT are required.

The Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adults Who Have Experienced Complex Childhood Trauma: A Systematic Review of Randomized Controlled Trials

PubMed Central

Chen, Runsen; Gillespie, Amy; Zhao, Yanhui; Xi, Yingjun; Ren, Yanping; McLean, Loyola

2018-01-01

Background: Survivors of complex childhood trauma (CT) such as sexual abuse show poorer outcomes compared to single event trauma survivors. A growing number of studies investigate Eye Movement Desensitization and Reprocessing (EMDR) treatment for posttraumatic stress disorder (PTSD), but no systematic reviews have focused on EMDR treatment for CT as an intervention for both adults and children. This study therefore systematically reviewed all randomized controlled trials (RCTs) evaluating the effect of EMDR on PTSD symptoms in adults and children exposed to CT. Methods: Databases including PubMed, Web of Science, and PsycINFO were searched in October 2017. Randomized controlled trials which recruited adult and children with experience of CT, which compared EMDR to alternative treatments or control conditions, and which measured PTSD symptoms were included. Study methodology quality was evaluated with Platinum Standard scale. Results: Six eligible RCTs of 251 participants were included in this systematic review. The results indicated that EMDR was associated with reductions in PTSD symptoms, depression and/or anxiety both post-treatment and at follow-up compared with all other alternative therapies (cognitive behavior therapy, individual/group therapy and fluoxetine) and control treatment (pill placebo, active listening, EMDR delayed treatment, and treatment as usual). However, studies suffered from significant heterogeneity in study populations, length of EMDR treatment, length of follow-up, comparison groups, and outcome measures. One study had a high risk of bias. Discussion: This systematic review suggests that there is growing evidence to support the clinical efficacy of EMDR in treating CT in both children and adults. However, conclusions are limited by the small number of heterogenous trials. Further RCTs with standardized methodologies, as well as studies addressing real world challenges in treating CT are required. PMID:29695993

Propensity score models in observational comparative effectiveness studies: cornerstone of design or statistical afterthought?

PubMed

Robinson, John W

2012-03-01

Propensity score models are increasingly used in observational comparative effectiveness studies to reduce confounding by covariates that are associated with both a study outcome and treatment choice. Any such potentially confounding covariate will bias estimation of the effect of treatment on the outcome, unless the distribution of that covariate is well-balanced between treatment and control groups. Constructing a subsample of treated and control subjects who are matched on estimated propensity scores is a means of achieving such balance for covariates that are included in the propensity score model. If, during study design, investigators assemble a comprehensive inventory of known and suspected potentially confounding covariates, examination of how well this inventory is covered by the chosen dataset yields an assessment of the extent of bias reduction that is possible by matching on estimated propensity scores. These considerations are explored by examining the designs of three recently published comparative effectiveness studies.

Meta-Analysis of Day Treatment and Contingency-Management Dismantling Research: Birmingham Homeless Cocaine Studies (1990-2006)

ERIC Educational Resources Information Center

Schumacher, Joseph E.; Milby, Jesse B.; Wallace, Dennis; Meehan, Dawna-Cricket; Kertesz, Stefan; Vuchinich, Rudy; Dunning, Jonathan; Usdan, Stuart

2007-01-01

Four successive randomized clinical trials studying contingency management (CM), involving various treatment arms of drug-abstinent housing and work therapy and day treatment (DT) with a behavioral component, were compared on common drug abstinence outcomes at 2 treatment completion points (2 and 6 months). The clinical trials were conducted from…

Comparing the Efficacy of Low Dose and Conventional Dose of Oral Isotretinoin in Treatment of Moderate and Severe Acne Vulgaris.

PubMed

Faghihi, Gita; Mokhtari, Fatemeh; Fard, Nasrin Motamedi; Motamedi, Narges; Hosseini, Sayed Mohsen

2017-01-01

This study was conducted to compare the effect of low-dose isotretinoin with its conventional dose in patients with moderate and severe acne. This was a clinical trial conducted on 60 male and female patients with moderate and severe acne vulgaris. The patients were divided into two treatment groups: 0.5 mg/kg/day isotretinoin capsule and low-dose isotretinoin capsule (0.25 mg/kg/day). Patients in both groups received 6-month treatment. At the end of the 6 th month and 12 th month (6 months after the end of the treatment), they were examined again, and their improvement was determined and compared. The average severity of acne in the two treatment groups did not differ significantly within any of the study periods. The most common side effects were nose dryness in the low-dose group (17%) and hair thinning and loss in the conventional-dose group (33.2%), although all the patients had dry lips. According to the same severity of the acne in two groups in different study periods, as well as fewer side effects and more patients' satisfaction, the low-dose isotretinoin can be considered in the treatment of acne.

Evaluation of the clinical usefulness of modulated arc treatment

NASA Astrophysics Data System (ADS)

Lee, Young Kyu; Jang, Hong Seok; Kim, Yeon Sil; Choi, Byung Ock; Kang, Young-Nam; Nam, Sang Hee; Park, Hyeong Wook; Kim, Shin Wook; Shin, Hun Joo; Lee, Jae Choon; Kim, Ji Na; Park, Sung Kwang; Kim, Jin Young

2015-07-01

The purpose of this study is to evaluate the clinical usefulness of modulated arc (mARC) treatment techniques. The mARC treatment plans for non-small-cell lung cancer (NSCLC) patients were made in order to verify the clinical usefulness of mARC. A pre-study was conducted to find the best plan condition for mARC treatment, and the usefulness of the mARC treatment plan was evaluated by comparing it with other Arc treatment plans such as tomotherapy and RapidArc plans. In the case of mARC, the optimal condition for the mARC plan was determined by comparing the dosimetric performance of the mARC plans developed by using various parameters, which included the photon energy (6 MV, 10 MV), the optimization point angle (6°- 10°intervals), and the total number of segments (36 - 59 segments). The best dosimetric performance of mARC was observed at a 10 MV photon energy, a point angle 6 degrees, and 59 segments. The treatment plans for the three different techniques were compared by using the following parameters: the conformity index (CI), homogeneity index (HI), the target coverage, the dose to the OARs, the number of monitor units (MU), the beam on time, and the normal tissue complication probability (NTCP). As a result, the three different treatment techniques showed similar target coverages. The mARC plan had the lowest V20 (volume of lung receiving > 20 Gy) and MU per fraction compared with both the RapidArc and the tomotherapy plans. The mARC plan reduced the beam on time as well. Therefore, the results of this study provide satisfactory evidence that the mARC technique can be considered as a useful clinical technique for radiation treatment.

Comparative efficacy of first-line natalizumab vs IFN-β or glatiramer acetate in relapsing MS

PubMed Central

Kalincik, Tomas; Jokubaitis, Vilija; Zhang, Annie; Pellegrini, Fabio; Wiendl, Heinz; Belachew, Shibeshih; Hyde, Robert; Verheul, Freek; Lugaresi, Alessandra; Havrdová, Eva; Horáková, Dana; Grammond, Pierre; Duquette, Pierre; Prat, Alexandre; Iuliano, Gerardo; Terzi, Murat; Izquierdo, Guillermo; Hupperts, Raymond M.M.; Boz, Cavit; Pucci, Eugenio; Giuliani, Giorgio; Sola, Patrizia; Spitaleri, Daniele L.A.; Lechner-Scott, Jeannette; Bergamaschi, Roberto; Grand'Maison, François; Granella, Franco; Kappos, Ludwig; Trojano, Maria; Butzkueven, Helmut

2016-01-01

Abstract Background: We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-β (IFN-β)/glatiramer acetate (GA) therapies, using propensity score–matched cohorts from observational multiple sclerosis registries. Methods: The study population initiated IFN-β/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had ≥3 months of on-treatment follow-up, and had active RRMS, defined as ≥1 gadolinium-enhancing lesion on cerebral MRI at baseline or ≥1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n = 366/group) and subgroups with higher baseline disease activity. Results: First-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-β/GA to 0.20 (0.63) (p [signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28–0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58–0.93; p = 0.01), compared with first-line IFN-β/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale–time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups. Conclusions: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-β/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients. Classification of evidence: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse rates and treatment persistence outcomes compared to first-line IFN-β/GA. PMID:27104064

Changes in brain activation in breast cancer patients depend on cognitive domain and treatment type

PubMed Central

Menning, Sanne; de Ruiter, Michiel B.; Veltman, Dick J.; Boogerd, Willem; Oldenburg, Hester S. A.; Reneman, Liesbeth

2017-01-01

Background Cognitive problems in breast cancer patients are common after systemic treatment, particularly chemotherapy. An increasing number of fMRI studies show altered brain activation in breast cancer patients after treatment, suggestive of neurotoxicity. Previous prospective fMRI studies administered a single cognitive task. The current study employed two task paradigms to evaluate whether treatment-induced changes depend on the probed cognitive domain. Methods Participants were breast cancer patients scheduled to receive systemic treatment (anthracycline-based chemotherapy +/- endocrine treatment, n = 28), or no systemic treatment (n = 24) and no-cancer controls (n = 31). Assessment took place before adjuvant treatment and six months after chemotherapy, or at similar intervals. Blood oxygen level dependent (BOLD) activation and performance were measured during an executive functioning task and an episodic memory task. Group-by-time interactions were analyzed using a flexible factorial design. Results Task performance did not differ between patient groups and did not change over time. Breast cancer patients who received systemic treatment, however, showed increased parietal activation compared to baseline with increasing executive functioning task load compared to breast cancer patients who did not receive systemic treatment. This hyperactivation was accompanied by worse physical functioning, higher levels of fatigue and more cognitive complaints. In contrast, in breast cancer patients who did not receive systemic treatment, parietal activation normalized over time compared to the other two groups. Conclusions Parietal hyperactivation after systemic treatment in the context of stable levels of executive task performance is compatible with a compensatory processing account of hyperactivation or maintain adequate performance levels. This over-recruitment of brain regions depends on the probed cognitive domain and may represent a response to decreased neural integrity after systemic treatment. Overall these results suggest different neurobehavioral trajectories in breast cancer patients depending on treatment type. PMID:28267750

Changes in brain activation in breast cancer patients depend on cognitive domain and treatment type.

PubMed

Menning, Sanne; de Ruiter, Michiel B; Veltman, Dick J; Boogerd, Willem; Oldenburg, Hester S A; Reneman, Liesbeth; Schagen, Sanne B

2017-01-01

Cognitive problems in breast cancer patients are common after systemic treatment, particularly chemotherapy. An increasing number of fMRI studies show altered brain activation in breast cancer patients after treatment, suggestive of neurotoxicity. Previous prospective fMRI studies administered a single cognitive task. The current study employed two task paradigms to evaluate whether treatment-induced changes depend on the probed cognitive domain. Participants were breast cancer patients scheduled to receive systemic treatment (anthracycline-based chemotherapy +/- endocrine treatment, n = 28), or no systemic treatment (n = 24) and no-cancer controls (n = 31). Assessment took place before adjuvant treatment and six months after chemotherapy, or at similar intervals. Blood oxygen level dependent (BOLD) activation and performance were measured during an executive functioning task and an episodic memory task. Group-by-time interactions were analyzed using a flexible factorial design. Task performance did not differ between patient groups and did not change over time. Breast cancer patients who received systemic treatment, however, showed increased parietal activation compared to baseline with increasing executive functioning task load compared to breast cancer patients who did not receive systemic treatment. This hyperactivation was accompanied by worse physical functioning, higher levels of fatigue and more cognitive complaints. In contrast, in breast cancer patients who did not receive systemic treatment, parietal activation normalized over time compared to the other two groups. Parietal hyperactivation after systemic treatment in the context of stable levels of executive task performance is compatible with a compensatory processing account of hyperactivation or maintain adequate performance levels. This over-recruitment of brain regions depends on the probed cognitive domain and may represent a response to decreased neural integrity after systemic treatment. Overall these results suggest different neurobehavioral trajectories in breast cancer patients depending on treatment type.

Biofeedback treatment of constipation: a critical review.

PubMed

Heymen, Steve; Jones, Kenneth R; Scarlett, Yolanda; Whitehead, William E

2003-09-01

This review was designed to 1) critically examine the research design used in investigations of biofeedback for pelvic floor dyssynergia, 2) compare the various biofeedback treatment protocols for pelvic floor dyssynergia-type constipation used in this research, 3) identify factors that influence treatment outcome, and 4) identify goals for future biofeedback research for pelvic floor dyssynergia. A comprehensive review of both the pediatric and adult research from 1970 to 2002 on "biofeedback for constipation" was conducted using a Medline search in all languages. Only prospective studies including five or more subjects that described the treatment protocol were included. In addition, a meta-analysis of these studies was performed to compare the outcome of different biofeedback protocols for treating constipation. Thirty-eight studies were reviewed, and sample size, treatment protocol, outcome rates, number of sessions, and etiology are shown in a table. Ten studies using a parallel treatment design were reviewed in detail, including seven that randomized subjects to treatment groups. A meta-analysis (weighted by subjects) was performed to compare the results of two treatment protocols prevalent in the literature. The mean success rate of studies using pressure biofeedback (78 percent) was superior (P = 0.018) to the mean success rate for studies using electromyography biofeedback (70 percent). However, the mean success rates comparing studies using intra-anal electromyography sensors to studies using perianal electromyography sensors were 69 and 72 percent, respectively, indicating no advantages for one type of electromyography protocol over the other (P = 0.428). In addition to the varied protocols and instrumentation used, there also are inconsistencies in the literature regarding the severity and etiology of symptoms, patient selection criteria, and the definition of a successful outcome. Finally, no anatomic, physiologic, or demographic variables were identified that would assist in predicting successful outcome. Having significant psychological symptoms was identified as a factor that may influence treatment outcome, but this requires further study. Although most studies report positive results using biofeedback to treat constipation, quality research is lacking. Specific recommendations are made for future investigations to 1) improve experimental design, 2) clearly define outcome measures, 3) identify the etiology and severity of symptoms, 4) determine which treatment protocol and which component of treatment is most effective for different types of subjects, 5) systematically explore the role of psychopathology in this population, 6) use an adequate sample size that allows for meaningful analysis, and 7) include long-term follow-up data.

Oral antivirals for the acute treatment of recurrent herpes labialis.

PubMed

Jensen, Lori A; Hoehns, James D; Squires, Cindy L

2004-04-01

To evaluate the use and benefit of oral antivirals in the acute treatment of episodic, recurrent herpes labialis. A literature search was performed in MEDLINE (1966-August 2003) using acyclovir, famciclovir, valacyclovir, cold sores, herpes labialis, and HSV-1 as search terms. We reviewed 5 placebo-controlled and 2 comparative studies evaluating oral antivirals for acute treatment of recurrent herpes labialis. No studies directly compared different antivirals. Studies discussing the efficacy of antivirals for chronic suppression of herpes simplex virus-1 infection were not included. Treatment with oral antivirals decreases the duration of lesion episodes and pain by approximately one day; however, the antivirals do not abort lesions from developing. Clinical implications of these results appear relatively modest.

Control Group Paradigms in Studies Investigating Acute Effects of Exercise on Cognitive Performance-An Experiment on Expectation-Driven Placebo Effects.

PubMed

Oberste, Max; Hartig, Philipp; Bloch, Wilhelm; Elsner, Benjamin; Predel, Hans-Georg; Ernst, Bernhard; Zimmer, Philipp

2017-01-01

Introduction: Many studies report improvements in cognitive performance following acute endurance exercise compared to control group treatment. These cognitive benefits are interpreted as a result of a physiological response to exercise. However, it was also hypothesized that expectation-driven placebo effects account for these positive effects. The purpose of this study was to investigate the differences between expectations for cognitive benefits toward acute endurance exercise and multiple control group treatments. Methods: Healthy individuals ( N = 247, 24.26 ± 3.88 years) were randomized to eight different groups watching videos of a moderate, a vigorous exercise treatment or one control group treatment (waiting, reading, video-watching, stretching, myofascial release workout, and very light exercise). Then, they were introduced to three commonly used cognitive test procedures in acute exercise-cognition research (Stroop-test, Trail-Making-test, Free-recall-task). Participants rated the effect they would expect on their performance in those tasks, if they had received the treatment shortly before the task, on an 11-point Likert scale. Results: No significantly different expectations for cognitive benefits toward acute moderate exercise and control group treatments could be revealed. Participants expected significantly worse performance following vigorous exercise compared to following waiting and stretching for all cognitive tests. Significantly worse performance after vigorous exercise compared to after very light exercise was expected for Stroop and Free-recall. For Free-recall, participants expected worse performance after vigorous exercise compared to myofascial release training as well. Conclusion: Our results indicate that expectation-driven placebo effects are unlikely to cause the reported greater cognitive improvements following acute moderate and vigorous endurance exercise compared to following common control group treatments.

Comparative Treatment Failure Rates of Respiratory Fluoroquinolones or β-Lactam + Macrolide Versus β-Lactam Alone in the Treatment for Community-Acquired Pneumonia in Adult Outpatients

PubMed Central

Lee, Meng-Tse Gabriel; Lee, Shih-Hao; Chang, Shy-Shin; Chan, Ya-Lan; Pang, Laura; Hsu, Sue-Ming; Lee, Chien-Chang

2015-01-01

Abstract No comparative effectiveness study has been conducted for the following 3 antibiotics: respiratory fluoroquinolone, β-lactam, and β-lactam + advanced macrolide. To gain insights into the real-world clinical effectiveness of these antibiotics for community-acquired pneumonia in adult outpatients, our study investigated the treatment failure rates in 2 million representative participants from the National Health Informatics Project (NHIP) of Taiwan. A new-user cohort design was used to follow NHIP participants from January 2000 until December 2009. Treatment failure was defined by either one of the following events: a second antibiotic prescription, hospitalization due to CAP, an emergency department visit with a diagnosis of CAP, or 30-day nonaccident-related mortality. From 2006 to 2009, we identified 9256 newly diagnosed CAP outpatients, 1602 of whom were prescribed levofloxacin, 2100 were prescribed moxifloxacin, 5049 were prescribed β-lactam alone, and 505 were prescribed advanced macrolide + β-lactam. Compared with the β-lactam-based regimen, the propensity score-matched odds ratio for composite treatment failure was 0.81 (95% CI, 0.67–0.97) for moxifloxacin, 1.10 (95% CI, 0.90–1.35) for levofloxacin, and 0.95 (95% CI, 0.67–1.35) for macrolide +β-lactam. Moxifloxacin was associated with lower treatment failure rates compared with β-lactam alone, or levofloxacin in Taiwanese CAP outpatients. However, due to inherent limitations in our claims database, more randomized controlled trials are required before coming to a conclusion on which antibiotic is more effective for Taiwanese CAP outpatients. More population-based comparative effectiveness studies are also encouraged and should be considered as an integral piece of evidence in local CAP treatment guidelines. PMID:26426664

Control Group Paradigms in Studies Investigating Acute Effects of Exercise on Cognitive Performance–An Experiment on Expectation-Driven Placebo Effects

PubMed Central

Oberste, Max; Hartig, Philipp; Bloch, Wilhelm; Elsner, Benjamin; Predel, Hans-Georg; Ernst, Bernhard; Zimmer, Philipp

2017-01-01

Introduction: Many studies report improvements in cognitive performance following acute endurance exercise compared to control group treatment. These cognitive benefits are interpreted as a result of a physiological response to exercise. However, it was also hypothesized that expectation-driven placebo effects account for these positive effects. The purpose of this study was to investigate the differences between expectations for cognitive benefits toward acute endurance exercise and multiple control group treatments. Methods: Healthy individuals (N = 247, 24.26 ± 3.88 years) were randomized to eight different groups watching videos of a moderate, a vigorous exercise treatment or one control group treatment (waiting, reading, video-watching, stretching, myofascial release workout, and very light exercise). Then, they were introduced to three commonly used cognitive test procedures in acute exercise-cognition research (Stroop-test, Trail-Making-test, Free-recall-task). Participants rated the effect they would expect on their performance in those tasks, if they had received the treatment shortly before the task, on an 11-point Likert scale. Results: No significantly different expectations for cognitive benefits toward acute moderate exercise and control group treatments could be revealed. Participants expected significantly worse performance following vigorous exercise compared to following waiting and stretching for all cognitive tests. Significantly worse performance after vigorous exercise compared to after very light exercise was expected for Stroop and Free-recall. For Free-recall, participants expected worse performance after vigorous exercise compared to myofascial release training as well. Conclusion: Our results indicate that expectation-driven placebo effects are unlikely to cause the reported greater cognitive improvements following acute moderate and vigorous endurance exercise compared to following common control group treatments. PMID:29276483

Inpatient satisfaction at different public sector hospitals of a metropolitan city in Pakistan: a comparative cross-sectional study.

PubMed

Hussain, Mehwish; Rehman, Rehana; Ikramuddin, Zia; Asad, Nava; Farooq, Ayesha

2018-04-01

To observe inpatient satisfaction at different public sector hospitals of Karachi, Pakistan. A cross sectional study was carried out during 2010-2012 in four major public sector hospitals of Karachi. A total of 710 patients completed the study. Responses were gathered in a self-structured questionnaire that comprised of four dimensions of satisfaction with doctor, staff, administration and treatment. Average Score of each dimension was taken and compared using one way analysis of variance. Satisfaction with doctors, staff and administration of provincial and federal hospitals were comparatively similar (P > 0.05). However, satisfaction with treatment significantly differed in all four hospitals (P < 0.0001). Highest satisfaction with treatment was observed among inpatients of hospital running by medical institute (P < 0.0001). Comparison with respect to different departments revealed significant difference for treatment satisfaction of medicine and surgery units. Patients who were admitted from emergency mode acquired lowest satisfaction in all aspects. Response of inpatients from public sector hospitals showed satisfaction with healthcare personnel and related administration. However, treatment dimension needs to be improved to get more satisfaction.

Composite scores in comparative effectiveness research: counterbalancing parsimony and dimensionality in patient-reported outcomes.

PubMed

Schwartz, Carolyn E; Patrick, Donald L

2014-07-01

When planning a comparative effectiveness study comparing disease-modifying treatments, competing demands influence choice of outcomes. Current practice emphasizes parsimony, although understanding multidimensional treatment impact can help to personalize medical decision-making. We discuss both sides of this 'tug of war'. We discuss the assumptions, advantages and drawbacks of composite scores and multidimensional outcomes. We describe possible solutions to the multiple comparison problem, including conceptual hierarchy distinctions, statistical approaches, 'real-world' benchmarks of effectiveness and subgroup analysis. We conclude that comparative effectiveness research should consider multiple outcome dimensions and compare different approaches that fit the individual context of study objectives.

Efficacy and Safety of Three Cryotherapy Devices for Wart Treatment: A Randomized, Controlled, Investigator-Blinded, Comparative Study.

PubMed

Walczuk, Imko; Eertmans, Frank; Rossel, Bart; Cegielska, Agnieszka; Stockfleth, Eggert; Antunes, Andre; Adriaens, Els

2018-06-01

Cutaneous warts are common skin lesions, caused by human papillomavirus. For years, liquid nitrogen is the cryogen of choice for wart treatment. Alternatively, several cryogenic devices for home treatment are commercially available. The present trial assessed efficacy and safety of a novel nitrous oxide-based cryogenic device for home use (EndWarts Freeze ® in Europe, Compound W ® Nitro-Freeze in the USA). This investigator-blinded, controlled, randomized study compared the nitrous oxide device (test product) with a dimethylether propane-based product (Wartner ® ; comparator 1). Subjects with common or plantar warts (50/50 ratio) were randomized into two groups (n = 58, test product; n = 40, comparator 1). Sequentially, an extra treatment arm (n = 40) was added to compare with a dimethylether-based product with metal nib (Wortie ® ; comparator 2). Main objective implied comparison of the percentage cured subjects after one to maximum three treatments. Efficacy and safety was evaluated by a blinded investigator. After a maximum of three applications, a significantly (p = 0.001) higher cure rate of 70.7% (Intention-to-Treat analysis) was observed with test product versus 46.2% (comparator 1) and 47.5% (comparator 2). Almost three times more subjects were cured after 1 test product application (29.3%), versus comparator 1 (10.4%) and comparator 2 (12.5%). Reported side effects were transient and typical of cryotherapy. All treatments were well-tolerated. The superior cure rates for the test product versus two comparators can be explained by its design. Combination of nitrous oxide (cooling agent), the specific activation method (holding the liquid coolant in the cap), and skin-conforming polyurethane foam, results in higher cooling efficiency (- 80 °C) and more effective wart freezing. This trial demonstrated that the nitrous oxide device is a safe, user-friendly and effective wart treatment for home use, comparing favourably to dimethylether (propane) devices with higher freezing temperature, regardless of the applicator type. Oystershell Laboratories. Clinicaltrials.gov identifier, NCT03129373.

A comparative study of three conservative treatments in patients with lumbar spinal stenosis: lumbar spinal stenosis with acupuncture and physical therapy study (LAP study).

PubMed

Oka, Hiroyuki; Matsudaira, Ko; Takano, Yuichi; Kasuya, Daichi; Niiya, Masaki; Tonosu, Juichi; Fukushima, Masayoshi; Oshima, Yasushi; Fujii, Tomoko; Tanaka, Sakae; Inanami, Hirohiko

2018-01-19

Although the efficiency of conservative management for lumbar spinal stenosis (LSS) has been examined, different conservative management approaches have not been compared. We have performed the first comparative trial of three types of conservative management (medication with acetaminophen, exercise, and acupuncture) in Japanese patients with LSS. Patients with L5 root radiculopathy associated with LSS who visited our hospital for surgical treatment were enrolled between December 2011 and January 2014. In this open-label study, patients were assigned to three treatment groups (medication, exercise, acupuncture) according to the visit time. The primary outcomes were Zurich claudication questionnaire (ZCQ) scores before and after 4 weeks of treatment. Least square mean analysis was used to assess the following dependent variables in the treatment groups: changes in symptom severity and physical function scores of the ZCQ and the ZCQ score of patient's satisfaction after treatment. Thirty-eight, 40, and 41 patients were allocated to the medication, exercise, and acupuncture groups, respectively. No patient underwent surgical treatment during the study period. The symptom severity scores of the ZCQ improved significantly after treatment in the medication (p = 0.048), exercise (p = 0.003), and acupuncture (p = 0.04) groups. The physical function score improved significantly in the acupuncture group (p = 0.045) but not in the medication (p = 0.20) and exercise (p = 0.29) groups. The mean reduction in the ZCQ score for physical function was significantly greater for acupuncture than for exercise. The mean ZCQ score for treatment satisfaction was significantly greater for acupuncture than for medication. Acupuncture was significantly more effective than physical exercise according to the physical function score of the ZCQ and than medication according to the satisfaction score. The present study provides new important information that will aid decision making in LSS treatment. This study was registered with the UMIN Clinical Trials Registry ( UMIN000006957 ).

Quality of Life in 807 Patients with Vestibular Schwannoma: Comparing Treatment Modalities.

PubMed

Soulier, Géke; van Leeuwen, Bibian M; Putter, Hein; Jansen, Jeroen C; Malessy, Martijn J A; van Benthem, Peter Paul G; van der Mey, Andel G L; Stiggelbout, Anne M

2017-07-01

Objective In vestibular schwannoma treatment, the choice among treatment modalities is controversial. The first aim of this study was to examine the quality of life of patients with vestibular schwannoma having undergone observation, radiation therapy, or microsurgical resection. The second aim was to examine the relationship between perceived symptoms and quality of life. Last, the association between quality of life and time since treatment was studied. Study Design Cross-sectional study. Setting Tertiary referral center. Subjects and Methods A total of 1208 patients treated for sporadic vestibular schwannoma between 2004 and 2014 were mailed the disease-specific Penn Acoustic Neuroma Quality of Life (PANQOL) questionnaire and additional questions on symptoms associated with vestibular schwannoma. Total and domain scores were calculated and compared among treatment groups. Propensity scores were used, and results were stratified according to tumor size to control for potential confounders. Correlations were calculated to examine the relationship between self-reported symptoms and quality of life, as well as between quality of life and time since treatment. Results Patients with small tumors (≤10 mm) under observation showed a higher PANQOL score when compared with the radiation therapy and microsurgical resection groups. A strong negative correlation was found between self-reported symptoms and quality of life, with balance problems and vertigo having the largest impact. No correlation was found between PANQOL score and time since treatment. Conclusion This study suggests that patients with small vestibular schwannomas experience better quality of life when managed with observation than do patients who have undergone active treatment.

Effectiveness of Neurofeedback Versus Medication in Treatment of ADHD.

PubMed

Sudnawa, Khemika Khemakanok; Chirdkiatgumchai, Vilawan; Ruangdaraganon, Nichara; Khongkhatithum, Chaiyos; Udomsubpayakul, Umaporn; Jirayucharoensak, Suwicha; Israsena, Pasin

2018-06-22

Neurofeedback (NF) is an operant conditioning procedure that trains participants for self-regulation of brain activity. Previous studies have shown that NF is a promising treatment of ADHD. However, there have been only a few RCT studies comparing effectiveness of NF with medication with various NF protocol and results. The aim of this study was to evaluate theeffectiveness of unipolar electrodeneurofeedback (NF) using theta/beta protocol compared with methylphenidate (MPH) in the treatment of ADHD. Children with newly diagnosed ADHD were randomly organised into NF and MPH groups. Each of children in NF group received 30 sessions of NF. Children in MPH group were prescribed methylphenidate for 12 weeks. Vanderbilt ADHD rating scales were completed by parents and teachers to evaluate ADHD symptoms pre- and post-treatment. Student's t-tests and Cohen's dwere used to compare symptoms between groups and evaluate effect size (ES) of each treatment respectively. Forty children participated in the study. No differences in ADHD baseline symptoms between groups were found. Post-treatment, teachers reported significantly lower ADHD symptoms in the MPH group (p = 0.01), but parents reported no differences betweenthe groups (p = 0.55). MPH demonstrated large ES (Cohen's d 1.30 - 1.69), while NF showed moderate ES (Cohen's d 0.49 - 0.68) for treatment of ADHD symptoms. This study supports NF as a promising alternative treatment for ADHD in children who do not respond or experience significant adverse effects to ADHD medications. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Treatment of ocular rosacea: comparative study of topical cyclosporine and oral doxycycline.

PubMed

Arman, Aysegul; Demirseren, Duriye Deniz; Takmaz, Tamer

2015-01-01

To compare the effectiveness of topical cyclosporine A emulsion with that of oral doxycycline for rosacea associated ocular changes and dry eye complaints. One hundred and ten patients with rosacea were screened. Thirty-eight patients having rosacea associated eyelid and ocular surface changes and dry eye complaints were included in the study. Patients were randomly divided into two groups: nineteen patients were given topical cyclosporine twice daily and nineteen patients were given oral doxycycline 100 mg twice daily for the first month and once daily for the following two months. Symptom and sign scores, ocular surface disease index questionnarie and tear function tests were evaluated at baseline and monthly for 3mo. Three months after results were compared with that of baseline. Mean values of symptom, eyelid sign and corneal/conjunctival sign scores of each treatment group at baseline and 3mo after treatments were compared and both drugs were found to be effective on rosacea associated ocular changes (P<0.001). Cyclosporine was more effective in symptomatic relief and in the treatment of eyelid signs (P=0.01). There was statistically significant increase in the mean Schirmer score with anesthesia and tear break up time scores in the cyclosporine treatment group compared to the doxycycline treatment group (P<0.05). Cyclosporine as a topical drug can be used in the treatment of rosacea associated ocular complications because it is more effective than doxycycline. In addition ocular rosacea as a chronic disease requires long term treatment and doxycycline has various side effects limiting its long term usage.

Systematic review: third-line susceptibility-guided treatment for Helicobacter pylori infection

PubMed Central

Puig, Ignasi; López-Góngora, Sheila; Calvet, Xavier; Villoria, Albert; Baylina, Mireia; Sanchez-Delgado, Jordi; Suarez, David; García-Hernando, Victor; Gisbert, Javier P.

2015-01-01

Background: Susceptibility-guided therapies (SGTs) have been proposed as preferable to empirical rescue treatments after two treatment failures. The aim of this study was to perform a systematic review and meta-analysis evaluating the effectiveness and efficacy of SGT as third-line therapy. Methods: A systematic search was performed in multiple databases. Studies reporting cure rates of Helicobacter pylori with SGT in third-line therapy were selected. A qualitative analysis describing the current evidence and a pooled mean analysis summarizing the cure rates of SGT in third-line therapy was performed. Results: No randomized controlled trials or comparative studies were found. Four observational studies reported cure rates with SGT in third-line treatment, and three studies which mixed patients with second- and third-line treatment also reported cure rates with SGT. The majority of the studies included the patients when culture had been already obtained, and so the effectiveness of SGT and empirical therapy has never been compared. A pooled mean analysis including four observational studies (283 patients) showed intention-to-treat and per-protocol eradication rates with SGT of 72% (95% confidence interval 56–87%; I2: 92%) and 80% (95% confidence interval 71–90%; I2: 80%), respectively. Conclusions: SGT may be an acceptable option as rescue treatment. However, cure rates are, at best, moderate and this approach has never been compared with a well-devised empirical therapy. The evidence in favor of SGT as rescue therapy is currently insufficient to recommend its use. PMID:27366212

Efficacy of tulathromycin compared with tilmicosin and florfenicol for the control of respiratory disease in cattle at high risk of developing bovine respiratory disease.

PubMed

Rooney, Kathleen A; Nutsch, Robert G; Skogerboe, Terry L; Weigel, Daniel J; Gajewski, Kimberly; Kilgore, W Randal

2005-01-01

Three studies conducted at feedlots in Colorado, Idaho, and Texas examined the comparative efficacy of tulathromycin injectable solution for the treatment of cattle at high risk of developing undifferentiated bovine respiratory disease (BRD). Each study randomly allocated 250 calves to receive tulathromycin at 2.5 mg/kg and 250 calves to receive either tilmicosin at 10 mg/kg (Colorado site) or florfenicol at 40 mg/kg (Idaho and Texas sites) on arrival at the feedlot. Calves were housed by treatment group in pens with 50 calves/pen. Beginning 3 days after antimicrobial treatment, cattle were observed for signs of BRD daily until harvest. In all three studies, the treatment success rates at 28 days after treatment and at harvest were significantly higher (P < or = .013) for cattle treated with tulathromycin than for cattle treated with either tilmicosin or florfenicol. Fewer tulathromycin-treated cattle were removed from the group as "chronics" or "mortalities" at 28 days posttreatment (P < or = .014) in all three studies. Tulathromycin demonstrated superior efficacy compared with tilmicosin and florfenicol when treating groups of high-risk cattle before the onset of signs of BRD.

Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation.

PubMed

Bruins Slot, Karsten Mh; Berge, Eivind

2018-03-06

Factor Xa inhibitors and vitamin K antagonists (VKAs) are now recommended in treatment guidelines for preventing stroke and systemic embolic events in people with atrial fibrillation (AF). This is an update of a Cochrane review previously published in 2013. To assess the effectiveness and safety of treatment with factor Xa inhibitors versus VKAs for preventing cerebral or systemic embolic events in people with AF. We searched the trials registers of the Cochrane Stroke Group and the Cochrane Heart Group (September 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (August 2017), MEDLINE (1950 to April 2017), and Embase (1980 to April 2017). We also contacted pharmaceutical companies, authors and sponsors of relevant published trials. We used outcome data from marketing authorisation applications of apixaban, edoxaban and rivaroxaban that were submitted to regulatory authorities in Europe and the USA. We included randomised controlled trials (RCTs) that directly compared the effects of long-term treatment (lasting more than four weeks) with factor Xa inhibitors versus VKAs for preventing cerebral and systemic embolism in people with AF. The primary efficacy outcome was the composite endpoint of all strokes and systemic embolic events. Two review authors independently extracted data, and assessed the quality of the trials and the risk of bias. We calculated a weighted estimate of the typical treatment effect across trials using the odds ratio (OR) with 95% confidence interval (CI) by means of a fixed-effect model. In case of moderate or high heterogeneity of treatment effects, we used a random-effects model to compare the overall treatment effects. We also performed a pre-specified sensitivity analysis excluding any open-label studies. We included data from 67,688 participants randomised into 13 RCTs. The included trials directly compared dose-adjusted warfarin with either apixaban, betrixaban, darexaban, edoxaban, idraparinux, idrabiotaparinux, or rivaroxaban. The majority of the included data (approximately 90%) was from apixaban, edoxaban, and rivaroxaban.The composite primary efficacy endpoint of all strokes (both ischaemic and haemorrhagic) and non-central nervous systemic embolic events was reported in all of the included studies. Treatment with a factor Xa inhibitor significantly decreased the number of strokes and systemic embolic events compared with dose-adjusted warfarin in participants with AF (OR 0.89, 95% CI 0.82 to 0.97; 13 studies; 67,477 participants; high-quality evidence).Treatment with a factor Xa inhibitor significantly reduced the number of major bleedings compared with warfarin (OR 0.78, 95% CI 0.73 to 0.84; 13 studies; 67,396 participants; moderate-quality evidence). There was, however, statistically significant and high heterogeneity (I 2 = 83%). When we repeated this analysis using a random-effects model, it did not show a statistically significant decrease in the number of major bleedings (OR 0.88, 95% CI 0.66 to 1.17). A pre-specified sensitivity analysis excluding all open-label studies showed that treatment with a factor Xa inhibitor significantly reduced the number of major bleedings compared with warfarin (OR 0.75, 95% CI 0.69 to 0.81), but high heterogeneity was also observed in this analysis (I 2 = 72%). The same sensitivity analysis using a random-effects model also showed a statistically significant decrease in the number of major bleedings in participants treated with factor Xa inhibitors (OR 0.76, 95% CI 0.60 to 0.96).Treatment with a factor Xa inhibitor significantly reduced the risk of intracranial haemorrhages (ICHs) compared with warfarin (OR 0.50, 95% CI 0.42 to 0.59; 12 studies; 66,259 participants; high-quality evidence). We observed moderate, but statistically significant heterogeneity (I 2 = 55%). The pre-specified sensitivity analysis excluding open-label studies showed that treatment with a factor Xa inhibitor significantly reduced the number of ICHs compared with warfarin (OR 0.47, 95% CI 0.40 to 0.56), with low, non-statistically significant heterogeneity (I 2 = 27%).Treatment with a factor Xa inhibitor also significantly reduced the number of all-cause deaths compared with warfarin (OR 0.89, 95% 0.83 to 0.95; 10 studies; 65,624 participants; moderate-quality evidence). Treatment with factor Xa inhibitors significantly reduced the number of strokes and systemic embolic events compared with warfarin in people with AF. The absolute effect of factor Xa inhibitors compared with warfarin treatment was, however, rather small. Factor Xa inhibitors also reduced the number of ICHs, all-cause deaths and major bleedings compared with warfarin, although the evidence for a reduction in the latter is less robust.

Rutosides for treatment of post-thrombotic syndrome.

PubMed

Morling, Joanne R; Yeoh, Su Ern; Kolbach, Dinanda N

2015-09-16

Post-thrombotic syndrome (PTS) is a long-term complication of deep venous thrombosis (DVT) that is characterised by pain, swelling, and skin changes in the affected limb. One in three patients with DVT will develop post-thrombotic sequelae within five years. Rutosides are a group of compounds derived from horse chestnut (Aesculus hippocastanum), a traditional herbal remedy for treating oedema formation in chronic venous insufficiency (CVI). However, it is not known whether rutosides are effective and safe in the treatment of PTS. This is an update of the review first published in 2013. To determine the effectiveness (improvement or deterioration in symptoms) and safety of rutosides for treatment of post-thrombotic syndrome (PTS) in patients with DVT compared to placebo, no intervention, elastic compression stockings (ECS) or any other treatment. For this update the Cochrane Vascular Group Trials Search Co-ordinator searched the Specialised Register (last searched September 2015) and the Cochrane Register of Studies (CRS) (CENTRAL (2015, Issue 8)). Clinical trials databases were searched for details of ongoing and unpublished studies. Two review authors (JM and DNK) independently assessed studies for inclusion. Studies were included to allow the comparison of rutosides versus placebo or no treatment, rutosides versus ECS, and rutosides versus any other treatment. Two review authors (JM and SEY) extracted information from the trials. Disagreements were resolved by discussion. Data were extracted using designated data extraction forms. The Cochrane risk of bias tool was used for all included studies to assist in the assessment of quality. Primary outcome measures were the occurrence of leg ulceration over time (yes or no) and any improvement or deterioration of post-thrombotic syndrome (yes or no). Secondary outcomes included reduction of oedema, pain, recurrence of deep venous thrombosis or pulmonary embolism, compliance with therapy, and adverse effects. All of the outcome measures were analysed using Mantel-Haenzel fixed-effect model odds ratios. The unit of analysis was the number of patients. Ten reports of nine studies were identified following searching and three studies with a total of 233 participants met the inclusion criteria. Overall quality of the evidence using the GRADE approach was low or very low, predominantly due to the lack of both participant and researcher blinding in the included studies. The quality of the evidence was further limited as only three small studies contributed to the review findings. A subjective scoring system was used to obtain the symptoms of PTS so it was important that the assessors were blinded to the intervention. One study compared rutoside with placebo, one study compared rutosides with ECS and rutosides plus ECS versus ECS alone, and one study compared rutosides with an alternative venoactive remedy. Occurrence of leg ulceration was not reported in any of the included studies. There was a 29% odds of an improvement in PTS in the rutoside treated group versus placebo or no treatment, and lower rates of improvement in PTS in the rutoside treated group when compared with ECS, however these were statistically non-significant. Lower rates of improvement in PTS were shown in the rutoside treated group when compared with an alternative venoactive remedy. More PTS deterioration was shown in the placebo or no treatment group when compared with rutosides but this was not statistically significant. Compared with ECS, rutosides showed higher odds of PTS deterioration but this was also not statistically significant. One study reported on adverse effects showing higher odds of mild adverse effects in the rutoside treated group compared to placebo but this was not statistically significant. There was no evidence that rutosides were superior to the use of placebo or ECS. Overall, there is currently limited and low or very low quality evidence that 'venoactive' or 'phlebotonic' remedies such as rutosides reduce symptoms of PTS. Mild side effects were noted in one study. The three studies included in this review provide no evidence for the use of rutosides in the treatment of PTS.

Mental Health and Behavioral Problems of Youth in the Child Welfare System: Residential Treatment Centers Compared to Therapeutic Foster Care in the Odyssey Project Population

ERIC Educational Resources Information Center

Baker, Amy J. L.; Kurland, David; Curtis, Patrick; Alexander, Gina; Papa-Lentini, Cynthia

2007-01-01

This is the first multisite, prospective study of behavioral and mental health disorders of youth in residential treatment centers (RTC) and therapeutic foster care (TFC), and the first study to compare the two. This study addressed two questions in a sample of 22 agencies in 13 states: (1) how prevalent were emotional and behavioral disorders in…

Dental treatment under general anesthesia in a group of patients with cerebral palsy and a group of healthy pediatric patients

PubMed Central

Escanilla-Casal, Alejandro; Aznar-Gómez, Mirella; Viaño, José M.; Rivera-Baró, Alejandro

2014-01-01

This is a comparative study between two groups, one of healthy children and the other of children with cerebral palsy, which underwent dental treatment under general anesthesia at Hospital Sant Joan de Déu Barcelona. The purpose of the study was to compare and determine oral pathology, frequency, severity and postoperative complications in pediatric patients with and without an underlying disease which undergo a dental treatment under general anesthesia. Key words:General anesthesia, cerebral palsy, pediatric patients. PMID:24608223

Integrating Tobacco Treatment into Cancer Care: Study Protocol for a Randomized Controlled Comparative Effectiveness Trial

PubMed Central

Park, Elyse R.; Ostroff, Jamie S.; Perez, Giselle K.; Hyland, Kelly A.; Rigotti, Nancy A.; Borderud, Sarah; Regan, Susan; Muzikansky, Alona; Friedman, Emily R.; Levy, Douglas E.; Holland, Susan; Eusebio, Justin; Peterson, Lisa; Rabin, Julia; Miller-Sobel, Jacob; Gonzalez, Irina; Malloy, Laura; O’Brien, Maureen; de León-Sanchez, Suhana; Will Whitlock, C.

2016-01-01

Background Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. Methods/Design A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30 days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6 months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. Discussion This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients. PMID:27444428

Sedatives for opiate withdrawal in newborn infants.

PubMed

Osborn, D A; Jeffery, H E; Cole, M J

2002-01-01

Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. To assess the effectiveness and safety of using a sedative compared to a non-opiate control for NAS due to withdrawal from opiates, and to determine which type of sedative is most effective and safe. The standard search strategy of the Neonatal Review Group was used. This included searches of the Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002) and MEDLINE 1966-2002. Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to sedative or control. Control could include another sedative or non-pharmacological treatment. Each author assessed study quality and extracted data independently. Primary outcomes included treatment failure (failure to achieve symptom control or use of additional drug treatment), seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. Five studies enrolling a total of 285 patients met inclusion criteria (Finnegan 1984, Kahn 1969, Kaltenbach 1986, Khoo 1995, Madden 1977); however, two (Finnegan 1984, Kaltenbach 1986) may be sequential reports that include some identical patients. Methodological concerns included the use of quasi-random rather than random patient allocation methods in three studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in three studies. Phenobarbital compared to supportive care alone has not been shown to reduce treatment failure or time to regain birthweight (one study). However, the duration of supportive care required to be given to infants each day was significantly reduced (MD -162.1 minutes/day, 95% CI -249.2, -75.1). Comparing phenobarbital to diazepam, meta-analysis of two studies found that phenobarbital produced a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). There was no significant difference in duration of treatment or duration of hospital stay. Comparing phenobarbital with chlorpromazine, one study found no significant difference in treatment failure rate. No data for neurodevelopment were available, reported by treatment group as allocated. No trials were eligible that assessed clonidine for NAS. In newborn infants with NAS, there is no evidence that phenobarbital, compared with supportive care alone, reduces treatment failure; however, phenobarbital may reduce the daily duration of supportive care needed. Phenobarbital, compared to diazepam, reduces treatment failure. There is insufficient evidence to support the use of chlorpromazine or clonidine in newborn infants with NAS. Clonidine and chlorpromazine should only be used in the context of a randomised clinical trial. The results of this review, taken in conjunction with the related review, Opiate treatment for opiate withdrawal in newborn infants (Osborn 2002), indicate that treatment with opiates is the preferred initial therapy for NAS. It is hypothesised that this is particularly true for infants whose mothers have used only opiates during pregnancy. If a sedative is used, phenobarbital is preferred to diazepam. The results of an ongoing trial of the addition of phenobarbital to an opiate are awaited.

Pharmacological interventions for pain relief during orthodontic treatment.

PubMed

Monk, Aoife B; Harrison, Jayne E; Worthington, Helen V; Teague, Annabel

2017-11-28

Pain is a common side effect of orthodontic treatment. It increases in proportion to the amount of force applied to the teeth, and the type of orthodontic appliance used can affect the intensity of the pain. Pain during orthodontic treatment has been shown to be the most common reason for people wanting to discontinue treatment, and has been ranked as the worst aspect of treatment. Although pharmacological methods of pain relief have been investigated, there remains some uncertainty among orthodontists about which painkillers are most suitable and whether pre-emptive analgesia is beneficial. We conducted this Cochrane Review to assess and summarize the international evidence relating to the effectiveness of analgesics for preventing this unwanted side effect associated with orthodontic treatment. The objectives of this review are to determine:- the effectiveness of drug interventions for pain relief during orthodontic treatment; and- whether there is a difference in the analgesic effect provided by different types, forms and doses of analgesia taken during orthodontic treatment. Cochrane Oral Health's Information Specialist searched the following databases: the Cochrane Oral Health Trials Register (to 19 June 2017), the Cochrane Central Register of Controlled Trials (CENTRAL;the Cochrane Library 2016, Issue 7), MEDLINE Ovid (1946 to 19 June 2017), Embase Ovid (1980 to 19 June 2017) and CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to 19 June 2017). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched on the 19 June 2017 for ongoing studies. We placed no restrictions on language or date of publication when searching the electronic databases. We included randomized controlled trials (RCTs) relating to pain control during orthodontic treatment. Pain could be measured on a visual analogue scale (VAS), numerical rating scale (NRS) or categorical scale. Two review authors independently screened the search results, agreed the studies to be included and extracted information from the included studies regarding methods, participants, interventions, outcomes, harms and results. We planned to resolve any discrepancies or disagreements through discussion. We used the Cochrane 'Risk of bias' tool to assess the risk of bias in the studies. We identified 32 relevant RCTs, which included 3110 participants aged 9 to 34 years, 2348 of whom we were able to include in our analyses. Seventeen of the studies had more than two arms. We were able to use data from 12 trials in meta-analyses that compared analgesics versus control (no treatment or a placebo); nine that compared non-steroidal anti-inflammatories (NSAIDs) versus paracetamol; and two that compared pre-emptive versus post-treatment ibuprofen for pain control following orthodontic treatment. One study provided data for the comparison of NSAIDs versus local anaesthetic.We found moderate-quality evidence that analgesics effectively reduced pain following orthodontic treatment when compared to no treatment or a placebo at 2 hours (mean difference (MD) -11.66 mm on a 0 to 100 mm VAS, 95% confidence interval (CI) -16.15 to -7.17; 10 studies, 685 participants), 6 hours (MD -24.27 mm on a VAS, 95% CI -31.44 to -17.11; 9 studies, 535 participants) and 24 hours (MD -21.19 mm on a VAS, 95% CI -28.31 to -14.06; 12 studies, 1012 participants).We did not find any evidence of a difference in efficacy between NSAID and paracetamol at 2, 6 or 24 hours (at 24 hours: MD -0.51, 95% CI -8.93 to 7.92; 9 studies, 734 participants; low-quality evidence).Very low-quality evidence suggested pre-emptive ibuprofen gave better pain relief at 2 hours than ibuprofen taken post treatment (MD -11.30, 95% CI -16.27 to -6.33; one study, 41 participants), however, the difference was no longer significant at 6 or 24 hours.A single study of 48 participants compared topical NSAIDs versus local anaesthetic and showed no evidence of a difference in the effectiveness of the interventions (very low-quality evidence).Use of rescue analgesia was poorly reported. The very low-quality evidence did not show evidence of a difference between participants taking ibuprofen and participants taking paracetamol (relative risk (RR) 1.5, 95% CI 0.6 to 3.6). Nor did we find evidence of a difference between groups in likelihood of requiring rescue analgesia when ibuprofen was taken pre-emptively compared to after treatment (RR 0.8, 95% CI 0.3 to 1.9).Adverse effects were identified in one study, with one participant developing a rash that required treatment with antihistamines. This was provisionally diagnosed as a hypersensitivity to paracetamol. Analgesics are more effective at reducing pain following orthodontic treatment than placebo or no treatment. Low-quality evidence did not show a difference in effectiveness between systemic NSAIDs compared with paracetamol, or topical NSAIDs compared with local anaesthetic. More high-quality research is needed to investigate these comparisons, and to evaluate pre-emptive versus post-treatment administration of analgesics.

Are beta-blockers effective for preventing post-coronary artery bypass grafting atrial fibrillation? Direct and network meta-analyses.

PubMed

Ji, T; Feng, C; Sun, L; Ye, X; Bai, Y; Chen, Q; Qin, Y; Zhu, J; Zhao, X

2016-05-01

Atrial fibrillation is the most common arrhythmia in clinical practice and is a major contributor to mortality. Recently, several studies have reported different results for treatments aimed at reducing the risk of postoperative AF. The aim of this study was to evaluate the efficacy of beta-blockers (BBs) in preventing post-coronary artery bypass grafting (CABG) AF and to compare the efficacies of different BB treatments using a network meta-analytical approach. The PubMed, EMBASE and Cochrane Library databases were searched (Jan 1995 to May 2014) to identify randomized controlled trials. Two independent investigators separately extracted the data using a seven-point scoring system to assess randomization, allocation concealment, blinding, withdrawals and dropouts. A direct meta-analysis of these randomized controlled trials was conducted. Then, six trials comparing different BB treatments for the prevention of postoperative AF were added to perform a Bayesian network meta-analysis with mixed treatment comparisons. Treatment with BBs was associated with a significant reduction in the postoperative incidence of AF compared with placebo/control [22.37 % compared with 34.45 %, relative risk (RR) = 0.53, 95 % confidence interval (CI): 0.37-0.75, p < 0.00001]. The network meta-analysis revealed no significant differences among eight types of BB treatments but did provide a ranking. BB treatments could significantly reduce the occurrence of post-CABG AF. Insufficient evidence was available to show that one BB treatment was more effective than the others were. According to our network meta-analysis, bisoprolol and landiolol+bisoprolol are better alternatives compared with the other treatments.

Effectiveness of additional supervised exercises compared with conventional treatment alone in patients with acute lateral ankle sprains: systematic review

PubMed Central

van Ochten, John; Luijsterburg, Pim A J; van Middelkoop, Marienke; Koes, Bart W; Bierma-Zeinstra, Sita M A

2010-01-01

Objective To summarise the effectiveness of adding supervised exercises to conventional treatment compared with conventional treatment alone in patients with acute lateral ankle sprains. Design Systematic review. Data sources Medline, Embase, Cochrane Central Register of Controlled Trials, Cinahl, and reference screening. Study selection Included studies were randomised controlled trials, quasi-randomised controlled trials, or clinical trials. Patients were adolescents or adults with an acute lateral ankle sprain. The treatment options were conventional treatment alone or conventional treatment combined with supervised exercises. Two reviewers independently assessed the risk of bias, and one reviewer extracted data. Because of clinical heterogeneity we analysed the data using a best evidence synthesis. Follow-up was classified as short term (up to two weeks), intermediate (two weeks to three months), and long term (more than three months). Results 11 studies were included. There was limited to moderate evidence to suggest that the addition of supervised exercises to conventional treatment leads to faster and better recovery and a faster return to sport at short term follow-up than conventional treatment alone. In specific populations (athletes, soldiers, and patients with severe injuries) this evidence was restricted to a faster return to work and sport only. There was no strong evidence of effectiveness for any of the outcome measures. Most of the included studies had a high risk of bias, with few having adequate statistical power to detect clinically relevant differences. Conclusion Additional supervised exercises compared with conventional treatment alone have some benefit for recovery and return to sport in patients with ankle sprain, though the evidence is limited or moderate and many studies are subject to bias. PMID:20978065

Orthodontic treatment need among young Saudis attending public versus private dental practices in Riyadh

PubMed Central

Al-Jobair, Asma M; Baidas, Laila F; Al-Hamid, Anfal A; Al-Qahtani, Sara G; Al-Najjar, Amani T; Al-Kawari, Huda M

2016-01-01

Objective To assess and compare the severity of malocclusion and orthodontic treatment need among young Saudis receiving free treatment at public dental practices versus those paying for treatment at private practices. Materials and methods This retrospective study evaluated the records of 300 patients (179 females, 121 males; age 13–21 years) treated at orthodontic clinics from 2013 through 2015. The public sample was selected from orthodontic clinics at the College of Dentistry, King Saud University (KSU); the private sample was selected from five private orthodontic clinics in Riyadh, Saudi Arabia. The records were examined for the severity of malocclusion and for orthodontic treatment need using the Dental Health Component of the Index of Orthodontic Treatment Need. The prevalence of each occlusal discrepancy and the Dental Health Component grade were recorded. The severity of malocclusion and orthodontic treatment need were compared between practice types, age groups, and sexes with the chi-square test. Results Displacement, increased overjet, and Class II and III malocclusion were the most common orthodontic problems in this study. Patients attending public clinics at KSU generally had more severe malocclusion than the patients attending private clinics. Seventy-seven percent of orthodontically treated patients at KSU clinics were in great need of treatment, compared with 58.5% of patients treated at private clinics (P=0.003). Among the patients with great treatment need, approximately 62% of male patients and 70% of patients ≤16 years of age were treated at KSU clinics, compared with 38% and 48%, respectively, treated at private clinics (P<0.0001). Conclusion Young Saudis receiving free orthodontic treatment at public clinics at KSU had more severe malocclusion with greater need of orthodontic treatment than the patients paying for treatment at private clinics. PMID:27843351

Orthodontic treatment need among young Saudis attending public versus private dental practices in Riyadh.

PubMed

Al-Jobair, Asma M; Baidas, Laila F; Al-Hamid, Anfal A; Al-Qahtani, Sara G; Al-Najjar, Amani T; Al-Kawari, Huda M

2016-01-01

To assess and compare the severity of malocclusion and orthodontic treatment need among young Saudis receiving free treatment at public dental practices versus those paying for treatment at private practices. This retrospective study evaluated the records of 300 patients (179 females, 121 males; age 13-21 years) treated at orthodontic clinics from 2013 through 2015. The public sample was selected from orthodontic clinics at the College of Dentistry, King Saud University (KSU); the private sample was selected from five private orthodontic clinics in Riyadh, Saudi Arabia. The records were examined for the severity of malocclusion and for orthodontic treatment need using the Dental Health Component of the Index of Orthodontic Treatment Need. The prevalence of each occlusal discrepancy and the Dental Health Component grade were recorded. The severity of malocclusion and orthodontic treatment need were compared between practice types, age groups, and sexes with the chi-square test. Displacement, increased overjet, and Class II and III malocclusion were the most common orthodontic problems in this study. Patients attending public clinics at KSU generally had more severe malocclusion than the patients attending private clinics. Seventy-seven percent of orthodontically treated patients at KSU clinics were in great need of treatment, compared with 58.5% of patients treated at private clinics ( P =0.003). Among the patients with great treatment need, approximately 62% of male patients and 70% of patients ≤16 years of age were treated at KSU clinics, compared with 38% and 48%, respectively, treated at private clinics ( P <0.0001). Young Saudis receiving free orthodontic treatment at public clinics at KSU had more severe malocclusion with greater need of orthodontic treatment than the patients paying for treatment at private clinics.

Mobile phone text messaging for promoting adherence to anti-tuberculosis treatment: a systematic review

PubMed Central

2013-01-01

Background Mobile phone text messaging (SMS) has the potential to promote adherence to tuberculosis treatment. This systematic review aims to synthesize current evidence on the effectiveness of SMS interventions in improving patients’ adherence to tuberculosis treatment. Methods We searched electronic databases (PubMed, EMBASE, Science Citation Index), reference lists of relevant articles, conference proceedings, and selected websites for eligible studies available by 15 February 2013; regardless of language or publication status. Two authors independently screened selected eligible studies, and assessed risk of bias in included studies; resolving discrepancies by discussion and consensus. Results We identified four studies that compared the outcomes of the SMS intervention group with controls. Only one of the four studies was a randomized controlled trial. This was conducted in Argentina and the SMS intervention did not significantly improve adherence to tuberculosis treatment compared to self-administration of tuberculosis treatment (risk ratio [RR] 1.49, 95% confidence intervals [CI] 0.90 to 2.42). One of the non-randomized studies, conducted in South Africa, which compared SMS reminders to directly observed therapy short course (DOTS) reported similar rates of tuberculosis cure (62.35% vs. 66.4%) and treatment success (72.94% vs. 69.4%). A second study from South Africa, utilized SMS reminders when patients delayed in opening their pill bottles and reported increased tuberculosis cure (RR 2.32, 95% CI 1.60 to 3.36) and smear conversion (RR 1.62, 95% CI 1.09 to 2.42) rates compared to DOTS. In the third non-randomized study, conducted in Kenya, use of SMS reminders increased rates of clinic attendance on scheduled days compared to standard care (RR 1.56, 95% CI 1.06 to 2.29). Using the GRADE approach, we rate the quality of the evidence as low, mainly because of the high risk of bias and heterogeneity of effects across studies. Conclusions This systematic review indicates that there is a paucity of high-quality data on the effectiveness of SMS interventions for improving patients’ adherence to tuberculosis treatment. The low quality of the current evidence implies that further studies (in particular randomized trials) on the subject are needed. In the interim, if the intervention is implemented outside research settings an impact evaluation is warranted. PMID:24295439

Respiratory protection during simulated emergency pediatric life support: a randomized, controlled, crossover study.

PubMed

Schumacher, Jan; Gray, Stuart A; Michel, Sophie; Alcock, Roger; Brinker, Andrea

2013-02-01

Emergency pediatric life support (EPLS) of children infected with transmissible respiratory diseases requires adequate respiratory protection for medical first responders. Conventional air-purifying respirators (APR) and modern loose-fitting powered air-purifying respirator-hoods (PAPR-hood) may have a different impact during pediatric resuscitation and therefore require evaluation. This study investigated the influence of APRs and PAPR-hoods during simulated pediatric cardiopulmonary resuscitation. Study design was a randomized, controlled, crossover study. Sixteen paramedics carried out a standardized EPLS scenario inside an ambulance, either unprotected (control) or wearing a conventional APR or a PAPR-hood. Treatment times and wearer comfort were determined and compared. All paramedics completed the treatment objectives of the study arms without adverse events. Study subjects reported that communication, dexterity and mobility were significantly better in the APR group, whereas the heat-build-up was significantly less in the PAPR-hood group. Treatment times compared to the control group did not significantly differ for the APR group but did with the PAPR-hood group (261±12 seconds for the controls, 275±9 seconds for the conventional APR and 286±13 seconds for the PAPR-hood group, P < .05. APRs showed a trend to better treatment times compared to PAPR-hoods during simulated pediatric cardiopulmonary resuscitation. Study participants rated mobility, ease of communication and dexterity with the tight-fitting APR system significantly better compared to the loose-fitting PAPR-hood.

A comparison of approaches to mitigate hypothetical bias

Treesearch

Patricia A. Champ; Rebecca Moore; Richard C. Bishop

2009-01-01

We compare two approaches to mitigating hypothetical bias. The study design includes three treatments: an actual payment treatment, a contingent valuation (CV) treatment with a followup certainty question, and a CV treatment with a cheap talk script. Our results suggest that both the follow-up certainty treatment and the cheap talk treatment produce...

Intravenous versus intramuscular cobinamide compared to intravenous saline (control) in the treatment of acute, survivable, hydrogen sulfide toxicity in swine (Sus Scrofa).

DTIC Science & Technology

2017-11-09

FWH20140070A, “Intravenous versus intramuscular // compared to intravenous saline ( control ) in the treatment of acute, survivable, hydrogen sulfide toxicity... control ) in the treatment of acute, survivable, hydrogen sulfide toxicity in swine (Sus Scrofa). 4. Principal Investigator (PI): Name Rank Date...remainder of the study. Animals were treated with IV HOC, IV Cobinamide or control (no treatment) 1 minute post apnea. There were no significant

Comparison of raloxifene and bisphosphonates based on adherence and treatment satisfaction in postmenopausal Asian women.

PubMed

Pasion, Ellewellyn G; Sivananthan, Shanmugam K; Kung, Annie Wai-Chee; Chen, Sung-Hsiung; Chen, Yen-Jen; Mirasol, Roberto; Tay, Boon Keng; Shah, Ghazanfar Ali; Khan, Mansoor Ali; Tam, Frances; Hall, Belinda J; Thiebaud, Daniel

2007-01-01

We evaluated adherence with raloxifene therapy compared with daily bisphosphonate in Asian postmenopausal women at increased risk of osteoporotic fractures. In this 12-month observational study conducted in Asia (Hong Kong, Malaysia, Pakistan, Philippines, Singapore, Taiwan), 984 postmenopausal women (aged 55 years or older) were treated with raloxifene 60 mg/day (n = 707; 72%) or daily bisphosphonate (alendronate 10 mg/day; n = 206; 21%, or risedronate 5 mg/day; n = 71; 7%) during their normal course of care. Patients were assessed at baseline, 6, and 12 months. Baseline characteristics (including age, race, education, menopausal status, and baseline fractures) were comparable between the raloxifene and bisphosphonate groups. More women on raloxifene completed the study compared with those on bisphosphonate (50.2% versus 37.5%; P < 0.001). Patients also took raloxifene for a longer period than bisphosphonate (median, 356 versus 348 days; P = 0.011). Compared with those taking bisphosphonate, significantly fewer patients taking raloxifene discontinued the study because of stopping treatment (5.7% versus 10.1%, P = 0.017) or changing treatment (2.8% versus 9.7%, P < 0.001). Inconvenient dosing was reported as a primary reason for discontinuation due to stopping or changing treatment in 19 (6.9%) bisphosphonate patients compared with 0 raloxifene patients. The percentage of patients who had consumed 80% or more of their study medication was similar for raloxifene patients (48-56 weeks; 95.2%) and bisphosphonate patients (48-56 weeks; 93.3%). More raloxifene patients responded that they were satisfied with their medication than bisphosphonate patients at 48-56 weeks (P = 0.002). We concluded that Asian postmenopausal women at increased risk of osteoporotic fractures showed a greater propensity to remain on raloxifene compared with bisphosphonate. The women on raloxifene exhibited lower discontinuation rates and higher treatment satisfaction.

The timing of exposure in clinic-based treatment for childhood anxiety disorders.

PubMed

Gryczkowski, Michelle R; Tiede, Michael S; Dammann, Julie E; Jacobsen, Amy Brown; Hale, Lisa R; Whiteside, Stephen P H

2013-03-01

The present study examines treatment length and timing of exposure from two child anxiety disorders clinics. Data regarding symptoms and treatment characteristics for 28 youth were prospectively obtained through self, parent, and therapist report at each session. Information regarding length of treatment, timing of exposure initiation, and drop-out rates were compared with those obtained through efficacy and effectiveness trials of manualized treatment for anxious youth. Findings from the authors' clinical data revealed significantly shorter treatment duration with exposures implemented sooner than in the previous studies. Dropout rates were significantly higher than in the efficacy trial but comparable with the effectiveness trial. Outcome data from a subset of eight patients revealed large effect sizes. These findings suggest that effective treatment can be shorter and more focused on exposure than is often outlined in manuals and have important implications for outcome research and dissemination.

Blending Face-to-Face and Internet-Based Interventions for the Treatment of Mental Disorders in Adults: Systematic Review

PubMed Central

Eichert, Hans-Christoph; Riper, Heleen

2017-01-01

Background Many studies have provided evidence for the effectiveness of Internet-based stand-alone interventions for mental disorders. A newer form of intervention combines the strengths of face-to-face (f2f) and Internet approaches (blended interventions). Objective The aim of this review was to provide an overview of (1) the different formats of blended treatments for adults, (2) the stage of treatment in which these are applied, (3) their objective in combining face-to-face and Internet-based approaches, and (4) their effectiveness. Methods Studies on blended concepts were identified through systematic searches in the MEDLINE, PsycINFO, Cochrane, and PubMed databases. Keywords included terms indicating face-to-face interventions (“inpatient,” “outpatient,” “face-to-face,” or “residential treatment”), which were combined with terms indicating Internet treatment (“internet,” “online,” or “web”) and terms indicating mental disorders (“mental health,” “depression,” “anxiety,” or “substance abuse”). We focused on three of the most common mental disorders (depression, anxiety, and substance abuse). Results We identified 64 publications describing 44 studies, 27 of which were randomized controlled trials (RCTs). Results suggest that, compared with stand-alone face-to-face therapy, blended therapy may save clinician time, lead to lower dropout rates and greater abstinence rates of patients with substance abuse, or help maintain initially achieved changes within psychotherapy in the long-term effects of inpatient therapy. However, there is a lack of comparative outcome studies investigating the superiority of the outcomes of blended treatments in comparison with classic face-to-face or Internet-based treatments, as well as of studies identifying the optimal ratio of face-to-face and Internet sessions. Conclusions Several studies have shown that, for common mental health disorders, blended interventions are feasible and can be more effective compared with no treatment controls. However, more RCTs on effectiveness and cost-effectiveness of blended treatments, especially compared with nonblended treatments are necessary. PMID:28916506

A One Year Study of Mode Deactivation Therapy: Adolescent Residential Patients with Conduct and Personality Disorders

ERIC Educational Resources Information Center

Murphy, Christopher J.; Siv, Alexander M.

2011-01-01

This case study is to evaluate the effectiveness of Mode Deactivation Therapy (MDT) implementation in a child and adolescent residential treatment unit and provide preliminary effectiveness data on MDT versus treatment as usual (TAU). This case study compared the efficacy of two treatment methodologies for adolescent males in residential treatment…

Clinical study in genital herpes: natural Gene-Eden-VIR/Novirin versus acyclovir, valacyclovir, and famciclovir.

PubMed

Polansky, Hanan; Javaherian, Adrian; Itzkovitz, Edan

2016-01-01

This paper reports the results of a clinical study that tested the effect of suppressive treatment with the botanical product Gene-Eden-VIR/Novirin on the number of genital herpes outbreaks. The results in this study were compared to those published in clinical studies of acyclovir, valacyclovir, and famciclovir. The framework was a retrospective chart review. The population included 139 participants. The treatment was one to four capsules of Gene-Eden-VIR/Novirin per day. The duration of treatment was 2-48 months. The study included three controls recommended by the US Food and Drug Administration (FDA): baseline, no treatment, and dose response. The treatment decreased the number of outbreaks per year in 90.8% of the participants. The treatment also decreased the mean number of outbreaks per year from 7.27 and 5.5 in the control groups to 2.39 (P<0.0001 and P<0.001, respectively). The treated participants reported no adverse experiences. Out of the 15 tests that compared Gene-Eden-VIR/Novirin to the three drugs, Gene-Eden-VIR/Novirin had superior efficacy in eight tests, inferior efficacy in three tests, and comparable efficacy in four tests. Gene-Eden-VIR/Novirin also had superior safety. The clinical study showed that the natural Gene-Eden-VIR/Novirin decreases the number of genital herpes outbreaks without any side effects. The study also showed that the clinical effects reported in this study are mostly better than those reported in the reviewed studies of acyclovir, valacyclovir, and famciclovir.

Comparative Study on the Performance of Anaerobic and Aerobic Biotrickling Filter for Removal of Chloroform

EPA Science Inventory

Use of biotrickling filter (BTF) for gas phase treatment of volatile trihalomethanes (THMs) stripped from water treatment plants could be an attractive treatment option. The aim of this study is to use laboratory-scale anaerobic BTF to treat gaseous chloroform (recalcitrant to bi...

Case Study Using Ultrasound to Treat /[turned r]/

ERIC Educational Resources Information Center

Modha, Geetanjalee; Bernhardt, B. May; Church, Robyn; Bacsfalvi, Penelope

2008-01-01

Background: Ultrasound has shown promise as visual feedback in remediation of /[turned r]/.Aims: To compare treatment for [turned r] with and without ultrasound.Methods & Procedures: A Canadian English-speaking adolescent participated in a case study with a no treatment baseline, alternating treatment blocks with and without ultrasound and a…

Relapse and Recurrence Prevention in the Treatment for Adolescents with Depression Study

ERIC Educational Resources Information Center

Simons, Anne D.; Rohde, Paul; Kennard, Betsy D.; Robins, Michele

2005-01-01

Relapse and recurrence in adolescent depression are important problems. Much less is known about relapse prevention compared to the acute treatment of depression in adolescents. Based on previous research, theoretical predictions, and clinical experience, the Treatment for Adolescents With Depression Study (TADS) protocol was designed to determine…

Clinical outcomes of traumatized youth in adolescent substance abuse treatment: a longitudinal multisite study.

PubMed

Williams, Julie K; Smith, Douglas C; An, Hyonggin; Hall, James A

2008-03-01

The purpose of this study was to evaluate the effectiveness of outpatient substance abuse treatment for youth with high traumatic stress compared to youth without high traumatic stress in substance abuse treatment centers across the United States. The data for this study were gathered using a longitudinal survey design with purposive sampling from nine drug treatment delivery systems across the United States participating in the cooperative grant Strengthening Communities for Youth (SCY) awarded by SAMHSA's Center for Substance Abuse Treatment (CSAT) between September 2002 and June 2006. Follow-up assessments were conducted with the youth at three,six, and 12 months following intake. Traumatized youth responded to outpatient treatment in a similar pattern when compared to nontraumatized youth, although the traumatized youth had consistently higher scores on substance use frequency and substance problems scales than nontraumatized youth throughout the study. Current empirically validated treatments for adolescent substance abuse do not prepare the practitioner for trauma-informed practice or specifically address trauma-informed recovery. Based on our results, we advocate for the development and integration of trauma-informed practice within substance abuse treatment for adolescents to help them recover from trauma and substance abuse issues.

Treatment of Test Anxiety by Cue-Controlled Desensitization and Study-Skills Training.

ERIC Educational Resources Information Center

Lent, Robert W.; Russell, Richard K.

1978-01-01

Compared relative effectiveness of two multicomponent strategies in the treatment of test anxiety. Test-anxious students were assigned to groups. Within-group changes between pre- and post-testing favored multicomponent treatments. Between groups, both desensitization treatment programs demonstrated significant improvement over no-treatment on…

Surgical Versus Nonsurgical Treatment for Midshaft Clavicle Fractures in Patients Aged 16 Years and Older: A Systematic Review, Meta-analysis, and Comparison of Randomized Controlled Trials and Observational Studies.

PubMed

Smeeing, Diederik P J; van der Ven, Denise J C; Hietbrink, Falco; Timmers, Tim K; van Heijl, Mark; Kruyt, Moyo C; Groenwold, Rolf H H; van der Meijden, Olivier A J; Houwert, Roderick M

2017-07-01

There is no consensus on the choice of treatment of midshaft clavicle fractures (MCFs). The aims of this systematic review and meta-analysis were (1) to compare fracture healing disorders and functional outcomes of surgical versus nonsurgical treatment of MCFs and (2) to compare effect estimates obtained from randomized controlled trials (RCTs) and observational studies. Systematic review and meta-analysis. The PubMed/MEDLINE, Embase, CENTRAL, and CINAHL databases were searched for both RCTs and observational studies. Using the MINORS instrument, all included studies were assessed on their methodological quality. The primary outcome was a nonunion. Effects of surgical versus nonsurgical treatment were estimated using random-effects meta-analysis models. A total of 20 studies were included, of which 8 were RCTs and 12 were observational studies including 1760 patients. Results were similar across the different study designs. A meta-analysis of 19 studies revealed that nonunions were significantly less common after surgical treatment than after nonsurgical treatment (odds ratio [OR], 0.18 [95% CI, 0.10-0.33]). The risk of malunions did not differ between surgical and nonsurgical treatment (OR, 0.38 [95% CI, 0.12-1.19]). Both the long-term Disabilities of the Arm, Shoulder and Hand (DASH) and Constant-Murley scores favored surgical treatment (DASH: mean difference [MD], -2.04 [95% CI, -3.56 to -0.52]; Constant-Murley: MD, 3.23 [95% CI, 1.52 to 4.95]). No differences were observed regarding revision surgery (OR, 0.85 [95% CI, 0.42-1.73]). Including only high-quality studies, both the number of malunions and days to return to work show significant differences in favor of surgical treatment (malunions: OR, 0.26 [95% CI, 0.07 to 0.92]; return to work: MD, -8.64 [95% CI, -16.22 to -1.05]). This meta-analysis of high-quality studies showed that surgical treatment of MCFs results in fewer nonunions, fewer malunions, and an accelerated return to work compared with nonsurgical treatment. A meta-analysis of surgical treatments need not be restricted to randomized trials, provided that the included observational studies are of high quality.

A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study).

PubMed

OʼToole, Robert V; Gary, Joshua L; Reider, Lisa; Bosse, Michael J; Gordon, Wade T; Hutson, James; Quinnan, Stephen M; Castillo, Renan C; Scharfstein, Daniel O; MacKenzie, Ellen J

2017-04-01

The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.

Comparative study of wastewater treatment and nutrient recycle via activated sludge, microalgae and combination systems.

PubMed

Wang, Liang; Liu, Jinli; Zhao, Quanyu; Wei, Wei; Sun, Yuhan

2016-07-01

Algal-bacterial synergistic cultivation could be an optional wastewater treatment technology in temperate areas. In this study, a locally screened vigorous Chlorella strain was characterized and then it was used in a comparative study of wastewater treatment and nutrient recycle assessment via activated sludge (AS), microalgae and their combination systems. Chlorella sp. cultured with AS in light showed the best performance, in which case the removal efficiencies of COD, NH3-N and TP were 87.3%, 99.2% and 83.9%, respectively, within a short period of 1day. Algal-bacterial combination in light had the best settleability. Chlorella sp. contained biomass, could be processed to feed, fertilizer or fuel due to the improved quality (higher C/H/N) compared with sludge. PCR-DGGE analysis shows that two types of rhizobacteria, namely, Pseudomonas putida and Flavobacterium hauense were enriched in sludge when cultured with algae in light, serving as the basics for artificial consortium construction for improved wastewater treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

The rate of sputum smear-positive tuberculosis after treatment default in a high-burden setting: a retrospective cohort study.

PubMed

Marx, Florian M; Dunbar, Rory; Enarson, Donald A; Beyers, Nulda

2012-01-01

High rates of recurrent tuberculosis after successful treatment have been reported from different high burden settings in Sub-Saharan Africa. However, little is known about the rate of smear-positive tuberculosis after treatment default. In particular, it is not known whether or not treatment defaulters continue to be or become again smear-positive and thus pose a potential for transmission of infection to others. To investigate, in a high tuberculosis burden setting, the rate of re-treatment for smear-positive tuberculosis among cases defaulting from standardized treatment compared to successfully treated cases. Retrospective cohort study among smear-positive tuberculosis cases treated between 1996 and 2008 in two urban communities in Cape Town, South Africa. Episodes of re-treatment for smear-positive tuberculosis were ascertained via probabilistic record linkage. Survival analysis and Poisson regression were used to compare the rate of smear-positive tuberculosis after treatment default to that after successful treatment. A total of 2,136 smear-positive tuberculosis cases were included in the study. After treatment default, the rate of re-treatment for smear-positive tuberculosis was 6.86 (95% confidence interval [CI]: 5.59-8.41) per 100 person-years compared to 2.09 (95% CI: 1.81-2.41) after cure (adjusted Hazard Ratio [aHR]: 3.97; 95% CI: 3.00-5.26). Among defaulters, the rate was inversely associated with treatment duration and sputum conversion prior to defaulting. Smear grade at start of the index treatment episode (Smear3+: aHR 1.61; 95%CI 1.11-2.33) was independently associated with smear-positive tuberculosis re-treatment, regardless of treatment outcome. In this high-burden setting, there is a high rate of subsequent smear-positive tuberculosis after treatment default. Treatment defaulters are therefore likely to contribute to the pool of infectious source cases in the community. Our findings underscore the importance of preventing treatment default, as a means of successful tuberculosis control in high-burden settings.

Intralesional Mycobacterium w Vaccine Versus Cryotherapy in Treatment of Refractory Extragenital Warts: A Randomized, Open-Label, Comparative Study.

PubMed

Dhakar, Ashok K; Dogra, Sunil; Vinay, Keshavamurthy; Sarangal, Rishu; Kanwar, Amrinder J; Singh, Mini P

2016-01-01

Initial reports of immunotherapy using intralesional Mycobacterium w (Mw) vaccine have documented its useful role in treatment of genital and extragenital warts. To compare the efficacy and safety of intralesional Mw vaccine versus cryotherapy in the treatment of refractory extragenital warts. This was a prospective, randomized, comparative study of 66 patients. The outcome was assessed in terms of complete clearance of warts and change in Dermatology Life Quality Index (DLQI) score. Complete clearance of treated warts was seen in 66.7% (20/30) and 65.5% (19/29) of patients in the Mw and cryotherapy groups, respectively (P = .769). Clearance of distant warts was significantly (P = .004) high in the Mw group. Improvement in DLQI was greater in the Mw group. Both treatment modalities were well tolerated, and no major side effects occurred. Mw vaccine and cryotherapy are equally efficacious in treatment of refractory extragenital warts. Mw vaccine has an added advantage of clearance of distant warts. © The Author(s) 2015.

Balneotherapy for osteoarthritis.

PubMed

Verhagen, A P; Bierma-Zeinstra, S M A; Boers, M; Cardoso, J R; Lambeck, J; de Bie, R A; de Vet, H C W

2007-10-17

Balneotherapy (or spa therapy, mineral baths) for patients with arthritis is one of the oldest forms of therapy. One of the aims of balneotherapy is to soothe the pain and as a consequence to relieve patients' suffering and make them feel well. In this update we included one extra study. To assess the effectiveness of balneotherapy for patients with osteoarthritis (OA). We searched the following databases up to October 2006: EMBASE, PubMed, the Cochrane 'Rehabilitation and Related Therapies' Field database, PEDro, CENTRAL (Issue 3, 2006) and performed reference checking and communicated with authors to retrieve eligible studies. Randomised controlled trials (RCT) comparing balneotherapy with any intervention or no intervention. At least 90% of the patient population had to be diagnosed with OA. Two authors independently assessed quality and extracted data. Disagreements were solved by consensus. In the event of clinical heterogeneity or lack of data we refrained from statistical pooling. Seven trials (498 patients) were included in this review. Two studies compared spa-treatment with no treatment. One study evaluated baths as an add-on treatment to home exercises and another compared thermal water from Cserkeszölö with tap water (placebo). Three studies evaluated sulphur or Dead Sea baths with no treatment or mineral baths with tap water baths or no treatment. Only one of the trials performed an intention-to-treat analysis and two studies provided data to perform an intention-to-treat analysis ourselves. A 'quality of life' outcome was reported by one trial. We found: silver level evidence concerning the beneficial effects on pain, quality of life and analgesic intake of mineral baths compared to no treatment (SMD between 1.82 and 0.34). a statistically significant difference in pain and function of Dead Sea + sulphur versus no treatment, only at end of treatment (WMD 5.7, 95%CI 3.3 to 8.1), but not at 3 month follow-up (WMD 2.6, 95%CI -1.1 to 6.3). no statistically significant differences in pain or function at one or three months of Dead Sea baths versus no treatment (WMD 0.5, 95%CI -0.6 to 1.6) or at one or three months of sulphur baths versus no treatment (WMD 0.4, 95%CI -0.9 to 1.7). Adverse events were not measured in the included trials. We found silver level evidence (www.cochranemsk.org) concerning the beneficial effects of mineral baths compared to no treatment. Of all other balneological treatments no clear effects were found. However, the scientific evidence is weak because of the poor methodological quality and the absence of an adequate statistical analysis and data presentation. Therefore, the noted "positive findings" should be viewed with caution.

A systematic review of cost-effectiveness studies of prevention and treatment for eating disorders.

PubMed

Le, Long Khanh-Dao; Hay, Phillipa; Mihalopoulos, Cathrine

2018-04-01

Eating disorders are serious mental disorders and are associated with substantial economic and social burden. The aim of this study is to undertake a systematic review of the cost-effectiveness studies of both preventive and treatment interventions for eating disorder. Electronic databases (including the Cochrane Controlled Trial Register, MEDLINE, PsycINFO, Academic Search Complete, Global Health, CINAHL complete, Health Business Elite, Econlit, Health Policy Reference Center and ERIC) were searched for published cost-effectiveness studies of eating disorder prevention and treatment including papers published up to January 2017. The quality of studies was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. In all, 13 studies met the review inclusion criteria as full cost-effectiveness studies and 8 were published since 2011. The studies included three modelled and one trial-based study focused on prevention, two trial-based and one modelled study for anorexia nervosa treatment and three trial-based studies for bulimia nervosa treatment. The remaining studies targeted binge-eating disorder or non-specific eating disorder treatment. The average percent of CHEERS checklist items reported was 71% (standard deviation 21%). Eating disorder interventions were mainly cost-saving or more effective and more costly compared to comparators; however, some results did not reach statistical significance. In the two studies that achieved 100% CHEERS checklist, one study reported that a cognitive dissonance intervention might be cost-effective for prevention of anorexia nervosa and bulimia nervosa with a 90% participation rate and the second study supported lisdexamfetamine to be cost-effective in the treatment of binge-eating disorder. Insufficient evidence for long-term cost-effectiveness (e.g. over 2 years) was found. Cost-effectiveness studies in eating disorder appear to be increasing in number over the last 6 years. Findings were inconsistent and no firm conclusion can be drawn with regard to comparative value-for-money conclusions. However, some promising interventions were identified. Further research with improved methodology is required.

Comparative study of integrated pest management and baiting for German cockroach management in public housing.

PubMed

Wang, Changlu; Bennett, Gary W

2006-06-01

This study assessed the cost and effectiveness of a building-wide cockroach integrated pest management (IPM) program compared with bait alone treatment in public housing. In total, 12 buildings (66 apartments) were treated and monitored for cockroach infestations over 7 mo. The buildings were divided into two groups: bait treatment and IPM. Apartments in the bait alone group were treated with Maxforce FC Select (0.01% fipronil) during the first 12 wk and Maxforce Roach Killer Bait Gel (2.15% hydramethylnon) from 16 wk when necessary. For the IPM group, cockroaches were flushed and vacuumed at the beginning of the study; sticky traps were placed in all apartments to monitor and reduce cockroach numbers; educational materials were delivered to the residents; and Maxforce FC Select and Maxforce Roach Killer Bait Gel were applied to kill cockroaches. Two seminars were presented to the manger, and Community Service Program staff of the Gary Housing Authority to help gain tenant cooperation in the program. Effects of the treatments were monitored using sticky traps (six per apartment) at 2, 4, 8, 12, 16, and 29 wk after treatment. More treatments were applied during each monitoring visit when necessary. Those apartments with high levels of infestations (> or =12 cockroaches in six traps) before treatment were used to compare the IPM and bait only treatments. IPM resulted in significantly greater trap catch reduction than the bait treatment. The IPM (n=12) and bait only treatment (n=11) resulted in 100.0 and 94.6%, respectively, reduction in trap catch after 16 wk. At 29 wk, only one apartment in the IPM group had a high level (>12 cockroaches) of cockroach infestation. In contrast, five apartments in the bait treatment group had high level infestations at 29 wk based on overnight trapping counts; thus, IPM is a more sustainable method of population reduction. Sanitation levels in the IPM group significantly improved at 29 wk (n=11) compared with that at the beginning of the study. The sanitation levels in the bait treatment group remained similar throughout the experiment (n=9). The cumulative cost of IPM was significantly higher than that of the bait treatment. The median costs per apartment during 29 wk were 64.8 dollars and 35.0 dollars for the IPM and bait treatment, respectively. The median amount of bait used per apartment in the IPM and bait treatment was 45.0 and 50.0 g, respectively. The cost of the IPM group for the 29 wk service was similar to that of the bait treatment group. We expect that IPM will provide better control at similar cost compared with bait treatment beyond 29 wk.

Rapid treatment reduces hospitalization for pediatric patients with odontogenic-based cellulitis.

PubMed

Thikkurissy, Sarat; Rawlins, Joseph T; Kumar, Ashok; Evans, Erik; Casamassimo, Paul S

2010-07-01

The study aimed to assess characteristics of facial cellulitis admissions and their relationship to cost of hospitalization (COH) and length of stay (LOS) in children ages 0 to 20 years at an urban hospital and to compare outcomes of rapid management to published and national statistics for LOS and COH. A retrospective review of 376 charts of facial cellulitis admissions between 2000 and 2006 revealed 63 of confirmed odontogenic cases from which cellulitis characteristics, COH, and LOS were gleaned. Variables were correlated to LOS and COH. Data on LOS and cost of admission were compared to published studies and 506 entries from the 2006 Kids' Inpatient Database (KID). Of 63 charts included, children included were 8.3 years (SD, +/-3.8 years) and equal in sex distribution. Treatment rendered and site of infection had no significant relationship to COH. Overall mean hospital LOS was 2.08 days and significantly less as compared to 3.97 days for published studies and 3.4 days for KID (P < .0001). The mean overall hospital COH was $4166 and significantly less compared to $3223 in the literature and $8998.43 for KID. In the management of pediatric facial cellulitis of odontogenic origin, rapid treatment had a significant positive impact on length of stay and total cost of treatment compared to published studies and nationally reflective data. Copyright 2010 Elsevier Inc. All rights reserved.

[Meta-analysis of needle-knife treatment on cervical spondylosis].

PubMed

Kan, Li-Li; Wang, Hai-Dong; Liu, An-Guo

2013-11-01

To assess the efficacy of cervical spondylosis by needle-knife treatment according to the correlated literature of RCT,to compare advantages of needle-knife treatment. Randomized Controlled Trials about needle-knife treatment of cervical spondylosis were indexed from Chinese HowNet (CNKI) and Wanfang (WF) from 2000 to 2012, then were analyzed the efficacy by Review Manager 5.1 software. A total of 13 RCT literatures and 1 419 patients were included. The methods of included studies were poor in quality evaluation because of large sample and multi-center RCT studies was lacked, randomization method was not accurate enough, diagnostic criteria and efficacy evaluation were various, only four studies described long-term efficacy, most of the literature didn't describe the adverse event and fall off,all studies did not use the blind method. The Meta analysis outcome showed overall efficiency of needle-knife therapy was better than acupuncture and traction. Needle-knife therapy compared with Acupuncture, the total RR = 0.19, 95% confidence interval was (0.15, 0.24), P < 0.000.01. Compared with traction therapy the total RR = 1.30, 95% confidence intervalwas (1.18,1.42), P < 0.00001. Compared with acupuncture therapy,the overall effectiveness of needle-knife therapy is higher;compared with traction therapy, although,needle-knife therapy has a high overall effectiveness, but because of the loss of total sample size, the outcome RCT researches to confirm.

The Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans: Toward Comparative Effectiveness in the Pediatric Rheumatic Diseases.

PubMed

Ringold, Sarah; Nigrovic, Peter A; Feldman, Brian M; Tomlinson, George A; von Scheven, Emily; Wallace, Carol A; Huber, Adam M; Schanberg, Laura E; Li, Suzanne C; Weiss, Pamela F; Fuhlbrigge, Robert C; Morgan, Esi M; Kimura, Yukiko

2018-05-01

The pediatric rheumatic diseases are a heterogeneous group of rare diseases, posing a number of challenges for the use of traditional clinical and translational research methods. Innovative comparative effectiveness approaches are needed to efficiently study treatment strategies and disease outcomes. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed the consensus treatment plan (CTP) approach as a comparative effectiveness tool for research in pediatric rheumatology. CTPs are treatment strategies, developed by consensus methods among CARRA members, intended to reduce variation in treatment approaches, standardize outcome measurements, and allow for comparison of the effectiveness of different approaches with the goal of improving disease outcomes. To date, CTPs have been published for 8 different diseases and disease manifestations. The approach has been successfully piloted for juvenile localized scleroderma, systemic juvenile idiopathic arthritis (JIA), polyarticular JIA, dermatomyositis, and lupus nephritis. Large-scale studies are underway for systemic JIA and polyarticular JIA, with the CARRA patient registry serving as the data collection platform. These studies have been designed with stakeholder involvement, including active input from CARRA providers, patients, and parents, with the goal of increasing feasibility and ensuring the relevance of the outcomes. These studies include ancillary biologic specimen collection intended to support additional translational and mechanistic studies. Data from these ongoing CTP studies will provide more information on the ability of this approach to identify effective treatment strategies and improve outcomes in the pediatric rheumatic diseases. © 2018, American College of Rheumatology.

Efficacy of surgery for rotator cuff tendinopathy: a systematic review.

PubMed

Toliopoulos, Panagiota; Desmeules, François; Boudreault, Jennifer; Roy, Jean-Sébastien; Frémont, Pierre; MacDermid, Joy C; Dionne, Clermont E

2014-01-01

The objective of this study is to review randomized controlled trials evaluating the efficacy of surgery for the treatment of rotator cuff (RC) tendinopathy. Studies up to August 2013 were located in the PubMed, Embase, CINAHL, and PEDro databases using relevant keywords. Studies were included if: (1) participants had rotator cuff tendinopathy, (2) the trials were conducted on an adult population (≥18 years old), (3) at least one of the interventions studied was a surgical procedure, (4) study design was a randomized controlled trial (RCT), and (5) the article was written in English or French. Characteristics of the included studies were extracted using a standardized form. Two independent raters reviewed the methodological quality of the studies using the Risk of Bias Assessment tool developed by the Cochrane Collaboration Group. Differences were resolved by consensus. Fifteen trials met our inclusion criteria. After consensus, the mean methodological quality for all studies was 58.9 ± 10.8 %. In three out of four RCTs of moderate or low methodological quality, no significant difference in treatment effectiveness was observed between open or arthroscopic acromioplasty compared to exercises in the treatment of RC tendinopathy. Based on two studies of low or moderate methodological quality, no difference in treatment effectiveness was observed between arthroscopic and open acromioplasty. Two other RCTs of low to moderate quality, however, found that arthroscopic acromioplasty yielded better results in the short-term for shoulder range of motion in flexion but that both procedures were comparable in the long-term. One additional study favored open acromioplasty over arthroscopic acromioplasty for the treatment of RC tendinopathy. Based on low- to moderate-quality evidence, acromioplasty, be it open or arthroscopic, is no more effective than exercises for the treatment of RC tendinopathy. Low-grade evidence also suggests that arthroscopic acromioplasty may yield better results in the short-term for shoulder range of motion in flexion compared to open acromioplasty, but long-term results are comparable between the two types of surgery. More high-quality RCTs are required in order to provide comprehensive treatment guidelines to healthcare providers.

Why do different criteria for 'cure' yield different conclusions in comparing two treatments for bacterial vaginosis?

PubMed

Thomas, Katherine K; Sanchez, Sixto; Garcia, Patricia J; Holmes, King K

2005-09-01

The objective of this study was to determine why different criteria for response to treatment of bacterial vaginosis (BV) led to markedly different conclusions about treatment efficacy in a randomized trial comparing metronidazole gel versus metronidazole/nystatin ovules. We compared the impact of two treatment regimens on individual components of Amsel and Nugent criteria at follow-up visits 14, 42, and 104 days after initiating treatment. Compared with gel, ovules more effectively eliminated amines, clue cells, and Gardnerella, Prevotella, or Mobiluncus morphotypes from vaginal fluid, thus achieving cure based on "usual" criteria (absence of BV by Amsel or Nugent criteria), but did not more effectively restore Lactobacillus morphotypes or lower vaginal pH, thus not meeting Federal Drug Administration (FDA) criteria for cure. Because early vaginal recolonization by lactobacilli was poor after both gel and ovules, FDA draft criteria for cure missed marked differences in treatment efficacies against Gardnerella, clue cells, and amines. Cure defined more "usually" may give more useful information.

Levonorgestrel-Releasing Intrauterine System versus Medical Therapy for Menorrhagia: A Systematic Review and Meta-Analysis

PubMed Central

Qiu, Jin; Cheng, Jiajing; Wang, Qingying; Hua, Jie

2014-01-01

Background The aim of this study was to compare the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) with conventional medical treatment in reducing heavy menstrual bleeding. Material/Methods Relevant studies were identified by a search of MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and clinical trials registries (from inception to April 2014). Randomized controlled trials comparing the LNG-IUS with conventional medical treatment (mefenamic acid, tranexamic acid, norethindrone, medroxyprogesterone acetate injection, or combined oral contraceptive pills) in patients with menorrhagia were included. Results Eight randomized controlled trials that included 1170 women (LNG-IUS, n=562; conventional medical treatment, n=608) met inclusion criteria. The LNG-IUS was superior to conventional medical treatment in reducing menstrual blood loss (as measured by the alkaline hematin method or estimated by pictorial bleeding assessment chart scores). More women were satisfied with the LNG-IUS than with the use of conventional medical treatment (odds ratio [OR] 5.19, 95% confidence interval [CI] 2.73–9.86). Compared with conventional medical treatment, the LNG-IUS was associated with a lower rate of discontinuation (14.6% vs. 28.9%, OR 0.39, 95% CI 0.20–0.74) and fewer treatment failures (9.2% vs. 31.0%, OR 0.18, 95% CI 0.10–0.34). Furthermore, quality of life assessment favored LNG-IUS over conventional medical treatment, although use of various measurements limited our ability to pool the data for more powerful evidence. Serious adverse events were statistically comparable between treatments. Conclusions The LNG-IUS was the more effective first choice for management of menorrhagia compared with conventional medical treatment. Long-term, randomized trials are required to further investigate patient-based outcomes and evaluate the cost-effectiveness of the LNG-IUS and other medical treatments. PMID:25245843

Fixed, low radiant exposure vs. incremental radiant exposure approach for diode laser hair reduction: a randomized, split axilla, comparative single-blinded trial.

PubMed

Pavlović, M D; Adamič, M; Nenadić, D

2015-12-01

Diode lasers are the most commonly used treatment modalities for unwanted hair reduction. Only a few controlled clinical trials but not a single randomized controlled trial (RCT) compared the impact of various laser parameters, especially radiant exposure, onto efficacy, tolerability and safety of laser hair reduction. To compare the safety, tolerability and mid-term efficacy of fixed, low and incremental radiant exposures of diode lasers (800 nm) for axillary hair removal, we conducted an intrapatient, left-to-right, patient- and assessor-blinded and controlled trial. Diode laser (800 nm) treatments were evaluated in 39 study participants (skin type II-III) with unwanted axillary hairs. Randomization and allocation to split axilla treatments were carried out by a web-based randomization tool. Six treatments were performed at 4- to 6-week intervals with study subjects blinded to the type of treatment. Final assessment of hair reduction was conducted 6 months after the last treatment by means of blinded 4-point clinical scale using photographs. The primary endpoint was reduction in hair growth, and secondary endpoints were patient-rated tolerability and satisfaction with the treatment, treatment-related pain and adverse effects. Excellent reduction in axillary hairs (≥ 76%) at 6-month follow-up visit after receiving fixed, low and incremental radiant exposure diode laser treatments was obtained in 59% and 67% of study participants respectively (Z value: 1.342, P = 0.180). Patients reported lower visual analogue scale (VAS) pain score on the fixed (4.26) than on the incremental radiant exposure side (5.64) (P < 0.0003). The only side-effect was mild and transient erythema. Subjects better tolerated the fixed, low radiant exposure protocol (P = 0.03). The majority of the study participants were satisfied with both treatments. Both low and incremental radiant exposures produced similar hair reduction and high and comparable patient satisfaction. However, low radiant exposure diode laser treatments were less painful and better tolerated. © 2015 European Academy of Dermatology and Venereology.

[Comparative study on effects of manipulation treatment and transcutaneous electrical nerve stimulation on patients with cervicogenic headache].

PubMed

Li, Chen; Zhang, Xiu-ling; Ding, Hong; Tao, Yue-qiang; Zhan, Hong-sheng

2007-07-01

To compare the effects of manipulation treatment and transcutaneous electrical nerve stimulation (TENS) on patients with cervicogenic headache. Seventy patients with cervicogenic headache were randomly allocated to receive manipulation treatment and TENS treatment, which were given every other day respectively for total 40 days. The headache degree (numeric rating scale, NRS), frequency, lasting time and the range of motion (ROM) of the cervical spine 2 weeks before treatment and 4 weeks after treatment, were compared. Before treatment, there were no significant differences in the headache NRS scores , frequency, lasting time and the ROM scores between the two groups (P>0.05). After treatment, the headache NRS score, frequency, lasting time in the manipulation group decreased significantly (P<0.01), while in the TENS group just the headache NRS score decreased significantly (P<0.05). The ROM scores in both groups showed no significant changes (P>0.05). The response rate of manipulation treatment is 94.5%, significantly higher than 64.5% of TENS treatment (P<0.05). The manipulation treatment is an effective method for patients with cervicogenic headache.

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1.

PubMed

Huang, David B; O'Riordan, William; Overcash, J Scott; Heller, Barry; Amin, Faisal; File, Thomas M; Wilcox, Mark H; Torres, Antoni; Dryden, Matthew; Holland, Thomas L; McLeroth, Patrick; Shukla, Rajesh; Corey, G Ralph

2018-04-03

Our objective in this study was to demonstrate the safety and efficacy of iclaprim compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs). REVIVE-1 was a phase 3, 600-patient, double-blinded, randomized (1:1), active-controlled trial among patients with ABSSSI that compared the safety and efficacy of iclaprim 80 mg fixed dose with vancomycin 15 mg/kg, both administered intravenously every 12 hours for 5-14 days. The primary endpoint of this study was a ≥20% reduction in lesion size (early clinical response [ECR]) compared with baseline among patients randomized to iclaprim or vancomycin at the early time point (ETP), 48 to 72 hours after the start of administration of study drug in the intent-to-treat population. ECR among patients who received iclaprim and vancomycin at the ETP was 80.9% (241 of 298) of patients receiving iclaprim compared with 81.0% (243 of 300) of those receiving vancomycin (treatment difference, -0.13%; 95% confidence interval, -6.42%-6.17%). Iclaprim was well tolerated in the study, with most adverse events categorized as mild. Iclaprim achieved noninferiority (10% margin) at ETP compared with vancomycin and was well tolerated in this phase 3 clinical trial for the treatment of ABSSSI. Based on these results, iclaprim appears to be an efficacious and safe treatment for ABSSSI suspected or confirmed to be due to gram-positive pathogens. NCT02600611.

Treatment-seeking behaviour for childhood fever among caretakers of Chivuna and Magoye rural communities of Mazabuka District, Zambia: a longitudinal study.

PubMed

Hamooya, Benson M; Chongwe, Gershom; Dambe, Rosalia; Halwiindi, Hikabasa

2016-08-11

Treatment-seeking for childhood fever among caretakers in most rural parts of African region is still a major challenge. The aim of this study was to determine the treatment seeking behaviour for fever in under-5 children of Magoye and Chivuna rural areas of Mazabuka district in Zambia. Treatment-seeking behaviour was explored longitudinally among caretakers of 362 children aged 12-59 months with fever. The data was collected from caretakers using a structured interviewer-administered questionnaire at their homes. Chi-square test, one-sample test of proportions and logistic regression were the statistical methods used for data analysis. Of the 362 children with fever, 77 % of them had their treatment sought externally. In which 64 % had their treatment at health facility (HF), 18 % from community health workers (CHW), and 18 % from other sources. Early treatment (≤ 24 h) was sought for 42 % of the fever episodes. In dry season, a child had 1.53 times more likely to have early treatment compared to rainy season [OR 1.53; 95 % CI 1.30, 1.80; p < 0.001]. A child in Chivuna was less likely to have early treatment compared to one in Magoye [OR 0.62; 95 % CI 0.50, 0.76; p < 0.001]. Caretakers had a reduced chance of 27 % [OR 0.73; 95 % CI 0.56, 0.95; p = 0.022] of seeking early treatment if they took a child to other sources compared to a HF. This study has revealed that seeking early and appropriate treatment was suboptimal in the study areas. Source of treatment, season and location were predictors of early treatment of fever among caretakers. Policies aimed at combating poor care-seeking behaviour should not omit to address these factors.

Comparative study of the clinical efficacy of the selective cyclooxygenase-2 inhibitor celecoxib compared with loxoprofen in patients with frozen shoulder.

PubMed

Ohta, Satoru; Komai, Osamu; Hanakawa, Hiroyoshi

2014-01-01

This is a randomized comparative study of the efficacy of celecoxib and loxoprofen in patients with frozen shoulder (scapulohumeral periarthritis). Patients with frozen shoulder who presented with pain as the symptom were divided at random into a celecoxib treatment group (100 mg/dose, twice daily; n = 37) and a loxoprofen treatment group (60 mg/dose, 3 times daily; n = 33). Medication was continued for 1-2 weeks in each group. Each patient was asked to rate the pain on a visual analog scale (score 0-5). This score significantly improved (indicating marked alleviation of pain) in both the celecoxib group (from 3.41 ± 0.86 before treatment to 2.30 ± 1.02 after treatment) and the loxoprofen group (from 3.73 ± 0.67 before treatment to 2.76 ± 0.96 after treatment). In the analysis of disappearance of pain, the percentage of patients showing disappearance of nocturnal pain was significantly higher in the celecoxib group (71.4 %) than in the loxoprofen group (36.8 %). The results confirm that celecoxib is comparable to loxoprofen in terms of analgesic efficacy in patients with frozen shoulder. Among other findings, we report that celecoxib was more effective for nocturnal pain than loxoprofen.

A New Approach for the Treatment of Lateral Periodontal Cysts with an 810-nm Diode Laser.

PubMed

Isola, Gaetano; Matarese, Giovanni; Lo Giudice, Giuseppe; Briguglio, Francesco; Alibrandi, Angela; Crupi, Andrea; Cordasco, Giancarlo; Ramaglia, Luca

The aim of this study was to test whether the combination of diode laser therapy and surgical treatment for a lateral periodontal cyst (LPC) would result in greater clinical improvement compared with surgery alone. A total of 18 patients with LPCs were assessed for eligibility for this study. At baseline, each patient was randomly allocated to one of two regimens: diode laser plus surgery (test group) or traditional surgical treatment alone (control group). Healing parameters were assessed at 7 to 21 days to monitor short-term complications, and periodontal parameters were assessed at 3, 6, and 12 months to evaluate long-term healing. The test group demonstrated highly significant differences in both the short-term and long-term parameters compared with the control group. This study showed that diode laser treatment results in a shorter wound-healing period and could be considered valuable for the surgical treatment of LPCs.

Efficacy of face-to-face versus self-guided treatments for disordered gambling: A meta-analysis.

PubMed

Goslar, Martina; Leibetseder, Max; Muench, Hannah M; Hofmann, Stefan G; Laireiter, Anton-Rupert

2017-06-01

Background and aims In the light of growing traditional and novel forms of gambling, the treatment of disordered gambling is gaining increasing importance and practical relevance. Most studies have examined face-to-face treatments. Although trials implementing self-guided treatments have recently been conducted, these options have not yet been systematically examined. The primary objective of this meta-analysis, therefore, was to analyze the efficacy of all types of psychological face-to-face and self-guided treatments. Methods A multilevel literature search yielded 27 randomized controlled studies totaling 3,879 participants to provide a comprehensive comparative evaluation of the short- and long-term efficacies of face-to-face and self-guided treatments for disordered gambling. Results As expected, the results revealed significantly higher effect sizes for face-to-face treatments (16 studies with Hedges's g ranging from 0.67 to 1.15) as compared with self-guided treatments (11 studies with Hedges's g ranging from 0.12 to 0.30) regarding the reduction of problematic gambling behavior. The intensity of treatment moderated the therapy effect, particularly for self-guided treatments. Discussion and Conclusions The results of this meta-analysis favor face-to-face treatments over self-guided treatments for the reduction of disordered gambling. Although the findings broaden the scope of knowledge about psychological treatment modalities for disordered gambling, further research is needed to identify the reasons for these differences with the goal to optimize the treatment for this disabling condition.

Impact of social and economic characteristics on orthodontic treatment among children and teenagers in France.

PubMed

Germa, A; Kaminski, M; Nabet, C

2010-04-01

This study aimed to estimate the prevalence of orthodontic treatment in France among children and teenagers aged 8-18 years, by sex and by age, and to investigate the specific role of social and economic characteristics on use of orthodontic treatment. We analyzed data from the cross-sectional national health survey conducted in France in 2002-2003, which included a sample of 5988 children aged 8-18 years. All data were collected by interview including the question on orthodontic treatment. Other data used in our study were family social status and income, maternal educational attainment and place of birth, whether the child was covered by a supplementary health insurance and whether the residence was urban or rural. We also calculated the density of orthodontists in the district. Multivariate logistic regression analyses were used to study the relationships between these social and economic factors and orthodontic treatment. The prevalence of orthodontic treatment was 14% of all children aged 8-18, 15% for girls, and 13% for boys, and 23% in the 12 to 15-year age group. Children were less likely to have orthodontic treatment when parents were service or sales workers compared with children whose parents were managers or professionals (aOR = 0.50; 95%CI: [0.34;0.76]), when family income was in the lowest, compared with highest quartile (aOR = 0,62; 95% CI: [0.45;0.85]), when children had no supplementary insurance compared with children covered by private insurance (aOR = 0.53; 95% CI: [0.34; 0.81]), or when they lived in rural compared with urban areas (aOR = 0.70; 95% CI: [0.54; 0.91]). There are social inequalities in orthodontic treatment in France, associated mainly with social status, annual income, supplementary insurance, and the residence area.

Evaluation of Planned Treatment Breaks During Radiation Therapy for Anal Cancer: Update of RTOG 92-08

DOE Office of Scientific and Technical Information (OSTI.GOV)

Konski, Andre; Garcia, Miguel; John, Madhu

2008-09-01

Purpose: Radiation Therapy Oncology Group (RTOG) 92-08 began as a single arm, Phase II trial for patients with anal cancer consisting of radiation (RT) + 5-flourouracil + mitomycin-C with a mandatory 2-week break and was amended after completion to evaluate the same treatment regimen without a treatment break. Long-term efficacy and late toxicity reporting are the specific aims of this study. Methods and Materials: Survivals were estimated with the Kaplan-Meier method. Overall survival (OS) was compared with RTOG 87-04 with the log-rank test. Time to local failure, regional failure, locoregional failure (LRF), distant metastases, second primary, and colostomy failure weremore » estimated by the cumulative incidence method. LRF was compared with RTOG 87-04 using the Gray's test. Results: Forty-seven patients entered in the mandatory treatment break cohort. The study was reopened in 1995 to the no mandatory treatment break cohort completing accrual with 20 patients in 1996. Of 67 total patients, 1 patient in the mandatory treatment break portion of the study did not receive any protocol treatment and is excluded from analyses. After adjusting for tumor size, neither cohort showed a statistically significant difference in OS or LRF compared with the RTOG 87-04 mitomycin-C arm. No patient in either cohort experienced a Grade 3 or higher late toxicity. Conclusions: No statistically significant differences were seen in OS or LRF when compared to the mitomycin-C arm of RTOG 87-04, but the sample sizes for the mandatory break cohort and the no mandatory break cohort are small. Late toxicity was low and similar for the treatment cohorts.« less

The treatment of severe premenstrual syndrome with goserelin with and without 'add-back' estrogen therapy: a placebo-controlled study.

PubMed

Leather, A T; Studd, J W; Watson, N R; Holland, E F

1999-02-01

The study aimed to determine if the addition of daily low-dose oral estrogen with a cyclical progestogen given to young women using a depot gonadotropin-releasing hormone (GnRH) analog implant for the treatment of their premenstrual syndrome (PMS) would affect the clinical outcome. In a double-blind placebo-controlled study in a specialist premenstrual syndrome clinic setting, 60 women aged between 20 and 45 years were randomized to one of three treatment groups: Group A (placebo implant four weekly + placebo tablets daily), Group B (goserelin 3.6 mg implant four weekly + estradiol valerate 2 mg daily with norethisterone 5 mg from days 21-28 of a 28-day cycle) or Group C (goserelin 3.6 mg implant four weekly + placebo tablets daily). Differences between PMS scores at 2, 4 and 6 months were compared with pretreatment values. There was a significant improvement in PMS scores in Group C (Zoladex + placebo) after 2, 4 and 6 months of treatment when compared to pretreatment values and Group A (placebo + placebo). The addition of a low-dose oral estrogen with a cyclical progestogen to GnRH analog treatment (Group B) resulted in a less dramatic response when compared to pretreatment values and no significant improvement when compared to Group A (placebo + placebo) at 2, 4 and 6 months of treatment. The addition of a low-dose oral estrogen with a cyclical progestogen to depot GnRH analog therapy in the treatment of PMS reduces the clinical response.

Comparisons of the Efficacy of Alpha Glucosidase Inhibitors on Type 2 Diabetes Patients between Asian and Caucasian

PubMed Central

Cai, Xiaoling; Han, Xueyao; Luo, Yingying; Ji, Linong

2013-01-01

Background To compare the efficacy of glycemic control and insulin secretion of alpha glucosidase inhibitors (AGI) on type 2 diabetes patients between Asian and Caucasian. Methodology/Principal Findings The MEDLINE®, EMBASE®, CENTRAL were searched and qualified studies in Asian and Caucasian population comparing AGI treatment with placebo or other oral anti-diabetic drugs in type 2 diabetic patients were included. Totally 58 qualified studies were included. When AGI treatment was compared with placebo, a significant difference in HbA1c decline from baseline favoring AGI treatment was found in Asian (weighted mean difference (WMD), −0.50%; 95% CI, −0.66% to −0.34%) and in Caucasian a significant difference in HbA1c decline favoring AGI treatment was also found (WMD, −0.68%; 95% CI, −0.76% to −0.60%). In Asian, fasting plasma glucose was reduced with AGI treatment compared with placebo (WMD, −0.53 mmol/L; 95% CI, −0.91 to −0.14 mmol/L) and in Caucasian there was also a significant difference in FPG changes favoring AGI therapy (WMD, −0.88 mmol/L; 95% CI, −1.00 to −0.77 mmol/L). Studies in Asian showed a significant difference in fasting insulin changes favoring AGI treatment (WMD, −0.78 uU/ml; 95% CI, −0.96 to −0.59 uU/ml). While in Caucasian fasting insulin was decreased without significance with AGI treatment (WMD-1.24 uU/ml; 95% CI, −2.51 to 0.04 uU/ml). Body weight was decreased with AGI treatment in Asian (WMD, −1.00 kg; 95% CI, −1.69 to −0.31 kg) and was also decreased with AGI treatment in Caucasian (WMD, −0.73 kg; 95% CI, −1.13 to −0.33 kg). Conclusions/Significance According to results from this meta-analysis, the efficacy in glucose lowering, body weight reduction and insulin secretion decreasing of AGI treatment in Asian were comparable with those in Caucasian. PMID:24236131

Antidepressant Studies in Parkinson’s Disease

PubMed Central

Weintraub, Daniel; Morales, Knashawn H.; Moberg, Paul J.; Bilker, Warren B.; Balderston, Catherine; Duda, John E.; Katz, Ira R.; Stern, Matthew B.

2007-01-01

The objective of this study was to determine effect sizes for both antidepressant treatment and placebo for depression in Parkinson’s disease (PD), and to compare the findings with those reported in elderly depressed patients without PD. Recent reviews have concluded that there is little empiric evidence to support the use of antidepressants in PD; however, available data has not been analyzed to determine the effect size for antidepressant treatment in PD depression. A literature review identified antidepressant studies in PD. Suitable studies were analyzed using meta-analytic techniques, and effect sizes were compared with those from antidepressant studies in elderly patients without PD. Large effect sizes were found for both active treatment and placebo in PD, but there was no difference between the two groups. In contrast, active treatment was superior to placebo in depressed elderly patients without PD. In PD, increasing age and a diagnosis of major depression were associated with better treatment response. Results also suggest that newer antidepressants are well tolerated in PD. Despite the high prevalence of depression and antidepressant use in PD, controlled treatment research has been almost non-existent. Meta-analysis results suggest a large but nonspecific effect for depression treatment in PD. In addition, PD patients may benefit less from antidepressant treatment, particularly selective serotonin reuptake inhibitors, than do elderly patients without PD. PMID:15954137

A 12-week, double-blind, multicenter study comparing diflunisal twice daily and ibuprofen four times daily in the treatment of rheumatoid arthritis.

PubMed

Bennett, R M

1986-01-01

Diflunisal, a nonacetylated salicylate preparation with a prolonged duration of action, was compared with ibuprofen for the treatment of rheumatoid arthritis in a multicenter trial comprising 210 patients. Diflunisal was administered twice a day (500 to 750 mg/day) and ibuprofen was administered four times a day (1,600 to 2,400 mg/day). To maintain double-blind conditions, all patients ostensibly followed the same regimen, ingesting their assigned drug and a matching placebo of their nonassigned drug. Disease activity assessments and laboratory tests were done periodically throughout the 12 weeks of the study, and results were compared with pretreatment findings. Efficacy evaluations in 187 patients showed that both treatments were similarly efficacious. Safety and tolerability also were similar in the two groups. Diflunisal, however, offers a more acceptable BID treatment schedule.

Exploratory randomised controlled clinical study to evaluate the comparative efficacy of two occluding toothpastes - a 5% calcium sodium phosphosilicate toothpaste and an 8% arginine/calcium carbonate toothpaste - for the longer-term relief of dentine hypersensitivity.

PubMed

Hall, Claire; Mason, Stephen; Cooke, Jonathan

2017-05-01

To compare the longer-term clinical efficacy of two occlusion-technology toothpastes - a 5% calcium sodium phosphosilicate (CSPS) toothpaste and a commercially available 8% arginine/calcium carbonate toothpaste - in relieving dentine hypersensitivity (DH). Efficacy was also compared with that of a regular fluoride toothpaste control. This was an exploratory, randomised, examiner-blind, parallel-group, 11-week, controlled study in healthy adults with self-reported and clinically diagnosed DH. After an acclimatisation period, subjects were randomised to one of three study treatments with which they brushed their teeth twice daily. Sensitivity was assessed at baseline and after 1, 2, 4, 6 and 11 weeks treatment in response to evaporative (air) and tactile stimuli (measured by the Schiff Sensitivity Scale/visual analogue scale and tactile threshold, respectively). A total of 135 subjects were randomised to treatment. The two occlusion-technology toothpastes performed similarly over the 11-week treatment period. All study treatments showed statistically significant reductions from baseline in DH at all timepoints for all measures (p<0.05). Statistically significant and clinically relevant sensitivity relief was observed for both occluding formulations compared with the regular fluoride toothpaste: for evaporative (air) sensitivity within 1 week and for tactile sensitivity at Week 11. No significant differences were detected between the two occluding formulations at any timepoint, for any endpoint. Study treatments were generally well tolerated. In this exploratory study, a 5% CSPS occluding toothpaste was effective in relieving DH compared with a regular fluoride toothpaste; an 8% arginine/calcium carbonate anti-sensitivity toothpaste provided similar benefits. Improvements in DH continued throughout the 11-week study. Dentine hypersensitivity (DH) is a common and painful condition. Twice-daily use of a 5% calcium sodium phosphosilicate toothpaste reduces DH within 1-2 weeks of initiating use. Ongoing, twice daily use of the sensitivity toothpastes evaluated in this study was associated with continued, clinically significant improvements in DH. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Cupping for Treating Pain: A Systematic Review

PubMed Central

Kim, Jong-In; Lee, Myeong Soo; Lee, Dong-Hyo; Boddy, Kate; Ernst, Edzard

2011-01-01

The objective of this study was to assess the evidence for or against the effectiveness of cupping as a treatment option for pain. Fourteen databases were searched. Randomized clinical trials (RCTs) testing cupping in patients with pain of any origin were considered. Trials using cupping with or without drawing blood were included, while trials comparing cupping with other treatments of unproven efficacy were excluded. Trials with cupping as concomitant treatment together with other treatments of unproven efficacy were excluded. Trials were also excluded if pain was not a central symptom of the condition. The selection of studies, data extraction and validation were performed independently by three reviewers. Seven RCTs met all the inclusion criteria. Two RCTs suggested significant pain reduction for cupping in low back pain compared with usual care (P < .01) and analgesia (P < .001). Another two RCTs also showed positive effects of cupping in cancer pain (P < .05) and trigeminal neuralgia (P < .01) compared with anticancer drugs and analgesics, respectively. Two RCTs reported favorable effects of cupping on pain in brachialgia compared with usual care (P = .03) or heat pad (P < .001). The other RCT failed to show superior effects of cupping on pain in herpes zoster compared with anti-viral medication (P = .065). Currently there are few RCTs testing the effectiveness of cupping in the management of pain. Most of the existing trials are of poor quality. Therefore, more rigorous studies are required before the effectiveness of cupping for the treatment of pain can be determined. PMID:19423657

A microcosting study of microsurgery, LINAC radiosurgery, and gamma knife radiosurgery in meningioma patients

PubMed Central

van Putten, Erik; Nijdam, Wideke M.; Hanssens, Patrick; Beute, Guus N.; Nowak, Peter J.; Dirven, Clemens M.; Hakkaart-van Roijen, Leona

2010-01-01

The aim of the present study is to determine and compare initial treatment costs of microsurgery, linear accelerator (LINAC) radiosurgery, and gamma knife radiosurgery in meningioma patients. Additionally, the follow-up costs in the first year after initial treatment were assessed. Cost analyses were performed at two neurosurgical departments in The Netherlands from the healthcare providers’ perspective. A total of 59 patients were included, of whom 18 underwent microsurgery, 15 underwent LINAC radiosurgery, and 26 underwent gamma knife radiosurgery. A standardized microcosting methodology was employed to ensure that the identified cost differences would reflect only actual cost differences. Initial treatment costs, using equipment costs per fraction, were €12,288 for microsurgery, €1,547 for LINAC radiosurgery, and €2,412 for gamma knife radiosurgery. Higher initial treatment costs for microsurgery were predominantly due to inpatient stay (€5,321) and indirect costs (€4,350). LINAC and gamma knife radiosurgery were equally expensive when equipment was valued per treatment (€2,198 and €2,412, respectively). Follow-up costs were slightly, but not significantly, higher for microsurgery compared with LINAC and gamma knife radiosurgery. Even though initial treatment costs were over five times higher for microsurgery compared with both radiosurgical treatments, our study gives indications that the relative cost difference may decrease when follow-up costs occurring during the first year after initial treatment are incorporated. This reinforces the need to consider follow-up costs after initial treatment when examining the relative costs of alternative treatments. PMID:20526795

Treatment seeking for problematic pornography use among women.

PubMed

Lewczuk, Karol; Szmyd, Joanna; Skorko, Maciej; Gola, Mateusz

2017-12-01

Background and aims Previous studies examined psychological factors related to treatment seeking for problematic pornography use (PU) among males. In this study, we focused on females who seek treatment for problematic PU and compared them with non-problematic pornography users with regard to variables related to problematic PU. Second, we investigated the relationships between critical constructs related to problematic PU with the path analysis method, emphasizing the predictors for treatment seeking among women. We also compared our results with previous studies on males. Methods A survey study was conducted on 719 Polish-speaking Caucasian females, 14-63 years old, including 39 treatment seekers for problematic PU. Results The positive relationship between the mere amount of PU and treatment seeking loses its significance after introducing two other predictors of treatment-seeking: religiosity and negative symptoms associated with PU. This pattern is different from the results obtained in previous studies on males. Discussion Different from previous studies on male samples, our analysis showed that in the case of women, mere amount of PU may be related to treatment-seeking behavior even after accounting for negative symptoms associated with PU. Moreover, religiousness is a significant predictor of treatment seeking among women, which may indicate that in the case of women, treatment seeking for problematic PU is motivated not only by experienced negative symptoms of PU but also by personal beliefs about PU and social norms. Conclusion For females, negative symptoms associated with PU, the amount of PU and religiosity is associated with treatment seeking. Those factors should be considered in treatment.

Focus on Clinical Research: Cognitive Rehabilitation of Severely Closed-Head-Injured Patients Using Computer-Assisted and Noncomputerized Treatment Techniques.

ERIC Educational Resources Information Center

Batchelor, J.; And Others

1988-01-01

The study compared computer assisted cognitive retraining of 47 patients with severe closed head injury with comparable noncomputerized treatment techniques. Results on neuropsychological tests did not support the increased effectiveness of the computer assisted cognitive therapy. (DB)

Comparative effectiveness of prostate cancer treatments for patient-centered outcomes: A systematic review and meta-analysis (PRISMA Compliant).

PubMed

Jayadevappa, Ravishankar; Chhatre, Sumedha; Wong, Yu-Ning; Wittink, Marsha N; Cook, Ratna; Morales, Knashawn H; Vapiwala, Neha; Newman, Diane K; Guzzo, Thomas; Wein, Alan J; Malkowicz, Stanley B; Lee, David I; Schwartz, Jerome S; Gallo, Joseph J

2017-05-01

In the context of prostate cancer (PCa) characterized by the multiple alternative treatment strategies, comparative effectiveness analysis is essential for informed decision-making. We analyzed the comparative effectiveness of PCa treatments through systematic review and meta-analysis with a focus on outcomes that matter most to newly diagnosed localized PCa patients. We performed a systematic review of literature published in English from 1995 to October 2016. A search strategy was employed using terms "prostate cancer," "localized," "outcomes," "mortality," "health related quality of life," and "complications" to identify relevant randomized controlled trials (RCTs), prospective, and retrospective studies. For observational studies, only those adjusting for selection bias using propensity-score or instrumental-variables approaches were included. Multivariable adjusted hazard ratio was used to assess all-cause and disease-specific mortality. Funnel plots were used to assess the level of bias. Our search strategy yielded 58 articles, of which 29 were RCTs, 6 were prospective studies, and 23 were retrospective studies. The studies provided moderate data for the patient-centered outcome of mortality. Radical prostatectomy demonstrated mortality benefit compared to watchful waiting (all-cause HR = 0.63 CI = 0.45, 0.87; disease-specific HR = 0.48 CI = 0.40, 0.58), and radiation therapy (all-cause HR = 0.65 CI = 0.57, 0.74; disease-specific HR = 0.51 CI = 0.40, 0.65). However, we had minimal comparative information about tradeoffs between and within treatment for other patient-centered outcomes in the short and long-term. Lack of patient-centered outcomes in comparative effectiveness research in localized PCa is a major hurdle to informed and shared decision-making. More rigorous studies that can integrate patient-centered and intermediate outcomes in addition to mortality are needed.

Estimating Treatment and Treatment Times for Special and Nonspecial Patients in Hospital Ambulatory Dental Clinics.

ERIC Educational Resources Information Center

Rosenberg, Dara J.; And Others

1986-01-01

A study compared the treatments and the amount of time needed for treatment of the dental needs of developmentally disabled, severely compromised, and moderately compromised patients with those of nondisabled patients in a hospital ambulatory dental clinic. (MSE)

The Treatment of Mid-shaft Clavicle Fractures

PubMed Central

Sang, Qing-Hua; Gou, Zhi-Gang; Zheng, Hua-Yong; Yuan, Jing-Tao; Zhao, Jian-Wen; He, Hong-Ying; Liu, Chuang; Liu, Zhi

2015-01-01

Objective: Through reviewing the relevant literature from the past decades, to summarize the assessment and management of fractures of the clavicle, and provide an overview of the clinical results of a range of treatment options. Data Sources: The data analyzed in this review are mainly from articles included in PubMed and EMBASE, published from 1960 to 2015. Study Selection: Studies involving assessment of fractures of the clavicle were reviewed. Further literatures were gathered regarding the conservative and surgical treatment of these fractures, including the methods of fixation and the surgical approaches used. Both conservative and surgical treatments were then compared and contrasted. Results: Through retrieving and reading the abstract, a total of 42 representative articles were selected, which covered all aspects of the conservative treatment and surgical treatment, and compared the advantages and disadvantages of different treatment options. Conclusions: Although the majority of recent data suggest that surgery may be more appropriate as it improves functional outcome and reduces the risk of complications, we recommend that the treatment should be individually assessed. PMID:26521795

Regeneration of cervix after excisional treatment for cervical intraepithelial neoplasia: a study of collagen distribution.

PubMed

Phadnis, S V; Atilade, A; Bowring, J; Kyrgiou, M; Young, M P A; Evans, H; Paraskevaidis, E; Walker, P

2011-12-01

To study the distribution of collagen in the regenerated cervical tissue after excisional treatment for cervical intraepithelial neoplasia (CIN). Cohort study. A large tertiary teaching hospital in London. Women who underwent repeat excisional treatment for treatment failure or persistent CIN. Eligible women who underwent a repeat excisional treatment for treatment failure, including hysterectomy, between January 2002 and December 2007 in our colposcopy unit were identified by the Infoflex(®) database and SNOMED encoded histopathology database. Collagen expression was assessed using picro-Sirius red stain and the intensity of staining was compared in paired specimens from the first and second treatments. Differences in collagen expression were examined in the paired excisional treatment specimens. A total of 17 women were included. Increased collagen expression in the regenerated cervical tissue of the second cone compared with the first cone was noted in six women, decreased expression was noted in five women, and the pattern of collagen distribution was equivocal in six women. There is no overall change in collagen distribution during regeneration following excisional treatment for CIN. © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.

Oral Omega-3 Fatty Acid Supplementation for Laser In Situ Keratomileusis-Associated Dry Eye.

PubMed

Goyal, Parul; Jain, Arun K; Malhotra, Chintan

2017-02-01

To determine the effect of oral omega-3 fatty acid (ω3FA) supplementation in laser in situ keratomileusis (LASIK)-associated dry eye. In this prospective, open-label study, patients undergoing LASIK were randomized to receive either 1.2 g/d of a triglyceride formulation of oral ω3FA (treatment group) or 400 mg/d vitamin E (control group) for 1 week before and continued for 12 weeks after surgery. Ocular surface disease index, tear breakup time, ocular surface staining, and Schirmer scores were evaluated and compared preoperatively and at 3 months after LASIK. The study included 30 patients in each group. All parameters were comparable at baseline. Ocular surface disease index scores increased comparably in both groups (1.9 ± 0.6 increase in the treatment group; 2.8 ± 0.5 in the control group) (P = 0.267). Compared with baseline levels, tear breakup time decreased significantly (P < 0.01) but comparably in both treatment (-2.3 ± 0.4 seconds decrease) and control (-3.5 ± 0.7 seconds decrease) groups (P = 0.105). More eyes in the control group (43.4%) had conjunctival staining with Lissamine green at 3 months compared with the treatment group (14%) (P = 0.009). The Schirmer score at 3 months was higher (P = 0.003) in the treatment group (30.5 ± 0.90 mm) than in the control group (25.7 ± 1.3 mm) with a increase of 5.9 ± 1.3 mm from baseline in the treatment group and a decrease of 1.5 ± 1.2 mm in the control group. Supplementation with ω3FA in patients undergoing LASIK had a positive influence on tear secretion, whereas tear film stability remained unaffected when compared with the control group.

Assessment of UASB-DHS technology for sewage treatment: a comparative study from a sustainability perspective.

PubMed

Maharjan, Namita; Nomoto, Naoki; Tagawa, Tadashi; Okubo, Tsutomu; Uemura, Shigeki; Khalil, Nadeem; Hatamoto, Masashi; Yamaguchi, Takashi; Harada, Hideki

2018-04-06

This paper assesses the technical and economic sustainability of a combined system of an up-flow anaerobic sludge blanket (UASB)-down-flow hanging sponge (DHS) for sewage treatment. Additionally, this study compares UASB-DHS with current technologies in India like trickling filters (TF), sequencing batch reactor (SBR), moving bed biofilm reactor (MBBR), and other combinations of UASB with post-treatment systems such as final polishing ponds (FPU) and extended aeration sludge process (EASP). The sustainability of the sewage treatment plants (STPs) was evaluated using a composite indicator, which incorporated environmental, societal, and economic dimensions. In case of the individual sustainability indicator study, the results showed that UASB-FPU was the most economically sustainable system with a score of 0.512 and aeration systems such as MBBR, EASP, and SBR were environmentally sustainable, whereas UASB-DHS system was socially sustainable. However, the overall comparative analysis indicated that the UASB-DHS system scored the highest value of 2.619 on the global sustainability indicator followed by EASP and MBBR with scores of 2.322 and 2.279, respectively. The highlight of this study was that the most environmentally sustainable treatment plants were not economically and socially sustainable. Moreover, sensitivity analysis showed that five out of the seven scenarios tested, the UASB-DHS system showed good results amongst the treatment system.

Comparative evaluation of soft tissue changes one year post-treatment in Twin Block and FORSUS FRD treated patients.

PubMed

Chaudhary, Dinesh Chander; Kumar, Prasanna; Sharma, Mohit; Nehra, Karan

2016-10-01

The objective of this study was to compare and evaluate the effects of two functional treatment modalities, namely, Twin Block (TB) and FORSUS fatigue resistant device (FORSUS FRD) on facial soft tissues before and at one-year post-treatment. This was a retrospective cephalometric study involving 10 patients with skeletal class II abnormalities in each group. The mean age of patients was 12.5 ± 1.5 and 13.5 ± 1 years and treatment duration 20 ± 2 and 18 ± 2 months, respectively for TB and FORSUS FRD groups, respectively. The pre-treatment (T0) and one-year post-treatment cephalograms (T1) were compared for evaluation. Data were analysed using a paired t -test and independent sample t -test for within-group and between-group comparisons, respectively. The groups were compared at T0 and T1, and treatment/observation differences (T1 - T0) were evaluated with paired samples t -test at P  < 0.05 level and unpaired sample t -test for group comparison. Statistically significant treatment changes were found for soft tissue changes in both TB and FORSUS FRD groups. Between the two groups, TB showed significant increase in the LAFH compared to the FORSUS FRD group. Statistically significant soft tissue changes were observed after TB and FORSUS FRD appliance therapy, resulting in improvement of facial balance and aesthetics. Both, TB and FORSUS FRD, have similar effects on soft tissues, but the effect of TB on LAFH and that of FORSUS on mentolabial sulcus was more profound.

Head lice and the use of spinosad.

PubMed

Villegas, Susan C; Breitzka, Robin L

2012-01-01

Head lice infestations are responsible for social and economic distress. Despite a reported increase in resistance, permethrin 1% is still the first-line treatment of head lice. Alternative topical pediculicidal agents include malathion and benzyl alcohol, but resistance is of growing concern. In 2011, a new pediculicide, spinosad, was introduced. Our aim was to review the clinical pharmacology, efficacy, tolerability, and current place in therapy of spinosad for the treatment of head lice. Pertinent articles and abstracts were identified through searches of MEDLINE/Ebsco and MEDLINE/Ovid from 1948 to September 2011 and International Pharmaceutical Abstracts from 1966 to September 2011. Two reports described 3 trials of spinosad used for the treatment of head lice. One study (n = 120) demonstrated efficacy of both spinosad 0.5% and spinosad 1% compared with placebo, with 82.5% and 86.1% of patients free of live lice 14 days after treatment, respectively, compared with 25.6% in the placebo group (P < 0.001 for each treatment). The difference between the spinosad 0.5% and 1% treatment groups was not significant. Two trials (n = 1038) comparing spinosad 0.9% with permethrin 1% reported greater efficacy for spinosad with absence of live lice 14 days after 1 or 2 treatments for 84.6% and 86.7%, respectively, of primary cases compared with 44.9% and 42.9% with permethrin (P < 0.001 for both studies). The most common reported adverse events were eye and scalp irritation, but they were not statistically significant (P = 0.329 and P = 0.395, respectively). Only application-site erythema reactions showed statistical significance, with 6.8% in the permethrin group versus 3.1% in the spinosad group (P = 0.007). Although limited, the available literature suggests that spinosad is an effective and well-tolerated agent for the treatment of head lice. In a time of increasing resistance, spinosad has demonstrated superior performance compared with permethrin. A review of the literature did not identify any studies comparing spinosad to benzyl alcohol 5% or malathion 0.5%. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Removal of organic wastewater contaminants in septic systems using advanced treatment technologies

USGS Publications Warehouse

Wilcox, J.D.; Bahr, J.M.; Hedman, C.J.; Hemming, J.D.C.; Barman, M.A.E.; Bradbury, K.R.

2009-01-01

The detection of pharmaceuticals and other organic wastewater contaminants (OWCs) in ground water and surface-water bodies has raised concerns about the possible ecological impacts of these compounds on nontarget organisms. On-site wastewater treatment systems represent a potentially significant route of entry for organic contaminants to the environment. In this study, effluent samples were collected and analyzed from conventional septic systems and from systems using advanced treatment technologies. Six of 13 target compounds were detected in effluent from at least one septic system. Caffeine, paraxanthine, and acetaminophen were the most frequently detected compounds, and estrogenic activity was detected in 14 of 15 systems. The OWC concentrations were significantly lower in effluent after sand filtration (p < 0.01) or aerobic treatment (p < 0.05) as compared with effluent that had not undergone advanced treatment. In general, concentrations in conventional systems were comparable to those measured in previous studies of municipal wastewater treatment plant (WWTP) influent, and concentrations in systems after advanced treatment were comparable to previously measured concentrations in WWTP effluent. These data indicate that septic systems using advanced treatment can reduce OWCs in treated effluent to similar concentrations as municipal WWTPs. Copyright ?? 2009 by the American Society of Agronomy, Crop Science Society of America, and Soil Science Society of America. All rights reserved.

"Meta-Analysis of Dropout in Treatments for Posttraumatic Stress Disorder": Correction to Imel et al. (2013).

PubMed

2016-09-01

Reports an error in "Meta-analysis of dropout in treatments for posttraumatic stress disorder" by Zac E. Imel, Kevin Laska, Matthew Jakupcak and Tracy L. Simpson ( Journal of Consulting and Clinical Psychology , 2013[Jun], Vol 81[3], 394-404). There are two errors in the Results section. Each is described alongside the corrected results. Corrections did not influence interpretation of the results. Neither the magnitude of effects nor statistical significance of any results is substantively altered. (The following abstract of the original article appeared in record 2013-01522-001.) Objective: Many patients drop out of treatments for posttraumatic stress disorder (PTSD); some clinicians believe that trauma-focused treatments increase dropout. We conducted a meta-analysis of dropout among active treatments in clinical trials for PTSD (42 studies; 17 direct comparisons). The average dropout rate was 18%, but it varied significantly across studies. Group modality and greater number of sessions, but not trauma focus, predicted increased dropout. When the meta-analysis was restricted to direct comparisons of active treatments, there were no differences in dropout. Differences in trauma focus between treatments in the same study did not predict dropout. However, trauma-focused treatments resulted in higher dropout compared with present-centered therapy (PCT), a treatment originally designed as a control but now listed as a research-supported intervention for PTSD. Dropout varies between active interventions for PTSD across studies, but variability is primarily driven by differences between studies. There do not appear to be systematic differences across active interventions when they are directly compared in the same study. The degree of clinical attention placed on the traumatic event does not appear to be a primary cause of dropout from active treatments. However, comparisons of PCT may be an exception to this general pattern, perhaps because of a restriction of variability in trauma focus among comparisons of active treatments. More research is needed comparing trauma-focused interventions to trauma-avoidant treatments such as PCT. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

The optimal treatment for stage 2-3 Goutallier rotator cuff tears: A systematic review of the literature.

PubMed

Hollman, Freek; Wolterbeek, Nienke; Flikweert, Petra E; Yang, Kiem G Auw

2018-06-01

Fatty infiltration is an important prognostic factor for cuff healing after rotator cuff repair. Treatment options for stage 2-3 Goutallier rotator cuff tears vary widely and there is lack of decent comparative studies. The objective of this study was 1) to give an overview of the treatment options of stage 2-3 Goutallier rotator cuff tears and their clinical outcome and 2) to give a recommendation of the optimal treatment within this specific subgroup. We searched the databases of Medline, Embase, Cochrane library, NHS Centre for Reviews and Dissemination, PEDro from inception to December 12th, 2016. Two authors, F.H. and N.W., selected the studies after consensus. Data was extracted by one author (F.H.) and checked for completeness by a second author (N.W.). Our primary outcome was physical function, measured by shoulder-specific patient reported outcomes. Secondary outcomes were cuff integrity after rotator cuff repair, shoulder pain, general health, quality of life, activity level and adverse events. For the first research question 28 prospective as well as retrospective studies were included. For the clinical outcome of these treatments three randomized controlled trials were included. Despite the high reported retear rate, rotator cuff repair has comparable results (clinical improvement) as partial repair and isolated bicepstenotomy or tenodesis. These findings suggest that the additional effect of rotator cuff repair compared to the less extensive treatment options like isolated bicepstenotomy or tenodesis should be studied, as these might form a good alternative treatment based on this systematic review. Level IV; systematic review.

Cost effectiveness of internet-based cognitive behaviour therapy and behavioural stress management for severe health anxiety.

PubMed

Hedman, Erik; Andersson, Erik; Ljótsson, Brjánn; Axelsson, Erland; Lekander, Mats

2016-04-25

Internet-delivered exposure-based cognitive behaviour therapy (ICBT) has been shown to be effective in the treatment of severe health anxiety. The health economic effects of the treatment have, however, been insufficiently studied and no prior study has investigated the effect of ICBT compared with an active psychological treatment. The aim of the present study was to investigate the cost effectiveness of ICBT compared with internet-delivered behavioural stress management (IBSM) for adults with severe health anxiety defined as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) hypochondriasis. ICBT was hypothesised to be the more cost-effective treatment. This was a cost-effectiveness study within the context of a randomised controlled trial conducted in a primary care/university setting. Participants from all of Sweden could apply to participate. Self-referred adults (N=158) with a principal diagnosis of DSM-IV hypochondriasis, of whom 151 (96%) provided baseline and post-treatment data. ICBT or IBSM for 12 weeks. The primary outcome was the Health Anxiety Inventory. The secondary outcome was the EQ-5D. Other secondary measures were used in the main outcome study but were not relevant for the present health economic analysis. Both treatments led to significant reductions in gross total costs, costs of healthcare visits, direct non-medical costs and costs of domestic work cutback (p=0.000-0.035). The incremental cost-effectiveness ratio (ICER) indicated that the cost of one additional case of clinically significant improvement in ICBT compared with IBSM was $2214. The cost-utility ICER, that is, the cost of one additional quality-adjusted life year, was estimated to be $10,000. ICBT is a cost-effective treatment compared with IBSM and treatment costs are offset by societal net cost reductions in a short time. A cost-benefit analysis speaks for ICBT to play an important role in increasing access to effective treatment for severe health anxiety. NCT01673035; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Comparing the Efficacy of Low Dose and Conventional Dose of Oral Isotretinoin in Treatment of Moderate and Severe Acne Vulgaris

PubMed Central

Faghihi, Gita; Mokhtari, Fatemeh; Fard, Nasrin Motamedi; Motamedi, Narges; Hosseini, Sayed Mohsen

2017-01-01

Objective: This study was conducted to compare the effect of low-dose isotretinoin with its conventional dose in patients with moderate and severe acne. Methods: This was a clinical trial conducted on 60 male and female patients with moderate and severe acne vulgaris. The patients were divided into two treatment groups: 0.5 mg/kg/day isotretinoin capsule and low-dose isotretinoin capsule (0.25 mg/kg/day). Patients in both groups received 6-month treatment. At the end of the 6th month and 12th month (6 months after the end of the treatment), they were examined again, and their improvement was determined and compared. Findings: The average severity of acne in the two treatment groups did not differ significantly within any of the study periods. The most common side effects were nose dryness in the low-dose group (17%) and hair thinning and loss in the conventional-dose group (33.2%), although all the patients had dry lips. Conclusion: According to the same severity of the acne in two groups in different study periods, as well as fewer side effects and more patients' satisfaction, the low-dose isotretinoin can be considered in the treatment of acne. PMID:29417084

Ethnic differences in the effectiveness of cognitive behavioral therapy combined with medication: Comparing Asian American and white psychiatric patients.

PubMed

Tang, Jennifer Y; Li, Chieh; Rodgers, Rachel F; Ballou, Mary

2016-12-01

Several meta-analyses have demonstrated the effectiveness of treatment utilizing cognitive behavioral therapy (CBT) combined with medication. There is, however, a paucity of research comparing the effectiveness of this combined treatment with psychiatric patients from different ethnic backgrounds. This study is the first of its kind to compare the effectiveness of CBT combined with medication for Asian American and White patients' psychiatric symptom severity levels of depression, anxiety, psychological well-being, and quality of life. The study examined the effects of CBT combined with medication for 43 Asian American and 43 White Non-Hispanic patients at an acute psychiatric partial hospital. A 2×2 between-within repeated measures analysis of variance was used. Results indicated significant improvement after treatment in all symptom categories assessed for the Asian American and White patients. The findings displayed trends over the course of treatment toward a greater decrease in anxiety symptoms among Asian patients but a larger increase in functioning level among White patients. In conclusion, the findings from this study provide preliminary cross-cultural support for CBT combined with medication as a treatment in partial hospital settings and suggest that the effectiveness of such treatments is similar across cultural groups. Copyright © 2016. Published by Elsevier B.V.

Efficacy of two anthelmintic treatments, spinosad/milbemycin oxime and ivermectin/praziquantel in dogs with natural Toxocara spp. infection.

PubMed

Heredia Cardenas, Rafael; Romero Núñez, Camilo; Miranda Contreras, Laura

2017-11-30

Toxocara canis is one of the most important zoonotic parasites of dogs. The aim of the present study was to compare the efficacy of spinosad/milbemycin oxime and ivermectin/praziquantel in dogs naturally infected with Toxocara spp. We studied 200 dogs with a positive diagnosis of Toxocara spp. Through coproparasitoscopic analysis, two study groups of 100 dogs each were assigned: spinosad/milbemycin oxime at a dose of 30-60mg/kg and 0.75-1.0mg/kg, respectively, or ivermectin/praziquantel administered at a dose of 0.2mg/kg and 5mg/kg, respectively. Both groups received a single dose. Three stool samples, one at day 0 before treatment, and at 14 and 28days post-treatment were examined using concentration-flotation techniques. In both treatments, the number of Toxocara spp. eggs decreased; with spinosad/milbemycin oxime treatment, eggs decreased by 87% at 14days (P=0.008) and 94% at 28days after treatment, compared with 71% at day 14 and 88% at day 28 in dogs medicated with ivermectin/praziquantel. The spinosad/milbemycin oxime treated group showed a greater decrease in the number of Toxocara spp. positive dogs compared to the group receiving ivermectin/praziquantel. Copyright © 2017 Elsevier B.V. All rights reserved.

Dentin hypersensitivity clinical study comparing LILT and LEDT keeping the same irradiation parameters

NASA Astrophysics Data System (ADS)

Lizarelli, R. F. Z.; Miguel, F. A. C.; Freitas-Pontes, K. M.; Villa, G. E. P.; Nunez, S. C.; Bagnato, V. S.

2010-11-01

Dentin hypersensitivity is a common condition associated with high dental pain. A new LED-based (light emitting diode) light source has been used as an experimental tool in some studies. Purpose: The main objective was to compare these two light sources emitting in the same spectral band (red - from 625 to 660 nm) to promote pain relief. Material and methods: A total of 6 sessions were accomplished, being three irradiation sessions and three follow-up sessions. This single-blind study compared a control group (Placebo) and two other groups with different equipments: low laser intensity treatment (LILT) and a light emitting diode system treatment (LEDT). Results: The results showed that there is no statistical difference between LILT and LEDT groups, however, both were better than control group (p <= 0.01) in terms of treatment efficiency; there is no difference between the second and the third sessions for both treatment, it means that the third session was not necessary; finally, the improvement at the end of the entire research (follow up care of 30 days) was very expressive in comparison to pre-treatment situation for all teeth (p <= 0.01). Conclusion: LILT and LEDT were equally effective to treat dentine hypersensitivity, a 3rd treatment session was not necessary/two sessions are enough.

Treatment of Intra-abdominal Abscesses in Crohn’s Disease – A Nationwide Analysis of Patterns and Outcomes of Care

PubMed Central

Ananthakrishnan, Ashwin N; McGinley, Emily L

2013-01-01

Background Abdominal abscesses are a common complication in Crohn’s disease (CD). Percutaneous drainage of such abscesses has become increasingly popular and may deliver outcomes comparable to surgical treatment; however, such comparative data are limited from single center studies. There have been no nationally representative studies comparing different treatment modalities for abdominal abscesses. Methods We identified all adult CD-related non-elective hospitalizations from the Nationwide Inpatient Sample 2007 that were complicated by an intra-abdominal abscess. Treatment modality was categorized into 3 strata – medical treatment alone, percutaneous drainage, and surgery. We analyzed the nationwide patterns in the treatment and outcomes of each treatment modality and examined for patient demographic, disease, or hospital-related disparities in treatment and outcome. Results There were an estimated 3,296 hospitalizations for abdominal abscesses in patients with CD. Approximately 39% were treated by medical treatment alone, 29% with percutaneous drainage, and 32% with surgery with a significant increase in the use of percutaneous drainage since 1998 (7%). Co-morbidity burden, admission to a teaching hospital, and complicated Crohn’s disease (fistulae, stricture) were associated with non-medical treatment. Use of percutaneous drainage was more common in teaching hospitals. Mean time to percutaneous drainage and surgical treatment were 4.6 and 3.3 days respectively and early intervention was associated with significantly shorter hospitalization. Conclusions We describe the nationwide pattern in the treatment of abdominal abscesses and demonstrate an increase in the use of percutaneous drainage for the treatment of this subgroup. Early treatment intervention was predictive of shorter hospitalization. PMID:23392744

Effectiveness of cognitive behavioral therapy supported by virtual reality in the treatment of body image in eating disorders: one year follow-up.

PubMed

Marco, José H; Perpiñá, Conxa; Botella, Cristina

2013-10-30

Body image disturbance is a significant maintenance and prognosis factor in eating disorders. Hence, existing eating disorder treatments can benefit from direct intervention in patients' body image. No controlled studies have yet compared eating disorder treatments with and without a treatment component centered on body image. This paper includes a controlled study comparing Cognitive Behavioral Treatment (CBT) for eating disorders with and without a component for body image treatment using Virtual Reality techniques. Thirty-four participants diagnosed with eating disorders were evaluated and treated. The clinical improvement was analyzed from statistical and clinical points of view. Results showed that the patients who received the component for body image treatment improved more than the group without this component. Furthermore, improvement was maintained in post-treatment and at one year follow-up. The results reveal the advantage of including a treatment component addressing body image disturbances in the protocol for general treatment of eating disorders. The implications and limitations of these results are discussed below. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

[Collagen powder dressing in the treatment of pressure ulcer. Multicenter comparative study assessing effectiveness and cost].

PubMed

Bou Torra, Joan-Enric; Soldevilla Agreda, J Javier; Martínez Cuervo, Fernando; Rueda López, Justo

2002-09-01

Pressure ulcers are lesions that usually occur to people to whom the social and economical repercusions are quite serious. Although present treatments with moisture cure dressings are efficient and have a lot of advantages than traditional cure, they do not solve the problem in a significant group of patients, whose ulcers do not heal or need a much longer treatment. Collagen dressings represent an important improvement, since collagen is a key element for wound scarring. We conducted a prospective, comparative and multicentrical study with Catrix, using as a control the same lesion. We compared pressure ulcers that had been previously treated on an average of 6 months without success with Catrix treatment within 7 weeks. We compared different variables, efficacy, opinion on the use of Catrix and economic cost. We included 104 pressure ulcers that fulfilled the inclusion requirements in the study. Three of them were excluded from the efficiency analysis because of a lack of data since they passed away 7 weeks later. We performed a statistical analysis on all the ulcers (GT) and we also analyzed the pressure ulcer subgroup (SG) included in this study because of a deterioration or a stagnation of the lesion despite previous treatments. Seven weeks after the beginning of the treatment with Catrix the healing or the stage change was observed in 73.3% of lesions of GT group and in 77.8% of lesions of SG group (p < 0.0001). The average material cost and nursing cost from all the lesions that scarred within 7 weeks (n = 39) with previous treatment was 17.234, 10 euros and 10.920 euros with Catrix. The average material cost per lesion used in the previous treatments was 441.9 euros and 280 euros with Catrix. These results prove that the treatment with Catrix significantly reduces the treatment length and therefore leads to a reduction of the sanitary cost in this kind of patients. Adding Catrix to the pressure ulcers treatment helps to increase significantly the scarring and improvement percentage of those pressure ulcers that do not respond to other treatments. It helps to improve patient's quality of life, and to reduce the costs of the treatment.

Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial.

PubMed

Kok, Tim; de Haan, Hein A; van der Meer, Margreet; Najavits, Lisa M; DeJong, Cor A J

2013-06-04

Traumatic experiences and, more specifically, posttraumatic stress disorder (PTSD) are highly prevalent among substance use disorder (SUD) patients. This comorbidity is associated with worse treatment outcomes in substance use treatment programs and more crisis interventions. International guidelines advise an integrated approach to the treatment of trauma related problems and SUD. Seeking Safety is an integrated treatment program that was developed in the United States. The aim of the current study is to test the efficacy of this program in the Netherlands in an outpatient SUD population. A randomized controlled trial (RCT) will be used to test the efficacy of Seeking Safety compared to Cognitive Behavioral Therapy (CBT) in a population of SUD outpatients. Each treatment will consist of 12 group sessions. The primary outcome measure will be substance use severity. Secondary outcome measures are PTSD and trauma symptoms, coping skills, functioning, and cognitions. Questionnaires will be administered at the start of treatment, at the end of treatment (three months after the start of treatment) and at follow-up (six months after the start of treatment). This study protocol presents a RCT in which the efficacy of an integrated treatment for comorbid PTSD and SUD, Seeking Safety, is evaluated in a SUD outpatient population compared to CBT. It is expected that the intervention group will show significantly more improvement in substance use severity compared to the control group at end-of-treatment and at follow-up. Furthermore, a lower drop-out rate is expected for the intervention group. If the intervention proves to be effective, it can be implemented. A cost-effectiveness analysis will be conducted to evaluate the two treatments. The protocol for this study is registered with the Netherlands Trial Register with number NTR3084 and approved by the local medical ethical committee (METC\\11270.haa).

Comparison of effectiveness of Transcutaneous Electrical Nerve Stimulation and Kinesio Taping added to exercises in patients with myofascial pain syndrome.

PubMed

Azatcam, Gokmen; Atalay, Nilgun Simsir; Akkaya, Nuray; Sahin, Fusun; Aksoy, Sibel; Zincir, Ozge; Topuz, Oya

2017-01-01

Although there are several studies of Transcutaneous Electrical Nerve Stimulation (TENS) and exercise in myofascial pain syndrome, there are no studies comparing the effectiveness of Kinesio Taping (KT) and TENS in myofascial pain syndrome patients. To compare the early and late effects of TENS and KT on pain, disability and range of motion in myofascial pain syndrome patients. Sixty-nine patients were divided into three groups randomly as TENS+Exercise, KT+Exercise and exercise groups. Visual Analogue Scale (VAS), pain threshold, Neck Disability Index and cervical contralateral lateral flexion were employed in the evaluation of the patients performed before treatment, after treatment and 3rd month after treatment. The VAS, pain threshold, Neck Disability Index and contralateral lateral flexion values were improved in all groups both in after treatment and 3rd month after treatment (p< 0.01). In the comparison of after treatment vs. before treatment evaluations, VAS score was decreased in KT group compared to the TENS and control group (p= 0.001), in the TENS group compared to control group (p= 0.011). In the comparison of 3rd month and before treatment evaluations, VAS score was decreased in the TENS group compared to control group (p= 0.001) and in the KT group compared to the control group (p= 0.001). There was no significant difference between TENS and KT groups. All other parameters did not differ between the groups. TENS and KT added exercises can decrease pain severity and increase pain threshold, function and cervical range of motion in myofascial pain syndrome patients. Addition of TENS or KT to the exercise therapy resulted in more significant improvement compared to exercise therapy alone with a more pronounced improvement in KT group compared to the TENS group in the early period. Because KT was found to be more effective in decreasing the pain and had the advantage of being used in every 3 days, it seems to be beneficial in acute painful periods in myofascial pain syndrome patients.

Local cooling for relieving pain from perineal trauma sustained during childbirth.

PubMed

East, C E; Begg, L; Henshall, N E; Marchant, P; Wallace, K

2007-10-17

Perineal trauma is common during childbirth and may be painful. Contemporary maternity practice includes offering women numerous forms of pain relief, including the local application of cooling treatments. To evaluate the effectiveness and side effects of localised cooling treatments compared with no treatment, other forms of cooling treatments and non-cooling treatments. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2007), CINAHL (1982 to January 2007) and contacted experts in the field. Published and unpublished randomised and quasi-randomised trials (RCTs) that compared localised cooling treatment applied to the perineum with no treatment or other treatments applied to relieve pain related to perineal trauma sustained during childbirth. At least two independent authors performed data extraction for each study. Analyses were performed on an intention-to-treat basis where data allowed. We sought additional information from the authors of three trials. Seven published RCTs were included, comparing local cooling treatments (ice packs, cold gel pads or cold/iced baths) with no treatment, hamamelis water (witch hazel), pulsed electromagnetic energy (PET), hydrocortisone/pramoxine foam [Epifoam] or warm baths. The RCTs reported on a total of 859 women. Ice packs provided improved pain relief 24 to 72 hours after birth compared with no treatment (risk ratio (RR) 0.61, 95% confidence interval (CI) 0.41 to 0.91). Women preferred the utility of the gel pads compared with ice packs or no treatment, although no differences in pain relief were detected between the treatments. None of our comparisons of treatments resulted in differences detected in perineal oedema or bruising. Women reported more pain (RR 5.60, 95% CI 2.35 to 13.33) and used more additional analgesia (RR 4.00, 95% CI 1.44 to 11.13) following the application of ice packs compared with PET. There is only limited evidence to support the effectiveness of local cooling treatments (ice packs, cold gel pads, cold/iced baths) applied to the perineum following childbirth to relieve pain.

A Post-Hurricane Katrina Examination of Substance Abuse Treatment Discharges With Co-Occurring Psychiatric and Substance Use Disorders.

PubMed

Shuler, Monique; Suzuki, Sumihiro; Podesta, Arwen; Qualls-Hampton, Raquel; Wallington, Sherrie Flynt

2017-01-01

There is increasing literature supporting the adverse effects of disasters on substance use and psychiatric disorders. The co-occurrence of psychiatric disorders with substance use intensifies the challenge of treatment delivery. Thus the aim of this study was to examine the prevalence of substance use, treatment characteristics, and demographics of discharges from substance abuse treatment in New Orleans, post-Hurricane Katrina. Trends associated with discharges that have a co-occurring psychiatric and substance use disorder (COD) were also assessed. The secondary aim of this study was to examine the association of successful substance abuse treatment completion among those with a COD post-Hurricane Katrina. Substance abuse treatment discharge data (N = 16,507) from New Orleans, Louisiana, for years 2006 through 2011 were obtained from the Treatment Episode Data Set-Discharge. Multiple logistic regression analysis was employed to examine the association of discharges with a COD and completion of substance abuse treatment. Demographic, psychiatric, and treatment characteristics of discharges in 2006 were compared to characteristics in 2011. Trends of characteristics were also assessed through the study period. Roughly a third (35.2%) of all discharges in New Orleans from 2006 to 2011 had a COD. After controlling for race, employment, treatment service setting at discharge, primary substance problem, and the discharge's principal source of referral, discharges with a COD were 29% less likely to complete treatment as compared to those with no COD (AOR = 0.71, 95% CI [0.56, 0.90], p = .004). Treatment completion among discharges with a COD has significantly declined from 36.8% in 2006 to 18.7% in 2011 (p < .0001). Notable significant trends in homelessness, criminality, and heroin use were identified among discharges with a COD. Substance abuse treatment undergoes various changes in the event of a natural disaster. These changes may increase challenges for successful treatment completion for vulnerable populations such as those with a COD. Results of this study demonstrate that discharges with a COD are less likely to complete treatment as compared to those with no COD disorder. Unmet treatment needs may also increase odds of criminalization and homelessness.

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial.

PubMed

Walker, Bruce F; Losco, Barrett; Clarke, Brenton R; Hebert, Jeff; French, Simon; Stomski, Norman J

2011-10-31

Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998.

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998 PMID:22040597

Predicting sex offender treatment entry among individuals convicted of sexual offense crimes.

PubMed

Jones, Nicole; Pelissier, Bernadette; Klein-Saffran, Jody

2006-01-01

This study examined what factors were predictive of who volunteers for sex offender treatment (self-selection) as well as who enters treatment after volunteering (administration selection). Research participants included 404 treatment volunteers and 387 nonvolunteers to treatment who were convicted of a sexual offense involving minors within the federal prison system. Maximum likelihood probit estimation procedures indicated that when compared with nonvolunteers, treatment volunteers were more likely to be recommended by a judge to receive treatment at the time of sentencing, had received prior treatment for sexually deviant behavior, reported higher levels of motivation to change their sexually deviant behavior, and had lower rates of a substance use disorder in the year prior to incarceration. Of those persons who initially volunteered, 62% were accepted and entered treatment, 16% were denied entry to treatment by program staff, and 22% refused treatment after being accepted to the waiting list. When compared with those who were accepted and entered treatment, motivation was the only predictor of being denied admission into treatment by program staff and for refusal of treatment once accepted. The findings emphasize the need to control for selection bias in treatment outcome studies and the importance of examining the role of motivation in treatment volunteerism and treatment entry for sexual offenders.

Study protocol for a randomised pragmatic trial comparing the clinical and cost effectiveness of lithium and quetiapine augmentation in treatment resistant depression (the LQD study).

PubMed

Marwood, L; Taylor, R; Goldsmith, K; Romeo, R; Holland, R; Pickles, A; Hutchinson, J; Dietch, D; Cipriani, A; Nair, R; Attenburrow, M-J; Young, A H; Geddes, J; McAllister-Williams, R H; Cleare, A J

2017-06-26

Approximately 30-50% of patients with major depressive disorder can be classed as treatment resistant, widely defined as a failure to respond to two or more adequate trials of antidepressants in the current episode. Treatment resistant depression is associated with a poorer prognosis and higher mortality rates. One treatment option is to augment an existing antidepressant with a second agent. Lithium and the atypical antipsychotic quetiapine are two such add-on therapies and are currently recommended as first line options for treatment resistant depression. However, whilst neither treatment has been established as superior to the other in short-term studies, they have yet to be compared head-to-head in longer term studies, or with a superiority design in this patient group. The Lithium versus Quetiapine in Depression (LQD) study is a parallel group, multi-centre, pragmatic, open-label, patient randomised clinical trial designed to address this gap in knowledge. The study will compare the clinical and cost effectiveness of the decision to prescribe lithium or quetiapine add-on therapy to antidepressant medication for patients with treatment resistant depression. Patients will be randomised 1:1 and followed up over 12 months, with the hypothesis being that quetiapine will be superior to lithium. The primary outcomes will be: (1) time to all-cause treatment discontinuation over one year, and (2) self-rated depression symptoms rated weekly for one year via the Quick Inventory of Depressive Symptomatology. Other outcomes will include between group differences in response and remission rates, quality of life, social functioning, cost-effectiveness and the frequency of serious adverse events and side effects. The trial aims to help shape the treatment pathway for patients with treatment resistant depression, by determining whether the decision to prescribe quetiapine is superior to lithium. Strengths of the study include its pragmatic superiority design, broad inclusion criteria (external validity) and longer follow up than previous studies. ISRCTN registry: ISRCTN16387615 , registered 28 February 2016. ClinicalTrials.gov: NCT03004521 , registered 17 November 2016.

Compared to dinoprost tromethamine, cloprostenol sodium increased rates of estrus detection, conception and pregnancy in lactating dairy cows on a large commercial dairy.

PubMed

Pursley, J R; Martins, J P N; Wright, C; Stewart, N D

2012-09-01

Using two PGF(2α) treatments 14 days apart as a way to enhance estrus detection rate following the 2nd treatment is a reproductive management tool that continues to be used on large dairy farms. In one study, in cows with a functional CL and a dominant follicle, treatment with cloprostenol vs. dinoprost resulted in greater peripheral estradiol concentrations. The objective of the present study was to determine if cloprostenol could enhance pregnancy rates of cows in a large dairy herd using a PGF(2α) program for 1st artificial insemination (AI). Lactating dairy cows (n = 4549) were randomly assigned to receive two treatments of either 500 μg cloprostenol or 25 mg dinoprost 14 days apart, with the 2nd treatment on the 1st day of the voluntary waiting period (57 DIM). Cows detected in estrus within 5 days after the 2nd treatment were inseminated. There was no effect of treatment on day of estrus detection, with 78% of cows inseminated on Days 3 or 4 following treatment. Cloprostenol increased (P < 0.01) estrus detection rates in 1st parity cows compared to dinoprost, 42.4 vs. 34.0%. In cows inseminated on Days 3 or 4 after treatment, cloprostenol increased (P = 0.05) conception rates compared to dinoprost, 38.3 vs. 34.4%. When treatments and parities were combined, conception rates increased (P < 0.02) with interval after treatment (27.0, 36.4, and 44.5% for Days 1 or 2, Days 3 or 4, and Day 5, respectively). Cloprostenol increased (P = 0.02) overall pregnancy rate compared to dinoprost, 14.4 vs. 12.2%. In summary, cloprostenol increased fertility in 1st parity cows inseminated on Days 3 or 4 following treatment and subsequently enhanced pregnancy rates of 1st parity lactating dairy cows compared to dinoprost. Fertility appeared greater in cows expected to have had a young antral ovarian follicle at treatment. Copyright © 2012 Elsevier Inc. All rights reserved.

Cost-effectiveness analysis of umeclidinium/vilanterol for the management of patients with moderate to very severe COPD using an economic model.

PubMed

Wilson, Michele R; Patel, Jeetvan G; Coleman, Amber; McDade, Cheryl L; Stanford, Richard H; Earnshaw, Stephanie R

2017-01-01

Bronchodilators such as long-acting muscarinic antagonists (LAMAs) and long-acting β 2 -agonists (LABAs) are central to the pharmacological management of COPD. Dual bronchodilation with umeclidinium/vilanterol (UMEC/VI; 62.5/25 μg) is a novel LAMA/LABA combination approved for maintenance treatment for patients with COPD. The objective of this study was to assess the cost-effectiveness of maintenance treatment with UMEC/VI compared with tiotropium (TIO) 18 μg, open dual LAMA + LABA treatment, or no long-acting bronchodilator treatment in patients with moderate to very severe COPD. A Markov model was developed to estimate the costs and outcomes associated with UMEC/VI treatment in patients with moderate to very severe COPD (GSK study number: HO-13-13411). Clinical efficacy, costs, utilities, and mortality obtained from the published literature were used as the model inputs. Costs are presented in US dollars based on 2015 prices. The model outputs are total costs, drug costs, other medical costs, number of COPD exacerbations, and quality-adjusted life-years (QALYs). Costs and outcomes were discounted at a 3% annual rate. Incremental cost-effectiveness ratios were calculated. One-way and probabilistic sensitivity analyses were conducted to assess the effects of changing parameters on the uncertainty of the results. UMEC/VI treatment for moderate to very severe COPD was associated with lower lifetime medical costs ($82,344) compared with TIO ($88,822), open dual LAMA + LABA treatment ($114,442), and no long-acting bronchodilator ($86,751). Fewer exacerbations were predicted to occur with UMEC/VI treatment compared with no long-acting bronchodilator treatment. UMEC/VI provided an 0.11 and 0.25 increase in QALYs compared with TIO and no long-acting bronchodilator treatment, and as such, dominated these cost-effectiveness analyses. Sensitivity analyses confirmed that the results were robust. The results from this model suggest that UMEC/VI treatment would be dominant compared with TIO and no long-acting bronchodilator treatment, and less costly than open dual LAMA + LABA treatment in patients with moderate to very severe COPD.

A comparative study of single-dose treatment of chancroid using thiamphenicol versus Azithromycin.

PubMed

Belda, Walter; Di Chiacchio, Nilton G; Di Chiacchio, Nilton; Romiti, Ricardo; Criado, Paulo R; Velho, Paulo Eduardo N Ferreira

2009-06-01

A study was conducted in São Paulo, Brazil, to compare azithromycin with thiamphenicol for the single-dose treatment of chancroid. In all, 54 men with chancroid were tested. The etiology was determined by clinical characterization and direct bacterioscopy with Gram staining. None of the patients had positive serology or dark-field examination indicating active infection with Treponema pallidum. Genital infections due to Neisseria gonorrhoeae and herpes simplex virus were excluded by polymerase chain reaction testing. For 54 patients with chancroid, cure rates with single-dose treatment were 73% with azithromycin and 89% with thiamphenicol. HIV seropositivity was found to be associated with treatment failure (p=0.001). The treatment failed in all HIV positive patients treated with azithromycin (p=0.002) and this drug should be avoided in these co-infected patients. In the view of the authors, thiamphenicol is the most indicated single-dose regimen for chancroid treatment.

Tribenoside and lidocaine in the local treatment of hemorrhoids: an overview of clinical evidence.

PubMed

Lorenc, Z; Gökçe, Ö

2016-06-01

The combination of tribenoside+lidocaine (Procto-Glyvenol®) is a medical preparation for the local treatment of hemorrhoids, delivered as a suppository or rectal cream. This product has been used for decades in the therapy of hemorrhoids. This review discusses available evidence on the use of tribenoside/lidocaine in clinical practice. Papers were retrieved by a PubMed search, using different combinations of pertinent keywords (e.g. tribenoside AND hemorrhoids), without any limitations in terms of publication date and language. Documents from Authors' personal collection of literature could also be considered. Papers were selected for inclusion according to their relevance for the topic, as judged by the Authors. The efficacy of the combination of tribenoside+lidocaine in relieving symptoms caused by hemorrhoids and its safety have been assessed in several clinical studies on patients of either gender, either versus its two individual components (tribenoside and lidocaine) or versus steroids in the same setting. Five studies compared the combination treatment with each of its single components, and of these, three studies compared tribenoside+ lidocaine with a tribenoside-free semi-placebo preparation containing only lidocaine, and two studies compared this combination with lidocaine-free preparations containing only tribenoside. Tribenoside+lidocaine was compared with steroid-containing preparations in six studies. Last, two studies evaluated the efficacy and tolerability of the tribenoside+lidocaine combination in women with hemorrhoids as a consequence of pregnancy or delivery. All the above-mentioned studies were well-conducted and can provide a comprehensive evaluation of tribenoside+lidocaine in the treatment of hemorrhoids. Enough evidence exists to recommend the use of this combination therapy as a fast, effective and safe option for the local treatment of low-grade hemorrhoids.

Persistence with oral contraceptive pills versus metformin in women with polycystic ovary syndrome.

PubMed

Karjane, Nicole W; Cheang, Kai I; Mandolesi, Gabriela A; Stovall, Dale W

2012-06-01

We studied patient persistence with oral contraceptive pills (OCPs) compared to metformin for treatment of polycystic ovary syndrome (PCOS) in an urban university clinic population. We conducted a retrospective cohort study of women with PCOS who were treated in our specialty clinic between 2004 and 2006. All women with the diagnosis of PCOS, defined as oligomenorrhea or amenorrhea in conjunction with clinical or biochemical evidence of hyperandrogenism, with exclusion of other causes, were included in the study. We abstracted data on demographic characteristics, medical history, anthropometrical measures, desire for pregnancy, prescribed treatment, and patient report of persistence with treatment at 3, 6, and 12 months. The primary outcome measure was persistence with prescribed treatment. One hundred nineteen subjects were included in the study. Demographic and anthropometrical characteristics were similar between the groups. At 3 months, 57.1% were persistent with OCPs, and 57.8% were persistent with metformin (p=0.93). At 6 months, the percentages dropped to 38.1% with OCPs and 43.9% with metformin (p=0.46). At 12 months, only 21.7% continued with OCPs compared to 31.2% with metformin (p=0.19). Subjects were significantly more likely to be persistent with either OCPs or metformin at 3 months compared to either 6 or 12 months (p<0.01). Women with PCOS showed similar persistence rates with OCPs compared to metformin. Persistence with either treatment precipitously decreases over time and is modest at 12 months.

Comparing the efficacy of mature mud pack and hot pack treatments for knee osteoarthritis.

PubMed

Sarsan, Ayşe; Akkaya, Nuray; Ozgen, Merih; Yildiz, Necmettin; Atalay, Nilgun Simsir; Ardic, Fusun

2012-01-01

The objective of this study is to compare the efficacy of mature mud pack and hot pack therapies on patients with knee osteoarthritis. This study was designed as a prospective, randomized-controlled, and single-blinded clinical trial. Twenty-seven patients with clinical and radiologic evidence of knee osteoarthritis were randomly assigned into two groups and were treated with mature mud packs (n 15) or hot packs (n=12). Patients were evaluated for pain [based on the visual analog scale (VAS)], function (WOMAC, 6 min walking distance), quality of life [Short Form-36 (SF-36)], and serum levels of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and insulin-like growth factor-1 (IGF-1) at baseline, post-treatment, and 3 and 6~months after treatment. The mud pack group shows a significant improvement in VAS, pain, stifness, and physical function domains of WOMAC. The difference between groups of pain and physical activity domains is significant at post-treatment in favor of mud pack. For a 6 min walking distance, mud pack shows significant improvement, and the difference is significant between groups in favor of mud pack at post-treatment and 3 and 6 months after treatment. Mud pack shows significant improvement in the pain subscale of SF-36 at the third month continuing until the sixth month after the treatment. Significant improvements are found for the social function, vitality/energy, physical role disability, and general health subscales of SF-36 in favor of the mud pack compared with the hot pack group at post-treatment. A significant increase is detected for IGF-1 in the mud pack group 3 months after treatment compared with the baseline, and the difference is significant between groups 3 months after the treatment. Mud pack is a favorable option compared with hotpack for pain relief and for the improvement of functional conditions in treating patients with knee osteoarthritis.

Effects of early and late treatments of low-intensity, high-frequency mechanical vibration on bone parameters in rats.

PubMed

Sasso, Gisela Rodrigues da Silva; Florencio-Silva, Rinaldo; Santos, Miriam Aparecida; Teixeira, Cristiane de Paula; Simões, Manuel de Jesus; Katchburian, Eduardo; Reginato, Rejane Daniele; Daniele Reginato, Rejane

2015-01-01

Low-intensity, high-frequency mechanical vibration (LHMV) has shown to increase bone formation. However, studies comparing the effectiveness of early- and late-treatments of LHMV to counteract bone loss have not been documented. This study was designed to compare the effects of early- and late-treatments of LHMV (at 30 Hz/0.6 g, 20 min per day/five days per week, for 12 weeks) on bone parameters in ovariectomized (Ovx) rats. Thirty days after ovariectomy, 40 adult rats were randomly divided into four groups: GI (early control group); GII treated with LHMV 3 weeks after Ovx (early treatment); GIII (late control group) and GIV treated with LHMV twelve weeks after Ovx (late treatment). Bone mineral density (BMD) was analyzed before Ovx and after treatments. Then, animals were killed, and the femurs were collected and their length and diaphysis diameter were measured; the distal femurs were taken and processed for histomorphometry and polarized light microscopy for collagen fibers analysis or subjected to immunohistochemistry of cleaved caspase-3 in osteocytes. Statistical analysis was done by ANOVA followed by the Bonferroni post hoc test (p < 0.05). BMD was similar among the groups before Ovx, but after treatments, it was significantly higher in GII and GIV compared with their control groups (p < 0.05). Femur length and cortical bone thickness were similar among the groups, but the diaphysis diameter of GII was higher compared with GI. Trabecular bone area was higher in the vibrated groups, but it was greater in GII (p < 0.05). Also, the vibrated groups showed the higher content collagen fibers and lower presence apoptotic osteocytes (positive caspase-3 immunoreactivity) when compared with the other groups (p < 0.05). These results suggest that both early- and late-treatments with LHMV counteract bone loss, being the early treatment more effective than the late treatment.

Treatment strategies and survival of older breast cancer patients - an international comparison between the Netherlands and Ireland.

PubMed

Kiderlen, Mandy; Walsh, Paul M; Bastiaannet, Esther; Kelly, Maria B; Audisio, Riccardo A; Boelens, Petra G; Brown, Chris; Dekkers, Olaf M; de Craen, Anton J M; van de Velde, Cornelis J H; Liefers, Gerrit-Jan

2015-01-01

Forty percent of breast cancers occur among older patients. Unfortunately, there is a lack of evidence for treatment guidelines for older breast cancer patients. The aim of this study is to compare treatment strategy and relative survival for operable breast cancer in the elderly between The Netherlands and Ireland. From the Dutch and Irish national cancer registries, women aged ≥65 years with non-metastatic breast cancer were included (2001-2009). Proportions of patients receiving guideline-adherent locoregional treatment, endocrine therapy, and chemotherapy were calculated and compared between the countries by stage. Secondly, 5-year relative survival was calculated by stage and compared between countries. Overall, 41,055 patients from The Netherlands and 5,826 patients from Ireland were included. Overall, more patients received guideline-adherent locoregional treatment in The Netherlands, overall (80% vs. 68%, adjusted p<0.001), stage I (83% vs. 65%, p<0.001), stage II (80% vs. 74%, p<0.001) and stage III (74% vs. 57%, P<0.001) disease. On the other hand, more systemic treatment was provided in Ireland, where endocrine therapy was prescribed to 92% of hormone receptor-positive patients, compared to 59% in The Netherlands. In The Netherlands, only 6% received chemotherapy, as compared 24% in Ireland. But relative survival was poorer in Ireland (5 years relative survival 89% vs. 83%), especially in stage II (87% vs. 85%) and stage III (61% vs. 58%) patients. Treatment for older breast cancer patients differed significantly on all treatment modalities between The Netherlands and Ireland. More locoregional treatment was provided in The Netherlands, and more systemic therapy was provided in Ireland. Relative survival for Irish patients was worse than for their Dutch counterparts. This finding should be a strong recommendation to study breast cancer treatment and survival internationally, with the ultimate goal to equalize the survival rates for breast cancer patients across Europe.

Greater occipital nerve block in the treatment of triptan-overuse headache: A randomized comparative study.

PubMed

Karadaş, Ö; Özön, A Ö; Özçelik, F; Özge, A

2017-04-01

This study aims to investigate the efficiency of a single and repeated greater occipital nerve (GON) block using lidocaine in the treatment of triptan-overuse headache (TOH), whose importance has increased lately. In the study, 105 consecutive subjects diagnosed with TOH were evaluated. The subjects were randomized into three groups. In Group 1 (n=35), only triptan was abruptly withdrawn. In Group 2 (n=35), triptan was abruptly withdrawn and single GON block was performed. In Group 3 (n=35), triptan was abruptly withdrawn and three-stage GON block was performed. All patients were injected bilaterally with a total amount of 5 cc 1% lidocaine in each stage. During follow-up, the number of headache days per month, the severity of pain (VAS), the number of triptans used, and hsCRP and IL-6 levels were recorded three times; in the pretreatment period, in the second month post-treatment, and in the fourth month post-treatment. They were then compared. There was a statistically significant difference in the post-treatment fourth month in comparison with the pretreatment period in Group 3 (P<.05). Compared to Group 1, the number of headache days, VAS, and decrease in triptan need in Group 3 was statistically significant compared to Group 2 (P<.05). Compared to pretreatment, in the fourth month post-treatment, both hsCRP and IL-6 levels were lower only in Group 3 (P<.05). We are of the opinion that repeated GON block in addition to the discontinuation of medication has significant efficacy for TOH cases. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Cost-effectiveness of brexpiprazole adjunctive treatment for major depressive disorder.

PubMed

Sussman, Matthew; Yu, Jeffrey; Kamat, Siddhesh A; Hartry, Ann; Legacy, Susan; Duffy, Ruth; Aigbogun, Myrlene Sanon

2017-01-01

Major depressive disorder (MDD) is a debilitating psychiatric illness with a high cost burden. This analysis evaluates the cost-effectiveness of adjunctive brexpiprazole versus comparator branded adjunctive treatment for MDD and background antidepressant therapy (ADT) alone from a US payer perspective. An economic model was developed to assess the cost-effectiveness of brexpiprazole versus comparator adjunctive treatment and ADT alone on total direct medical costs using a 6-week cycle time frame for a total of 48 weeks, with treatment response and remission as primary outcomes. The model consisted of 3 parts, 1 to represent the acute treatment phase and 2 to represent the maintenance stage. In the base-case analysis, brexpiprazole as reference treatment resulted in cost per additional responder ranging from $19,442-$48,745 and cost per additional remitter ranging from $27,196-$71,839 versus comparator treatments over 48 weeks. Sensitivity analyses showed treatment with brexpiprazole was more costly, but more clinically effective in all probabilistic simulations. This representation of disease natural history over 48 weeks may not account for all possible health states. Resource utilization on treatment was estimated using the resource use data from previous trials, and may overestimate medical costs compared to the real-world setting. Treatment comparators were limited to branded therapies, and head-to-head studies were not available to obtain data inputs. Compared to other branded adjunctive therapies, brexpiprazole increases response and remission at 6 weeks; medical care cost savings were observed with the use of brexpiprazole. These findings may assist clinicians and formulary decision makers when selecting treatment for MDD. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Comparison of the efficacy and safety of intensive-dose and standard-dose statin treatment for stroke prevention: A meta-analysis.

PubMed

Wang, Juan; Chen, Dan; Li, Da-Bing; Yu, Xin; Shi, Guo-Bing

2016-09-01

Previous study indicated that high-dose statin treatment might increase the risk of hemorrhagic stroke and adverse reactions. We aim to compare the efficacy and safety of intensive-dose and standard-dose statin treatment for preventing stroke in high-risk patients. A thorough search was performed of multiple databases for publications from 1990 to June 2015. We selected the randomized clinical trials comparing standard-dose statin with placebo and intensive-dose statin with standard-dose statin or placebo for the prevention of stroke events in patients. Duplicate independent data extraction and bias assessments were performed. Data were pooled using a fixed-effects model or a random-effects model if significant heterogeneity was present. For the all stroke incidences, intensive-dose statin treatment compared with placebo treatment and standard-dose statin treatment compared with placebo treatment showed a significant 21% reduction in relative risk (RR) (RR 0.79, 95% confidence interval (CI) [0.71, 0.87], P < 0.00001) and an 18% reduction in RR (RR 0.82, 95% CI [0.73, 0.93], P = 0.002) in the subgroup without renal transplant recipients and patients undergoing regular hemodialysis separately. For the fatal stroke incidences, intensive-dose statin treatment compared with standard dose or placebo was effective reducing fatal stroke (RR 0.61, 95% CI [0.39, 0.96], P = 0.03) and the RR was 1.01 (95% CI [0.85, 1.20], P = 0.90) in standard-dose statin treatment compared with placebo. The results of this meta-analysis suggest that intensive-dose statin treatment might be more favorable for reducing the incidences of all strokes than standard-dose statin treatment, especially for patients older than 65 years in reducing the incidences of all stroke incidences.

Opiate treatment for opiate withdrawal in newborn infants.

PubMed

Osborn, D A; Jeffery, H E; Cole, M

2005-07-20

Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. To assess the effectiveness and safety of using an opiate, compared to a sedative or non-pharmacological treatment, for treatment of NAS due to withdrawal from opiates. The previous review was updated with additional searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005), MEDLINE (1966-December 2004) and EMBASE (1980-December 2004) supplemented by searches of conference abstracts and citation lists of published articles. Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to opiate or control. Control could include an opiate, sedative or non-pharmacological treatment. Each author assessed study quality and extracted data independently. Primary outcomes included control of symptoms, seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using relative risk (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. Seven studies enrolling a total of 585 infants met inclusion criteria (Carin 1983; Finnegan 1984; Jackson 2004; Kaltenbach 1986; Kandall 1983; Khoo 1995; Madden 1977); however, two (Finnegan 1984; Kaltenbach 1986) may be sequential reports that include some identical patients. The studies enrolled infants of mothers who had used opiates with or without other drugs during pregnancy. Methodological concerns included the use of quasi-random rather than random patient allocation methods in three studies; sizeable, largely unexplained differences in reported numbers allocated to each group in four studies; and imbalances in group characteristics after randomisation in one study. Opiate (morphine) vs supportive care only: One study (Khoo 1995) found no significant effect on treatment failure (RR 1.29, 95% CI 0.41, 4.07), a significant increase in hospital stay (MD 15.0 days, 95% CI 8.9, 21.1) and significant reductions in time to regain birthweight (MD -2.8 days, 95% -5.3, -0.3) and duration of supportive care (MD -197.2 minutes/day, 95% CI -274.2, -120.3). Opiate vs phenobarbitone: Meta-analysis of four studies found no significant difference in treatment failure (typical RR 0.76, 95% CI 0.51, 1.11). One of these studies (Finnegan 1984) reported that opiate treatment resulted in a significant reduction in treatment failure among infants of mothers who had used only opiates; however, as this was a post-hoc analysis, this result should be interpreted with caution. One study (Jackson 2004) reported a significant reduction in duration of treatment and admission to the nursery for infants receiving morphine compared to phenobarbitone. One study (Kandall 1983) reported a reduction in seizures, of borderline statistical significance, with the use of opiate. Opiate vs diazepam: Meta-analysis of two studies found a significant reduction in treatment failure (RR 0.43, 95% CI 0.23, 0.80) with the use of opiate. No study reported neurodevelopment by allocated treatment group. Opiates, as compared to supportive care only, appear to reduce the time to regain birth weight and reduce the duration of supportive care, but increase the duration of hospital stay; there is no evidence of effect on treatment failure. When compared to phenobarbitone, opiates may reduce the incidence of seizures but, overall, there is no evidence of effect on treatment failure. One study reported a reduction in duration of treatment and nursery admission for infants on morphine. When compared to diazepam, opiates reduce the incidence of treatment failure. A post-hoc analysis generates the hypothesis that treatment effects may vary according to whether the population includes infants born to all opiate users (i.e. with or without other drug exposure) or is restricted to infants of mothers who used opiates only. In view of the methodologic limitations of the included studies the conclusions of this review should be treated with caution.

Lower self-reported depression in patients with erectile dysfunction after treatment with sildenafil.

PubMed

Müller, M J; Benkert, O

2001-10-01

Depressive symptoms in men with erectile dysfunction (ED) may improve under successful ED treatment. Self-reported depressive symptoms were compared in men with ED after sildenafil treatment to a group of untreated patients. In an open study, self-reported depressive symptoms of 54 men after successful treatment with sildenafil (>4 weeks) and 51 men awaiting ED treatment were investigated with the Center of Epidemiologic Studies-Depression Scale (CES-D). CES-D items were subjected to an exploratory factor analysis and group differences in CES-D items and factors were analyzed. Groups were comparable with respect to demographic characteristics and illness duration. CES-D total scores were lower in the group treated with sildenafil. Substantial differences were found in favor of the group treated with sildenafil, particularly in scores on a "positive affect" factor. The findings emphasize the relevance of depression associated with ED and the importance of effective ED treatment. Although depression was generally low in this sample, hedonistic aspects were substantially enhanced in the group of ED patients after sildenafil treatment. The open and cross-sectional study design does not permit causal inference. Selection bias and motivational aspects to participate in the study can not completely be ruled out.

Cost-effectiveness of vildagliptin for people with type 2 diabetes mellitus in Brazil; findings and implications.

PubMed

De Oliveira, Gustavo Laine Araujo; Guerra Júnior, Augusto Afonso; Godman, Brian; Acurcio, Francisco de Assis

2017-04-01

Vildagliptin is an inhibitor of the enzyme dipeptidyl peptidase 4, indicated for the treatment of type 2 diabetes mellitus, combined or not with metformin. This study aims to evaluate the cost-effectiveness of vildagliptin in the Brazilian context. Areas covered: Using MEDLINE, Cochrane Library, Lilacs and CRD, six studies were selected for the economic models. This study utilised cost data in the Brazilian health system to provide the context. Expert commentary: Type 2 diabetes mellitus is an epidemic disease and represents a challenge for all health care systems. Although guidelines clearly define first-line treatment, there are several other promising treatments. Vildagliptin is one of them, resulting in a mean lifetime increase of 0.31 years compared to metformin alone and 1.19 more life years compared to other metformin combinations. Considering observational data, life years with dual vildagliptin-containing treatments were 0.37 more compared to other dual treatments. However, its high cost versus generic metformin and its unclear safety profile weakens its subsequent cost-effectiveness. Consequently, the incorporation of vildagliptin or its combination with metformin is currently not recommended for the Brazilian Health Care System. This may change as more data becomes available.

Double-blind crossover study of branched-chain amino acid therapy in patients with spinocerebellar degeneration.

PubMed

Mori, Masatada; Adachi, Yoshiki; Mori, Nozomi; Kurihara, Saiko; Kashiwaya, Yoshihiro; Kusumi, Masayoshi; Takeshima, Takao; Nakashima, Kenji

2002-03-30

To determine whether treatment with branched-chain amino acids (BCAA) can improve the condition of patients with ataxia, a double-blind crossover study of BCAA therapy was performed in 16 patients with spinocerebellar degeneration (SCD). The patients were treated with BCAA in oral doses of 1.5, 3.0, or 6.0 g or with placebo daily for 4 weeks in each study phase. The order of treatment phases (placebo or BCAA) was assigned randomly. An International Cooperative Ataxia Rating Scale (ICARS) was used to quantify the severity of symptoms of SCD. The mean ICARS score improved significantly with BCAA treatment compared with the mean pretreatment score (p<0.01). In addition, the improvement in the mean global ICARS score was significant in the middle-dose group compared with that in the placebo group (p<0.02). The estimated improvement in kinetic functions compared with pretreatment (p<0.01) was significant after treatment with BCAA, 1.5 and 3.0 g. All of the responders manifested predominantly cerebellar symptoms, especially those with spinocerebellar ataxia type 6 (SCA6). Thus, treatment with BCAA may be effective in patients with the cerebellar form of SCD.

An observational study of patient satisfaction with fesoterodine in the treatment of overactive bladder: effects of additional educational material.

PubMed

Schneider, T; Arumi, D; Crook, T J; Sun, F; Michel, M C

2014-09-01

To compare the effects of additional educational material on treatment satisfaction of overactive bladder (OAB) patients treated with a muscarinic receptor antagonist. In an observational study of OAB patients being treated by their physician with fesoterodine for 4 months (FAKTEN study), sites were randomised to providing standard treatment or additional educational material including the SAGA tool. Patient satisfaction was assessed by three validated patient-reported outcomes including the Treatment Satisfaction Question. Because of premature discontinuation of the study, descriptive statistical analysis was performed. A total of 431 and 342 patients received standard treatment or additional educational material, respectively. At study end, 76.1% [95% CI = 71.3, 80.4] of patients with standard care and 79.6% [95% CI = 74.4, 84.1] with additional SAGA tool were satisfied with treatment (primary end-point). Comparable outcomes with and without the additional educational material were also found in various patient subgroups, at the 1-month time point, and for the other patient-reported outcomes. A notable exception was the subgroup of treatment-naïve patients in which the percentage of satisfied patients was 77.2% vs. 89.5% with standard treatment and additional SAGA tool, respectively (post hoc analysis). In an observational study, most overactive bladder patients were satisfied with fesoterodine treatment. Because of the small sample size, the study does not support or refute the hypothesis that adding the SAGA tool will improve patient satisfaction with treatment. The potential effect of additional educational material in treatment-naïve patients warrants further dedicated studies. © 2014 John Wiley & Sons Ltd.

Negative ion treatment increases positive emotional processing in seasonal affective disorder.

PubMed

Harmer, C J; Charles, M; McTavish, S; Favaron, E; Cowen, P J

2012-08-01

Antidepressant drug treatments increase the processing of positive compared to negative affective information early in treatment. Such effects have been hypothesized to play a key role in the development of later therapeutic responses to treatment. However, it is unknown whether these effects are a common mechanism of action for different treatment modalities. High-density negative ion (HDNI) treatment is an environmental manipulation that has efficacy in randomized clinical trials in seasonal affective disorder (SAD). The current study investigated whether a single session of HDNI treatment could reverse negative affective biases seen in seasonal depression using a battery of emotional processing tasks in a double-blind, placebo-controlled randomized study. Under placebo conditions, participants with seasonal mood disturbance showed reduced recognition of happy facial expressions, increased recognition memory for negative personality characteristics and increased vigilance to masked presentation of negative words in a dot-probe task compared to matched healthy controls. Negative ion treatment increased the recognition of positive compared to negative facial expression and improved vigilance to unmasked stimuli across participants with seasonal depression and healthy controls. Negative ion treatment also improved recognition memory for positive information in the SAD group alone. These effects were seen in the absence of changes in subjective state or mood. These results are consistent with the hypothesis that early change in emotional processing may be an important mechanism for treatment action in depression and suggest that these effects are also apparent with negative ion treatment in seasonal depression.

Moclobemide versus fluoxetine in the treatment of major depressive disorder in adults.

PubMed Central

Lapierre, Y D; Joffe, R; McKenna, K; Bland, R; Kennedy, S; Ingram, P; Reesal, R; Rickhi, B G; Beauclair, L; Chouinard, G; Annable, L

1997-01-01

The objective of the present study was to compare the safety and efficacy of moclobemide versus fluoxetine in adult patients with major depressive disorder. The design of the study was a multicenter, double-blind, comparative, and randomized trial. A 1- to 2-week single-blind placebo washout phase was followed by 6 weeks of double-blind treatment with moclobemide or fluoxetine. A total of 150 patients were enrolled in the study. There were 128 patients eligible to be randomized, with 66 patients receiving moclobemide and 62 patients receiving fluoxetine. At the termination of the study, patients in the moclobemide group were receiving a mean dose of 440 mg +/- 123 mg, while the mean dose in the fluoxetine group was 35 mg +/- 8 mg. No significant treatment differences were found for any of the efficacy parameters. Headache and nausea were the most frequently reported adverse events in both treatment groups. Headache and blurred vision were reported significantly more often (P < 0.05) in the fluoxetine group, whereas significantly more dry mouth was reported (P < 0.05) in the moclobemide group. These results provide supporting evidence of the comparable efficacy of moclobemide and fluoxetine and the better tolerability of moclobemide when used in the treatment of major depressive disorder. Images Figure 3 PMID:9074306

Intravitreal aflibercept versus intravitreal ranibizumab in patients with age-related macular degeneration: a comparative effectiveness study.

PubMed

Smit, Cornelis; Wiertz-Arts, Karin; van de Garde, Ewoudt Mw

2018-06-01

A hospital-wide, unselected switch of ranibizumab to aflibercept in treatment of age-related macular degeneration (AMD) allowed us to compare the clinical effectiveness of these agents. In a single-center before-after, observational study design new AMD-patients started with aflibercept treatment in 2013-2014 were compared with a control group of AMD-patients on ranibizumab before the switch. The mean difference in visual acuity (in logMAR units) after 1 year was comparable (+0.012 [aflibercept, n = 37] vs +0.17 [ranibizumab, n = 30], p = 0.154). However, the aflibercept-group did receive more intravitreal injections (5.8 vs 4.7 injections, p = 0.004) and were treated longer (265.7 vs 197.7 days; p = 0.011). With no difference in clinical effectiveness, longer treatment intervals for aflibercept should be investigated.

Inhaled mannitol for cystic fibrosis.

PubMed

Nolan, Sarah J; Thornton, Judith; Murray, Clare S; Dwyer, Tiffany

2015-10-09

Several agents are used to clear secretions from the airways of people with cystic fibrosis. Inhaled dry powder mannitol is now available in Australia and some countries in Europe. The exact mechanism of action of mannitol is unknown, but it increases mucociliary clearance. Phase III trials of inhaled dry powder mannitol for the treatment of cystic fibrosis have been completed. The dry powder formulation of mannitol may be more convenient and easier to use compared with established agents which require delivery via a nebuliser. To assess whether inhaled dry powder mannitol is well tolerated, whether it improves the quality of life and respiratory function in people with cystic fibrosis and which adverse events are associated with the treatment. We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic databases, handsearching relevant journals and abstracts from conferences.Date of last search: 16 April 2015. All randomised controlled studies comparing mannitol with placebo, active inhaled comparators (for example, hypertonic saline or dornase alfa) or with no treatment. Authors independently assessed studies for inclusion, carried out data extraction and assessed the risk of bias in included studies. The searches identified nine separate studies (45 publications), of which four studies (36 publications) were included with a total of 667 participants, one study (only available as an abstract) is awaiting assessment and two studies are ongoing. Duration of treatment in the included studies ranged from two weeks to six months with open-label treatment for an additional six months in two of the studies. Three studies compared mannitol with control (a very low dose of mannitol or non-respirable mannitol); two of these were parallel studies with a similar design and data could be pooled, where data for a particular outcome and time point were available; also, one short-term cross-over study supplied additional results. The fourth study compared mannitol to dornase alfa alone and to mannitol plus dornase alfa. There was generally a low risk of bias in relation to randomisation and blinding; evidence from the parallel studies was judged to be of low to moderate quality and from the cross-over studies was judged to be of low to very low quality. While the published papers did not provide all the data required for our analysis, additional unpublished data were provided by the drug's manufacturer and the author of one of the studies. There was an initial test to see if participants tolerated mannitol, with only those who could tolerate the drug being randomised to the studies; therefore the study results are not applicable to the cystic fibrosis population as a whole.For the comparison of mannitol and control, we found no consistent differences in health-related quality of life in any of the domains, except for burden of treatment, which was less for mannitol up to four months in the two pooled studies of a similar design; this difference was not maintained at six months. Up to and including six months, lung function in terms of forced expiratory volume at one second (millilitres) and per cent predicted were significantly improved in all three studies comparing mannitol to control. Beneficial results were observed in these studies in adults and in both concomitant dornase alfa users and non users. A significant reduction was shown in the incidence of pulmonary exacerbations in favour of mannitol at six months; however, the estimate of this effect was imprecise so it is unclear whether the effect is clinically meaningful. Cough, haemoptysis, bronchospasm, pharyngolaryngeal pain and post-tussive vomiting were the most commonly reported side effects on both treatments. Mannitol was not associated with any increase in isolation of bacteria over a six-month period.In the 12-week cross-over study (28 participants), no significant differences were found in the recorded domains of health-related quality of life or measures of lung function between mannitol versus dornase alfa alone and versus mannitol plus dornase alfa. There seemed to be a higher rate of pulmonary exacerbations in the mannitol plus dornase alfa arm compared with dornase alfa alone; although not statistically significant, this was the most common reason for stopping treatment in this arm. Cough was the most common side effect in the mannitol alone arm but there was no occurrence of cough in the dornase alfa alone arm and the most commonly reported reason of withdrawal from the mannitol plus dornase alfa arm was pulmonary exacerbations. Mannitol (with or without dornase alfa) was not associated with any increase in isolation of bacteria over the 12-week period. There is evidence to show that treatment with mannitol over a six-month period is associated with an improvement in some measures of lung function in people with cystic fibrosis compared to control. There is no evidence that quality of life is improved for participants taking mannitol compared to control; a decrease in burden of treatment was observed up to four months on mannitol compared to control but this difference was not maintained to six months. Randomised information regarding the burden of adding mannitol to an existing treatment is limited. There is no randomised evidence of improvement in lung function or quality of life comparing mannitol to dornase alfa alone and to mannitol plus dornase alfa.Mannitol as a single or concomitant treatment to dornase alfa may be of benefit to people with cystic fibrosis, but further research is required in order to establish who may benefit most and whether this benefit is sustained in the longer term.The clinical implications from this review suggest that mannitol could be considered as a treatment in cystic fibrosis; however, studies comparing its efficacy against other (established) mucolytic therapies need to be undertaken before it can be considered for mainstream practice.

Sedatives for opiate withdrawal in newborn infants.

PubMed

Osborn, David A; Jeffery, Heather E; Cole, Michael J

2010-10-06

Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. To assess the effectiveness and safety of using a sedative compared to a non-opiate control for NAS due to withdrawal from opiates, and to determine which type of sedative is most effective and safe. This update included searches of the Cochrane Central Register of Controlled Trials (Issue 1, 2010), MEDLINE 1966 to April 2010 and abstracts of conference proceedings. Trials enrolling infants with NAS born to mothers with an opiate dependence with > 80% follow-up and using random or quasi-random allocation to sedative or control. Control could include another sedative or non-pharmacological treatment. Each author assessed study quality and extracted data independently. Seven studies enrolling 385 patients were included. There were substantial methodological concerns for most studies including the use of quasi-random allocation methods and sizeable, largely unexplained differences in reported numbers allocated to each group.One study reported phenobarbitone compared to supportive care alone did not reduce treatment failure or time to regain birthweight, but resulted in a significant reduction in duration of supportive care (MD -162.1 min/day, 95% CI -249.2, -75.1). Comparing phenobarbitone to diazepam, meta-analysis of two studies found phenobarbitone resulted in a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). Comparing phenobarbitone with chlorpromazine, one study reported no significant difference in treatment failure.In infants treated with an opiate, one study reported addition of clonidine resulted in no significant difference in treatment failure, seizures or mortality. In infants treated with an opiate, one study reported addition of phenobarbitone significantly reduced the proportion of time infants had a high abstinence severity score, duration of hospitalisation and maximal daily dose of opiate. Infants with NAS due to opiate withdrawal should receive initial treatment with an opiate. Where a sedative is used, phenobarbitone should be used in preference to diazepam. In infants treated with an opiate, the addition of phenobarbitone or clonidine may reduce withdrawal severity. Further studies are needed to determine the role of sedatives in infants with NAS due to opiate withdrawal and the safety and efficacy of adding phenobarbitone or clonidine in infants treated with an opiate for NAS.

Modification of UASB reactor by using CFD simulations for enhanced treatment of municipal sewage.

PubMed

Das, Suprotim; Sarkar, Supriya; Chaudhari, Sanjeev

2018-02-01

Up-flow anaerobic sludge blanket (UASB) has been in use since last few decades for the treatment of organic wastewaters. However, the performance of UASB reactor is quite low for treatment of low strength wastewaters (LSWs) due to less biogas production leading to poor mixing. In the present research work, a modification was done in the design of UASB to improve mixing of reactor liquid which is important to enhance the reactor performance. The modified UASB (MUASB) reactor was designed by providing a slanted baffle along the height of the reactor having an angle of 5.7° with the vertical wall. A two-dimensional computational fluid dynamics (CFD) simulation of three phase gas-liquid-solid flow in MUASB reactor was performed and compared with conventional UASB reactor. The CFD study indicated better mixing in terms of vorticity magnitude in MUASB reactor as compared to conventional UASB, which was reflected in the reactor performance. The performance of MUASB was compared with conventional UASB reactor for the onsite treatment of domestic sewage as LSW. Around 16% higher total chemical oxygen demand removal efficiency was observed in MUASB reactor as compared to conventional UASB during this study. Therefore, this MUASB model demonstrates a qualitative relationship between mixing and performance during the treatment of LSW. From the study, it seems that MUASB holds promise for field applications.

A double-blind, randomized, placebo-controlled, single-dose study of the cyclooxygenase-2 inhibitor, GW406381, as a treatment for acute migraine.

PubMed

Wentz, A L; Jimenez, T B; Dixon, R M; Aurora, S K; Gold, M

2008-04-01

The objective of the present study was to explore the clinical efficacy and tolerability of GW406381, a cyclooxygenase-2 (COX-2) inhibitor with relatively high CNS penetration, in acute migraine. This was a double-blind, single-dose study of GW406381 compared with placebo and naproxen sodium compared with placebo (protocol number CXA20008). Three hundred and thirty-seven subjects were randomized 1:1:1 to GW406381 (70 mg), naproxen sodium (825 mg), or placebo for the treatment of one migraine headache of moderate or severe intensity in a potential 8-week period. The primary end-point was the proportion of subjects with headache relief [reduction in headache severity score from pre-dose 2 (moderate) or 3 (severe) to 0 (no pain) or 1 (mild)] at 2 h post-dose for GW406381 compared with placebo. Significantly higher proportions of subjects treated with GW406381 (50%, P = 0.032) or naproxen sodium (56%, P = 0.005) than with placebo (35%) reported headache relief at 2 h post-dose. Additional significant benefits were observed on many secondary outcomes, including proportions of subjects pain-free, for both GW406381 and naproxen sodium treatment compared with placebo. Both active treatments were well tolerated. Single-dose GW406381 (70 mg) and naproxen sodium (825 mg) were effective and well tolerated in the treatment of acute migraine.

Comparative study of group treatments for posttraumatic stress disorder.

PubMed

Maxwell, Kendal; Callahan, Jennifer L; Holtz, Pamela; Janis, Beth M; Gerber, Monica M; Connor, Dana R

2016-12-01

Presented herein is a comparative study of group treatments for posttraumatic stress disorder (PTSD). In this study, an emerging intervention, memory specificity training (MeST), was compared with cognitive processing therapy (CPT) using standardized outcome measures of target symptoms (i.e., anxiety and depression from client perspective; memory specificity from independent rater perspective) and global functioning (independent rater perspective), as well as a process measure of expectancy (client perspective). Clients were assessed on 3 separate occasions: at baseline, posttreatment, and 3 months posttreatment. Adherence and treatment fidelity (independent rater perspective) were monitored throughout the course of both treatment conditions. Improvement in PTSD symptoms, depressive symptoms, and global functioning were similar between MeST and CPT; an increase in ability to specify memories upon retrieval was also similar between MeST and CPT. Positive reliable change was observed in both groups on all outcome measures. With respect to the primary target of PTSD symptoms, 88% of participants in both treatment groups moved into the functional distribution by posttreatment and maintained these gains at follow-up. Notably, compared with CPT, MeST required only half the dosage (i.e., number of sessions) to accomplish these gains. Illustrative vignettes from client-therapist exchanges are provided, and results are discussed in terms of the potential mechanisms of action. Implications for both clinical practice and clinical research are also included. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Predictors of treatment with dialysis modalities in observational studies for comparative effectiveness research*

PubMed Central

Kuttykrishnan, Sooraj; Kalantar-Zadeh, Kamyar; Arah, Onyebuchi A.; Cheung, Alfred K.; Brunelli, Steve; Heagerty, Patrick J.; Katz, Ronit; Molnar, Miklos Z.; Nissenson, Allen; Ravel, Vanessa; Streja, Elani; Himmelfarb, Jonathan; Mehrotra, Rajnish

2015-01-01

Background The Institute of Medicine has identified the comparative effectiveness of renal replacement therapies as a kidney-related topic among the top 100 national priorities. Given the importance of ensuring internal and external validity, the goal of this study was to identify potential sources of bias in observational studies that compare outcomes with different dialysis modalities. Methods This observational cohort study used data from the electronic medical records of all patients that started maintenance dialysis in the calendar years 2007–2011 and underwent treatment for at least 60 days in any of the 2217 facilities operated by DaVita Inc. Each patient was assigned one of six dialysis modalities for each 91-day period from the date of first dialysis (thrice weekly in-center hemodialysis (HD), peritoneal dialysis (PD), less-frequent HD, home HD, frequent HD and nocturnal in-center HD). Results Of the 162 644 patients, 18% underwent treatment with a modality other than HD for at least one 91-day period. Except for PD, patients started treatment with alternative modalities after variable lengths of treatment with HD; the time until a change in modality was shortest for less-frequent HD (median time = 6 months) and longest for frequent HD (median time = 15 months). Between 30 and 78% of patients transferred to another dialysis facility prior to change in modality. Finally, there were significant differences in baseline and time-varying clinical characteristics associated with dialysis modality. Conclusions This analysis identified numerous potential sources of bias in studies of the comparative effectiveness of dialysis modalities. PMID:25883196

A Pooled Analysis of the Phase 3 REVIVE Trials: Randomized, Double-blind Studies to EValuate the Safety and Efficacy of Iclaprim Versus Vancomycin for trEatment of Acute Bacterial Skin and Skin Structure Infections.

PubMed

Huang, David B; Corey, G Ralph; Holland, Thomas L; Lodise, Thomas; O'Riordan, William; Wilcox, Mark H; File, Thomas M; Dryden, Matthew; Balser, Barbara; Desplats, Eve; Torres, Antoni

2018-05-18

Iclaprim, a diaminopyrimidine antibiotic, was compared with vancomycin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSIs) in two studies (REVIVE-1 and REVIVE-2). We explored the efficacy and tolerability of iclaprim in a pooled analysis of results from both studies. REVIVE-1 and REVIVE-2 were Phase 3, double-blind, randomized (1:1), multicenter, active-controlled, non-inferiority (margin of 10%) trials, each designed to enroll 600 patients a piece with ABSSSI. The studies used identical study protocols. Iclaprim 80 mg and vancomycin 15 mg/kg were administered IV every 12 hours for 5-14 days. The primary endpoint was a ≥20% reduction from baseline in lesion size (early clinical response [ECR]) at the early time point (48 to 72 hours after the start of study drug) in the intent-to-treat population. In REVIVE-1, ECR at the early time point was 80.9% with iclaprim vs. 81.0% with vancomycin (treatment difference, -0.13%; 95% confidence interval, -6.42% to 6.17%). In REVIVE-2, ECR was 78.3% with iclaprim vs. 76.7% with vancomycin (treatment difference: 1.58%, 95% CI: -5.10% to 8.26%). The pooled ECR was 79.6% with iclaprim vs. 78.8% with vancomycin (treatment difference: 0.75%, 95% CI: -3.84 to 5.35%). Iclaprim and vancomycin were comparable for the incidence of mostly mild adverse events, except for a higher incidence of elevated serum creatinine with vancomycin (n=7) compared with iclaprim (n=0). Iclaprim achieved noninferiority compared with vancomycin for early clinical response at the early time point and secondary endpoints with a similar safety profile in two Phase 3 studies for the treatment of ABSSSI suspected or confirmed to be caused by Gram-positive pathogens. NCT02600611 and NCT02607618. Copyright © 2018. Published by Elsevier B.V.

Early Stage Blood Purification for Paraquat Poisoning: A Multicenter Retrospective Study.

PubMed

Li, An; Li, Wenxiong; Hao, Fengtong; Wang, Haishi

2016-01-01

To evaluate the efficacy of conservative treatment vs. hemoperfusion (HP) vs. HP + continuous veno-venous hemofiltration (CVVH) for acute Paraquat (PQ) poisoning. This was a multicenter retrospective study of patients with PQ poisoning between January 2013 and June 2014. Clinical data and PQ serum levels were collected at baseline and after 24, 48, and 72 h of treatment. Seventy-five, 65, and 43 underwent conservative treatment only (conservative treatment group), conservative treatment + HP (HP group), and conservative treatment + HP + CVVH (HP + CVVH group), respectively. PQ serum levels decreased in all groups after 72 h of treatment (p < 0.001); meanwhile, these values decreased faster in the HP and HP + CVVH groups compared with the conservative treatment group. More importantly, PQ blood levels were significantly lower in the HP + CVVH group compared with the HP group at 24 h (p < 0.05). Sequential organ failure assessment (ΔSOFA) values in the HP and HP + CVVH groups were significantly lower compared with that obtained for the conservative treatment group (p < 0.05). The 60-day survival rates were 21.3, 43.1 and 46.5%, respectively. Multivariate analysis indicated that age, PQ dose, admission PQ levels, and admission SOFA score were independently associated with mortality. HP and HP + CVVH were protective factors. Early HP or HP + CVVH after PQ poisoning could decrease PQ blood levels, alleviate organ damage, and increase survival. © 2016 S. Karger AG, Basel.

Cost-effectiveness of Internet-based cognitive behavior therapy vs. cognitive behavioral group therapy for social anxiety disorder: results from a randomized controlled trial.

PubMed

Hedman, Erik; Andersson, Erik; Ljótsson, Brjánn; Andersson, Gerhard; Rück, Christian; Lindefors, Nils

2011-11-01

Social anxiety disorder (SAD) is highly prevalent and associated with a substantial societal economic burden, primarily due to high costs of productivity loss. Cognitive behavior group therapy (CBGT) is an effective treatment for SAD and the most established in clinical practice. Internet-based cognitive behavior therapy (ICBT) has demonstrated efficacy in several trials in recent years. No study has however investigated the cost-effectiveness of ICBT compared to CBGT from a societal perspective, i.e. an analysis where both direct and indirect costs are included. The aim of the present study was to investigate the cost-effectiveness of ICBT compared to CBGT from a societal perspective using a prospective design. We conducted a randomized controlled trial where participants with SAD were randomized to ICBT (n=64) or CBGT (n=62). Economic data were assessed at pre-treatment, immediately following treatment and six months after treatment. Results showed that the gross total costs were significantly reduced at six-month follow-up, compared to pre-treatment in both treatment conditions. As both treatments were equivalent in reducing social anxiety and gross total costs, ICBT was more cost-effective due to lower intervention costs. We conclude that ICBT can be more cost-effective than CBGT in the treatment of SAD and that both treatments reduce societal costs for SAD. Copyright © 2011 Elsevier Ltd. All rights reserved.

ECONOMICS OF INDIVIDUALIZATION IN COMPARATIVE EFFECTIVENESS RESEARCH AND A BASIS FOR A PATIENT-CENTERED HEALTH CARE

PubMed Central

Basu, Anirban

2011-01-01

The United States aspires to use information from comparative effectiveness research (CER) to reduce waste and contain costs without instituting a formal rationing mechanism or compromising patient or physician autonomy with regard to treatment choices. With such ambitious goals, traditional combinations of research designs and analytical methods used in CER may lead to disappointing results. In this paper, I study how alternate regimes of comparative effectiveness information help shape the marginal benefits (demand) curve in the population and how such perceived demand curves impact decision-making at the individual patient level and welfare at the societal level. I highlight the need to individualize comparative effectiveness research in order to generate the true (normative) demand curve for treatments. I discuss methodological principles that guide research designs for such studies. Using an example of the comparative effect of substance abuse treatments on crime, I use novel econometric methods to salvage individualized information from an existing dataset. PMID:21601299

Economics of individualization in comparative effectiveness research and a basis for a patient-centered health care.

PubMed

Basu, Anirban

2011-05-01

The United States aspires to use information from comparative effectiveness research (CER) to reduce waste and contain costs without instituting a formal rationing mechanism or compromising patient or physician autonomy with regard to treatment choices. With such ambitious goals, traditional combinations of research designs and analytical methods used in CER may lead to disappointing results. In this paper, I study how alternate regimes of comparative effectiveness information help shape the marginal benefits (demand) curve in the population and how such perceived demand curves impact decision-making at the individual patient level and welfare at the societal level. I highlight the need to individualize comparative effectiveness research in order to generate the true (normative) demand curve for treatments. I discuss methodological principles that guide research designs for such studies. Using an example of the comparative effect of substance abuse treatments on crime, I use novel econometric methods to salvage individualized information from an existing dataset. Copyright © 2011 Elsevier B.V. All rights reserved.

Bacillus Calmette-Guérin strain differences have an impact on clinical outcome in bladder cancer immunotherapy.

PubMed

Rentsch, Cyrill A; Birkhäuser, Frédéric D; Biot, Claire; Gsponer, Joël R; Bisiaux, Aurélie; Wetterauer, Christian; Lagranderie, Micheline; Marchal, Gilles; Orgeur, Mickael; Bouchier, Christiane; Bachmann, Alexander; Ingersoll, Molly A; Brosch, Roland; Albert, Matthew L; Thalmann, George N

2014-10-01

Whether the commonly used bacillus Calmette-Guérin (BCG) strains Connaught and Tice confer different treatment responses in non-muscle-invasive bladder cancer (NMIBC) is unknown. To compare clinical efficacy, immunogenicity, and genetics of BCG Connaught and Tice. A prospective randomized single-institution trial with treatment of 142 high-risk NMIBC patients with BCG Connaught or Tice. Patients were randomized to receive six instillations of BCG Connaught or Tice. For experimental studies, BCG strains were compared in C57Bl/6 mice. Bladders and lymphoid tissues were analyzed by cytometry and the latter cultivated to detect live BCG. BCG genomic DNA was sequenced and compared with reference genomes. Recurrence-free survival was the primary end point of the clinical study. The Kaplan-Meier estimator was used for estimating survival and time-to-event end points. Nonparametric tests served for the analysis of the in vivo results. Treatment with BCG Connaught conferred significantly greater 5-yr recurrence-free survival compared with treatment with BCG Tice (p=0.0108). Comparable numbers of patients experienced BCG therapy-related side effects in each treatment group (p=0.09). In mice, BCG Connaught induced stronger T-helper cell 1-biased responses, greater priming of BCG-specific CD8(+) T cells, and more robust T-cell recruitment to the bladder than BCG Tice. Genome sequencing of the BCG strains revealed candidate genes potentially involved in the differential clinical responses. BCG strain may have an impact on treatment outcome in NMIBC immunotherapy. We compared the efficacy of two commonly used bacillus Calmette-Guérin (BCG) strains for the treatment of NMIBC and found that treatment with BCG Connaught prevented recurrences more efficiently than BCG Tice. Comparison of the immunogenicity of the two strains in mice indicated superior immunogenicity of BCG Connaught. We also identified genetic differences that may explain the differential efficacy of the Connaught and Tice BCG strains. NCT00003779. Copyright © 2014. Published by Elsevier B.V.

Topical glycopyrrolate reduces axillary hyperhidrosis.

PubMed

Baker, D M

2016-12-01

Oral anti-cholinergic medications reduce generalized hyperhidrosis, but the effectiveness of topical anticholinergic solutions on axillary hyperhidrosis is unclear. This study determines the initial effectiveness of 1% and 2% topical glycopyrrolate spray and compares this with Botulinum toxin type A injections for the management of axillary hyperhidrosis. In a non-randomized, consecutive patient, prospective questionnaire, treatment comparison study, 40 patients with axillary hyperhidrosis were allocated to one of four study groups (10 patients to each group): (a) 1% glycopyrrolate spray, (b) 2% glycopyrrolate spray, (c) subcutaneous Botulinum toxin type A injections, (d) no treatment. Clinical outcomes were measured by comparing a prospectively administered questionnaire, completed both pre-treatment and 6 weeks after starting treatment. Forty healthy volunteers without axillary hyperhidrosis completed the same questionnaire. The three treatment groups showed a significant (P < 0.05) improvement in their hyperhidrosis scores following treatment. The degree of improvement was less for the 1% glycopyrrolate group when compared with the Botulinum toxin type A group (P < 0.05), but there was no difference in treatment outcomes between the 2% glycopyrrolate and Botulinum toxin type A groups. No treatment group experienced reduced hyperhidrosis to a level similar to those without hyperhidrosis. Patients in both, the 2% glycopyrrolate and Botulinum toxin type A groups reported a significant improvement in axillary hyperhidrosis symptoms. These included reduction in psychologically precipitating factors (e.g. public speaking) and axillary hyperhidrosis-specific physical effects (e.g. limitation of clothing choice). Topical glycopyrrolate spray could provide a further treatment modality to manage axillary hyperhidrosis. © 2016 European Academy of Dermatology and Venereology.

Clinical effectiveness and cost-effectiveness of treatments for patients with chronic pain.

PubMed

Turk, Dennis C

2002-01-01

Chronic pain is a prevalent and costly problem. This review addresses the question of the clinical effectiveness and cost-effectiveness of the most common treatments for patients with chronic pain. Representative published studies that evaluate the clinical effectiveness of pharmacological treatments, conservative (standard) care, surgery, spinal cord stimulators, implantable drug delivery systems (IDDSs), and pain rehabilitation programs (PRPs) are examined and compared. The cost-effectiveness of these treatment approaches is also considered. Outcome criteria including pain reduction, medication use, health care consumption, functional activities, and closure of disability compensation cases are examined. In addition to clinical effectiveness, the cost-effectiveness of PRPs, conservative care, surgery, spinal cord stimulators, and IDDSs are compared using costs to return a treated patient to work to illustrate the relative expenses for each of these treatments. There are limitations to the success of all the available treatments. The author urges caution in interpreting the results, particularly in comparisons between treatments and across studies, because there are broad differences in the pain syndromes and inclusion criteria used, the drug dosages, comparability of treatments, the definition of "chronic" used, the outcome criteria selected to determine success, and societal differences. None of the currently available treatments eliminates pain for the majority of patients. Pain rehabilitation programs provide comparable reduction in pain to alternative pain treatment modalities, but with significantly better outcomes for medication use, health care utilization, functional activities, return to work, closure of disability claims, and with substantially fewer iatrogenic consequences and adverse events. Surgery, spinal cord stimulators, and IDDSs appear to have substantial benefits on some outcome criteria for carefully selected patients. These modalities are, however, expensive. Pain rehabilitation programs are significantly more cost effective than implantation of spinal cord stimulators, IDDSs, conservative care, and surgery, even for selected patients. Research is needed to identify which patients are most likely to benefit from the available treatments and to study combinations of the available treatments since none of them appear capable of eliminating pain or significantly improving functional outcomes for all treated.

Comparative efficacy of disease-modifying therapies for patients with relapsing remitting multiple sclerosis: Systematic review and network meta-analysis.

PubMed

Fogarty, Emer; Schmitz, Susanne; Tubridy, Niall; Walsh, Cathal; Barry, Michael

2016-09-01

Randomised studies have demonstrated efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis (RRMS). However it is unclear how the magnitude of treatment efficacy varies across all currently available therapies. To perform a systematic review and network meta-analysis to evaluate the comparative efficacy of available therapies in reducing relapses and disability progression in RRMS. A systematic review identified 28 randomised, placebo-controlled and direct comparative trials. A network meta-analysis was conducted within a Bayesian framework to estimate comparative annualised relapse rates (ARR) and risks of disability progression (defined by both a 3-month, and 6-month confirmation interval). Potential sources of treatment-effect modification from study-level covariates and baseline risk were evaluated through meta-regression methods. The Surface Under the Cumulative RAnking curve (SUCRA) method was used to provide a ranking of treatments for each outcome. The magnitude of ARR reduction varied between 15-36% for all interferon-beta products, glatiramer acetate and teriflunomide, and from 50 to 69% for alemtuzumab, dimethyl fumarate, fingolimod and natalizumab. The risk of disability progression (3-month) was reduced by 19-28% with interferon-beta products, glatiramer acetate, fingolimod and teriflunomide, by 38-45% for pegylated interferon-beta, dimethyl fumarate and natalizumab and by 68% with alemtuzumab. Broadly similar estimates for the risk of disability progression (6-month), with the exception of interferon-beta-1b 250mcg which was much more efficacious based on this definition. Alemtuzumab and natalizumab had the highest SUCRA scores (97% and 95% respectively) for ARR, while ranking for disability progression varied depending on the definition of the outcome. Interferon-beta-1b 250mcg ranked among the most efficacious treatments for disability progression confirmed after six months (92%) and among the least efficacious when the outcome was confirmed after three months (30%). No significant modification of relative treatment effects was identified from study-level covariates or baseline risk. Compared with placebo, clear reductions in ARR with disease-modifying therapies were accompanied by more uncertain changes in disability progression. The magnitude of the reduction and the uncertainty associated with treatment effects varied between DMTs. While natalizumab and alemtuzumab demonstrated consistently high ranking across outcomes, with older interferon-beta and glatiramer acetate products ranking lowest, variation in disability progression definitions lead to variation in the relative ranking of treatments. Rigorously conducted comparative studies are required to fully evaluate the comparative treatment effects of disease modifying therapies for RRMS. Copyright © 2016 Elsevier B.V. All rights reserved.

Systematic review of the use of honey as a wound dressing

PubMed Central

Moore, Owen A; Smith, Lesley A; Campbell, Fiona; Seers, Kate; McQuay, Henry J; Moore, R Andrew

2001-01-01

Objective To investigate topical honey in superficial burns and wounds though a systematic review of randomised controlled trials. Data sources Cochrane Library, MEDLINE, EMBASE, PubMed, reference lists and databases were used to seek randomised controlled trials. Seven randomised trials involved superficial burns, partial thickness burns, moderate to severe burns that included full thickness injury, and infected postoperative wounds. Review methods Studies were randomised trials using honey, published papers, with a comparator. Main outcomes were relative benefit and number-needed-to-treat to prevent an outcome relating to wound healing time or infection rate. Results One study in infected postoperative wounds compared honey with antiseptics plus systemic antibiotics. The number needed to treat with honey for good wound healing compared with antiseptic was 2.9 (95% confidence interval 1.7 to 9.7). Five studies in patients with partial thickness or superficial burns involved less than 40% of the body surface. Comparators were polyurethane film, amniotic membrane, potato peel and silver sulphadiazine. The number needed to treat for seven days with honey to produce one patient with a healed burn was 2.6 (2.1 to 3.4) compared with any other treatment and 2.7 (2.0 to 4.1) compared with potato and amniotic membrane. For some or all outcomes honey was superior to all these treatments. Time for healing was significantly shorter for honey than all these treatments. The quality of studies was low. Conclusion Confidence in a conclusion that honey is a useful treatment for superficial wounds or burns is low. There is biological plausibility. PMID:11405898

Watchful waiting with periodic liver biopsy versus immediate empirical therapy for histologically mild chronic hepatitis C. A cost-effectiveness analysis.

PubMed

Wong, J B; Koff, R S

2000-11-07

Not all patients with histologically mild chronic hepatitis C progress to cirrhosis. To compare no antiviral treatment, periodic liver biopsy with subsequent antiviral treatment for moderate hepatitis or cirrhosis, and immediate antiviral therapy. Cost-effectiveness analysis. Clinical trial data and published studies. Hepatitis C virus-infected patients with histologically mild hepatitis. Lifetime. Societal. Immediate combination antiviral treatment or biopsy every 3 years plus combination antiviral therapy for moderate hepatitis or cirrhosis. Life expectancy, quality-adjusted life expectancy, and costs. Over 20 years, biopsy every 3 years with treatment of moderate hepatitis would avoid treatment in 50% of the cohort and would result in an 18% likelihood of cirrhosis compared with 16% for immediate treatment and 27% for no antiviral therapy. Immediate antiviral treatment should increase life expectancy by 1.0 quality-adjusted life-year compared with biopsy management. Over an average lifetime, biopsy management would lead to six liver biopsies costing $6200; immediate antiviral treatment would cost $5100 less than biopsy management because of savings related to biopsy and prevention of future hepatitis C-related morbidity. Immediate therapy was cost-effective compared with biopsy management and had a cost-effectiveness ratio of $7000 compared with no antiviral therapy. When age, sex, genotype, and estimates of histologic progression or compliance with follow-up are varied, immediate therapy should result in an increase of at least 0. 8 quality-adjusted life-year compared with biopsy management. For histologically mild chronic hepatitis C, initial combination treatment compared with periodic liver biopsy should reduce the future risk for cirrhosis, prolong life, and be cost-effective.

Cost-effectiveness analysis of dolutegravir plus backbone compared with raltegravir plus backbone, darunavir+ritonavir plus backbone and efavirenz/tenofovir/emtricitabine in treatment naïve and experienced HIV-positive patients.

PubMed

Restelli, Umberto; Rizzardini, Giuliano; Antinori, Andrea; Lazzarin, Adriano; Bonfanti, Marzia; Bonfanti, Paolo; Croce, Davide

2017-01-01

In January 2014, the European Medicines Agency issued a marketing authorization for dolutegravir (DTG), a second-generation integrase strand transfer inhibitor for HIV treatment. The study aimed at determining the incremental cost-effectiveness ratio (ICER) of the use of DTG+backbone compared with raltegravir (RAL)+backbone, darunavir (DRV)+ritonavir(r)+backbone and efavirenz/tenofovir/emtricitabine (EFV/TDF/FTC) in HIV-positive treatment-naïve patients and compared with RAL+backbone in treatment-experienced patients, from the Italian National Health Service's point of view. A published Monte Carlo Individual Simulation Model (ARAMIS-DTG model) was used to perform the analysis. Patients pass through mutually exclusive health states (defined in terms of diagnosis of HIV with or without opportunistic infections [OIs] and cardiovascular disease [CVD]) and successive lines of therapy. The model considers costs (2014) and quality of life per monthly cycle in a lifetime horizon. Costs and quality-adjusted life years (QALYs) are dependent on OI, CVD, AIDS events, adverse events and antiretroviral therapies. In treatment-naïve patients, DTG dominates RAL; compared with DRV/r, the ICER obtained is of 38,586 €/QALY (6,170 €/QALY in patients with high viral load) and over EFV/TDF/FTC, DTG generates an ICER of 33,664 €/QALY. In treatment-experienced patients, DTG compared to RAL leads to an ICER of 12,074 €/QALY. The use of DTG+backbone may be cost effective in treatment-naïve and treatment-experienced patients compared with RAL+backbone and in treatment-naïve patients compared with DRV/r+backbone and EFV/TDF/FTC considering a threshold of 40,000 €/QALY.

Milrinone for persistent pulmonary hypertension of the newborn.

PubMed

Bassler, Dirk; Kreutzer, Karen; McNamara, Patrick; Kirpalani, Haresh

2010-11-10

Persistent pulmonary hypertension of the newborn (PPHN) is a clinical syndrome characterized by suboptimal oxygenation as a result of sustained elevation in pulmonary vascular resistance after birth. Currently, the therapeutic mainstay for PPHN is optimal lung inflation and selective vasodilatation with inhaled nitric oxide (iNO). However, iNO is not available in all countries and not all infants will respond to iNO. Milrinone is a phosphodiesterase III inhibitor which induces pulmonary vasodilatation by its actions through a cyclic adenylate monophosphate mediated signaling pathway. To assess efficacy and safety in infants with PPHN either treated with: milrinone compared with placebo or no treatment; milrinone compared with iNO; milrinone as an adjunct to iNO compared with iNO alone; milrinone compared with potential treatments for PPHN other than iNO. We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2010), MEDLINE and EMBASE databases from their inception until January 2010. We searched the reference lists of potentially relevant studies without any language restriction. Fully published randomized controlled trials (RCTs) and quasi-RCTs comparing milrinone with placebo, iNO or potential treatments other than iNO in neonates with PPHN were included if trials reported any clinical outcome. We found no studies meeting the criteria for inclusion in this review. We found no studies meeting the criteria for inclusion in this review. The efficacy and safety of milrinone in the treatment of PPHN are not known and its use should be restricted within the context of RCTs. Such studies should address a comparison of milrinone with placebo (in clinical situations where iNO is not available) or, in well resourced countries, should compare milrinone with iNO or as an adjunct to iNO compared with iNO alone.

A Comparison of Alprazolam and Behavior Therapy in Treatment of Panic Disorder.

ERIC Educational Resources Information Center

Klosko, Janet S.; And Others

1990-01-01

Compared panic control treatment (PCT), behavior therapy for panic disorders, with alprazolam medication, placebo, and waiting-list control groups. Percentage of clients (N=57) completing study who were free of panic attacks following PCT was 87 percent, compared with 50 percent for alprazolam, 36 percent for placebo, and 33 percent for…

Injury Treatment among Children with Autism or Pervasive Developmental Disorder

ERIC Educational Resources Information Center

McDermott, Suzanne; Zhou, Li; Mann, Joshua

2008-01-01

This study examined the differences in the frequency and type of injury for children with autism and pervasive developmental disorder (PDD) compared with typically developing peers, when both groups are insured by Medicaid. The relative rate (RR) of emergency/hospital treatment of injury for children with autism or PDD compared to controls was…

The treatment of extensive scalp lesions combining electrons with intensity-modulated photons.

PubMed

Chan, Maria F; Song, Yulin; Burman, Chandra; Chui, Chen S; Schupak, Karen

2006-01-01

This study was to investigate the feasibility and potential benefits of combining electrons with intensity modulated photons (IMRT+e) for patients with extensive scalp lesions. A case of a patient with an extensive scalp lesion, in which the target volume covered the entire front half of the scalp, is presented. This approach incorporated the electron dose into the inverse treatment planning optimization. The resulting doses to the planning target volume (PTV) and relevant critical structures were compared. Thermoluminescent dosimeters (TLD), diodes, and GAFCHROMIC EBT films were used to verify the accuracy of the techniques. The IMRT+e plan produced a superior dose distribution to the patient as compared to the IMRT plan in terms of reduction of the dose to the brain with the same dose conformity and homogeneity in the target volumes. This study showed that IMRT+e is a viable treatment modality for extensive scalp lesions patients. It provides a feasible alternative to existing treatment techniques, resulting in improved homogeneity of dose to the PTV compared to conventional electron techniques and a decrease in dose to the brain compared to photon IMRT alone.

Biodegradable implants versus standard metal fixation for displaced radial head fractures. A prospective, randomized, multicenter study.

PubMed

Helling, Hanns-Joachim; Prokop, Axel; Schmid, Hans Ulrich; Nagel, Michael; Lilienthal, Jürgen; Rehm, Klaus Emil

2006-01-01

This multicenter, prospective, randomized study compares the use of biodegradable polylactide pins with standard metal mini-fragment implants for the treatment of displaced radial head fractures. It compares complication rates and clinical outcomes of both treatment methods. At 2 years, 135 (82%) of 164 patients were available for evaluation. Equivalence of treatment method was defined as a difference of 10% or less in the number of complication-free patients. Functional status was assessed by using the Broberg and Morrey Elbow Score and compared by an unpaired t test. Good or excellent clinical results were achieved by 92% (56/61) of the control patients and 96% (71/74) of the polylactide patients. The incidence of complication-free patients was 3.7% less in the polylactide group than in the control group. The 1-sided 95% confidence interval for the treatment difference between the 2 groups was more than -6.1%. Biodegradable polylactide pins have at least comparable outcomes as standard metal implants for the internal fixation of reconstructable displaced radial head fractures.

Childhood Sexual Abuse Patterns, Psychosocial Correlates, and Treatment Outcomes among Adults in Drug Abuse Treatment

ERIC Educational Resources Information Center

Boles, Sharon M.; Joshi, Vandana; Grella, Christine; Wellisch, Jean

2005-01-01

This study reports on the effects of having a history of childhood sexual abuse (CSA) on treatment outcomes among substance abusing men and women (N = 2,434) in a national, multisite study of drug treatment outcomes. A history of CSA was reported by 27.2% of the women and 9.2% of the men. Controlling for gender, compared to patients without CSA,…

Comparison of high-sensitivity C-reactive protein and fetuin-A levels before and after treatment for subjects with subclinical hyperthyroidism.

PubMed

Bilgir, Oktay; Bilgir, Ferda; Topcuoglu, Tuba; Calan, Mehmet; Calan, Ozlem

2014-03-01

This study was designed to show the effect of propylthiouracil treatment on sCD40L, high-sensitivity C-reactive protein, and fetuin-A levels on subjects with subclinical hyperthyroidism. After checking sCD40L, high-sensitivity C-reactive protein, and fetuin-A levels of 35 patients with subclinical hyperthyroidism, each was given 50 mg tablets of propylthiouracil three times daily. After 3 months, sCD40L, high-sensitivity C-reactive protein, and fetuin-A levels were then compared to the levels before treatment. Although high-sensitivity C-reactive protein and sCD40L levels were normal in the subclinical hyperthyroidism patients compared to the healthy controls, fetuin-A levels were statistically significantly higher (*p = 0.022). After treatment, fetuin-A levels of subclinical hyperthyroidism patients decreased statistically significantly compared to the levels before treatment (**p = 0.026). sCD40L and high-sensitivity C-reactive protein levels did not have a statistically significant difference compared to the control group and post-propylthiouracil treatment. In subclinical hyperthyroidism patients, high fetuin-A levels before propylthiouracil treatment and decreases in these levels after treatment in cases with subclinical hyperthyroidism indicated the possibility of preventing long-term cardiac complications with propylthiouracil treatment.

Methodology for a trial of brain-centered versus anticholinergic therapy in women with urgency urinary incontinence.

PubMed

Komesu, Yuko M; Rogers, Rebecca G; Sapien, Robert E; Schrader, Ronald M; Simmerman-Sierra, Timothy; Mayer, Andrew R; Ketai, Loren H

2017-06-01

We describe the rationale and methodology for a study comparing mind-body treatment and pharmacotherapy in women with urgency urinary incontinence (UUI). To explore brain associations in UUI, a subset of patients will also undergo functional magnetic resonance imaging (fMRI). We hypothesize that hypnotherapy, a mind-body intervention, will be at least as effective as pharmacotherapy in treating UUI. We also hypothesize that fMRI findings will change following treatment, with changes potentially differing between groups. We describe the development and design challenges of a study comparing the efficacy of hypnotherapy and conventional pharmacotherapy in the treatment of UUI. The study randomizes women to either of these treatments, and outcome measures include bladder diaries and validated questionnaires. Sample size estimates, based on a noninferiority test (alpha = 0.025, beta = 0.20), after considering dropout subjects and subjects lost to follow-up, indicated that approximately 150 woman would be required to test the hypothesis that hypnotherapy is not inferior to pharmacotherapy within a 5 % noninferiority margin. The study will also evaluate fMRI changes in a subset of participants before and after therapy. Challenges included designing a study with a mind-body therapy and a comparison treatment equally acceptable to participants, standardizing the interventions, and confronting the reality that trials are time-consuming for participants who have to make appropriate accommodations in their schedule. Study enrollment began in March 2013 and is ongoing. We describe the design of a randomized controlled trial comparing mind-body therapy and pharmacotherapy in the treatment of UUI and the challenges encountered in its implementation.

Treatment of transverse patellar fractures: a comparison between metallic and non-metallic implants.

PubMed

Heusinkveld, Maarten H G; den Hamer, Anniek; Traa, Willeke A; Oomen, Pim J A; Maffulli, Nicola

2013-01-01

Several methods of transverse patellar fixation have been described. This study compares the clinical outcome and the occurrence of complications of various fixation methods. The databases PubMed, Web of Science, Science Direct, Google Scholar and Google were searched. A direct comparison between fixation techniques using mixed or non-metallic implants and metallic K-wire and tension band fixation shows no significant difference in clinical outcome between both groups. Additionally, studies reporting novel operation techniques show good clinical results. Studies describing the treatment of patients using non-metallic or mixed implants are fewer compared with those using metallic fixation. A large variety of clinical scoring systems were used for assessing the results of treatment, which makes direct comparison difficult. More data of fracture treatment using non-metallic or mixed implants is needed to achieve a more balanced comparison.

Gender Comparison in Referrals and Treatment Completion to Residential and Outpatient Alcohol Treatment.

PubMed

Bazargan-Hejazi, Shahrzad; De Lucia, Valory; Pan, Deyu; Mojtahedzadeh, Mona; Rahmani, Elham; Jabori, Sinan; Zahmatkesh, Golara; Bazargan, Mohsen

2016-01-01

Residential treatment for alcoholism is associated with high completion rates for clients, yet there appear to be gender disparities in patient referrals and treatment completion rates. We studied whether (A) gender is associated with differential patient placement to outpatient vs. residential treatment facilities and (B) completion rates differ by gender. In this cross-sectional study, we analyzed the admission and discharge data from 185 publicly funded substance abuse treatment facilities across Los Angeles County between 2005 and 2010. Among the 33,745 studied cases, women were referred to residential treatment facilities less frequently than men (75% vs. 66%). The adjusted results derived from logistic regression models confirmed that females were more likely to be referred to outpatient treatment than to residential treatment facilities (odds ratio [OR]: 1.15, 95% confidence interval [CI]: 1.05-1.26). In addition, we observed that compared to White/Caucasian patients, all other races were associated with more referral to outpatient facilities (ie, less referral to residential facilities), indicating a racial disparity on the top of the observed gender disparity. However, there was no significant link between gender and treatment completion rates (OR: 0.93, 95% CI: 0.86-1.00). Women seem to have treatment completion rates comparable to men, yet they are less likely to be referred to residential treatment facilities. Hence, there still remains a gender disparity in alcoholic patient referrals. Further studies should delineate which specific therapeutic aspects and programmatic components of women-focused treatments are essential to augment positive treatment outcomes.

Systematic Review with Network Meta-Analysis: Comparative Efficacy of Biologics in the Treatment of Moderately to Severely Active Ulcerative Colitis.

PubMed

Vickers, Adrian D; Ainsworth, Claire; Mody, Reema; Bergman, Annika; Ling, Caroline S; Medjedovic, Jasmina; Smyth, Michael

2016-01-01

Biological therapies are increasingly used to treat ulcerative colitis (UC). To compare the efficacy of biologics in adults with moderately-to-severely active UC, stratified by prior exposure to anti-tumour necrosis factor (anti-TNF) therapy. A systematic literature review was undertaken to identify studies of biologics approved for UC. Network meta-analysis was conducted for endpoints at induction and maintenance. Seven studies were included in the meta-analysis of induction treatment for anti-TNF therapy-naïve patients. All biologics were more effective than placebo in inducing clinical response, clinical remission, and mucosal healing. Infliximab demonstrated a statistically significant improvement over adalimumab in clinical response (odds ratio [OR] [95% credible interval (CrI)]: 2.19 [1.35-3.55]), clinical remission (OR [95% CrI]: 2.81 [1.49-5.49]), and mucosal healing (OR [95% CrI]: 2.23 [1.21-4.14]); there were no other significant differences between biologics for induction efficacy. Five studies were included in the meta-analysis of maintenance treatment, two studies rerandomised responder patients at end of induction, and three followed the same patients 'straight through'. To account for design differences, the number of responders at end of induction was assumed to be equivalent to the number rerandomised. Vedolizumab showed significantly different durable clinical response from comparators (OR [95% CrI] infliximab 3.18 [1.14-9.20], golimumab 2.33 [1.04-5.41], and adalimumab 3.96 [1.67-9.84]). In anti-TNF therapy-experienced patients, only vedolizumab and adalimumab could be compared. At induction, no significant differences in efficacy were seen. During maintenance, vedolizumab showed significantly improved rates of mucosal healing versus adalimumab (OR [95% CrI]: 6.72 [1.36-41.0]). This study expands the understanding of comparative efficacies of biologic treatments for UC, encompassing outcomes and populations not previously studied. All biologic treatments were effective for UC during induction. Vedolizumab demonstrated possible clinical benefits in the maintenance setting versus all comparators, irrespective of prior anti-TNF exposure and after adjusting for differences in study design.

Comparison of conventional therapies for dentin hypersensitivity versus medical hypnosis.

PubMed

Eitner, Stephan; Bittner, Christian; Wichmann, Manfred; Nickenig, Hans-Joachim; Sokol, Biljana

2010-10-01

This study compared the efficacy of conventional treatments for dentin hypersensitivity (DHS) and hypnotherapy. During a 1-month period at an urban practice in a service area of approximately 22,000 inhabitants, all patients were examined. A total of 102 individuals were included in the evaluation. Values of 186 teeth were analyzed. The comparison of the different treatment methods (desensitizer, fluoridation, and hypnotherapy) did not show significant differences in success rates. However, a noticeable difference was observed in terms of onset and duration of effect. For both desensitizer and hypnotherapy treatments, onset of effect was very rapid. Compared to the other methods studied, hypnotherapy effects had the longest duration. In conclusion, hypnotherapy was as effective as other methods in the treatment of DHS.

Comparative survival study of glial cells and cells composing walls of blood vessels in crustacean ventral nerve cord after photodynamic treatment

NASA Astrophysics Data System (ADS)

Kolosov, Mikhail S.; Shubina, Elena

2015-03-01

Photodynamic therapy is a prospective treatment modality of brain cancers. It is of importance to have information about relative survival rate of different cell types in nerve tissue during photodynamic treatment. Particularly, for development of sparing strategy of the photodynamic therapy of brain tumors, which pursuits both total elimination of malignant cells, which are usually of glial origin, and, at the same time, preservation of normal blood circulation as well as normal glial cells in the brain. The aim of this work was to carry out comparative survival study of glial cells and cells composing walls of blood vessels after photodynamic treatment, using simple model object - ventral nerve cord of crustacean.

Patient Perception of Treatment Burden is High in Celiac Disease Compared to Other Common Conditions

PubMed Central

Shah, Sveta; Akbari, Mona; Vanga, Rohini; Kelly, Ciaran P.; Hansen, Joshua; Theethira, Thimmaiah; Tariq, Sohaib; Dennis, Melinda; Leffler, Daniel A.

2014-01-01

Introduction The only treatment for celiac disease (CD) is life-long adherence to a gluten-free diet (GFD). Noncompliance is associated with signs and symptoms of celiac disease, yet long-term adherence rates are poor. It is not known how the burden of the GFD compares to other medical treatments, and there are limited data on the socio-economic factors influencing treatment adherence. In this study we compared treatment burden and health state in CD compared with other chronic illnesses and evaluated the relationship between treatment burden and adherence. Methods A survey was mailed to participants with: CD, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), hypertension (HTN), diabetes mellitus (DM), congestive heart failure (CHF), and end stage renal disease on dialysis (ESRD). Surveys included demographic information and visual analog scales measuring treatment burden, importance of treatment, disease-specific and overall health status. Results We collected surveys from 341 celiac and 368 non-celiac participants. Celiac participants reported high treatment burden, greater than participants with GERD or HTN and comparable to ESRD. Conversely, patients with CD reported the highest health state of all groups. Factors associated with high treatment burden in CD included poor adherence, concern regarding food cost, eating outside the home, higher income, lack of college education and time limitations in preparing food. Poor adherence in CD was associated with increased symptoms, income, and low perceived importance of treatment. Discussion Participants with CD have high treatment burden but also excellent overall health status in comparison with other chronic medical conditions. The significant burden of dietary therapy for celiac disease argues for the need for safe adjuvant treatment as well as interventions designed to lower the perceived burden of the GFD. PMID:24980880

Comparing Safety and Efficacy of "Third-Generation" Antiepileptic Drugs: Long-Term Extension and Post-marketing Treatment.

PubMed

Kwok, Charlotte S; Johnson, Emily L; Krauss, Gregory L

2017-11-01

Four "third-generation" antiepileptic drugs (AEDs) were approved for adjunctive treatment of refractory focal onset seizures during the past 10 years. Long-term efficacy and safety of the drugs were demonstrated in large extension studies and in reports of subgroups of patients not studied in pivotal trials. Reviewing extension study and post-marketing outcome series for the four newer AEDs-lacosamide, perampanel, eslicarbazepine acetate and brivaracetam-can guide clinicians in treating and monitoring patients. AED extension studies evaluate treatment retention, drug tolerability, and drug safety during individualized treatment with flexible dosing and thus provide information not available in rigid pivotal trials. Patient retention in the studies ranged from 75 to 80% at 1 year and from 36 to 68% at 2-year treatment intervals. Safety findings were generally similar to those of pivotal trials, with no major safety risks identified and with several specific adverse drug effects, such as hyponatremia, reported. The third-generation AEDs, some through new mechanisms and others with improved tolerability compared to related AEDs, provide new options in efficacy and tolerability.

Sedatives for opiate withdrawal in newborn infants.

PubMed

Osborn, D A; Jeffery, H E; Cole, M J

2005-07-20

Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. To assess the effectiveness and safety of using a sedative compared to a non-opiate control for NAS due to withdrawal from opiates, and to determine which type of sedative is most effective and safe. The standard search strategy of the Neonatal Review Group was used. This update included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005), MEDLINE 1966-March 2005 and abstracts of conference proceedings. Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to sedative or control. Control could include another sedative or non-pharmacological treatment. Each author assessed study quality and extracted data independently. Primary outcomes included treatment failure (failure to achieve symptom control or use of additional drug treatment), seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. Six studies enrolling a total of 305 patients met inclusion criteria (Coyle 2002; Finnegan 1984; Kahn 1969; Kaltenbach 1986; Khoo 1995; Madden 1977); however, two (Finnegan 1984; Kaltenbach 1986) may be sequential reports that include some identical patients. Methodological concerns included the use of quasi-random allocation methods in four studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in three studies. Phenobarbitone compared to supportive care alone has not been shown to reduce treatment failure or time to regain birthweight (one study). However, the duration of supportive care given to infants was significantly reduced (MD -162.1 mins/day, 95% CI -249.2, -75.1). Comparing phenobarbitone to diazepam, meta-analysis of two studies found phenobarbitone produced a significant reduction in treatment failure (typical RR 0.39, 95% CI 0.24, 0.62). There was no significant difference in duration of treatment or hospital stay. Comparing phenobarbitone with chlorpromazine, one study found no significant difference in treatment failure rate. No data for neurodevelopment reported by treatment group of allocation were available. No trials were eligible that assessed clonidine for NAS. In infants treated with an opiate, a small quasi-random study reported a reduced severity of withdrawal. Infants were weaned from an opiate more quickly which allowed earlier hospital discharge and reduced hospital costs. These findings may reflect the low dose of opiate used for initial treatment and the policy of discharging infants home on phenobarbitone but not morphine. In newborn infants with NAS, there is no evidence that phenobarbitone compared with supportive care alone reduces treatment failure; however, phenobarbitone may reduce the daily duration of supportive care needed. Phenobarbitone, compared to diazepam, reduces treatment failure. In infants treated with an opiate, the addition of phenobarbitone may reduce withdrawal severity. Further trials are required to determine if this finding is applicable when a higher initial dose of opiate is used, and determine the effects of phenobabritone on infant development. There is insufficient evidence to support the use of chlorpromazine or clonidine in newborn infants with NAS. Clonidine and chlorpromazine should only be used in the context of a randomised clinical trial. This review should be taken in conjunction with the review "Opiate treatment for opiate withdrawal in newborn infants" (Osborn 2002a) which indicates that an opiate is the preferred initial therapy for NAS.

Education and Treatment for Boys Who Set Fires: Specificity, Moderators, and Predictors of Recidivism

ERIC Educational Resources Information Center

Kolko, David J.; Herschell, Amy D.; Scharf, Deborah M.

2006-01-01

Given the relative absence of treatment outcome studies, information about the specificity and utility of interventions for children who set fires has not been reported. In a treatment outcome study with young boys referred for firesetting that compared brief home visitation from a firefighter, fire safety education (FSE), and cognitive-behavioral…

Impact of Childhood Trauma on Treatment Outcome in the Treatment for Adolescents with Depression Study (TADS)

ERIC Educational Resources Information Center

Lewis, Cara C.; Simons, Anne D.; Nguyen, Lananh J.; Murakami, Jessica L.; Reid, Mark W.; Silva, Susan G.; March, John S.

2010-01-01

Objective: The impact of childhood trauma was examined in 427 adolescents (54% girls, 74% Caucasian, mean = 14.6, SD = 1.5) with major depressive disorder participating in the Treatment for Adolescents with Depression Study (TADS). Method: TADS compared the efficacy of cognitive behavioral therapy (CBT), fluoxetine (FLX), their combination (COMB),…

Analysis of Cytokine Levels in Tears and Clinical Correlations After Intense Pulsed Light Treating Meibomian Gland Dysfunction.

PubMed

Liu, Ruixing; Rong, Bei; Tu, Ping; Tang, Yun; Song, Wenjing; Toyos, Rolando; Toyos, Melissa; Yan, Xiaoming

2017-11-01

To investigate the change from baseline of inflammatory markers in tears of dry eye disease (DED) subjects owing to meibomian gland dysfunction (MGD) after intense pulsed light (IPL) treatment and meibomian gland expression (MGE) compared to sham treatment, and the correlations with ocular surface parameters. Randomized, double-masked, controlled study. Those randomized into the active treatment arm received 3 consecutive treatments (14∼16 J/cm 2 ) approximately 4 weeks apart in the periocular region. Control eyes received 3 treatments in the same intervals of 0 J/cm 2 . Tear samples in all eyes were collected and analyzed at baseline, week 12, and/or week 4 for interleukin (IL)-17A, IL-6, and prostaglandin E2 (PGE2). The correlations between cytokines and ocular surface parameters were analyzed before and after IPL treatment. All of the inflammatory markers declined in value compared to baselines. IL-17A and IL-6 showed statistically significant decreases compared to sham treatment at each measured time point. PGE2 showed statistically significant decreases compared to sham at week 12. Results showed that the expressions of IL-17A and IL-6 correlated well with ocular surface parameters of the lower eyelid before IPL. The changed values of IL-6 and PGE2 in tears correlated with the changed values of partial ocular surface parameters after IPL treatment in study eyes, respectively. The study results suggest that IPL can significantly reduce inflammatory markers in tears of patients suffering with DED owing to MGD after IPL treatment. These findings indicate that IL-17A and IL-6 play roles in the pathogenesis of DED owing to MGD, and the reduction of the inflammatory factors is consistent with the improvement of partial clinical symptoms and signs. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Mineralocorticoid receptor blockade in addition to angiotensin converting enzyme inhibitor or angiotensin II receptor blocker treatment: an emerging paradigm in diabetic nephropathy: a systematic review.

PubMed

Mavrakanas, Thomas A; Gariani, Karim; Martin, Pierre-Yves

2014-02-01

Blockade of the renin-angiotensin-aldosterone system (RAAS) is a standard therapeutic intervention in diabetic patients with chronic kidney disease (CKD). Concomitant mineralocorticoid receptor blockade has been studied as a novel approach to further slow down CKD progression. We used PubMed and EMBASE databases to search for relevant literature. We included in our review eight studies in patients of at least 18 years of age, with a diagnosis of type 1 or type 2 diabetes mellitus and diabetic nephropathy, under an angiotensin converting enzyme inhibitor (ACEI) and/or an angiotensin II receptor blocker (ARB) as standard treatment. A subset of patients in each study also received a mineralocorticoid receptor blocker (MRB) (either spironolactone or eplerenone) in addition to standard treatment. Combined treatment with a mineralocorticoid receptor blocker further reduced albuminuria by 23 to 61% compared with standard treatment. Estimated glomerular filtration rate values upon study completion slightly decreased under combined treatment. Blood pressure levels upon study completion were significantly lower with combined treatment in three studies. Hyperkalemia prevalence increased in patients under combined treatment raising dropout rate up to 17%. Therefore, combined treatment by an ACEI/ARB and a MRB may further decrease albuminuria in diabetic nephropathy. This effect may be due to the specific properties of the MRB treatment. Clinicians should regularly check potassium levels because of the increased risk of hyperkalemia. Available evidence should be confirmed by an adequately powered comparative trial of the standard treatment (ACEI or ARB) versus combined treatment by an ACEI/ARB and a MRB. Copyright © 2013 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

The effects of mometasone furoate and desloratadine in obstructive sleep apnea syndrome patients with allergic rhinitis.

PubMed

Acar, Mustafa; Cingi, Cemal; Sakallioglu, Oner; San, Turhan; Fatih Yimenicioglu, Mehmet; Bal, Cengiz

2013-01-01

Allergic rhinitis (AR) and obstructive sleep apnea syndrome (OSAS) are worldwide prevalent diseases. These diseases impair patient quality of life. The aim of this study was to investigate and compare the efficacy of treatment of AR on OSAS by objective and subjective methods. The study group was composed of 80 OSAS patients with AR between the ages of 30 and 50 years. The patients were admitted with the complaint of snoring, and they were asked about AR-related symptoms (nasal discharge, nasal itching, sneeze, and nasal obstruction). Daytime somnolence was measured by the Epworth sleepiness scale (ESS). Sleep parameters on polysomnography tests before and after treatment were compared, and the effects of different AR treatment protocols on sleep quality were evaluated. When pretreatment and posttreatment apnea-hypopnea index (AHI) values of the groups were compared, the most significant difference was observed in the nasal steroid (Ns) + antihistamine (Ah) group (p < 0.05). The ESS results were significantly decreased in the Ns and Ns + Ah groups after treatment (p < 0.05). AHI oxygen saturation <90% were significantly decreased in the Ns and Ns + Ah groups after treatment (p < 0.05). Nasal obstruction due to nasal congestion causes increases in airway resistance and can lead to development of OSAS. We concluded that treating AR with Ns has both positive effects on OSAS and daily activity. However, adding Ah to this treatment did not show improved effects compared with placebo treatment.

Pirfenidone treatment in idiopathic pulmonary fibrosis: A Saudi experience.

PubMed

Alhamad, Esam H

2015-01-01

Recent trials involving pirfenidone suggest a beneficial effect in the treatment of idiopathic pulmonary fibrosis (IPF). To report on the efficacy and safety of pirfenidone in the treatment of patients with IPF, at a tertiary care hospital in Saudi Arabia. The study included 58 patients with IPF who were evaluated from March 2012 to March 2013. During the study period, 33 patients received pirfenidone, and the remaining patients (n = 25) served as a control group. Baseline clinical characteristics, physiological parameters and the results of a 36-Item Short Form Health Survey (SF-36) were compared between the groups. Furthermore, we compared changes in forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLco), six-minute walk distance (6MWD) and SF-36 for both groups during follow-up. The last follow-up period ended in January 2014. There were no significant differences in baseline clinical characteristics between the groups. Furthermore, we found no differences in FVC, DLco and SF-36 during follow-up (median, 12 months). However, patients receiving pirfenidone treatment were less likely to experience reductions in 6MWD compared with the control group (13% vs. 52%, respectively; P = 0.001). Although adverse events were more frequently reported by the pirfenidone group compared with the control group (85 vs. 56%, respectively; P = 0.015), these patients did not require discontinuation of treatment. Pirfenidone treatment preserves functional capacity, as reflected by the 6MWD. Adverse events associated with pirfenidone treatment were generally well tolerated by the patients.

Topical liposomal Rose Bengal for photodynamic white hair removal: randomized, controlled, double-blind study.

PubMed

Samy, Nevien; Fadel, Maha

2014-04-01

Blond and white hair removal by laser is a complicated task with weak satisfactory results due to the deficiency in laser-absorbing chromophore. To investigate if repetitive sessions of photodynamic therapy (PDT) using external application of liposomal Rose bengal (RB) photosensitizer followed by intense pulsed light (IPL) exposure enables removal of gray and white hair. Rose bengal loaded in liposomes (LRB) was constructed, prepared in hydrogel, and was studied for some pharmaceutical properties. Penetration and selective hair follicle damage in mice skin were studied. Topical gel containing LRB was used for treating fifteen adult females who were complaining of facial white terminal hair. Unwanted facial hair was treated for three sessions at intervals of 4-6 weeks using intense pulsed light (IPL). At each session, the treatment area was pre-treated with topical LRB gel, while a control group of another 15 patients applied placebo gel before IPL treatment. Evaluations included hair regrowth, which was measured 4 weeks after each treatment session and at 6 months follow-up by counting the number of terminal hair compared with baseline pretreatment values. Treatment outcomes and complications if any were also reported. Average hair regrowth in the LRB group was 56% after 3 treatment cycles. After six-months follow up, average terminal hair count compared with baseline pretreatment showed 40% reduction and no recorded side effects. A significant difference (P<0.05) was seen compared with the control group; the clinical results were promising. Photodynamic hair removal using rose bengal-encapsulated liposomal gel in combination with IPL treatment showed significant efficacy in the treatment of white hair compared with a control group.

Cost effectiveness of pharmacological maintenance treatment for chronic obstructive pulmonary disease: a review of the evidence and methodological issues.

PubMed

Rutten-van Mölken, Maureen P M H; Goossens, Lucas M A

2012-04-01

Over 200 million people have chronic obstructive pulmonary disease (COPD) worldwide. The number of disease-year equivalents and deaths attributable to COPD are high. Guidelines for the pharmacological treatment of the disease recommend an individualized step-up approach in which treatment is intensified when results are unsatisfactory. Our objective was to present a systematic review of the cost effectiveness of pharmacological maintenance treatment for COPD and to discuss the methodological strengths and weaknesses of the studies. A systematic literature search for economic evaluations of drug therapy in COPD was performed in MEDLINE, EMBASE, the Economic Evaluation Database of the UK NHS (NHS-EED) and the European Network of Health Economic Evaluation Databases (EURONHEED). Full economic evaluations presenting both costs and health outcomes were included. A total of 40 studies were included in the review. Of these, 16 were linked to a clinical trial, 14 used Markov models, eight were based on observational data and two used a different approach. The few studies on combining short-acting bronchodilators were consistent in finding net cost savings compared with monotherapy. Studies comparing inhaled corticosteroids (ICS) with placebo or no maintenance treatment reported inconsistent results. Studies comparing fluticasone with salmeterol consistently found salmeterol to be more cost effective. The cost-effectiveness studies of tiotropium versus placebo, ipratropium or salmeterol pointed towards a reduction in total COPD-related healthcare costs for tiotropium in many but not all studies. All of these studies reported additional health benefits of tiotropium. The cost-effectiveness studies of the combination of inhaled long-acting β₂-agonists and ICS all report additional health benefits at an increase in total COPD-related costs in most studies. The cost-per-QALY estimates of this combination treatment vary widely and are very sensitive to the assumptions on mortality benefit and time horizon. The currently available economic evaluations indicate differences in cost effectiveness between COPD maintenance therapies, but for a more meaningful comparison of results it is important to improve the consistency with respect to study methodology and choice of comparator.

Waste battery treatment options: comparing their environmental performance.

PubMed

Briffaerts, K; Spirinckx, C; Van der Linden, A; Vrancken, K

2009-08-01

Waste consumer batteries are recycled using different routes based on hydrometallurgical and pyrometallurgical processes. Two hydrometallurgical and two pyrometallurgical treatment scenarios are compared starting from an average composition of Belgian waste batteries. The environmental performance is compared using life cycle analysis (LCA). The recycling rate is studied through mass balance calculation. Each treatment scenario results in a specific recycling rate. The environmental impact and benefits also vary between the treatment options. There is no such thing as a typical hydrometallurgical or pyrometallurgical treatment. When applying a hydrometallurgical treatment scenario, the focus lies on zinc and iron recycling. When allowing manganese recycling, the energy demand of the hydrometallurgical process increases considerably. Both pyrometallurgical options recycle zinc, iron and manganese. According to the LCA, none of the treatment scenarios performs generally better or worse than the others. Each option has specific advantages and disadvantages. The Batteries Directive 2006/66/EC sets out a recycling rate of 50% for consumer waste batteries. Based on metal recycling alone, the mass balances show that the target is difficult to obtain.

Fewer acute respiratory infection episodes among patients receiving treatment for gastroesophageal reflux disease

PubMed Central

Xirasagar, Sudha; Chung, Shiu-Dong; Tsai, Ming-Chieh; Chen, Chao-Hung

2017-01-01

Patients with gastroesophageal reflux disease (GERD) present with comorbid complications with implications for healthcare utilization. To date, little is known about the effects of GERD treatment with a proton-pump inhibitor (PPI) on patients’ subsequent healthcare utilization for acute respiratory infections (ARIs). This population-based study compared ARI episodes captured through outpatient visits, one year before and one year after GERD patients received PPI treatment. We used retrospective data from the Longitudinal Health Insurance Database 2005 in Taiwan, comparing 21,486 patients diagnosed with GERD from 2010 to 2012 with 21,486 age-sex matched comparison patients without GERD. Annual ARI episodes represented by ambulatory care visits for ARI (visits during a 7-day period bundled into one episode), were compared between the patient groups during the 1-year period before and after the index date (date of GERD diagnosis for study patients, first ambulatory visit in the same year for their matched comparison counterpart). Multiple regression analysis using a difference-in-difference approach was performed to estimate the adjusted association between GERD treatment and the subsequent annual ARI rate. We found that the mean annual ARI episode rate among GERD patients reduced by 11.4%, from 4.39 before PPI treatment, to 3.89 following treatment (mean change = -0.5 visit, 95% confidence interval (CI) = (-0.64, -0.36)). In Poisson regression analysis, GERD treatment showed an independent association with the annual ARI rate, showing a negative estimate (with p<0.001). The study suggests that GERD treatment with PPIs may help reduce healthcare visits for ARIs, highlighting the importance of treatment-seeking by GERD patients and compliance with treatment. PMID:28222168

Individual cognitive-behavioral therapy and behavioral couples therapy in alcohol use disorder: a comparative evaluation in community-based addiction treatment centers.

PubMed

Vedel, Ellen; Emmelkamp, Paul M G; Schippers, Gerard M

2008-01-01

Alcohol abuse serves as a chronic stressor between partners and has a deleterious effect on relationship functioning. Behavioral Couples Therapy (BCT) for alcohol dependence, studied as an adjunct to individual outpatient counseling, has shown to be effective in decreasing alcohol consumption and enhancing marital functioning, but no study has directly tested the comparative effectiveness of stand-alone BCT versus an individually focused cognitive-behavioral therapy (CBT) in a clinical community sample. The present study is a randomized clinical trial evaluating the effectiveness of stand-alone BCT (n = 30) compared to individual CBT (n = 34) in the treatment of alcohol use disorders in community treatment centers in Dutch male and female alcoholics and their partners. Results show both BCT and CBT to be effective in changing drinking behavior after treatment. BCT was not found to be superior to CBT. Marital satisfaction of the spouse increased significantly in the BCT condition but not in the CBT condition, the differences being significant at the post-test. Patients' self-efficacy to withstand alcohol-related high-risk situations increased significantly in both treatment conditions, but more so in CBT than in BCT after treatment. Treatment involvement of the spouse did not increase retention. Regular practitioners in community treatment centers can effectively deliver both treatments. Stand-alone BCT is as effective as CBT in terms of reduced drinking and to some extent more effective in terms of enhancing relationship satisfaction. However, BCT is a more costly intervention, given that treatment sessions lasted almost twice as long as individual CBT sessions. Copyright 2008 S. Karger AG, Basel.

Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study.

PubMed

Pullman, J; Gardovskis, J; Farley, B; Sun, E; Quintas, M; Lawrence, L; Ling, R; Cammarata, S

2017-12-01

Delafloxacin is an investigational anionic fluoroquinolone in development for oral or intravenous administration for the treatment of infections caused by Gram-positive (including MRSA), Gram-negative, atypical and anaerobic organisms. To establish the non-inferiority of delafloxacin compared with vancomycin plus aztreonam for the treatment of acute bacterial skin and skin structure infections and to compare the safety of the two antimicrobials. A Phase 3, multicentre, randomized, double-blind, active-controlled study with 660 patients compared delafloxacin 300 mg or vancomycin 15 mg/kg plus aztreonam 2 g each administered twice daily intravenously for 5-14 days. Non-inferiority was evaluated by objective response (≥20% erythema reduction) at 48-72 h after initiation of study drug, investigator subjective assessment of outcome and microbiological responses. Clinical Trials Registration: NCT01811732. EudraCT number: 2012-001767-71. In the ITT analysis set, the objective response was 78.2% in the delafloxacin arm and 80.9% in the vancomycin/aztreonam arm (mean treatment difference, -2.6%; 95% CI, -8.78% to 3.57%). Investigator-assessed cure was similar between the two groups at follow-up (52.0% versus 50.5%) and late follow-up (70.4% versus 66.6%). Bacterial eradication of MRSA was 100% and 98.5% in the delafloxacin group and the vancomycin/aztreonam group, respectively. Frequency of treatment-emergent adverse events in the delafloxacin and vancomycin/aztreonam groups was similar. Treatment-emergent adverse events leading to study drug discontinuation were higher in the vancomycin/aztreonam group compared with the delafloxacin group (4.3% versus 0.9%). Delafloxacin, an anionic fluoroquinolone, was statistically non-inferior to vancomycin/aztreonam at 48-72 h following the start of therapy and was well tolerated as monotherapy in the treatment of acute bacterial skin and skin structure infections. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy.

Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study

PubMed Central

Pullman, J; Gardovskis, J; Farley, B; Sun, E; Quintas, M; Lawrence, L; Ling, R; Cammarata, S

2017-01-01

Abstract Background Delafloxacin is an investigational anionic fluoroquinolone in development for oral or intravenous administration for the treatment of infections caused by Gram-positive (including MRSA), Gram-negative, atypical and anaerobic organisms. Objectives To establish the non-inferiority of delafloxacin compared with vancomycin plus aztreonam for the treatment of acute bacterial skin and skin structure infections and to compare the safety of the two antimicrobials. Patients and methods A Phase 3, multicentre, randomized, double-blind, active-controlled study with 660 patients compared delafloxacin 300 mg or vancomycin 15 mg/kg plus aztreonam 2 g each administered twice daily intravenously for 5–14 days. Non-inferiority was evaluated by objective response (≥20% erythema reduction) at 48–72 h after initiation of study drug, investigator subjective assessment of outcome and microbiological responses. Clinical Trials Registration: NCT01811732. EudraCT number: 2012-001767-71. Results In the ITT analysis set, the objective response was 78.2% in the delafloxacin arm and 80.9% in the vancomycin/aztreonam arm (mean treatment difference, −2.6%; 95% CI, −8.78% to 3.57%). Investigator-assessed cure was similar between the two groups at follow-up (52.0% versus 50.5%) and late follow-up (70.4% versus 66.6%). Bacterial eradication of MRSA was 100% and 98.5% in the delafloxacin group and the vancomycin/aztreonam group, respectively. Frequency of treatment-emergent adverse events in the delafloxacin and vancomycin/aztreonam groups was similar. Treatment-emergent adverse events leading to study drug discontinuation were higher in the vancomycin/aztreonam group compared with the delafloxacin group (4.3% versus 0.9%). Conclusions Delafloxacin, an anionic fluoroquinolone, was statistically non-inferior to vancomycin/aztreonam at 48–72 h following the start of therapy and was well tolerated as monotherapy in the treatment of acute bacterial skin and skin structure infections. PMID:29029278

One-year outcomes of a randomized controlled trial of housing first with ACT in five Canadian cities.

PubMed

Aubry, Tim; Tsemberis, Sam; Adair, Carol E; Veldhuizen, Scott; Streiner, David; Latimer, Eric; Sareen, Jitender; Patterson, Michelle; McGarvey, Kathleen; Kopp, Brianna; Hume, Catharine; Goering, Paula

2015-05-01

Housing First is a groundbreaking approach to ending chronic homelessness among people with mental illness. This article presents one-year findings from a multisite randomized controlled trial (RCT) comparing Housing First with treatment as usual. The study was a nonblind, parallel-group RCT conducted in five Canadian cities. A sample of 950 high-need participants with severe mental illness, who were either absolutely homeless or precariously housed, was randomly assigned to Housing First (N=469) or treatment as usual (N=481). Housing First participants received a rent supplement, assistance to find housing, and assertive community treatment. Treatment-as-usual participants had access to all other existing programs. At one-year follow-up, 73% of Housing First participants and 31% of treatment-as-usual participants resided in stable housing (p<.001, odds ratio=6.35, covariate adjusted difference=42%, 95% confidence interval [CI]=36%-48%). Improvement in overall quality of life was significantly greater among Housing First participants compared with treatment-as-usual participants (p<.001, d=.31, CI=.16-.46). Housing First participants also showed greater improvements in community functioning compared with treatment-as-usual participants (p=.003, d=.25, CI=.09-.41). Compared with treatment as usual, Housing First produced greater improvements in housing stability, quality of life, and community functioning after one year of enrollment. The study provides support for adopting Housing First as an approach for ending chronic homelessness among persons with severe mental illness, even if they are actively symptomatic or using substances.

Feasibility of a computerized intervention for offenders with substance use disorders: a research note.

PubMed

Chaple, Michael; Sacks, Stanley; McKendrick, Karen; Marsch, Lisa A; Belenko, Steven; Leukefeld, Carl; Prendergast, Michael; French, Michael

2014-01-01

Despite evidence that treatment is effective in reducing recidivism among inmates with substance use problems, scarce resources mean that few of those in need of treatment actually receive it. Computerized substance abuse interventions could be used to expand access to treatment in prisons without placing an undue burden on resources. The major aim of the study was to compare treatment conditions in terms of their service utilization, skills acquisition, and treatment satisfaction. The study recruited men and women with substance use disorders from 10 prisons in 4 states. In an open label clinical trial, 494 subjects were randomly assigned either to the Experimental condition, a computerized drug treatment intervention, the Therapeutic Education System (TES; n  = 249), or to the Control condition, Standard Care ( n  = 245). Chi-square tests compared groups on categorical variables and independent samples t tests were used for interval level continuous variables. Initial evidence demonstrated: (1) comparable group rates of session attendance and high rates of TES module completion for experimental subjects; (2) comparable group gains in the development of coping skills; and (3) a more favorable view of TES than of Standard Care . Collectively, these results show that a computerized intervention, such as TES, can be implemented successfully in prison. Given the barriers to the delivery of substance abuse treatment typically encountered in correctional settings, computerized interventions have the potential to fill a significant treatment gap and are particularly well suited to inmates with mild to moderate substance use disorders who often are not treated.

Evaluation of plasma C-reactive protein levels in pregnant women with and without periodontal disease: A comparative study.

PubMed

Sharma, Anupriya; Ramesh, Amitha; Thomas, Biju

2009-09-01

Circulating C-reactive protein (CRP) levels are a marker of systemic inflammation and are associated with periodontal disease, a chronic bacterial infection associated with elevation of proinflammatory cytokines and prostaglandins. CRP has been associated with adverse pregnancy outcomes, including preterm delivery, preeclampsia, and intrauterine growth restriction. Furthermore, periodontal disease has been associated with increased risk of preterm low birth weight, low birth weight, and preterm birth. The present study was conducted to assess plasma CRP levels in pregnant women with and without periodontal disease; to evaluate the effect of periodontal therapy on the incidence of preterm delivery; and to compare the incidence of preterm delivery in pregnant women with and without periodontal disease. A total of 90 pregnant women aged between 18-35 years with gestational age between 12-28 weeks were recruited and divided into three equal groups (control group, study group, treatment group) of 30 each. Blood samples were taken for estimation of C-reactive protein levels from all groups at 12-20 weeks of gestation, determined using ultrasensitive turbidimetric immunoassay (QUANTIA-CRP US). The treatment group comprised plaque control, scaling, and root planning and daily rinsing with 0.2% chlorhexidine mouth before 28 weeks of gestation. The mean value of C-reactive protein levels in subjects with periodontal disease was higher compared to control group i.e., 1.20 +/- 0.247 mg/dl and 1.22 +/- 0.250 mg/dl, respectively, compared to 0.713 +/- 0.139 mg/ dl (P = 0.001). The mean value of CRP levels before treatment was greater than the mean value after treatment i.e., 1.22 +/- 0.25 compared to 0.84 +/- 0.189 (P < 0.001). The incidence of preterm delivery (< 37 weeks) was 31.7% in the periodontal disease group (study group) compared to 8.3% in the control group (P = 0.001). The incidence of preterm delivery in the treatment group was 15.0% compared to 31.7% in the nontreatment group (study group). The findings from the study suggest that periodontal disease in pregnant women is associated with increased C- reactive protein levels in early pregnancy, incidence of preterm delivery is higher in pregnant women with periodontal disease compared to healthy controls, periodontal therapy during pregnancy reduces plasma CRP levels and there is decrease in incidence of preterm delivery after periodontal therapy.

Current role of cryotherapy in retinopathy of prematurity: a report by the American Academy of Ophthalmology.

PubMed

Simpson, Jennifer L; Melia, Michele; Yang, Michael B; Buffenn, Angela N; Chiang, Michael F; Lambert, Scott R

2012-04-01

To evaluate the role of cryotherapy in the current treatment of retinopathy of prematurity (ROP). Literature searches of PubMed and the Cochrane Library were conducted on December 2, 2009, for articles published after 1984. The searches included all languages and retrieved 187 relevant citations. Thirteen articles were deemed relevant to the assessment question and were rated according to the strength of evidence. Four articles reported results from 2 large multicenter randomized clinical trials, and the remaining 9 articles reported results of 3 small randomized trials that directly compared cryotherapy and laser. Neither of the multicenter randomized clinical trials was a direct comparison of cryotherapy with laser. These studies were used to evaluate the comparative trials based on treatment criteria, study populations, and clinical results. Higher percentages of poor structural and functional outcomes generally were seen in eyes treated with cryotherapy compared with eyes undergoing laser treatment. Higher rates of systemic complications and myopia also were identified after treatment with cryotherapy. Despite a relative paucity of level I evidence directly comparing cryotherapy and laser treatment for threshold ROP, the literature suggests that neonatal facilities should gain access to laser technology and laser-trained ophthalmic staff to achieve better outcomes for treatment of the disease. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

TREATMENT OF LANDFILL LEACHATE BY COUPLING COAGULATION-FLOCCULATION OR OZONATION TO GRANULAR ACTIVATED CARBON ADSORPTION.

PubMed

Oloibiri, Violet; Ufomba, Innocent; Chys, Michael; Audenaert, Wim; Demeestere, Kristof; Van Hulle, Stijn W H

2015-01-01

A major concern for landfilling facilities is the treatment of their leachate. To optimize organic matter removal from this leachate, the combination of two or more techniques is preferred in order to meet stringent effluent standards. In our study, coagulation-flocculation and ozonation are compared as pre- treatment steps for stabilized landfill leachate prior to granular activated carbon (GAC) adsorption. The efficiency of the pre treatment techniques is evaluated using COD and UVA254 measurements. For coagulation- flocculation, different chemicals are compared and optimal dosages are determined. After this, iron (III) chloride is selected for subsequent adsorption studies due to its high percentage of COD and UVA254 removal and good sludge settle-ability. Our finding show that ozonation as a single treatment is effective in reducing COD in landfill leachate by 66% compared to coagulation flocculation (33%). Meanwhile, coagulation performs better in UVA254 reduction than ozonation. Subsequent GAC adsorption of ozonated effluent, coagulated effluent and untreated leachate resulted in 77%, 53% and 8% total COD removal respectively (after 6 bed volumes). The effect of the pre-treatment techniques on GAC adsorption properties is evaluated experimentally and mathematically using Thomas and Yoon-Nelson models. Mathematical modelling of the experimental GAC adsorption data shows that ozonation increases the adsorption capacity and break through time with a factor of 2.5 compared to coagulation-flocculation.

Comparative study of clozapine, electroshock and the combination of ECT with clozapine in treatment-resistant schizophrenic patients.

PubMed

Masoudzadeh, A; Khalilian, A R

2007-12-01

The aim of this study was to compare the results of treatment with clozapine alone, Electroshock (ECT) alone and the combination of clozapine with ECT in treatment-resistant schizophrenic patients. Eighteen treatment-resistant schizophrenic patients were assigned to three equal groups: one group was given clozapine; one group was treated with ECT and one group was treated with the combination of clozapine and ECT. The treatment response was evaluated using the PANSS criteria and the data were analyzed with ANOVA. Combination therapy was superior to single modality therapy. The reduction of PANSS scores was 46% in the clozapine group, 40% in the ECT groups and 71% in the combination group, the difference between the combination group and the other groups was statistically significant (p < 0.05). Patients had a quick response to combination treatment, which resulted in a higher cure rate of positive and negative symptoms and improved the patients general performance. There were no significant adverse effects with combination treatment. Combination treatment with clozapine and ECT was safe and effective in treatment-resistant schizophrenic patients. It should be considered for the treatment of treatment-resistant schizophrenic patients.

Autologous whole blood versus corticosteroid local injection in treatment of plantar fasciitis: A randomized, controlled multicenter clinical trial.

PubMed

Karimzadeh, Afshin; Raeissadat, Seyed Ahmad; Erfani Fam, Saleh; Sedighipour, Leyla; Babaei-Ghazani, Arash

2017-03-01

Plantar fasciitis is the most common cause of heel pain. Local injection modalities are among treatment options in patients with resistant pain. The aim of the present study was to evaluate the effect of local autologous whole blood compared with corticosteroid local injection in treatment of plantar fasciitis. In this randomized controlled multicenter study, 36 patients with chronic plantar fasciitis were recruited. Patients were allocated randomly into three treatment groups: local autologous blood, local corticosteroid injection, and control groups receiving no injection. Patients were assessed with visual analog scale (VAS), pressure pain threshold (PPT), and plantar fasciitis pain/disability scale (PFPS) before treatment, as well as 4 and 12 weeks post therapy. Variables of pain and function improved significantly in both corticosteroid and autologous blood groups compared to control group. At 4 weeks following treatment, patients in corticosteroid group had significantly lower levels of pain than patients in autologous blood and control groups (higher PPT level, lower PFPS, and VAS). After 12 weeks of treatment, both corticosteroid and autologous blood groups had lower average levels of pain than control group. The corticosteroid group showed an early sharp and then more gradual improvement in pain scores, but autologous blood group had a steady gradual drop in pain. Autologous whole blood and corticosteroid local injection can both be considered as effective methods in the treatment of chronic plantar fasciitis. These treatments decrease pain and significantly improve function compared to no treatment.

Does decentralisation of tuberculosis care influence treatment outcomes? The case of Oromia Region, Ethiopia

PubMed Central

Raya, J.; Workineh, T.; Klinkenberg, E.; Enquselassie, F.

2014-01-01

Setting: Oromia Region, Ethiopia. Objective: To investigate the effect of decentralised care on anti-tuberculosis treatment outcomes and identify factors affecting outcome among new smear-positive tuberculosis (TB) patients. Design: This was a retrospective cohort study comparing patients treated in the community during the continuation phase with those managed throughout treatment in health facilities. Data were collected from TB registers and patient cards using a pre-tested data capture form. Results: Of the 2226 new smear-positive TB patients registered from July 2010 to June 2012 who were included in the study, 1599 (72.6%) received treatment in health facilities, and the rest in the community. Overall treatment success was 94.7%. Patients treated in the community had comparable treatment success with those managed in health facilities (aOR 1.7, 95%CI 0.80–3.57). Missing doses (OR 0.22, 95%CI 0.08–0.55), supervision during the continuation phase (OR 2.6, 95%CI 1.34–5.05), positive sputum at month 2 (OR 0.07, 95%CI 0.04–0.13) and human immunodeficiency virus infection (OR 0.25, 95%CI 0.13–0.46) were independent predictors of treatment success. Conclusion: Overall treatment success is high in new smear-positive TB patients in Oromia. Patients receiving treatment in the community during the continuation phase have treatment success comparable with that of patients managed in health facilities. PMID:26478507

Using mixed treatment comparisons and meta-regression to perform indirect comparisons to estimate the efficacy of biologic treatments in rheumatoid arthritis.

PubMed

Nixon, R M; Bansback, N; Brennan, A

2007-03-15

Mixed treatment comparison (MTC) is a generalization of meta-analysis. Instead of the same treatment for a disease being tested in a number of studies, a number of different interventions are considered. Meta-regression is also a generalization of meta-analysis where an attempt is made to explain the heterogeneity between the treatment effects in the studies by regressing on study-level covariables. Our focus is where there are several different treatments considered in a number of randomized controlled trials in a specific disease, the same treatment can be applied in several arms within a study, and where differences in efficacy can be explained by differences in the study settings. We develop methods for simultaneously comparing several treatments and adjusting for study-level covariables by combining ideas from MTC and meta-regression. We use a case study from rheumatoid arthritis. We identified relevant trials of biologic verses standard therapy or placebo and extracted the doses, comparators and patient baseline characteristics. Efficacy is measured using the log odds ratio of achieving six-month ACR50 responder status. A random-effects meta-regression model is fitted which adjusts the log odds ratio for study-level prognostic factors. A different random-effect distribution on the log odds ratios is allowed for each different treatment. The odds ratio is found as a function of the prognostic factors for each treatment. The apparent differences in the randomized trials between tumour necrosis factor alpha (TNF- alpha) antagonists are explained by differences in prognostic factors and the analysis suggests that these drugs as a class are not different from each other. Copyright (c) 2006 John Wiley & Sons, Ltd.

Can we predict the outcome for people with patellofemoral pain? A systematic review on prognostic factors and treatment effect modifiers.

PubMed

Matthews, M; Rathleff, M S; Claus, A; McPoil, T; Nee, R; Crossley, K; Vicenzino, B

2017-12-01

Patellofemoral pain (PFP) is a multifactorial and often persistent knee condition. One strategy to enhance patient outcomes is using clinically assessable patient characteristics to predict the outcome and match a specific treatment to an individual. A systematic review was conducted to determine which baseline patient characteristics were (1) associated with patient outcome (prognosis); or (2) modified patient outcome from a specific treatment (treatment effect modifiers). 6 electronic databases were searched (July 2016) for studies evaluating the association between those with PFP, their characteristics and outcome. All studies were appraised using the Epidemiological Appraisal Instrument. Studies that aimed to identify treatment effect modifiers underwent a checklist for methodological quality. The 24 included studies evaluated 180 participant characteristics. 12 studies investigated prognosis, and 12 studies investigated potential treatment effect modifiers. Important methodological limitations were identified. Some prognostic studies used a retrospective design. Studies aiming to identify treatment effect modifiers often analysed too many variables for the limiting sample size and typically failed to use a control or comparator treatment group. 16 factors were reported to be associated with a poor outcome, with longer duration of symptoms the most reported (>4 months). Preliminary evidence suggests increased midfoot mobility may predict those who have a successful outcome to foot orthoses. Current evidence can identify those with increased risk of a poor outcome, but methodological limitations make it difficult to predict the outcome after one specific treatment compared with another. Adequately designed randomised trials are needed to identify treatment effect modifiers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

PubMed

Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

2015-09-01

Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with lateral epicondylitis, a combination injection of HA + CS may offer better pain benefits for 6 months after injection, when compared to triamcinolone. Level II, Randomized Clinical Trial, Prospective Comparative Study.

A regulator's view of comparative effectiveness research.

PubMed

Temple, Robert

2012-02-01

'Comparative effectiveness' is the current enthusiasm, and for good reason. After knowing a treatment works, the most critical question is how it compares with alternatives. Comparative studies are not commonly conducted by drug companies and they represent a significant methodological challenge. Comparative data could include evidence of overall superiority to an alternative or advantages in identifiable subsets, for example, people who do not respond to or tolerate alternatives, or members of a genetic subset and could also include convincing evidence that there is little difference between two treatments. To describe regulations, guidance, and Food and Drug Administration experience related to studies of comparative effectiveness, including approaches to showing superiority and problems encountered in showing similarity. Review of Food and Drug Administration regulations and guidance and experience with showing superiority and similarity, particularly related to randomized trials and epidemiologic studies. Methods exist, and they have been successful for showing overall superiority of one drug over another, advantages in specific population subsets. Efforts to show true equivalence face problems of definition and very large sample sizes needed to rule out small differences. There is need for further discussion of what is meant by similarity or equivalence of two treatments. Comparative studies are challenging because differences between effective therapies are likely to be small and can be detected reliably only in randomized trials, often large ones. Despite the difficulties, comparative trials have been successful and we clearly would like to see more of them.

Dysthymia in a cross-cultural perspective.

PubMed

Gureje, Oye

2011-01-01

Dysthymia is a relatively less-studied condition within the spectrum of depressive disorders. New and important information about its status has emerged in recent scientific literature. This review highlights some of the findings of that literature. Even though studies addressing the cross-cultural validity of dysthymia are being awaited, results of studies using comparable ascertainment procedures suggest that the lifetime and 12-month estimates of the condition may be higher in high-income than in low and middle-income countries. However, the disorder is associated with elevated risks of suicidal outcomes and comparable levels of disability whereever it occurs. Dysthymia commonly carries a worse prognosis than major depressive disorder and comparable or worse clinical outcome than other forms of chronic depression. Whereas there is some evidence that psychotherapy may be less effective than pharmacotherapy in the treatment of dysthymia, the best treatment approach is one that combines both forms of treatment. Dysthymia is a condition of considerable public health importance. Our current understanding suggests that it should receive more clinical and research attention. Specifically, the development of better treatment approaches, especially those that can be implemented in diverse populations, deserves research attention.

Healing of the Acutely Injured Anterior Cruciate Ligament: Functional Treatment with the ACL-Jack, a Dynamic Posterior Drawer Brace

PubMed Central

Reischl, Nikolaus; Rönn, Karolin; Magnusson, Robert A.; Gautier, Emanuel; Jakob, Roland P.

2016-01-01

Background. The injured anterior cruciate ligament (ACL) has a limited healing capacity leading to persisting instability. Hypothesis/Purpose. To study if the application of a brace, producing a dynamic posterior drawer force, after acute ACL injury reduces initial instability. Study Design. Cohort study. Methods. Patients treated with the ACL-Jack brace were compared to controls treated with primary ACL reconstruction und controls treated nonsurgically with functional rehabilitation. Measurements included anterior laxity (Rolimeter), clinical scores (Lysholm, Tegner, and IKDC), and MRI evaluation. Patients were followed up to 24 months. Results. Patients treated with the ACL-Jack brace showed a significant improvement of anterior knee laxity comparable to patients treated with ACL reconstruction, whereas laxity persisted after nonsurgical functional rehabilitation. The failure risk (secondary reconstruction necessary) of the ACL-Jack group was however 21% (18 of 86) within 24 months. Clinical scores were similar in all treatment groups. Conclusion. Treatment of acute ACL tears with the ACL-Jack brace leads to improved anterior knee laxity compared to nonsurgical treatment with functional rehabilitation. PMID:28053787

Relative benefit-risk comparing diclofenac to other traditional non-steroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors in patients with osteoarthritis or rheumatoid arthritis: a network meta-analysis.

PubMed

van Walsem, Anneloes; Pandhi, Shaloo; Nixon, Richard M; Guyot, Patricia; Karabis, Andreas; Moore, R Andrew

2015-03-19

There is argument over the benefits and risks of drugs for treating chronic musculoskeletal pain. This study compared the efficacy, safety, and tolerability of diclofenac, ibuprofen, naproxen, celecoxib, and etoricoxib for patients with pain caused by osteoarthritis (OA) or rheumatoid arthritis (RA). A systematic literature review used Medline and EMBASE to identify randomised controlled trials. Efficacy outcomes assessed included: pain relief measured by visual analogue scale (VAS); Western Ontario McMaster Universities Arthritis Index (WOMAC) VAS or WOMAC Likert scale; physical functioning measured by WOMAC VAS or Likert scale; and patient global assessment (PGA) of disease severity measured on VAS or 5-point Likert scale. Safety outcomes included: Antiplatelet Trialists' Collaboration (APTC), major cardiovascular (CV) and major upper gastrointestinal (GI) events, and withdrawals. Data for each outcome were synthesized by a Bayesian network meta-analysis (NMA). For efficacy assessments, labelled doses for OA treatment were used for the base case while labelled doses for RA treatment were also included in the sensitivity analysis. Pooled data across dose ranges were used for safety. Efficacy, safety, and tolerability data were found for 146,524 patients in 176 studies included in the NMA. Diclofenac (150 mg/day) was likely to be more effective in alleviating pain than celecoxib (200 mg/day), naproxen (1000 mg/day), and ibuprofen (2400 mg/day), and similar to etoricoxib (60 mg/day); a lower dose of diclofenac (100 mg/day) was comparable to all other treatments in alleviating pain. Improved physical function with diclofenac (100 and 150 mg/day) was mostly comparable to all other treatments. PGA with diclofenac (100 and 150 mg/day) was likely to be more effective or comparable to all other treatments. All active treatments were similar for APTC and major CV events. Major upper GI events with diclofenac were lower compared to naproxen and ibuprofen, comparable to celecoxib, and higher than etoricoxib. Risk of withdrawal with diclofenac was lower compared to ibuprofen, similar to celecoxib and naproxen, and higher than etoricoxib. The benefit-risk profile of diclofenac was comparable to other treatments used for pain relief in OA and RA; benefits and risks vary in individuals and need consideration when making treatment decisions.

Cost-effectiveness analysis of gemcitabine, S-1 and gemcitabine plus S-1 for treatment of advanced pancreatic cancer based on GEST study.

PubMed

Zhou, Jing; Zhao, Rongce; Wen, Feng; Zhang, Pengfei; Tang, Ruilei; Du, Zedong; He, Xiaofeng; Zhang, Jian; Li, Qiu

2015-04-01

Gemcitabine (GEM) alone, S-1 alone and gemcitabine plus S-1 (GS) have shown a marginal clinical benefit for the treatment of advanced pancreatic cancer. However, there is no clearly defined optimal cost-effectiveness treatment. The objective of this study was to assess the cost-effectiveness of GEM alone, S-1 alone and GS for the treatment of advanced pancreatic cancer based on GEST study for public payers. A decision model compared GEM alone, S-1 alone and GS. Primary base case data were identified using the GEST study and the literatures. Costs were estimated from West China Hospital, Sichuan University, China, and incremental cost-effectiveness ratios (ICERs) were calculated. Survival benefits were reported in quality-adjusted life-months (QALMs). Sensitive analyses were performed by varying potentially modifiable parameters of the model. The base case analysis showed that the GEM cost $21,912 and yielded survival of 6.93 QALMs, S-1 cost $19,371 and yielded survival of 7.90 QALMs and GS cost $22,943 and yielded survival of 7.46 QALMs in the entire treatment. The one-way sensitivity analyses showed that the ICER of S-1 was driven mostly by the S-1 group utility score of stable state compared with GEM, and the GEM group utility score of progressed state played a key role on the ICER of GS compared with GEM. S-1 represents an attractive cost-effective treatment for advanced pancreatic cancer, given the favorable cost per QALM and improvement in clinical efficacy, especially the limited available treatment options.

Missing Data in Alcohol Clinical Trials with Binary Outcomes

PubMed Central

Hallgren, Kevin A.; Witkiewitz, Katie; Kranzler, Henry R.; Falk, Daniel E.; Litten, Raye Z.; O’Malley, Stephanie S.; Anton, Raymond F.

2017-01-01

Background Missing data are common in alcohol clinical trials for both continuous and binary endpoints. Approaches to handle missing data have been explored for continuous outcomes, yet no studies have compared missing data approaches for binary outcomes (e.g., abstinence, no heavy drinking days). The present study compares approaches to modeling binary outcomes with missing data in the COMBINE study. Method We included participants in the COMBINE Study who had complete drinking data during treatment and who were assigned to active medication or placebo conditions (N=1146). Using simulation methods, missing data were introduced under common scenarios with varying sample sizes and amounts of missing data. Logistic regression was used to estimate the effect of naltrexone (vs. placebo) in predicting any drinking and any heavy drinking outcomes at the end of treatment using four analytic approaches: complete case analysis (CCA), last observation carried forward (LOCF), the worst-case scenario of missing equals any drinking or heavy drinking (WCS), and multiple imputation (MI). In separate analyses, these approaches were compared when drinking data were manually deleted for those participants who discontinued treatment but continued to provide drinking data. Results WCS produced the greatest amount of bias in treatment effect estimates. MI usually yielded less biased estimates than WCS and CCA in the simulated data, and performed considerably better than LOCF when estimating treatment effects among individuals who discontinued treatment. Conclusions Missing data can introduce bias in treatment effect estimates in alcohol clinical trials. Researchers should utilize modern missing data methods, including MI, and avoid WCS and CCA when analyzing binary alcohol clinical trial outcomes. PMID:27254113

Missing Data in Alcohol Clinical Trials with Binary Outcomes.

PubMed

Hallgren, Kevin A; Witkiewitz, Katie; Kranzler, Henry R; Falk, Daniel E; Litten, Raye Z; O'Malley, Stephanie S; Anton, Raymond F

2016-07-01

Missing data are common in alcohol clinical trials for both continuous and binary end points. Approaches to handle missing data have been explored for continuous outcomes, yet no studies have compared missing data approaches for binary outcomes (e.g., abstinence, no heavy drinking days). This study compares approaches to modeling binary outcomes with missing data in the COMBINE study. We included participants in the COMBINE study who had complete drinking data during treatment and who were assigned to active medication or placebo conditions (N = 1,146). Using simulation methods, missing data were introduced under common scenarios with varying sample sizes and amounts of missing data. Logistic regression was used to estimate the effect of naltrexone (vs. placebo) in predicting any drinking and any heavy drinking outcomes at the end of treatment using 4 analytic approaches: complete case analysis (CCA), last observation carried forward (LOCF), the worst case scenario (WCS) of missing equals any drinking or heavy drinking, and multiple imputation (MI). In separate analyses, these approaches were compared when drinking data were manually deleted for those participants who discontinued treatment but continued to provide drinking data. WCS produced the greatest amount of bias in treatment effect estimates. MI usually yielded less biased estimates than WCS and CCA in the simulated data and performed considerably better than LOCF when estimating treatment effects among individuals who discontinued treatment. Missing data can introduce bias in treatment effect estimates in alcohol clinical trials. Researchers should utilize modern missing data methods, including MI, and avoid WCS and CCA when analyzing binary alcohol clinical trial outcomes. Copyright © 2016 by the Research Society on Alcoholism.

Beneficial effects of growth hormone treatment on cognition in children with Prader-Willi syndrome: a randomized controlled trial and longitudinal study.

PubMed

Siemensma, Elbrich P C; Tummers-de Lind van Wijngaarden, Roderick F A; Festen, Dederieke A M; Troeman, Zyrhea C E; van Alfen-van der Velden, A A E M Janielle; Otten, Barto J; Rotteveel, Joost; Odink, Roelof J H; Bindels-de Heus, G C B Karen; van Leeuwen, Mariette; Haring, Danny A J P; Oostdijk, Wilma; Bocca, Gianni; Mieke Houdijk, E C A; van Trotsenburg, A S Paul; Hoorweg-Nijman, J J Gera; van Wieringen, Hester; Vreuls, René C F M; Jira, Petr E; Schroor, Eelco J; van Pinxteren-Nagler, Evelyn; Willem Pilon, Jan; Lunshof, L Bert; Hokken-Koelega, Anita C S

2012-07-01

Knowledge about the effects of GH treatment on cognitive functioning in children with Prader-Willi syndrome (PWS) is limited. Fifty prepubertal children aged 3.5 to 14 yr were studied in a randomized controlled GH trial during 2 yr, followed by a longitudinal study during 4 yr of GH treatment. Cognitive functioning was measured biennially by short forms of the WPPSI-R or WISC-R, depending on age. Total IQ (TIQ) score was estimated based on two subtest scores. During the randomized controlled trial, mean sd scores of all subtests and mean TIQ score remained similar compared to baseline in GH-treated children with PWS, whereas in untreated controls mean subtest sd scores and mean TIQ score decreased and became lower compared to baseline. This decline was significant for the Similarities (P = 0.04) and Vocabulary (P = 0.03) subtests. After 4 yr of GH treatment, mean sd scores on the Similarities and Block design subtests were significantly higher than at baseline (P = 0.01 and P = 0.03, respectively), and scores on Vocabulary and TIQ remained similar compared to baseline. At baseline, children with a maternal uniparental disomy had a significantly lower score on the Block design subtest (P = 0.01) but a larger increment on this subtest during 4 yr of GH treatment than children with a deletion. Lower baseline scores correlated significantly with higher increases in Similarities (P = 0.04) and Block design (P < 0.0001) sd scores. Our study shows that GH treatment prevents deterioration of certain cognitive skills in children with PWS on the short term and significantly improves abstract reasoning and visuospatial skills during 4 yr of GH treatment. Furthermore, children with a greater deficit had more benefit from GH treatment.

Health economic analyses of psoriasis management: a systematic literature search.

PubMed

Gutknecht, Mandy; Krensel, Magdalene; Augustin, Matthias

2016-11-01

In the course of the chronic skin disease psoriasis, where a variety of treatment interventions is available, a strong growth of health economic studies comparing treatment costs and benefits can be noticed. The objective was to identify health economic evaluations of psoriasis treatments that have been published to date. Of particular interest were the mostly used analysis and outcome parameters, the compared treatments, and the question, if available health economic studies may be used to perform a meta-analysis of qualitative findings. A systematic literature search using PubMed Medline, Ovid Medline, and Cochrane Library was performed for articles, published and available until mid of January 2016. Among the key words were the terms "psoriasis" and "cost-effectiveness". The search resulted in 318 articles without duplicates. Thereof 60 health economic analyses in psoriasis management were identified. Most of these are cost-effectiveness evaluations (45). The clinical parameter PASI (Psoriasis Area Severity Index) is the most often used cost-effectiveness outcome (33) followed by the Dermatology Life Quality Index (DLQI) (6). In case of cost-utility analyses, QALYs (quality-adjusted life-years) were mostly generated with the help of EuroQol five dimensions questionnaire (EQ-5D) (12), which was partly based on PASI and DLQI values. The majority of health economic studies is focusing on the direct medical and non-medical costs without consideration of productivity losses. Almost 70 % of 60 publications were conducted in Europe. Overall, most considered systemic treatments were the biological agents etanercept (36), adalimumab (27), and infliximab (26) followed by ustekinumab (17) and phototherapy (incl. UV-B, PUVA/psoralen combined with UV-A) (14). Comparisons including only topical treatments mostly focused on vitamin D treatment (14), corticosteroids (13), and coal tar products (6) followed by dithranol (5) and tazarotene (4). Given the setting, compared treatments, and study conditions, different results can be found for medical decision-making. Thereby, it can be noted that there are no standards on methods and outcomes measures available. This leads to a very limited comparability of health economic studies and presents no comfortable basis to examine a meta-analysis of health economic results. The presented systematic review shows the need for nationwide data and interpretation.

The TOPSHOCK study: Effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial

PubMed Central

2011-01-01

Background Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. Methods/design The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. Discussion The TOPSHOCK study is the first randomised controlled trial that directly compares the effectiveness of focused shockwave therapy and radial shockwave therapy, both in combination with eccentric decline squat training, for treating patellar tendinopathy. Trial registration Trial registration number NTR2774. PMID:21989041

CHoosing Options for Insomnia in Cancer Effectively (CHOICE): Design of a patient centered comparative effectiveness trial of acupuncture and cognitive behavior therapy for insomnia.

PubMed

Garland, Sheila N; Gehrman, Philip; Barg, Frances K; Xie, Sharon X; Mao, Jun J

2016-03-01

Insomnia is a prevalent and persistent side effect of cancer, which if left unaddressed, can be unremitting and negatively influence physical and mental well-being. Acupuncture and Cognitive Behavioral Therapy (CBT) are commonly used non-pharmacological treatments that are efficacious for treating insomnia in cancer patients; however, little is known about the comparative effectiveness of these options. The goal of personalized medicine is to determine which treatments are most effective for which individuals, and patient preference for treatment is a particularly important contributor to adherence and outcomes. Here we describe the design of a clinical trial that begins to determine how best to personalize the treatment of insomnia for cancer survivors. This project is a randomized controlled comparative effectiveness trial with a nested qualitative study comparing acupuncture and CBT for insomnia and co-morbid symptoms in a heterogeneous sample of 160 cancer survivors. The primary aim is to determine which treatment is associated with the largest reduction in insomnia severity. The secondary aim is to examine the demographic, clinical, and psychological characteristics that predict and/or moderate treatment effect. Patients will receive ten treatments of acupuncture or 7 sessions of CBT over eight weeks and complete validated patient-reported outcome measures of sleep and co-morbid symptoms at baseline, mid-treatment, post-treatment, and at three-months to assess durability of effect. The results of the proposed study have the potential to improve healthcare outcomes by helping cancer survivors and their caregivers make informed and evidence-based decisions, leading to patient-centered and personalized care for cancer survivors with insomnia. Copyright © 2016 Elsevier Inc. All rights reserved.

Long-term pediatric skin eruption-related hospitalizations in offspring conceived via fertility treatment.

PubMed

Krieger, Yuval; Wainstock, Tamar; Sheiner, Eyal; Harlev, Avi; Landau, Daniella; Horev, Amir; Bogdanov-Berezovsky, Alexander; Walfisch, Asnat

2018-03-01

Although concerns have been raised regarding the long-term health risks of offspring conceived following fertility treatments, limited information is available regarding their health status beyond the neonatal period. We aimed to evaluate the risk of long-term eruptive dermatological morbidity among children born following fertility treatments as compared to those conceived spontaneously. A population-based cohort study was conducted, including all singleton deliveries occurring between the years 1991 and 2014 at a single tertiary medical center. Fetuses with congenital malformations and multiple gestations were excluded. Children delivered following fertility treatment pregnancies and spontaneous pregnancies were compared. Hospitalizations of the offspring up to the age of 18 years involving cutaneous eruptions were evaluated. A Kaplan-Meier survival curve was used to compare cumulative morbidity incidence and a Cox regression model to control for confounders. During the study period, 242,187 singleton deliveries met the inclusion criteria, 1.8% of which were following fertility treatments (n = 4324). Eruptive dermatological morbidity of the offspring up to the age of 18 years was significantly more common in the fertility treatment group (1.5%) as compared to spontaneous pregnancies (1.1%; P = 0.023). The Kaplan-Meier survival curve demonstrated a significantly higher cumulative incidence of eruptive dermatological morbidity following fertility treatments (log-rank P = 0.007). Using the Cox regression model, while controlling for multiple confounders, fertility treatment was noted as an independent risk factor for long-term pediatric eruptive dermatological morbidity (adjusted HR = 1.43, CI 1.12-1.83, P = 0.004). Singletons conceived via fertility treatments appear to be at an increased risk for long-term eruptive dermatological morbidity. © 2018 The International Society of Dermatology.

Drug treatment completion and post-discharge employment in the TOPPS-II Interstate Cooperative Study.

PubMed

Arria, Amelia M

2003-07-01

The objective of this study was to use administrative data to examine the effect of drug treatment completion on patients' subsequent employment and wages earned in the year following discharge, and to compare the consistency of these results across three states. Drug treatment and wage data from 20,495 drug treatment patients were used in this study. Treatment data were provided by the state substance abuse management information systems for Baltimore City, Washington State, and Oklahoma. Wage data were provided by the agency in each state responsible for collecting and reporting wage information. A quasi-experimental design was used to compare treatment completers and non-completers in the year after an index treatment episode. In addition, employment history in the year prior to the index episode was used to statistically adjust for group differences. The index episode of care may have included services under more than one treatment modality. The full social security number was used to link the drug treatment and wage administrative datasets. Treatment completers were 22% to 49% more likely than non-completers to be employed and to earn higher wages in the year following treatment, holding other variables constant. Patients staying in treatment longer than 90 days were 22% to 43% more likely to be employed in the year following treatment than those who stayed a shorter time. These findings were consistent across the three project states with different client populations, treatment delivery systems, and labor markets.

The anxiety of Taiwanese women with or without continuity treatment after previous in vitro fertilisation failure.

PubMed

Su, Tsann-Juu; Tzeng, Ya-Ling; Kuo, Pi-Chao

2011-08-01

To compare the anxiety levels of Taiwanese women who continued with in vitro fertilisation treatment and those who discontinued treatment post-in vitro fertilisation failure. In vitro fertilisation is perceived as the last resort of infertility treatment. The impact of unsuccessful in vitro fertilisation treatment on psychological function has been documented; however, research comparing the levels of anxiety of women who cease and those who continue in vitro fertilisation post-failure is scant. A cross-sectional comparative study design was used. Fifty-eight women in whom in vitro fertilisation had failed within the previous year were recruited to this study from a medical centre in northern Taiwan; 34 women continued treatment and 24 discontinued treatment. The State-Trait Anxiety Inventory was used to assess their levels of anxiety. Women in the group who continued treatment exhibited higher state and trait anxiety (TA) than women in the group who discontinued treatment (p < 0·005). The number and frequency of in vitro fertilisation cycles were significantly higher in the group who continued treatment than in those who did not. A strong positive correlation between state and TA (r = 0·8, p < 0·01) existed in both groups. Both groups exhibited considerable levels of anxiety; however, the women who continued in vitro fertilisation treatment had higher levels of anxiety than those who discontinued treatment. The level of anxiety of women who decide to continue in vitro fertilisation treatment should be assessed as early as possible and counselling services provided to women who experience in vitro fertilisation failure should concentrate more on relieving psychological distress. One year after discontinuing treatment, some women still experience considerable anxiety; therefore, the care and assistance provided to these women need to be continually evaluated. © 2011 Blackwell Publishing Ltd.

Comparison of the Efficacy, Side Effects, and Cost of Modafinil and Intranasal Mometasone Furoate in Obstructive Sleep Apnea-Hypopnea Syndrome: A Preliminary Clinical Study

PubMed Central

Zhang, Shujia; Duan, Zhongnin

2018-01-01

Background Obstructive sleep apnea-hypopnea syndrome (OSAHS) is characterized by repeated episodes of reduction in airflow due to the collapse of the upper airway during sleep. The aim of this study was to compare clinical outcome, side effects, and cost of treatment between modafinil and intranasal mometasone furoate in patients with OSAHS. Material/Methods Patients with OSAHS (N=250) were divided into two groups: the modafinil group (MG) (N=125) were treated with 100 mg modafinil twice a day; the intranasal mometasone furoate group (IMFG) (N=125) were treated with 100 μg of intranasal mometasone furoate in the evening. Quality of life, grading of OSAHS, plain-film radiography, the adenoidal-nasopharyngeal ratio (AN ratio), side effects, cost of treatment, and beneficial effects after discontinuation of treatment were evaluated for all patients. Results Duration of sleep apnea was significantly reduced in the IMFG compared with the MG (p=0.0145, q=9.262). Modafinil and intranasal mometasone furoate both had moderate effects on improvement of the OSAHS score. The IMFG showed a significantly greater beneficial effect on the AN ratio when compared with the MG (p=0.0001, q=6.584). No adverse events of treatment with modafinil and intranasal mometasone furoate were reported. Cost of treatment and beneficial effect after discontinuation were both significantly greater for the IMFG compared with the MG. Conclusions The findings of this preliminary clinical study were that for patients diagnosed with OSAHS, night-time treatment with intranasal mometasone furoate was more effective than modafinil. PMID:29749371

Correlation of diffusion tensor imaging parameters with neural status in Pott's spine.

PubMed

Jain, Nikhil; Saini, Namita Singh; Kumar, Sudhir; Rajagopalan, Mukunth; Chakraborti, Kanti Lal; Jain, Anil Kumar

2016-04-29

Diffusion tensor imaging (DTI) has been used in cervical trauma and spondylotic myelopathy, and it has been found to correlate with neural deficit and prognosticate neural recovery. Such a correlation has not been studied in Pott's spine with paraplegia. Hence, this prospective study has been used to find correlation of DTI parameters with neural deficit in these patients. Thirty-four patients of spinal TB were enrolled and DTI was performed before the start of treatment and after six months. Fractional anisotropy (FA), Mean diffusivity (MD), and Tractography were studied. Neurological deficit was graded by the Jain and Sinha scoring. Changes in FA and MD at and below the site of lesion (SOL) were compared to above the SOL (control) using the unpaired t-test. Pre-treatment and post-treatment values were also compared using the paired t-test. Correlation of DTI parameters with neurological score was done by Pearson's correlation. Subjective assessment of Tractography images was done. Mean average FA was not significantly decreased at the SOL in patients with paraplegia as compared to control. After six months of treatment, a significant decrease (p = 0.02) in mean average FA at the SOL compared to pre-treatment was seen. Moderate positive correlation (r = 0.49) between mean average FA and neural score after six months of treatment was found. Tractography images were not consistent with severity of paraplegia. Unlike spondylotic myelopathy and trauma, epidural collection and its organized inflammatory tissue in Pott's spine precludes accurate assessment of diffusion characteristics of the compressed cord.

Cigarette Smoking During Substance Use Disorder Treatment: Secondary Outcomes from a National Drug Abuse Treatment Clinical Trials Network study.

PubMed

McClure, Erin A; Campbell, Aimee N C; Pavlicova, Martina; Hu, Meichen; Winhusen, Theresa; Vandrey, Ryan G; Ruglass, Lesia M; Covey, Lirio S; Stitzer, Maxine L; Kyle, Tiffany L; Nunes, Edward V

2015-06-01

The majority of patients enrolled in treatment for substance use disorders (SUDs) also use tobacco. Many will continue to use tobacco even during abstinence from other drugs and alcohol, often leading to smoking-related illnesses. Despite this, little research has been conducted to assess the influence of being a smoker on SUD treatment outcomes and changes in smoking during a treatment episode. In this secondary analysis, cigarette smoking was evaluated in participants completing outpatient SUD treatment as part of a multi-site study conducted by the National Drug Abuse Treatment Clinical Trials Network. Analyses included the assessment of changes in smoking and nicotine dependence via the Fagerström Test for Nicotine Dependence during the 12-week study among all smokers (aim #1), specifically among those in the experimental treatment group (aim #2), and the moderating effect of being a smoker on treatment outcomes (aim #3). Participants generally did not reduce or quit smoking throughout the course of the study. Among a sub-set of participants with higher baseline nicotine dependence scores randomized to the control arm, scores at the end of treatment were lower compared to the experimental arm, though measures of smoking quantity did not appear to decrease. Further, being a smoker was associated with poorer treatment outcomes compared to non-smokers enrolled in the trial. This study provides evidence that patients enrolled in community-based SUD treatment continue to smoke, even when abstaining from drugs and alcohol. These results add to the growing literature encouraging the implementation of targeted, evidence-based interventions to promote abstinence from tobacco among SUD treatment patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Time-intensive cognitive behaviour therapy for obsessive-compulsive disorder: A case series and matched comparison group.

PubMed

Oldfield, Victoria B; Salkovskis, Paul M; Taylor, Tracey

2011-03-01

A time-intensive format may be both useful and effective for the delivery of cognitive behaviour therapy (CBT) for obsessive-compulsive disorder (OCD). Intensive treatments also offer a pragmatic alternative to in-patient admission for those in a geographically remote location. Published studies of intensive treatment include pioneering exposure-response prevention (ERP) trials that emphasized the requirement for high-intensity treatment; more recently several studies have used treatment protocols with a heavy emphasis on ERP. This study compares intensive versus standard weekly treatment format following the integrated formulation-driven CBT approach widely used in UK adult mental health settings. An analysis of patients undertaking intensive CBT using a matched comparison group of those who undertook weekly CBT for OCD. Twenty-two adult patients undertook intensive format treatment (matched with a weekly group for age, gender, and initial symptoms). A range of self-report measures were examined at the end of treatment and at a 3-month follow-up. Significant treatment effects were found on a range of self-report measures; both conditions were found to be equally effective at the end of treatment and at 3-month follow-up. Uncontrolled effect sizes show that the intensive treatment was comparable to other trials of CBT for OCD. An intensive treatment format for the delivery of CBT for OCD was found to be as effective as weekly treatment. This is consistent with the recommendations from the National Institute for Clinical Excellence guidelines. This study adds to the growing literature on the effectiveness of intensive format treatment. ©2010 The British Psychological Society.

The effectiveness of treatment for Severe Acute Malnutrition (SAM) delivered by community health workers compared to a traditional facility based model.

PubMed

Alvarez Morán, J L; Alé, G B Franck; Charle, P; Sessions, N; Doumbia, S; Guerrero, S

2018-03-27

In most health systems, Community Health Workers (CHWs) identify and screen for severe acute malnutrition (SAM) in the community. This study aimed to investigate the potential of integrating SAM identification and treatment delivered by CHWs, in order to improve the coverage of SAM treatment services. This multicentre, randomised intervention study was conducted in Kita, Southwest Mali between February 2015 and February 2016. Treatment for uncomplicated SAM was provided in health facilities in the control area, and by Community Health Workers and health facilities in the intervention area. Clinical outcomes (cure, death and defaulter ratios), treatment coverage and quality of care were examined in both the control and intervention group. Six hundred ninety nine children were admitted to the intervention group and 235 children to the control group. The intervention group reported cure ratios of 94.2% compared to 88.6% in the control group (risk ratio 1.07 [95% CI 1.01; 1.13]). Defaulter ratios were twice as high in the control group compared to the intervention group (10.8% vs 4.5%; RR 0.42 [95% CI 0.25; 0.71]). Differences in mortality ratios were not statistically significant (0.9% in the intervention group compared to 0.8% in the control group). Coverage rates in December 2015 were 86.7% in intervention group compared to 41.6% in the control (p < 0.0001). With minimal training, CHWs are able to appropriately treat SAM in the community. Allowing CHWs to treat SAM reduces defaulter ratios without compromising treatment outcomes and can lead to improved access to treatment. Retrospectively registered in ISRCTN Register with ISRCTN33578874 on March 7th 2018.

Acute pesticide poisoning outcomes: a nationwide study in Taiwan.

PubMed

Chen, Chieh-Fan; Lin, Hsing-Lin; Chou, Huei-Yin; Hsu, Wen-Chi; Shi, Hon-Yi

2015-03-01

This study presents the findings of a nationwide study of acute pesticide poisoning (APP) outcomes, including outcome predictors such as physician and hospital volume and associated factors. This study of data contained in the Taiwan National Health Insurance Research Database analysed 27 046 patients who had been hospitalised for APP from January 1996 to December 2007. Patient characteristics were then compared among quartiles. The primary outcome measures were length of stay (LOS) and hospital treatment cost. Effect size (ES) was compared among three equally divided periods, and multiple regression models were used to identify outcome predictors. The overall prevalence of APP per 100 000 patients decreased from 12.43 in 1996 to 6.87 in 2007. The LOS for APP treatment was negatively associated with physician volume during the study period. Both LOS and hospital treatment cost were lowest in the high hospital volume subgroup. Comparisons of LOS and hospital treatment cost among the three periods showed that high-volume hospitals and high-volume physicians had better ESs compared to low-volume hospitals and low-volume physicians. Age and number of co-morbidities had significant positive associations with LOS, while admission year, male gender, hospital level, hospital volume and physician volume had significant negative associations with LOS (p<0.05). Hospital treatment cost and hospital level correlated positively with admission year, number of co-morbidities and LOS but correlated negatively with hospital volume and physician volume (p<0.05). In APP patients, treatment by a high-volume physician can reduce LOS and treatment cost. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Intensive group-based CBT for child social phobia: a pilot study.

PubMed

Donovan, Caroline L; Cobham, Vanessa; Waters, Allison M; Occhipinti, Stefano

2015-05-01

Although CBT has proven efficacious in the treatment of child social phobia (SP), most children do not present for treatment and child SP may be less responsive to treatment than other anxiety disorders. Intensive, group-based, SP-specific CBT may improve the efficacy of, and access to, treatment for child SP. The aim of this study was to provide a preliminary examination of such a program. Forty Australian children aged 7-12 years (15 male and 25 female) were allocated into treatment and waitlist groups. Clinical interviews to determine diagnostic status were conducted prior to treatment, following treatment and at 6-month follow-up. Parent and child questionnaire measures of child anxiety symptoms, internalizing symptoms, depression, social skills, social competence, and parental social anxiety were administered at the same time points. Treatment was delivered in 4 separate 3-hour sessions conducted over 3 consecutive weekends. At postassessment, 52.4% of children in the treatment group and 15.8% of children in the waitlist group were free of their SP diagnosis. At postassessment, compared to waitlist children, treatment group children demonstrated a greater drop in clinical severity, a greater increase in overall functioning, and held fewer clinical diagnoses. Treatment group children also reported a greater reduction in SP symptoms compared to waitlist children, and treatment group parents reported a greater reduction in child internalizing and anxiety symptoms, a greater increase in child social competence, and a greater decrease in parental SP symptoms, compared to parents of children in the waitlist group. By 6-month follow-up, 76.9% of the treatment group were free of their SP diagnosis and gains on all other measures were maintained. The results of this study are encouraging, and suggest that brief, intensive, group CBT for children with social anxiety is beneficial for many youngsters. Copyright © 2014. Published by Elsevier Ltd.

Efficacy and tolerability of a fixed-dose combination of metoprolol extended release/amlodipine in patients with mild-to-moderate hypertension: a randomized, parallel-group, multicentre comparison with losartan plus amlodipine.

PubMed

Pareek, Anil; Chandurkar, Nitin B; Sharma, Ravishankar; Tiwari, Dharmendra; Gupta, Bhagwan S

2010-01-01

Epidemiological studies and clinical trials have shown that prevention of cardiovascular disease, the ultimate goal of hypertension treatment, requires a sufficient reduction in blood pressure. The primary objective of this study was to compare the mean decrease in systolic (SBP) and diastolic (DBP) blood pressure between metoprolol extended release (XL)/amlodipine fixed-dose combination and losartan plus amlodipine combination in patients with mild-to-moderate essential hypertension. The secondary objectives of this study were to compare the proportion of responders in the two treatment groups and to evaluate the tolerability of the study medications. This was a randomized, parallel-group, multicentre comparative study conducted at the outpatient departments of three teaching hospitals in India. Patients with mild-to-moderate hypertension (defined as DBP 90-109 mmHg) aged between 18 and 75 years were enrolled in this study and followed up for 12 weeks. Response to study treatments was evaluated in terms of mean decrease in SBP and DBP and the response rate (reduction to SBP <140 mmHg and DBP <90 mmHg). Out of 152 patients who underwent a 1-week placebo washout, 148 eligible patients were randomized to receive either metoprolol XL 25 mg/amlodipine 2.5 mg fixed-dose combination (76 patients) or losartan 25 mg plus amlodipine 2.5 mg (72 patients). The two treatment groups were similar with respect to demographic and baseline characteristics. Non-responders after 4 weeks of therapy were escalated to metoprolol XL 50 mg/amlodipine 5 mg fixed-dose combination or losartan 50 mg plus amlodipine 5 mg, respectively. The study was completed by 66 patients in each group, of whom 43 patients in each group responded to the starting doses. After 4 weeks' therapy, both treatments were associated with significant decreases in SBP and DBP from baseline (p < 0.001) and were comparable with respect to mean decrease in SBP (p = 0.304), mean decrease in DBP (p = 0.630) and response rate (p = 1.0). Also, both the step-up therapies were comparable with respect to mean decrease in SBP (p = 0.484), mean decrease in DBP (p = 0.650) and response rate (p = 0.134) at week 12. Both treatments were well tolerated in the studied population. Metoprolol XL/amlodipine fixed-dose combination was found to be as effective and well tolerated as losartan plus amlodipine in the treatment of essential hypertension.

The Impact of a Line Probe Assay Based Diagnostic Algorithm on Time to Treatment Initiation and Treatment Outcomes for Multidrug Resistant TB Patients in Arkhangelsk Region, Russia.

PubMed

Eliseev, Platon; Balantcev, Grigory; Nikishova, Elena; Gaida, Anastasia; Bogdanova, Elena; Enarson, Donald; Ornstein, Tara; Detjen, Anne; Dacombe, Russell; Gospodarevskaya, Elena; Phillips, Patrick P J; Mann, Gillian; Squire, Stephen Bertel; Mariandyshev, Andrei

2016-01-01

In the Arkhangelsk region of Northern Russia, multidrug-resistant (MDR) tuberculosis (TB) rates in new cases are amongst the highest in the world. In 2014, MDR-TB rates reached 31.7% among new cases and 56.9% among retreatment cases. The development of new diagnostic tools allows for faster detection of both TB and MDR-TB and should lead to reduced transmission by earlier initiation of anti-TB therapy. The PROVE-IT (Policy Relevant Outcomes from Validating Evidence on Impact) Russia study aimed to assess the impact of the implementation of line probe assay (LPA) as part of an LPA-based diagnostic algorithm for patients with presumptive MDR-TB focusing on time to treatment initiation with time from first-care seeking visit to the initiation of MDR-TB treatment rather than diagnostic accuracy as the primary outcome, and to assess treatment outcomes. We hypothesized that the implementation of LPA would result in faster time to treatment initiation and better treatment outcomes. A culture-based diagnostic algorithm used prior to LPA implementation was compared to an LPA-based algorithm that replaced BacTAlert and Löwenstein Jensen (LJ) for drug sensitivity testing. A total of 295 MDR-TB patients were included in the study, 163 diagnosed with the culture-based algorithm, 132 with the LPA-based algorithm. Among smear positive patients, the implementation of the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 50 and 66 days compared to the culture-based algorithm (BacTAlert and LJ respectively, p<0.001). In smear negative patients, the LPA-based algorithm was associated with a median decrease in time to MDR-TB treatment initiation of 78 days when compared to the culture-based algorithm (LJ, p<0.001). However, several weeks were still needed for treatment initiation in LPA-based algorithm, 24 days in smear positive, and 62 days in smear negative patients. Overall treatment outcomes were better in LPA-based algorithm compared to culture-based algorithm (p = 0.003). Treatment success rates at 20 months of treatment were higher in patients diagnosed with the LPA-based algorithm (65.2%) as compared to those diagnosed with the culture-based algorithm (44.8%). Mortality was also lower in the LPA-based algorithm group (7.6%) compared to the culture-based algorithm group (15.9%). There was no statistically significant difference in smear and culture conversion rates between the two algorithms. The results of the study suggest that the introduction of LPA leads to faster time to MDR diagnosis and earlier treatment initiation as well as better treatment outcomes for patients with MDR-TB. These findings also highlight the need for further improvements within the health system to reduce both patient and diagnostic delays to truly optimize the impact of new, rapid diagnostics.

Cost-Effectiveness Analysis of Initial Treatment Strategies for Nonembolic Acute Limb Ischemia Using Real-Word Data.

PubMed

Vaidya, Varun; Gangan, Nilesh; Comerota, Anthony; Lurie, Fedor

2017-02-01

Nonembolic acute limb ischemia (ALI) is a condition characterized by a sudden decrease in limb perfusion and requires immediate interventions. There are multiple treatment options available including surgery, catheter-directed thrombolysis (CDT), endovascular procedures, and hybrid treatment (a combination of open and endovascular techniques). Randomized trials provide information only on clinical efficacy, but not on economic outcomes. The objective of the study was to perform the cost-effective analysis comparing different treatment alternatives of ALI. The data were collected from 4r ProMedica community hospitals in the Northwest Ohio from January 2009 to December 2012. Patients were included if they were treated within 14 days of onset of symptoms for nonembolic ALI and were divided into groups of receiving CDT, surgery, endovascular, or hybrid treatments. Demographics, comorbidities, medications taken before admission, and smoking status were collected at baseline for all patients and were compared among the treatment groups. A cost-effectiveness decision tree was developed to calculate expected costs and life years gained associated with available treatment options. A probabilistic sensitivity analysis was also performed to check the robustness of the model. A population of 205 patients with the diagnosis of ALI was included and divided into different treatment groups. There was no major significant difference in baseline characteristics among the studied groups (P > 0.05). The total costs were $17,163.47 for surgery, $20,620.39 for endovascular, $21,277.61 for hybrid, and $30,675.42 for CDT. The life years gained were 17.25 for surgery, 18 for endovascular, 18 for hybrid, and 17 for CDT. CDT was dominated because of the high cost and the low effectiveness, while hybrid treatment was dominated when compared with endovascular treatment because these 2 treatments have similar outcomes. The incremental cost-effectiveness ratio of the endovascular group over the surgery group was found to be $4,609.23 per life year gained. The sensitivity analysis showed that the endovascular treatment was found to be cost-effective under willingness to pay $50,000. This study provides economic evaluation of ALI treatments for a defined clinical population in the real-world setting. Compared with other available alternatives, the endovascular treatment showed to be a cost-effective use of healthcare resources. Copyright © 2016 Elsevier Inc. All rights reserved.

Therapist adherence in the strong without anorexia nervosa (SWAN) study: A randomized controlled trial of three treatments for adults with anorexia nervosa.

PubMed

Andony, Louise J; Tay, Elaine; Allen, Karina L; Wade, Tracey D; Hay, Phillipa; Touyz, Stephen; McIntosh, Virginia V W; Treasure, Janet; Schmidt, Ulrike H; Fairburn, Christopher G; Erceg-Hurn, David M; Fursland, Anthea; Crosby, Ross D; Byrne, Susan M

2015-12-01

To develop a psychotherapy rating scale to measure therapist adherence in the Strong Without Anorexia Nervosa (SWAN) study, a multi-center randomized controlled trial comparing three different psychological treatments for adults with anorexia nervosa. The three treatments under investigation were Enhanced Cognitive Behavioural Therapy (CBT-E), the Maudsley Anorexia Nervosa Treatment for Adults (MANTRA), and Specialist Supportive Clinical Management (SSCM). The SWAN Psychotherapy Rating Scale (SWAN-PRS) was developed, after consultation with the developers of the treatments, and refined. Using the SWAN-PRS, two independent raters initially rated 48 audiotapes of treatment sessions to yield inter-rater reliability data. One rater proceeded to rate a total of 98 audiotapes from 64 trial participants. The SWAN-PRS demonstrated sound psychometric properties, and was considered a reliable measure of therapist adherence. The three treatments were highly distinguishable by independent raters, with therapists demonstrating significantly more behaviors consistent with the actual allocated treatment compared to the other two treatment modalities. There were no significant site differences in therapist adherence observed. The findings provide support for the internal validity of the SWAN study. The SWAN-PRS was deemed suitable for use in other trials involving CBT-E, MANTRA, or SSCM. The Authors. International Journal of Eating Disorders Published by Wiley Periodicals, Inc.

Comparative efficacy of tulathromycin versus florfenicol and tilmicosin against undifferentiated bovine respiratory disease in feedlot cattle.

PubMed

Skogerboe, Terry L; Rooney, Kathleen A; Nutsch, Robert G; Weigel, Daniel J; Gajewski, Kimberly; Kilgore, W Randal

2005-01-01

Four studies conducted at feedlots in Greeley and Wellington, Colorado; Nebraska; and Texas compared the efficacy of tulathromycin to florfenicol or tilmicosin for the treatment of cattle with undifferentiated bovine respiratory disease (BRD) and subsequent feedlot performance and carcass characteristics. In each study, 100 calves with BRD were treated with tulathromycin given SC at 2.5 mg/kg body weight. At the Greeley, CO, and Nebraska study locations, 100 calves were treated with florfenicol given SC at 40 mg/kg body weight, and at the Wellington, CO, and Texas study locations, tilmicosin was given SC at 10 mg/kg body weight. Cure rate, a derived variable that included assessments of mortality, rectal temperature, and attitude and respiratory scores from day 3 to day 28 and day 3 through harvest, was the primary assessment of BRD efficacy. Cure rates of calves treated with tulathromycin were significantly (P < or = .009) higher than those calves treated with florfenicol. At Wellington, CO, the cure rate of calves treated with tulathromycin was significantly higher (P < or = .018) compared with tilmicosin-treated calves. The differences in cure rates between tulathromycin and tilmicosin treatment groups in the Texas study were not significantly different (P > .05). Tulathromycin was more efficacious in the treatment of undifferentiated BRD compared with florfenicol and, in one study, compared with tilmicosin.

Musical Auditory Stimulation Influences Heart Rate Autonomic Responses to Endodontic Treatment

PubMed Central

Martiniano, Eli Carlos; Monteiro, Larissa Raylane Lucas; Valenti, Vitor E.; Sorpreso, Isabel Cristina Esposito; de Abreu, Luiz Carlos

2017-01-01

We aimed to evaluate the acute effect of musical auditory stimulation on heart rate autonomic regulation during endodontic treatment. The study included 50 subjects from either gender between 18 and 40 years old, diagnosed with irreversible pulpitis or pulp necrosis of the upper front teeth and endodontic treatment indication. HRV was recorded 10 minutes before (T1), during (T2), and immediately (T3 and T4) after endodontic treatment. The volunteers were randomly divided into two equal groups: exposed to music (during T2, T3, and T4) or not. We found no difference regarding salivary cortisol and anxiety score. In the group with musical stimulation heart rate decreased in T3 compared to T1 and mean RR interval increased in T2 and T3 compared to T1. SDNN and TINN indices decreased in T3 compared to T4, the RMSSD and SD1 increased in T4 compared to T1, the SD2 increased compared to T3, and LF (low frequency band) increased in T4 compared to T1 and T3. In the control group, only RMSSD and SD1 increased in T3 compared to T1. Musical auditory stimulation enhanced heart rate autonomic modulation during endodontic treatment. PMID:28182118

[Clinical effect of Saccharomyces boulardii powder combined with azithromycin sequential therapy in treatment of children with diarrhea secondary to Mycoplasma pneumoniae pneumonia].

PubMed

Chen, Qi-Fen; Zhang, Yi-Wei

2018-02-01

To investigate the clinical effect of Saccharomyces boulardii powder combined with azithromycin sequential therapy in the treatment of children with diarrhea secondary to Mycoplasma pneumoniae pneumonia. A total of 88 children with diarrhea secondary to Mycoplasma pneumoniae pneumonia between June 2015 and March 2017 were divided into control group and study group using a random number table, with 44 children in each group. The children in the control group were given routine treatment combined with azithromycin sequential therapy, and those in the study group were given oral Saccharomyces boulardii powder in addition to the treatment in the control group until the end of azithromycin sequential therapy. After the treatment ended, the two groups were compared in terms of time to improvement of clinical symptoms, length of hospital stay, clinical outcome, defecation frequency before and after treatment, condition of intestinal dysbacteriosis, and incidence of adverse events. Compared with the control group, the study group had significantly shorter time to improvement of clinical symptoms and length of hospital stay (P<0.05). The study group had a significantly higher response rate than the control group (P<0.05). On days 3 and 5 of treatment, the study group had a significant reduction in defecation frequency compared with the control group (P<0.05). The study group had a significantly lower rate of intestinal dysbacteriosis than the control group (P<0.05). There was no significant difference in the incidence of adverse events between the two groups (P>0.05). In the treatment of children with diarrhea secondary to Mycoplasma pneumoniae pneumonia, Saccharomyces boulardii powder combined with azithromycin sequential therapy can improve clinical symptoms, shorten the length of hospital stay, reduce defecation frequency and the incidence of intestinal dysbacteriosis, and improve clinical outcomes, and does not increase the risk of adverse events.

A comparative study of spray keratinocytes and autologous meshed split-thickness skin graft in the treatment of acute burn injuries.

PubMed

Sood, Rajiv; Roggy, David Edward; Zieger, Madeline Jane; Nazim, Muhammad; Hartman, Brett Colby; Gibbs, Jeff Thomas

2015-02-01

ReCell (Avita Medical, Northridge, CA) is an autologous cell harvesting (ACH) device that enables a thin split-thickness skin biopsy to be processed to produce a cell population that includes a mixed population of keratinocytes, melanocytes, Langerhans cells, and papillary dermal fibroblasts for immediate delivery via a spray applicator onto a prepared skin surface. In this Institutional Review Board-approved US Food and Drug Administration phase 2 study, the authors prospectively evaluated the treatment of partial-thickness burns in patients with two 320 cm2 areas, 1 area treated with the ACH device and the other with a meshed split-thickness skin graft (MSTSG) as a control. The authors compared the treatment areas for graft take, pigmentation, and color match to surrounding healthy tissue, scarring, and pain. In this preliminary study, 10 patients were treated with this protocol. Eight patients had 100% take to both treatment areas and 2 patients had significant non-take and graft loss attributable to underexcised wound beds and difficulty with the spray applicator. Pigmentation and color match ratings were identical at week 52 and the Modified Vancouver Scar Scale scores were comparable. One subject rated the autologous cell harvesting site as having a better appearance, while the remaining subjects rated their ACH and MSTSG sites' appearances as being comparable. In early follow-up visits, pain ratings were slightly elevated in the ACH group due to graft healing; however, in visits following week 2, pain ratings at the ACH and MSTSG sites were rated similarly by all patients. This preliminary report describes an early experience with the ACH device and the treatment of partial-thickness burn injuries. In this 10-patient series, patients benefitted from having a decreased donor site size and comparable outcomes with MSTSG treatment. While this preliminary underpowered study has provided positive results, there is a learning curve with choosing the proper wound for treatment with the ACH device, as well as with using the device.

Anticonvulsants for alcohol withdrawal.

PubMed

Minozzi, Silvia; Amato, Laura; Vecchi, Simona; Davoli, Marina

2010-03-17

Alcohol abuse and dependence represents a most serious health problem worldwide with major social, interpersonal and legal interpolations. Besides benzodiazepines, anticonvulsants are often used for the treatment of alcohol withdrawal symptoms. Anticonvulsants drugs are indicated for the treatment of alcohol withdrawal syndrome, alone or in combination with benzodiazepine treatments. In spite of the wide use, the exact role of the anticonvulsants for the treatment of alcohol withdrawal has not yet bee adequately assessed. To evaluate the effectiveness and safety of anticonvulsants in the treatment of alcohol withdrawal. We searched Cochrane Drugs and Alcohol Group' Register of Trials (December 2009), PubMed, EMBASE, CINAHL (1966 to December 2009), EconLIT (1969 to December 2009). Parallel searches on web sites of health technology assessment and related agencies, and their databases. Randomized controlled trials (RCTs) examining the effectiveness, safety and overall risk-benefit of anticonvulsants in comparison with a placebo or other pharmacological treatment. All patients were included regardless of age, gender, nationality, and outpatient or inpatient therapy. Two authors independently screened and extracted data from studies. Fifty-six studies, with a total of 4076 participants, met the inclusion criteria. Comparing anticonvulsants with placebo, no statistically significant differences for the six outcomes considered.Comparing anticonvulsant versus other drug, 19 outcomes considered, results favour anticonvulsants only in the comparison carbamazepine versus benzodiazepine (oxazepam and lorazepam) for alcohol withdrawal symptoms (CIWA-Ar score): 3 studies, 262 participants, MD -1.04 (-1.89 to -0.20), none of the other comparisons reached statistical significance.Comparing different anticonvulsants no statistically significant differences in the two outcomes considered.Comparing anticonvulsants plus other drugs versus other drugs (3 outcomes considered), results from one study, 72 participants, favour paraldehyde plus chloral hydrate versus chlordiazepoxide, for the severe-life threatening side effects, RR 0.12 (0.03 to 0.44). Results of this review do not provide sufficient evidence in favour of anticonvulsants for the treatment of AWS. There are some suggestions that carbamazepine may actually be more effective in treating some aspects of alcohol withdrawal when compared to benzodiazepines, the current first-line regimen for alcohol withdrawal syndrome. Anticonvulsants seem to have limited side effects, although adverse effects are not rigorously reported in the analysed trials.

Upper GI tract findings in patients with heartburn in whom proton pump inhibitor treatment failed versus those not receiving antireflux treatment.

PubMed

Poh, Choo Hean; Gasiorowska, Anita; Navarro-Rodriguez, Tomas; Willis, Marcia R; Hargadon, Deborah; Noelck, North; Mohler, Jane; Wendel, Christopher S; Fass, Ronnie

2010-01-01

Failure of proton pump inhibitor (PPI) treatment in patients with heartburn is very common. Because endoscopy is easily accessible, it is commonly used as the first evaluative tool in these patients. To compare GERD-related endoscopic and histologic findings in patients with heartburn in whom once-daily PPI therapy failed versus those not receiving antireflux treatment. Cross-sectional study. A Veterans Affairs hospital. Heartburn patients from the GI outpatient clinic. Recording of endoscopic results. Endoscopic findings and association between PPI treatment failure and esophageal mucosal injury by using logistic regression models. A total of 105 subjects (mean age 54.7 +/- 15.7 years; 71 men, 34 women) were enrolled in the PPI treatment failure group and 91 (mean age 53.4 +/- 15.8 years; 68 men, 23 women) were enrolled in the no-treatment group (P = not significant). Anatomic findings during upper endoscopy were significantly more common in the no-treatment group compared with the PPI treatment failure group (55.2% vs 40.7%, respectively; P = .04). GERD-related findings were significantly more common in the no-treatment group compared with the PPI treatment failure group (erosive esophagitis: 30.8% vs 6.7%, respectively; P < .05). Eosinophilic esophagitis was found in only 0.9% of PPI treatment failure patients. PPI treatment failure was associated with a significantly decreased odds ratio of erosive esophagitis compared with no treatment, adjusted for age, sex, and body mass index (adjusted odds ratio 0.11; 95% CI, 0.04-0.30). Heartburn patients in whom once-daily PPI treatment failed demonstrated a paucity of GERD-related findings compared with those receiving no treatment. Eosinophilic esophagitis was uncommon in PPI therapy failure patients. Upper endoscopy seems to have a very low diagnostic yield in this patient population. 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Post-surgical treatment of thyroid carcinoma in dogs with retinoic acid 9 cis improves patient outcome

PubMed Central

Castillo, V.; Pessina, P.; Hall, P.; Blatter, M.F. Cabrera; Miceli, D.; Arias, E. Soler; Vidal, P.

2016-01-01

The objective of the present study was to compare the effects of isotretinoin 9-cis (RA9-cis) as a post-surgery treatment of thyroid carcinoma to a traditional treatment (doxorubicin) and no treatment. Owners who did not want their dogs to receive treatment were placed into the control group A (GA; n=10). The remaining dogs were randomly placed into either group B (GB; n=12) and received doxorubicin at a dose of 30 mg/m2 every three weeks, for six complete cycles or group C (GC; n=15) and treated with RA9-cis at a dose of 2 mg/kg/day for 6 months. The time of the recurrence was significantly shorter in the GA and GB compared to GC (P=0.0007; P=0.0015 respectively), while we did not detect differences between GA and GB. The hazard ratio of recurrence between GA and GB compared to GC were 7.25 and 5.60 times shorter, respectively. We did not detect any differences between the other groups. The risk ratio of recurrence was 2.0 times higher in GA compared to GC and 2.1 times higher in GB compared to GC. The type of carcinoma had an effect on time of survival with follicular carcinomas having an increased mean survival time than follicular-compact carcinomas (P<0.0001) and follicular-compact carcinomas had a longer mean survival time than compact carcinomas. The interaction among treatment and type was significant, but survival time in follicular carcinomas did not differ between treatments. In follicular-compact carcinomas the survival time of GC was greater than GB (P<0.05), but we did not detect a difference between GA and GB. In conclusion, this study shows that the use of surgery in combination with RA9-cis treatment significantly increases survival rate and decreases the time to tumor recurrence when compared to doxorubicin treated or untreated dogs. The histological type of carcinoma interacted with treatment for time to recurrence and survival time, with more undifferentiated carcinomas having a worse prognosis than differentiated carcinomas. PMID:26862515

The Effectiveness of Two Grammar Treatment Procedures for Children with SLI: A Randomized Clinical Trial

ERIC Educational Resources Information Center

Smith-Lock, Karen M.; Leitão, Suze; Prior, Polly; Nickels, Lyndsey

2015-01-01

Purpose: This study compared the effectiveness of two grammar treatment procedures for children with specific language impairment. Method: A double-blind superiority trial with cluster randomization was used to compare a cueing procedure, designed to elicit a correct production following an initial error, to a recasting procedure, which required…

Is the Allegiance Effect an Epiphenomenon of True Efficacy Differences between Treatments? A Meta-Analysis

ERIC Educational Resources Information Center

Munder, Thomas; Fluckiger, Christoph; Gerger, Heike; Wampold, Bruce E.; Barth, Jurgen

2012-01-01

Many meta-analyses of comparative outcome studies found a substantial association of researcher allegiance (RA) and relative treatment effects. Therefore, RA is regarded as a biasing factor in comparative outcome research (RA bias hypothesis). However, the RA bias hypothesis has been criticized as causality might be reversed. That is, RA might be…

Moist Exposed Burn Ointment (MEBO) in partial thickness burns - a randomized, comparative open mono-center study on the efficacy of dermaheal (MEBO) ointment on thermal 2nd degree burns compared to conventional therapy.

PubMed

Hirsch, T; Ashkar, W; Schumacher, O; Steinstraesser, L; Ingianni, G; Cedidi, C C

2008-11-24

Wound healing in burn wounds presents a challenge in healthcare, and there is still a lack of alternatives in topical burn wound treatments. - The purpose of this study was to evaluate the efficacy of a new therapeutic ointment (MEBO) in the treatment of partial thickness burns. 40 patients received either topical treatment with Moist Exposed Burn Ointment (MEBO) or standard Flammazine treatment. All patients suffered from partial-thickness burn injuries (< 20% TBSA). Wounds were evaluated for 60 up to days regarding wound healing, water loss, inflammation, and pain alleviation. For transepidermal water loss, there was a difference of 2.3 gr/m2/h between MEBO, and Flammazine, favoring MEBO. However, this difference was not statistically significant (p=0.78). For all secondary efficacy parameter results were similar. - This study showed that MEBO ointment for topical treatment of burn injuries presents an attractive alternative for the topical treatment of limited partial thickness thermal burns.

Desensitization And Study-Skills Training As Treatment For Two Types of Test-Anxious Students

ERIC Educational Resources Information Center

Osterhouse, Robert A.

1972-01-01

This study compared the effectiveness of systematic desensitization and training in efficient study methods for reducing test anxiety among subjects selected on the basis of two types of self reported anxiety. Desensitization offered more promise as a treatment method for test anxiety than did training in study skills. (Author)

Corneal wound healing promoted by 3 blood derivatives: an in vitro and in vivo comparative study.

PubMed

Freire, Vanesa; Andollo, Noelia; Etxebarria, Jaime; Hernáez-Moya, Raquel; Durán, Juan A; Morales, María-Celia

2014-06-01

The aim of this study was to compare the effect on corneal wound healing of 3 differently manufactured blood derivatives [autologous serum (AS), platelet-rich plasma, and serum derived from plasma rich in growth factors (s-PRGF)]. Scratch wound-healing assays were performed on rabbit primary corneal epithelial cultures and human corneal epithelial cells. Additionally, mechanical debridement of rabbit corneal epithelium was performed. Wound-healing progression was assessed by measuring the denuded areas remaining over time after treatment with each of the 3 blood derivatives or a control treatment. In vitro data show statistically significant differences in the healing process with all the derivatives compared with the control, but 2 of them (AS and s-PRGF) induced markedly faster wound healing. In contrast, although the mean time required to complete in vivo reepithelization was similar to that of AS and s-PRGF treatment, only wounds treated with s-PRGF were significantly smaller in size from 2.5 days onward with respect to the control treatment. All 3 blood derivatives studied are promoters of corneal reepithelization. However, the corneal wound-healing progresses differently with each derivative, being faster in vitro under AS and s-PRGF treatment and producing in vivo the greatest decrease in wound size under s-PRGF treatment. These findings highlight that the manufacturing process of the blood derivatives may modulate the efficacy of the final product.

Long-term treatment of deep-vein thrombosis with low-molecular-weight heparin: an update of the evidence.

PubMed

Hull, Russell D; Townshend, Grace

2013-07-01

This article reviews updated evidence-based knowledge on long-term treatment of deep-vein thrombosis (DVT) with low-molecular-weight heparin (LMWH) or vitamin K antagonists (VKAs). Eleven trials were identified comparing the two treatments in a broad spectrum of patients with DVT and with >100 study participants. Four comparative trials were identified in patients with cancer and DVT (in whom anticoagulation treatment is more complex and bleeding complications more frequent). In the 11 trials in broad patient populations, LMWHs were as effective as VKAs in preventing recurrent venous thromboembolism (VTE), and there were no consistent differences in the incidence of bleeding complications during long-term treatment. In patients with cancer, VTE recurrence was significantly reduced with LMWH versus VKA in two studies, while major bleeding complications did not differ between groups in any of the four trials. Current evidence-based European and American guidelines recommend LMWH over VKA for the long-term treatment of DVT in patients with cancer. LMWH and VKA are recommended over the new oral anticoagulant drugs, for which there are limited data on use in long-term treatment. Post-thrombotic syndrome (PTS), a common complication of DVT, causes considerable morbidity. Long-term use of tinzaparin reduced the risk of PTS compared with VKA in one trial, and a meta-analysis of nine studies in total demonstrated a consistently favourable effect of LMWHs versus VKA on PTS-related outcomes. Given the limited treatment options available for PTS, this suggests that LMWHs provide a useful therapeutic option in any patient particularly at risk of developing PTS.

Prolonged remission from hepatic encephalopathy with rifaximin: results of a placebo crossover analysis

PubMed Central

Bajaj, J S; Barrett, A C; Bortey, E; Paterson, C; Forbes, W P

2015-01-01

Background Rifaximin therapy reduced risk of hepatic encephalopathy (HE) recurrence and HE-related hospitalisations during a 6-month, randomised, placebo-controlled trial (RCT) and a 24-month open-label maintenance (OLM) study. However, the impact of crossover from placebo to rifaximin therapy is unclear. Aim To study the impact of crossing over from placebo to rifaximin treatment on breakthrough HE and hospitalisation rates using a within-subjects design. Methods Adults with cirrhosis and history of overt HE episodes, currently in HE remission, received placebo during the RCT and crossed over to rifaximin 550 mg twice daily during the OLM study. Rate of breakthrough overt HE episodes, hospitalisations and incidence and rate of adverse events (AEs) were analysed during RCT and first 6 months of OLM. Results Of 82 patients randomised to placebo in the RCT who crossed over to the OLM study, 39 experienced an HE episode during the RCT compared with 14 during the OLM study (P < 0.0001). Significantly lower rates of HE events were observed with rifaximin treatment compared with placebo treatment (P < 0.0001). Rates of HE-related hospitalisation were numerically lower during rifaximin treatment compared with placebo treatment, although not significant. Rates of most common AEs, serious AEs and infection-related AEs were similar between the two treatments. Conclusions This analysis confirms the repeatability of results from the RCT on safety and efficacy of rifaximin 550 mg twice daily in reducing the risk of hepatic encephalopathy recurrence, and suggests these findings are translatable outside of a rigorous, controlled trial setting. PMID:25339518

Preventive drugs restore visual evoked habituation and attention in migraineurs.

PubMed

Ince, Ferda; Erdogan-Bakar, Emel; Unal-Cevik, Isin

2017-06-01

Visual system pathway dysfunction has been postulated in migraineurs. We wanted to investigate if any difference exists interictally in visual attention and visual evoked habituation of frequently attacked migraineurs compared to the healthy control group. The effects of 3-month prophylactic migraine treatment on these parameters were also assessed. The migraineurs at headache-free interval (n = 52) and age, sex-matched healthy controls (n = 35) were compared by habituation response to 10 blocks of repetitive pattern-reversal visual stimuli (each block consisted 100 responses). The amplitude changes of 5th and 10th blocks were further compared with that of block 1 to assess the response of habituation (i.e., decrease) or potentiation (i.e., increase). The level of sustained visual attention was assessed by Cancellation test. Migraineurs were randomized to three different preventive treatments: propranolol 40 mg tid, flunarizine 5 mg bid, or topiramate 50 mg bid. After 3 months of preventive treatment, migraineurs data were compared with their baseline values. The groups did not differ by sex and age. In electrophysiological studies, the habituation ability observed in the healthy group was not observed in migraineurs. However, it was restored 3 months after preventive treatment. In migraineurs, compared to their baseline values, the distorted visual attention parameters also improved after treatment. All drugs were effective. The loss of habituation ability and low visual attention performance in migraineurs can be restored by migraine preventive treatment. This electrophysiological study accompanied by neuropsychological test may aid an objective and quantitative assessment tool for understanding migraine pathophysiology.

Early mobilization of acute whiplash injuries.

PubMed Central

Mealy, K; Brennan, H; Fenelon, G C

1986-01-01

Acute whiplash injuries are a common cause of soft tissue trauma for which the standard treatment is rest and initial immobilisation with a soft cervical collar. Because the efficacy of this treatment is unknown a randomised study in 61 patients was carried out comparing the standard treatment with an alternative regimen of early active mobilisation. Results showed that eight weeks after the accident the degree of improvement seen in the actively treated group compared with the group given standard treatment was significantly greater for both cervical movement (p less than 0.05) and intensity of pain (p less than 0.0125). PMID:3081211

Comparative efficacy of the Cognitive Behavioral Analysis System of Psychotherapy versus Supportive Psychotherapy for early onset chronic depression: design and rationale of a multisite randomized controlled trial

PubMed Central

2011-01-01

Background Effective treatment strategies for chronic depression are urgently needed since it is not only a common and particularly disabling disorder, but is also considered treatment resistant by most clinicians. There are only a few studies on chronic depression indicating that traditional psycho- and pharmacological interventions are not as effective as in acute, episodic depression. Current medications are no more effective than those introduced 50 years ago whereas the only psychotherapy developed specifically for the subgroup of chronic depression, the Cognitive Behavioral Analysis System of Psychotherapy (CBASP), faired well in one large trial. However, CBASP has never been directly compared to a non-specific control treatment. Methods/Design The present article describes the study protocol of a multisite parallel-group randomized controlled trial in Germany. The purpose of the study is to estimate the efficacy of CBASP compared to supportive psychotherapy in 268 non-medicated early-onset chronically depressed outpatients. The intervention includes 20 weeks of acute treatment with 24 individual sessions followed by 28 weeks of continuation treatment with another 8 sessions. Depressive symptoms are evaluated 20 weeks after randomisation by means of the 24-item Hamilton Rating Scale of Depression (HRSD). Secondary endpoints are depressive symptoms after 12 and 48 weeks, and remission after 12, 20, and 48 weeks. Primary outcome will be analysed using analysis of covariance (ANCOVA) controlled for pre-treatment scores and site. Analyses of continuous secondary variables will be performed using linear mixed models. For remission rates, chi-squared tests and logistic regression will be applied. Discussion The study evaluates the comparative effects of a disorder-specific psychotherapy and a well designed non-specific psychological approach in the acute and continuation treatment phase in a large sample of early-onset chronically depressed patients. Trial registration ClinicalTrials.gov (NCT00970437). PMID:21849054

Efficacy of lycopene in the treatment of gingivitis: a randomised, placebo-controlled clinical trial.

PubMed

Chandra, Rampalli Viswa; Prabhuji, M L Venkatesh; Roopa, D Adinarayana; Ravirajan, Sandhya; Kishore, Hadal C

2007-01-01

The aim of the present study was to compare the effect of systemically administered lycopene (LycoRed) as a monotherapy and as an adjunct to scaling and root planing in gingivitis patients. Twenty systemically healthy patients showing clinical signs of gingivitis were involved in a randomised, double-blind, parallel, split-mouth study. The subjects were randomly distributed between the two treatment groups: experimental group (n = 10), 8 mg lycopene/day for 2 weeks; and controls (n = 10), placebo for 2 weeks. Quadrant allocation within each group was randomised with two quadrants treated with oral prophylaxis (OP) and two quadrants not receiving any form of treatment (non-OP). Bleeding index (SBI) and non-invasive measures of plaque (PI) and gingivitis (GI) were assessed at baseline, 1 and 2 weeks. Salivary uric acid levels were also measured. All the treatment groups demonstrated statistically significant reductions in the GI, SBI and PI. Treatment with OP-lycopene resulted in a statistically significant decrease in GI when compared with OP-placebo (p < 0.05) and non-OP-placebo (p < 0.01). Treatment with non-OP-lycopene resulted in a statistically significant decrease in GI when compared with non-OP-placebo (p < 0.01). The OP-lycopene group showed a statistically significant reduction in SBI values when compared with the non-OP-lycopene group (p < 0.05) and the non-OP-placebo group (p < 0.001). There was a strong negative correlation between the salivary uric acid levels and the percentage reduction in GI at 1 and 2 weeks in the OP-lycopene group (r = -0.852 and -0.802 respectively) and in the non-OP-lycopene group (r = -0.640 and -0.580 respectively). The results presented in this study suggest that lycopene shows great promise as a treatment modality in gingivitis. The possibility of obtaining an additive effect by combining routine oral prophylaxis with lycopene is also an exciting possibility, which deserves further study.

Pregnancy outcomes in youth with type 2 diabetes: The TODAY Study experience

USDA-ARS?s Scientific Manuscript database

We evaluated pregnancy outcomes, maternal and fetal/neonatal, during the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. The TODAY study was a randomized controlled trial comparing three treatment options for youth with type 2 diabetes. Informed consent included the req...

Comparative Study of Lettuce and Radish Grown Under Red and Blue Light-Emitting Diodes (LEDs) and White Fluorescent Lamps

NASA Technical Reports Server (NTRS)

Mickens, Matthew A.

2012-01-01

Growing vegetable crops in space will be an essential part of sustaining astronauts during long-term missions. To drive photosynthesis, red and blue light-emitting diodes (LEDs) have attracted attention because of their efficiency, longevity, small size, and safety. In efforts to optimize crop production, there have also been recent interests in analyzing the subtle effects of green light on plant growth, and to determine if it serves as a source of growth enhancement or suppression. A comparative study was performed on two short cycle crops of lettuce (Outredgeous) and radish (Cherry Bomb) grown under two light treatments. The first treatment being red and blue LEDs, and the second treatment consisting of white fluorescent lamps which contain a portion of green light. In addition to comparing biomass production, physiological characterizations were conducted on how the light treatments influence morphology, water use, chlorophyll content, and the production of A TP within plant tissues.

A Feasibility Study of Virtual Reality-Based Coping Skills Training for Nicotine Dependence

PubMed Central

Bordnick, Patrick S.; Traylor, Amy C.; Carter, Brian L.; Graap, Ken M.

2014-01-01

Objective Virtual reality (VR)-based cue reactivity has been successfully used for the assessment of drug craving. Going beyond assessment of cue reactivity, a novel VR-based treatment approach for smoking cessation was developed and tested for feasibility. Method In a randomized experiment, 10-week treatment feasibility trial, 46 nicotine-dependent adults, completed the10-week program. Virtual reality skills training (VRST) combined with nicotine replacement therapy (NRT) was compared to NRT alone. Participants were assessed for smoking behavior and coping skills during, at end of treatment, and at posttreatment follow-up. Results Smoking rates and craving for nicotine were significantly lower for the VRST group compared to NRT-only group at the end of treatment. Self-confidence and coping skills were also significantly higher for the VRST group, and number of cigarettes smoked was significantly lower, compared to the control group at follow-up. Conclusions Feasibility of VRST was supported in the current study. PMID:25484549

Can Ashi points stimulation have specific effects on shoulder pain? A systematic review of randomized controlled trials.

PubMed

Wang, Kang-Feng; Zhang, Li-Juan; Lu, Feng; Lu, Yong-Hui; Yang, Chuan-Hua

2016-06-01

To provide an evidence-based overview regarding the efficacy of Ashi points stimulation for the treatment of shoulder pain. A comprehensive search [PubMed, Chinese Biomedical Literature Database, China National Knowledge Infrastructure (CNKI), Chongqing Weipu Database for Chinese Technical Periodicals (VIP) and Wanfang Database] was conducted to identify randomized or quasi-randomized controlled trials that evaluated the effectiveness of Ashi points stimulation for shoulder pain compared with conventional treatment. The methodological quality of the included studies was assessed using the Cochrane risk of bias tool. RevMan 5.0 was used for data synthesis. Nine trials were included. Seven studies assessed the effectiveness of Ashi points stimulation on response rate compared with conventional acupuncture. Their results suggested significant effect in favour of Ashi points stimulation [odds ratio (OR): 5.89, 95% confidence interval (CI): 2.97 to 11.67, P<0.01, heterogeneity: χ(2) =3.81, P=0.70, I (2) =0% ]. One trial compared Ashi points stimulation with drug therapy. The result showed there was a significantly greater recovery rate in group of Ashi points stimulation (OR: 9.58, 95% CI: 2.69 to 34.12). One trial compared comprehensive treatment on the myofascial trigger points (MTrPs) with no treatment and the result was in favor of MTrPs. Ashi points stimulation might be superior to conventional acupuncture, drug therapy and no treatment for shoulder pain. However, due to the low methodological quality of included studies, a firm conclusion could not be reached until further studies of high quality are available.

Do observational studies using propensity score methods agree with randomized trials? A systematic comparison of studies on acute coronary syndromes

PubMed Central

Dahabreh, Issa J.; Sheldrick, Radley C.; Paulus, Jessica K.; Chung, Mei; Varvarigou, Vasileia; Jafri, Haseeb; Rassen, Jeremy A.; Trikalinos, Thomas A.; Kitsios, Georgios D.

2012-01-01

Aims Randomized controlled trials (RCTs) are the gold standard for assessing the efficacy of therapeutic interventions because randomization protects from biases inherent in observational studies. Propensity score (PS) methods, proposed as a potential solution to confounding of the treatment–outcome association, are widely used in observational studies of therapeutic interventions for acute coronary syndromes (ACS). We aimed to systematically assess agreement between observational studies using PS methods and RCTs on therapeutic interventions for ACS. Methods and results We searched for observational studies of interventions for ACS that used PS methods to estimate treatment effects on short- or long-term mortality. Using a standardized algorithm, we matched observational studies to RCTs based on patients’ characteristics, interventions, and outcomes (‘topics’), and we compared estimates of treatment effect between the two designs. When multiple observational studies or RCTs were identified for the same topic, we performed a meta-analysis and used the summary relative risk for comparisons. We matched 21 observational studies investigating 17 distinct clinical topics to 63 RCTs (median = 3 RCTs per observational study) for short-term (7 topics) and long-term (10 topics) mortality. Estimates from PS analyses differed statistically significantly from randomized evidence in two instances; however, observational studies reported more extreme beneficial treatment effects compared with RCTs in 13 of 17 instances (P = 0.049). Sensitivity analyses limited to large RCTs, and using alternative meta-analysis models yielded similar results. Conclusion For the treatment of ACS, observational studies using PS methods produce treatment effect estimates that are of more extreme magnitude compared with those from RCTs, although the differences are rarely statistically significant. PMID:22711757

Biological effective dose evaluation in gynaecological brachytherapy: LDR and HDR treatments, dependence on radiobiological parameters, and treatment optimisation.

PubMed

Bianchi, C; Botta, F; Conte, L; Vanoli, P; Cerizza, L

2008-10-01

This study was undertaken to compare the biological efficacy of different high-dose-rate (HDR) and low-dose-rate (LDR) treatments of gynaecological lesions, to identify the causes of possible nonuniformity and to optimise treatment through customised calculation. The study considered 110 patients treated between 2001 and 2006 with external beam radiation therapy and/or brachytherapy with either LDR (afterloader Selectron, (137)Cs) or HDR (afterloader microSelectron Classic, (192)Ir). The treatments were compared in terms of biologically effective dose (BED) to the tumour and to the rectum (linear-quadratic model) by using statistical tests for comparisons between independent samples. The difference between the two treatments was statistically significant in one case only. However, within each technique, we identified considerable nonuniformity in therapeutic efficacy due to differences in fractionation schemes and overall treatment time. To solve this problem, we created a Microsoft Excel spreadsheet allowing calculation of the optimal treatment for each patient: best efficacy (BED(tumour)) without exceeding toxicity threshold (BED(rectum)). The efficacy of a treatment may vary as a result of several factors. Customised radiobiological evaluation is a useful adjunct to clinical evaluation in planning equivalent treatments that satisfy all dosimetric constraints.

Treatment of hospitalized patients with complicated gram-positive skin and skin structure infections: two randomized, multicentre studies of quinupristin/dalfopristin versus cefazolin, oxacillin or vancomycin. Synercid Skin and Skin Structure Infection Group.

PubMed

Nichols, R L; Graham, D R; Barriere, S L; Rodgers, A; Wilson, S E; Zervos, M; Dunn, D L; Kreter, B

1999-08-01

Quinupristin/dalfopristin (Synercid), the first injectable streptogramin antibiotic available for the treatment of complicated gram-positive skin and skin structure infections, was compared with standard comparators (cefazolin, oxacillin or vancomycin) in one USA and one international trial. These two randomized, open-label trials of virtually identical design enrolled a total of 893 patients (450 quinupristin/dalfopristin, 443 comparator). The majority of patients had erysipelas, traumatic wound infection or clean surgical wound infection. Staphylococcus aureus was the most frequently isolated pathogen in both treatment groups and polymicrobial infection was more common in the quinupristin/dalfopristin group than in the comparator group. The clinical success rate (cure plus improvement) in the clinically evaluable population was equivalent between the two treatment groups (68.2% quinupristin/dalfopristin, 70.7% comparator; 95% CI, -10.1, 5.1) despite a shorter mean duration of treatment for quinupristin/dalfopristin patients. In the bacteriologically evaluable population, by-patient and by-pathogen bacteriological eradication rates were somewhat lower for quinupristin/dalfopristin (65.8% and 66.6%, respectively) than for the comparator regimens (72.7% and 77.7%, respectively). The lower bacteriological response rates in the quinupristin/dalfopristin group were, in part, due to a higher rate of polymicrobial infections and a higher incidence of patients classified as clinical failure, a category which included premature discontinuation of treatment because of local venous adverse events. The bacteriological eradication rate for quinupristin/dalfopristin was higher in monomicrobial infections than in polymicrobial infections (72.6% versus 63.3%, respectively), whereas the corresponding rate for the comparator regimens was lower for monomicrobial infections than polymicrobial infections (70.8% versus 83.1%). This finding was not unexpected, since the spectrum of quinupristin/dalfopristin is focused on gram-positive pathogens and additional antibiotics to treat gram-negative bacteria were not required per protocol. The systemic tolerability of both treatment regimens was qualitatively similar. A higher rate of drug-related venous adverse events was reported for quinupristin/dalfopristin (66.2%) than for the comparator regimen (28.4%). Premature discontinuation of study drug was primarily due to adverse clinical events for quinupristin/dalfopristin (19.1%), whereas the most common reason for discontinuation among those receiving the comparator regimens was treatment failure (11.5%). Quinupristin/dalfopristin is an effective alternative for the treatment of hospitalized patients with complicated skin and skin structure infections due to quinupristin/ dalfopristin-susceptible gram-positive organisms, including methicillin- and erythromycin-resistant S. aureus.

Estimating the optimal dynamic antipsychotic treatment regime: Evidence from the sequential multiple assignment randomized CATIE Schizophrenia Study

PubMed Central

Shortreed, Susan M.; Moodie, Erica E. M.

2012-01-01

Summary Treatment of schizophrenia is notoriously difficult and typically requires personalized adaption of treatment due to lack of efficacy of treatment, poor adherence, or intolerable side effects. The Clinical Antipsychotic Trials in Intervention Effectiveness (CATIE) Schizophrenia Study is a sequential multiple assignment randomized trial comparing the typical antipsychotic medication, perphenazine, to several newer atypical antipsychotics. This paper describes the marginal structural modeling method for estimating optimal dynamic treatment regimes and applies the approach to the CATIE Schizophrenia Study. Missing data and valid estimation of confidence intervals are also addressed. PMID:23087488

Efficacy and safety of pharmacological agents in the treatment of erythema migrans in early Lyme borreliosis-systematic review protocol.

PubMed

Torbahn, Gabriel; Hofmann, Heidelore; Allert, Roman; Freitag, Michael H; Dersch, Rick; Fingerle, Volker; Sommer, Harriet; Motschall, Edith; Meerpohl, Jörg J; Schmucker, Christine

2016-05-03

Erythema migrans represents an early cutaneous and most common manifestation of Lyme borreliosis. Recommendations regarding pharmacological agents, dose and duration of treatment are subject of intense debate. This review aims to explore differences in efficacy and safety between pharmacological treatments and control treatment. To identify relevant studies, we will conduct a systematic literature search. We will include randomised controlled trials (RCTs) and non-RCTs. Eligible comparative studies need to (1) consider patients with a diagnosis of erythema migrans resulting from Lyme borreliosis and (2) compare different pharmacological agents against each other, against any other non-pharmacological treatment, placebo or no treatment. Two review authors will independently assess included studies for risk of bias according to the methods of the Cochrane Handbook for Systematic Reviews of Interventions and related to specific study designs. We will address patient-relevant outcomes including clinical remission of cutaneous symptoms, any treatment-related adverse events, quality of life and progressive symptoms such as neuroborreliosis or Lyme carditis and flu-like symptoms. Provided that the identified trials are comparable in terms of clinical issues, combined estimates will be provided. Estimations of treatment effects will be calculated based on a random effects model. Heterogeneity will be evaluated based on I (2) and chi-square test. In case of significant heterogeneity, a pooled estimate will not be provided, but heterogeneity will be investigated on the basis of methodological and clinical study aspects. We plan subgroup analysis to reveal potential differences in the effect estimates between patient populations and treatment specifications. We will consider risk of bias using sensitivity analyses to decide whether to rely on the pooled estimates. The quality of a body of evidence for individual outcomes will be assessed using the GRADE approach. Benefits and harms of pharmacological treatment in erythema migrans have not yet been adequately assessed. This systematic review will evaluate and summarise available evidence addressing benefits and harms of different pharmacological treatments. In addition, this summary of clinical evidence will inform decision-making between clinicians and patients and will play an important part in patient care. CRD42016037932.

The EVERT (effective verruca treatments) trial protocol: a randomised controlled trial to evaluate cryotherapy versus salicylic acid for the treatment of verrucae.

PubMed

Cockayne, E Sarah

2010-02-08

Verrucae are a common, infectious and sometimes painful problem. The optimal treatment for verrucae is unclear due to a lack of high quality randomised controlled trials. The primary objective of this study is to compare the clinical effectiveness of two common treatments for verrucae: cryotherapy using liquid nitrogen versus salicylic acid. Secondary objectives include a comparison of the cost-effectiveness of the treatments, and an investigation of time to clearance of verrucae, recurrence/clearance of verrucae at six months, patient satisfaction with treatment, pain associated with treatment, and use of painkillers for the treatments. This is an open, pragmatic, multicentre, randomised controlled trial with two parallel groups: cryotherapy using liquid nitrogen delivered by a healthcare professional for a maximum of 4 treatments (treatments 2-3 weeks apart) or daily self-treatment with 50% salicylic acid for a maximum of 8 weeks. Two hundred and sixty-six patients aged 12 years and over with a verruca are being enrolled into the study. The primary outcome is complete clearance of all verrucae as observed on digital photographs taken at 12 weeks compared with baseline and assessed by an independent healthcare professional. Secondary outcomes include self-reported time to clearance of verrucae, self-reported clearance of verrucae at 6 months, cost-effectiveness of the treatments compared to one another, and patient acceptability of both treatments including possible side effects such as pain. The primary analysis will be intention to treat. It is planned that recruitment will be completed by December 2009 and results will be available by June 2010. Current Controlled Trials ISRCTN18994246.

Treating periodontal disease for preventing adverse birth outcomes in pregnant women.

PubMed

Iheozor-Ejiofor, Zipporah; Middleton, Philippa; Esposito, Marco; Glenny, Anne-Marie

2017-06-12

Periodontal disease has been linked with a number of conditions, such as cardiovascular disease, stroke, diabetes and adverse pregnancy outcomes, all likely through systemic inflammatory pathways. It is common in women of reproductive age and gum conditions tend to worsen during pregnancy. Some evidence from observational studies suggests that periodontal intervention may reduce adverse pregnancy outcomes. There is need for a comprehensive Cochrane review of randomised trials to assess the effect of periodontal treatment on perinatal and maternal health. To assess the effects of treating periodontal disease in pregnant women in order to prevent or reduce perinatal and maternal morbidity and mortality. Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 6 October 2016), Cochrane Pregnancy and Childbirth's Trials Register (to 7 October 2016), the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 9) in the Cochrane Library, MEDLINE Ovid (1946 to 6 October 2016), Embase Ovid (1980 to 6 October 2016), and LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; 1982 to 6 October 2016). ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials on 6 October 2016. We placed no restrictions on the language or date of publication when searching the electronic databases. We included all randomised controlled trials (RCTs) investigating the effects of periodontal treatment in preventing or reducing perinatal and maternal morbidity and mortality. We excluded studies where obstetric outcomes were not reported. Two review authors independently screened titles and abstracts and extracted data using a prepiloted data extraction form. Missing data were obtained by contacting authors and risk of bias was assessed using Cochrane's 'Risk of bias' tool. Where appropriate, results of comparable trials were pooled and expressed as risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI) . The random-effects model was used for pooling except where there was an insufficient number of studies. We assessed the quality of the evidence using GRADE. There were 15 RCTs (n = 7161 participants) meeting our inclusion criteria. All the included studies were at high risk of bias mostly due to lack of blinding and imbalance in baseline characteristics of participants. The studies recruited pregnant women from prenatal care facilities who had periodontitis (14 studies) or gingivitis (1 study).The two main comparisons were: periodontal treatment versus no treatment during pregnancy and periodontal treatment versus alternative periodontal treatment. The head-to-head comparison between periodontal treatments assessed a more intensive treatment versus a less intensive one.Eleven studies compared periodontal treatment with no treatment during pregnancy. The meta-analysis shows no clear difference in preterm birth < 37 weeks (RR 0.87, 95% CI 0.70 to 1.10; 5671 participants; 11 studies; low-quality evidence) between periodontal treatment and no treatment. There is low-quality evidence that periodontal treatment may reduce low birth weight < 2500 g (9.70% with periodontal treatment versus 12.60% without treatment; RR 0.67, 95% CI 0.48 to 0.95; 3470 participants; 7 studies).It is unclear whether periodontal treatment leads to a difference in preterm birth < 35 weeks (RR 1.19, 95% CI 0.81 to 1.76; 2557 participants; 2 studies; ) and < 32 weeks (RR 1.35, 95% CI 0.78 to 2.32; 2755 participants; 3 studies), low birth weight < 1500 g (RR 0.80, 95% CI 0.38 to 1.70; 2550 participants; 2 studies), perinatal mortality (including fetal and neonatal deaths up to the first 28 days after birth) (RR 0.85, 95% CI 0.51 to 1.43; 5320 participants; 7 studies; very low-quality evidence), and pre-eclampsia (RR 1.10, 95% CI 0.74 to 1.62; 2946 participants; 3 studies; very low-quality evidence). There is no evidence of a difference in small for gestational age (RR 0.97, 95% CI 0.81 to 1.16; 3610 participants; 3 studies; low-quality evidence) when periodontal treatment is compared with no treatment.Four studies compared periodontal treatment with alternative periodontal treatment. Data pooling was not possible due to clinical heterogeneity. The outcomes reported were preterm birth < 37 weeks, preterm birth < 35 weeks, birth weight < 2500 g, birth weight < 1500 g and perinatal mortality (very low-quality evidence). It is unclear whether there is a difference in < 37 weeks, preterm birth < 35 weeks, birth weight < 2500 g, birth weight < 1500 g and perinatal mortality when different periodontal treatments are compared because the quality of evidence is very low.Maternal mortality and adverse effects of the intervention did not occur in any of the studies that reported on either of the outcomes. It is not clear if periodontal treatment during pregnancy has an impact on preterm birth (low-quality evidence). There is low-quality evidence that periodontal treatment may reduce low birth weight (< 2500 g), however, our confidence in the effect estimate is limited. There is insufficient evidence to determine which periodontal treatment is better in preventing adverse obstetric outcomes. Future research should aim to report periodontal outcomes alongside obstetric outcomes.

Ecological effects of alternative fuel-reduction treatments: highlights of the National Fire and Fire Surrogate study (FFS)

Treesearch

James D. McIver; Scott L. Stephens; James K. Agee; Jamie Barbour; Ralph E. J. Boerner; Carl B. Edminster; Karen L. Erickson; Kerry L. Farris; Christopher J. Fettig; Carl E. Fiedler; Sally Haase; Stephen C. Hart; Jon E. Keeley; Eric E. Knapp; John F. Lehmkuhl; Jason J. Moghaddas; William Otrosina; Kenneth W. Outcalt; Dylan W. Schwilk; Carl N. Skinner; Thomas A. Waldrop; C. Phillip Weatherspoon; Daniel A. Yaussy; Andrew Youngblood; Steve Zack

2012-01-01

The 12-site National Fire and Fire Surrogate study (FFS) was a multivariate experiment that evaluated ecological consequences of alternative fuel-reduction treatments in seasonally dry forests of the US. Each site was a replicated experiment with a common design that compared an un-manipulated control, prescribed fire, mechanical and mechanical + fire treatments....

Quality of Life Outcomes after Primary Treatment for Clinically Localised Prostate Cancer: A Systematic Review.

PubMed

Lardas, Michael; Liew, Matthew; van den Bergh, Roderick C; De Santis, Maria; Bellmunt, Joaquim; Van den Broeck, Thomas; Cornford, Philip; Cumberbatch, Marcus G; Fossati, Nicola; Gross, Tobias; Henry, Ann M; Bolla, Michel; Briers, Erik; Joniau, Steven; Lam, Thomas B; Mason, Malcolm D; Mottet, Nicolas; van der Poel, Henk G; Rouvière, Olivier; Schoots, Ivo G; Wiegel, Thomas; Willemse, Peter-Paul M; Yuan, Cathy Yuhong; Bourke, Liam

2017-12-01

Current evidence-based management for clinically localised prostate cancer includes active surveillance, surgery, external beam radiotherapy (EBRT) and brachytherapy. The impact of these treatment modalities on quality of life (QoL) is uncertain. To systematically review comparative studies investigating disease-specific QoL outcomes as assessed by validated cancer-specific patient-reported outcome measures with at least 1 yr of follow-up after primary treatment for clinically localised prostate cancer. MEDLINE, EMBASE, AMED, PsycINFO, and Cochrane Library were searched to identify relevant studies. Studies were critically appraised for the risk of bias. A narrative synthesis was undertaken. Of 11486 articles identified, 18 studies were eligible for inclusion, including three randomised controlled trials (RCTs; follow-up range: 60-72 mo) and 15 nonrandomised comparative studies (follow-up range: 12-180 mo) recruiting a total of 13604 patients. Two RCTs recruited small cohorts and only one was judged to have a low risk of bias. The quality of evidence from observational studies was low to moderate. For a follow-up of up to 6 yr, active surveillance was found to have the lowest impact on cancer-specific QoL, surgery had a negative impact on urinary and sexual function when compared with active surveillance and EBRT, and EBRT had a negative impact on bowel function when compared with active surveillance and surgery. Data from one small RCT reported that brachytherapy has a negative impact on urinary function 1 yr post-treatment, but no significant urinary toxicity was reported at 5 yr. This is the first systematic review comparing the impact of different primary treatments on cancer-specific QoL for men with clinically localised prostate cancer, using validated cancer-specific patient-reported outcome measures only. There is robust evidence that choice of primary treatment for localised prostate cancer has distinct impacts on patients' QoL. This should be discussed in detail with patients during pretreatment counselling. Our review of the current evidence suggests that for a period of up to 6 yr after treatment, men with localised prostate cancer who were managed with active surveillance reported high levels of quality of life (QoL). Men treated with surgery reported mainly urinary and sexual problems, while those treated with external beam radiotherapy reported mainly bowel problems. Men eligible for brachytherapy reported urinary problems up to a year after therapy, but then their QoL returned gradually to as it was before treatment. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

An evaluation of interrupted and uninterrupted measurement of vocal stereotypy on perceived treatment outcomes.

PubMed

Carroll, Regina A; Kodak, Tiffany

2014-01-01

The type of procedure used to measure a target behavior may directly influence the perceived treatment outcomes. In the present study, we examined the influence of different data-analysis procedures on the outcomes of two commonly used treatments on the vocal stereotypy of 2 children with an autism spectrum disorder. In Study 1, we compared an interrupted and uninterrupted data-analysis procedure to measure vocal stereotypy during the implementation of response interruption and redirection (RIRD). The results showed that the interrupted data-analysis procedure overestimated the effectiveness of RIRD. In Study 2, we examined the influence of different data-analysis procedures on the interpretation of the relative effects of 2 different treatments for vocal stereotypy. Specifically, we compared interrupted and uninterrupted data-analysis procedures during the implementation of RIRD and noncontingent reinforcement (NCR) as a treatment for vocal stereotypy. The results showed that, as in Study 1, the interrupted data-analysis procedure overestimated the effectiveness of RIRD; however, this effect was not apparent with NCR. These findings suggest that different types of data analysis can influence the perceived success of a treatment. © Society for the Experimental Analysis of Behavior.

Comparing the Performance Status Scale and MD Anderson Dysphagia Inventory as swallowing outcome measures in head and neck cancer: a prospective cohort study.

PubMed

Khan, M K; Patterson, J; Owen, S; Rees, S; Gamberini, L; Paleri, V

2015-08-01

To examine the relationship between the two disease-specific measures currently in use to assess swallowing outcomes following treatment in patients with head and neck cancer: the Performance Status Scale (PSS) and MD Anderson Dysphagia Inventory (MDADI). A prospective cohort study. Four head and neck cancer multidisciplinary clinics in the North of England Cancer Network. 114 patients with cancers of the upper aerodigestive tract. Measures of swallowing function administered prospectively across 4 timepoints Spearman's correlation coefficients were used to measure the relationship between the two scales. There was statistically significant correlation between the two tools at pre-treatment (rs = 0.428, P < 0.000), 3 months post-treatment (rs = 0.454, P < 0.002), 6 months post-treatment (rs = 0.551, P < 0.000) and 12 months post-treatment (rs = 0.680, P < 0.000). This is the first prospective study comparing the MDADI and PSS questionnaires at multiple time points. Our study shows that these different instruments have a good relationship in measuring swallowing function in patients with head and neck cancer in short and medium term after treatment. © 2015 John Wiley & Sons Ltd.

Administration of clomiphene citrate in patients with polycystic ovary syndrome, without inducing withdrawal bleeding, achieves comparable treatment characteristics and outcome.

PubMed

Farhi, Jacob; Orvieto, Raoul; Homburg, Roy

2010-04-01

In an attempt to evaluate the effect of random timing of the start of clomiphene citrate (CC) treatment in anovulatory patients with polycystic ovary syndrome on treatment characteristics and outcome, with no regard to time of menstruation, we studied 291 women in their first CC treatment cycle. Duration of treatment was shorter by 2 days and number of leading follicles was higher when treatment was started late (7-29 days from starting a bleed, as compared with day 5), but no effect of starting day was observed on response rate to CC, maximal E(2) level, endometrial thickness, and pregnancy rate. Copyright 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Cardiovascular morbidity and mortality after treatment of hyperthyroidism with either radioactive iodine or thyroidectomy.

PubMed

Ryodi, Essi; Metso, Saara; Huhtala, Heini; Välimäki, Matti; Auvinen, Anssi; Jaatinen, Pia

2018-06-08

BACKGROUND Hyperthyroid patients remain at an increased risk of cardiovascular diseases (CVDs) after restoring euthyroidism. The impact of the different treatment modalities of hyperthyroidism on future CVD risk remains unclear. The aim of this paper is to assess cardiovascular morbidity and mortality in hyperthyroidism before and after the treatment, and to compare the effects of two different treatment modalities, radioactive iodine (RAI) and thyroid surgery. METHODS A comparative cohort study was conducted among 6,148 hyperthyroid patients treated either with RAI or thyroidectomy, and 18,432 age- and gender-matched controls. Firstly, hospitalizations due to CVDs prior to the treatment were analyzed. Secondly, the hazard ratios (HR) for any new hospitalization and mortality due to CVDs after the treatment were estimated among all the hyperthyroid patients compared to the age- and gender-matched controls and also in the RAI-treated patients compared to the thyroidectomy-treated patients. The results were adjusted for prevalent CVDs at the time of treatment. RESULTS Before the treatment of hyperthyroidism, hospitalizations due to all CVDs were more common in the hyperthyroid patients compared to the controls (OR 1.61, 95% CI 1.49-1.73). During the post-treatment follow-up, hospitalizations due to CVDs remained more frequent among the patients (HR 1.15, 95% CI 1.09-1.21), but there was no difference in CVD mortality (HR 0.93, 95% CI 0.84-1.03). Compared to the patients treated with thyroidectomy, the RAI-treated patients had a higher risk of hospitalization due to all CVDs (HR 1.17), and atrial fibrillation (HR 1.28), as well as a higher CVD mortality (HR 2.56). Yet, treatment with RAI resulting in hypothyroidism was not associated with increased CVD morbidity compared with thyroidectomy. CONCLUSIONS Hyperthyroidism increases the risk of CVD-related hospitalization, and the risk is sustained for up to two decades after treatment with RAI or surgery. Hyperthyroid patients treated with RAI remain at a higher CVD risk compared to patients treated with thyroidectomy. Hypothyroidism during the follow-up, however, predicts better cardiovascular outcome.

[Comparative evaluation of the effectiveness of the treatment of gastroduodenal Campylobacter infection in children].

PubMed

Korovina, N A; Levitskaia, S V; Bokser, G V; Spirina, T S; Taranenko, L A; Safonova, T B

1991-01-01

Schemes developed by the authors for antibacterial therapy of gastroduodenal bacterosis caused by Campylobacter spp. in children are described. The data on the treatment of 56 patients with duodenal ulcer and gastroduodenitis are presented. The efficacy of the treatment with medicines under the control of the clinical, endoscopic and microbiological indices was compared. The study showed that De-Nol, furazolidone and combination of trichopol (metronidazole) with vicair were the most efficient drugs for therapy of children with such diseases.

Fertility treatment: long-term growth and mental development of the children.

PubMed

Bay, Bjørn

2014-10-01

Fertility treatment has been associated with obstetrical and perinatal complications. It is, however, uncertain whether fertility treatment or parental subfertility is associated with long-term development of the children. We aimed to assess the growth and mental health of children and adolescents conceived after fertility treatment compared to spontaneously conceived controls. First, we evaluated all previous studies comparing neurodevelopmental outcomes between children conceived after fertility treatment and spontaneous conceived controls. The systematic review clarified methodological limitations in the existing literature on the long-term development of children conceived after medical assisted reproduction. Although several studies had been published, large, well-controlled studies with long-term follow-up and thorough statistical adjustments were still few. Second, we evaluated the children's mental health by assessing the risk of mental disorders. We studied a population of 555,828 children conceived after spontaneous conception and 33,139 children conceived after fertility treatment with follow-up in 2012 when the children were 8-17 years old. The absolute risk and hazard ratio of overall and specific mental disorders were estimated while adjusting for potential confounding variables. Further, we estimated the association between subtypes of procedures, hormonal treatment, gamete types and cause of infertility on the one hand and the risk of mental disorders on the other. Children conceived after ovulation induction had a low, but significantly increased risks of autism spectrum disorders, hyperkinetic disorders, conduct, emotional, or social disorders, and tic disorders. Children conceived after IVF or ICSI showed no increased risk, except for a small risk of tic disorders. There was no risk systematically related to any specific type of hormone drug treatment. Thus, the increased risks may rely on residual confounding such as unknown parental factors associated with infertility in the ovulation induction group. Third, we assessed the intelligence, attention and executive functions in 1782 5-year-old singletons. Compared with children conceived after spontaneous conception, there were no differences in test scores in children conceived by subfertile parents waiting more than 12 months before conceiving naturally or children born by parents conceiving after fertility treatment. Finally, we evaluated the growth of children born after fertility treatment or to subfertile parents. Compared to children conceived spontaneously, children born after fertility treatment or by subfertile parents had a significantly lower birth weight - an important predictor of mental development. In contrast, no differences on height, weight, or head circumference were found at the age of 5 years. In conclusion, we found no differences on long-term growth and neurodevelopment of children conceived after fertility treatment or by subfertile parents compared with spontaneously conceived children. Children born after ovulation induction had a low, but increased risk of mental disorders in childhood or adolescence, although this risk may rely on unknown parental factors associated with infertility.

Benefit of Delayed Fertility Therapy With Preconception Weight Loss Over Immediate Therapy in Obese Women With PCOS

PubMed Central

Dodson, William C.; Kunselman, Allen R.; Stetter, Christy M.; Kris-Etherton, Penny M.; Williams, Nancy I.; Gnatuk, Carol L.; Estes, Stephanie J.; Allison, Kelly C.; Sarwer, David B.; Diamond, Michael P.; Schlaff, William D.; Casson, Peter R.; Christman, Gregory M.; Barnhart, Kurt T.; Bates, G. Wright; Usadi, Rebecca; Lucidi, Scott; Baker, Valerie; Zhang, Heping; Eisenberg, Esther; Coutifaris, Christos; Dokras, Anuja

2016-01-01

Context: In overweight/obese women with polycystic ovary syndrome (PCOS), the relative benefit of delaying infertility treatment to lose weight vs seeking immediate treatment is unknown. Objective: We compared the results of two, multicenter, concurrent clinical trials treating infertility in women with PCOS. Design, Setting, and Participants: This was a secondary analysis of two randomized trials conducted at academic health centers studying women 18–40 years of age who were overweight/obese and infertile with PCOS. Intervention: We compared immediate treatment with clomiphene from the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial (N = 187) to delayed treatment with clomiphene after preconception treatment with continuous oral contraceptives, lifestyle modification (Lifestyle: including caloric restriction, antiobesity medication, behavioral modification, and exercise) or the combination of both (combined) from the Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (OWL PCOS) trial (N = 142). Main Outcome Measures: Live birth, pregnancy loss, and ovulation were measured. Results: In PPCOS II, after four cycles of clomiphene, the cumulative per-cycle ovulation rate was 44.7% (277/619) and the cumulative live birth rate was 10.2% (19/187), nearly identical to that after oral contraceptive pretreatment in the OWL PCOS trial (ovulation 45% [67/149] and live birth: 8.5% [4/47]). In comparison, deferred clomiphene treatment preceded by lifestyle and combined treatment in OWL PCOS offered a significantly better cumulative ovulation rate compared to immediate treatment with clomiphene. (Lifestyle: 62.0% [80/129]; risk ratio compared to PPCOS II = 1.4; 95% confidence interval [CI], 1.1–1.7; P = .003; combined: 64.3% [83/129]; risk ratio compared to PPCOS II = 1.4; 95% CI, 1.2–1.8; P < .001 and a significantly better live birth rate lifestyle: 25.0% [12/48]; risk ratio compared to PPCOS II = 2.5; 95% CI, 1.3–4.7; P = .01 and combined: 25.5% [12/47]; risk ratio compared to PPCOS II = 2.5; 95% CI, 1.3–4.8; P = .01). Conclusions: These data show the benefit of improved ovulation and live birth with delayed infertility treatment with clomiphene citrate when preceded by lifestyle modification with weight loss compared with immediate treatment. Pretreatment with oral contraceptives likely has little effect on the ovulation and live birth rate compared with immediate treatment. PMID:27172435

Benefit of Delayed Fertility Therapy With Preconception Weight Loss Over Immediate Therapy in Obese Women With PCOS.

PubMed

Legro, Richard S; Dodson, William C; Kunselman, Allen R; Stetter, Christy M; Kris-Etherton, Penny M; Williams, Nancy I; Gnatuk, Carol L; Estes, Stephanie J; Allison, Kelly C; Sarwer, David B; Diamond, Michael P; Schlaff, William D; Casson, Peter R; Christman, Gregory M; Barnhart, Kurt T; Bates, G Wright; Usadi, Rebecca; Lucidi, Scott; Baker, Valerie; Zhang, Heping; Eisenberg, Esther; Coutifaris, Christos; Dokras, Anuja

2016-07-01

In overweight/obese women with polycystic ovary syndrome (PCOS), the relative benefit of delaying infertility treatment to lose weight vs seeking immediate treatment is unknown. We compared the results of two, multicenter, concurrent clinical trials treating infertility in women with PCOS. This was a secondary analysis of two randomized trials conducted at academic health centers studying women 18-40 years of age who were overweight/obese and infertile with PCOS. We compared immediate treatment with clomiphene from the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial (N = 187) to delayed treatment with clomiphene after preconception treatment with continuous oral contraceptives, lifestyle modification (Lifestyle: including caloric restriction, antiobesity medication, behavioral modification, and exercise) or the combination of both (combined) from the Treatment of Hyperandrogenism Versus Insulin Resistance in Infertile Polycystic Ovary Syndrome (OWL PCOS) trial (N = 142). Live birth, pregnancy loss, and ovulation were measured. In PPCOS II, after four cycles of clomiphene, the cumulative per-cycle ovulation rate was 44.7% (277/619) and the cumulative live birth rate was 10.2% (19/187), nearly identical to that after oral contraceptive pretreatment in the OWL PCOS trial (ovulation 45% [67/149] and live birth: 8.5% [4/47]). In comparison, deferred clomiphene treatment preceded by lifestyle and combined treatment in OWL PCOS offered a significantly better cumulative ovulation rate compared to immediate treatment with clomiphene. (Lifestyle: 62.0% [80/129]; risk ratio compared to PPCOS II = 1.4; 95% confidence interval [CI], 1.1-1.7; P = .003; combined: 64.3% [83/129]; risk ratio compared to PPCOS II = 1.4; 95% CI, 1.2-1.8; P < .001 and a significantly better live birth rate lifestyle: 25.0% [12/48]; risk ratio compared to PPCOS II = 2.5; 95% CI, 1.3-4.7; P = .01 and combined: 25.5% [12/47]; risk ratio compared to PPCOS II = 2.5; 95% CI, 1.3-4.8; P = .01). These data show the benefit of improved ovulation and live birth with delayed infertility treatment with clomiphene citrate when preceded by lifestyle modification with weight loss compared with immediate treatment. Pretreatment with oral contraceptives likely has little effect on the ovulation and live birth rate compared with immediate treatment.

Tinidazole versus Metronidazole for the Treatment of Bacterial Vaginosis

PubMed Central

SCHWEBKE, Jane R.; DESMOND, Renee A.

2010-01-01

Objective To compare the efficacy of two different doses of tinidazole with metronidazole for treatment of bacterial vaginosis and compare side effects of the drugs. Study design Women were randomized to metronidazole 500 mg BID, tinidazole 500 mg BID, or tinidazole 1 gm BID all for 7 days. Follow-up visits were conducted at day 14 and day 28. Results 593 women were enrolled. There were no significant differences between the treatment arms. Overall cure rates were 76.8% at 14 days and 64.5% at one month. Women who admitted to engaging in sexual intercourse during the study were significantly more likely to have BV at follow-up. There were no significant differences in adverse events across treatment arms. Conclusions There were no differences in cure rates between metronidazole and either of the tinidazole dosing regimens studied. In addition, there were no important differences in the side effect profiles of metronidazole and tinidazole. PMID:21167471

Predictors of treatment with dialysis modalities in observational studies for comparative effectiveness research.

PubMed

Kuttykrishnan, Sooraj; Kalantar-Zadeh, Kamyar; Arah, Onyebuchi A; Cheung, Alfred K; Brunelli, Steve; Heagerty, Patrick J; Katz, Ronit; Molnar, Miklos Z; Nissenson, Allen; Ravel, Vanessa; Streja, Elani; Himmelfarb, Jonathan; Mehrotra, Rajnish

2015-07-01

The Institute of Medicine has identified the comparative effectiveness of renal replacement therapies as a kidney-related topic among the top 100 national priorities. Given the importance of ensuring internal and external validity, the goal of this study was to identify potential sources of bias in observational studies that compare outcomes with different dialysis modalities. This observational cohort study used data from the electronic medical records of all patients that started maintenance dialysis in the calendar years 2007-2011 and underwent treatment for at least 60 days in any of the 2217 facilities operated by DaVita Inc. Each patient was assigned one of six dialysis modalities for each 91-day period from the date of first dialysis (thrice weekly in-center hemodialysis (HD), peritoneal dialysis (PD), less-frequent HD, home HD, frequent HD and nocturnal in-center HD). Of the 162 644 patients, 18% underwent treatment with a modality other than HD for at least one 91-day period. Except for PD, patients started treatment with alternative modalities after variable lengths of treatment with HD; the time until a change in modality was shortest for less-frequent HD (median time = 6 months) and longest for frequent HD (median time = 15 months). Between 30 and 78% of patients transferred to another dialysis facility prior to change in modality. Finally, there were significant differences in baseline and time-varying clinical characteristics associated with dialysis modality. This analysis identified numerous potential sources of bias in studies of the comparative effectiveness of dialysis modalities. © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

The effect of ethnicity on prescribing practice and treatment outcome in inpatients suffering from schizophrenia in Greece.

PubMed

Douzenis, Athanassios; Apostolopoulos, Athanassios; Seretis, Dionisios; Rizos, Emmanouil N; Christodoulou, Christos; Lykouras, Lefteris

2011-04-20

No studies have been conducted in Greece with the aim of investigating the influence of ethnicity on the prescribing and treatment outcome of voluntarily admitted inpatients. Most studies conducted in the UK and the US, both on inpatients and outpatients, focus on the dosage of antipsychotics for schizophrenic patients and many suffer from significant methodological limitations. Using a simple design, we aimed to assess negative ethnic bias in psychotropic medication prescribing by comparing discrepancies in use between native and non-native psychiatric inpatients. We also aimed to compare differences in treatment outcome between the two groups. In this retrospective study, the prescribing of medication was compared between 90 Greek and 63 non-Greek inpatients which were consecutively admitted into the emergency department of a hospital covering Athens, the capital of Greece. Participants suferred from schizophrenia and other psychotic disorders. Overall, groups were compared with regard to 12 outcomes, six related to prescribing and six related to treatment outcome as assesed by standardised psychometric tools. No difference between the two ethnic groups was found in terms of improvement in treatment as measured by GAF and BPRS-E. Polypharmacy, use of first generation antipsychotics, second generation antipsychotics and use of mood stabilizers were not found to be associated with ethnicity. However, non-Greeks were less likely to receive SSRIs-SNRIs and more likely to receive benzodiazepines. Our study found limited evidence for ethnic bias. The stronger indication for racial bias was found in benzodiazepine prescribing. We discuss alternative explanations and give arguments calling for future research that will focus on disorders other than schizophrenia and studying non-inpatient populations.

The effect of ethnicity on prescribing practice and treatment outcome in inpatients suffering from schizophrenia in Greece

PubMed Central

2011-01-01

Background No studies have been conducted in Greece with the aim of investigating the influence of ethnicity on the prescribing and treatment outcome of voluntarily admitted inpatients. Most studies conducted in the UK and the US, both on inpatients and outpatients, focus on the dosage of antipsychotics for schizophrenic patients and many suffer from significant methodological limitations. Using a simple design, we aimed to assess negative ethnic bias in psychotropic medication prescribing by comparing discrepancies in use between native and non-native psychiatric inpatients. We also aimed to compare differences in treatment outcome between the two groups. Methods In this retrospective study, the prescribing of medication was compared between 90 Greek and 63 non-Greek inpatients which were consecutively admitted into the emergency department of a hospital covering Athens, the capital of Greece. Participants suferred from schizophrenia and other psychotic disorders. Overall, groups were compared with regard to 12 outcomes, six related to prescribing and six related to treatment outcome as assesed by standardised psychometric tools. Results No difference between the two ethnic groups was found in terms of improvement in treatment as measured by GAF and BPRS-E. Polypharmacy, use of first generation antipsychotics, second generation antipsychotics and use of mood stabilizers were not found to be associated with ethnicity. However, non-Greeks were less likely to receive SSRIs-SNRIs and more likely to receive benzodiazepines. Conclusions Our study found limited evidence for ethnic bias. The stronger indication for racial bias was found in benzodiazepine prescribing. We discuss alternative explanations and give arguments calling for future research that will focus on disorders other than schizophrenia and studying non-inpatient populations. PMID:21507225

Traction for low-back pain with or without sciatica.

PubMed

Wegner, Inge; Widyahening, Indah S; van Tulder, Maurits W; Blomberg, Stefan E I; de Vet, Henrica Cw; Brønfort, Gert; Bouter, Lex M; van der Heijden, Geert J

2013-08-19

Traction has been used to treat low-back pain (LBP), often in combination with other treatments. We included both manual and machine-delivered traction in this review. This is an update of a Cochrane review first published in 1995, and previously updated in 2006. To assess the effects of traction compared to placebo, sham traction, reference treatments and no treatment in people with LBP. We searched the Cochrane Back Review Group Specialized Register, the Cochrane Central Register of Controlled Trials (2012, Issue 8), MEDLINE (January 2006 to August 2012), EMBASE (January 2006 to August 2012), CINAHL (January 2006 to August 2012), and reference lists of articles and personal files. The review authors are not aware of any important new randomized controlled trial (RCTs) on this topic since the date of the last search. RCTs involving traction to treat acute (less than four weeks' duration), subacute (four to 12 weeks' duration) or chronic (more than 12 weeks' duration) non-specific LBP with or without sciatica. Two review authors independently performed study selection, risk of bias assessment and data extraction. As there were insufficient data for statistical pooling, we performed a descriptive analysis. We did not find any case series that identified adverse effects, therefore we evaluated adverse effects that were reported in the included studies. We included 32 RCTs involving 2762 participants in this review. We considered 16 trials, representing 57% of all participants, to have a low risk of bias based on the Cochrane Back Review Group's 'Risk of bias' tool.For people with mixed symptom patterns (acute, subacute and chronic LBP with and without sciatica), there was low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status, global improvement or return to work when compared to placebo, sham traction or no treatment. Similarly, when comparing the combination of physiotherapy plus traction with physiotherapy alone or when comparing traction with other treatments, there was very-low- to moderate-quality evidence that traction may make little or no difference in pain intensity, functional status or global improvement.For people with LBP with sciatica and acute, subacute or chronic pain, there was low- to moderate-quality evidence that traction probably has no impact on pain intensity, functional status or global improvement. This was true when traction was compared with controls and other treatments, as well as when the combination of traction plus physiotherapy was compared with physiotherapy alone. No studies reported the effect of traction on return to work.For chronic LBP without sciatica, there was moderate-quality evidence that traction probably makes little or no difference in pain intensity when compared with sham treatment. No studies reported on the effect of traction on functional status, global improvement or return to work.Adverse effects were reported in seven of the 32 studies. These included increased pain, aggravation of neurological signs and subsequent surgery. Four studies reported that there were no adverse effects. The remaining studies did not mention adverse effects. These findings indicate that traction, either alone or in combination with other treatments, has little or no impact on pain intensity, functional status, global improvement and return to work among people with LBP. There is only limited-quality evidence from studies with small sample sizes and moderate to high risk of bias. The effects shown by these studies are small and are not clinically relevant. Implications for practice To date, the use of traction as treatment for non-specific LBP cannot be motivated by the best available evidence. These conclusions are applicable to both manual and mechanical traction. Implications for research Only new, large, high-quality studies may change the point estimate and its accuracy, but it should be noted that such change may not necessarily favour traction. Therefore, little priority should be given to new studies on the effect of traction treatment alone or as part of a package.

The physiological and biochemical effects of salicylic acid on sunflowers (Helianthus annuus) exposed to flurochloridone.

PubMed

Kaya, Armagan; Yigit, Emel

2014-08-01

In this study, we comparatively evaluated the effects of the flurochloridone as well as flurochloridone and exogenously applied salicylic acid (SA) on Helianthus annuus L. to find out herbicide-induced toxicity reducing influence of SA. We examined and compared the physiological and biochemical effects of different concentrations of flurochloridone (11, 32 and 72 mM) in both the SA pre-treated and non-treated plants. The plants treated with flurochloridone exhibited reduced total chlorophyll, carotenoid, and relative water content compared to the control group, whereas the plants that were pre-treated with SA exhibited relatively higher values for the same physiological parameters. In the SA non-treated plants, the superoxide dismutase, glutathione reductase and glutathione S-transferase activities were increased in the treatment groups compared to the control group. In the treatment groups, these enzyme activities were decreased in the SA-pre-treated plants compared to the non-treated plants. Ascorbate peroxidase and catalase activities decreased in the flurochloridone-treated plants compared to the control plants. The ascorbate peroxidase activity increased in the control groups but decreased in the treatment groups in the SA pre-treated plants compared to the non-treated plants. However, SA treatment decreased the activity of catalase in the control and treatment groups compared to the plants that were not treated with SA. Flurochloridone treatment increased the malondialdehyde content in the treated groups compared to the control groups, whereas SA-pretreatment decreased malondialdehyde content compared to plants that were not treated with SA. Flurochloridone treatment increased endogenous SA content compared to the control. Although the residual levels of herbicide in the plants increased proportionately with increasing herbicide concentrations, the SA-pre-treated plants exhibited reduced residual herbicide levels compared to the plants that were not treated with SA. These results indicate that the flurochloridone induces various physiological and biochemical responses in non-target plants and that treatment with exogenous SA can increase stress resistance by altering these responses. Copyright © 2014 Elsevier Inc. All rights reserved.

Long-term antibiotics for preventing recurrent urinary tract infection in children.

PubMed

Williams, Gabrielle; Craig, Jonathan C

2011-03-16

Urinary tract infection (UTI) is common in children. Symptoms include fever, lethargy, anorexia, and vomiting. UTI is caused by Escherichia coli in over 80% of cases and treatment is a course of antibiotics. Due to acute illness caused by UTI and the risk of pyelonephritis-induced permanent kidney damage, many children are given long-term antibiotics aimed at preventing recurrence. To determine the efficacy and harms of long-term antibiotics to prevent recurrent UTI in children. In November 2010 we searched without language restriction MEDLINE, EMBASE, CENTRAL (in the Cochrane Library), the Cochrane Renal Group's Specialised Register, reference lists of review articles and contacted content experts. Randomised comparisons of antibiotics with other antibiotics, placebo or no treatment to prevent recurrent UTI. Two authors independently assessed and extracted information. A random-effects model was used to estimate risk ratio (RR) and risk difference (RD) for recurrent UTI with 95% confidence intervals (CI). Twelve studies (1557 children) were identified with six (five analysed, 1069 children) comparing antibiotics with placebo/no treatment. Duration of antibiotic prophylaxis varied from 10 weeks to 12 months. Compared to placebo/no treatment, when all studies were included, antibiotics did not appear to reduce the risk of symptomatic UTI (RR 0.75, 95% CI 0.36 to 1.53) however when we evaluated the effects of antibiotics in studies with low risk of bias, there was a statistically significant reduction (RR 0.68, 95% CI 0.48 to 0.95). The effect was similar in children with vesicoureteric reflux (VUR) (RR 0.65, 95% CI 0.39 to 1.07) compared to those without VUR (RR 0.56, 95% CI 0.15 to 2.12). There was no consistency in occurrence of adverse events. Three studies reported antibiotic resistance, showing a non-significant increased risk for resistance to the antibiotic in the active treatment groups (RR 2.4, 95% CI 0.62 to 9.26).Five studies (4 analysed, 367 children) compared one antibiotic with another but all compared different combinations or different outcomes and studies were not pooled. Two studies reported microbial resistance, nitrofurantoin having a significantly lower risk of resistance than cotrimoxazole (RR 0.54, 95% CI 0.31 to 0.92).One study compared alternate with every day cefadroxil treatment. Long-term antibiotics appear to reduce the risk of repeat symptomatic UTI in susceptible children but the benefit is small and must be considered together with the increased risk of microbial resistance.

The impact of new insights and revised practice guidelines on prescribing drugs in the treatment of Type 2 diabetes mellitus

PubMed Central

Lub, René; Denig, Petra; van den Berg, Paul B; Hoogenberg, Klaas; de Jong-van den Berg, Lolkje T W

2006-01-01

Aims The aim of this study was to investigate the impact of new insights and revised guidelines on initial and follow-up treatment with antihyperglycaemic drugs over the period 1998–2003. Methods The InterAction Database (IADB), which contains pharmacy dispensing data from 53 community pharmacies in the Northern and Eastern part of the Netherlands, was used in this study. Prevalence and incidence rates of oral antihyperglycaemic drug use were calculated for each year. Follow-up treatment was compared for two cohorts of initial users of oral antihyperglycaemic drugs, starting treatment either 1 year before or 1 year after guideline revision. Results The prevalence and incidence rate of oral antihyperglycaemic drug use increased over the study period from 1.8% to 2.4% (P < 0.001) and 0.3% to 0.4% (P= 0.04). The proportion of metformin as initial treatment increased rapidly in the observation period from 14% to 50% (P < 0.001). Initial users of metformin in 2000 received additional treatment with a sulphonylurea in the follow-up period less often compared with those who started metformin in 1998 (46%vs. 60%, P < 0.004). In contrast, initial users of sulphonylurea in 2000 received additional treatment with metformin more often compared with those who started a sulphonylurea in 1998 (42%vs. 36%, P < 0.008). The new drugs, thiazolidinediones and meglitinides, were seldom used as initial treatment Conclusions New insights and the revision of the practice guideline were followed by a significant increase in both initial and follow-up treatment with metformin among patients with Type 2 diabetes mellitus. PMID:16796700

Clinical outcomes and genome-wide association for a brain methylation site in an antidepressant pharmacogenetics study in Mexican Americans.

PubMed

Wong, Ma-Li; Dong, Chuanhui; Flores, Deborah L; Ehrhart-Bornstein, Monika; Bornstein, Stefan; Arcos-Burgos, Mauricio; Licinio, Julio

2014-12-01

The authors compared the effectiveness of fluoxetine and desipramine treatment in a prospective double-blind pharmacogenetics study in first-generation Mexican Americans and examined the role of whole-exome functional gene variations in the patients' antidepressant response. A total of 232 Mexican Americans who met DSM-IV criteria for major depressive disorder were randomly assigned to receive 8 weeks of double-blind treatment with desipramine (50-200 mg/day) or fluoxetine (10-40 mg/day) after a 1-week placebo lead-in period. Outcome measures included the Hamilton Depression Rating Scale (HAM-D), the Hamilton Anxiety Rating Scale, and the Beck Depression Inventory. At week 8, whole-exome genotyping data were obtained for 36 participants who remitted and 29 who did not respond to treatment. Compared with desipramine treatment, fluoxetine treatment was associated with a greater reduction in HAM-D score, higher response and remission rates, shorter time to response and remission, and lower incidences of anticholinergic and cardiovascular side effects. Pharmacogenetics analysis showed that exm-rs1321744 achieved exome-wide significance for treatment remission. This variant is located in a brain methylated DNA immunoprecipitation sequencing site, which suggests that it may be involved in epigenetic regulation of neuronal gene expression. This and two other common gene variants provided a highly accurate cross-validated predictive model for treatment remission of major depression (receiver operating characteristic integral=0.95). Compared with desipramine, fluoxetine treatment showed a more rapid reduction of HAM-D score and a lower incidence of side effects in a population comprising primarily first-generation Mexican Americans with major depression. This study's pharmacogenetics approach strongly implicates the role of functional variants in antidepressant treatment response.

[Mirtazapine versus other antidepressive agents for depression].

PubMed

Knud Larsen, Jens

2012-11-12

A Cochrane analysis compared efficacy and side effects of mirtazapine with other antidepressants. After six weeks of treatment no reliable difference of efficacy between mirtazapine, selective serotonin reuptake inhibitors (SSRI), noradrenaline reuptake inhibitors or tricyclic antidepressants was found. The side effects like increased sleep and weight gain were compared by treatment with mirtazapine and treatment with SSRI antidepressants. The very fact of the sleep effect and the fast onset of action have probably increased the effect size compared with SSRI antidepressants. The results of the Cochrane analysis cannot for certain be generalized to inpatients, as other studies have found tricyclic antidepressants to be especially effective.

Comparison of Autologous Serum Versus Preservative Free Artificial Tear in Patients with Dry Eyes Due to Systemic Isotretinoin Therapy.

PubMed

Yılmaz, Uğur; Küçük, Erkut; Koç, Çağdaş; Gökler, Enes

2017-06-01

To investigate dry eye development in the patients receiving systemic retinoic acid therapy and to compare effectiveness of Autologous Serum (AS) and preservative free artificial tear (PFAT) in the patients with dry eye disease. This prospective, crossover, double blind study was conducted on patients who have dry eyes due to systemic isotretinoin treatment for different indications. Patients detected as having dry eye during systemic isotretinoin treatment were included to our study. At baseline, 1 and 2 month of study, detailed ocular examination, best corrected visual acuity measurement, intraocular pressure measurement, and Tear Break-up Time (TBUT) and Schirmer Test (ST) without topical anesthesia were performed. We compared the efficacy of AS and PFAT. To accomplish crossover after the first month, treatment given to each patient was switched to the other treatment. Statistical analysis was measured using SPSS version 20.0. p values of < 0.05 were considered as statistically significant. At the end of the first month, there was a significant improvement for the TBUT test in both AS and PFAT groups compared to baseline (respectively p < 0.001, p < 0.001). TBUT was found to be significantly higher in the AS group compared to the PFAT group at the end of the first month (p < 0.001). At the end of the second month, TBUT was found to be significantly higher in the AS group compared to the PFAT group at the posttreatment time (p < 0.001). There was a significant OSDI score decreasing in both groups compared to that reported previously at the end of the first and second months (respectively p < 0.001, p < 0.001). OSDI score decreasing was more significant in the AS group compared to the PFAT group at both time points (respectively p < 0.001, p < 0.001). AS may be an effective alternative to PFAT in the treatment of dry eye developed during isotretinoin use.

Update on clinical trials in Dysphagia.

PubMed

Logemann, Jeri A

2006-04-01

Randomized clinical trials (RCTs) are often known as the gold standard in treatment efficacy studies. This article defines the characteristics of RCTs and the factors that investigators must consider in designing clinical trials in dysphagia. Design issues unique to behavioral treatments often used in dysphagia are discussed. Ongoing RCTs in dysphagia are described including studies of (1) the effectiveness of the Shaker exercise versus standardized treatment in patients with severe dysphagia resulting from stroke or treatment for head and neck cancer who have been nonoral for at least three months; (2) the comparative effects of nectar- and honey-thickened liquids versus chin tuck posture and in patients with dementia or Parkinson's disease with or without dementia who aspirate on thin liquids; and (3) the comparative effects of muscle exercise versus sensory postural therapy for dysphagia resulting from treatment for head and neck cancer. Issues in generalizing from the results of clinical trials are also described.

Abnormalities of P300 before and after antidepressant treatment in depression: an ERP-sLORETA study.

PubMed

Zhou, Lina; Wang, Gaohua; Wang, Huiling

2018-02-07

Despite a wide range of reports on depression-induced P300 changes, it is still debatable whether P300 can return to a pattern characteristic of healthy individuals following antidepressant treatment. Thus, the present study aims to compare P300 and its underlying neural activation in depressed patients before and after antidepressant treatment to explore the brain regions related to pathogenesis and to evaluate the prognosis after treatment. P300 was evoked by the oddball auditory paradigm and collected from 14 sex-matched, age-matched, and education level-matched patients and controls. P300 was also collected in the same patients after treatment. sLORETA was used to explore the source activation of P300 components. Depressed patients before and after antidepressant treatment tended to show lower P300 amplitudes compared with healthy controls, and their P300 amplitudes of F3 electrodes were correlated negatively to their scores on the 24-item Hamilton Depression Rating Scale, the Snaith-Hamilton Pleasure Scale, and the nine-item Patient Health Questionnaire. P300 amplitudes of P4 electrodes were correlated negatively with their scores on the Dysfunctional Attitude Scale. P300 source activation of depressed patients before antidepressant treatment was reduced in the left superior parietal lobule and the precuneus compared with healthy controls and depressed patients after treatment. No difference was found between healthy controls and depressed patients after treatment. The left superior parietal lobule and the precuneus might be therapeutic targets of depression.

Wellbeing during Active Surveillance for localised prostate cancer: a systematic review of psychological morbidity and quality of life.

PubMed

Carter, Gregory; Clover, Kerrie; Britton, Ben; Mitchell, Alex J; White, Martin; McLeod, Nicholas; Denham, Jim; Lambert, Sylvie D

2015-01-01

Active Surveillance (AS) is recommended for the treatment of localised prostate cancer; however this option may be under-used, at least in part because of expectations of psychological adverse events in those offered or accepting AS. (1) Determine the impact on psychological wellbeing when treated with AS (non-comparative studies). (2) Compare AS with active treatments for the impact on psychological wellbeing (comparative studies). We used the PRISMA guidelines and searched Medline, PsychInfo, EMBASE, CINHAL, Web of Science, Cochrane Library and Scopus for articles published January 2000-2014. Eligible studies reported original quantitative data on any measures of psychological wellbeing. We identified 34 eligible articles (n=12,497 individuals); 24 observational, eight RCTs, and two other interventional studies. Studies came from North America (16), Europe (14) Australia (3) and North America/Europe (1). A minority (5/34) were rated as high quality. Most (26/34) used validated instruments, whilst a substantial minority (14/34) used watchful waiting or no active treatment rather than Active Surveillance. There was modest evidence of no adverse impact on psychological wellbeing associated with Active Surveillance; and no differences in psychological wellbeing compared to active treatments. Patients can be informed that Active Surveillance involves no greater threat to their psychological wellbeing as part of the informed consent process, and clinicians need not limit access to Active Surveillance based on an expectation of adverse impacts on psychological wellbeing. Copyright © 2014 Elsevier Ltd. All rights reserved.

Ketorolac therapy for the prevention of acute pseudophakic cystoid macular edema: a systematic review

PubMed Central

Yilmaz, T; Cordero-Coma, M; Gallagher, M J

2012-01-01

To assess the effectiveness of ketorolac vs control for prevention of acute pseudophakic cystoid macular edema (CME). The following databases were searched: Medline (1950–June 11, 2011), The Cochrane Library (Issue 2, 2011), and the TRIP Database (up to 11 June 2011), using no language or other limits. Randomized controlled clinical trials (RCTs) were included that consisted of patients with acute pseudophakic cystoid macular edema, those comparing ketorolac with control, and those having at least a minimum follow-up of 28 days. In the four RCTs evaluating ketorolac vs control, treatment with ketorolac significantly reduced the risk of CME development at the end of treatment (∼4 weeks) compared to control (P=0.008; 95% confidence interval (0.03–0.58)). When analyzed individually, each individual study was statistically nonsignificant in its findings with the exception of one study. When the pooled relative risk was calculated, the large sample size of this systematic review led to overall statistical significance, which is attributable to the review's large sample size and not to the individual studies themselves. In this systematic review of four RCTs, two of which compared ketorolac with no treatment and two of which evaluated ketorolac vs placebo drops, treatment with ketorolac significantly reduced the risk of developing CME at the end of ∼4 weeks of treatment compared with controls. These results, however, should be interpreted with caution considering the paucity of large randomized clinical trials in the literature. PMID:22094296

Benzodiazepine use in seizure emergencies: A systematic review.

PubMed

Haut, Sheryl R; Seinfeld, Syndi; Pellock, John

2016-10-01

The aim of this review was to systematically examine safety and efficacy outcomes, as well as patient/caregiver satisfaction, from clinical studies in pediatric and adult patients treated with benzodiazepines (BZDs) through various administration routes in response to seizure emergencies. A literature search was conducted to identify articles describing the use of various routes of administration (RoAs) of BZDs for the treatment of seizure emergencies through April 21, 2015, using Embase™ and PubMed®. Eligible studies included (a) randomized controlled trials or (b) controlled nonrandomized clinical trials, either retrospective or prospective. Outcome assessments reviewed were 1) time to administration, 2) time to seizure termination, 3) rate of treatment failure, 4) prevention of seizure recurrence, 5) patient and caregiver treatment satisfaction, 6) adverse events related to BDZ treatment or RoA, and 7) respiratory adverse events. Seventy-five studies evaluated safety and efficacy using individual or comparator BDZs of various RoAs for treating seizure emergencies in all-aged patients with epilepsy. Buccal, intranasal (IN), or intramuscular (IM) BZDs were often more rapidly administered compared with rectal and intravenous (IV) formulations. Time to seizure termination, seizure recurrence rates, and adverse events were generally similar among RoAs, whereas nonrectal RoAs resulted in greater patient and caregiver satisfaction compared with rectal RoA. Results of this systematic literature review suggest that nonrectal and non-IV BZD formulations provide equal or improved efficacy and safety outcomes compared with rectal and IV formulations for the treatment of seizure emergencies. Copyright © 2016. Published by Elsevier Inc.

Weighing the potential effectiveness of various treatments for sleep bruxism.

PubMed

Huynh, Nelly; Manzini, Christiane; Rompré, Pierre H; Lavigne, Gilles J

2007-10-01

Sleep bruxism may lead to a variety of problems, but its pathophysiology has not been completely elucidated. As such, there is no definitive treatment, but certain preventive measures and/or drugs may be used in acute cases, particularly those involving pain. This article is intended to guide clinician scientists to the treatment most appropriate for future clinical studies. To determine the best current treatment, 2 measures were used to compare the results of 10 clinical studies on sleep bruxism, 3 involving oral devices and 7 involving pharmacologic therapy. The first measure, the number needed to treat (NNT), allows several randomized clinical studies to be compared and a general conclusion to be drawn. The second measure, effect size, allows evaluation of the impact of treatment relative to a placebo using different studies of similar design. Taking into account the NNT, the effect size and the power of each study, it can be concluded that the following treatments reduce sleep bruxism: mandibular advancement device, clonidine and occlusal splint. However, the first 2 of these have been linked to adverse effects. The occlusal splint is therefore the treatment of choice, as it reduces grinding noise and protects the teeth from premature wear with no reported adverse effects. The NNT could not be calculated for an alternative pharmacologic treatment, short-term clonazepam therapy, which had a large effect size and reduced the average bruxism index. However, the risk of dependency limits its use over long periods. Assessment of efficacy and safety of the most promising treatments will require studies with larger sample sizes over longer periods.

Malocclusion and the need for orthodontic treatment in 8-year-old children with Down syndrome: a cross-sectional population-based study.

PubMed

Andersson, Els-Marie; Axelsson, Stefan; Katsaris, Kristoffer P

2016-07-01

To describe the arch morphology and the prevalence and severity of malocclusions in 8-year-old children with DS, and to evaluate their need for treatment using the Norwegian Need for Orthodontic Treatment Index (NOTI), and comparing the findings with a control group. This population-based cross-sectional study was part of a national prospective study evaluating upper airway function, hearing, dental, and craniofacial characteristics in a cohort of children with DS in Norway. The cohort consisted of 32 children with DS and represented 57% of all children born with DS in Norway in 2002. Dental arch morphology and malocclusion were assessed on dental casts. Data were collected prospectively at the TAKO-centre, National Resource Center for Oral Health in Rare Medical Conditions. All the children with DS (100%) had objectively assessed needs for orthodontic treatment, compared with 30% of the normative comparison group. Among the children with DS, 68% were objectively categorized as being in "great need" (Category B) for treatment and the 75% were categorized as having "obvious need" (Category C). In comparison, only 20% of children without DS were in Category B, and 44% were in Category C. This study indicates significantly higher prevalence and severity of malocclusions in 8-year-old children with DS compared with control group. © 2016 Special Care Dentistry Association and Wiley Periodicals, Inc.

A comparative study of the effects of topical application of Aloe vera, thyroid hormone and silver sulfadiazine on skin wounds in Wistar rats

PubMed Central

Norouzian, Mohsen; Zarein-Dolab, Saeed; Dadpay, Masoomeh; Gazor, Roohollah

2012-01-01

Many research studies report the healing effects of Aloe Vera, thyroid hormone cream and silver sulfadiazine. However, the effects of these therapeutic agents are not well understood and have not been compared in one study. This study aimed at investigating the effects of topical application of an Aloe vera gel, a thyroid hormone cream and a silver sulfadiazine cream on the healing of skin wounds surgically induced in Wistar rats for determining the treatment of choice. In a randomized controlled trial, twelve male rats, aged 120 days and with a mean weight of 250 to 300 g, were divided randomly into 5 groups based on drug treatments: Aloe vera gel (AV), thyroid hormone cream (TC), silver sulfadiazine 1% (S), vehicle (V) and control. To evaluate the efficacy of each treatment technique, a biomechanical approach was used to assess tensile stress after 14 days of treatment. Tensile stress was significantly improved in the Aloe vera gel group as compared with the other four groups (P≤0.05). While the other treatment options resulted in better healing than the control group, this difference was not significant. We conclude that Aloe vera topical application accelerated the healing process more than thyroid hormone, silver sulfadiazine and vehicle in surgically induced incisions in rats. PMID:22474470

Are Children the Better Placebo Analgesia Responders? An Experimental Approach.

PubMed

Wrobel, Nathalie; Fadai, Tahmine; Sprenger, Christian; Hebebrand, Johannes; Wiech, Katja; Bingel, Ulrike

2015-10-01

There is little information regarding changes in placebo responsiveness with age, although first predictors of placebo responders such as psychological and physiological processes have been identified. Reviews and meta-analyses indicate that placebo response rates in randomized controlled trials (RCTs) are higher in children and adolescents compared with adults. As these studies cannot control for age-dependent differences in the natural course of the disease, biases might contribute to different placebo rates in RCTs. To avoid these biases, this study investigated age-related differences in placebo responsiveness between children and adults in a well-established experimental model of placebo analgesia combining classic conditioning and expectation. Our data confirm placebo analgesic responses in children, which did not differ in magnitude from those of adults. The influence of previous experience on subsequent treatment outcome was stronger in children than in adults, indicating an increased relevance of learning processes for treatment outcomes in children. Further studies are needed to understand the influence of treatment-related learning processes in children and adolescents, which might critically determine treatment responsiveness during adulthood. This study is the first to experimentally explore placebo analgesia and influences of previous experience on placebo responses in children compared with adults. We found comparable placebo responses in both groups and an increased relevance of learning processes for treatment outcomes in children. Copyright © 2015 American Pain Society. Published by Elsevier Inc. All rights reserved.

Retrospective Study to Compare Selective Decongestive Devascularization and Gastrosplenic Shunt versus Splenectomy with Pericardial Devascularization for the Treatment of Patients with Esophagogastric Varices Due to Cirrhotic Portal Hypertension.

PubMed

Bao, Haili; He, Qikuan; Dai, Ninggao; Ye, Ruifan; Zhang, Qiyu

2017-06-08

BACKGROUND For patients with esophagogastric varices secondary to portal hypertension due to liver cirrhosis, portosystemic shunts and devascularization have become the most commonly used treatment methods. We have developed a novel surgical approach for the treatment of patients with cirrhotic portal hypertension, selective decongestive devascularization, and shunt of the gastrosplenic region (SDDS-GSR). This aim of this study was to compare the efficacy and safety of SDDS-GSR with splenectomy with pericardial devascularization (SPD). MATERIAL AND METHODS A retrospective study was undertaken between 2006 and 2013 and included 110 patients with cirrhotic portal hypertension, 34 of whom underwent SDDS-GSR; 76 patients underwent SPD. Kaplan-Meier analysis was used to evaluate clinical outcomes, mortality, the incidence of re-bleeding, encephalopathy, and portal venous system thrombosis (PVST). RESULTS Postoperatively portal venous pressure decreased by 20% in both groups. The long-term incidence of re-bleeding and PVST was significantly lower in the SDDS-GSR group compared with the SPD group (P=0.018 and P=0.039, respectively). CONCLUSIONS This preliminary retrospective study has shown that SDDS-GSR was an effective treatment for patients with esophagogastric varices secondary to portal hypertension that may be used as a first-line treatment to prevent variceal bleeding and lower the incidence of PVST.

Characterizing smoking, cessation services, and quit interest across outpatient substance abuse treatment modalities

PubMed Central

McClure, Erin A.; Acquavita, Shauna P.; Dunn, Kelly E.; Stoller, Kenneth B.; Stitzer, Maxine L.

2013-01-01

The majority of individuals seeking treatment for substance use disorders are cigarette smokers, yet smoking cessation is rarely addressed during treatment. Conducting a detailed smoking-related characterization of substance abuse treatment patients across treatment modalities may facilitate the development of tailored treatment strategies. This study administered a battery of self-report instruments to compare tobacco use, quit attempts, smoking knowledge and attitudes, program services, and interest in quitting among smoking patients enrolled in opioid replacement therapy (ORT) vs. non-opioid replacement (non-ORT). ORT compared with non-ORT participants smoked more heavily, had greater tobacco dependence, and endorsed greater exposure to smoking cessation services at their treatment programs. Favorable attitudes towards cessation during treatment were found within both groups. These data identify several potential clinical targets, most notably including confidence in abstaining and attitudes toward cessation pharmacotherapies that may be addressed by substance abuse treatment clinics. PMID:23988192

Effectiveness of a treatment guideline for schizophrenia in adolescents: Lessons from a middle-income country.

PubMed

Ulloa, Rosa-Elena; Arce, Sofía; Victoria, Gamaliel; Sarmiento, Emmanuel; Jiménez, Israel; Arroyo, Eduardo; Díaz Calvo, Ana-Teresa; Del Valle, Miriam; Santos, Gabriela; Rosetti, Marcos; Apiquian, Rogelio

2018-02-01

Treatment guidelines for schizophrenia represent a standard way to manage patients, especially in countries with limited staff resources. However, they have not been compared on their efficacy with treatment as usual, despite adult studies suggesting they can be more effective. Inpatient and outpatient adolescents with schizophrenia were randomly allocated to be either treated according to a guideline-based treatment ( n = 43) or treatment as usual ( n = 44). The effects on symptoms, psychosocial functioning and cognition were compared in a 6-month follow-up. There were no differences between groups in the pharmacological treatment, reduction in symptom severity or cognition. The guideline-based treatment group showed a better functioning at months 3 and 6. The guideline-based treatment had a greater effect than the treatment as usual in the psychosocial functioning of adolescent patients ( www.clinicaltrials.gov ; II3/02/0811).

[Comparative study of combined local treatment (sulfadimidine, metronidazole and nystatin) and the standard monotherapy in uncomplicated bacterial vaginosis].

PubMed

Milánkovits, Márton; Baksay, László; Plachy, János

2002-12-22

Comparative, in vivo, human, prospective, single blind, clinical and microbiological diagnoses based and randomised study of the treatment of uncomplicated bacterial vaginosis with two forms of combined (metronidazole + nystatin + sulfadimidin) vaginal suppositories (laminated and mixed containing the same ingredients) and the standard preparations available in the Hungarian market (Dalacin vaginal cream and Klion vaginal suppository). The examinations involved 60 volunteers and were performed in the Gynecological Outpatient Clinic of the Council of Erd, the microbiological samples were examined at Saint Rókus Hospital in Budapest. The combined treatment was better tolerated and resulted in normal vaginal pH significantly more often at the same rate of recovery. The combined treatment is simultaneously effective in cases of the most prevalent coinfections too.

Combination Pharmacotherapies for Stimulant Use Disorder: A Review of Clinical Findings and Recommendations for Future Research

PubMed Central

Stoops, William W.; Rush, Craig R.

2014-01-01

Despite concerted efforts to identify a pharmacotherapy for managing stimulant use disorders, no widely effective medications have been approved. Innovative strategies are necessary to develop successful pharmacotherapies for stimulant use disorders. This manuscript reviews human laboratory studies and clinical trials to determine whether one such strategy, use of combination pharmacotherapies, holds promise. The extant literature shows that combination pharmacotherapy produced results that were better than placebo treatment, especially with medications shown to have efficacy as monotherapies. However, many studies did not compare individual constituents to the combination treatment, making it impossible to determine whether combination treatment is more effective than monotherapy. Future research should systematically compare combined treatments with individual agents using medications showing some efficacy when tested alone. PMID:24716825

On-demand tramadol hydrochloride use in premature ejaculation treatment.

PubMed

Kaynar, Mehmet; Kilic, Ozcan; Yurdakul, Talat

2012-01-01

To determine the efficacy of tramadol in premature ejaculation (PE) treatment compared with placebo. A single-blind, placebo-controlled, crossover study was conducted with 60 lifelong (primary) patients with PE. The patients were randomized into 2 groups, each consisting of 30 patients, who took tramadol or placebo on demand. PE was defined as an intravaginal ejaculation latency time of ≤60 seconds in 90% of intercourse episodes. The efficacy of the drugs was assessed using the intravaginal ejaculation latency time, ability of ejaculation control, and sexual satisfaction scores after an 8-week treatment period. All participants completed the study voluntarily. Two groups were similar in terms of the patient demographics. Increases in the intravaginal ejaculation latency time, ability of ejaculation control, and sexual satisfaction score between the placebo and tramadol groups were compared with the baseline values in both groups. At the end of study period, the tramadol group had significantly (P<.001) greater values for all 3 parameters compared with those in the placebo group. On-demand use of low-dose tramadol is effective for lifelong PE. Currently, selective seratonin reuptake inhibitors such as dapoxetine, are a more popular treatment option for PE. However, tramadol might be considered an alternative agent for primary PE treatment. Copyright © 2012 Elsevier Inc. All rights reserved.

[Treatment of Alcohol Withdrawal Syndrome with Oxazepam or Clomethiazole - A Naturalistic Observational Study].

PubMed

Verthein, Uwe; Kuhn, Silke; Gabriel, Katrin; Mautsch, Ulrich; Reimer, Jens; Behrendt, Klaus

2018-03-01

Whilst internationally benzodiazepines are first choice for treatment of alcohol withdrawal syndrome, Germany has a long tradition with clomethiazole. This study explores effectiveness of clomethiazole versus oxazepam in the treatment of alcohol withdrawal syndrome within an observational, stratified, non-inferiority study in routine care. Main outcome criterion was severity of the alcohol withdrawal syndrome (Alcohol Withdrawal Syndrome [AWS]) Scale in the first five days. Additionally, the association between the detoxification protocol (five vs. ten days) and AWS-Score was examined. 453 patients (74.2 % male, average age 47.1 years [± 9.2]) took part; 249 received oxazepam (55.0 %) and 204 clomethiazole (45.0 %). The average duration of inpatient treatment was 14.0 days (± 6.3) in both groups. The average AWS-score was lower in the oxazepam group compared to the clomethiazole group (50.0 [± 26.5] vs. 56.2 [± 31.5]; p < .05; effect size d = - .25). Patients with a shorter detoxification protocol had a lower AWS sum score compared to patients with a longer protocol (p < .001; d = - .46). In treatment of alcohol withdrawal syndrome in routine care oxazepam yields at least comparable results to clomethiazole. © Georg Thieme Verlag KG Stuttgart · New York.

The treatment of perfectionism within the eating disorders: a pilot study.

PubMed

Goldstein, Mandy; Peters, Lorna; Thornton, Christopher E; Touyz, Stephen W

2014-05-01

The aim of this pilot study was to investigate the impact of the direct treatment of perfectionism on the outcome of perfectionism and eating disorder pathology. Sixty-one participants, attending day hospital treatment, participated in a randomised controlled study, in which treatment as usual (TAU) was compared with TAU combined with a clinician-lead cognitive behavioural treatment for perfectionism (TAU+P). Linear mixed model analysis revealed no significant interaction effects but significant main effects for time on variables measuring eating pathology and perfectionism. Outcomes supported the effectiveness of overall treatment but suggested that adding direct treatment of perfectionism did not enhance treatment. The results are discussed in relation to the existing literature on the treatment of perfectionism. Copyright © 2014 John Wiley & Sons, Ltd and Eating Disorders Association.

Assessment of the quality of reporting observational studies in the pediatric dental literature.

PubMed

Butani, Yogita; Hartz, Arthur; Levy, Steven; Watkins, Catherine; Kanellis, Michael; Nowak, Arthur

2006-01-01

The purpose of this assessment was to evaluate reporting of observational studies in the pediatric dental literature. This assessment included the following steps: (1) developing a model for reporting information in clinical dentistry studies; (2) identifying treatment comparisons in pediatric dentistry that were evaluated by at least 5 observational studies; (3) abstracting from these studies any data indicated by applying the reporting model; and (4) comparing available data elements to the desired data elements in the reporting model. The reporting model included data elements related to: (1) patients; (2) providers; (3) treatment details; and (4) study design. Two treatment comparisons in pediatric dentistry were identified with 5 or more observational studies: (1) stainless steel crowns vs amalgams (10 studies); and (2) composite restorations vs amalgam (5 studies). Results from studies comparing the same treatments varied substantially. Data elements from the reporting model that could have explained some of the variation were often reported inadequately or not at all. Reporting of observational studies in the pediatric dental literature may be inadequate for an informed interpretation of the results. Models similar to that used in this study could be used for developing standards for the conduct and reporting of observational studies in pediatric dentistry.

Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis.

PubMed

Vieira, Maria-Cecilia; Zwillich, Samuel H; Jansen, Jeroen P; Smiechowski, Brielan; Spurden, Dean; Wallenstein, Gene V

2016-12-01

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This analysis compared the efficacy and safety of tofacitinib with biologic disease-modifying antirheumatic drugs in patients with RA and a prior inadequate response (IR) to tumor necrosis factor inhibitors (TNFi). A systematic literature review identified 5 randomized placebo-controlled trials that evaluated tofacitinib or biologic disease-modifying antirheumatic drugs (bDMARDs) against placebo in patient populations with RA with a prior IR to TNFi. The definition of TNFi-IR varied across studies, and included patients with an IR or who had failed treatment with TNFi for any reason. A network meta-analysis was conducted comparing study data with regard to American College of Rheumatology response rates and Health Assessment Questionnaire-Disability Index improvement at weeks 12 and 24, rates of treatment withdrawal due to all causes; adverse events (AEs) and lack of efficacy; and rates of AEs, serious AEs, and serious infections. The 5 trials included a total of 2136 patients. Tofacitinib 5 mg twice daily combined with methotrexate was found to have relative risk estimates of American College of Rheumatology responses and change from baseline in Health Assessment Questionnaire-Disability Index score comparable with abatacept, golimumab, rituximab, and tocilizumab combined with conventional synthetic disease-modifying antirheumatic drugs. Withdrawal rates from trials due to all causes and AEs were comparable between treatments, and tofacitinib had a lower rate of withdrawals due to lack of efficacy. Rates of AEs and HAQ-DI were comparable between tofacitinib, other active treatments, and placebo. No serious infections were reported with tofacitinib during the placebo-controlled period (up to week 12) in this study population; rates of serious infection with other active treatments were generally low and similar to placebo. During a 24-week period, tofacitinib had efficacy and rates of AEs comparable with currently available bDMARDs in the treatment of patients with RA who had a prior IR to TNFi. ClinicalTrials.gov identifiers: ORAL Step, NCT00960440; ATTAIN, NCT00124982; GO-AFTER, NCT00299546; RADIATE, NCT00106522; REFLEX, NCT00462345. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Comparative analysis of 11 different radioisotopes for palliative treatment of bone metastases by computational methods

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guerra Liberal, Francisco D. C., E-mail: meb12020@fe.up.pt, E-mail: adriana-tavares@msn.com; Tavares, Adriana Alexandre S., E-mail: meb12020@fe.up.pt, E-mail: adriana-tavares@msn.com; Tavares, João Manuel R. S., E-mail: tavares@fe.up.pt

Purpose: Throughout the years, the palliative treatment of bone metastases using bone seeking radiotracers has been part of the therapeutic resources used in oncology, but the choice of which bone seeking agent to use is not consensual across sites and limited data are available comparing the characteristics of each radioisotope. Computational simulation is a simple and practical method to study and to compare a variety of radioisotopes for different medical applications, including the palliative treatment of bone metastases. This study aims to evaluate and compare 11 different radioisotopes currently in use or under research for the palliative treatment of bonemore » metastases using computational methods. Methods: Computational models were used to estimate the percentage of deoxyribonucleic acid (DNA) damage (fast Monte Carlo damage algorithm), the probability of correct DNA repair (Monte Carlo excision repair algorithm), and the radiation-induced cellular effects (virtual cell radiobiology algorithm) post-irradiation with selected particles emitted by phosphorus-32 ({sup 32}P), strontium-89 ({sup 89}Sr), yttrium-90 ({sup 90}Y ), tin-117 ({sup 117m}Sn), samarium-153 ({sup 153}Sm), holmium-166 ({sup 166}Ho), thulium-170 ({sup 170}Tm), lutetium-177 ({sup 177}Lu), rhenium-186 ({sup 186}Re), rhenium-188 ({sup 188}Re), and radium-223 ({sup 223}Ra). Results: {sup 223}Ra alpha particles, {sup 177}Lu beta minus particles, and {sup 170}Tm beta minus particles induced the highest cell death of all investigated particles and radioisotopes. The cell survival fraction measured post-irradiation with beta minus particles emitted by {sup 89}Sr and {sup 153}Sm, two of the most frequently used radionuclides in the palliative treatment of bone metastases in clinical routine practice, was higher than {sup 177}Lu beta minus particles and {sup 223}Ra alpha particles. Conclusions: {sup 223}Ra and {sup 177}Lu hold the highest potential for palliative treatment of bone metastases of all radioisotopes compared in this study. Data reported here may prompt future in vitro and in vivo experiments comparing different radionuclides for palliative treatment of bone metastases, raise the need for the careful rethinking of the current widespread clinical use of {sup 89}Sr and {sup 153}Sm, and perhaps strengthen the use of {sup 223}Ra and {sup 177}Lu in the palliative treatment of bone metastases.« less

Rationale and design of ASTEROID 2, a randomized, placebo- and active comparator-controlled study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids.

PubMed

Seitz, Christian; Bumbuliene, Žana; Costa, Ana Rosa; Heikinheimo, Oskari; Heweker, Andrea; Hudeček, Robert; Jacquemyn, Yves; Melis, Gian Benedetto; Parashar, Pooja; Rechberger, Tomasz; Sánchez, Antonio Cano; van Aken, Bart; Zatik, János; Gemzell-Danielsson, Kristina

2017-04-01

Uterine fibroids (UFs) may be treated with progesterone receptor modulators (PRMs), which have been shown to reduce heavy menstrual bleeding and the size of UFs. To date, one PRM (ulipristal acetate) has received regulatory approval for the treatment of UFs; therapy comprises intermittent treatment courses of up to 3months each, followed by a break to allow two menstruations to occur. We report the design of ASTEROID (Assess Safety and efficacy of vilaprisan in patients with uTERine fibrOIDs) 2, a phase 2 study examining the efficacy and safety of a novel PRM, vilaprisan, in women with UFs. In this randomized multi-arm study, vilaprisan (2mg daily) will be administered in different regimens: continuous treatment for 12 or 24weeks, or two 12-week treatment periods separated by a break to allow one menstruation to occur. Efficacy and safety will be compared with that of ulipristal acetate (5mg daily) and placebo. Patients randomized to receive placebo for 12weeks will also be given active treatment for 12weeks. The primary measure of efficacy will be amenorrhoea rate; secondary measures include time to normalized menstrual bleeding and percentage change in UF volume. Endometrial changes will be monitored throughout the study. The placebo- and active comparator-controlled trial ASTEROID 2 is the first study to evaluate systematically the efficacy and safety of different treatment regimens of PRMs in women with UFs. The findings of this study will direct the planning of future clinical trials of vilaprisan. Copyright © 2017 Bayer AG. Published by Elsevier Inc. All rights reserved.

A systematic review and analysis of long-term outcomes in attention deficit hyperactivity disorder: effects of treatment and non-treatment

PubMed Central

2012-01-01

Background In childhood, attention deficit/hyperactivity disorder (ADHD) is characterized by age-inappropriate levels of inattentiveness/disorganization, hyperactivity/impulsiveness, or a combination thereof. Although the criteria for ADHD are well defined, the long-term consequences in adults and children need to be more comprehensively understood and quantified. We conducted a systematic review evaluating the long-term outcomes (defined as 2 years or more) of ADHD with the goal of identifying long-term outcomes and the impact that any treatment (pharmacological, non-pharmacological, or multimodal) has on ADHD long-term outcomes. Methods Studies were identified using predefined search criteria and 12 databases. Studies included were peer-reviewed, primary studies of ADHD long-term outcomes published between January 1980 to December 2010. Inclusion was agreed on by two independent researchers on review of abstracts or full text. Published statistical comparison of outcome results were summarized as poorer than, similar to, or improved versus comparators, and quantified as percentage comparisons of these categories. Results Outcomes from 351 studies were grouped into 9 major categories: academic, antisocial behavior, driving, non-medicinal drug use/addictive behavior, obesity, occupation, services use, self-esteem, and social function outcomes. The following broad trends emerged: (1) without treatment, people with ADHD had poorer long-term outcomes in all categories compared with people without ADHD, and (2) treatment for ADHD improved long-term outcomes compared with untreated ADHD, although not usually to normal levels. Only English-language papers were searched and databases may have omitted relevant studies. Conclusions This systematic review provides a synthesis of studies of ADHD long-term outcomes. Current treatments may reduce the negative impact that untreated ADHD has on life functioning, but does not usually 'normalize' the recipients. PMID:22947230

Antibiotic Treatment of Experimental Pneumonic Plague in Mice

PubMed Central

Byrne, William R.; Welkos, Susan L.; Pitt, M. Louise; Davis, Kelly J.; Brueckner, Ralf P.; Ezzell, John W.; Nelson, Gene O.; Vaccaro, Joseph R.; Battersby, Luann C.; Friedlander, Arthur M.

1998-01-01

A mouse model was developed to evaluate the efficacy of antibiotic treatment of pneumonic plague; streptomycin was compared to antibiotics with which there is little or no clinical experience. Infection was induced by inhalation of aerosolized Yersinia pestis organisms. Antibiotics were administered by intraperitoneal injection every 6 hours for 5 days, at doses that produced levels of drug in serum comparable to those observed in humans treated for other serious infections. These studies compared in vitro to in vivo activity and evaluated the efficacy of antibiotics started at different times after exposure. Early treatment (started 24 h after challenge, when 0 of 10 mice tested had positive blood cultures) with netilmicin, ciprofloxacin, ofloxacin, ceftriaxone, ceftazidime, aztreonam, ampicillin, and rifampin (but not cefazolin, cefotetan, or ceftizoxime) demonstrated efficacy comparable to streptomycin. Late treatment (started 42 h after exposure, when five of five mice tested had positive blood cultures) with netilmicin, ciprofloxacin, ofloxacin, and a high dose (20 mg/kg of body weight every 6 h) of gentamicin produced survival rates comparable to that with streptomycin, while all of the beta-lactam antibiotics (cefazolin, cefotetan, ceftriaxone, ceftazidime, aztreonam, and ampicillin) and rifampin were significantly inferior to streptomycin. In fact, all groups of mice treated late with beta-lactam antibiotics experienced accelerated mortality rates compared to normal-saline-treated control mice. These studies indicate that netilmicin, gentamicin, ciprofloxacin, and ofloxacin may be alternatives for the treatment of pneumonic plague in humans. However, the beta-lactam antibiotics are not recommended, based upon poor efficacy in this mouse model of pneumonic plague, particularly when pneumonic plague may be associated with bacteremia. PMID:9517950

Masticatory function and temporomandibular disorders in patients with dentofacial deformities.

PubMed

Abrahamsson, Cecilia

2013-01-01

About 30% of individuals in the Swedish population will at some stage during life have treatment with orthodontic appliances. In more severe cases, when orthodontic treatment is not considered sufficient enough to correct the malocclusion, the orthodontic treatment is combined with orthognathic surgery. For these cases, a satisfying jaw relation is achieved by surgically moving the maxilla and/or the mandible into a pre-planned position. Patients due to be treated with orthognathic surgery often suffer from an impaired masticatory function, symptoms from the masticatory muscles or temporomandibular joints (temporomandibular disorders), headaches as well as dissatisfaction with their facial aesthetics. Since orthognathic treatment is expensive, in many cases arduous to the patient and not without complications, it is important to assess the treatment outcome and if this is satisfying for the patients. Previous studies that have examined the outcome after orthognathic treatment have had diverging study designs and have come to different conclusions with regard to both temporomandibular disorders and masticatory function. The overall aim of this thesis was to assess and compare the frequencies of temporomandibular disorders and the masticatory function in patients with dentofacial deformities before and after orthognathic treatment. THE THESIS IS BASED ON THE FOLLOWING STUDIES: Paper I is a systematic literature review aiming to, in an evidence-based approach, answer the question whether orthognathic treatment affects the prevalence of signs and symptoms of temporomandibular disorders. The review encompasses the period from January 1966 to April 2006 and was further extended to May 2013 in the frame story of this thesis. CONCLUSIONS IN PAPER I AND THE COMPLEMENTARY SURVEY: There is insufficient scientific evidence for a decrease of sub diagnoses of temporomandibular disorders after orthognathic treatment. There is limited scientific evidence for a reduction of masticatory muscle pain on palpation after orthognathic treatment. There is insufficient scientific evidence for an effect on temporomandibular joint pain on palpation and temporomandibular joint sounds from orthognathic surgery. Further controlled, well-designed studies assessing temporomandibular disorders before and after orthognathic treatment are needed to consolidate strong evidence considering treatment outcomes. Papers II and III are studies comparing frequencies of temporomandibular disorders in patients with dentofacial deformities with a control group. The patients were referred for a combined orthodontic and orthognathic treatment to correct their malocclusion. The control group comprised individuals with normal occlusion or minor malocclusion traits not in need of orthodontic treatment. In Paper III, temporomandibular disorders were longitudinally analysed by assessing and comparing frequencies before and after orthognathic treatment. All individuals in the studies were diagnosed according to the research diagnostic criteria for temporomandibular disorders. CONCLUSIONS IN PAPERS II AND III: Patients due to be treated with orthognathic surgery had more signs and symptoms of temporomandibular disorders and a higher frequency of diagnosed temporomandibular disorders compared with the age- and gender matched control group. Patients with dentofacial deformities, corrected by orthodontic treatment in conjunction with orthognathic surgery, had a positive treatment outcome in respect of myofascial pain and arthralgia. After treatment the frequency of temporomandibular disorders . in the treatment group was low and at an equivalent level of that in the control group. Paper IV evaluates the self-estimated masticatory ability and the masticatory performance before and after orthognathic treatment in the same individuals as in Paper II and III. CONCLUSIONS IN PAPER IV: Masticatory ability and performance increased after orthognathic treatment. The number of occlusal contacts and severity of overall symptoms of TMD influenced both the masticatory ability and performance. Open bite had a negative effect on masticatory performance.

The effectiveness of the low-power laser and kinesiotaping in the treatment of carpal tunnel syndrome, a pilot study.

PubMed

Güner, A; Altan, L; Kasapoğlu Aksoy, M

2018-05-01

In mild and moderate cases of carpal tunnel syndrome (CTS), the conservative approach is suggested. The purpose of this study is to assess and compare the effect of low-power laser versus the combination of low-power laser and kinesiotaping on pain, muscle strength, functionality, and electrophysiologic parameters in the patients with CTS. The study was planned as single-blind, prospective, randomized control. 64 hands diagnosed with CTS were included in the study. The patients were randomly divided into three groups by closed envelope method. Low-power laser therapy was applied to Group 1 (21 hands), kinesiotaping and low-power laser therapy in group 2 (22 hands), sham laser therapy in Group 3 (21 hands). All patients were assessed by visual numeric pain scale (VNS), hand grip strength (HGS), finger pinch strength (FPS), the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ), before treatment, after treatment (3rd week), and after (12th week) 3 months the treatment with the same physician. Motor and sensory nerve conduction studies were performed with electroneuromyography (ENMG) before the treatment (0th week) and at the end of the 12th week. Comparison of the group 1 with the group 3 showed significantly better improvement in the former in VNS, BCTSQ at 3rd week and 12th week compared to 0th week, and in FPS and HGS at 3rd week. Comparison of the group 2 with the group 3 showed significantly better improvement in the former VNS, BCTSQ, FPS and HGS at 3rd and 12th week compared to 0th week. When Group 1 and Group 2 were compared there was no statistically significant difference in any parameters in the 3rd week, but there was a statistically significant difference in favor of group 2 in FPS and HGS parameters at the 12th week. We have found that the kinesiotaping method applied with low-power laser treatment does not provide any additional benefit to the low-power laser treatment in the short term, however, in the long term, the increase in the HGS and FPS has occurred. In conclusion, low-power laser and kinesiotaping method in the treatment of CTS may be an effective and reliable treatment option in clinical parameters.

Unresectable Hepatocellular Carcinoma: Radioembolization Versus Chemoembolization: A Systematic Review and Meta-analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lobo, Laila; Yakoub, Danny; Picado, Omar

BackgroundTransarterial radioembolization (TARE) has emerged as a newer regional therapy to transarterial chemoembolization (TACE) for treatment of unresectable hepatocellular carcinoma (HCC). The aim of this study is to compare clinical outcomes of both the techniques.MethodsOnline search for studies comparing TARE to TACE from 2005 to present was performed. Primary outcome was overall survival rate for up to 4 years. Secondary outcomes included post-treatment complications and treatment response. Quality of included studies was evaluated by STrengthening the Reporting of OBservational studies in Epidemiology criteria. Relative risk (RR) and 95 % confidence intervals (CI) were calculated from pooled data.ResultsThe search strategy yielded 172 studies,more » five met selection criteria and included 553 patients with unresectable HCC, 284 underwent TACE and 269 underwent TARE. Median ages were 63 and 64 years for TACE and TARE, respectively. Meta-analysis showed no statistically significant difference in survival for up to 4 years between the two groups (HR = 1.06; 95 % CI 0.81–1.46, p = 0.567). TACE required at least one day of hospital stay compared to TARE which was mostly an outpatient procedure. TACE had more post-treatment pain than TARE (RR = 0.51, 95 % CI 0.36–0.72, p < 0.01), but less subjective fatigue (RR = 1.68, 95 % CI 1.08–2.62, p < 0.01). There was no difference between the two groups in the incidence of post-treatment nausea, vomiting, fever, or other complications. In addition, there was no difference in partial or complete response rates between the two groups.ConclusionTARE appears to be a safe alternative treatment to TACE with comparable complication profile and survival rates. Larger prospective randomized trials, focusing on patient-reported outcomes and cost–benefit analysis are required to consolidate these results.« less

Treatment strategies for coronary in-stent restenosis: systematic review and hierarchical Bayesian network meta-analysis of 24 randomised trials and 4880 patients

PubMed Central

Giacoppo, Daniele; Gargiulo, Giuseppe; Aruta, Patrizia; Capranzano, Piera; Tamburino, Corrado

2015-01-01

Study question What is the most safe and effective interventional treatment for coronary in-stent restenosis? Methods In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses. Study answer and limitations Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval −0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a low number of events. Trials had heterogeneity regarding investigation periods, baseline characteristics, and endpoint reporting, with a lack of information at long term follow-up. Direct and indirect evidence was also inconsistent for the comparison between drug eluting stents and drug coated balloons. What this study adds Compared with other currently available interventional treatments for coronary in-stent restenosis, drug coated balloons and drug eluting stents are associated with superior clinical and angiographic outcomes, with a similar comparative efficacy. Funding, competing interests, data sharing This study received no external funding. The authors declare no competing interests. No additional data available. PMID:26537292

Orthodontic treatment of children/adolescents with special health care needs: an analysis of treatment length and clinical outcome

PubMed Central

2014-01-01

Background The aim of this retrospective study was to analyse the treatment time and differences between the pre- and post-treatment peer assessment rating (PAR) index and aesthetic component (AC) of the index of orthodontic treatment need (IOTN) scores in children/adolescents with special health care needs (SHCNs), compared to non-special health care needs (NSHCNs) controls. Methods Based on certain inclusion and exclusion criteria, medical records of SHCNs and randomly selected NSHCNs controls at the Department of Orthodontics, University Hospital Muenster were analysed retrospectively for the treatment time, number of appointments, chair time (“moderate” or “considerable”), PAR scores, and AC scores. Sample size calculation, descriptive statistics, and explorative analyses were performed using the Mann–Whitney U Test. Results Twenty-nine children with SHCNs (21 boys, 9 girls; median age: 11 years, pre-treatment) and 29 children with NSHCNs (12 boys, 17 girls; median age: 12 years, pre-treatment) were enrolled in this study. The overall treatment time did not differ between the patient groups. However, more “considerable chair time” was needed for the SHCNs group compared to the control group (p < 0.05), whereas “moderate chair time” was more often needed in patients with NSHCNs (p = 0.001). The age of the patients at the first and last appointments showed significant statistical differences: children in the SHCNs group commenced orthodontic treatment earlier, by a median of 1 year, compared to children in the NSHCNs group. The SHCNs group had significantly higher pre- and post-treatment PAR scores (median 21/median 6) and AC scores (median 9/median 3) compared to NSHCNs patients (PAR: median 17/median 0; AC: median 5/median 1). However, the overall treatment time and the overall PAR and AC score reduction did not differ significantly between the SHCNs and NSHCNs groups. Conclusions While the overall treatment time and number of appointments did not differ, the overall chair time was higher in the SHCNs group. The pre- and post-treatment PAR and AC scores were significantly higher in the SHCNs group. PMID:24915851

Insufficient evidence for effectiveness of any treatment for oral lichen planus.

PubMed

Keenan, Analia Veitz; Ferraiolo, Debra

2011-01-01

The Cochrane Oral Health Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), Medline and Embase databases were searched with no restrictions regarding language or date of publication. Bibliographies of identified publications were also checked for relevant studies, and authors were contacted to identify missing and unreported trials. The WHO International Trials Registry Platform was searched for ongoing studies, using the term 'oral lichen planus'. Randomised controlled clinical trials (RCTs) of therapy for symptomatic OLP which compared treatment with a placebo or between treatments or no intervention were considered for this review. The titles and abstracts of all reports identified were scanned independently by two review authors. All studies meeting the inclusion criteria were assessed for risk of bias and data were extracted. For dichotomous outcomes, the estimates of effects for the intervention were expressed as risk ratios (RR) together with 95% confidence intervals. For continuous outcomes, mean differences (MD) and 95% confidence intervals were used to summarise the data. Meta-analyses were conducted for studies with similar comparisons reporting the same outcome measures. Twenty-eight trials were included. Although topical steroids are considered first line treatment for symptomatic OLP, we identified no RCTs that compared steroids with placebo. There is no evidence from the three trials of pimecrolimus that this treatment is better than placebo in reducing pain from OLP. There is weak evidence from two trials, at unclear and high risk of bias respectively, that aloe vera may be associated with a reduction in pain compared to placebo, but it was not possible to pool the pain data from these trials. There is weak and unreliable evidence from two small trials, at high risk of bias, that cyclosporin may reduce pain and clinical signs of OLP, but meta-analysis of these trials was not possible.There were five trials that compared steroids with calcineurin inhibitors, each evaluating a different pair of interventions. There is no evidence from these trials that there is a difference between treatment with steroids compared to calcineurin inhibitors with regard to reducing pain associated with OLP. From six trials there is no evidence that any specific steroid therapy is more or less effective at reducing pain compared to another type or dose of steroid. From the 28 trials included in this systematic review, the wide range of interventions compared means there is insufficient evidence to support the effectiveness of any specific treatment as being superior.

Effectiveness of the homeopathic preparation Zeel compared with carprofen in dogs with osteoarthritis.

PubMed

Neumann, Stephan; Stolt, Pelle; Braun, Gabriele; Hellmann, Klaus; Reinhart, Erich

2011-01-01

The authors compared the symptomatic effectiveness of a complex homeopathic preparation Zeel (1-3 tablets orally per day depending on body weight) to carprofen (4 mg/kg body weight) in dogs (n=68) aged >1 yr diagnosed with osteoarthritis in a multicenter, prospective, observational open-label cohort study in 12 German veterinary clinics. The active treatment period was 56 days. Symptomatic effectiveness, lameness, stiffness of movements, and pain on palpation were evaluated by treating veterinarians and owners. Clinical signs of osteoarthritis improved significantly (P<0.05) at all time points (days 1, 28, and 56) with both therapies. At the end of the treatment period, effectiveness was comparable in both groups. Both treatment regimens were well tolerated with only three treatment-related adverse events, all in the carprofen group.

Cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% in the treatment of actinic keratosis in Spain.

PubMed

Nieves, Diana; Puig-Peiró, Ruth; Ferrándiz, Carlos; Plazas, Maria Josep; Brosa, Max

2015-06-01

The aim of this study is to conduct a cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% (5-FU/SA) in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain. An analytical decision-making model was constructed to compare whether 5-FU/SA was a cost-effective option compared with cryotherapy from the perspective of the Spanish National Health System with a time horizon of 6 months. Costs were expressed in 2014 euros. The cost of patients with hyperkeratotic actinic keratosis treated with 5-FU/SA or cryotherapy was €266 and €285, respectively. 5-FU/SA was associated with higher rates of treatment success and, consequently, more quality-adjusted life years, than cryotherapy. Therefore, 5-FU/SA was the dominant treatment, as it was associated with a lower treatment cost and greater effectiveness than cryotherapy. Economically, 5-FU/SA was a dominant option compared with cryotherapy in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain.

Balloon-occluded retrograde transvenous obliteration versus endoscopic injection sclerotherapy for isolated gastric varices: a comparative study.

PubMed

Emori, Keigo; Toyonaga, Atsushi; Oho, Kazuhiko; Kumamoto, Masafumi; Haruta, Tsuyoshi; Inoue, Hiroto; Morita, Yukihiko; Mitsuyama, Keiichi; Tsuruta, Osamu; Sata, Michio

2014-01-01

Isolated gastric varices (IGV) have a lower risk of bleeding than esophageal varices, however IGV bleeding is associated with a higher mortality than bleeding of esophageal varices. In recent years, two widely used treatments for IGV have been balloon-occluded retrograde transvenous obliteration (B-RTO) and endoscopic injection sclerotherapy (EIS) using cyanoacrylate or ethanolamine oleate (EO). This study compared these two treatment methods for IGV. The subjects were 112 patients who were treated at our hospital for IGV bleeding between October 1990 and December 2003. Forty-nine (49) patients were treated with B-RTO and 63 patients with EIS. These two patient groups were compared as regards content of treatment, post-treatment incidence of variceal bleeding, incidence of IGV rebleeding, survival rate, cause of death, and complications. Multivariate analysis was performed on post-treatment variceal bleeding and survival. Although EO was used in higher amounts in the B-RTO group than in the EIS group, the B-RTO group had a significantly lower number of treatment sessions and a significantly shorter treatment period (p<0.05). The EIS group had significantly more patients with IGV rebleeding after treatment than the B-RTO group. Treatment method was the only independent prognostic factor of IGV bleeding after treatment (p=0.024). The two groups did not differ significantly in the percentage of patients with aggravated esophageal varices after treatment. Bleeding from ectopic varices was not observed in any patient. There was no significant difference in survival by treatment method. The presence of hepatocellular carcinoma was the only independent prognostic factor for survival (p=0.003). It is concluded that B-RTO was more effective than EIS in the eradication of IGV and prevention of IGV recurrence and rebleeding.

Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial.

PubMed

Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

2014-12-01

Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

PubMed Central

Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

2014-01-01

Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care. PMID:25709653

The comparative effectiveness of clinic, work-site, phone, and Web-based tobacco treatment programs.

PubMed

An, Lawrence C; Betzner, Anne; Schillo, Barbara; Luxenberg, Michael G; Christenson, Matthew; Wendling, Ann; Saul, Jessie E; Kavanaugh, Annette

2010-10-01

Tobacco treatment programs may be offered in clinical settings, at work-sites, via telephone helplines, or over the Internet. Little comparative data exist regarding the real-world effectiveness of these programs. This paper compares the reach, effectiveness, and costs of these different modes of cessation assistance. This is an observational study of cohorts of participants in Minnesota's QUITPLAN programs in 2004. Cessation assistance was provided in person at 9 treatment centers, using group counseling at 68 work-sites, via a telephone helpline, or via the Internet. The main outcomes of the study are enrollment by current smokers, self-reported 30-day abstinence, and cost per quit. Reach was calculated statewide for the helpline and Web site, regionally for the treatment centers, and for the employee population for work-site programs. Enrollment was greatest for the Web site (n = 4,698), followed by the helpline (n = 2,351), treatment centers (n = 616), and work-sites (n = 479). The Web site attracted younger smokers. Smokers at treatment centers had higher levels of nicotine dependence. The helpline reached more socially disadvantaged smokers. Responder 30-day abstinence rates were higher for the helpline (29.3%), treatment centers (25.8%), and work-sites (19.6%) compared with the online program (12.5%). These differences persisted after controlling for baseline differences in participant characteristics and use of pharmacological therapy. The cost per quit was lowest for the Web site program ($291 per quit, 95% CI = $229-$372). Treatment center, work-site, helpline, and Web site programs differ in their reach, effectiveness, and estimated cost per quit. Each program plays a part in assisting populations of tobacco users in quitting.

Comparative safety and effectiveness of serotonin receptor antagonists in patients undergoing chemotherapy: a systematic review and network meta-analysis.

PubMed

Tricco, Andrea C; Blondal, Erik; Veroniki, Areti Angeliki; Soobiah, Charlene; Vafaei, Afshin; Ivory, John; Strifler, Lisa; Cardoso, Roberta; Reynen, Emily; Nincic, Vera; Ashoor, Huda; Ho, Joanne; Ng, Carmen; Johnson, Christy; Lillie, Erin; Antony, Jesmin; Roberts, Derek J; Hemmelgarn, Brenda R; Straus, Sharon E

2016-12-23

Although serotonin (5-HT 3 ) receptor antagonists are effective in reducing nausea and vomiting, they may be associated with increased cardiac risk. Our objective was to examine the comparative safety and effectiveness of 5-HT 3 receptor antagonists (e.g., dolasetron, granisetron, ondansetron, palonosetron, tropisetron) alone or combined with steroids for patients undergoing chemotherapy. We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception until December 2015 for studies comparing 5-HT 3 receptor antagonists with each other or placebo in chemotherapy patients. The search results were screened, data were abstracted, and risk of bias was appraised by pairs of reviewers, independently. Random-effects meta-analyses and network meta-analyses (NMAs) were conducted. After screening 9226 citations and 970 full-text articles, we included 299 studies (n = 58,412 patients). None of the included studies reported harms for active treatment versus placebo. For NMAs on the risk of arrhythmia (primary outcome; three randomized controlled trials [RCTs], 627 adults) and mortality (secondary outcome; eight RCTs, 4823 adults), no statistically significant differences were observed between agents. A NMA on the risk of QTc prolongation showed a significantly greater risk for dolasetron + dexamethasone versus ondansetron + dexamethasone (four RCTs, 3358 children and adults, odds ratio 2.94, 95% confidence interval 2.13-4.17). For NMAs on the number of patients without nausea (44 RCTs, 11,664 adults, 12 treatments), number of patients without vomiting (63 RCTs, 15,460 adults, 12 treatments), and number of patients without chemotherapy-induced nausea or vomiting (27 RCTs, 10,924 adults, nine treatments), all agents were significantly superior to placebo. For a NMA on severe vomiting (10 RCTs, 917 adults), all treatments decreased the risk, but only ondansetron and ramosetron were significantly superior to placebo. According to a rank-heat plot with the surface under the cumulative ranking curve results, palonosetron + steroid was ranked the safest and most effective agent overall. Most 5-HT 3 receptor antagonists were relatively safe when compared with each other, yet none of the studies compared active treatment with placebo for harms. However, dolasetron + dexamethasone may prolong the QTc compared to ondansetron + dexamethasone. All agents were effective for reducing risk of nausea, vomiting, and chemotherapy-induced nausea or vomiting. This study was registered at PROSPERO: ( CRD42013003564 ).

Neuromodulation integrating rTMS and neurofeedback for the treatment of autism spectrum disorder: an exploratory study.

PubMed

Sokhadze, Estate M; El-Baz, Ayman S; Tasman, Allan; Sears, Lonnie L; Wang, Yao; Lamina, Eva V; Casanova, Manuel F

2014-12-01

Autism spectrum disorder (ASD) is a pervasive developmental disorder characterized by deficits in social interaction, language, stereotyped behaviors, and restricted range of interests. In previous studies low frequency repetitive transcranial magnetic stimulation (rTMS) has been used, with positive behavioral and electrophysiological results, for the experimental treatment in ASD. In this study we combined prefrontal rTMS sessions with electroencephalographic (EEG) neurofeedback (NFB) to prolong and reinforce TMS-induced EEG changes. The pilot trial recruited 42 children with ASD (~14.5 years). Outcome measures included behavioral evaluations and reaction time test with event-related potential (ERP) recording. For the main goal of this exploratory study we used rTMS-neurofeedback combination (TMS-NFB, N = 20) and waitlist (WTL, N = 22) groups to examine effects of 18 sessions of integrated rTMS-NFB treatment or wait period) on behavioral responses, stimulus and response-locked ERPs, and other functional and clinical outcomes. The underlying hypothesis was that combined TMS-NFB will improve executive functions in autistic patients as compared to the WTL group. Behavioral and ERP outcomes were collected in pre- and post-treatment tests in both groups. Results of the study supported our hypothesis by demonstration of positive effects of combined TMS-NFB neurotherapy in active treatment group as compared to control WTL group, as the TMS-NFB group showed significant improvements in behavioral and functional outcomes as compared to the WTL group.

Neuromodulation integrating rTMS and neurofeedback for the treatment of autism spectrum disorder: An exploratory study

PubMed Central

Sokhadze, Estate M.; El-Baz, Ayman S.; Tasman, Allan; Sears, Lonnie L.; Wang, Yao; Lamina, Eva V.; Casanova, Manuel F.

2014-01-01

Autism spectrum disorder (ASD) is a pervasive developmental disorder characterized by deficits in social interaction, language, stereotyped behaviors, and restricted range of interests. In previous studies low frequency repetitive transcranial magnetic stimulation (rTMS) has been used, with positive behavioral and electrophysiological results, for the experimental treatment in ASD. In this study we combined prefrontal rTMS sessions with electroencephalographic (EEG) neurofeedback (NFB) to prolong and reinforce TMS-induced EEG changes. The pilot trial recruited 42 children with ASD (~14.5 yrs). Outcome measures included behavioral evaluations and reaction time test with event-related potential (ERP) recording. For the main goal of this exploratory study we used rTMS-neurofeedback combination (TMS-NFB, N=20) and waitlist (WTL, N=22) groups to examine effects of 18 sessions of integrated rTMS-NFB treatment or wait period) on behavioral responses, stimulus and response-locked ERPs, and other functional and clinical outcomes. The underlying hypothesis was that combined TMS-NFB will improve executive functions in autistic patients as compared to the waitlist group. Behavioral and ERP outcomes were collected in pre- and post-treatment tests in both groups. Results of the study supported our hypothesis by demonstration of positive effects of combined TMS-NFB neurotherapy in active treatment group as compared to control waitlist group, as the TMS-NFB group showed significant improvements in behavioral and functional outcomes as compared to the waitlist group. PMID:25267414

Comparison of anesthetics in electroconvulsive therapy: an effective treatment with the use of propofol, etomidate, and thiopental.

PubMed

Zahavi, Guy Sender; Dannon, Pinhas

2014-01-01

Electroconvulsive therapy (ECT) is considered to be one of the most effective treatments in psychiatry. Currently, three medications for anesthesia are used routinely during ECT: propofol, etomidate, and thiopental. The objective of this study was to evaluate the effects of the anesthetics used in ECT on seizure threshold and duration, hemodynamics, recovery from ECT, and immediate side effects. Our study is a retrospective cohort study, in which a comparison was made between three groups of patients who underwent ECT and were anesthetized with propofol, etomidate, or thiopental. The main effect compared was treatment dose and seizure duration. All patients were chosen as responders to ECT. Data were gathered about 91 patients (39 were anesthetized with thiopental, 29 with etomidate, and 23 with propofol). Patients in the thiopental group received a lower electrical dose compared to the propofol and etomidate group (mean of 459 mC compared to 807 mC and 701 mC, respectively, P<0.001). Motor seizure duration was longer in the thiopental group compared to propofol and etomidate (mean of 40 seconds compared to 21 seconds and 23 seconds, respectively, P=0.018). Seizure duration recorded by electroencephalography was similar in the thiopental and etomidate groups and lower in the propofol group (mean of 57 seconds in both groups compared to 45 seconds, respectively, P=0.038). Patients who were anesthetized with thiopental received a lower electrical treatment dose without an unwanted decrease in seizure duration. Thiopental might be the anesthetic of choice when it is congruent with other medical considerations.

Comparison of survival in adult antiretroviral treatment naïve patients treated in primary health care centers versus those treated in hospitals: retrospective cohort study; Oromia region, Ethiopia.

PubMed

Megerso, Abebe; Garoma, Sileshi

2016-10-18

Antiretroviral treatment (ART) service scaling up has been practiced in the Ethiopia since 2006. Regardless of increasing number of primary health care centers providing the service, the existing hospitals are still overcrowded with ART service seeking patients may be because of the common belief that treatment outcome is better for hospital patients than those treated at the primary health centers. However, documented evidence comparing the treatment outcome for the two categories of health facilities is scarce in the study setting. The purpose of the current study was to compare major treatment outcomes among new patients treated at the two health facility categories. Retrospective cohort study was implemented using secondary data from medical records collected between October 2010 and January 2014 in the selected health facilities. All patients (1895) who started the treatment in the facilities during the period were included in the study. Univariate analyses were made using descriptive methods such as frequency distributions and measures of central tendency. Bivariate and multivariate analyses were made using Kaplan Meier and Cox regression models respectively to compare the mean survival time between the two facility categories. P-value less than 0.05 was considered as statistically significant. A total of 1895 patient records were followed for 27,990 person-months. Risks of unwanted treatment outcomes (death and lose-to-follow-up) were the same for both categories of patients. The median survival probability was similar to the facility categories (P-value = 0.11). Baseline performance scale III/IV (AHR, 2.4; 95 % CI: 2.0, 3.0), baseline WHO clinical stages III/IV (AHR, 2.8; 95 % CI: 2.3, 3.4), and low adherence (<95 %) to ART drugs (AHR, 3.4; 95 % CI: 2.8, 5.2) were the independent predictors of the unwanted treatment outcomes. Antiretroviral treatment service delivery at primary health care facilities did not compromise the treatment outcomes among adult ART naïve patients. This implies that, ART services decentralization can result in acceptable treatment outcome in less developed settings. Therefore, treatment requiring patients should be encouraged to start the treatment in either of the health facilities as early as possible.

Drug delivery systems for ovarian cancer treatment: a systematic review and meta-analysis of animal studies

PubMed Central

Raavé, René; de Vries, Rob B.M.; Massuger, Leon F.; van Kuppevelt, Toin H.

2015-01-01

Current ovarian cancer treatment involves chemotherapy that has serious limitations, such as rapid clearance, unfavorable biodistribution and severe side effects. To overcome these limitations, drug delivery systems (DDS) have been developed to encapsulate chemotherapeutics for delivery to tumor cells. However, no systematic assessment of the efficacy of chemotherapy by DDS compared to free chemotherapy (not in a DDS) has been performed for animal studies. Here, we assess the efficacy of chemotherapy in DDS on survival and tumor growth inhibition in animal studies. We searched PubMed and EMBASE (via OvidSP) to systematically identify studies evaluating chemotherapeutics encapsulated in DDS for ovarian cancer treatment in animal studies. Studies were assessed for quality and risk of bias. Study characteristics were collected and outcome data (survival/hazard ratio or tumor growth inhibition) were extracted and used for meta-analyses. Meta-analysis was performed to identify and explore which characteristics of DDS influenced treatment efficacy. A total of 44 studies were included after thorough literature screening (2,735 studies found after initial search). The risk of bias was difficult to assess, mainly because of incomplete reporting. A total of 17 studies (377 animals) and 16 studies (259 animals) could be included in the meta-analysis for survival and tumor growth inhibition, respectively. In the majority of the included studies chemotherapeutics entrapped in a DDS significantly improved efficacy over free chemotherapeutics regarding both survival and tumor growth inhibition. Subgroup analyses, however, revealed that cisplatin entrapped in a DDS did not result in additional tumor growth inhibition compared to free cisplatin, although it did result in improved survival. Micelles did not show a significant tumor growth inhibition compared to free chemotherapeutics, which indicates that micelles may not be a suitable DDS for ovarian cancer treatment. Other subgroup analyses, such as targeted versus non-targeted DDS or IV versus IP administration route, did not identify specific characteristics of DDS that affected treatment efficacy. This systematic review shows the potential, but also the limitations of chemotherapy by drug delivery systems for ovarian cancer treatment. For future animal research, we emphasize that data need to be reported with ample attention to detailed reporting. PMID:26713240

A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain.

PubMed

Furlan, Andrea D; Yazdi, Fatemeh; Tsertsvadze, Alexander; Gross, Anita; Van Tulder, Maurits; Santaguida, Lina; Gagnier, Joel; Ammendolia, Carlo; Dryden, Trish; Doucette, Steve; Skidmore, Becky; Daniel, Raymond; Ostermann, Thomas; Tsouros, Sophia

2012-01-01

Background. Back pain is a common problem and a major cause of disability and health care utilization. Purpose. To evaluate the efficacy, harms, and costs of the most common CAM treatments (acupuncture, massage, spinal manipulation, and mobilization) for neck/low-back pain. Data Sources. Records without language restriction from various databases up to February 2010. Data Extraction. The efficacy outcomes of interest were pain intensity and disability. Data Synthesis. Reports of 147 randomized trials and 5 nonrandomized studies were included. CAM treatments were more effective in reducing pain and disability compared to no treatment, physical therapy (exercise and/or electrotherapy) or usual care immediately or at short-term follow-up. Trials that applied sham-acupuncture tended towards statistically nonsignificant results. In several studies, acupuncture caused bleeding on the site of application, and manipulation and massage caused pain episodes of mild and transient nature. Conclusions. CAM treatments were significantly more efficacious than no treatment, placebo, physical therapy, or usual care in reducing pain immediately or at short-term after treatment. CAM therapies did not significantly reduce disability compared to sham. None of the CAM treatments was shown systematically as superior to one another. More efforts are needed to improve the conduct and reporting of studies of CAM treatments.

Indirect Treatment Comparisons of Ibrutinib Versus Physician's Choice and Idelalisib Plus Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia.

PubMed

Sorensen, Sonja; Wildgust, Mark; Sengupta, Nishan; Trambitas, Cristina; Diels, Joris; van Sanden, Suzy; Xu, Yingxin; Dorman, Emily

2017-01-01

Treatment options for patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL) are limited. Until recently, few effective treatment options existed, and even with the advent of new agents, studies evaluating comparative efficacy are scarce. In the Ibrutinib Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RESONATE) Phase III study, ibrutinib, an oral, once-a-day, first-in-class covalent Bruton tyrosine kinase inhibitor, improved progression-free survival (PFS) and overall survival (OS) compared with ofatumumab (PFS hazard ratio [HR] = 0.106 and OS HR = 0.369 [adjusted for crossover] at a median of 16 months' follow-up). We sought to establish the relative efficacy of ibrutinib versus other treatment options for patients with R/R CLL using indirect comparison methods. A systematic literature review was conducted to identify clinical trials sharing a common treatment arm with the RESONATE Phase III trial such that a network meta-analysis or indirect treatment comparisons (ITCs) could be conducted. Two trials were identified, each using the same comparator (ofatumumab) as the RESONATE study. Two pairwise ITCs were conducted using the Bucher method to establish the relative treatment efficacy of ibrutinib versus (1) idelalisib plus ofatumumab in the first study and (2) physician's choice, defined as a mix of therapies commonly used in R/R CLL, in the second study. Odds ratios for these ITCs were calculated for overall response rate (ORR) and HRs for PFS and OS. A strong and consistent trend of superiority for ibrutinib was observed via these ITC models with idelalisib plus ofatumumab and physician's choice for ORR, PFS, and OS. Ibrutinib revealed prolonged PFS and OS versus comparators (PFS HR = 0.06; 95% CI, 0.04-0.11; and OS HR = 0.25; 95% CI, 0.12-0.54), physician's choice (PFS HR = 0.41; 95% CI, 0.25-0.66; and OS HR = 0.50; 95% CI, 0.23-1.08), and idelalisib plus ofatumumab. These findings were robust and continued to favor ibrutinib when adjusting (where appropriate) for underlying differences in patient population between the trials. Some trial differences were not accounted for in the models and thus some limitations remain; however, consistency of results supports the overall findings. In a randomized Phase III study, ibrutinib significantly improved ORR, PFS, and OS in patients with R/R CLL versus ofatumumab. In ITC models that used ofatumumab as the common comparator, ibrutinib appears to have higher ORR and longer PFS and OS versus both idelalisib plus ofatumumab and physician's choice. In the absence of head-to-head studies and taking into consideration inherent limitations of ITCs, these models provide useful estimates of comparative efficacy. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Oseltamivir Treatment for Children with Influenza-Like Illness in China: A Cost-Effectiveness Analysis.

PubMed

Shen, Kunling; Xiong, Tengbin; Tan, Seng Chuen; Wu, Jiuhong

2016-01-01

Influenza is a common viral respiratory infection that causes epidemics and pandemics in the human population. Oseltamivir is a neuraminidase inhibitor-a new class of antiviral therapy for influenza. Although its efficacy and safety have been established, there is uncertainty regarding whether influenza-like illness (ILI) in children is best managed by oseltamivir at the onset of illness, and its cost-effectiveness in children has not been studied in China. To evaluate the cost-effectiveness of post rapid influenza diagnostic test (RIDT) treatment with oseltamivir and empiric treatment with oseltamivir comparing with no antiviral therapy against influenza for children with ILI. We developed a decision-analytic model based on previously published evidence to simulate and evaluate 1-year potential clinical and economic outcomes associated with three managing strategies for children presenting with symptoms of influenza. Model inputs were derived from literature and expert opinion of clinical practice and research in China. Outcome measures included costs and quality-adjusted life year (QALY). All the interventions were compared with incremental cost-effectiveness ratios (ICER). In base case analysis, empiric treatment with oseltamivir consistently produced the greatest gains in QALY. When compared with no antiviral therapy, the empiric treatment with oseltamivir strategy is very cost effective with an ICER of RMB 4,438. When compared with the post RIDT treatment with oseltamivir, the empiric treatment with oseltamivir strategy is dominant. Probabilistic sensitivity analysis projected that there is a 100% probability that empiric oseltamivir treatment would be considered as a very cost-effective strategy compared to the no antiviral therapy, according to the WHO recommendations for cost-effectiveness thresholds. The same was concluded with 99% probability for empiric oseltamivir treatment being a very cost-effective strategy compared to the post RIDT treatment with oseltamivir. In the Chinese setting of current health system, our modelling based simulation analysis suggests that empiric treatment with oseltamivir to be a cost-saving and very cost-effective strategy in managing children with ILI.

Comparison of the efficacy and safety of intensive-dose and standard-dose statin treatment for stroke prevention

PubMed Central

Wang, Juan; Chen, Dan; Li, Da-Bing; Yu, Xin; Shi, Guo-Bing

2016-01-01

Abstract Background: Previous study indicated that high-dose statin treatment might increase the risk of hemorrhagic stroke and adverse reactions. We aim to compare the efficacy and safety of intensive-dose and standard-dose statin treatment for preventing stroke in high-risk patients. Methods: A thorough search was performed of multiple databases for publications from 1990 to June 2015. We selected the randomized clinical trials comparing standard-dose statin with placebo and intensive-dose statin with standard-dose statin or placebo for the prevention of stroke events in patients. Duplicate independent data extraction and bias assessments were performed. Data were pooled using a fixed-effects model or a random-effects model if significant heterogeneity was present. Results: For the all stroke incidences, intensive-dose statin treatment compared with placebo treatment and standard-dose statin treatment compared with placebo treatment showed a significant 21% reduction in relative risk (RR) (RR 0.79, 95% confidence interval (CI) [0.71, 0.87], P < 0.00001) and an 18% reduction in RR (RR 0.82, 95% CI [0.73, 0.93], P = 0.002) in the subgroup without renal transplant recipients and patients undergoing regular hemodialysis separately. For the fatal stroke incidences, intensive-dose statin treatment compared with standard dose or placebo was effective reducing fatal stroke (RR 0.61, 95% CI [0.39, 0.96], P = 0.03) and the RR was 1.01 (95% CI [0.85, 1.20], P = 0.90) in standard-dose statin treatment compared with placebo. Conclusion: The results of this meta-analysis suggest that intensive-dose statin treatment might be more favorable for reducing the incidences of all strokes than standard-dose statin treatment, especially for patients older than 65 years in reducing the incidences of all stroke incidences. PMID:27684837

Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design.

PubMed

Bian, Zhao-Xiang; Moher, David; Dagenais, Simon; Li, You-Ping; Liu, Liang; Wu, Tai-Xiang; Miao, Jiang-Xia

2006-03-01

To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical characteristics of test intervention as closely as possible and is completely inert; (5) No treatment control groups should only be used when withholding treatment is ethical and objectives outcomes will not be subject to bias due to absent blinding; (6) Crossover control groups may be appropriate in chronic and stable conditions.

Comparing the Effects of Four Instructional Treatments on EFL Students' Achievement in Writing Classified Ads

ERIC Educational Resources Information Center

Khodabandeh, Farzaneh

2016-01-01

The current study set out to compare the effect of traditional and non-traditional instructional treatments; i.e. explicit, implicit, task-based and no-instruction approaches on students' abilities to learn how to write classified ads. 72 junior students who have all taken a course in Reading Journalistic Texts at the Payame-Noor University…

Comparing the efficacy of four immersion flush and static hydorgen peroxide and copper sulfate treatments on channel catfish eggs infected with water molds

USDA-ARS?s Scientific Manuscript database

Water mold infestations on channel catfish eggs lower the hatch rate (egg survival) and ultimately the number of catfish fry available for stocking in production ponds. This study compared the potential of two hydrogen peroxide (HP) and two copper sulfate pentahydrate (CSP) treatments to increase c...

Self-stigma and the intention to seek psychological help online compared to face-to-face.

PubMed

Wallin, Emma; Maathz, Pernilla; Parling, Thomas; Hursti, Timo

2018-07-01

The present study aims to investigate the impact of help-seeking self-stigma on the preference and intention to seek psychological treatment delivered online compared to face-to-face. This study uses survey data from two Swedish samples. Sample 1 consists of 267 students (78.7% women) with a mean age of 24.5 (SD = 6.1). Sample 2 consists of 195 primary care patients (56.9% women) with a mean age of 45.3 (SD = 17.7). The number of participants who preferred online treatment was higher if seeking psychological help for a perceived stigmatized problem compared to mental health problems in general. The odds ratios for choosing treatment online over face-to-face were 6.41, 95% CI [4.05, 10.14] in Sample 1 and 11.19, 95% CI [5.29, 23.67] in Sample 2. In addition, findings suggest that higher levels of help-seeking self-stigma predicted higher intention to seek treatment online compared to face-to-face. Our results suggest that online interventions may facilitate help-seeking among individuals deterred by stigma. © 2018 Wiley Periodicals, Inc.

Photodynamic Therapy for Actinic Keratoses: A Randomized Prospective Non-sponsored Cost-effectiveness Study of Daylight-mediated Treatment Compared with Light-emitting Diode Treatment.

PubMed

Neittaanmäki-Perttu, Noora; Grönroos, Mari; Karppinen, Toni; Snellman, Erna; Rissanen, Pekka

2016-02-01

Daylight-mediated photodynamic therapy (DL-PDT) is considered as effective as conventional PDT using artificial light (light-emitting diode (LED)-PDT) for treatment of actinic keratoses (AK). This randomized prospective non-sponsored study assessed the cost-effectiveness of DL-PDT compared with LED-PDT. Seventy patients with 210 AKs were randomized to DL-PDT or LED-PDT groups. Effectiveness was assessed at 6 months. The costs included societal costs and private costs, including the time patients spent in treatment. Results are presented as incremental cost-effectiveness ratio (ICER). The total costs per patient were significantly lower for DL-PDT (€132) compared with LED-PDT (€170), giving a cost saving of €38 (p = 0.022). The estimated probabilities for patients' complete response were 0.429 for DL-PDT and 0.686 for LED-PDT; a difference in probability of being healed of 0.257. ICER showed a monetary gain of €147 per unit of effectiveness lost. DL-PDT is less costly and less effective than LED-PDT. In terms of cost-effectiveness analysis, DL-PDT provides lower value for money compared with LED-PDT.

Surface Erosion Control Techniques on Newly Constructed Forest Roads

Treesearch

Johnny M. Grace; John Wilhoit; Robert Rummer; Bryce Stokes

1999-01-01

A newly constructed forest road was treated with three erosion control treatments: wood excelsior erosion mat, native grass species, and exotic grass species. The study evaluates treatment methods on the basis of sediment reduction and runoff volume reduction compared to no treatment. The erosion mat treatment was most effective in mitigating erosion losses with a 98...

Prospective observational study comparing three different treatment regimes in patients with Clostridium difficile infection.

PubMed

Wenisch, Judith M; Schmid, Daniela; Kuo, Hung-Wei; Allerberger, Franz; Michl, Verena; Tesik, Philip; Tucek, Gerhard; Laferl, Hermann; Wenisch, Christoph

2012-04-01

In a hospital-based, prospective cohort study, the effects of the three standard treatment regimens for mild Clostridium difficile infection (CDI), oral (p.o.) metronidazole at 500 mg three times/day, intravenous (i.v.) metronidazole at 500 mg three times/day, and oral (p.o.) vancomycin at 250 mg four times/day, were compared with respect to the risk of occurrence of complications, sequelae, and all-cause death within 30 days after the date of starting treatment. Differences in the incidence of these outcomes were tested by χ² or Fisher's exact tests. A Poisson regression model was performed to control for possible confounding effects of sex, age, and severity of comorbidity categorized according to the Charlson comorbidity index. The highest mortality was observed in the metronidazole i.v. group, with a mortality rate 38.1% (16/42) compared to mortality rates of 7.4% (9/121) in the metronidazole p.o. group and 9.5% (4/42) in the vancomycin p.o. group (P < 0.001). After adjustment for possible effects of sex, age (> 65 years), and severity of comorbidity, the relative risk of a 30-day fatal outcome for patients receiving metronidazole i.v. was 4.3 (95% confidence interval [CI] = 1.92 to 10; P < 0.0001) compared to patients treated with metronidazole p.o. and 4.0 (95% CI = 1.31 to 5.0; P < 0.015) compared to patients treated with vancomycin p.o. There were no significant differences in the risk of complications between the three treatment groups. This study generates the hypothesis that treatment with i.v. metronidazole is inferior to the oral alternatives metronidazole and vancomycin.

Prospective Observational Study Comparing Three Different Treatment Regimes in Patients with Clostridium difficile Infection

PubMed Central

Wenisch, Judith M.; Schmid, Daniela; Kuo, Hung-Wei; Allerberger, Franz; Michl, Verena; Tesik, Philip; Tucek, Gerhard; Laferl, Hermann

2012-01-01

In a hospital-based, prospective cohort study, the effects of the three standard treatment regimens for mild Clostridium difficile infection (CDI), oral (p.o.) metronidazole at 500 mg three times/day, intravenous (i.v.) metronidazole at 500 mg three times/day, and oral (p.o.) vancomycin at 250 mg four times/day, were compared with respect to the risk of occurrence of complications, sequelae, and all-cause death within 30 days after the date of starting treatment. Differences in the incidence of these outcomes were tested by χ2 or Fisher's exact tests. A Poisson regression model was performed to control for possible confounding effects of sex, age, and severity of comorbidity categorized according to the Charlson comorbidity index. The highest mortality was observed in the metronidazole i.v. group, with a mortality rate 38.1% (16/42) compared to mortality rates of 7.4% (9/121) in the metronidazole p.o. group and 9.5% (4/42) in the vancomycin p.o. group (P < 0.001). After adjustment for possible effects of sex, age (>65 years), and severity of comorbidity, the relative risk of a 30-day fatal outcome for patients receiving metronidazole i.v. was 4.3 (95% confidence interval [CI] = 1.92 to 10; P < 0.0001) compared to patients treated with metronidazole p.o. and 4.0 (95% CI = 1.31 to 5.0; P < 0.015) compared to patients treated with vancomycin p.o. There were no significant differences in the risk of complications between the three treatment groups. This study generates the hypothesis that treatment with i.v. metronidazole is inferior to the oral alternatives metronidazole and vancomycin. PMID:22252830

A Comparative Study of the ReCell® Device and Autologous Spit-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries.

PubMed

Holmes, J H; Molnar, J A; Carter, J E; Hwang, J; Cairns, B A; King, B T; Smith, D J; Cruse, C W; Foster, K N; Peck, M D; Sood, R; Feldman, M J; Jordan, M H; Mozingo, D W; Greenhalgh, D G; Palmieri, T L; Griswold, J A; Dissanaike, S; Hickerson, W L

2018-05-24

Early excision and autografting are standard care for deeper burns. However, donor sites are a source of significant morbidity. To address this, the ReCell® Autologous Cell Harvesting Device (ReCell) was designed for use at the point-of-care to prepare a non-cultured, autologous skin cell suspension (ASCS) capable of epidermal regeneration utilizing minimal donor skin. A prospective study was conducted to evaluate the clinical performance of ReCell versus meshed split-thickness skin grafts (STSG, Control) for the treatment of deep partial-thickness (DPT) burns. Effectiveness measures were assessed to 1 year for both ASCS and Control treatment sites and donor sites, including the incidence of healing, scarring, and pain. At 4 weeks, 98% of the ASCS-treated sites were healed compared to 100% of the Controls. Pain and assessments of scarring at the treatment sites were reported to be similar between groups. Significant differences were observed between ReCell and Control donor sites. The mean ReCell donor area was approximately 40 times smaller than that of the Control (194.1±158.5 cm2; p<0.0001), and after 1 week, significantly more ReCell donor sites were healed than Controls (p=0.04). Over the first 16 weeks, patients reported significantly less pain at the ReCell donor sites compared with Controls (p≤0.05 at each time point). Long-term, patients reported higher satisfaction with ReCell donor site outcomes compared with the Controls. This study provides evidence that the treatment of DPT burns with ASCS results in comparable healing, with significantly reduced donor site size and pain and improved appearance relative to STSG.

The Role of Dairy in Effectiveness and Cost of Treatment of Children With Moderate Acute Malnutrition: A Narrative Review.

PubMed

Suri, Devika J; Moorthy, Denish; Rosenberg, Irwin H

2016-06-01

Dairy is recommended in specially formulated supplementary foods to treat children with moderate acute malnutrition (MAM) but with limited evidence and added cost. Review studies of ready-to-use foods (RUFs) versus fortified blended foods (FBFs) to determine whether inclusion of dairy modifies the comparative effectiveness and cost. We reviewed literature comparing FBF and RUF in treatment of MAM among children younger than 5 years in developing countries. Outcomes of recovery from MAM, weight, and length gain were compared among treatment categories: FBF with dairy (FBF+), FBF without dairy (FBF-), RUF with dairy (RUF+), and RUF without dairy (RUF-). Supplement cost was compared per 500 kcal. Eight studies were included. Rations were heterogeneous in energy and type of dairy. Overall, RUF+, RUF-, and FBF+ performed similarly, with higher recovery and weight gain compared with FBF-. RUF+ had higher recovery (in 5 of 6 comparisons), weight gain (4 of 4), and length gain (1 of 4) versus FBF-. The RUF+ had higher recovery (1 of 2) versus FBF+, with no other differences. The RUF- versus FBF+ had no differences (0 of 2). The RUF- had higher recovery (1 of 2), weight gain (2 of 2) versus FBF-. Four studies reported supplement costs, which averaged US$0.15 (FBF-), US$0.18 (FBF+), US$0.18 (RUF-), and US$0.37 (RUF+) per 500 kcal. There is a consistent benefit of FBF that include dairy in treatment of children with MAM. Benefits of dairy in RUF require further investigation. Evidence from rigorous quantitative analysis of existing data, cost-effectiveness, and prospective trials will be essential in determining policy on treatment for children with MAM. © The Author(s) 2016.

Granular biochar compared with activated carbon for wastewater treatment and resource recovery.

PubMed

Huggins, Tyler M; Haeger, Alexander; Biffinger, Justin C; Ren, Zhiyong Jason

2016-05-01

Granular wood-derived biochar (BC) was compared to granular activated carbon (GAC) for the treatment and nutrient recovery of real wastewater in both batch and column studies. Batch adsorption studies showed that BC material had a greater adsorption capacity at the high initial concentrations of total chemical oxygen demand (COD-T) (1200 mg L(-1)), PO4 (18 mg L(-1)), and NH4 (50 mg L(-1)) compared to GAC. Conversely the BC material showed a lower adsorption capacity for all concentrations of dissolved chemical oxygen demand (COD-D) and the lower concentrations of PO4 (5 mg L(-1)) and NH4 (10 mg L(-1)). Packed bed column studies showed similar average COD-T removal rate for BC with 0.27 ± 0.01 kg m(-3) d(-1) and GAC with 0.24 ± 0.01 kg m(-3) d(-1), but BC had nearly twice the average removal rate (0.41 ± 0.08 kg m(-3) d(-3)) compared to GAC during high COD-T concentrations (>500 mg L(-1)). Elemental analysis showed that both materials accumulated phosphorous during wastewater treatment (2.6 ± 0.4 g kg(-1) and 1.9 ± 0.1 g kg(-1) for BC and GAC respectively). They also contained high concentrations of other macronutrients (K, Ca, and Mg) and low concentrations of metals (As, Cd, Cr, Pb, Zn, and Cu). The good performance of BC is attributed to its macroporous structure compared with the microporous GAC. These favorable treatment data for high strength wastewater, coupled with additional life-cycle benefits, helps support the use of BC in packed bed column filters for enhanced wastewater treatment and nutrient recovery. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Three Month Comparative Evaluation of the Effect of Different Surface Treatment Agents on the Surface Integrity and Softness of Acrylic based Soft Liner: An In vivo Study

PubMed Central

Mahajan, Neerja; Naveen, Y. G.; Sethuraman, Rajesh

2017-01-01

Introduction Acrylic based soft liners are cost effective, yet are inferior in durability as compared to silicone based liners. Hence, this study was conducted to evaluate if the softness and surface integrity of acrylic based soft liner can be maintained by using different surface treatment agents. Aim To comparatively evaluate the effects of Varnish, Monopoly and Kregard surface treatment agents on the surface integrity and softness of acrylic based soft liner at baseline, at one month and after three months. Materials and Methods A total of 37 participants who required conventional maxillary dentures were selected according to the determined inclusion and exclusion criteria of the study. In the maxillary denture on the denture bearing surface, eight palatal recesses (5 mm x 3 mm) were made and filled with acrylic based soft liner (Permasoft). The soft liners in these recesses were given surface treatment and divided as control (uncoated), Varnish, Monopoly and Kregard groups. The hardness and surface integrity were evaluated with Shore A Durometer and Scanning Electron Microscope (SEM) respectively at baseline, one month and three months interval. Surface integrity between groups was compared using Kruskal-Wallis test. Intergroup comparison for hardness was done using ANOVA and Tukey’s HSD post-hoc tests. Results Amongst all the groups tested, surface integrity was maintained in the Kregard group, as compared to control, Varnish and Monopoly groups for all three time intervals (p< 0.001). Kregard treated samples also demonstrated significantly higher softness at all the time intervals (p<0.001). Conclusion Surface treatment with Kregard demonstrated better surface integrity and softness at all the time intervals. PMID:29207842

Effect of rabeprazole and omeprazole on the onset of gastro-oesophageal reflux disease symptom relief during the first seven days of treatment.

PubMed

Bytzer, Peter; Morocutti, Anna; Kennerly, Peter; Ravic, Miroslav; Miller, Neil

2006-10-01

Gastro-oesophageal reflux disease (GORD) symptoms have a significant impact on patients' well-being. Onset of symptom relief is therefore an important consideration in GORD treatment. The primary objective was to compare the efficacy of rabeprazole (20 mg) and omeprazole (20 mg) regarding onset of heartburn control during the first 7 days of treatment in patients with erosive oesophagitis. Secondary objectives included maintenance of sustained heartburn control, control of other GORD symptoms (e.g. acid regurgitation, epigastric pain, dysphagia), effect on quality of life, patient satisfaction with treatment, and adverse events. In this multicentre, randomized, parallel-group, double-blind, comparative study, performed in Europe and Iceland, patients with endoscopically confirmed erosive oesophagitis were randomized to receive once-daily treatment with rabeprazole 20 mg (n=358) or omeprazole 20 mg (n=359) for 7 days. Symptoms were recorded (scored on a 5-point Likert scale) twice daily by the patients on their diary cards. Median time to reach heartburn control was 1.5 days for both the rabeprazole and omeprazole groups (p<0.43). The results were similar between treatments for other study parameters. Both treatments were well tolerated. Unlike previous studies, no significant differences were found between treatments with rabeprazole (20 mg) and omeprazole (20 mg) in this study. Further studies are needed to evaluate the potential benefit of fast-acting proton-pump inhibitors, such as rabeprazole, with respect to onset of symptom control in erosive GORD.

Information processing speed in obstructive sleep apnea syndrome: a review.

PubMed

Kilpinen, R; Saunamäki, T; Jehkonen, M

2014-04-01

To provide a comprehensive review of studies on information processing speed in patients with obstructive sleep apnea syndrome (OSAS) as compared to healthy controls and normative data, and to determine whether continuous positive airway pressure (CPAP) treatment improves information processing speed. A systematic review was performed on studies drawn from Medline and PsycINFO (January 1990-December 2011) and identified from lists of references in these studies. After inclusion criteria, 159 articles were left for abstract review, and after exclusion criteria 44 articles were fully reviewed. The number of patients in the studies reviewed ranged from 10 to 157 and the study samples consisted mainly of men. Half of the studies reported that patients with OSAS showed reduced information processing speed when compared to healthy controls. Reduced information processing speed was seen more often (75%) when compared to norm-referenced data. Psychomotor speed seemed to be particularly liable to change. CPAP treatment improved processing speed, but the improvement was marginal when compared to placebo or conservative treatment. Patients with OSAS are affected by reduced information processing speed, which may persist despite CPAP treatment. Information processing is usually assessed as part of other cognitive functioning, not as a cognitive domain per se. However, it is important to take account of information processing speed when assessing other aspects of cognitive functioning. This will make it possible to determine whether cognitive decline in patients with OSAS is based on lower-level or higher-level cognitive processes or both. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Serotonin 2A Receptor SNP rs7330461 Association with Treatment Response to Pomaglumetad Methionil in Patients with Schizophrenia

PubMed Central

Nisenbaum, Laura K.; Downing, AnnCatherine M.; Zhao, Fangyi; Millen, Brian A.; Munsie, Leanne; Kinon, Bruce J.; Adams, David H.; Gomez, Juan Carlos; Penny, Michelle Ann

2016-01-01

This study aims to confirm the initial pharmacogenetic finding observed within the clinical proof-of-concept trial of an enhanced response to treatment with pomaglumetad methionil (LY2140023 monohydrate) in Caucasian schizophrenia patients homozygous for T/T at single nucleotide polymorphism rs7330461 in the serotonin (5-hydroxytryptamine) 2A receptor gene compared to A/A homozygous patients. The effect of the rs7330461 genotype on the response to pomaglumetad methionil treatment was assessed in three additional clinical trials and in an integrated analysis. Overall, this study includes data from 1115 Caucasian patients for whom genotyping information for rs7330461 was available, consisting of 513 A/A homozygous, 466 A/T heterozygous and 136 T/T homozygous patients. Caucasian T/T homozygous patients showed significantly (p ≤ 0.05) greater improvement in Positive and Negative Syndrome Scale (PANSS) total scores during treatment with pomaglumetad methionil 40 mg twice daily compared to A/A homozygous patients. Additionally, T/T homozygous patients receiving pomaglumetad methionil had significantly (p ≤ 0.05) greater improvements in PANSS total scores compared to placebo and similar improvements as T/T homozygous patients receiving standard-of-care (SOC) treatment. The findings reported here in conjunction with prior reports show that in Caucasian patients with schizophrenia, the T/T genotype at rs7330461 is consistently associated with an increased treatment response to pomaglumetad methionil compared to the A/A genotype. PMID:26861400

Serotonin 2A Receptor SNP rs7330461 Association with Treatment Response to Pomaglumetad Methionil in Patients with Schizophrenia.

PubMed

Nisenbaum, Laura K; Downing, AnnCatherine M; Zhao, Fangyi; Millen, Brian A; Munsie, Leanne; Kinon, Bruce J; Adams, David H; Gomez, Juan Carlos; Penny, Michelle Ann

2016-02-05

This study aims to confirm the initial pharmacogenetic finding observed within the clinical proof-of-concept trial of an enhanced response to treatment with pomaglumetad methionil (LY2140023 monohydrate) in Caucasian schizophrenia patients homozygous for T/T at single nucleotide polymorphism rs7330461 in the serotonin (5-hydroxytryptamine) 2A receptor gene compared to A/A homozygous patients. The effect of the rs7330461 genotype on the response to pomaglumetad methionil treatment was assessed in three additional clinical trials and in an integrated analysis. Overall, this study includes data from 1115 Caucasian patients for whom genotyping information for rs7330461 was available, consisting of 513 A/A homozygous, 466 A/T heterozygous and 136 T/T homozygous patients. Caucasian T/T homozygous patients showed significantly (p ≤ 0.05) greater improvement in Positive and Negative Syndrome Scale (PANSS) total scores during treatment with pomaglumetad methionil 40 mg twice daily compared to A/A homozygous patients. Additionally, T/T homozygous patients receiving pomaglumetad methionil had significantly (p ≤ 0.05) greater improvements in PANSS total scores compared to placebo and similar improvements as T/T homozygous patients receiving standard-of-care (SOC) treatment. The findings reported here in conjunction with prior reports show that in Caucasian patients with schizophrenia, the T/T genotype at rs7330461 is consistently associated with an increased treatment response to pomaglumetad methionil compared to the A/A genotype.

Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial.

PubMed

Huo, Jian; Liu, Li-Sha; Jian, Wen-Yuan; Zeng, Jie-Ping; Duan, Jun-Guo; Lu, Xue-Jing; Yin, Shuo

2018-06-18

Microvascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear. To appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications. This trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events. This study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).

Validation of the translation of an instrument to measure reliability of written information on treatment choices: a study on attention deficit/hyperactivity disorder (ADHD).

PubMed

Montoya, A; Llopis, N; Gilaberte, I

2011-12-01

DISCERN is an instrument designed to help patients assess the reliability of written information on treatment choices. Originally created in English, there is no validated Spanish version of this instrument. This study seeks to validate the Spanish translation of the DISCERN instrument used as a primary measure on a multicenter study aimed to assess the reliability of web-based information on treatment choices for attention deficit/hyperactivity disorder (ADHD). We used a modified version of a method for validating translated instruments in which the original source-language version is formally compared with the back-translated source-language version. Each item was ranked in terms of comparability of language, similarity of interpretability, and degree of understandability. Responses used Likert scales ranging from 1 to 7, where 1 indicates the best interpretability, language and understandability, and 7 indicates the worst. Assessments were performed by 20 raters fluent in the source language. The Spanish translation of DISCERN, based on ratings of comparability, interpretability and degree of understandability (mean score (SD): 1.8 (1.1), 1.4 (0.9) and 1.6 (1.1), respectively), was considered extremely comparable. All items received a score of less than three, therefore no further revision of the translation was needed. The validation process showed that the quality of DISCERN translation was high, validating the comparable language of the tool translated on assessing written information on treatment choices for ADHD.

Cancer outcomes for Aboriginal and Torres Strait Islander Australians in rural and remote areas.

PubMed

Diaz, Abbey; Whop, Lisa J; Valery, Patricia C; Moore, Suzanne P; Cunningham, Joan; Garvey, Gail; Condon, John R

2015-02-01

To examine the association between residential remoteness and stage of cancer at diagnosis, treatment uptake, and survival within the Australian Indigenous population. Systematic review and matched retrospective cohort study. Australia. Systematic review: published papers that included a comparison of cancer stage at diagnosis, treatment uptake, mortality and/or survival for Indigenous people across remoteness categories were identified (n = 181). Fifteen papers (13 studies) were included in the review. Original analyses: new analyses were conducted using data from the Queensland Indigenous Cancer Study (QICS) comparing cancer stage at diagnosis, treatment uptake, and survival for Indigenous cancer patients living in rural/remote areas (n = 627, 66%) and urban areas (n = 329, 34%). Systematic review: Papers were included if there were related to stage of disease at diagnosis, treatment, mortality and survival of cancer. Restrictions were not placed on the outcome measures reported (e.g. standardised mortality ratios versus crude mortality rates). Original analyses: Odds ratios (OR, 95%CI) were used to compare stage of disease and treatment uptake between the two remoteness groups. Treatment uptake (treated/not treated) was analysed using logistic regression analysis. Survival was analysed using Cox proportional hazards regression. The final multivariate models included stage of cancer at diagnosis and area-level socioeconomic status (SEIFA). Existing evidence of variation in cancer outcomes for Indigenous people in remote compared with metropolitan areas is limited. While no previous studies have reported on differences in cancer stage and treatment uptake by remoteness within the Indigenous population, the available evidence suggests Indigenous cancer patients are less likely to survive their cancer the further they live from urban centres. New analysis of QICS data indicates that Indigenous cancer patients in rural/remote Queensland were less likely to be diagnosed with localised disease and less likely to receive treatment for their cancer compared to their urban counterparts. More research is needed to fully understand geographic differentials in cancer outcomes within the Indigenous population. Knowing how geographical location interacts with Indigenous status can help to identify ways of improving cancer outcomes for Indigenous Australians. © 2015 National Rural Health Alliance Inc.

Comparative study of the prognosis of an extracorporeal reduction and a closed treatment in mandibular condyle head and/or neck fractures.

PubMed

Park, Jung-Min; Jang, Yong-Wook; Kim, Seong-Gon; Park, Young-Wook; Rotaru, Horatiu; Baciut, Grigore; Hurubeanu, Lucia

2010-12-01

The objective of this study was a comparison of the prognosis between an extracorporeal reduction technique and closed treatment of a mandibular condyle fracture. The relationship between condylar resorption and several clinical variables was also studied. Seventy-one patients who had a mandibular condyle fracture took part in this study. Thirty-five patients (female: 7, male: 28, age: 30.46 ± 14.27 years) were treated by extracorporeal reduction, and 36 patients (male: 24, female: 12, age: 24.28 ± 9.99 years) were treated using a closed treatment. The presence of complications such as condylar resorption, malocclusion, nerve disorder, and disc displacement was evaluated with panoramic radiographs and clinical examinations 12 months after treatment. The relationships between the complications and other clinical variables were evaluated statistically. The anatomic site and fracture type were closely related to condyle resorption in the bivariate analysis. Condylar head fractures showed significantly higher condyle resorption than condylar neck fractures (P = .023). A complex or compound fracture showed significantly higher condyle resorption compared with a simple fracture (P = .006). Patients who had a complex/compound fracture were 34.366 times more likely to have condyle resorption compared with those who had a simple fracture (P = .002). The patient's age and treatment method were also significant predictors for condyle resorption. Fracture type was the strongest predictor of condylar resorption. Because treatment method and patient age were also related to the prognosis, the optimal treatment for mandibular condylar head and/or neck fractures should be individualized according to the patient's condition. Copyright © 2010 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Radioactive iodide (131 I-) excretion profiles in response to potassium iodide (KI) and ammonium perchlorate (NH4ClO4) prophylaxis.

PubMed

Harris, Curtis; Dallas, Cham; Rollor, Edward; White, Catherine; Blount, Benjamin; Valentin-Blasini, Liza; Fisher, Jeffrey

2012-08-01

Radioactive iodide ((131)I-) protection studies have focused primarily on the thyroid gland and disturbances in the hypothalamic-pituitary-thyroid axis. The objective of the current study was to establish (131)I- urinary excretion profiles for saline, and the thyroid protectants, potassium iodide (KI) and ammonium perchlorate over a 75 hour time-course. Rats were administered (131)I- and 3 hours later dosed with either saline, 30 mg/kg of NH(4)ClO(4) or 30 mg/kg of KI. Urinalysis of the first 36 hours of the time-course revealed that NH(4)ClO(4) treated animals excreted significantly more (131)I- compared with KI and saline treatments. A second study followed the same protocol, but thyroxine (T(4)) was administered daily over a 3 day period. During the first 6-12 hour after (131)I- dosing, rats administered NH(4)ClO(4) excreted significantly more (131)I- than the other treatment groups. T(4) treatment resulted in increased retention of radioiodide in the thyroid gland 75 hour after (131)I- administration. We speculate that the T(4) treatment related reduction in serum TSH caused a decrease synthesis and secretion of thyroid hormones resulting in greater residual radioiodide in the thyroid gland. Our findings suggest that ammonium perchlorate treatment accelerates the elimination rate of radioiodide within the first 24 to 36 hours and thus may be more effective at reducing harmful exposure to (131)I- compared to KI treatment for repeated dosing situations. Repeated dosing studies are needed to compare the effectiveness of these treatments to reduce the radioactive iodide burden of the thyroid gland.

Pregnancy outcome after in utero exposure to local anesthetics as part of dental treatment: A prospective comparative cohort study.

PubMed

Hagai, Aharon; Diav-Citrin, Orna; Shechtman, Svetlana; Ornoy, Asher

2015-08-01

Dental treatment and use of local anesthetics during pregnancy generally are considered harmless because of lack of evidence of adverse pregnancy effects. Data on the safety of dental treatment and local anesthetics during pregnancy are scant. Dental care is often a reason for concern both among women and their health care providers. The primary objective of this study was to evaluate the rate of major anomalies after exposure to local anesthetics as part of dental care during pregnancy. The authors performed a prospective, comparative observational study at the Israeli Teratology Information Services between 1999 and 2005. The authors followed 210 pregnancies exposed to dental local anesthetics (112 [53%] in the first trimester) and compared them with 794 pregnancies not exposed to teratogens. The rate of major anomalies was not significantly different between the groups (4.8% versus 3.3%, P = .300). There was no difference in the rate of miscarriages, gestational age at delivery, or birth weight. The most common types of dental treatment were endodontic treatment (43%), tooth extraction (31%), and tooth restoration (21%). Most women (63%) were not exposed to additional medications. Approximately one-half (51%) of the women were not exposed to dental radiography, and 44% were exposed to radiation, mostly bite-wing radiography. This study's results suggest that use of dental local anesthetics, as well as dental treatment during pregnancy, do not represent a major teratogenic risk. There seems to be no reason to prevent pregnant women from receiving dental treatment and local anesthetics during pregnancy. Copyright © 2015 American Dental Association. Published by Elsevier Inc. All rights reserved.

Adherence to Internet-Based and Face-to-Face Cognitive Behavioural Therapy for Depression: A Meta-Analysis

PubMed Central

van Ballegooijen, Wouter; Cuijpers, Pim; van Straten, Annemieke; Karyotaki, Eirini; Andersson, Gerhard; Smit, Jan H.; Riper, Heleen

2014-01-01

Background Internet-based cognitive behavioural therapy (iCBT) is an effective and acceptable treatment for depression, especially when it includes guidance, but its treatment adherence has not yet been systematically studied. We conducted a meta-analysis, comparing the adherence to guided iCBT with the adherence to individual face-to-face CBT. Methods Studies were selected from a database of trials that investigate treatment for adult depression (see www.evidencebasedpsychotherapies.org), updated to January 2013. We identified 24 studies describing 26 treatment conditions (14 face-to-face CBT, 12 guided iCBT), by means of these inclusion criteria: targeting depressed adults, no comorbid somatic disorder or substance abuse, community recruitment, published in the year 2000 or later. The main outcome measure was the percentage of completed sessions. We also coded the percentage of treatment completers (separately coding for 100% or at least 80% of treatment completed). Results We did not find studies that compared guided iCBT and face-to-face CBT in a single trial that met our inclusion criteria. Face-to-face CBT treatments ranged from 12 to 28 sessions, guided iCBT interventions consisted of 5 to 9 sessions. Participants in face-to-face CBT completed on average 83.9% of their treatment, which did not differ significantly from participants in guided iCBT (80.8%, P  =  .59). The percentage of completers (total intervention) was significantly higher in face-to-face CBT (84.7%) than in guided iCBT (65.1%, P < .001), as was the percentage of completers of 80% or more of the intervention (face-to-face CBT: 85.2%, guided iCBT: 67.5%, P  =  .003). Non-completers of face-to-face CBT completed on average 24.5% of their treatment, while non-completers of guided iCBT completed on average 42.1% of their treatment. Conclusion We did not find studies that compared guided iCBT and face-to-face CBT in a single trial. Adherence to guided iCBT appears to be adequate and could be equal to adherence to face-to-face CBT. PMID:25029507

Alcohol and drug treatment outcome studies: new methodological review (2005-2010) and comparison with past reviews.

PubMed

Robinson, Sean M; Sobell, Linda Carter; Sobell, Mark B; Arcidiacono, Steven; Tzall, David

2014-01-01

Several methodological reviews of alcohol treatment outcome studies and one review of drug studies have been published over the past 40 years. Although past reviews demonstrated methodological improvements in alcohol studies, they also found continued deficiencies. The current review allows for an updated evaluation of the methodological rigor of alcohol and drug studies and, by utilizing inclusion criteria similar to previous reviews, it allows for a comparative review over time. In addition, this is the first review that compares the methodology of alcohol and drug treatment outcome studies published during the same time period. The methodology for 25 alcohol and 11 drug treatment outcome studies published from 2005 through 2010 that met the review's inclusion criteria was evaluated. The majority of variables evaluated were used in prior reviews. The current review found that more alcohol and drug treatment outcome studies are now using continuous substance use measures and assessing problem severity. Although there have been methodological improvements over time, the current reviews differed little from their most recent past counterpart. Despite this finding, some areas, particularly the continued low reporting of demographic data, needs strengthening. Improvement in the methodological rigor of alcohol and drug treatment outcome studies has occurred over time. The current review found few differences between alcohol and drug study methodologies as well as few differences between the current review and the most recent past alcohol and drug reviews. © 2013 Elsevier Ltd. All rights reserved.

Drug Court Effectiveness: A Matched Cohort Study in the Dane County Drug Treatment Court

ERIC Educational Resources Information Center

Brown, Randall

2011-01-01

Drug treatment courts (DTCs) are widely viewed as effective diversion programs for drug-involved offenders; however, previous studies frequently used flawed comparison groups. In the current study, the author compared rates of recidivism for drug court participants to rates for a traditionally adjudicated comparison group matched on potentially…

Laboratory and clinical trials of cocamide diethanolamine lotion against head lice

PubMed Central

Brunton, Elizabeth R.; Brown, Christine M.

2015-01-01

Context. During the late 1990s, insecticide resistance had rendered a number of treatment products ineffective; some companies saw this as an opportunity to develop alternative types of treatment. We investigated the possibility that a surfactant-based lotion containing 10% cocamide diethanolamine (cocamide DEA) was effective to eliminate head louse infestation. Settings and Design. Initial in vitro testing of the lotion formulation versus laboratory reared body/clothing lice, followed by two randomised, controlled, community-based, assessor blinded, clinical studies. Materials and Methods. Preliminary laboratory tests were performed by exposing lice or louse eggs to the product using a method that mimicked the intended use. Clinical Study 1: Children and adults with confirmed head louse infestation were treated by investigators using a single application of aqueous 10% cocamide DEA lotion applied for 60 min followed by shampooing or a single 1% permethrin creme rinse treatment applied to pre-washed hair for 10 min. Clinical Study 2: Compared two treatment regimens using 10% cocamide DEA lotion that was concentrated by hair drying. A single application left on for 8 h/overnight was compared with two applications 7 days apart of 2 h duration, followed by a shampoo wash. Results. The initial laboratory tests showed a pediculicidal effect for a 60 min application but limited ovicidal effect. A longer application time of 8 h or overnight was found capable of killing all eggs but this differed between batches of test material. Clinical Study 1: Both treatments performed badly with only 3/23 (13%) successful treatments using cocamide DEA and 5/25 (23.8%) using permethrin. Clinical Study 2: The single overnight application of cocamide DEA concentrated by hair drying gave 10/56 (17.9%) successes compared with 19/56 (33.9%) for the 2 h application regimen repeated after 1 week. Intention to treat analysis showed no significant difference (p = 0.0523) between the treatments. Over the two studies, there were 18 adverse events possibly or probably associated with treatment, most of which were increased pruritus after treatment. Conclusions. Cocamide DEA 10% lotion, even when concentrated by hair drying, showed limited activity to eliminate head louse infestation. PMID:26557439

A retrospective study of feline gastric lymphoma in 16 chemotherapy-treated cats.

PubMed

Gustafson, Tanya L; Villamil, Armando; Taylor, Bonnie E; Flory, Andrea

2014-01-01

The purposes of this study were to describe cases of feline gastric lymphoma with regards to signalment, clinical presentation, laboratory and ancillary study findings, response to therapy, and outcomes and to identify prognostic variables. Sixteen cats with stage I and II gastric lymphoma treated with chemotherapy were included in this study. Seventy-five percent of cats experienced remission. Overall, first remission duration was 108 days. Response to treatment was prognostic as in other types of feline lymphoma. Cats with a complete remission (CR) had longer survival times compared with cats with a partial remission (PR). Sex and treatment with a rescue protocol were found to be prognostic with castrated males having longer survivals than spayed females. Cats that received rescue chemotherapy had shorter first remission durations than those that did not. Prior treatment with steroids and stage were not found to be significant prognostic variables. This study characterizes gastric lymphoma treated with chemotherapy in cats. Further studies are needed to determine the comparative efficacy of surgical and chemotherapeutic treatments for feline gastric lymphoma.

Clinical efficacy of moxifloxacin versus comparator therapies for community-acquired pneumonia caused by Legionella spp.

PubMed

Garau, J; Fritsch, A; Arvis, P; Read, R C

2010-08-01

The aim of this study was to compare outcomes for patients with community-acquired pneumonia (CAP) caused by Legionella spp. following treatment with moxifloxacin or a range of comparator antimicrobial agents. Data were pooled from four sequential I.V./P.O. trials of moxifloxacin in the treatment of CAP. Comparators were ceftriaxone +/- erythromycin, amoxicillin/clavulanate +/- clarithromycin, trovafloxacin, levofloxacin, or ceftriaxone + levofloxacin. Legionella infection was diagnosed by culture, urine antigen testing and/or serology. Clinical success rates for the efficacy-valid (per protocol) populations were recorded at the test-of-cure visit (5-30 days post-therapy). Severity of CAP was determined using the modified American Thoracic Society criteria.Of 1786 efficacy-valid patients, 33 (1.8%) had documented infection with Legionella spp. (moxifloxacin: n=13; comparator: n=20). Of these, 30 cases were identified by serology and/or urine antigen detection and 3 by respiratory culture. The success rate of moxifloxacin vs. comparator therapy was 92.3% vs. 80.0% for the I.V./P.O. trials.Sequential (I.V./P.O.) moxifloxacin demonstrated clinical efficacy that was at least as good as that of comparator treatments for the treatment of CAP due to Legionella.

Auditory Processing Assessment in Children with Attention Deficit Hyperactivity Disorder: An Open Study Examining Methylphenidate Effects

PubMed Central

Lanzetta-Valdo, Bianca Pinheiro; Oliveira, Giselle Alves de; Ferreira, Jane Tagarro Correa; Palacios, Ester Miyuki Nakamura

2016-01-01

Introduction Children with Attention Deficit Hyperactivity Disorder can present Auditory Processing (AP) Disorder. Objective The study examined the AP in ADHD children compared with non-ADHD children, and before and after 3 and 6 months of methylphenidate (MPH) treatment in ADHD children. Methods Drug-naive children diagnosed with ADHD combined subtype aging between 7 and 11 years, coming from public and private outpatient service or public and private school, and age-gender-matched non-ADHD children, participated in an open, non-randomized study from February 2013 to December 2013. They were submitted to a behavioral battery of AP tests comprising Speech with white Noise, Dichotic Digits (DD), and Pitch Pattern Sequence (PPS) and were compared with non-ADHD children. They were followed for 3 and 6 months of MPH treatment (0.5 mg/kg/day). Results ADHD children presented larger number of errors in DD (p < 0.01), and less correct responses in the PPS (p < 0.0001) and in the SN (p < 0.05) tests when compared with non-ADHD children. The treatment with MPH, especially along 6 months, significantly decreased the mean errors in the DD (p < 0.01) and increased the correct response in the PPS (p < 0.001) and SN (p < 0.01) tests when compared with the performance before MPH treatment. Conclusions ADHD children show inefficient AP in selected behavioral auditory battery suggesting impaired in auditory closure, binaural integration, and temporal ordering. Treatment with MPH gradually improved these deficiencies and completely reversed them by reaching a performance similar to non-ADHD children at 6 months of treatment. PMID:28050211

Auditory Processing Assessment in Children with Attention Deficit Hyperactivity Disorder: An Open Study Examining Methylphenidate Effects.

PubMed

Lanzetta-Valdo, Bianca Pinheiro; Oliveira, Giselle Alves de; Ferreira, Jane Tagarro Correa; Palacios, Ester Miyuki Nakamura

2017-01-01

Introduction  Children with Attention Deficit Hyperactivity Disorder can present Auditory Processing (AP) Disorder. Objective  The study examined the AP in ADHD children compared with non-ADHD children, and before and after 3 and 6 months of methylphenidate (MPH) treatment in ADHD children. Methods  Drug-naive children diagnosed with ADHD combined subtype aging between 7 and 11 years, coming from public and private outpatient service or public and private school, and age-gender-matched non-ADHD children, participated in an open, non-randomized study from February 2013 to December 2013. They were submitted to a behavioral battery of AP tests comprising Speech with white Noise, Dichotic Digits (DD), and Pitch Pattern Sequence (PPS) and were compared with non-ADHD children. They were followed for 3 and 6 months of MPH treatment (0.5 mg/kg/day). Results  ADHD children presented larger number of errors in DD ( p  < 0.01), and less correct responses in the PPS ( p  < 0.0001) and in the SN ( p  < 0.05) tests when compared with non-ADHD children. The treatment with MPH, especially along 6 months, significantly decreased the mean errors in the DD ( p  < 0.01) and increased the correct response in the PPS ( p  < 0.001) and SN ( p  < 0.01) tests when compared with the performance before MPH treatment. Conclusions  ADHD children show inefficient AP in selected behavioral auditory battery suggesting impaired in auditory closure, binaural integration, and temporal ordering. Treatment with MPH gradually improved these deficiencies and completely reversed them by reaching a performance similar to non-ADHD children at 6 months of treatment.

Photodynamic therapy is more effective than imiquimod for actinic keratosis in organ transplant recipients: a randomized intraindividual controlled trial.

PubMed

Togsverd-Bo, K; Halldin, C; Sandberg, C; Gonzalez, H; Wennberg, A M; Sørensen, S S; Wulf, H C; Haedersdal, M

2018-04-01

Actinic keratoses (AKs) in solid organ transplant recipients (OTRs) are difficult-to-treat premalignancies and comparison of topical therapies is therefore warranted. In an intraindividual study to compare the efficacy and safety of field treatment with methyl aminolaevulinate photodynamic therapy (MAL-PDT) and imiquimod (IMIQ) for AKs in OTRs. OTRs (n = 35) with 572 AKs (grade I-III) in two similar areas on the face, scalp, dorsal hands or forearms were included. All patients received one MAL-PDT and one IMIQ session (three applications per week for 4 weeks) in each study area according to randomization. Treatments were repeated after 2 months (IMIQ) and 3 months (PDT) in skin with incomplete AK response. Outcome measures were complete lesion response (CR), skin reactions, laboratory results and treatment preference. The majority of study areas received two treatment sessions (PDT n = 25 patients; IMIQ n = 29 patients). At 3 months after two treatments, skin treated with PDT achieved a higher rate of CR (AK I-III median 78%; range 50-100) compared with IMIQ-treated skin areas (median 61%, range 33-100; P < 0·001). Fewer emergent AKs were seen in PDT-treated skin vs. IMIQ-treated skin (0·7 vs. 1·5 AKs, P = 0·04). Patients developed more intense inflammatory skin reactions following PDT, which resolved more rapidly compared with IMIQ (median 10 days vs. 18 days, P < 0·01). Patient preference (P = 0·47) and cosmesis (P > 0·30) were similar for PDT and IMIQ. Compared with IMIQ, PDT treatment obtained a higher rate of AK clearance at 3-month follow-up and achieved shorter-lasting, but more intense, short-term skin reactions. © 2017 British Association of Dermatologists.

Low versus High Fluence Parameters in the Treatment of Facial Laceration Scars with a 1,550 nm Fractional Erbium-Glass Laser

PubMed Central

Shim, Hyung-Sup; Jun, Dai-Won; Kim, Sang-Wha; Jung, Sung-No; Kwon, Ho

2015-01-01

Purpose. Early postoperative fractional laser treatment has been used to reduce scarring in many institutions, but the most effective energy parameters have not yet been established. This study sought to determine effective parameters in the treatment of facial laceration scars. Methods. From September 2012 to September 2013, 57 patients were enrolled according to the study. To compare the low and high fluence parameters of 1,550 nm fractional erbium-glass laser treatment, we virtually divided the scar of each individual patient in half, and each half was treated with a high and low fluence setting, respectively. A total of four treatment sessions were performed at one-month intervals and clinical photographs were taken at every visit. Results. Results were assessed using the Vancouver Scar Scale (VSS) and global assessment of the two portions of each individual scar. Final evaluation revealed that the portions treated with high fluence parameter showed greater difference compared to pretreatment VSS scores and global assessment values, indicating favorable cosmetic results. Conclusion. We compared the effects of high fluence and low fluence 1,550 nm fractional erbium-glass laser treatment for facial scarring in the early postoperative period and revealed that the high fluence parameter was more effective for scar management. PMID:26236738

Cognitive Behavioral Therapy for Children with Dental Anxiety: A Randomized Controlled Trial.

PubMed

Shahnavaz, S; Hedman, E; Grindefjord, M; Reuterskiöld, L; Dahllöf, G

2016-10-01

Dental anxiety affects approximately 9% of children and is associated with poor oral health, pain, and psychosocial problems. The objective of this study was to investigate the efficacy of cognitive behavioral therapy (CBT) for children with dental anxiety in specialist pediatric dentistry. The study used a parallel-group superiority randomized controlled trial design. The primary outcome measure was the behavioral avoidance test; assessors were blind to treatment allocation. Participants were 8 boys and 22 girls 7 to 18 y old (mean ± SD, 10 ± 3.1). Children fulfilling the diagnostic criteria for dental anxiety were randomized to CBT (n = 13) or treatment as usual (n = 17), such as various sedation methods. Psychologists provided 10 h of CBT based on a treatment manual. Treatments were conducted in a naturalistic real-world clinical setting. Assessments were conducted before the treatment, 3 mo after the start of treatment, and at 1-y follow-up. The analyses of the primary outcome measure by repeated-measures analysis of variance and independent t test showed that children receiving CBT made superior, statistically significant improvements at follow-up (16.8 ± 2.4) compared with treatment as usual (11.4 ± 3.1, P < 0.01). A large between-group effect size (Cohen's d = 1.9) was found. Following treatment, 73% of those in the CBT group managed all stages of the dental procedures included in the behavioral avoidance test compared with 13% in the treatment-as-usual group. Furthermore, 91% in the CBT group compared with 25% in the treatment-as-usual group no longer met the diagnostic criteria for dental anxiety at the 1-y follow-up according to the secondary outcome measure. Measures of dental anxiety and self-efficacy showed larger improvements in the CBT group compared with controls. We conclude that CBT is an efficacious treatment for children and adolescents with dental anxiety and should be made accessible in pediatric dentistry (ClinicalTrials.gov: NCT01798355). Knowledge transfer statement: The results of this study can be used by decision makers and clinicians when planning to implement evidence-based treatment in pediatric dentistry and give children and adolescents access to methods for treating dental anxiety. The results can also be used by parents of children with dental anxiety when asking dentists to cooperate with psychologists using cognitive behavioral therapy.

Cost–Utility of Angiotensin-Converting Enzyme Inhibitor-Based Treatment Compared With Thiazide Diuretic-Based Treatment for Hypertension in Elderly Australians Considering Diabetes as Comorbidity

PubMed Central

Chowdhury, Enayet K.; Ademi, Zanfina; Moss, John R.; Wing, Lindon M.H.; Reid, Christopher M.

2015-01-01

Abstract The objective of this study was to examine the cost-effectiveness of angiotensin-converting enzyme inhibitor (ACEI)-based treatment compared with thiazide diuretic-based treatment for hypertension in elderly Australians considering diabetes as an outcome along with cardiovascular outcomes from the Australian government's perspective. We used a cost–utility analysis to estimate the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) gained. Data on cardiovascular events and new onset of diabetes were used from the Second Australian National Blood Pressure Study, a randomized clinical trial comparing diuretic-based (hydrochlorothiazide) versus ACEI-based (enalapril) treatment in 6083 elderly (age ≥65 years) hypertensive patients over a median 4.1-year period. For this economic analysis, the total study population was stratified into 2 groups. Group A was restricted to participants diabetes free at baseline (n = 5642); group B was restricted to participants with preexisting diabetes mellitus (type 1 or type 2) at baseline (n = 441). Data on utility scores for different events were used from available published literatures; whereas, treatment and adverse event management costs were calculated from direct health care costs available from Australian government reimbursement data. Costs and QALYs were discounted at 5% per annum. One-way and probabilistic sensitivity analyses were performed to assess the uncertainty around utilities and cost data. After a treatment period of 5 years, for group A, the ICER was Australian dollars (AUD) 27,698 (€ 18,004; AUD 1–€ 0.65) per QALY gained comparing ACEI-based treatment with diuretic-based treatment (sensitive to the utility value for new-onset diabetes). In group B, ACEI-based treatment was a dominant strategy (both more effective and cost-saving). On probabilistic sensitivity analysis, the ICERs per QALY gained were always below AUD 50,000 for group B; whereas for group A, the probability of being below AUD 50,000 was 85%. Although the dispensed price of diuretic-based treatment of hypertension in the elderly is lower, upon considering the potential enhanced likelihood of the development of diabetes in addition to the costs of treating cardiovascular disease, ACEI-based treatment may be a more cost-effective strategy in this population. PMID:25738481

Comparison between extracorporeal shockwave therapy, placebo ESWT and endoscopic plantar fasciotomy for the treatment of chronic plantar heel pain in the athlete.

PubMed

Saxena, Amol; Fournier, Magali; Gerdesmeyer, Ludger; Gollwitzer, Hans

2012-10-01

Plantar fasciitis can be a chronic and debilitating condition affecting athletes of all levels. The aim of this study is to compare treatment outcomes for the treatment of chronic plantar fasciitis in athletes, comparing focused extra corporeal sound wave therapy (ESWT) and the surgical endoscopic plantar fasciotomy (EPF). A total of 37 eligible patients were enrolled in the study between May 2006 and December 2008 at a single institution. Patients were either enrolled in the surgical group, or to the ESWT group which included a placebo controlled, randomized group (P-ESWT). Pre and post Visual Analog Scores (VAS) and Roles and Maudlsey (RM) scores were recorded and compared between the three groups. The patient's return to activity (RTA) was also documented. The results showed statistical improvement within the EPF and ESWT groups with both VAS & RM scores, with EPF being significantly better than both ESWT and P-ESWT in terms of treatment outcomes. Patients enrolled in the ESWT were able though to continue with their exercise regimen, while the EPF group was able to return to their athletic activity in an average of 2.8 months. In conclusion, EPF and ESWT are both effective forms of treatment for chronic plantar fasciitis; EPF being superior in outcomes yet ESWT treatment could be preferable since the athlete can remain active during treatment. II.

Effects of feed supplemented with fermented pine needles (Pinus ponderosa) on growth performance and antioxidant status in broilers.

PubMed

Wu, Q J; Wang, Z B; Wang, G Y; Li, Y X; Qi, Y X

2015-06-01

The objective of this study was to compare the effects of Aspergillus niger-fermented pine needles and nonfermented pine needles on growth performance and antioxidant capacity in broiler chicks. In total, 300 1-day-old broiler chicks were randomly allocated to 5 dietary treatments, which were then denoted as the control treatment (basal diet); the nonfermented treatment (containing 0.3% and 0.6% nonfermented treatment, respectively, in the starter and grower phase); or the fermented 1, fermented 2, or fermented 3 treatments. The fermented 1, fermented 2, and fermented 3 treatments contained 0.1, 0.3, and 0.5% fermented treatment, respectively, in the starter phase and 0.2, 0.6, and 1.0% fermented treatment, respectively, in the growth phase for 42 d. The results showed that fermentation treated supplementation had no adverse effect on the growth performance of broilers at 42 d of age. The activity of total nitric oxide synthase was significantly (P<0.05) decreased in the fermented treatment compared with the control and nonfermented treatments in broilers at 21 d of age. Compared with the control, broilers had higher (P<0.05) total superoxide dismutase activities and total antioxidant capacity when they were provided with either the fermented 2 or fermented 3 diet. The malondialdehyde content was significantly (P<0.05) decreased in the fermented 2 and fermented 3 treatments compared with the control and nonfermented treatments. It was concluded that the addition of fermented treatment to the diet could improve antioxidant capacity in broilers, as evidenced by the decrease in malondialdehyde and the increase in total superoxide dismutase activities; however, the effect of fermentation treatment on growth performance was negligible. © 2015 Poultry Science Association Inc.

The Effectiveness of Daily Behavior Report Cards for Children With ADHD: A Meta-Analysis.

PubMed

Iznardo, Michelle; Rogers, Maria A; Volpe, Robert J; Labelle, Patrick R; Robaey, Philippe

2017-11-01

This meta-analysis examined group-design studies investigating the effectiveness of Daily Behavior Report Cards (DBRC) as a school-based intervention to manage the classroom behavior of students with ADHD. A search of three article databases (PsycINFO, ERIC and Medline) identified seven group design evaluations of DBRC interventions. This meta-analysis included a total of 272 participants, with an average age of 7.9 years old. Three of the studies compared a control group to a treatment group with randomized group assignment, one study compared a control group to three treatment groups, two studies compared pre-and post-treatment scores in the same group, and one study compared pre-and post-treatment results of two intervention groups without random assignment. Dependent measures for these studies were teacher ratings (n = 5) and systematic direct observation of student academic and social behaviour (n = 2). Standardized mean differences ( Hedge's g) were calculated to obtain a pooled effect size using fixed effects. DBRCs were associated with reductions teacher-rated ADHD symptoms, with a Hedge's g of 0.36 (95% CI: 0.12-0.60, z=2.93, p ≤ .005) with low heterogeneity (Q-value: 2.40, I 2 = 0.00). This result excluded two studies that used observational coding instead of standardized tests to evaluate the effects of the intervention. A moderator analysis indicated that the effect size for systematic direct observation was large ( Hedge's G = 1.05[95% CI: 0.66-1.44, z=5.25, p ≤ .00]), with very high heterogeneity (Q-value: 46.34, I 2 : 93.53). A second moderator analysis found differences in the effects of DBRCs for comorbid externalizing symptoms with an overall effect size of 0.34 (95%CI: -0.04-0.72, z=1.76 p =0.08) with high heterogeneity (Q-value: 3.98, I 2 : 74.85). DBRCs effectively reduce the frequency and severity of ADHD symptoms in classroom settings. Additionally, they have a significant effect on co-occuring externalizing behaviors. It appears that systematic direct observation may be a more sensitive measure of treatment effects compared to teacher ratings of ADHD symptoms.

Integrated Treatment to Achieve Functional Recovery for First-Episode Psychosis

PubMed Central

Valencia, Marcelo; Juarez, Francisco; Ortega, Hector

2012-01-01

This study describes an integrated treatment approach that was implemented to enhance functional recovery in first-episode psychotic patients. Patients were randomized to two treatment conditions: either to an integrated treatment approach: pharmacotherapy, psychosocial treatment, and psychoeducation (experimental group: N = 39) or to medication alone (control group: N = 34). Patients were evaluated at baseline and after one year of treatment. Functional recovery was assessed according to symptomatic and functional remission. At the end of treatment, experimental patients showed a 94.9% of symptomatic remission compared to 58.8% of the control group. Functional remission was 56.4% for the experimental group and 3.6% for the control group, while 56.4% of the experimental group met both symptomatic and functional remission criteria and were considered recovered compared to 2.9% of the control group. PMID:22970366

Assessment of in vitro cyto/genotoxicity of sequentially treated electroplating effluent on the human hepatocarcinoma HuH-7 cell line.

PubMed

Naik, Umesh Chandra; Das, Mihir Tanay; Sauran, Swati; Thakur, Indu Shekhar

2014-03-01

The present study compares in vitro toxicity of electroplating effluent after the batch treatment process with that obtained after the sequential treatment process. Activated charcoal prepared from sugarcane bagasse through chemical carbonization, and tolerant indigenous bacteria, Bacillus sp. strain IST105, were used individually and sequentially for the treatment of electroplating effluent. The sequential treatment involving activated charcoal followed by bacterial treatment removed 99% of Cr(VI) compared with the batch processes, which removed 40% (charcoal) and 75% (bacteria), respectively. Post-treatment in vitro cyto/genotoxicity was evaluated by the MTT test and the comet assay in human HuH-7 hepatocarcinoma cells. The sequentially treated sample showed an increase in LC50 value with a 6-fold decrease in comet-assay DNA migration compared with that of untreated samples. A significant decrease in DNA migration and an increase in LC50 value of treated effluent proved the higher effectiveness of the sequential treatment process over the individual batch processes. Copyright © 2014 Elsevier B.V. All rights reserved.

A randomized controlled study comparing community based with health facility based direct observation of treatment models on patients' satisfaction and TB treatment outcome in Nigeria.

PubMed

Adewole, Olanisun O; Oladele, T; Osunkoya, Arinola H; Erhabor, Greg E; Adewole, Temitayo O; Adeola, Oluwaseun; Obembe, Olufemi; Ota, Martin O C

2015-12-01

Directly observed treatment short-course (DOTS) strategy is an effective mode of treating TB. We aimed to study the cost effectiveness and patients' satisfaction with home based direct observation of treatment (DOT), an innovative approach to community-based DOT (CBDOT) and hospital based DOT (HBDOT). A randomized controlled trial involving 150 newly diagnosed pulmonary TB patients in four TB clinics in Ile Ife , Nigeria, was done. They were randomly assigned to receive treatment with anti TB drugs for the intensive phase administered at home by a TB worker (CBDOT) or at the hospital (HBDOT). Outcome measures were treatment completion/default rates, cost effectiveness and patients' satisfaction with care using a 13 item patients satisfaction questionnaire (PS-13) at 2 months. This trial was registered with pactr.org: number PACTR 201503001058381. At the end of intensive phase, 15/75 (20%) and 2/75 (3%) of patients in the HBDOT and CBDOT, respectively had defaulted from treatment, p= 0.01. Of those with pretreatment positive sputum smear, 97% (68/70) on CBDOT and 54/67 (81%) on HBDOT were sputum negative for AFB at the end of 2 months of treatment, p=0.01. The CBDOT method was associated with a higher patient satisfaction score compared with HBDOT (OR 3.1; 95% CI 1.25-7.70), p=0.001.The total cost for patients was higher in HBDOT (US$159.38) compared with the CBDOT (US$89.52). The incremental cost effectiveness ratio was US$410 per patient who completed the intensive phase treatment with CBDOT. CBDOT is a cost effective approach associated with better compliance to treatment and better patient satisfaction compared to HBDOT. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Cost effectiveness of a manual based coping strategy programme in promoting the mental health of family carers of people with dementia (the START (STrAtegies for RelaTives) study): a pragmatic randomised controlled trial.

PubMed

Knapp, Martin; King, Derek; Romeo, Renee; Schehl, Barbara; Barber, Julie; Griffin, Mark; Rapaport, Penny; Livingston, Debbie; Mummery, Cath; Walker, Zuzana; Hoe, Juanita; Sampson, Elizabeth L; Cooper, Claudia; Livingston, Gill

2013-10-25

To assess whether the START (STrAtegies for RelatTives) intervention added to treatment as usual is cost effective compared with usual treatment alone. Cost effectiveness analysis nested within a pragmatic randomised controlled trial. Three mental health and one neurological outpatient dementia service in London and Essex, UK. Family carers of people with dementia. Eight session, manual based, coping intervention delivered by supervised psychology graduates to family carers of people with dementia added to usual treatment, compared with usual treatment alone. Costs measured from a health and social care perspective were analysed alongside the Hospital Anxiety and Depression Scale total score (HADS-T) of affective symptoms and quality adjusted life years (QALYs) in cost effectiveness analyses over eight months from baseline. Of the 260 participants recruited to the study, 173 were randomised to the START intervention, and 87 to usual treatment alone. Mean HADS-T scores were lower in the intervention group than the usual treatment group over the 8 month evaluation period (mean difference -1.79 (95% CI -3.32 to -0.33)), indicating better outcomes associated with the START intervention. There was a small improvement in health related quality of life as measured by QALYs (0.03 (-0.01 to 0.08)). Costs were no different between the intervention and usual treatment groups (£252 (-28 to 565) higher for START group). The cost effectiveness calculations suggested that START had a greater than 99% chance of being cost effective compared with usual treatment alone at a willingness to pay threshold of £30,000 per QALY gained, and a high probability of cost effectiveness on the HADS-T measure. The manual based coping intervention START, when added to treatment as usual, was cost effective compared with treatment as usual alone by reference to both outcome measures (affective symptoms for family carers, and carer based QALYs). ISCTRN 70017938.

Alternating treatments design: one strategy for comparing the effects of two treatments in a single subject.

PubMed Central

Barlow, D H; Hayes, S C

1979-01-01

A little used and often confused design, capable of comparing two treatments within a single subject, has been termed, variously, a multielement baseline design, a multiple schedule design, and a randomization design. The background of these terms is reviewed, and a new, more descriptive term, Alternating Treatments Design, is proposed. Critical differences between this design and a Simultaneous Treatment Design are outlined, and experimental questions answerable by each design are noted. Potential problems with multiple treatment interference in this procedure are divided into sequential confounding, carryover effects, and alternation effects and the importance of these issues vis-a-vis other single-case experimental designs is considered. Methods of minimizing multiple treatment interference as well as methods of studying these effects are outlined. Finally, appropriate uses of Alternating Treatments Designs are described and discussed in the context of recent examples. PMID:489478

Cost-effectiveness analysis of dolutegravir plus backbone compared with raltegravir plus backbone, darunavir+ritonavir plus backbone and efavirenz/tenofovir/emtricitabine in treatment naïve and experienced HIV-positive patients

PubMed Central

Restelli, Umberto; Rizzardini, Giuliano; Antinori, Andrea; Lazzarin, Adriano; Bonfanti, Marzia; Bonfanti, Paolo; Croce, Davide

2017-01-01

Background In January 2014, the European Medicines Agency issued a marketing authorization for dolutegravir (DTG), a second-generation integrase strand transfer inhibitor for HIV treatment. The study aimed at determining the incremental cost-effectiveness ratio (ICER) of the use of DTG+backbone compared with raltegravir (RAL)+backbone, darunavir (DRV)+ritonavir(r)+backbone and efavirenz/tenofovir/emtricitabine (EFV/TDF/FTC) in HIV-positive treatment-naïve patients and compared with RAL+backbone in treatment-experienced patients, from the Italian National Health Service’s point of view. Materials and methods A published Monte Carlo Individual Simulation Model (ARAMIS-DTG model) was used to perform the analysis. Patients pass through mutually exclusive health states (defined in terms of diagnosis of HIV with or without opportunistic infections [OIs] and cardiovascular disease [CVD]) and successive lines of therapy. The model considers costs (2014) and quality of life per monthly cycle in a lifetime horizon. Costs and quality-adjusted life years (QALYs) are dependent on OI, CVD, AIDS events, adverse events and antiretroviral therapies. Results In treatment-naïve patients, DTG dominates RAL; compared with DRV/r, the ICER obtained is of 38,586 €/QALY (6,170 €/QALY in patients with high viral load) and over EFV/TDF/FTC, DTG generates an ICER of 33,664 €/QALY. In treatment-experienced patients, DTG compared to RAL leads to an ICER of 12,074 €/QALY. Conclusion The use of DTG+backbone may be cost effective in treatment-naïve and treatment-experienced patients compared with RAL+backbone and in treatment-naïve patients compared with DRV/r+backbone and EFV/TDF/FTC considering a threshold of 40,000 €/QALY. PMID:28721059

Impacts of manure application on soil environment, rainfall use efficiency and crop biomass under dryland farming

PubMed Central

Wang, Xiaojuan; Jia, Zhikuan; Liang, Lianyou; Yang, Baoping; Ding, Ruixia; Nie, Junfeng; Wang, Junpeng

2016-01-01

Because of inadequate nutrient and water supply, soils are often unproductive in Northwest China. We studied the effects of manure application at low (LM 7.5  t ha–1), medium (MM 15 t ha–1), and high (HM 22.5 t ha–1) rates combined with fixed levels of chemical fertilizers on maize growth and rainfall use efficiency compared with chemical fertilizers (CK) under semi-arid conditions over a three-year period. HM and MM treatments could significantly increase soil water storage (0–120 cm) at tasseling stage of maize compared with LM treatment and CK (P < 0.05). Dry matter accumulation and rainfall use efficiency increased as manure application rate increasing (P < 0.05). HM treatment significantly increased rainfall use efficiency by 6.5–12.7% at big trumpeting – tasseling stage compared with LM and MM treatments. HM and MM treatments increased rainfall use efficiency by 8.6–18.1% at tasseling – grain filling stage compared with CK. There was no significant difference on biomass between HM and MM treatments at grain filling and maturity stages of maize in 2009 and 2010. PMID:26869520

Impacts of manure application on soil environment, rainfall use efficiency and crop biomass under dryland farming.

PubMed

Wang, Xiaojuan; Jia, Zhikuan; Liang, Lianyou; Yang, Baoping; Ding, Ruixia; Nie, Junfeng; Wang, Junpeng

2016-02-12

Because of inadequate nutrient and water supply, soils are often unproductive in Northwest China. We studied the effects of manure application at low (LM 7.5  t ha(-1)), medium (MM 15 t ha(-1)), and high (HM 22.5 t ha(-1)) rates combined with fixed levels of chemical fertilizers on maize growth and rainfall use efficiency compared with chemical fertilizers (CK) under semi-arid conditions over a three-year period. HM and MM treatments could significantly increase soil water storage (0-120 cm) at tasseling stage of maize compared with LM treatment and CK (P < 0.05). Dry matter accumulation and rainfall use efficiency increased as manure application rate increasing (P < 0.05). HM treatment significantly increased rainfall use efficiency by 6.5-12.7% at big trumpeting - tasseling stage compared with LM and MM treatments. HM and MM treatments increased rainfall use efficiency by 8.6-18.1% at tasseling - grain filling stage compared with CK. There was no significant difference on biomass between HM and MM treatments at grain filling and maturity stages of maize in 2009 and 2010.

Opiate treatment for opiate withdrawal in newborn infants.

PubMed

Osborn, D A; Cole, M J; Jeffery, H E

2002-01-01

Neonatal abstinence syndrome (NAS) due to opiate withdrawal may result in disruption of the mother-infant relationship, sleep-wake abnormalities, feeding difficulties, weight loss and seizures. Treatments used to ameliorate symptoms and reduce morbidity include opiates, sedatives and non-pharmacological treatments. To assess the effectiveness and safety of using an opiate, compared to a sedative or non-pharmacological treatment, for treatment of NAS due to withdrawal from opiates. The evidence for use of different opiates was assessed in subgroup analyses. The standard search strategy of the Cochrane Neonatal Review Group including searches (up to March 2002) of the Oxford Database of Perinatal Trials, Cochrane Controlled Trials Register (The Cochrane Library, Issue 1, 2002), MEDLINE (1966-March 2002), previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal handsearching mainly in the English language. Trials enrolling infants with NAS born to mothers with an opiate dependence, with > 80% follow up and using random or quasi-random allocation to opiate or control. Control could include an opiate, sedative or non-pharmacological treatment. Each author assessed study quality and extracted data independently. Primary outcomes included control of symptoms, seizure occurrence, mortality and neurodevelopment. Treatment effect was expressed using relative risk (RR), risk difference (RD), mean difference (MD) and weighted mean difference (WMD). Meta-analysis was performed using a fixed effect model. Six studies enrolling a total of 511 infants met inclusion criteria (Carin 1983, Finnegan 1984, Kaltenbach 1986, Kandall 1983, Khoo 1995, Madden 1977); however, two (Finnegan 1984, Kaltenbach 1986) may be sequential reports that include some identical patients. The studies enrolled infants of mothers who had used opiates with or without other drugs during pregnancy. Methodological concerns included the use of quasi-random rather than random patient allocation methods in three studies, and sizeable, largely unexplained differences in reported numbers allocated to each group in four studies. Opiate (morphine) vs supportive care only: One study (Khoo 1995) found no significant effect on treatment failure (RR 1.29, 95% CI 0.41, 4.07), a significant increase in hospital stay (MD 15.0 days, 95% CI 8.9, 21.1) and significant reductions in time to regain birthweight (MD -2.8 days, 95% -5.3, -0.3) and duration of supportive care (MD -197.2 minutes/day, 95% CI -274.2, -120.3). Opiate vs phenobarbital: Meta-analysis of three studies found no significant difference in treatment failure (typical RR 0.78, 95% CI 0.46, 1.32). One of these studies (Finnegan 1984) reported that opiate treatment resulted in a significant reduction in treatment failure among infants of mothers who had used only opiates; however, as this was a post-hoc analysis, this result should be interpreted with caution. One study (Kandall 1983) reported a reduction in seizures, of borderline statistical significance, with the use of opiate. Opiate vs diazepam: Meta-analysis of two studies found a significant reduction in treatment failure (RR 0.43, 95% CI 0.23, 0.80) with the use of opiate. No study reported neurodevelopment by allocated treatment group. Opiates, as compared to supportive care only, appear to reduce the time to regain birth weight and reduce the duration of supportive care, but increase the duration of hospital stay; there is no evidence of effect on treatment failure. When compared to phenobarbital, opiates may reduce the incidence of seizures but, overall, there is no evidence of effect on treatment failure. When compared to diazepam, opiates reduce the incidence of treatment failure. A post-hoc analysis generates the hypothesis that treatment effects may vary according to whether the population includes infants born to all opiate users (i.e. with or without other drug exposure) or is restricted to infants of mothers who used opiates only. In view of the methodologic limitations of the included studies the conclusions of this review should be treated with caution. Further research is needed.

Comparison ofdvanced turboprop interior noise control ground and flight test data

NASA Technical Reports Server (NTRS)

Simpson, Myles A.; Tran, Boi N.

1992-01-01

Interior noise ground tests conducted on a DC-9 aircraft test section are described. The objectives were to study ground test and analysis techniques for evaluating the effectiveness of interior noise control treatments for advanced turboprop aircraft, and to study the sensitivity of the ground test results to changes in various test conditions. Noise and vibration measurements were conducted under simulated advanced turboprop excitation, for two interior noise control treatment configurations. These ground measurement results were compared with results of earlier UHB (Ultra High Bypass) Demonstrator flight sts with comparable interior treatment configurations. The Demonstrator is an MD-80 test aircraft with the left JT8D engine replaced with a prototype UHB advanced turboprop engine.

Comparison ofdvanced turboprop interior noise control ground and flight test data

NASA Astrophysics Data System (ADS)

Simpson, Myles A.; Tran, Boi N.

Interior noise ground tests conducted on a DC-9 aircraft test section are described. The objectives were to study ground test and analysis techniques for evaluating the effectiveness of interior noise control treatments for advanced turboprop aircraft, and to study the sensitivity of the ground test results to changes in various test conditions. Noise and vibration measurements were conducted under simulated advanced turboprop excitation, for two interior noise control treatment configurations. These ground measurement results were compared with results of earlier UHB (Ultra High Bypass) Demonstrator flight sts with comparable interior treatment configurations. The Demonstrator is an MD-80 test aircraft with the left JT8D engine replaced with a prototype UHB advanced turboprop engine.