Metformin as an adjunct therapy for the treatment of moderate to severe acne vulgaris.
Lee, John K; Smith, Andrew D
2017-11-15
The purpose of this literature review is to evaluate the use of metformin as an adjunct therapy in the treatment of moderate-to-severe acne in those not diagnosed with polycystic ovary syndrome (PCOS) or androgen excess. The authors conducted independent literature searches. Results were limited to clinical trials and randomized controlled trials. Studies with participants diagnosed with moderateto-severe acne vulgaris taking metformin versus placebo or other active treatment were included;studies with participants diagnosed with PCOS or androgen excess were excluded. The authors found three studies consistent with the search guidelines that evaluated the effects of metformin as adjunct therapy in moderate to severe acne vulgaris. In eachstudy, metformin was an effective adjunct therapy in the treatment of moderate-to-severe acne vulgaris.
Tseng, Ping-Tao; Chen, Yen-Wen; Lin, Pao-Yen; Tu, Kun-Yu; Wang, Hung-Yu; Cheng, Yu-Shian; Chang, Yi-Chung; Chang, Chih-Hua; Chung, Weilun; Wu, Ching-Kuan
2016-01-26
Music therapy (MT) has been used as adjunct therapy for schizophrenia for decades. However, its role is still inconclusive. A recent meta-analysis demonstrated that MT for schizophrenic patients only significantly benefits negative symptoms and mood symptoms rather than positive symptoms. In addition, the association between specific characteristics of MT and the treatment effect remains unclear. The aim of this study was to update the published data and to explore the role of music therapy in adjunct treatment in schizophrenia with a thorough meta-analysis. We compared the treatment effect in schizophrenic patients with standard treatment who did and did not receive adjunct MT through a meta-analysis, and investigated the clinical characteristics of MT through meta-regression. The main finding was that the treatment effect was significantly better in the patients who received adjunct MT than in those who did not, in negative symptoms, mood symptoms, and also positive symptoms (all p < 0.05). This significance did not change after dividing the patients into subgroups of different total duration of MT, amounts of sessions, or frequency of MT. Besides, the treatment effect on the general symptoms was significantly positively associated with the whole duration of illness, indicating that MT would be beneficial for schizophrenic patients with a chronic course. Our meta-analysis highlights a significantly better treatment effect in schizophrenic patients who received MT than in those who did not, especially in those with a chronic course, regardless of the duration, frequency, or amounts of sessions of MT. These findings provide evidence that clinicians should apply MT for schizophrenic patients to alleviate disease severity.
Ball, Susan; Dellva, Mary Anne; D'Souza, Deborah N; Marangell, Lauren B; Russell, James M; Goldberger, Celine
2014-01-01
This phase 2 study examined the efficacy and tolerability of edivoxetine, a highly selective norepinephrine reuptake inhibitor, as an adjunctive treatment for patients with major depressive disorder (MDD) who have a partial response to selective serotonin reuptake inhibitor (SSRI) treatment. Study design consisted of double-blind, 10-week therapy of adjunctive edivoxetine (6-18 mg once daily) or adjunctive placebo with SSRI. Inclusion/entry criteria included partial response to current SSRI by investigator opinion and a GRID 17-item Hamilton Rating Scale for Depression (HAMD17) total score ≥16. The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Safety measures included treatment-emergent adverse events (TEAE) and vital signs. For the primary evaluable population (n=63 for adjunctive edivoxetine and n=68 for adjunctive placebo), the treatment groups did not differ significantly on the primary outcome of change from baseline to week 8 in the MADRS total score; the effect size of edivoxetine treatment was 0.26. Significant treatment differences, favoring adjunctive edivoxetine (p≤.05), were shown for improvements in role functioning and the functional impact of fatigue. For the adjunctive edivoxetine randomized group (N=111), the most frequent TEAEs were hyperhidrosis (7.2%), nausea (7.2%), erectile dysfunction (6.3%) and testicular pain (6.3%). Hemodynamic changes were observed in blood pressure and pulse rate between treatment groups. Study was underpowered for an alpha 2-sided 0.05 significance level for the primary outcome. For patients with MDD who had a partial response to SSRIs, adjunctive edivoxetine treatment was not statistically superior to adjunctive placebo on the primary outcome measure. However, pending further study, improved functioning and remission rate suggest a potential role for edivoxetine for patients with depression. Copyright © 2014 Elsevier B.V. All rights reserved.
Hobart, Mary; Skuban, Aleksandar; Zhang, Peter; Josiassen, Mette Krog; Hefting, Nanco; Augustine, Carole; Brewer, Claudette; Sanchez, Raymond; McQuade, Robert D
2018-04-01
To assess the efficacy, safety, and tolerability of brexpiprazole as adjunctive treatment in adults with major depressive disorder (MDD) and an inadequate response to prior antidepressant treatment (ADT). Patients with a current major depressive episode after prior treatment with 1-3 ADTs entered an 8- or 10-week prospective treatment phase in which they received double-blind placebo adjunct to open-label ADT. Inadequate responders were randomized (2:2:1) to brexpiprazole 2-3 mg/day, placebo, or quetiapine extended-release (XR) 150-300 mg/day, adjunct to the same ADT, for 6 weeks. The primary efficacy endpoint was the change from baseline (randomization) to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The key secondary efficacy endpoint was the change in Sheehan Disability Scale (SDS) mean score. Adjunctive brexpiprazole showed a greater improvement in MADRS total score than adjunctive placebo (least squares mean difference [95% confidence interval] = -1.48 [-2.56, -0.39]; p = .0078), whereas adjunctive quetiapine XR did not separate from placebo (-0.30 [-1.63, 1.04]; p = .66). Adjunctive brexpiprazole failed to separate from placebo on the SDS mean score (-0.23 [-0.52, 0.07]; p = .13), but did improve functioning on two of the three SDS items (family life and social life). The most frequent treatment-emergent adverse events in patients receiving brexpiprazole were akathisia (6.1%), somnolence (5.6%), and headache (5.6%). Adjunctive brexpiprazole 2-3 mg/day improved symptoms of depression compared with adjunctive placebo in patients with MDD and an inadequate response to ADTs, and was well tolerated with no unexpected side effects.
Cost-effectiveness of brexpiprazole adjunctive treatment for major depressive disorder.
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.
Kuckertz, Jennie M.; Amir, Nader; Boffa, Joseph W.; Warren, Ciara K.; Rindt, Susan E. M.; Norman, Sonya; Ram, Vasudha; Ziajko, Lauretta; Webb-Murphy, Jennifer; McLay, Robert
2014-01-01
Attention bias modification (ABM) may be an effective treatment for anxiety disorders (Beard, Sawyer, & Hofmann, 2012). As individuals with PTSD possess an attentional bias towards threat-relevant information ABM may prove effective in reducing PTSD symptoms. We examined the efficacy of ABM as an adjunct treatment for PTSD in a real-world setting. We administered ABM in conjunction with prolonged exposure or cognitive-processing therapy and medication in a community inpatient treatment facility for military personnel diagnosed with PTSD. Participants were randomized to either ABM or an attention control condition (ACC). While all participants experienced reductions in PTSD symptoms, participants in the ABM group experienced significantly fewer PTSD and depressive symptoms at post-treatment when compared to the ACC group. Moreover, change in plasticity of attentional bias mediated this change in symptoms and initial attentional bias moderated the effects of the treatment. These results suggest that ABM may be an effective adjunct treatment for PTSD. PMID:25277496
Qiao, Ying; Yang, Fuzhong; Li, Chunbo; Guo, Qian; Wen, Hui; Zhu, Suoyu; Ouyang, Qiong; Shen, Weidi; Sheng, Jianhua
2016-03-30
This study investigated the effects of a low-dose aripiprazole adjunctive treatment for risperidone- or paliperidone-induced hyperprolactinemia in Han Chinese women with schizophrenia. After 4 weeks of risperidone or paliperidone treatment, 60 out of 66 patients improved significantly and experienced hyperprolactinemia. They were randomly assigned to the treatment group (aripiprazole adjunctive treatment) (n=30) or control group (non-adjunctive treatment) (n=30). The dosage of risperidone and paliperidone were maintained; and aripiprazole was maintained at 5mg/day during the 8-week study period. The prolactin levels at the end of the 8th week were significantly lower in the treatment group than in the control group. The estradiol level correlated negatively with serum prolactin level both in the treatment group and the control group at the end of the 8th week and the 4th week respectively. The Positive and Negative Syndrome Scale score improved significantly during the 8-week study period in both groups. The incidence of treatment-emergent adverse event was similar in two groups. Low-dose aripiprazole adjunctive treatment is effective in relieving risperidone- and paliperidone-induced hyperprolactinemia in female schizophrenic patients without increasing adverse event. Copyright © 2016. Published by Elsevier Ireland Ltd.
Adjunctive raloxifene treatment improves attention and memory in men and women with schizophrenia.
Weickert, T W; Weinberg, D; Lenroot, R; Catts, S V; Wells, R; Vercammen, A; O'Donnell, M; Galletly, C; Liu, D; Balzan, R; Short, B; Pellen, D; Curtis, J; Carr, V J; Kulkarni, J; Schofield, P R; Weickert, C S
2015-06-01
There is increasing clinical and molecular evidence for the role of hormones and specifically estrogen and its receptor in schizophrenia. A selective estrogen receptor modulator, raloxifene, stimulates estrogen-like activity in brain and can improve cognition in older adults. The present study tested the extent to which adjunctive raloxifene treatment improved cognition and reduced symptoms in young to middle-age men and women with schizophrenia. Ninety-eight patients with a diagnosis of schizophrenia or schizoaffective disorder were recruited into a dual-site, thirteen-week, randomized, double-blind, placebo-controlled, crossover trial of adjunctive raloxifene treatment in addition to their usual antipsychotic medications. Symptom severity and cognition in the domains of working memory, attention/processing speed, language and verbal memory were assessed at baseline, 6 and 13 weeks. Analyses of the initial 6-week phase of the study using a parallel groups design (with 39 patients receiving placebo and 40 receiving raloxifene) revealed that participants receiving adjunctive raloxifene treatment showed significant improvement relative to placebo in memory and attention/processing speed. There was no reduction in symptom severity with treatment compared with placebo. There were significant carryover effects, suggesting some cognitive benefits are sustained even after raloxifene withdrawal. Analysis of the 13-week crossover data revealed significant improvement with raloxifene only in attention/processing speed. This is the first study to show that daily, oral adjunctive raloxifene treatment at 120 mg per day has beneficial effects on attention/processing speed and memory for both men and women with schizophrenia. Thus, raloxifene may be useful as an adjunctive treatment for cognitive deficits associated with schizophrenia.
Does Dexamethasone Helps in Meningococcal Sepsis?
Tolaj, Ilir; Ramadani, Hamdi; Mehmeti, Murat; Gashi, Hatixhe; Kasumi, Arbana; Gashi, Visar; Jashari, Haki
2017-06-01
Prompt recognition and aggressive early treatment are the only effective measures against invasive meningococcal disease (IMD). Anti-inflammatory adjunctive treatment remains controversial and difficult to assess in patients with IMD. The purpose of this study was to evaluate the effect of dexamethasone (DXM) as adjunctive treatment in different clinical forms of IMD, and attempt to answer if DXM should be routinely used in the treatment of IMD. In this non-interventional clinical study (NIS), 39 patients with meningococcal septicaemia with or without of meningitis were included, and compared regarding the impact of dexamethasone (DXM), as an adjunctive treatment, on the outcome of IMD. SPSS statistics is used for statistical processing of data. Thirty (76.9%) patients with IMD had sepsis and meningitis, and 9 (23.1%) of them had sepsis alone. Dexamethasone was used in 24 (61.5%) cases, in both clinical groups. The overall mortality rate was 10.3%. Pneumonia was diagnosed in 6 patients (15.4%), arthritis in 3 of them (7.7%), and subdural effusion in one patient (2.6%). The data showed a significant statistical difference on the length of hospitalization, and WBC normalization in groups of patients treated with DXM. The use of DXM as adjunctive therapy in invasive meningococcal disease has a degree of proven benefits and no harmful effects. In fighting this very dangerous and complex infection, even a limited benefit is sufficient to recommend the use of DXM as adjunctive treatment in invasive meningococcal disease.
Does Dexamethasone Helps in Meningococcal Sepsis?
Tolaj, Ilir; Ramadani, Hamdi; Mehmeti, Murat; Gashi, Hatixhe; Kasumi, Arbana; Gashi, Visar; Jashari, Haki
2017-01-01
Purpose: Prompt recognition and aggressive early treatment are the only effective measures against invasive meningococcal disease (IMD). Anti-inflammatory adjunctive treatment remains controversial and difficult to assess in patients with IMD. The purpose of this study was to evaluate the effect of dexamethasone (DXM) as adjunctive treatment in different clinical forms of IMD, and attempt to answer if DXM should be routinely used in the treatment of IMD. Methods: In this non-interventional clinical study (NIS), 39 patients with meningococcal septicaemia with or without of meningitis were included, and compared regarding the impact of dexamethasone (DXM), as an adjunctive treatment, on the outcome of IMD. SPSS statistics is used for statistical processing of data. Results: Thirty (76.9%) patients with IMD had sepsis and meningitis, and 9 (23.1%) of them had sepsis alone. Dexamethasone was used in 24 (61.5%) cases, in both clinical groups. The overall mortality rate was 10.3%. Pneumonia was diagnosed in 6 patients (15.4%), arthritis in 3 of them (7.7%), and subdural effusion in one patient (2.6%). The data showed a significant statistical difference on the length of hospitalization, and WBC normalization in groups of patients treated with DXM. Conclusion: The use of DXM as adjunctive therapy in invasive meningococcal disease has a degree of proven benefits and no harmful effects. In fighting this very dangerous and complex infection, even a limited benefit is sufficient to recommend the use of DXM as adjunctive treatment in invasive meningococcal disease. PMID:28974828
Rosenblat, Joshua D; Kakar, Ron; Berk, Michael; Kessing, Lars V; Vinberg, Maj; Baune, Bernhard T; Mansur, Rodrigo B; Brietzke, Elisa; Goldstein, Benjamin I; McIntyre, Roger S
2016-03-01
Inflammation has been implicated in the risk, pathophysiology, and progression of mood disorders and, as such, has become a target of interest in the treatment of bipolar disorder (BD). Therefore, the objective of the current qualitative and quantitative review was to determine the overall antidepressant effect of adjunctive anti-inflammatory agents in the treatment of bipolar depression. Completed and ongoing clinical trials of anti-inflammatory agents for BD published prior to 15 May 15 2015 were identified through searching the PubMed, Embase, PsychINFO, and Clinicaltrials.gov databases. Data from randomized controlled trials (RCTs) assessing the antidepressant effect of adjunctive mechanistically diverse anti-inflammatory agents were pooled to determine standard mean differences (SMDs) compared with standard therapy alone. Ten RCTs were identified for qualitative review. Eight RCTs (n = 312) assessing adjunctive nonsteroidal anti-inflammatory drugs (n = 53), omega-3 polyunsaturated fatty acids (n = 140), N-acetylcysteine (n = 76), and pioglitazone (n = 44) in the treatment of BD met the inclusion criteria for quantitative analysis. The overall effect size of adjunctive anti-inflammatory agents on depressive symptoms was -0.40 (95% confidence interval -0.14 to -0.65, p = 0.002), indicative of a moderate and statistically significant antidepressant effect. The heterogeneity of the pooled sample was low (I² = 14%, p = 0.32). No manic/hypomanic induction or significant treatment-emergent adverse events were reported. Overall, a moderate antidepressant effect was observed for adjunctive anti-inflammatory agents compared with conventional therapy alone in the treatment of bipolar depression. The small number of studies, diversity of agents, and small sample sizes limited interpretation of the current analysis. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Li, Xianbin; Tang, Yilang; Wang, Chuanyue
2013-01-01
Objective To compare the safety and efficacy of adjunctive aripiprazole versus placebo for antipsychotic-induced hyperprolactinemia. Methods Population: adult patients presenting with antipsychotic-induced hyperprolactinemia diagnosed by prolactin level with or without prolactin-related symptoms. Interventions: adjunctive aripiprazole vs. adjunctive placebo. Outcome measures: adverse events and efficacy of treatment. Studies: randomized controlled trials. Results Five randomized controlled trials with a total of 639 patients (326 adjunctive aripiprazole, 313 adjunctive placebo) met the inclusion criteria. Adjunctive aripiprazole was associated with a 79.11% (125/158) prolactin level normalization rate. Meta-analysis of insomnia, headache, sedation, psychiatric disorder, extrapyramidal symptom, dry mouth, and fatigue showed no significant differences in the adjunctive aripiprazole treatment group compared with the placebo group (risk difference (Mantel-Haenszel, random or fixed) −0.05 to 0.04 (95% confidence interval −0.13 to 0.16); I2 = 0% to 68%, P = 0.20 to 0.70). However, sedation, insomnia, and headache were more frequent when the adjunctive aripiprazole dose was higher than 15 mg/day. Meta-analysis of the prolactin level normalization indicated adjunctive aripiprazole was superior to placebo (risk difference (Mantel-Haenszel, random) 0.76 (95% confidence interval 0.67 to 0.85); I2 = 43%, P<0.00001). The subgroup analysis confirmed that the subjects who received adjunctive aripiprazole 5 mg/day showed a degree of prolactin normalization similar to that of all participants. No significant differences between groups in discontinuation and improvements of psychiatric symptoms. Conclusion Adjunctive aripiprazole is both safe and effective as a reasonable choice treatment for patients with antipsychotic-induced hyperprolactinemia. The appropriate dose of adjunctive aripiprazole may be 5 mg/day. PMID:23936389
Weinstock, Jeremiah; Wadeson, Heather K; VanHeest, Jaci L
2012-01-01
Opiate dependence is a significant public health concern linked to poor quality of life, comorbid psychiatric disorders, and high costs to society. Current opiate agonist treatments are an effective but limited intervention. Adjunctive interventions could improve and augment opiate agonist treatment outcomes, including drug abstinence, quality of life, and physical health. This article reviews exercise as an adjunctive intervention for opiate agonist treatment, especially in regards to improving mood and overall quality of life, while reducing other substance use. Poor adherence and dropout frequently prevent many individuals from garnering the many physical and mental health benefits of exercise. Strategies for implementing an exercise intervention, including safety considerations, are discussed.
Peverly, Stephen T.; Wood, Rhea
2001-01-01
Adjunct question research has typically focused on the effects of adjunct questions on improving the learning of college students. This study investigated the effects of inserted and massed postquestions (inference, main idea, and detail), with and without feedback, on improving the comprehension skills of adolescents labeled as reading disabled. Students practiced using adjunct questions for 6 weeks. The results suggested that inserted questions (and to a lesser extent massed postquestions) were beneficial in improving the comprehension of texts that did not contain adjunct questions. Specifically, the results indicated that (a) inserted questions were more effective than massed postquestions or no questions, (b) massed postquestions were more effective than no questions, and (c) the effects of inserted questions on comprehension increased over the time of treatment. The beneficial effects of feedback were limited to inference and main idea questions. Copyright 2001 Academic Press.
Walter, Martin A; Briel, Matthias; Christ-Crain, Mirjam; Bonnema, Steen J; Connell, John; Cooper, David S; Bucher, Heiner C; Müller-Brand, Jan; Müller, Beat
2007-03-10
To determine the effect of adjunctive antithyroid drugs on the risk of treatment failure, hypothyroidism, and adverse events after radioiodine treatment. Meta-analysis. Electronic databases (Cochrane central register of controlled trials, Medline, Embase) searched to August 2006 and contact with experts. Review methods Three reviewers independently assessed trial eligibility and quality. Pooled relative risks for treatment failure and hypothyroidism after radioiodine treatment with and without adjunctive antithyroid drugs were calculated with a random effects model. We identified 14 relevant randomised controlled trials with a total of 1306 participants. Adjunctive antithyroid medication was associated with an increased risk of treatment failure (relative risk 1.28, 95% confidence interval 1.07 to 1.52; P=0.006) and a reduced risk for hypothyroidism (0.68, 0.53 to 0.87; P=0.006) after radioiodine treatment. We found no difference in summary estimates for the different antithyroid drugs or for whether antithyroid drugs were given before or after radioiodine treatment. Antithyroid drugs potentially increase rates of failure and reduce rates of hypothyroidism if they are given in the week before or after radioiodine treatment, respectively.
Chen, Catherine; Koch, Laine H; Dice, James E; Dempsey, Kimberly K; Moskowitz, Alan B; Barnes-Eley, Myra L; Hubbard, Thomas W; Williams, Judith V
2010-01-01
Our objective was to compare the efficacy of selenium sulfide shampoo 1% and ciclopirox shampoo 1% as adjunctive treatments for tinea capitis in children. Forty children aged 1-11 years with clinically diagnosed tinea capitis were randomized to receive selenium sulfide shampoo 1% or ciclopirox shampoo 1% twice a week as adjuncts to an 8-week course of ultramicronized griseofulvin dosed at 10-12 mg/kg/day. At weeks 2, 4, and 8, subjects returned to the clinic for evaluation and scalp cultures. Subjects then returned for follow-up visits 4 weeks after completing treatment. Overall, by 8 weeks, 30 of 33 (90.9%) treated children demonstrated mycological cure. Selenium sulfide shampoo 1% and ciclopirox shampoo 1% were equally effective as adjunctive treatments for tinea capitis in children in our study. © 2010 Wiley Periodicals, Inc.
Brivaracetam: An Adjunctive Treatment for Partial-Onset Seizures.
Kappes, John A; Hayes, William J; Strain, Joe D; Farver, Debra K
2017-07-01
Brivaracetam is an analogue of levetiracetam that is Food and Drug Administration-approved for adjunctive treatment of partial-onset seizures in patients 16 years and older. In placebo-controlled trials adjunct brivaracetam demonstrated efficacy in reducing the frequency of seizures. The most commonly reported adverse effects are somnolence, dizziness, and fatigue. Clinical trials have evaluated brivaracetam for safety and efficacy in adjunctive treatment of partial-onset seizures in patients 16 years and older for up to 16 weeks. Brivaracetam's mechanism is similar to that of levetiracetam but with greater receptor binding affinity on synaptic vesicle protein 2A and inhibitory effects on sodium channels. Clinically significant differences between these agents are undetermined. Brivaracetam is available as oral tablets, oral solution, and intravenous solution. The Food and Drug Administration-approved dose is 50 mg twice daily, and titration is not required. Brivaracetam does not need dose adjustment for renal impairment and has minimal drug-drug interactions. Current limitations of brivaracetam include lack of head-to-head trials, limited long-term safety and efficacy data, and cost. Overall, brivaracetam is a viable adjunct therapeutic option for refractory partial-onset seizures in those who have failed conventional therapies. © 2017, The American College of Clinical Pharmacology.
Overprompting Science Students Using Adjunct Study Questions.
ERIC Educational Resources Information Center
Holliday, William G.
1983-01-01
The selective attention model was used to explain effects of overprompting students (N=170) provided with study questions adjunct to a complex flow diagram describing scientific cyclical schema. Strongly prompting students to answers of questions was less effective than an unprompted question treatment, suggesting that prompting techniques be used…
ERIC Educational Resources Information Center
Abbasi, Seyed-Hesameddin; Heidari, Shahram; Mohammadi, Mohammad-Reza; Tabrizi, Mina; Ghaleiha, Ali; Akhondzadeh, Shahin
2011-01-01
The objective of this study was to test whether a previous observed Acetyl-L-carnitine (ALC) treatment effect could be repeated in an ALC adjunctive therapy treatment trial of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. This was a six-week, randomized clinical trial undertaken in an outpatient child and adolescent…
Briel, Matthias; Christ-Crain, Mirjam; Bonnema, Steen J; Connell, John; Cooper, David S; Bucher, Heiner C; Müller-Brand, Jan; Müller, Beat
2007-01-01
Objective To determine the effect of adjunctive antithyroid drugs on the risk of treatment failure, hypothyroidism, and adverse events after radioiodine treatment. Design Meta-analysis. Data sources Electronic databases (Cochrane central register of controlled trials, Medline, Embase) searched to August 2006 and contact with experts. Review methods Three reviewers independently assessed trial eligibility and quality. Pooled relative risks for treatment failure and hypothyroidism after radioiodine treatment with and without adjunctive antithyroid drugs were calculated with a random effects model. Results We identified 14 relevant randomised controlled trials with a total of 1306 participants. Adjunctive antithyroid medication was associated with an increased risk of treatment failure (relative risk 1.28, 95% confidence interval 1.07 to 1.52; P=0.006) and a reduced risk for hypothyroidism (0.68, 0.53 to 0.87; P=0.006) after radioiodine treatment. We found no difference in summary estimates for the different antithyroid drugs or for whether antithyroid drugs were given before or after radioiodine treatment. Conclusions Antithyroid drugs potentially increase rates of failure and reduce rates of hypothyroidism if they are given in the week before or after radioiodine treatment, respectively. PMID:17309884
ERIC Educational Resources Information Center
Sanford, Mark; Boyle, Michael; McCleary, Lynn; Miller, Jennifer; Steele, Margaret; Duku, Eric; Offord, David
2006-01-01
Objective: To obtain preliminary evidence of the feasibility and effectiveness of adjunctive family psychoeducation in adolescent major depressive disorder. Method: Participants were from outpatient clinics in Hamilton and London, Ontario. Over 24 months, 41 adolescents ages 13 through 18 years meeting major depressive disorder criteria were…
Zhang, Lina; Zhang, Zhiqin; Chen, Yangmei; Qin, Xinyue; Zhou, Huadong; Zhang, Chaodong; Sun, Hongbin; Tang, Ronghua; Zheng, Jinou; Yi, Lin; Deng, Liying; Li, Jinfang
2013-08-01
Rasagiline mesylate is a highly potent, selective and irreversible monoamine oxidase type B (MAOB) inhibitor and is effective as monotherapy or adjunct to levodopa for patients with Parkinson's disease (PD). However, few studies have evaluated the efficacy and safety of rasagiline in the Chinese population. This study was designed to investigate the safety and efficacy of rasagiline as adjunctive therapy to levodopa treatment in Chinese PD patients. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-centre trial conducted over a 12-wk period that enrolled 244 PD patients with motor fluctuations. Participants were randomly assigned to oral rasagiline mesylate (1 mg) or placebo, once daily. Altogether, 219 patients completed the trial. Rasagiline showed significantly greater efficacy compared with placebo. During the treatment period, the primary efficacy variable--mean adjusted total daily off time--decreased from baseline by 1.7 h in patients treated with 1.0 mg/d rasagiline compared to placebo (p < 0.05). Scores using the Unified Parkinson's Disease Rating Scale also improved during rasagiline treatment. Rasagiline was well tolerated. This study demonstrated that rasagiline mesylate is effective and well tolerated as an adjunct to levodopa treatment in Chinese PD patients with fluctuations.
Roncati, Marisa; Gariffo, Annalisa
2014-04-01
The aims of this study were (1) to conduct a literature search and systematically evaluate the additional therapeutic effects of pulsed Nd:YAG or diode laser use in patients with periodontitis, (2) to assess evidence supporting the additional benefit of laser-mediated periodontal treatment in conjunction with scaling and root planning (SRP) (not as monotherapy), and (3) to interpret the evidence presented in retrieved publications. Opinions about the additional use of diode lasers in the nonsurgical treatment of plaque-induced periodontal lesions are conflicting. The April 2011 American Academy of Periodontology's "Statement on the Efficacy of Lasers in the Non-Surgical Treatment of Inflammatory Periodontal Disease" asserted that the use of a laser as monotherapy or in addition to nonsurgical periodontal instrumentation conveyed no advantage. After initial screening, 23/77 potentially relevant articles and abstracts identified through electronic and manual searches of the MEDLINE(®)/PubMed database and the Cochrane Central Register of Controlled Trials (1990-2012) were included in this review. A meta-analysis could be performed. The results indicate that Nd:YAG or diode laser, used in an adjunctive capacity to SRP, may provide some additional benefit, in 6 month studies, compared with mechanical debridement. The results show the adjunctive benefits that diode laser treatment can provide when it is used as an adjunct to nonsurgical periodontal treatment in adults with chronic periodontitis. Further long-term, well-designed, parallel randomized clinical trials are needed to assess the effectiveness of the adjunctive use of the diode laser, as well as the appropriate dosimetry and laser settings.
Alshehri, Mohammad; Alshail, Faisal; Alqahtani, Sami H; Aloriny, Tawfeeg Saleh; Alsharif, Abdulhakim; Kujan, Omar
2015-09-01
The aim of the present short-term follow-up study was to assess the effects of scaling and root planing (SRP) with or without adjunctive use of an essential-oil-based mouthwash in the treatment of periodontal inflammation in smokers. In total, 120 individuals were divided into 2 groups. In Group-1, 60 smokers with periodontal inflammation received SRP alone; and in Group-2, 60 smokers with periodontal inflammation received adjunct essential-oil mouthwash therapy. Periodontal parameters (plaque index [PI], bleeding-on-probing [BOP], and probing pocket depth [PD] ≥ 4 mm) were assessed at baseline and after 90 days of treatment. There was no significant difference in periodontal parameters (PI, BOP, and PD ≥ 4 mm) among participants in Group-1 and -2. Participants in both groups showed significant reductions in PI (P < 0.01), BOP (P < 0.01), and PD ≥ 4 mm (P < 0.01) at follow-up compared to baseline. At 90 days of follow-up, PI (P < 0.05), BOP (P < 0.05), and PD ≥ 4 mm (P < 0.05) were significantly higher in Group-1 compared to Group-2. SRP with adjunct essential-oil mouthwash therapy is more effective in the treatment of periodontal inflammation in smokers as compared to when SRP is performed alone.
The Case for the Use of PPARγ Agonists as an Adjunctive Therapy for Cerebral Malaria
Serghides, Lena
2012-01-01
Cerebral malaria is a severe complication of Plasmodium falciparum infection associated with high mortality even when highly effective antiparasitic therapy is used. Adjunctive therapies that modify the pathophysiological processes caused by malaria are a possible way to improve outcome. This review focuses on the utility of PPARγ agonists as an adjunctive therapy for the treatment of cerebral malaria. The current knowledge of PPARγ agonist use in malaria is summarized. Findings from experimental CNS injury and disease models that demonstrate the potential for PPARγ agonists as an adjunctive therapy for cerebral malaria are also discussed. PMID:21772838
Influence of adjunctive lacosamide in patients with seizures: a systematic review and meta-analysis.
Liu, Hongju; Xu, Xiaoli
2018-07-01
Adjunctive lacosamide treatment might be promising to treat seizures. However, the results remained controversial. We conducted a systematic review and meta-analysis to compare the efficacy and safety of adjunctive lacosamide versus placebo in patients with seizures. PubMed, EMbase, Web of science, EBSCO and Cochrane library databases were systematically searched. Randomized controlled trials (RCTs) assessing the effect of adjunctive lacosamide versus placebo on seizures were included. Two investigators independently searched articles, extracted data and assessed the quality of included studies. The primary outcomes were 50% responder rate and seizure freedom. Four RCTs involving 1199 patients were included in the meta-analysis. Overall, compared with placebo treatment, adjunctive lacosamide treatment was associated with a significantly increased 50% responder rate (RR = 1.89; 95% CI = 1.51-2.36; P < 0.00001) and seizure freedom (RR = 4.97; 95% CI = 1.78-13.91; P = 0.002), but improved dizziness (RR = 3.97; 95% CI = 2.91-5.42; P < 0.00001), nausea (RR = 2.85; 95% CI = 1.75-4.66; P < 0.0001), vomiting (RR = 4.11; 95% CI = 2.23-7.57; P < 0.00001), diplopia (RR = 6.85; 95% CI = 3.36-13.94; P < 0.00001), treatment-emergent adverse events (RR = 2.29; 95% CI = 1.93-2.71; P < 0.00001) and serious adverse events (RR = 2.52; 95% CI = 1.33-4.78; P = 0.005). Compared to placebo, adjunctive lacosamide resulted in a significantly improved 50% responder rate and seizure freedom, but with increased dizziness, nausea, vomiting, diplopia, treatment-emergent adverse events and serious adverse events.
Ji, E; Weickert, C S; Lenroot, R; Kindler, J; Skilleter, A J; Vercammen, A; White, C; Gur, R E; Weickert, T W
2016-05-03
Estrogen has been implicated in the development and course of schizophrenia with most evidence suggesting a neuroprotective effect. Treatment with raloxifene, a selective estrogen receptor modulator, can reduce symptom severity, improve cognition and normalize brain activity during learning in schizophrenia. People with schizophrenia are especially impaired in the identification of negative facial emotions. The present study was designed to determine the extent to which adjunctive raloxifene treatment would alter abnormal neural activity during angry facial emotion recognition in schizophrenia. Twenty people with schizophrenia (12 men, 8 women) participated in a 13-week, randomized, double-blind, placebo-controlled, crossover trial of adjunctive raloxifene treatment (120 mg per day orally) and performed a facial emotion recognition task during functional magnetic resonance imaging after each treatment phase. Two-sample t-tests in regions of interest selected a priori were performed to assess activation differences between raloxifene and placebo conditions during the recognition of angry faces. Adjunctive raloxifene significantly increased activation in the right hippocampus and left inferior frontal gyrus compared with the placebo condition (family-wise error, P<0.05). There was no significant difference in performance accuracy or reaction time between active and placebo conditions. To the best of our knowledge, this study provides the first evidence suggesting that adjunctive raloxifene treatment changes neural activity in brain regions associated with facial emotion recognition in schizophrenia. These findings support the hypothesis that estrogen plays a modifying role in schizophrenia and shows that adjunctive raloxifene treatment may reverse abnormal neural activity during facial emotion recognition, which is relevant to impaired social functioning in men and women with schizophrenia.
Lacosamide: A Review in Focal Seizures in Patients with Epilepsy.
Scott, Lesley J
2015-12-01
Lacosamide (Vimpat(®)) is a functionalized amino acid available orally (as a solution or tablets) and as an intravenous infusion for use as monotherapy (only in the USA) or adjunctive therapy for the treatment of focal seizures in adult and adolescent (aged ≥17 years in the USA) patients with epilepsy. As adjunctive therapy to other antiepileptic drugs (AEDs), lacosamide provided effective seizure control and was generally well tolerated in adults and adolescents (aged ≥16 years) in randomized clinical trials and in the real-world setting. In clinical trials, adjunctive lacosamide provided significantly greater reductions in 28-day seizure rates than adjunctive placebo, with these benefits maintained after up to 8 years of therapy in open-label extension studies. Moreover, patients were effectively switched from oral to short-term intravenous adjunctive therapy at the same dosage, which may be particularly beneficial in situations where oral therapy is not suitable. Conversion to lacosamide monotherapy was superior to a historical-control cohort in patients with focal seizures converting from previous AED therapy. In the absence of head-to-head comparisons with other AEDs, the exact position of lacosamide relative to other AEDs remains to be fully determined. In the meantime, oral and intravenous lacosamide provides a useful option as monotherapy (only in the USA) or adjunctive therapy for the treatment of focal seizures in adult and adolescent (aged ≥17 years in the USA) patients with epilepsy.
Jing, Yonghua; Kim, Edward; You, Min; Pikalov, Andrei; Tran, Quynh-Van
2009-06-01
Bipolar disorder has an associated economic burden due to its treatment, including medication and hospitalization costs as well as costs associated with treatment of comorbid conditions. This study compared healthcare costs in patients treated with a mood stabilizer and adjunctive aripiprazole versus adjunctive olanzapine, quetiapine, risperidone or ziprasidone. A retrospective propensity score-matched cohort study was conducted in the LabRx integrated claims database from January 2003 to December 2006. Patients (18-65 years) with bipolar disorder and 180 days of pre-index enrolment without atypical treatment and 90 days post-index enrolment were eligible. Mood stabilizer therapy was initiated prior to index atypical prescription. Generalized gamma regressions were used to compare the total healthcare costs of adjunctive aripiprazole treatment and treatment with adjunctive olanzapine, quetiapine, risperidone or ziprasidone. After controlling for differences in baseline characteristics and pre-index cost, psychiatric costs and subtotal psychiatric and general medical costs were higher for all adjunctive atypicals than adjunctive aripiprazole (p<0.001). Based on gamma regressions cost ratios, there was no significant difference in general medical costs between aripiprazole and ziprasidone, olanzapine, or quetiapine; risperidone general medical costs were 18% higher versus aripiprazole (p=0.041). Aripiprazole pharmacy costs were higher than quetiapine and risperidone (p<0.001) but not olanzapine or ziprasidone. Total healthcare costs were higher for ziprasidone, olanzapine, or risperidone (p<0.001) but not quetiapine. Methodological restriction of patients to those newly initiated on an atypical antipsychotic and incomplete medication history limit the generalizability of the findings. Adjunctive aripiprazole may have economic benefits over other atypicals in terms of lower psychiatric treatment costs than adjunctive olanzapine, quetiapine, risperidone or ziprasidone, and lower total healthcare costs than adjunctive olanzapine, risperidone or ziprasidone.
Al-Hamoudi, Nawwaf
2017-09-01
To determine whether treatment with antimicrobial photodynamic therapy (aPDT) as an adjunct to scaling and root planing (SRP) improves clinical, microbiological and immunological outcomes in type 2 diabetes mellitus (T2DM) and cigarette smokers with chronic periodontitis (CP). Databases (MEDLINE, PubMed; Cochrane Central Register of Controlled Trials and Cochrane Oral Health Group Trials Register) were searched up to and including May 2017. The addressed PICO question was: "Does aPDT as an adjunct to SRP improves clinical, microbiological and immunological outcomes in T2DM and smokers with CP?" Six randomized clinical trials were included. All studies reporting clinical periodontal, microbiological, and immunological parameters showed that aPDT was effective in the treatment of CP in T2DM and smokers at follow up. When compared with SRP alone, none of the studies showed additional benefits of aPDT at follow up. Considering the effects of adjunctive aPDT as compared to SRP on clinical signs of CP in T2DM and smokers, no difference could be observed for all evaluated parameters (PD: Z=-0.81, P=0.41; CAL: Z=-0.19, P=0.84) except IL-1β (Z=4.57, P<0.001). Due to limited evidence, it remains debatable whether aPDT as an adjunct to SRP is effective in improving clinical, microbiological and immunological outcomes compared to SRP alone in T2DM and smokers with CP. Further well-designed, large-scale clinical trials with microbiological parameters and long follow up periods are needed in order to assess the efficacy of adjunctive aPDT in T2DM and cigarette smokers with CP. Copyright © 2017 Elsevier B.V. All rights reserved.
Zheng, Wei; Xiang, Ying-Qiang; Ungvari, Gabor S; Chiu, F K Helen; H Ng, Chee; Wang, Ying; Xiang, Yu-Tao
2016-04-25
Acetylcholinesterase (AChE) inhibitors have been shown to be effective in treating cognitive impairment in animal models and in human subjects with major depressive disorder (MDD). Huperzine A (HupA), a Traditional Chinese Medicine derived from a genus of clubmosses known as Huperzineserrata, is a powerful AChE inhibitor that has been used as an adjunctive treatment for MDD, but no meta-analysis on HupA augmentation for MDD has yet been reported. Conduct a systematic review and meta-analysis of randomized controlled trials (RCTS) about HupA augmentation in the treatment of MDD to evaluate its efficacy and safety. Two evaluators independently searched nine English-language and Chinese-language databases, selected relevant studies that met pre-determined inclusion criteria, extracted data about outcome and safety, and conducted quality assessments and data synthesis. Three low-quality RCTs (pooled n=238) from China were identified that compared monotherapy antidepressant treatment for depression versus combined treatment with antidepressants and HupA. Participants in the studies ranged from 16 to 60 years of age. The average duration of adjunctive antidepressant and HupA treatment in the studies was only 6.7 weeks. All three studies were open label and non-blinded, so their overall quality was judged as poor. Meta-analysis of the pooled sample found no significant difference in the improvement in depressive symptoms between the two groups (weighted mean difference: -1.90 (95%CI: -4.23, 0.44), p=0.11). However, the adjunctive HupA group did have significantly greater improvement than the antidepressant only group in cognitive functioning (as assessed by the Wisconsin Card Sorting Test and the Wechsler Memory Scale-Revised) and in quality of life. There was no significant difference in the incidence of adverse drug reactions between groups. The data available on the effectiveness and safety of adjunctive treatment using HupA in patients with MDD who are receiving antidepressants is insufficient to arrive at a definitive conclusion about its efficacy and safety. Pooling of the data from three low-quality RCTs from China found no advantage of adjunctive HupA in the treatment of depressive symptoms, but adjunctive treatment with HupA was associated with a faster resolution of the cognitive symptoms that frequently accompany MDD.
ZHENG, Wei; XIANG, Ying-Qiang; UNGVARI, Gabor S.; CHIU, F.K. Helen; H. NG, Chee; WANG, Ying; XIANG, Yu-Tao
2016-01-01
Background Acetylcholinesterase (AChE) inhibitors have been shown to be effective in treating cognitive impairment in animal models and in human subjects with major depressive disorder (MDD). Huperzine A (HupA), a Traditional Chinese Medicine derived from a genus of clubmosses known as Huperzineserrata, is a powerful AChE inhibitor that has been used as an adjunctive treatment for MDD, but no meta-analysis on HupA augmentation for MDD has yet been reported. Aim Conduct a systematic review and meta-analysis of randomized controlled trials (RCTS) about HupA augmentation in the treatment of MDD to evaluate its efficacy and safety. Methods Two evaluators independently searched nine English-language and Chinese-language databases, selected relevant studies that met pre-determined inclusion criteria, extracted data about outcome and safety, and conducted quality assessments and data synthesis. Results Three low-quality RCTs (pooled n=238) from China were identified that compared monotherapy antidepressant treatment for depression versus combined treatment with antidepressants and HupA. Participants in the studies ranged from 16 to 60 years of age. The average duration of adjunctive antidepressant and HupA treatment in the studies was only 6.7 weeks. All three studies were open label and non-blinded, so their overall quality was judged as poor. Meta-analysis of the pooled sample found no significant difference in the improvement in depressive symptoms between the two groups (weighted mean difference: -1.90 (95%CI: -4.23, 0.44), p=0.11). However, the adjunctive HupA group did have significantly greater improvement than the antidepressant only group in cognitive functioning (as assessed by the Wisconsin Card Sorting Test and the Wechsler Memory Scale-Revised) and in quality of life. There was no significant difference in the incidence of adverse drug reactions between groups. Conclusions The data available on the effectiveness and safety of adjunctive treatment using HupA in patients with MDD who are receiving antidepressants is insufficient to arrive at a definitive conclusion about its efficacy and safety. Pooling of the data from three low-quality RCTs from China found no advantage of adjunctive HupA in the treatment of depressive symptoms, but adjunctive treatment with HupA was associated with a faster resolution of the cognitive symptoms that frequently accompany MDD. PMID:27605862
Hlastala, Stefanie A; Kotler, Julie S; McClellan, Jon M; McCauley, Elizabeth A
2010-05-01
In adolescents and adults, bipolar disorder (BD) is associated with significant morbidity, mortality, and impairment in psychosocial and occupational functioning. IPSRT is an empirically supported adjunctive psychotherapy for adults with bipolar disorder, which has been shown to help delay relapse, speed recovery from a bipolar depressive episode, and increase occupational and psychosocial functioning in adults with BD. This study is designed to describe the adolescent-specific developmental adaptations made to IPSRT (i.e., IPSRT-A) and to report the results from an open trial of IPSRT-A with 12 adolescents with a bipolar spectrum disorder. Interpersonal and Social Rhythm Therapy was adapted to be developmentally relevant to adolescents with bipolar disorder. Twelve adolescents (mean age 16.5+/-1.3 years) diagnosed with a bipolar spectrum disorder participated in 16-18 sessions of adjunctive IPSRT-A over 20 weeks. Manic, depressive, and general symptoms and global functioning were measured at baseline, monthly during treatment, and at post-treatment. Adolescent satisfaction with treatment was also measured. Feasibility and acceptability of IPSRT-A were high; 11/12 participants completed treatment, 97% of sessions were attended, and adolescent-rated satisfaction scores were high. IPSRT-A participants experienced significant decreases in manic, depressive, and general psychiatric symptoms over the 20 weeks of treatment. Participants' global functioning increased significantly as well. Effect sizes ranged from medium-large to large. IPSRT-A appears to be a promising adjunctive treatment for adolescents with bipolar disorder. A current randomized controlled trial is underway to examine effects of adjunctive IPSRT-A on psychiatric symptoms and psychosocial functioning.
LaForce, Craig; Gentile, Deborah A; Skoner, David P
2008-07-01
This study assessed the efficacy and safety of guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg extended-release bilayer tablets in providing relief of acute respiratory symptoms when used as an adjunct to antibiotics in patients with an acute respiratory infection (ARI). Adult patients experiencing symptoms of ARI and meeting the physician's usual diagnostic criteria for oral antibiotic treatment were prescribed an antibiotic and randomized to adjunctive guaifenesin/pseudoephedrine hydrochloride or matching placebo twice daily for 7 days. Patients completed symptom diaries and treatment assessments twice daily and attended office visits on Days 4 and 8. The safety/intent-to-treat (ITT) population analysis included 601 patients (guaifenesin/pseudoephedrine, n = 303; placebo, n = 298). Mean symptom scores were lower with guaifenesin/pseudoephedrine from Day 3 for every symptom assessed, with statistically significant improvements in total symptom score from Day 3 (P = 0.026). The greatest effects of treatment with guaifenesin/pseudoephedrine were observed for nasal congestion and sinus headache. Time to overall relief was shorter with guaifenesin/pseudoephedrine (P = 0.038). Significantly more patients reported "the medication was helping during the day" on Day 2 with guaifenesin/pseudoephedrine (P = 0.002). Patient assessments of symptom relief showed a significant preference for guaifenesin/pseudoephedrine versus placebo (P = 0.021). Treatment with guaifenesin/pseudoephedrine was well tolerated. Insomnia (2.6%), nausea (2.3%), and headache (1.3%) were the most common treatment-related adverse effects. As adjunctive therapy for symptom relief for patients taking antibiotics for ARIs, guaifenesin/pseudoephedrine shortened time to relief and improved bothersome respiratory symptoms better than placebo, with greatest effects seen for nasal congestion and sinus headache.
Ellegaard, Pernille Kempel; Licht, Rasmus Wentzer; Poulsen, Henrik Enghusen; Nielsen, René Ernst; Berk, Michael; Dean, Olivia May; Mohebbi, Mohammadreza; Nielsen, Connie Thuroee
2018-04-05
Oxidative stress and inflammation may be involved in the development and progression of mood disorders, including bipolar disorder. Currently, there is a scarcity of useful treatment options for bipolar depressive episodes, especially compared with the efficacy of treatment for acute mania. N-Acetylcysteine (NAC) has been explored for psychiatric disorders for some time given its antioxidant and anti-inflammatory properties. The current trial aims at testing the clinical effects of adjunctive NAC treatment (compared to placebo) for bipolar depression. We will also explore the biological effects of NAC in this context. We hypothesize that adjunctive NAC treatment will reduce symptoms of depression, which will be reflected by changes in selected markers of oxidative stress. In the study, we will include adults diagnosed with bipolar disorder, in a currently depressive episode. Participants will undertake a 20-week, adjunctive, randomized, double-blinded, parallel group placebo-controlled trial comparing 3 grams of adjunctive NAC daily with placebo. The primary outcome is the mean change over time from baseline to end of study on the Montgomery-Asberg Depression Rating Scale (MADRS). Among the secondary outcomes are mean changes from baseline to end of study on the Bech-Rafaelsen Melancholia Scale (MES), the Young Mania Rating Scale (YMRS), the WHO-Five Well-being Index (WHO-5), the Global Assessment of Functioning scale (GAF-F), the Global Assessment of Symptoms scale (GAF-S) and the Clinical Global Impression-Severity scale (CGI-S). The potential effects on oxidative stress by NAC treatment will be measured through urine and blood samples. DNA will be examined for potential polymorphisms related to oxidative defences. Registered at The European Clinical Trials Database, ClinicalTrials.gov: NCT02294591 and The Danish Data Protection Agency: 2008-58-0035.
Local oxygen therapy for treating acute necrotizing periodontal disease in smokers.
Gaggl, Alexander J; Rainer, Heribert; Grund, Eveline; Chiari, Friedrich M
2006-01-01
The main aim of treatment for acute necrotizing periodontal disease is fast and effective reduction of anaerobic destructive microorganisms to avoid periodontal damage. The effect of adjunctive local oxygen therapy in the treatment of necrotizing periodontal disease was examined in this study. Thirty patients with acute necrotizing periodontal disease were treated with the systemic antibiotics amoxicillin, clavulanic acid, and metronidazole. In 15 out of 30 patients, adjunctive local oxygen therapy was administered. The patients were followed from the first to 10th day of treatment with clinical and bacteriological examinations. The clinical examination registered gingival bleeding, periodontal probing depth, and attachment loss; to follow up microbiological colonization of the periodontal sulcus, five representative bacteria were registered by a semiquantitative DNA polymerase chain reaction test. In both groups of patients, colonization with Prevotella intermedia, Tannerella forsythensis, and Treponema denticola was initially positive. None of these three microorganisms were completely eradicated in any of the patients in the group without oxygen therapy within the first 10 days of treatment. In the group with adjunctive oxygen therapy, all patients either showed a reduction in or complete eradication of the microorganisms, resulting in more rapid clinical restitution with less periodontal destruction. Adjunctive oxygen therapy results in early eradication of pathogenic anaerobic microorganisms in cases of acute necrotizing periodontal disease. The damage to periodontal tissue is reduced.
Ambroggio, Lilliam; Test, Matthew; Metlay, Joshua P; Graf, Thomas R; Blosky, Mary Ann; Macaluso, Maurizio; Shah, Samir S
2015-03-01
The role of adjunct systemic corticosteroid therapy in children with community-acquired pneumonia (CAP) is not known. The objective was to determine the association between adjunct systemic corticosteroid therapy and treatment failure in children who received antibiotics for treatment of CAP in the outpatient setting. The study included a retrospective cohort study of children, aged 1-18 years, with a diagnosis of CAP who were managed at an outpatient practice affiliated with Geisinger Health System from January 1, 2008 to January 31, 2010. The primary exposure was the receipt of adjunct corticosteroid therapy. The primary outcome was treatment failure defined as a respiratory-associated follow-up within 14 days of diagnosis in which the participant received a change in antibiotic therapy. The probability of receiving adjunct systemic corticosteroid therapy was calculated using a matched propensity score. A multivariable conditional logistic regression model was used to estimate the association between adjunct corticosteroids and treatment failure. Of 2244 children with CAP, 293 (13%) received adjunct corticosteroids, 517 (23%) had underlying asthma, and 624 (28%) presented with wheezing. Most patients received macrolide monotherapy for their CAP diagnosis (n = 1329; 59%). Overall, treatment failure was not associated with adjunct corticosteroid treatment (odds ratio [OR], 1.72; 95% confidence interval [CI], 0.93 and 3.19), but the association was statistically significant among patients with no history of asthma (OR, 2.38; 95% CI, 1.03 and 5.52), with no statistical association among patients with a history of asthma. Adjunct corticosteroid therapy was associated with treatment failure among children diagnosed with CAP who did not have underlying asthma. © The Author 2014. Published by Oxford University Press on behalf of the Pediatric Infectious Diseases Society. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.
Nomura, Shunsunke; Aihara, Yasuo; Amano, Kosaku; Eguchi, Seiichiro; Chiba, Kentaro; Komori, Takashi; Kawamata, Takakazu
2018-06-19
Malignant craniopharyngioma or anaplastic craniopharyngioma was first reported in 1987 by Akachi. It has a malignant clinical and histological feature; remarkably rapid progression, atypical pathology like squamous cell carcinoma and poor prognosis. To date seventeen cases of malignant craniopharyngioma have been reported and of these cases, most were of secondary malignant tumor in nature. With respect to traditional benign craniopharyngioma, adjunctive treatment after gross total removal is not necessary, but in the case of malignant types of the tumor, adjunctive treatment is important. This paper presents the first case of malignant craniopharyngioma reactive to adjunctive Gamma knife stereotactic radiosurgery and chemotherapy. Malignant craniopharyngioma is very rare, and we report Gamma knife stereotactic radiosurgery and chemotherapy (Carboplatine and etoposide chemotherapy), as well as Temozolomide chemotherapy were effective and could control progression of the tumor temporarily. Since adjunctive Gamma knife stereotactic radiosurgery and chemotherapy of malignant craniopharyngioma cases affects follow-up strategies, we propose supporting the need to a revision to the WHO classification regarding malignancy evaluation of craniopharyngioma. Copyright © 2018 Elsevier Inc. All rights reserved.
Fogarty, Sarah; Ramjan, Lucie Michelle
2015-02-01
Anorexia nervosa is a potentially life-threatening eating disorder where people intentionally refuse to eat sufficient amounts to maintain a healthy body-weight for fear of becoming fat. The intense preoccupation with restriction of food and control of body weight makes this one of the most complex and confusing conditions for practitioners to treat. While no single treatment has been found to be superior to another in the treatment of anorexia nervosa, general practice guidelines are available to guide mainstream treatment, however there are no guidelines for practitioners of complementary therapies. Complementary therapies such as acupuncture show promise as an adjunctive therapy in improving co-morbidities such as depression and anxiety levels among people with anorexia nervosa, by strengthening mind, body and overall well-being. The aim of this guideline is to assist and support acupuncture practitioners to deliver effective and safe adjunctive acupuncture treatments to people with anorexia nervosa, by providing a practice guideline that is underpinned by an ethical and evidence-based framework. The use of complementary therapies and specifically acupuncture in the treatment of anorexia nervosa may provide important adjunctive care to allow a comprehensive treatment approach that potentially improves quality of life, reduces anxiety and instils hope for recovery. It is hoped that acupuncture practitioners treating patients with anorexia nervosa will refer to these guidelines and apply the guidance (as deemed appropriate). Copyright © 2015 Elsevier Ltd. All rights reserved.
Weisler, Richard H; Ota, Ai; Tsuneyoshi, Kana; Perry, Pamela; Weiller, Emmanuelle; Baker, Ross A; Sheehan, David V
2016-11-01
Major depressive disorder (MDD) is a common, debilitating disorder with substantial socioeconomic burden. Many patients with MDD experience symptoms that impair functioning and productivity, often negatively affecting work or educational pursuits. This Phase 3b open-label study evaluated adjunctive brexpiprazole in young adults with MDD, who were in work or study. Young patients (18-35 years) with MDD (inadequate responders to 1-3 antidepressant treatments [ADT] for their current episode) received brexpiprazole 1-3mg/day (target dose, 2mg/day) adjunctive to the same stable dose of ADT for 12 weeks. Depressive symptoms improved during treatment with adjunctive brexpiprazole (primary endpoint, least squares [LS] mean change from baseline in Montgomery-Åsberg Depression Rating Scale [MADRS] total score, -18.1 [p<0.0001]). Reductions from baseline in Sheehan Disability Scale Score (SDS; LS mean change -11.2 [p<0.0001]) and Work Limitations Questionnaire (WLQ; p<0.0001) indicated improvements in the effects of patients' symptoms on functioning (work/school, social life, and home responsibilities). Changes from baseline in additional measures supported improvements in patient functioning and depression symptoms. The most common adverse events were headache (21.3%), weight increase (17.0%), and somnolence (17.0%); reported rates of akathisia were low (6.4%). Clinically relevant increases in weight (≥7%) occurred in 10.5% of patients. Open-label design; absence of comparator. Brexpiprazole may represent an effective therapy for adjunctive treatment strategy of young adults with MDD who are working or studying. The observed improvements in work/school functioning in patients with MDD, whose depression was treated with ADT+brexpiprazole, suggests potential to reduce socioeconomic burden. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.
Charunwatthana, Prakaykaew; Faiz, M. Abul; Ruangveerayut, Ronnatrai; Maude, Richard; Rahman, M. Ridwanur; Roberts, L. Jackson; Moore, Kevin; Yunus, Emran Bin; Hoque, M. Gofranul; Hasan, Mahatab Uddin; Lee, Sue J.; Pukrittayakamee, Sasithon; Newton, Paul N.; White, Nicholas J.; Day, Nicholas P.J.; Dondorp, Arjen M.
2009-01-01
Objective Markers of oxidative stress are reported to be increased in severe malaria. It has been suggested that the antioxidant N-acetylcysteine (NAC) may be beneficial in treatment. We studied the efficacy and safety of parenteral N-acetylcysteine as an adjunct to artesunate treatment of severe falciparum malaria. Design A randomized double-blind placebo controlled trial on the use of high dose intravenous NAC as adjunctive treatment to artesunate. Setting A provincial hospital in Western Thailand and a tertiary referral hospital in Chittagong, Bangladesh. Patients One hundred and eight adult patients with severe falciparum malaria. Interventions Patients were randomized to receive N-acetylcysteine or placebo as adjunctive treatment to intravenous artesunate. Measurements and main results A total of 56 patients were treated with NAC and 52 received placebo. NAC had no significant effect on mortality, lactate clearance times (p=0.74) or coma recovery times (p=0.46). Parasite clearance time was increased from 30h (range 6h to 144h) to 36h (range 6h to 120h) (p=0.03), but this could be explained by differences in admission parasitemia. Urinary F2-isoprostane metabolites, measured as a marker of oxidative stress, were increased in severe malaria compared to patients with uncomplicated malaria and healthy volunteers. Admission red cell rigidity correlated with mortality, but did not improve with NAC. Conclusion Systemic oxidative stress is increased in severe malaria. Treatment with N-acetylcysteine had no effect on outcome in patients with severe falciparum malaria in this setting. PMID:19114891
Kerling, Arno; Tegtbur, Uwe; Gützlaff, Elke; Kück, Momme; Borchert, Luise; Ates, Zeynep; von Bohlen, Anne; Frieling, Helge; Hüper, Katja; Hartung, Dagmar; Schweiger, Ulrich; Kahl, Kai G
2015-05-15
Major depressive disorder (MDD) is associated with decreased physical activity and increased rates of the metabolic syndrome (MetS), a risk factor for the development of type 2 diabetes and cardiovascular disorders. Exercise training has been shown to improve cardiorespiratory fitness and metabolic syndrome factors. Therefore, our study aimed at examining whether patients receiving an exercise program as an adjunct to inpatient treatment will benefit in terms of physiological and psychological factors. Fourty-two inpatients with moderate to severe depression were included. Twenty-two patients were randomized to additional 3x weekly exercise training (EXERCISE) and compared to treatment as usual (TAU). Exercise capacity was assessed as peak oxygen uptake (VO2peak), ventilatory anaerobic threshold (VAT) and workload expressed as Watts (W). Metabolic syndrome was defined according to NCEP ATPIII panel criteria. After 6 weeks of treatment, cardiorespiratory fitness (VO2peak, VAT, Watt), waist circumference and HDL cholesterol were significantly improved in EXERCISE participants. Treatment response expressed as ≥50% MADRS reduction was more frequent in the EXERCISE group. Adjunctive exercise training in depressed inpatients improves physical fitness, MetS factors, and psychological outcome. Given the association of depression with cardiometablic disorders, exercise training is recommended as an adjunct to standard antidepressant treatment. Copyright © 2015 Elsevier B.V. All rights reserved.
Sheldon, P. W.; Clarke, C.; Dawson, K. B.
1984-01-01
Using a quantitative cytochemical technique for measuring beta-glucuronidase activity in the peripheral nerves of mice, we have investigated the effectiveness of four potential adjuncts for reducing the dose limiting neurotoxicity of misonidazole (MISO) in the clinic. Under the conditions used, the most effective adjunct was the steroid anti-inflammatory agent dexamethasone. When given over the week previous to MISO treatment, this agent almost completely eliminated the MISO neurotoxicity as determined at week 4 after commencement of MISO dosing. The second most effective adjunct was phenytoin, the third flurbiprofen and the last adjunct, phenobarbitone, was ineffective. Dexamethasone, phenytoin and phenobarbitone all reduced the clearance half-life of MISO and hence the drug exposure dose calculated as the area under the curve of MISO tissue concentration against time. However, no correlation was evident with these parameters and MISO neurotoxicity in the mouse. Dexamethasone, whilst affording protection against MISO toxicity, did not alter the radiosensitivity of the anaplastic MT tumour. PMID:6696821
Lacosamide: A Review in Focal-Onset Seizures in Patients with Epilepsy.
Hoy, Sheridan M
2018-05-01
Lacosamide (Vimpat ® ) is a functionalized amino acid (available orally and intravenously) approved in the EU and the USA for use as monotherapy and adjunctive therapy for the treatment of focal-onset seizures in adults, adolescents and children aged ≥ 4 years with epilepsy. In adults and adolescents (aged ≥ 16 years), oral lacosamide as adjunctive therapy to other antiepileptic drugs was generally effective in reducing seizure frequency during short-term (up to 18 weeks) treatment, with efficacy sustained over the longer-term (up to 8 years). Moreover, patients were effectively switched from adjunctive oral lacosamide to the same dosage of intravenous lacosamide. Oral lacosamide was an effective conversion to monotherapy agent in this patient population and as monotherapy demonstrated noninferiority to carbamazepine controlled release in terms of seizure freedom. Antiepileptic benefits were maintained during longer-term (≤ 2 years) monotherapy. The antiepileptic efficacy of lacosamide in children aged ≥ 4 years has been extrapolated from data from adults and adolescents, with a similar response expected provided paediatric dosage adaptations are used and safety is demonstrated. Indeed, preliminary data demonstrated the efficacy of short-term (16 weeks) adjunctive lacosamide in patients aged ≥ 4 to < 17 years. Oral lacosamide was generally well tolerated over the short- and longer-term when administered as adjunctive therapy, a conversion to monotherapy agent and monotherapy in adults and adolescents and when administered as adjunctive therapy in children aged ≥ 4 years. Thus, lacosamide is a useful option for the management of focal-onset seizures across a broad age range, starting as early as 4 years of age.
Lacosamide: a review of its use as adjunctive therapy in the management of partial-onset seizures.
Hoy, Sheridan M
2013-12-01
Lacosamide (Vimpat(®)) is a functionalized amino acid available orally (as a syrup or tablet) and as an intravenous infusion. It is believed to exert its antiepileptic effect by selectively enhancing the slow inactivation of voltage-gated sodium channels. Lacosamide is approved in several countries worldwide as an adjunctive therapy for the treatment of partial-onset seizures; however, prescribing regulations differ between countries. This article reviews the use of lacosamide as indicated in adults and adolescents (aged 16-18 years) in the EU, where it is approved in this patient population as an adjunctive therapy to other AEDs in the treatment of partial-onset seizures, with or without secondary generalization. In three randomized, double-blind, placebo-controlled, multicentre studies in adults and adolescents (aged 16-18 years) with partial-onset seizures, adjunctive therapy with oral lacosamide (administered for an initial titration period followed by 12 weeks' maintenance therapy) generally reduced the frequency of seizures to a significantly greater extent than placebo, with antiepileptic efficacy sustained following longer-term treatment (up to 8 years) in this patient population. Oral and intravenous lacosamide were generally well tolerated in clinical studies, with the majority of adverse events being mild or moderate in severity. Very common adverse reactions following adjunctive therapy with oral lacosamide included diplopia, dizziness, headache and nausea; the tolerability profile of intravenous lacosamide appeared consistent with that of oral lacosamide, although intravenous administration was associated with local adverse events, such as injection site discomfort or pain, irritation and erythema. Thus, oral and intravenous lacosamide as an adjunctive therapy to other AEDs provides a useful option in the treatment of patients with partial-onset seizures.
Lobo, Tanya Marguerite; Pol, Dilip Ganpat
2015-01-01
Background: Lasers have several potential benefits such as antibacterial effect and stimulation of wound healing. In addition, hemostasis and delaying epithelial migration may facilitate the outcome of flap surgery. There is a minimal research and evidence currently available for the optimum method of use of a diode laser in flap surgery and its benefit and safety. Hence, this study aimed to investigate the adjunctive effect of diode laser irradiation in open flap debridement (OFD), while treating chronic periodontitis. Materials and Methods: A total of 30 patients with generalized chronic moderate to severe periodontitis with pocket probing depth (PD) ≥5 mm post - Phase I therapy were selected for a split-mouth study. Flap surgery with adjunctive diode laser irradiation was performed in the test quadrant while routine OFD was done in the control quadrant. Clinical parameters including PD, clinical attachment level, gingival recession, plaque index, gingival index and tooth mobility were recorded at baseline, 3 months and 6 months following treatment. In addition, patients’ rating of procedural pain as well as the development of complications postoperatively was assessed. Results: All clinical parameters significantly improved after therapy without any statistically significant difference between the two groups for any of the parameters. The exception was a significantly greater reduction in gingival inflammation in the laser treated group. The laser treatment was acceptable to the patient and did not cause any complications. Conclusion: The diode laser can be safely and effectively used as an adjunct to the treatment of chronic periodontitis with the advantage of decreased gingival inflammation. PMID:25810592
Hlastala, Stefanie A.; Kotler, Julie S.; McClellan, Jon M.; McCauley, Elizabeth A.
2010-01-01
Background In adolescents and adults, bipolar disorder (BD) is associated with significant morbidity, mortality, and impairment in psychosocial and occupational functioning. IPSRT is an empirically-supported adjunctive psychotherapy for adults with bipolar disorder which has been shown to help delay relapse, speed recovery from a bipolar depressive episode, and increase occupational and psychosocial functioning in adults with BD. The current study is designed to describe the adolescent-specific developmental adaptations made to IPSRT (i.e., IPSRT-A) and to report the results from an open trial of IPSRT-A with 12 adolescents with a bipolar spectrum disorder. Method Interpersonal and Social Rhythm Therapy was adapted to be developmentally-relevant to adolescents with bipolar disorder. Twelve adolescents (mean age 16.5 ± 1.3 years) diagnosed with a bipolar spectrum disorder participated in 16–18 sessions of adjunctive IPSRT-A over 20 weeks. Manic, depressive, and general symptoms and global functioning were measured at baseline, monthly during treatment, and at post-treatment. Adolescent satisfaction with treatment was also measured. Results Feasibility and acceptability of IPSRT-A were high; 11/12 participants completed treatment, 97% of sessions were attended, and adolescent-rated satisfaction scores were high. IPSRT-A participants experienced significant decreases in manic, depressive and general psychiatric symptoms over the 20 weeks of treatment. Participants’ global functioning increased significantly as well. Effect sizes ranged from medium-large to large. Conclusions IPSRT-A appears to be a promising adjunctive treatment for adolescents with bipolar disorder. A current randomized controlled trial is underway to examine effects of adjunctive IPSRT-A on psychiatric symptoms and psychosocial functioning. PMID:20186968
Jacobsen, Jacob P.R.; Krystal, Andrew D.; Krishnan, K. Ranga R.; Caron, Marc G.
2017-01-01
Serotonin transporter (SERT) inhibitors treat depression by elevating brain extracellular 5-hydroxytryptamine (5-HTExt). However, only one-third of patients respond adequately. Treatment-resistant depression (TRD) is a major unmet need. Interestingly, elevating 5-HTExt beyond what is achieved by a SERT inhibitor appears to treat TRD. Adjunctive administration of 5-hydroxytryptophan (5-HTP) safely elevates 5-HTExt beyond the SERT inhibitor effect in humans; but, 5-HTP cannot be a clinically viable drug because of its poor pharmacokinetics. A slow-release (SR) delivery mode would be predicted to overcome the pharmacokinetic limitations of 5-HTP, substantially enhance the pharmacological action, and transform 5-HTP into a clinically viable drug. Animal studies bear out this prediction. Thus, adjunct 5-HTP SR could be an important new treatment for TRD. Here we review the clinical and preclinical evidence. PMID:27692695
Post-Acute Effectiveness of Lithium in Pediatric Bipolar I Disorder
Kafantaris, Vivian; Pavuluri, Mani; McNamara, Nora K; Frazier, Jean A; Sikich, Linmarie; Kowatch, Robert; Rowles, Brieana M; Clemons, Traci E; Taylor-Zapata, Perdita
2013-01-01
Abstract Objective This study examined the long-term effectiveness of lithium for the treatment of pediatric bipolar disorder within the context of combination mood stabilizer therapy for refractory mania and pharmacological treatment of comorbid psychiatric conditions. Methods Outpatients, ages 7–17 years, meeting American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV) diagnostic criteria for bipolar disorder I (BP-I) (manic or mixed) who demonstrated at least a partial response to 8 weeks of open-label treatment with lithium (Phase I) were eligible to receive open-label lithium for an additional 16 weeks (Phase II). Up to two adjunctive medications could be prescribed to patients experiencing residual symptoms of mania or comorbid psychiatric conditions, following a standardized algorithm. Results Forty-one patients received continued open-label long-term treatment with lithium for a mean of 14.9 (3.0) weeks during Phase II. The mean weight-adjusted total daily dose at end of Phase II was 27.8 (6.7) mg/kg/day, with an average lithium concentration of 1.0 (0.3) mEq/L. Twenty-five of the 41 patients (60.9%) were prescribed adjunctive psychotropic medications for residual symptoms. The most frequent indications for adjunctive medications were refractory mania (n=13; 31.7%) and attention-deficit/hyperactivity disorder (ADHD) (n=15; 36.6%). At the end of this phase 28 (68.3%) patients met a priori criteria for response (≥50% reduction from Phase I baseline in Young Mania Rating Scale [YMRS] summary score and a Clinical Global Impressions-Improvement [CGI-I] score of 1 or 2), with 22 (53.7%) considered to be in remission (YMRS summary score≤12 and CGI-Severity score of 1 or 2). These data suggest that patients who initially responded to lithium maintained mood stabilization during continuation treatment, but partial responders did not experience further improvement during Phase II, despite the opportunity to receive adjunctive medications. The most commonly reported (≥20%) adverse events associated with lithium treatment were vomiting, headache, abdominal pain, and tremor. Conclusions Lithium may be a safe and effective longer-term treatment for patients with pediatric bipolar disorder who respond to acute treatment with lithium. Partial responders to acute lithium did not appear to experience substantial symptom improvement during the continuation phase, despite the possibility that adjunctive medications could be prescribed. PMID:23510444
Adjuvant treatment with a symbiotic in patients with inflammatory non-allergic rhinitis.
Gelardi, M; De Luca, C; Taliente, S; Fiorella, M L; Quaranta, N; Russo, C; Ciofalo, A; Macchi, A; Mancini, M; Rosso, P; Seccia, V; Guagnini, F; Ciprandi, G
2017-01-01
Inflammatory non-allergic rhinitis (INAR) is characterized by the presence of an inflammatory infiltrate and a non-IgE-mediated pathogenesis. This retrospective, controlled, multicentre study investigated whether a symbiotic, containing Lactobacillus acidophilus NCFM, Bifidobacterium lactis, and fructo-oligosaccharides (Pollagen®, Allergy Therapeutics, Italy), prescribed as adjunctive therapy to a standard pharmacological treatment, was able to reduce symptom severity, endoscopic features, and nasal cytology in 93 patients (49 males and 44 females, mean age 36.3±7.1 years) with INAR. The patients were treated with nasal corticosteroid, oral antihistamine, and isotonic saline. At randomization, 52 patients were treated also with symbiotic as adjunctive therapy, whereas the remaining 41 patients served as controls. Treatment lasted for 4 weeks. Patients were visited at baseline, after treatment, and after 4-week follow-up. Adjunctive symbiotic treatment significantly reduced the percentages of patients with symptoms and endoscopic signs, and diminished inflammatory cells. In conclusion, the present study demonstrates that a symbiotic was able, as adjuvant treatment, to significantly improve symptoms, endoscopic feature, and cytology in patients with INAR, and its effect may be long lasting.
Hurtubise, Jessica L; Marks, Wendie N; Davies, Don A; Catton, Jillian K; Baker, Glen B; Howland, John G
2017-01-01
The cognitive symptoms observed in schizophrenia are not consistently alleviated by conventional antipsychotics. Following a recent pilot study, sodium nitroprusside (SNP) has been identified as a promising adjunct treatment to reduce the working memory impairments experienced by schizophrenia patients. The present experiments were designed to explore the effects of SNP on the highly translatable trial-unique, delayed nonmatching-to-location (TUNL) task in rats with and without acute MK-801 treatment. SNP (0.5, 1.0, 2.0, 4.0, and 5.0 mg/kg) and MK-801 (0.05, 0.075, and 0.1 mg/kg) were acutely administered to rats trained on the TUNL task. Acute MK-801 treatment impaired TUNL task accuracy. Administration of SNP (2.0 mg/kg) with MK-801 (0.1 mg/kg) failed to rescue performance on TUNL. SNP (5.0 mg/kg) administration nearly 4 h prior to MK-801 (0.05 mg/kg) treatment had no preventative effect on performance impairments. SNP (2.0 mg/kg) improved performance on a subset of trials. These results suggest that SNP may possess intrinsic cognitive-enhancing properties but is unable to block the effects of acute MK-801 treatment on the TUNL task. These results are inconsistent with the effectiveness of SNP as an adjunct therapy for working memory impairments in schizophrenia patients. Future studies in rodents that assess SNP as an adjunct therapy will be valuable in understanding the mechanisms underlying the effectiveness of SNP as a treatment for schizophrenia.
Hasebe, Kyoko; Gray, Laura; Bortolasci, Chiara; Panizzutti, Bruna; Mohebbi, Mohammadreza; Kidnapillai, Srisaiyini; Spolding, Briana; Walder, Ken; Berk, Michael; Malhi, Gin; Dodd, Seetal; Dean, Olivia M
2017-12-01
This study aimed to explore effects of adjunctive N-acetylcysteine (NAC) treatment on inflammatory and neurogenesis markers in unipolar depression. We embarked on a 12-week clinical trial of NAC (2000 mg/day compared with placebo) as an adjunctive treatment for unipolar depression. A follow-up visit was conducted 4 weeks following the completion of treatment. We collected serum samples at baseline and the end of the treatment phase (week 12) to determine changes in interleukin-6 (IL6), C-reactive protein (CRP) and brain-derived neurotrophic factor (BDNF) following NAC treatment. NAC treatment significantly improved depressive symptoms on the Montgomery-Asberg Depression Rating Scale (MADRS) over 16 weeks of the trial. Serum levels of IL6 were associated with reductions of MADRS scores independent of treatment response. However, we found no significant changes in IL6, CRP and BDNF levels following NAC treatment. Overall, this suggests that our results failed to support the hypothesis that IL6, CRP and BDNF are directly involved in the therapeutic mechanism of NAC in depression. IL6 may be a useful marker for future exploration of treatment response.
Ford, Emily; Adams, Jon; Graves, Nicholas
2012-01-01
Objective An economic model was developed to evaluate the cost-effectiveness of hawthorn extract as an adjunctive treatment for heart failure in Australia. Methods A Markov model of chronic heart failure was developed to compare the costs and outcomes of standard treatment and standard treatment with hawthorn extract. Health states were defined by the New York Heart Association (NYHA) classification system and death. For any given cycle, patients could remain in the same NYHA class, experience an improvement or deterioration in NYHA class, be hospitalised or die. Model inputs were derived from the published medical literature, and the output was quality-adjusted life years (QALYs). Probabilistic sensitivity analysis was conducted. The expected value of perfect information (EVPI) and the expected value of partial perfect information (EVPPI) were conducted to establish the value of further research and the ideal target for such research. Results Hawthorn extract increased costs by $1866.78 and resulted in a gain of 0.02 QALYs. The incremental cost-effectiveness ratio was $85 160.33 per QALY. The cost-effectiveness acceptability curve indicated that at a threshold of $40 000 the new treatment had a 0.29 probability of being cost-effective. The average incremental net monetary benefit (NMB) was −$1791.64, the average NMB for the standard treatment was $92 067.49, and for hawthorn extract $90 275.84. Additional research is potentially cost-effective if research is not proposed to cost more than $325 million. Utilities form the most important target parameter group for further research. Conclusions Hawthorn extract is not currently considered to be cost-effective in as an adjunctive treatment for heart failure in Australia. Further research in the area of utilities is warranted. PMID:22942231
Ford, Emily; Adams, Jon; Graves, Nicholas
2012-01-01
An economic model was developed to evaluate the cost-effectiveness of hawthorn extract as an adjunctive treatment for heart failure in Australia. A Markov model of chronic heart failure was developed to compare the costs and outcomes of standard treatment and standard treatment with hawthorn extract. Health states were defined by the New York Heart Association (NYHA) classification system and death. For any given cycle, patients could remain in the same NYHA class, experience an improvement or deterioration in NYHA class, be hospitalised or die. Model inputs were derived from the published medical literature, and the output was quality-adjusted life years (QALYs). Probabilistic sensitivity analysis was conducted. The expected value of perfect information (EVPI) and the expected value of partial perfect information (EVPPI) were conducted to establish the value of further research and the ideal target for such research. Hawthorn extract increased costs by $1866.78 and resulted in a gain of 0.02 QALYs. The incremental cost-effectiveness ratio was $85 160.33 per QALY. The cost-effectiveness acceptability curve indicated that at a threshold of $40 000 the new treatment had a 0.29 probability of being cost-effective. The average incremental net monetary benefit (NMB) was -$1791.64, the average NMB for the standard treatment was $92 067.49, and for hawthorn extract $90 275.84. Additional research is potentially cost-effective if research is not proposed to cost more than $325 million. Utilities form the most important target parameter group for further research. Hawthorn extract is not currently considered to be cost-effective in as an adjunctive treatment for heart failure in Australia. Further research in the area of utilities is warranted.
Aguilera, Adrian; Bruehlman-Senecal, Emma; Demasi, Orianna; Avila, Patricia
2017-05-08
Cognitive Behavioral Therapy (CBT) for depression is efficacious, but effectiveness is limited when implemented in low-income settings due to engagement difficulties including nonadherence with skill-building homework and early discontinuation of treatment. Automated messaging can be used in clinical settings to increase dosage of depression treatment and encourage sustained engagement with psychotherapy. The aim of this study was to test whether a text messaging adjunct (mood monitoring text messages, treatment-related text messages, and a clinician dashboard to display patient data) increases engagement and improves clinical outcomes in a group CBT treatment for depression. Specifically, we aim to assess whether the text messaging adjunct led to an increase in group therapy sessions attended, an increase in duration of therapy attended, and reductions in Patient Health Questionnaire-9 item (PHQ-9) symptoms compared with the control condition of standard group CBT in a sample of low-income Spanish speaking Latino patients. Patients in an outpatient behavioral health clinic were assigned to standard group CBT for depression (control condition; n=40) or the same treatment with the addition of a text messaging adjunct (n=45). The adjunct consisted of a daily mood monitoring message, a daily message reiterating the theme of that week's content, and medication and appointment reminders. Mood data and qualitative responses were sent to a Web-based platform (HealthySMS) for review by the therapist and displayed in session as a tool for teaching CBT skills. Intent-to-treat analyses on therapy attendance during 16 sessions of weekly therapy found that patients assigned to the text messaging adjunct stayed in therapy significantly longer (median of 13.5 weeks before dropping out) than patients assigned to the control condition (median of 3 weeks before dropping out; Wilcoxon-Mann-Whitney z=-2.21, P=.03). Patients assigned to the text messaging adjunct also generally attended more sessions (median=6 sessions) during this period than patients assigned to the control condition (median =2.5 sessions), but the effect was not significant (Wilcoxon-Mann-Whitney z=-1.65, P=.10). Both patients assigned to the text messaging adjunct (B=-.29, 95% CI -0.38 to -0.19, z=-5.80, P<.001) and patients assigned to the control conditions (B=-.20, 95% CI -0.32 to -0.07, z=-3.12, P=.002) experienced significant decreases in depressive symptom severity over the course of treatment; however, the conditions did not significantly differ in their degree of symptom reduction. This study provides support for automated text messaging as a tool to sustain engagement in CBT for depression over time. There were no differences in depression outcomes between conditions, but this may be influenced by low follow-up rates of patients who dropped out of treatment. ©Adrian Aguilera, Emma Bruehlman-Senecal, Orianna Demasi, Patricia Avila. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.05.2017.
Bruehlman-Senecal, Emma; Demasi, Orianna; Avila, Patricia
2017-01-01
Background Cognitive Behavioral Therapy (CBT) for depression is efficacious, but effectiveness is limited when implemented in low-income settings due to engagement difficulties including nonadherence with skill-building homework and early discontinuation of treatment. Automated messaging can be used in clinical settings to increase dosage of depression treatment and encourage sustained engagement with psychotherapy. Objectives The aim of this study was to test whether a text messaging adjunct (mood monitoring text messages, treatment-related text messages, and a clinician dashboard to display patient data) increases engagement and improves clinical outcomes in a group CBT treatment for depression. Specifically, we aim to assess whether the text messaging adjunct led to an increase in group therapy sessions attended, an increase in duration of therapy attended, and reductions in Patient Health Questionnaire-9 item (PHQ-9) symptoms compared with the control condition of standard group CBT in a sample of low-income Spanish speaking Latino patients. Methods Patients in an outpatient behavioral health clinic were assigned to standard group CBT for depression (control condition; n=40) or the same treatment with the addition of a text messaging adjunct (n=45). The adjunct consisted of a daily mood monitoring message, a daily message reiterating the theme of that week’s content, and medication and appointment reminders. Mood data and qualitative responses were sent to a Web-based platform (HealthySMS) for review by the therapist and displayed in session as a tool for teaching CBT skills. Results Intent-to-treat analyses on therapy attendance during 16 sessions of weekly therapy found that patients assigned to the text messaging adjunct stayed in therapy significantly longer (median of 13.5 weeks before dropping out) than patients assigned to the control condition (median of 3 weeks before dropping out; Wilcoxon-Mann-Whitney z=−2.21, P=.03). Patients assigned to the text messaging adjunct also generally attended more sessions (median=6 sessions) during this period than patients assigned to the control condition (median =2.5 sessions), but the effect was not significant (Wilcoxon-Mann-Whitney z=−1.65, P=.10). Both patients assigned to the text messaging adjunct (B=−.29, 95% CI −0.38 to −0.19, z=−5.80, P<.001) and patients assigned to the control conditions (B=−.20, 95% CI −0.32 to −0.07, z=−3.12, P=.002) experienced significant decreases in depressive symptom severity over the course of treatment; however, the conditions did not significantly differ in their degree of symptom reduction. Conclusions This study provides support for automated text messaging as a tool to sustain engagement in CBT for depression over time. There were no differences in depression outcomes between conditions, but this may be influenced by low follow-up rates of patients who dropped out of treatment. PMID:28483742
Adjunctive minocycline treatment for major depressive disorder: A proof of concept trial.
Dean, Olivia M; Kanchanatawan, Buranee; Ashton, Melanie; Mohebbi, Mohammadreza; Ng, Chee Hong; Maes, Michael; Berk, Lesley; Sughondhabirom, Atapol; Tangwongchai, Sookjaroen; Singh, Ajeet B; McKenzie, Helen; Smith, Deidre J; Malhi, Gin S; Dowling, Nathan; Berk, Michael
2017-08-01
Conventional antidepressant treatments result in symptom remission in 30% of those treated for major depressive disorder, raising the need for effective adjunctive therapies. Inflammation has an established role in the pathophysiology of major depressive disorder, and minocycline has been shown to modify the immune-inflammatory processes and also reduce oxidative stress and promote neuronal growth. This double-blind, randomised, placebo-controlled trial examined adjunctive minocycline (200 mg/day, in addition to treatment as usual) for major depressive disorder. This double-blind, randomised, placebo-controlled trial investigated 200 mg/day adjunctive minocycline (in addition to treatment as usual) for major depressive disorder. A total of 71 adults with major depressive disorder ( Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition) were randomised to this 12-week trial. Outcome measures included the Montgomery-Asberg Depression Rating Scale (primary outcome), Clinical Global Impression-Improvement and Clinical Global Impression-Severity, Hamilton Anxiety Rating Scale, Quality of Life Enjoyment and Satisfaction Questionnaire, Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool. The study was registered on the Australian and New Zealand Clinical Trials Register: www.anzctr.org.au , #ACTRN12612000283875. Based on mixed-methods repeated measures analysis of variance at week 12, there was no significant difference in Montgomery-Asberg Depression Rating Scale scores between groups. However, there were significant differences, favouring the minocycline group at week 12 for Clinical Global Impression-Improvement score - effect size (95% confidence interval) = -0.62 [-1.8, -0.3], p = 0.02; Quality of Life Enjoyment and Satisfaction Questionnaire score - effect size (confidence interval) = -0.12 [0.0, 0.2], p < 0.001; and Social and Occupational Functioning Scale and the Range of Impaired Functioning Tool score - 0.79 [-4.5, -1.4], p < 0.001. These effects remained at follow-up (week 16), and Patient Global Impression also became significant, effect size (confidence interval) = 0.57 [-1.7, -0.4], p = 0.017. While the primary outcome was not significant, the improvements in other comprehensive clinical measures suggest that minocycline may be a useful adjunct to improve global experience, functioning and quality of life in people with major depressive disorder. Further studies are warranted to confirm the potential of this accessible agent to optimise treatment outcomes.
Biron, Bethany; Beck, Katie; Dyer, David; Mattix, Marc; Twenhafel, Nancy; Nalca, Aysegul
2015-04-01
Inhalational anthrax is characterized by extensive bacteremia and toxemia as well as nonspecific to mild flu-like symptoms, until the onset of hypotension, shock, and mortality. Without treatment, the mortality rate approaches 100%. Antibiotic treatment is not always effective, and alternative treatments are needed, such as monotherapy for antibiotic-resistant inhalational anthrax or as an adjunct therapy in combination with antibiotics. The Bacillus anthracis antitoxin monoclonal antibody (MAb) ETI-204 is a high-affinity chimeric deimmunized antibody which targets the anthrax toxin protective antigen (PA). In this study, a partial protection New Zealand White (NZW) rabbit model was used to evaluate the protective efficacy of the adjunct therapy with the MAb. Following detection of PA in the blood, NZW rabbits were administered either an antibiotic (doxycycline) alone or the antibiotic in conjunction with ETI-204. Survival was evaluated to compare the efficacy of the combination adjunct therapy with that of an antibiotic alone in treating inhalational anthrax. Overall, the results from this study indicate that a subtherapeutic regimen consisting of an antibiotic in combination with an anti-PA MAb results in increased survival compared to the antibiotic alone and would provide an effective therapeutic strategy against symptomatic anthrax in nonvaccinated individuals. Copyright © 2015, American Society for Microbiology. All Rights Reserved.
Treanor, Michael; Barry, Tom J
2017-09-01
Pathological avoidance of benign stimuli is a hallmark of anxiety and related disorders, and exposure-based treatments have often encouraged the removal of avoidance, or safety behaviors, due to their negative effects on extinction learning. Unfortunately, empirical evidence suggests that avoidance behaviors can persist following treatment, and the mere availability of avoidance behavior can be sufficient to renew fear following successful extinction learning. The present paper critically examines the function of avoidance behavior through the lens of modern learning theory, and speculates on novel behavioral and pharmacological strategies for targeting avoidance as an adjunct to current evidence-based treatments. Copyright © 2017. Published by Elsevier Ltd.
Chen, Jing-Xu; Su, Yun-Ai; Bian, Qing-Tao; Wei, Li-He; Zhang, Rong-Zhen; Liu, Yan-Hong; Correll, Christoph; Soares, Jair C; Yang, Fu-De; Wang, Shao-Li; Zhang, Xiang-Yang
2015-08-01
Hyperprolactinemia is an unwanted adverse effect associated with several antipsychotics. The addition of partial dopamine receptor agonist aripiprazole may attenuate antipsychotic-induced hyperprolactinemia effectively. However, the ideal dosing regimen for this purpose is unknown. We aimed to evaluate the dose effects of adjunctive treatment with aripiprazole on prolactin levels and hyperprolactinemia in schizophrenia patients. Stable subjects 18-45 years old with schizophrenia and hyperprolactinemia (i.e., >24 ng/ml for females and >20 ng/ml for males) were randomly assigned to receive 8 weeks of placebo (n=30) or oral aripiprazole 5mg/day (n=30), 10mg/day (n=29), or 20mg/day (n=30) added on to fixed dose risperidone treatment. Serum prolactin levels were measured at baseline and after 2, 4 and 8 weeks; clinical symptoms and side effects were assessed at baseline and week 8 using the Positive and Negative Syndrome Scale, Clinical Global Impressions Severity scale, Barnes Akathisia Scale, Simpson-Angus Scale and UKU Side Effects Rating Scale. Of 119 randomized patients, 107 (89.9%) completed the 8-week study. At study end, all three aripiprazole doses resulted in significantly lower prolactin levels (beginning at week 2), higher response rates (≥30% prolactin reduction) and higher prolactin normalization rates than placebo. Effects were significantly greater in the 10 and 20mg/day groups than the 5mg/day group. No significant changes were observed in any treatment groups regarding psychopathology and adverse effect ratings. Adjunctive aripiprazole treatment was effective and safe for resolving risperidone-induced hyperprolactinemia, producing significant and almost maximal improvements by week 2 without significant effects on psychopathology and side effects. Copyright © 2015 Elsevier Ltd. All rights reserved.
Meschede, Carolin; Witt, Juri-Alexander; Rademacher, Michael; von Wrede, Randi D; Elger, Christian E; Helmstaedter, Christoph
2018-04-22
This retrospective longitudinal study aims to compare the longer-term cognitive and behavioral side effects of adjunctive antiepileptic treatment with perampanel (PER) and lacosamide (LCM), two third generation antiepileptic drugs with suggested favorable cognitive profiles. The two drugs were monitored according to a previously established routine diagnostic protocol (Helmstaedter et al. E&B 2013;26:182-7) which facilitates the retrospective comparison of antiepileptic drug tolerability in a naturalistic outpatient setting. Records from 94 patients were evaluated who underwent neuropsychological assessment before and under adjunctive treatment with either PER (n = 57) or LCM (n = 37). Cognition was assessed using the EpiTrack screening for executive functions and a VLMT short form for verbal memory. Subjective assessments included a German QOLIE-10 adaptation (quality of life) and an extended Adverse Events Profile (AEP). The median follow-up interval was 36 weeks. Multivariate repeated measures statistics revealed a non-significant trend towards an interaction effect "time - treatment arm" on both executive function and memory. When analyzed separately executive functions and memory scores significantly improved under LCM (t = -2.76 p < 0.01 and t = -2.44 p < 0.05 respectively). Subjectively, PER was associated with improvements in 2/18 physiological domains and in the LCM group 1/9 cognitive domains deteriorated. Seizure freedom was achieved for five patients treated with LCM (14%) and 15 treated with PER (26%, χ 2 = 2.2, n.s.). In a naturalistic outpatient setting, chronic adjunctive treatment with PER and LCM did not negatively affect cognition and LCM may even improve cognition. Neither drug increased self-reported irritability or aggression. This suggests favorable longer-term tolerability. Copyright © 2018 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
Wilby, J; Kainth, A; Hawkins, N; Epstein, D; McIntosh, H; McDaid, C; Mason, A; Golder, S; O'Meara, S; Sculpher, M; Drummond, M; Forbes, C
2005-04-01
To examine the clinical effectiveness, tolerability and cost-effectiveness of gabapentin (GBP), lamotrigine (LTG), levetiracetam (LEV), oxcarbazepine (OXC), tiagabine (TGB), topiramate (TPM) and vigabatrin (VGB) for epilepsy in adults. Electronic databases. Internet resources. Pharmaceutical company submissions. Selected studies were screened and quality assessed. Separate analyses assessed clinical effectiveness, serious, rare and long-term adverse events and cost-effectiveness. An integrated economic analysis incorporating information on costs and effects of newer and older antiepileptic drugs (AEDs) was performed to give direct comparisons of long-term costs and benefits. A total of 212 studies were included in the review. All included systematic reviews were Cochrane reviews and of good quality. The quality of randomised controlled trials (RCTs) was variable. Assessment was hampered by poor reporting of methods of randomisation, allocation concealment and blinding. Few of the non-randomised studies were of good quality. The main weakness of the economic evaluations was inappropriate use of the cost-minimisation design. The included systematic reviews reported that newer AEDs were effective as adjunctive therapy compared to placebo. For newer versus older drugs, data were available for all three monotherapy AEDs, although data for OXC and TPM were limited. There was limited, poor-quality evidence of a significant improvement in cognitive function with LTG and OXC compared with older AEDs. However, there were no consistent statistically significant differences in other clinical outcomes, including proportion of seizure-free patients. No studies assessed effectiveness of AEDs in people with intellectual disabilities or in pregnant women. There was very little evidence to assess the effectiveness of AEDs in the elderly; no significant differences were found between LTG and carbamazepine monotherapy. Sixty-seven RCTs compared adjunctive therapy with placebo, older AEDs or other newer AEDs. For newer AEDs versus placebo, a trend was observed in favour of newer drugs, and there was evidence of statistically significant differences in proportion of responders favouring newer drugs. However, it was not possible to assess long-term effectiveness. Most trials were conducted in patients with partial seizures. For newer AEDs versus older drugs, there was no evidence to assess the effectiveness of LEV, LTG or OXC, and evidence for other newer drugs was limited to single studies. Trials only included patients with partial seizures and follow-up was relatively short. There was no evidence to assess effectiveness of adjunctive LEV, OXC or TPM versus other newer drugs, and there were no time to event or cognitive data. No studies assessed the effectiveness of adjunctive AEDs in the elderly or pregnant women. There was some evidence from one study (GBP versus LTG) that both drugs have some beneficial effect on behaviour in people with learning disabilities. Eighty RCTs reported the incidence of adverse events. There was no consistent or convincing evidence to draw any conclusions concerning relative safety and tolerability of newer AEDs compared with each other, older AEDs or placebo. The integrated economic analysis for monotherapy for newly diagnosed patients with partial seizures showed that older AEDs were more likely to be cost-effective, although there was considerable uncertainty in these results. The integrated analysis suggested that newer AEDs used as adjunctive therapy for refractory patients with partial seizures were more effective and more costly than continuing with existing treatment alone. Combination therapy, involving new AEDs, may be cost-effective at a threshold willingness to pay per quality-adjusted life year (QALY) greater than 20,000 pounds, depending on patients' previous treatment history. There was, again, considerable uncertainty in these results. There were few data available to determine effectiveness of treatments for patients with generalised seizures. LTG and VPA showed similar health benefits when used as monotherapy. VPA was less costly and was likely to be cost-effective. The analysis indicated that TPM might be cost-effective when used as an adjunctive therapy, with an estimated incremental cost-effectiveness ratio of 34,500 pounds compared with continuing current treatment alone. There was little good-quality evidence from clinical trials to support the use of newer monotherapy or adjunctive therapy AEDs over older drugs, or to support the use of one newer AED in preference to another. In general, data relating to clinical effectiveness, safety and tolerability failed to demonstrate consistent and statistically significant differences between the drugs. The exception was comparisons between newer adjunctive AEDs and placebo, where significant differences favoured newer AEDs. However, trials often had relatively short-term treatment durations and often failed to limit recruitment to either partial or generalised onset seizures, thus limiting the applicability of the data. Newer AEDs, used as monotherapy, may be cost-effective for the treatment of patients who have experienced adverse events with older AEDs, who have failed to respond to the older drugs, or where such drugs are contraindicated. The integrated economic analysis also suggested that newer AEDs used as adjunctive therapy may be cost-effective compared with the continuing current treatment alone given a QALY of about 20,000 pounds. There is a need for more direct comparisons of the different AEDs within clinical trials, considering different treatment sequences within both monotherapy and adjunctive therapy. Length of follow-up also needs to be considered. Trials are needed that recruit patients with either partial or generalised seizures; that investigate effectiveness and cost-effectiveness in patients with generalised onset seizures and that investigate effectiveness in specific populations of epilepsy patients, as well as studies evaluating cognitive outcomes to use more stringent testing protocols and to adopt a more consistent approach in assessing outcomes. Further research is also required to assess the quality of life within trials of epilepsy therapy using preference-based measures of outcomes that generate cost-effectiveness data. Future RCTs should use CONSORT guidelines; and observational data to provide information on the use of AEDs in actual practice, including details of treatment sequences and doses.
Park, Kyung Hea; Jang, Yong Hyun; Chung, Ho Yun; Lee, Weon Ju; Kim, Do Won; Lee, Seok-Jong
2015-01-01
Although oral beta-blocker, propranolol, was shown excellent outcome for infantile hemangioma (IH) up to date, concern of side effects and reluctance of treatment-related cumbersome evaluations are major obstacles to employ. Instead, topical beta-blockers were recently introduced as an effective alternative, but few studies are reported. So we performed a retrospective study of IH treated with topical beta-blockers, timolol maleate 0.5%, and adjunctive role of pulsed dye laser from 2011 to 2014. Among 102 IH enrolled, 61 patients (59.8%) treated with only timolol maleate and 41 (40.2%) patients treated with combination of pulsed dye laser. A clinical review of medical records and evaluation at 4-8 weeks intervals using the physicians' Global Assessment Scores (GAS) and patients' parents' GAS at the latest visit. Physicians' GAS was used to grade the lesions compared with the baseline photo by two physicians' evaluation. And parents' GAS was assessed by direct or telephone interview. In the only timolol treatment group, mean change was within 47.0% improvement from baseline by physicians. In addition, adjunctive treatment of pulsed dye laser group showed 66.5% improvement. No side effects were found on both groups, and mean change was 54.5% improvement by overall parent assessments.
Schedule-induced polydipsia: a rat model of obsessive-compulsive disorder.
Platt, Brian; Beyer, Chad E; Schechter, Lee E; Rosenzweig-Lipson, Sharon
2008-04-01
Obsessive-compulsive disorder (OCD) is difficult to model in animals due to the involvement of both mental (obsessions) and physical (compulsions) symptoms. Due to limitations of using animals to evaluate obsessions, OCD models are limited to evaluation of the compulsive and repetitive behaviors of animals. Of these, models of adjunctive behaviors offer the most value in regard to predicting efficacy of anti-OCD drugs in the clinic. Adjunctive behaviors are those that are maintained indirectly by the variables that control another behavior, rather than directly by their own typical controlling variables. Schedule-induced polydipsia (SIP) is an adjunctive model in which rats exhibit exaggerated drinking behavior (polydipsia) when presented with food pellets under a fixed-time schedule. The polydipsic response is an excessive manifestation of a normal behavior (drinking), providing face validity to the model. Furthermore, clinically effective drugs for the treatment of OCD decrease SIP. This protocol describes a rat SIP model of OCD and provides preclinical data for drugs that decrease polydipsia and are clinically effective in the treatment of OCD.
Dukić, Walter; Bago, Ivona; Aurer, Andrej; Roguljić, Marija
2013-08-01
The aim of this randomized clinical study is to evaluate the effect of a 980-nm diode laser as an adjunct to scaling and root planing (SRP) treatment. Thirty-five patients with chronic periodontitis were selected for the split-mouth clinical study. SRP was performed using a sonic device and hand instruments. Quadrants were equally divided between the right and left sides. Teeth were treated with SRP in two control quadrants (control groups [CG]), and the diode laser was used adjunctively with SRP in contralateral quadrants (laser groups [LG]). Diode laser therapy was applied to periodontal pockets on days 1, 3, and 7 after SRP. Baseline data, including approximal plaque index (API), bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL), were recorded before the treatment and 6 and 18 weeks after treatment. Changes in PD and CAL were analyzed separately for initially moderate (4 to 6 mm) and deep (7 to 10 mm) pockets. The results were similar for both groups in terms of API, BOP, PD in deep pockets, and CAL. The laser group showed only significant PD gain in moderate pockets during the baseline to 18-week (P <0.05) and 6- to 18- week (P <0.05) periods, whereas no difference was found between LG and CG in the remaining clinical parameters (P >0.05). The present study indicates that, compared to SRP alone, multiple adjunctive applications of a 980-nm diode laser with SRP showed PD improvements only in moderate periodontal pockets (4 to 6 mm).
Monamine oxidase inhibitors: current and emerging agents for Parkinson disease.
Fernandez, Hubert H; Chen, Jack J
2007-01-01
Monoamine oxidase type B (MAO-B) is the predominant isoform responsible for the metabolic breakdown of dopamine in the brain. Selective inhibition of brain MAO-B results in elevation of synaptosomal dopamine concentrations. Data have been reported regarding the selective MAO-B inhibitors, rasagiline and selegiline, for the symptomatic treatment of Parkinson disease (PD). Selegiline has demonstrated efficacy as monotherapy in patients with early PD (Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism study), but evidence of selegiline efficacy as adjunctive treatment in levodopa-treated PD patients with motor fluctuations is equivocal. A new formulation of selegiline (Zydis selegiline) has been evaluated in 2 small, placebo-controlled studies as adjunctive therapy to levodopa. The Zydis formulation allows pregastric absorption of selegiline, minimizing first-pass metabolism, and thereby increasing selegiline bioavailability and reducing the concentration of amphetamine metabolites. Rasagiline is a selective, second-generation, irreversible MAO-B inhibitor, with at least 5 times the potency of selegiline in vitro and in animal models. Rasagiline has demonstrated efficacy in 1 large, randomized, double-blind, placebo-controlled trial (TVP-1012 in Early Monotherapy for Parkinson's Disease Outpatients) as initial monotherapy in patients with early PD, and in 2 large, controlled trials (Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "Off," Lasting Effect in Adjunct Therapy With Rasagiline Given Once Daily) as adjunctive treatment in levodopa-treated PD patients with motor fluctuations. Unlike selegiline, rasagiline is an aminoindan derivative with no amphetamine metabolites. A randomized clinical trial is underway to confirm preclinical and preliminary clinical data suggesting rasagiline has disease-modifying effects.
Polak, David; Martin, Conchita; Sanz-Sánchez, Ignacio; Beyth, Nurit; Shapira, Lior
2015-04-01
Systematically review the scientific evidence for efficiency of anti-inflammatory agents against gingivitis, either as solo treatments or adjunctive therapies. A protocol was developed aimed to answer the following focused question: "Are anti-inflammatory agents effective in treating gingivitis as solo or adjunct therapies?" RCTs and cohort studies on anti-inflammatory agents against gingivitis studies were searched electronically. Screening, data extraction and quality assessment were conducted. The primary outcome measures were indices of gingival inflammation. A sub-analysis was performed dividing the active agents into anti-inflammatory and other drugs. The search identified 3188 studies, of which 14 RCTs met the inclusion criteria. The use of anti-inflammatory or other agents, in general showed a higher reduction in the test than in the control in terms of gingival indexes and bleeding scores. Only two RCTs on inflammatory drugs could be meta-analysed, showing a statistically significant reduction in the GI in the experimental group [WMD = -0.090; 95% CI (-0.105; -0.074); p = 0.000]. However, the contribution of both studies to the global result was unbalanced (% weight: 99.88 and 0.12 respectively). Most of the tested material showed beneficial effect as anti-inflammatory agents against gingivitis, either as a single treatment modality or as an adjunctive therapy. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Akram, Zohaib; Vohra, Fahim; Javed, Fawad
2018-05-01
The action of statins in stimulating bone formation and having other pleiotropic effects, such as anti-inflammatory and immunomodulatory effects, has justified their use as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis (CP). The aim of the present study was to evaluate the efficacy of statin delivery as an adjunct to SRP in the treatment of CP. Electronic searches were conducted using the following databases: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and Cochrane Oral Health Group Trials Register, up until July 2017. The primary outcome was probing depth (PD), while the secondary outcomes were changes in clinical attachment level (CAL) and bone defect (BD) fill. Eleven studies were included, and all showed significant PD reduction, CAL gain, and BD fill with adjunctive statin delivery compared to SRP alone. The meta-analysis showed significant improvement in periodontal parameters for atorvastatin (PD: weighted mean difference [WMD] = -1.84, -2.56 to -1.12, P < .001; CAL: WMD = -2.31, -3.58 to -1.03, P < .001; BD fill: WMD = 2.66, -3.92 to -1.39, P < .001), simvastatin (PD: WMD = -1.91, -2.27 to -1.55, P < .001; CAL: WMD = -1.91, -2.27 to -1.55, P = .001; BD: WMD = -1.52, -2.20 to -0.85, P < .001), and rosuvastatin (PD: WMD = -0.94, -1.32 to -0.55, P < .001; CAL: WMD = -1.00, -1.41 to -0.60, P < .001; BD fill: WMD = -1.30, -1.80 to -0.79, P < .001). Adjunctive statin delivery appears to be effective in reducing PD, CAL gain, and BD fill in CP, and therefore, these drugs could be a promising therapeutic option for periodontal regeneration in future. © 2017 John Wiley & Sons Australia, Ltd.
Little evidence for the use of diode lasers as an adjunct to non-surgical periodontal therapy.
Dederich, Douglas N
2015-03-01
Medline, PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL) and Embase databases. Randomised controlled trials (RCTs) using thermal diode lasers as an adjunct to non-surgical conventional periodontal initial therapy conducted in patients ≥18 years old written in English or Dutch were considered. Study assessment data extraction and quality assessment was carried out independently by two reviewers. The main outcome variables were probing pocket depth (PPD) and clinical attachment loss (CAL), but plaque scores (PS), bleeding scores (BS) and the Gingival Index (GI) were also considered. Meta-analysis was carried out using a random effects model. Nine studies involving 247 patients were included. Seven studies were of split mouth design and two were parallel group studies. The study designs showed considerable heterogeneity and follow up ranged from six weeks to six months. Meta-analysis found no significant effect on PPD, CAL and PS. There was however a significant effect for GI and BS favouring adjunctive use of the diode laser. The collective evidence regarding adjunctive use of the diode laser with SRP indicates that the combined treatment provides an effect comparable to that of SRP alone. With respect to BS the results showed a small but significant effect favouring the diode laser, however, the clinical relevance of this difference remains uncertainStandard . This systematic review questions the adjunctive use of diode laser with traditional mechanical modalities of periodontal therapy in patients with periodontitis. The strength of the recommendation for the adjunctive use of the diode laser is considered to be 'moderate' for changes in PPD and CAL.
Adjunctive treatment of manic agitation with lorazepam versus haloperidol: a double-blind study.
Lenox, R H; Newhouse, P A; Creelman, W L; Whitaker, T M
1992-02-01
While lithium is effective in treating the majority of bipolar patients during a manic episode, the addition of neuroleptic during the early phase of treatment has been common clinical practice in inpatient settings. In an earlier open study, we demonstrated the utility of the short-acting benzodiazepine lorazepam as an adjunct to lithium for the clinical management of manic agitation. We now present data from a randomized, double-blind clinical study of lorazepam versus haloperidol in 20 hospitalized patients with a DSM-III-R diagnosis of bipolar disorder who were being treated concomitantly with lithium. Patients were rated using the Mania Rating Scale, Brief Psychiatric Rating Scale, Physician Global Impression Scale, and side effects scales. Data were analyzed using standard group comparisons and survival analysis. There was no evidence for a significant difference between the two treatment groups in the magnitude of or time to response (5.0 +/- .82 days for haloperidol; 6.5 +/- .93 days for lorazepam). Of the patients who were terminated from the protocol early, nonresponse was the primary reason in the lorazepam group while side effects were the reason in the haloperidol group. Lorazepam may offer an efficacious and safe alternative to haloperidol as an adjunctive treatment to lithium in the clinical management of the early phase of manic agitation in a subgroup of bipolar patients.
Translating G-CSF as an Adjunct Therapy to Stem Cell Transplantation for Stroke.
Peña, Ike dela; Borlongan, Cesar V
2015-12-01
Among recently investigated stroke therapies, stem cell treatment holds great promise by virtue of their putative ability to replace lost cells, promote endogenous neurogenesis,and produce behavioral and functional improvement through their "bystander effects." Translating stem cell in the clinic, however, presents a number of technical difficulties. A strategy suggested to enhance therapeutic utility of stem cells is combination therapy, i.e., co-transplantation of stem cells or adjunct treatment with pharmacological agents and substrates,which is assumed to produce more profound therapeutic benefits by circumventing limitations of individual treatments and facilitating complementary brain repair processes. We previously demonstrated enhanced functional effects of cotreatment with granulocyte-colony stimulating factor (GCSF)and human umbilical cord blood cell (hUCB) transplantation in animal models of traumatic brain injury (TBI). Here,we suggest that the aforementioned combination therapy may also produce synergistic effects in stroke. Accordingly, G-CSF treatment may reduce expression of pro-inflammatory cytokines and enhance neurogenesis rendering a receptive microenvironment for hUCB engraftment. Adjunct treatment of GCSF with hUCB may facilitate stemness maintenance and guide neural lineage commitment of hUCB cells. Moreover, regenerative mechanisms afforded by G-CSF-mobilized endogenous stem cells, secretion of growth factors by hUCB grafts and G-CSF-recruited endothelial progenitor cells(EPCs), as well as the potential graft–host integration that may promote synaptic circuitry re-establishment could altogether produce more pronounced functional improvement in stroked rats subjected to a combination G-CSF treatment and hUCB transplantation. Nevertheless, differences in pathology and repair processes underlying TBI and stroke deserve consideration when testing the effects of combinatorial G-CSF and hUCB cell transplantation for stroke treatment. Further studies are also required to determine the safety and efficacy of this intervention in both preclinical and clinical stroke studies.
Adjunctive therapy in Parkinson’s disease: the role of rasagiline
Gaines, Kathryn D; Hinson, Vanessa K
2012-01-01
Parkinson’s disease is the second most common neurodegenerative disorder, currently affecting 1.5 million people in the US. In this review, we describe the diagnostic and pathological features of Parkinson’s disease, as well as its clinical course. We then review pharmacologic treatments for the disease, with a particular focus on therapies adjunctive to levodopa and specifically the role of rasagiline. We review the four pivotal rasagiline trials, and discuss rasagiline and its use as adjunctive therapy for Parkinson’s disease. Finally, we discuss potential side effects, drug interactions, and other practical aspects concerning the use of rasagiline in Parkinson’s disease. PMID:22802692
Shiranibidabadi, Shahrzad; Mehryar, Amirhooshang
2015-09-15
Previous studies have highlighted the potential therapeutic benefits of music therapy as an adjunct to standard care, in a variety of psychiatric ailments including mood and anxiety disorders. However, the role of music in the treatment of obsessive-compulsive disorder (OCD) have not been investigated to date. In a single-center, parallel-group, randomized clinical trial (NCT02314195) 30 patients with OCD were randomly assigned to standard treatment (pharmacotherapy and cognitive-behavior therapy) plus 12 sessions of individual music therapy (n = 15) or standard treatment only (n = 15) for one month. Maudsley Obsessive-Compulsive Inventory, Beck Anxiety Inventory, and Beck Depression Inventory-Short Form were administered baseline and after one month. Thirty patients completed the study. Music therapy resulted in a greater decrease in total obsessive score (post-intervention score: music therapy+standard treatment: 12.4 ± 1.9 vs standard treatment only: 15.1 ± 1.7, p < 0.001, effect size = 56.7%). For subtypes, significant between-group differences were identified for checking (p = 0.004), and slowness (p = 0.019), but not for washing or responsibility. Music therapy was significantly more effective in reducing anxiety (post-intervention score: music therapy + standard treatment: 16.9 ± 7.4 vs standard treatment only: 22.9 ± 4.6, p < 0.001, effect size = 47.0%), and depressive symptoms (post-intervention score: music therapy + standard treatment: 10.8 ± 3.8 vs standard treatment: 17.1 ± 3.7, p < 0.001, effect size = 47.0%). Inclusion of a small sample size, lack of blinding due to the nature of the intervention, short duration of follow-up. In patients with OCD, music therapy, as an adjunct to standard care, seems to be effective in reducing obsessions, as well as co-morbid anxiety and depressive symptoms. Copyright © 2015. Published by Elsevier B.V.
Möller, Hans-Jürgen; Demyttenaere, Koen; Olausson, Bengt; Szamosi, Johan; Wilson, Ellis; Hosford, David; Dunbar, Geoffrey; Tummala, Raj; Eriksson, Hans
2015-10-01
To evaluate the neuronal nicotinic channel modulator TC-5214 (dexmecamylamine) as adjunct therapy in patients with major depressive disorder (MDD) and inadequate response to prior antidepressant treatment. Study 004 (D4130C00004) and Study 005 (D4130C00005) comprised an 8-week open-label antidepressant (SSRI/SNRI) treatment period followed by an 8-week randomised, active treatment with twice-daily TC-5214 (0.5, 2 or 4 mg in Study 004; 0.1, 1 or 4 mg in Study 005) or placebo, adjunct to ongoing SSRI/SNRI. Primary efficacy endpoint was change in MADRS total score from randomisation (Week 8) to treatment end (Week 16). Secondary endpoints included MADRS response and remission, and changes in SDS and HAM-D-17-item scores. Safety and tolerability were monitored throughout. Studies 004 and 005 randomised 640 and 696 patients, respectively, to TC-5214 or placebo. No statistically significant improvements in MADRS total score or any secondary endpoints were seen with TC-5214 versus placebo in either study at treatment end. The most commonly reported adverse events (> 10%) with TC-5214 were constipation, dizziness and dry mouth. TC-5214 adjunct to antidepressant was generally well tolerated. However, the studies were not supportive of an antidepressant effect for TC-5214 in patients with MDD and inadequate response to prior antidepressant therapy.
Port wine stain treated with a combination of pulsed dye laser and topical rapamycin ointment.
Griffin, Thomas D; Foshee, James P; Finney, Robert; Saedi, Nazanin
2016-02-01
A port wine stain (PWS) is a type of capillary vascular malformation composed of malformed, dilated blood vessels within the papillary and reticular dermis. Currently, pulsed dye laser (PDL) is considered the therapeutic gold standard, although greater than 90% of lesions may be refractory to treatment. Studies have shown that a delay in treatment results in a higher proportion of patients who develop hypertrophy and nodularity within lesions that become more resistant to therapy. Therapeutic resistance is multifactorial, but is believed to be largely due to revascularization after laser treatment. Oral sirolimus and topical imiquimod have shown promise as adjunctive therapies to minimize post-laser revascularization, but both have significant side effects. We wish to demonstrate the utility of adjunct topical sirolimus to reduce revascularization after PDL treatment. This is a single patient case report of a 56-year-old male patient with an extensive PWS. After seeing initial improvement with PDL alone, he began to experience thickening and nodularity of his PWS necessitating surgical debulking. Since this procedure, topical sirolimus 0.5% ointment has been added to his treatment regimen as an adjunct to PDL. The patient is being treated with PDL (Vbeam Perfecta, Candela/Syneron, Wayland, MA) every 4-6 weeks at varied settings with the following laser parameters: fluence 9-11 J/cm(2), pulse duration 0.45-1.5 ms, focal spot size 7 mm, cooling 30/20. Sirolimus 0.5% ointment is applied to the area twice daily. The patient showed significant improvement in color and texture of his PWS. Compared to the initial therapy of PDL alone, topical sirolimus ointment in conjunction with PDL demonstrated greater improvement and maintenance of therapeutic results with fewer overall laser treatments. Topical sirolimus 0.5% ointment is a safe and effective adjunct to PDL in the treatment of PWS. © 2015 Wiley Periodicals, Inc.
A preliminary, randomized trial of aerobic exercise for alcohol dependence
Brown, Richard A.; Abrantes, Ana M.; Minami, Haruka; Read, Jennifer P.; Marcus, Bess H.; Jakicic, John M.; Strong, David R.; Dubreuil, Mary Ella; Gordon, Alan A.; Ramsey, Susan E.; Kahler, Christopher W.; Stuart, Gregory L.
2015-01-01
Interventions targeting physical activity may be valuable as an adjunct to alcohol treatment, but have been relative untested. In the current study, alcohol dependent, physically sedentary patients were randomized to: a 12-week moderate-intensity, group aerobic exercise intervention (AE; n = 25) or a brief advice to exercise intervention (BA-E; n=23). Results showed that individuals in AE reported significantly fewer drinking and heavy drinking days, relative to BA-E during treatment. Furthermore adherence to AE strengthened the beneficial effect of intervention on alcohol use outcomes. While high levels of moderate-intensity exercise appeared to facilitate alcohol recovery regardless of intervention arm, attending the group-based AE intervention seemed to further enhance the positive effects of exercise on alcohol use. Study findings indicate that a moderate intensity, group aerobic exercise intervention is an efficacious adjunct to alcohol treatment. Improving adherence to the intervention may enhance its beneficial effects on alcohol use. PMID:24666811
Adjuncts in the IVF laboratory: where is the evidence for 'add-on' interventions?
Harper, Joyce; Jackson, Emily; Sermon, Karen; Aitken, Robert John; Harbottle, Stephen; Mocanu, Edgar; Hardarson, Thorir; Mathur, Raj; Viville, Stephane; Vail, Andy; Lundin, Kersti
2017-03-01
Globally, IVF patients are routinely offered and charged for a selection of adjunct treatments and tests or 'add-ons' that they are told may improve their chance of a live birth, despite there being no clinical evidence supporting the efficacy of the add-on. Any new IVF technology claiming to improve live birth rates (LBR) should, in most cases, first be tested in an appropriate animal model, then in clinical trials, to ensure safety, and finally in a randomized controlled trial (RCT) to provide high-quality evidence that the procedure is safe and effective. Only then should the technique be considered as 'routine' and only when applied to the similar patient population as those studied in the RCT. Even then, further pediatric and long-term follow-up studies will need to be undertaken to examine the long-term safety of the procedure. Alarmingly, there are currently numerous examples where adjunct treatments are used in the absence of evidence-based medicine and often at an additional fee. In some cases, when RCTs have shown the technique to be ineffective, it is eventually withdrawn from the clinic. In this paper, we discuss some of the adjunct treatments currently being offered globally in IVF laboratories, including embryo glue and adherence compounds, sperm DNA fragmentation, time-lapse imaging, preimplantation genetic screening, mitochondria DNA load measurement and assisted hatching. We examine the evidence for their safety and efficacy in increasing LBRs. We conclude that robust studies are needed to confirm the safety and efficacy of any adjunct treatment or test before they are offered routinely to IVF patients. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
Doo, Kyeong-Hee; Lee, Ji-Hyun; Cho, Seung-Yeon; Jung, Woo-Sang; Moon, Sang-Kwan; Park, Jung-Mi; Ko, Chang-Nam; Kim, Ho; Park, Hi-Joon; Park, Seong-Uk
2015-10-01
The purpose of this study was to examine the effectiveness and safety of combined treatment using acupuncture and bee venom acupuncture (BVA) as an adjunctive treatment for idiopathic Parkinson's disease (PD). Eleven patients (7 men and 4 women) with idiopathic PD who had been receiving a stable dose of anti-parkinsonian medication for at least 4 weeks. Participants received conventional treatment for 12 weeks. Subsequently, they received additional treatment with acupuncture and BVA twice weekly for 12 weeks while still maintaining conventional treatment. All participants were assessed at baseline, 12 weeks, and 24 weeks by using the Unified Parkinson's Disease Rating Scale (UPDRS), the Parkinson's Disease Quality of Life Questionnaire (PDQL), the speed and number of steps required to walk 20 m, and the Beck Depression Inventory (BDI). Maximum excursion and directional control, measured by computerized dynamic posturography (Balance Master(®) System, NeuroCom, San Carlos, CA), were used to assess postural stability. Patients who underwent 12 weeks of twice-weekly combined treatment with acupuncture and BVA showed significant improvements in gait speed, PDQL score, activities of daily living (UPDRS part II), motor symptoms (UPDRS part III), and combined UPDRS part II+III scores compared with assessments after conventional treatment. Combined treatment with acupuncture and BVA showed promising results as a safe adjunctive therapy for PD.
Effectiveness of urine surveillance as an adjunct to outpatient psychotherapy for drug abusers.
Milby, J B; Clarke, C; Toro, C; Thornton, S; Rickert, D
1980-10-01
Twenty-nine polydrug abusers were randomly assigned to three out-patient treatment groups after inpatient detoxification. The groups were outpatient psychotherapy (1) with urine surveillance, (2) without surveillance, and (3) waiting list control. Tests were administered before and 3 months after outpatient treatment began. All groups made positive changes during treatment including significant reduction in drugs abused and numbers of subjects reporting less time spent in illegal activity. Notable significant differences were Group 3's reduction in social introversion vs Groups 1 and 2, and Group 1's retaining fewer drug-using friends and showing greatest reduction in barbiturate use frequency vs Groups 2 and 3. Experimenters concluded urine surveillance was somewhat helpful as an adjunct to outpatient psychotherapy but suggested its effect could be amplified by employing more rigorous surveillance procedures, especially if contingency contracting were utilized.
Castro Dos Santos, Nídia Cristina; Andere, Naira Maria Rebelatto Bechara; Araujo, Cássia Fernandes; de Marco, Andrea Carvalho; Dos Santos, Lúcio Murilo; Jardini, Maria Aparecida Neves; Santamaria, Mauro Pedrine
2016-11-01
Diabetes has become a global epidemic. Its complications can have a significant impact on quality of life, longevity, and public health costs. The presence of diabetes might impair the prognosis of periodontal treatments due to its negative influence on wound healing. Antimicrobial photodynamic therapy (aPDT) is a local approach that can promote bacterial decontamination in periodontal pockets. The aim of this study was to investigate the local effect of adjunct aPDT to ultrasonic periodontal debridement (UPD) and compare it to UD only for the treatment of chronic periodontitis in type 2 diabetic patients. Twenty type 2 diabetic patients with moderate to severe generalized chronic periodontitis were selected. Two periodontal pockets with probing depth (PD) and clinical attachment level (CAL) ≥5 mm received UPD only (UPD group) or UPD plus adjunct aPDT (UPD + aPDT group). Periodontal clinical measures were collected and compared at baseline and 30, 90, and 180 days. After 180 days of follow-up, there were statistically significant reductions in PD from 5.75 ± 0.91 to 3.47 ± 0.97 mm in the UPD group and from 6.15 ± 1.27 to 3.71 ± 1.63 mm in the UPD + aPDT group. However, intergroup analysis did not reveal statistically significant differences in any of the evaluated clinical parameters (p > 0.05). The adjunct application of aPDT to UPD did not present additional benefits for the treatment of chronic periodontitis in type 2 diabetic patients. The ClinicalTrials.gov identifier of the present study is NCT02627534.
Effectiveness of hypnosis as an adjunct to behavioral weight management.
Bolocofsky, D N; Spinler, D; Coulthard-Morris, L
1985-01-01
This study examined the effect of adding hypnosis to a behavioral weight-management program on short- and long-term weight change. One hundred nine subjects, who ranged in age from 17 to 67, completed a behavioral treatment either with or without the addition of hypnosis. At the end of the 9-week program, both interventions resulted in significant weight reduction. However, at the 8-month and 2-year follow-ups, the hypnosis clients showed significant additional weight loss, while those in the behavioral treatment exhibited little further change. More of the subjects who used hypnosis also achieved and maintained their personal weight goals. The utility of employing hypnosis as an adjunct to a behavioral weight-management program is discussed.
Kessler, Lynn; Palla, Jyothsna; Baru, Joshua S; Onyenwenyi, Chioma; George, Amrutha M; Lucas, Brian P
2014-07-01
Radioactive iodine (RAI) is commonly used in the treatment of hyperthyroidism but is not uniformly successful. Lithium increases thyroidal iodine retention without reducing iodide uptake, increasing the radiation dose to the thyroid when administered with RAI. Although these actions suggest that adjuvant lithium may increase the efficacy of RAI, its role as an adjunct to RAI remains contentious. To evaluate the safety and efficacy of adding lithium to RAI to treat hyperthyroidism. Relevant studies were identified by a search of Medline and the Cochrane Central Register of Controlled Trials. To be included, a study had to be a controlled trial comparing the effect of RAI alone to RAI with lithium in the treatment of hyperthyroidism. Relevant data were extracted and meta-analyses were performed. Of the 75 identified studies, 6 met the inclusion criteria; 4 of these studies were interventional and 2 were observational trials. Meta-analysis of the observational trials (N = 851), both of which were retrospective cohort studies, showed significant improvement in the primary outcome (i.e., cure rate) with adjunctive lithium (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.24 to 2.96). The combined interventional trials (N = 485) also showed an improvement in cure rate, but the difference did not reach statistical significance (OR, 1.28; 95% CI, 0.85 to 1.91). Adjunctive lithium reduced time to cure and blunted thyroid hormone excursions after RAI. Lithium-related side effects were infrequent and usually mild. The observational trials demonstrated significant improvement in the cure rate of hyperthyroidism when lithium is added to RAI. The improvements shown in the interventional trials did not reach statistical significance due to the effect of a single, large negative trial.
Propranolol as an adjunct therapy for hyperthyroid tremor.
Henderson, J M; Portmann, L; Van Melle, G; Haller, E; Ghika, J A
1997-01-01
We evaluated the use of propranolol as an adjunct to carbimazole in the treatment of hyperthyroid tremor and tachycardia in a double-blind, cross-over and placebo-controlled study. Seven patients were given carbimazole plus either placebo or propranolol (40 mg) for 1 month and then switched to the alternative adjunct treatment for a further month. All patients showed significant improvements (p < 0.001) of heart rate and tremor amplitude after 1 or 2 months from baseline. One month after the baseline, the mean improvements of heart rate were 23% for the carbimazole + placebo group and 38% for carbimazole + propranolol group. Tremor also improved during the 1st month of the study by 31% in the carbimazole + placebo group versus 59% in the carbimazole + propranolol group. Whereas further improvements were observed in both variables in those receiving propranolol as the second adjunct treatment, this was not the case in those who received placebo during the same period. These findings confirm that the beta-blocker propranolol is a useful adjunct in the early treatment of both the tremor and tachycardia of hyperthyroidism.
Computerized Working-Memory Training as a Candidate Adjunctive Treatment for Addiction
Bickel, Warren K.; Moody, Lara; Quisenberry, Amanda
2014-01-01
Alcohol and other drug dependencies are, in part, characterized by deficits in executive functioning, including working memory. Working-memory training is a candidate computerized adjunctive intervention for the treatment of alcoholism and other drug dependencies. This article reviews emerging evidence for computerized working memory training as an efficacious adjunctive treatment for drug dependence and highlights future challenges and opportunities in the field of working-memory training, including duration of training needed, persistence of improvements and utility of booster sessions, and selection of patients based on degree of deficits. PMID:26259006
Calderini, A; Pantaleo, G; Rossi, A; Gazzolo, D; Polizzi, E
2013-08-01
The aim of the present case series was to evaluate the clinical and microbiological effects of a single session of mechanical and manual scaling and root planing (SRP) combined with the use of two different chlorhexidine formulations in the treatment for generalized chronic periodontitis. Ten patients affected by chronic periodontal disease with periodontal probing depth (PPD) ≥ 5 mm were treated with SRP plus local chlorhexidine. In each patient, similar teeth, treated with SRP with the adjunctive use of chlorhexidine digluconate and dihydrochloride or chlorhexidine gluconate, respectively, were selected and assigned to a test and a control group. In both groups, PPD, bleeding on probing (BOP) parameters, total bacterial counts (TBC) and quality of periodontal bacteria at time 0 and 6 weeks after treatment were measured. PPD significantly decreased over time both in the test and in the control group; however, no significant differences between the two groups were observed. BOP and TBC were significantly lower in the test than in the control group 6 weeks after treatment. In the post-treatment revaluation, a significant decrease both in the treatment and in the control group, for each of the single periodontal pathogens, was observed. In this study--a preliminary case series with small sample size and short follow-up--the adjunctive use of chlorhexidine (CHX) to SRP resulted in clinical and microbiological benefits in the treatment for generalized chronic periodontitis. A CHX gel formulation consisting of CHX digluconate and CHX dihydrochloride seems to lead some additional benefits over SRP plus CHX gluconate in the short term. Additional investigations are needed to evaluate the effectiveness of this antiseptic therapy. © 2012 John Wiley & Sons A/S.
Wood, G Christopher; Boucher, Andrew B; Johnson, Jessica L; Wisniewski, Jennifer N; Magnotti, Louis J; Croce, Martin A; Swanson, Joseph M; Boucher, Bradley A; Fabian, Timothy C
2014-01-01
To evaluate the effectiveness of pseudoephedrine as adjunctive therapy for neurogenic shock in patients with acute spinal cord injury (SCI). Case series. Academic medical center. Thirty-eight patients admitted to the trauma intensive care unit between September 2005 and October 2012 with an acute SCI and who received more than 1 day of pseudoephedrine for one or more of the following: treatment of bradycardia (heart rate ≤ 50 beats/min), treatment of hypotension (systolic blood pressure < 90 mm Hg), or were receiving intravenous vasopressor support. The effect of adjunctive pseudoephedrine (PSE) was categorized as a success if vasopressors were discontinued after the initiation of PSE or improvement in the number of episodes of bradycardia was noted after the initiation of PSE as evidenced by decreased use of atropine. The effect of pseudoephedrine was categorized as a failure if it did not meet one of the criteria for success. The effect of pseudoephedrine was categorized as inconclusive if there were confounding factors such as vasopressors being restarted for another indication after initial discontinuation. Pseudoephedrine was successful in 31/38 (82%) patients, failed in 2/38 (5%) patients, and had inconclusive results in 5/38 (13%) patients. The mean ± SD time to successful weaning of intravenous vasopressors was 7 ± 7 days. Daily maximum pseudoephedrine doses ranged from 60-720 mg. Mean ± SD duration of pseudoephedrine therapy was 32 ± 23 days (range 2-135 days), with 64.5% of surviving patients discharged while receiving pseudoephedrine. These data suggest that pseudoephedrine is an effective adjunctive therapy in facilitating the discontinuation of intravenous vasopressors and/or atropine in patients with acute SCI with neurogenic shock, although patients will typically require long durations of therapy. © 2013 Pharmacotherapy Publications, Inc.
Augmentation treatment in major depressive disorder: focus on aripiprazole
Nelson, J Craig; Pikalov, Andrei; Berman, Robert M
2008-01-01
Major depressive disorder (MDD) is a disabling psychiatric condition for which effective treatment remains an outstanding need. Antidepressants are currently the mainstay of treatment for depression; however, almost two-thirds of patients will fail to achieve remission with initial treatment. As a result, a range of augmentation and combination strategies have been used in order to improve outcomes for patients. Despite the popularity of these approaches, limited data from double-blind, randomized, placebo-controlled studies are available to allow clinicians to determine which are the most effective augmentation options or which patients are most likely to respond to which options. Recently, evidence has shown that adjunctive therapy with atypical antipsychotics has the potential for beneficial antidepressant effects in the absence of psychotic symptoms. In particular, aripiprazole has shown efficacy as an augmentation option with standard antidepressant therapy in two, large, randomized, double-blind studies. Based on these efficacy and safety data, aripiprazole was recently approved by the FDA as adjunctive therapy for MDD. The availability of this new treatment option should allow more patients with MDD to achieve remission and, ultimately, long-term, successful outcomes. PMID:19183784
Thase, Michael E.; Trivedi, Madhukar H.; Nelson, J. Craig; Fava, Maurizio; Swanink, Rene; Tran, Quynh-Van; Pikalov, Andrei; Yang, Huyuan; Carlson, Berit X.; Marcus, Ronald N.; Berman, Robert M.
2008-01-01
Background: Patients with major depressive disorder (MDD) who fail to achieve complete remission with antidepressant therapy may benefit from augmentation therapy with an atypical antipsychotic. Method: A pooled analysis was performed on 2 identical 14-week studies (8-week prospective antidepressant therapy treatment phase followed by 6-week randomized double-blind phase) evaluating the efficacy of adjunctive aripiprazole (2–20 mg/day) in DSM-IV-TR–defined MDD patients with an inadequate response to antidepressant therapy. Primary efficacy endpoint was the mean change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from end of the prospective phase (week 8) to end of randomized phase (week 14, last observation carried forward). Subgroup analyses were performed. The key secondary endpoint was mean change in Sheehan Disability Scale (SDS) mean score. Results: At endpoint, mean change in MADRS total score was significantly greater with adjunctive aripiprazole (–8.7) than with adjunctive placebo (–5.7; p < .001). Except for a differential treatment-by-sex interaction, change in MADRS total scores were consistently greater with adjunctive aripiprazole than with adjunctive placebo, regardless of race, age, episode duration, prior antidepressant therapy response, number of historical treatment failures, severity of depressive symptoms, and antidepressant. At endpoint, MADRS remission rates were significantly greater with adjunctive aripiprazole than with placebo (25.7% vs. 15.4%; p < .001). Adjunctive aripiprazole also demonstrated significantly greater improvements in mean change from baseline in SDS total score than adjunctive placebo (–1.2 vs. –0.6; p = .001). Conclusion: Augmentation of antidepressant therapy with the atypical antipsychotic aripiprazole resulted in significant efficacy benefits across a range of subgroups of patients with MDD. Further study of a treatment-by-sex interaction is needed. Trial Registration: www.clinicaltrials.gov Identifiers: NCT00095823 and NCT00095758 PMID:19287552
Sensorimotor rhythm neurofeedback as adjunct therapy for Parkinson's disease.
Philippens, Ingrid H C H M; Wubben, Jacqueline A; Vanwersch, Raymond A P; Estevao, Dave L; Tass, Peter A
2017-08-01
Neurofeedback may enhance compensatory brain mechanisms. EEG-based sensorimotor rhythm neurofeedback training was suggested to be beneficial in Parkinson's disease. In a placebo-controlled study in parkinsonian nonhuman primates we here show that sensorimotor rhythm neurofeedback training reduces MPTP-induced parkinsonian symptoms and both ON and OFF scores during classical L-DOPA treatment. Our findings encourage further development of sensorimotor rhythm neurofeedback training as adjunct therapy for Parkinson's disease which might help reduce L-DOPA-induced side effects.
Zheng, W; Zhang, Q-E; Cai, D-B; Yang, X-H; Qiu, Y; Ungvari, G S; Ng, C H; Berk, M; Ning, Y-P; Xiang, Y-T
2018-05-01
This systematic review and meta-analysis of randomized controlled trials (RCTs) examined the efficacy and safety of adjunctive N-acetylcysteine (NAC), an antioxidant drug, in treating major depressive disorder (MDD), bipolar disorder, and schizophrenia. The PubMed, Cochrane Library, PsycINFO, CNKI, CBM, and WanFang databases were independently searched and screened by two researchers. Standardized mean differences (SMDs), risk ratios, and their 95% confidence intervals (CIs) were computed. Six RCTs (n = 701) of NAC for schizophrenia (three RCTs, n = 307), bipolar disorder (two RCTs, n = 125), and MDD (one RCT, n = 269) were identified and analyzed as separate groups. Adjunctive NAC significantly improved total psychopathology (SMD = -0.74, 95% CI: -1.43, -0.06; I 2 = 84%, P = 0.03) in schizophrenia, but it had no significant effect on depressive and manic symptoms as assessed by the Young Mania Rating Scale in bipolar disorder and only a small effect on major depressive symptoms. Adverse drug reactions to NAC and discontinuation rates between the NAC and control groups were similar across the three disorders. Adjunctive NAC appears to be a safe treatment that has efficacy for schizophrenia, but not for bipolar disorder or MDD. Further higher quality RCTs are warranted to determine the role of adjunctive NAC in the treatment of major psychiatric disorders. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
ERIC Educational Resources Information Center
Clarke, Gregory; DeBar, Lynn; Lynch, Frances; Powell, James; Gale, John; O'Connor, Elizabeth; Ludman, Evette; Bush, Terry; Lin, Elizabeth H. B.; Von Korff, Michael; Hertert, Stephanie
2005-01-01
Objective: To test a collaborative-care, cognitive-behavioral therapy (CBT) program adjunctive to selective serotonin reuptake inhibitor (SSRI) treatment in HMO pediatric primary care. Method: A randomized effectiveness trial comparing a treatment-as-usual (TAU) control condition consisting primarily of SSRI medication delivered outside the…
Varo, Rosauro; Crowley, Valerie M; Sitoe, Antonio; Madrid, Lola; Serghides, Lena; Bila, Rubao; Mucavele, Helio; Mayor, Alfredo; Bassat, Quique; Kain, Kevin C
2017-05-23
Despite the widespread use and availability of rapidly acting anti-malarials, the fatality rate of severe malaria in sub-Saharan Africa remains high. Adjunctive therapies that target the host response to malaria infection may further decrease mortality over that of anti-malarial agents alone. Peroxisome proliferator-activated receptor-gamma agonists (e.g. rosiglitazone) have been shown to act on several pathways implicated in the pathogenesis of severe malaria and may improve clinical outcome as an adjunctive intervention. In this study, the safety and tolerability of adjunctive rosiglitazone in paediatric uncomplicated malaria infection was evaluated in Mozambique, as a prelude to its evaluation in a randomized controlled trial in paediatric severe malaria. The study was a prospective, randomized, double-blind, placebo-controlled, phase IIa trial of rosiglitazone (0.045 mg/kg/dose) twice daily for 4 days versus placebo as adjunctive treatment in addition to Mozambican standard of care (artemisinin combination therapy Coartem ® ) in children with uncomplicated malaria. The primary outcomes were tolerability and safety, including clinical, haematological, biochemical, and electrocardiographic evaluations. Thirty children were enrolled: 20 were assigned to rosiglitazone and 10 to placebo. Rosiglitazone treatment did not induce hypoglycaemia nor significantly alter clinical, biochemical, haematological, or electrocardiographic parameters. Adjunctive rosiglitazone was safe and well-tolerated in children with uncomplicated malaria, permitting the extension of its evaluation as adjunctive therapy for severe malaria. The trial is registered with Clinicaltrials.gov, NCT02694874.
Translating G-CSF as an adjunct therapy to stem cell transplantation for stroke
dela Peña, Ike; Borlongan, Cesar V.
2015-01-01
Among recently investigated stroke therapies, stem cell treatment holds great promise by virtue of their putative ability to replace lost cells, promote endogenous neurogenesis and produce behavioral and functional improvement through their “bystander effects.” Translating stem cell in the clinic, however, presents a number of technical difficulties. A strategy suggested to enhance therapeutic utility of stem cells is combination therapy, i.e., cotransplantation of stem cells or adjunct treatment with pharmacological agents and substrates, which is assumed to produce more profound therapeutic benefits by circumventing limitations of individual treatments, and facilitating complementary brain repair processes. We previously demonstrated enhanced functional effects of co-treatment with granulocyte-colony stimulating factor (G-CSF) and human umbilical cord blood cell (hUCB) transplantation in animal models of traumatic brain injury (TBI). Here, we suggest that the aforementioned combination therapy may also produce synergistic effects in stroke. Accordingly, G-CSF treatment may reduce expression of pro-inflammatory cytokines and enhance neurogenesis rendering a receptive microenvironment for hUCB engraftment. Adjunct treatment of G-CSF with hUCB may facilitate stemness maintenance and guide neural lineage commitment of hUCB cells. Moreover, regenerative mechanisms afforded by G-CSF-mobilized endogenous stem cells, secretion of growth factors by hUCB grafts and G-CSF-recruited endothelial progenitor cells (EPCs) , as well as the potential graft–host integration that may promote synaptic circuitry re-establishment could altogether produce more pronounced functional improvement in stroked rats subjected to a combination G-CSF treatment and hUCB transplantation. Nevertheless, differences in pathology and repair processes underlying TBI and stroke deserve consideration when testing effects of combinatorial G-CSF and hUCB cell transplantation for stroke treatment. Further studies are also required to determine safety and efficacy of this intervention in both preclinical and clinical stroke studies. PMID:26482176
Qadri, Talat; Javed, Fawad; Johannsen, Gunnar; Gustafsson, Anders
2015-11-01
The purpose of this study was to systematically review currently available evidence regarding the role of diode lasers (810-980 nm) as adjuncts to scaling and root planing (SRP) in the treatment of chronic periodontitis (CP). Mechanical instrumentation of periodontal tissues followed by diode laser application leads to complete removal of pocket epithelium compared with conventional SRP. To address the focused question "Is SRP with adjunct diode lasers (810-980 nm) therapy more effective in the treatment of CP than when CP is treated by SRP alone?" databases were searched using the following key words: chronic periodontitis, diode laser, surgical, AND scaling and root planing, periodontal diseases, periodontal therapy, AND periodontal treatment. Original studies were included. Letters to the editor, case reports, commentaries, and reviews were excluded. Ten clinical studies were included. In all studies, patients were systemically healthy, and cigarette smokers were included in two studies. In five studies, SRP plus diode laser application was more effective in the treatment of CP than SRP, and three studies showed no difference. In two studies, there was a moderate reduction in periodontal inflammation using SRP plus diode laser. The diameter of optic fiber, laser wavelengths, power, pulse repetition rate, and duration of laser exposure ranged between 300 μm and 2 mm, 810-980 nm, 0.8-2.5 W, 10-60 Hz, and 10-100 ms, respectively. In CP patients with probing depths ≤5 mm, diode lasers, SRP plus diode laser (800-980 nm) is more effective in the treatment of CP than when SRP is used alone.
2017-01-12
ABSTRACT Purpose: To determine the efficacy of self -treatment with Pulsed Electromagnetic Frequency (PEMF) therapy, delivered via the Biomodulator...3 Abstract Purpose: To determine the efficacy of self -treatment with Pulsed Electromagnetic Frequency (PEMF) therapy, delivered via the...sought to determine whether adjunctive self -treatment PEMF had any effect on the biopsychosocial secondary sequelae of chronic pain, namely
Safinamide for the treatment of Parkinson's disease.
Kandadai, Rukmini Mridula; Jabeen, Shaik Afshan; Kanikannan, Meena A; Borgohain, Rupam
2014-11-01
Parkinson's disease (PD) is a neurodegenerative disease caused by a complex interaction of loss of dopaminergic and non-dopaminergic neurotransmitter systems. Drugs acting on the dopaminergic pathways are the mainstay of treatment for motor symptoms today. Safinamide (NW-1015) is a novel drug with multiple actions. It is a monoamine oxidase B inhibitor and improves dopaminergic transmission. In addition, it has antiglutamatergic effects and can thus reduce dyskinesias, which is a side effect limiting most dopaminergic therapy. In Phase III trials, safinamide has been found to be a useful adjunctive to dopamine agonists in early PD and has been shown to increase time without increasing troublesome dyskinesias when used as an adjunct to levodopa in patients with advanced PD. A possible neuroprotective role in inhibiting PD disease progression is envisaged and warrants future studies.
Safinamide for the treatment of Parkinson's disease.
deSouza, Ruth Mary; Schapira, Anthony
2017-06-01
The major unmet needs in the medical treatment of Parkinson disease (PD) are reduction of motor side effects from dopaminergic drugs, management of non-motor symptoms and disease modification. Areas covered: Motor fluctuations and OFF periods are a significant determinant of quality of life in PD and reducing their duration and severity can significantly improve motor function. This aim may be partly facilitated by the development of effective adjunctive drugs for dopamine replacement. Safinamide (Xadago), which is a first generation anticonvulsant, has pharmacological properties which are of interest in the context of neurodegenerative diseases, leading to research into its potential as an adjunct to levodopa in PD. Expert opinion: Although its mechanism has not been fully defined, safinamide provides enhanced symptom control of motor function in advanced PD and improves quality of life.
Abduljabbar, Tariq; Javed, Fawad; Shah, Altaf; Samer, Mazin Saleh; Vohra, Fahim; Akram, Zohaib
2017-02-01
The aim of the study was to assess the efficacy of adjunctive use of laser therapy (LT) alone or antimicrobial photodynamic therapy (aPDT) to improve clinical periodontal and HbA1c levels in patients with both chronic periodontitis (CP) and type 2 diabetes mellitus (T2DM). Electronic search of the MEDLINE, PubMed, EMBASE, Science Direct, and SCOPUS databases were combined with hand searching of articles published from 1975 up to and including March 2016 using relevant MeSH terms. Six studies were selected for this review. In these six studies, laser treatment was applied, after scaling and root planing (SRP), in two ways: Three studies used laser alone and three studies used laser with photosensitizer. All the six included studies reporting clinical periodontal and glycemic parameters showed that LT and aPDT were effective in the treatment of CP in T2DM subjects at follow-up. Two studies showed significantly better periodontal outcomes for LT as an adjunct to SRP as compared to SRP alone, whereas four studies showed comparable periodontal outcomes among adjunctive LT or aPDT with SRP. Two studies showed significant reduction of HbA1c levels in LT and aPDT as compared to SRP, whereas three studies showed comparable percentage levels at follow-up. It remains debatable whether LT or aPDT as adjunct to SRP is more effective as compared to SRP alone in the improvement of clinical periodontal and glycemic control in patients with both CP and T2DM, given that the scientific evidence is weak.
Spielmans, Glen I.; Berman, Margit I.; Linardatos, Eftihia; Rosenlicht, Nicholas Z.; Perry, Angela; Tsai, Alexander C.
2013-01-01
Background Atypical antipsychotic medications are widely prescribed for the adjunctive treatment of depression, yet their total risk–benefit profile is not well understood. We thus conducted a systematic review of the efficacy and safety profiles of atypical antipsychotic medications used for the adjunctive treatment of depression. Methods and Findings We included randomized trials comparing adjunctive antipsychotic medication to placebo for treatment-resistant depression in adults. Our literature search (conducted in December 2011 and updated on December 14, 2012) identified 14 short-term trials of aripiprazole, olanzapine/fluoxetine combination (OFC), quetiapine, and risperidone. When possible, we supplemented published literature with data from manufacturers' clinical trial registries and US Food and Drug Administration New Drug Applications. Study duration ranged from 4 to 12 wk. All four drugs had statistically significant effects on remission, as follows: aripiprazole (odds ratio [OR], 2.01; 95% CI, 1.48–2.73), OFC (OR, 1.42; 95% CI, 1.01–2.0), quetiapine (OR, 1.79; 95% CI, 1.33–2.42), and risperidone (OR, 2.37; 95% CI, 1.31–4.30). The number needed to treat (NNT) was 19 for OFC and nine for each other drug. All drugs with the exception of OFC also had statistically significant effects on response rates, as follows: aripiprazole (OR, 2.07; 95% CI, 1.58–2.72; NNT, 7), OFC (OR, 1.30, 95% CI, 0.87–1.93), quetiapine (OR, 1.53, 95% CI, 1.17–2.0; NNT, 10), and risperidone (OR, 1.83, 95% CI, 1.16–2.88; NNT, 8). All four drugs showed statistically significant effects on clinician-rated depression severity measures (Hedges' g ranged from 0.26 to 0.48; mean difference of 2.69 points on the Montgomery–Asberg Depression Rating Scale across drugs). On measures of functioning and quality of life, these medications produced either no benefit or a very small benefit, except for risperidone, which had a small-to-moderate effect on quality of life (g = 0.49). Treatment was linked to several adverse events, including akathisia (aripiprazole), sedation (quetiapine, OFC, and aripiprazole), abnormal metabolic laboratory results (quetiapine and OFC), and weight gain (all four drugs, especially OFC). Shortcomings in study design and data reporting, as well as use of post hoc analyses, may have inflated the apparent benefits of treatment and reduced the apparent incidence of adverse events. Conclusions Atypical antipsychotic medications for the adjunctive treatment of depression are efficacious in reducing observer-rated depressive symptoms, but clinicians should interpret these findings cautiously in light of (1) the small-to-moderate-sized benefits, (2) the lack of benefit with regards to quality of life or functional impairment, and (3) the abundant evidence of potential treatment-related harm. Please see later in the article for the Editors' Summary PMID:23554581
Laquieze, Sabine; Czernielewski, Janusz; Rueda, Marie-José
2006-01-01
Despite their beneficial effects on the treatment of acne vulgaris, topical and oral retinoids may cause severe local irritation (retinoid dermatitis) due to their mechanism of action, thereby jeopardizing patient adherence, and thus compromising treatment efficacy. Alleviating dryness and improving skin comfort by using a moisturizer concomitantly to retinoids could enhance efficacy. In the present study, 30 subjects receiving either oral isotretinoin for at least 2 months or topical tretinoin for at least one month applied a moisturizing cream (Cetaphil Moisturizing Cream) twice daily for 15 days on one half of the face while the other side remained untreated. Clinical assessments, confirmed by biophysical measurements, showed that the moisturizer provided a significant improvement in skin dryness, roughness, and desquamation. Skin properties and skin discomfort were also greatly improved and subjects were very satisfied with the product. Retinoid-induced skin irritation can be relieved by the regular use of a gentle moisturizing cream as an adjunctive treatment.
Gavatha, M; Ioannou, I; Papavasiliou, A S
2011-04-01
The results of adjunctive lacosamide treatment in 18 pediatric patients with pharmacoresistant focal epilepsy are reported. All had severe forms of focal epilepsy with or without secondary generalization and were concurrently receiving one to three other antiepileptic drugs. Lacosamide was administered orally, and final dose, after slow titration, ranged between 1.7 and 10 mg/kg. Mean treatment duration was 8 months (range=3 weeks-17 months). Treatment efficacy was assessed at two time points with a 1-year interval. The reported greater than 50% reduction in seizure frequency was 36% in the initial short-term and 20% in the following long-term assessment. Side effects, mostly somnolence and irritability, were reported by 39% of patients in both evaluations. Our data suggest that lacosamide treatment in pediatric patients is safe at doses up to 10 mg/kg/day without any major side effects, but studies in larger series are needed to validate and extend these findings. Copyright © 2011 Elsevier Inc. All rights reserved.
A preliminary, randomized trial of aerobic exercise for alcohol dependence.
Brown, Richard A; Abrantes, Ana M; Minami, Haruka; Read, Jennifer P; Marcus, Bess H; Jakicic, John M; Strong, David R; Dubreuil, Mary Ella; Gordon, Alan A; Ramsey, Susan E; Kahler, Christopher W; Stuart, Gregory L
2014-07-01
Interventions targeting physical activity may be valuable as an adjunct to alcohol treatment, but have been relatively untested. In the current study, alcohol dependent, physically sedentary patients were randomized to: a 12-week moderate-intensity, group aerobic exercise intervention (AE; n=25) or a brief advice to exercise intervention (BA-E; n=23). Results showed that individuals in AE reported significantly fewer drinking and heavy drinking days, relative to BA-E during treatment. Furthermore adherence to AE strengthened the beneficial effect of intervention on alcohol use outcomes. While high levels of moderate-intensity exercise appeared to facilitate alcohol recovery regardless of intervention arm, attending the group-based AE intervention seemed to further enhance the positive effects of exercise on alcohol use. Study findings indicate that a moderate intensity, group aerobic exercise intervention is an efficacious adjunct to alcohol treatment. Improving adherence to the intervention may enhance its beneficial effects on alcohol use. Copyright © 2014 Elsevier Inc. All rights reserved.
Winters, Drew E; Beerbower, Emily
2017-08-01
Adolescents involved in the juvenile justice system are prone to more traumatic events than other adolescents, leaving them in danger of developmental difficulties. Trauma exposure is predictive of poor outcomes including mental and physical health issues as well as criminal activity. Current treatment approaches either have a nominal effect on recidivism rates or increase the likelihood of future criminal offenses. This article explores adolescent brain development, the unique difficulties that juvenile justice youth face, and mindfulness meditation as an adjunctive treatment to system-based treatment. Mindfulness meditation may be a way to redress damage to the brain and facilitate healthy brain development, thus impacting prosocial behavior. Practice implications include integrating mindfulness meditation as an important part of rehabilitative efforts with juvenile justice youth.
Fox, Gregory J; Mitnick, Carole D; Benedetti, Andrea; Chan, Edward D; Becerra, Mercedes; Chiang, Chen-Yuan; Keshavjee, Salmaan; Koh, Won-Jung; Shiraishi, Yuji; Viiklepp, Piret; Yim, Jae-Joon; Pasvol, Geoffrey; Robert, Jerome; Shim, Tae Sun; Shin, Sonya S; Menzies, Dick; Ahuja, S; Ashkin, D; Avendaño, M; Banerjee, R; Bauer, M; Burgos, M; Centis, R; Cobelens, F; Cox, H; D'Ambrosio, L; de Lange, W C M; DeRiemer, K; Enarson, D; Falzon, D; Flanagan, K; Flood, J; Gandhi, N; Garcia-Garcia, L; Granich, R M; Hollm-Delgado, M G; Holtz, T H; Hopewell, P; Iseman, M; Jarlsberg, L G; Kim, H R; Lancaster, J; Lange, C; Leimane, V; Leung, C C; Li, J; Menzies, D; Migliori, G B; Narita, M; Nathanson, E; Odendaal, R; O'Riordan, P; Pai, M; Palmero, D; Park, S K; Pena, J; Pérez-Guzmán, C; Ponce-de-Leon, A; Quelapio, M I D; Quy, H T; Riekstina, V; Royce, S; Salim, M; Schaaf, H S; Seung, K J; Shah, L; Shean, K; Sifuentes-Osornio, J; Sotgiu, G; Strand, M J; Sung, S W; Tabarsi, P; Tupasi, T E; Vargas, M H; van Altena, R; van der Walt, M; van der Werf, T S; Westenhouse, J; Yew, W W
2016-04-01
Medical treatment for multidrug-resistant (MDR)-tuberculosis is complex, toxic, and associated with poor outcomes. Surgical lung resection may be used as an adjunct to medical therapy, with the intent of reducing bacterial burden and improving cure rates. We conducted an individual patient data metaanalysis to evaluate the effectiveness of surgery as adjunctive therapy for MDR-tuberculosis. Individual patient data, was obtained from the authors of 26 cohort studies, identified from 3 systematic reviews of MDR-tuberculosis treatment. Data included the clinical characteristics and medical and surgical therapy of each patient. Primary analyses compared treatment success (cure and completion) to a combined outcome of failure, relapse, or death. The effects of all forms of resection surgery, pneumonectomy, and partial lung resection were evaluated. A total of 4238 patients from 18 surgical studies and 2193 patients from 8 nonsurgical studies were included. Pulmonary resection surgery was performed on 478 patients. Partial lung resection surgery was associated with improved treatment success (adjusted odds ratio [aOR], 3.0; 95% confidence interval [CI], 1.5-5.9; I(2)R, 11.8%), but pneumonectomy was not (aOR, 1.1; 95% CI, .6-2.3; I(2)R, 13.2%). Treatment success was more likely when surgery was performed after culture conversion than before conversion (aOR, 2.6; 95% CI, 0.9-7.1; I(2)R, 0.2%). Partial lung resection, but not pneumonectomy, was associated with improved treatment success among patients with MDR-tuberculosis. Although improved outcomes may reflect patient selection, partial lung resection surgery after culture conversion may improve treatment outcomes in patients who receive optimal medical therapy. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.
Toniolo, Ricardo Alexandre; Silva, Michelle; Fernandes, Francy de Brito Ferreira; Amaral, José Antonio de Mello Siqueira; Dias, Rodrigo da Silva; Lafer, Beny
2018-02-01
Depressive episodes are a major cause of morbidity and dysfunction in individuals suffering from bipolar disorder. Currently available treatments for this condition have limited efficacy and new therapeutic options are needed. Extensive research in the pathophysiology of bipolar disorder points to the existence of mitochondrial and bioenergetic dysfunction. We hypothesized that creatine monohydrate, a nutraceutical that works as a mitochondrial modulator, would be effective as an adjunctive therapy for bipolar depression. We conducted a double-blind trial in which 35 patients with bipolar disorder type I or II in a depressive episode by DSM-IV criteria and in use of regular medication for the treatment of this phase of the disease were randomly allocated into two adjunctive treatment groups for 6 weeks: creatine monohydrate 6 g daily (N = 17) or placebo (N = 18). Primary efficacy was assessed by the change in the Montgomery-Åsberg Depression Rating Scale (MADRS). We did not find a statistically significant difference in the comparison between groups for the change in score on the MADRS after 6 weeks in an intention-to-treat (ITT) analysis (p = 0.560; Cohen's d = 0.231). However, we found significant superiority of creatine add-on vs. placebo when we considered the remission criterion of a MADRS score ≤ 12 at week 6 analyzing the outcome of the 35 randomized patients on ITT (52.9% remission in the creatine group vs. 11.1% remission in the placebo group) and of the 23 completers (66.7% remission in the creatine group vs. 18.2% remission in the placebo group) (p = 0.012; OR = 9.0 and p = 0.036; OR = 9.0, respectively). Two patients who received creatine switched to hypomania/mania early in the trial. No clinically relevant physical side-effects were reported or observed. This proof-of-concept study, aiming to restore brain bioenergetics using an adjunctive mitochondrial modulator, is not conclusive on the efficacy of creatine add-on for bipolar depression, but suggests that this compound may have a role in the adjunctive treatment of this phase of the illness. Further investigation through randomized controlled trials with larger samples should be conducted to verify the efficacy of creatine supplementation for bipolar depression and also for subsyndromal depressive symptoms.
2016-01-01
Purpose Alendronate has been proposed as a local and systemic drug treatment used as an adjunct to scaling and root planing (SRP) for the treatment of periodontitis. However, its effectiveness has yet to be conclusively established. The purpose of the present meta-analysis was to assess the effectiveness of SRP with alendronate on periodontitis compared to SRP alone. Methods Five electronic databases were used by 2 independent reviewers to identify relevant articles from the earliest records up to September 2016. Randomized controlled trials (RCTs) comparing SRP with alendronate to SRP with placebo in the treatment of periodontitis were included. The outcome measures were changes in bone defect fill, probing depth (PD), and clinical attachment level (CAL) from baseline to 6 months. A fixed-effect or random-effect model was used to pool the extracted data, as appropriate. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was assessed using the Cochrane χ2 and I2 tests. Results After the selection process, 8 articles were included in the meta-analysis. Compared with SRP alone, the adjunctive mean benefits of locally delivered alendronate were 38.25% for bone defect fill increase (95% CI=33.05–43.45; P<0.001; I2=94.0%), 2.29 mm for PD reduction (95% CI=2.07–2.52 mm; P<0.001; I2=0.0%) and 1.92 mm for CAL gain (95% CI=1.55–2.30 mm; P<0.001; I2=66.0%). In addition, systemically administered alendronate with SRP significantly reduced PD by 0.36 mm (95% CI=0.18–0.55 mm; P<0.001; I2=0.0%) and increased CAL by 0.39 mm (95% CI=0.11–0.68 mm; P=0.006; I2=6.0%). Conclusions The collective evidence regarding the adjunctive use of alendronate locally and systemically with SRP indicates that the combined treatment can improve the efficacy of non-surgical periodontal therapy on increasing CAL and bone defect fill and reducing PD. However, precautions must be exercised in interpreting these results, and multicenter studies evaluating this specific application should be carried out. PMID:28050316
Individualized homeopathy in a group of Egyptian asthmatic children.
Shafei, Heba Farid; AbdelDayem, Soha Mahmoud; Mohamed, Nagwa Hassan
2012-10-01
To evaluate homeopathy as an adjunctive treatment for bronchial asthma in children. In a prospective observational longitudinal study the effects of individualised homeopathic medicines were assessed in 30 children with asthma as an adjunct to conventional treatment. The main outcome measures were frequency of attacks, use of medication, night awakening and spirometry at baseline and at follow-up till 6 months. There were clinically relevant and statistically significant changes in those measuring severity, indicating relative improvements after 3 months and absolute improvements after 6 months of treatment by homeopathic medicines. This study provides evidence that homeopathic medicines, as prescribed by experienced homeopathic practitioners, improve severity of asthma in children. Controlled studies should be conducted. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.
Bulimic Adolescents Benefit from Massage Therapy.
ERIC Educational Resources Information Center
Field, Tiffany; Schanberg, Saul; Kuhn, Cynthia; Field, Tory; Fierro, Karen; Henteleff, Tanja; Mueller, Cynthia; Yando, Regina; Shaw, Seana; Burman, Iris
1998-01-01
Female bulimic inpatients (N=24) were randomly assigned to massage therapy or standard treatment group. Massaged patients showed immediate reductions in anxiety and depression; additional improvements were noted by the last day of therapy. Massage therapy is shown to be effective as an adjunct treatment for bulimia. (Author/EMK)
Sanz-Sánchez, Ignacio; Ortiz-Vigón, Alberto; Herrera, David; Sanz, Mariano
2016-07-01
The objective of this study was to assess the microbiological effects and recolonization patterns after non-surgical periodontal treatment protocol based on the adjunctive use of erbium-doped yttrium aluminium garnet (Er:YAG) laser. Patients diagnosed with chronic periodontitis were randomly assigned to two different treatment protocols: test, full-mouth subgingival ultrasonic instrumentation followed by Er-YAG laser application 1 week later to sites with initial probing pocket depth ≥4.5 mm; and control, full-mouth ultrasonic subgingival instrumentation within 1 week. Clinical (at sampled sites) and microbiological (culture-based) parameters were recorded at baseline and 3 and 12 months. Microbiological variables included total counts, frequency of detection, proportions and counts of target species. Results from 19 test and 21 control patients were compared. Minor changes were observed for total colony-forming units, with no differences between groups. For the frequency of detection, a limited and similar impact in both groups was observed for the most prevalent (over 80 %) periodontal pathogens (Porphyromonas gingivalis, Prevotella intermedia, Fusobacterium nucleatum). For proportions, reductions in P. gingivalis occurred at 3 months, both in the test and control groups (from 16.3 to 10 % and 16 to 14.8 %, respectively), although these differences were not statistically significant. At 12 months, the test group showed a statistically significant greater reduction in probing depth for the sampled sites. The adjunctive use of Er:YAG laser when compared with conventional ultrasonic debridement did not provide a microbiological added benefit. Even though some clinical benefits with the adjunctive laser application were identified when comparing both treatment protocols, there were no differences in microbiological outcomes or in the bacterial recolonization patterns.
Schoemaker, Joep H; Jansen, Wim T; Schipper, Jacques; Szegedi, Armin
2014-04-01
Using a selective glycine uptake inhibitor as adjunctive to second-generation antipsychotic (SGA) was hypothesized to ameliorate negative and/or cognitive symptoms in subjects with schizophrenia. Subjects with predominant persistent negative symptoms (previously stabilized ≥3 months on an SGA) were enrolled in a randomized, placebo-controlled trial to investigate adjunctive treatment with Org 25935, a selective inhibitor of type 1 glycine transporter, over 12 weeks in a flexible dose design. Org 25935 was tested at 4 to 8 mg twice daily and 12 to 16 mg twice daily versus placebo. Primary efficacy outcome was mean change from baseline in Scale for Assessment of Negative Symptoms composite score. Secondary efficacy end points were Positive and Negative Syndrome Scale total and subscale scores, depressive symptoms (Calgary Depression Scale for Schizophrenia), global functioning (Global Assessment of Functioning scale), and cognitive measures using a computerized battery (Central Nervous System Vital Signs). Responder rates were assessed post hoc. A total of 215 subjects were randomized, of which 187 (87%) completed the trial. Both dose groups of Org 25935 did not differ significantly from placebo on Scale for Assessment of Negative Symptoms, Positive and Negative Syndrome Scale (total or subscale scores), Global Assessment of Functioning, or the majority of tested cognitive domains. Org 25935 was generally well tolerated within the tested dose range, with no meaningful effects on extrapyramidal symptoms and some reports of reversible visual adverse effects. Org 25935 did not differ significantly from placebo in reducing negative symptoms or improving cognitive functioning when administered as adjunctive treatment to SGA. In our study population, Org 25935 appeared to be well tolerated in the tested dose ranges.
Effect of memantine on C-reactive protein and lipid profiles in bipolar disorder.
Chang, Hui Hua; Chen, Po See; Wang, Tzu-Yun; Lee, Sheng-Yu; Chen, Shiou-Lan; Huang, San-Yuan; Hong, Jau-Shyong; Yang, Yen Kuang; Lu, Ru-Band
2017-10-15
Balance in the immune system plays roles in bipolar disorder (BD) and its metabolic co-morbidities. Memantine is an NMDA receptor antagonist with anti-inflammatory effects. However, the effects of memantine adjunct treatment on metabolic status of BD are unclear. During the 12 weeks period, a total of 191 BD patients were enrolled and split into valproate (VPA) + placebo and VPA + memantine (5mg/day) arms. The fasting plasma levels of high-sensitivity C-reactive protein (CRP) and metabolic indices were assessed. BD patients were stratified according to their initial CRP level. A cut-off value of initial CRP level of 2322ng/mL discriminated the waist circumference in these BD patients after 12-week VPA treatment. In the high CRP (> 2322ng/mL) group, patients in the VPA + memantine arm had a significantly decreased in their CRP (p= 0.009), total cholesterol (p= 0.002), LDL (p= 0.002) levels, BMI (p= 0.001), and waist circumference (p< 0.001), compared to those in the VPA + placebo arm. However, analysis of the low CRP group did not showed the effect. We recruited BD patients in depressed states and the sample size was relative small. The effects of the fixed dose of memantine on metabolic indices were 12-week follow up in BD patients treated with VPA. BD patients with high initial CRP levels receiving memantine adjunct treatment have a reduced risk of inflammation and metabolic imbalance. Prospective studies are needed to confirm the long-term outcome for memantine adjunct therapy in BD patients. Copyright © 2017 Elsevier B.V. All rights reserved.
Bahrami, Bobak; Greenwell, Timothy; Muecke, James S
2014-01-01
To report rates of recurrence and complications of localized ocular surface squamous neoplasia treated with 5-fluorouracil or mitomycin C as adjunctive treatment to surgical excision. Long-term follow up of two prospective, non-comparative interventional case series. One hundred fifty-three eyes with histologically confirmed localized, non-invasive ocular surface squamous neoplasia. 89 eyes were treated with adjuvant 5-fluorouracil and 64 eyes were treated with adjuvant mitomycin C. Following surgical excision±cryotherapy patients received topical 5-fluorouracil 1% four times daily for two weeks or topical mitomycin C 0.04% four times daily for two to three 1-week cycles. Ocular surface squamous neoplasia recurrence, complications of therapy and compliance. Median follow up was 33.6 (range 12-84) months and 57.9 (range 12-160) months in 5-fluorouracil and mitomycin C groups, respectively. There was one recurrence in the 5-fluorouracil group and no recurrences in the mitomycin C group. Side-effects occurred in 69% of 5-fluorouracil patients and 41% of mitomycin C patients. Five patients (6%) required intervention for treatment-related side-effects in the 5-fluorouracil group versus 11 (17%) in the mitomycin C group. No vision-threatening complications were noted. Long-term recurrence of localised ocular surface squamous neoplasia is rare when topical 5-fluorouracil or mitomycin C are used as adjunctive treatment to surgical excision. While side-effects are common, the majority are transient and rarely limit compliance. © 2013 Royal Australian and New Zealand College of Ophthalmologists.
Shulman, Barbara; Dueck, Royce; Ryan, Deirdre; Breau, Genevieve; Sadowski, Isabel; Misri, Shaila
2018-08-01
Many women experience moderate-to-severe depression and anxiety in the postpartum period for which pharmacotherapy is often the first-line treatment. Many breastfeeding mothers are reticent to increase their dose or consider additional medication, despite incomplete response, due to potential adverse effects on their newborn. These mothers are amenable to non-pharmacological intervention for complete symptom remission. The current study evaluated the feasibility of an eight-week mindfulness-based cognitive therapy (MBCT) intervention as an adjunctive treatment for postpartum depression and anxiety. Women were recruited at an outpatient reproductive mental health clinic based at a maternity hospital. Participants had a diagnosis of postpartum depression/anxiety within the first year following childbirth. They were enrolled in either the MBCT intervention group (n = 14) or the treatment-as-usual control group (n = 16), and completed the Patient Health Questionnaire-9 (PHQ-9), the Generalized Anxiety Disorder-7 (GAD-7) questionnaire, and the Mindful Attention Awareness Scale (MAAS) at baseline and at 4 weeks, 8 weeks, and 3 months following baseline. Multivariate analyses demonstrated that depression and anxiety levels decreased, and mindfulness levels increased, in the MBCT group, but not in the control group. Many of the between-group and over time comparisons displayed trends towards significance, although these differences were not always statistically significant. Additionally, the effect sizes for anxiety, depression, and mindfulness were frequently large, indicating that the MBCT intervention may have had a clinically significant effect on participants. Limitations include small sample size and the non-equivalent control group design. We demonstrated that MBCT has potential as an adjunctive, non-pharmacological treatment for postpartum depression/anxiety that does not wholly remit with pharmacotherapy. (249 words). Copyright © 2018 Elsevier B.V. All rights reserved.
Toupin, Jean-François; Lortie, Anne; Major, Philippe; Diadori, Paola; Vanasse, Michel; Rossignol, Elsa; D'Anjou, Guy; Perreault, Sebastien; Larbrisseau, Albert; Carmant, Lionel; Birca, Ala
2015-12-01
Lacosamide is an antiepileptic drug approved for the treatment of focal epilepsy in adult patients. The aim of this observational study was to review our centre's experience with lacosamide and to characterize its effectiveness and tolerability as an adjunctive antiepileptic drug in a retrospective cohort of children with refractory focal epilepsy. We retrospectively reviewed the medical records of 22 patients who received lacosamide from November 2009 to April 2014 at the CHU Ste-Justine, University of Montreal. Treatment responders were defined as children with a ≥50% reduction in seizure frequency compared to baseline, and this was determined three months after the initiation of treatment and at the last follow-up visit. We included 14 boys and eight girls with a mean age of 12.9 years (SD: 5.2; range: 5.2-20.7 years) at the initiation of treatment. The average length of follow-up was 11.9 months. Patients had previously received an average of 7.5 antiepileptic drugs. The mean number of concomitant antiepileptic drugs was 2.3. The mean initial and maintenance doses were 2.9 and 8.4 mg/kg/d, respectively. Thirteen (59%) and ten (45%) patients were responders after three months of treatment and at the last follow-up visit, respectively. One became seizure-free. Adverse effects were reported in 11 patients and none were severe. Responders and non-responders were identical with respect to all studied parameters except gender, with the proportion of responders being greater in girls than in boys (75% vs 29%; p=0.035). Our study adds evidence that lacosamide appears to be a safe and effective adjunctive therapy for children with refractory focal epilepsy.
Zheng, Honggang; He, Shulin; Liu, Rui; Xu, Xinyao; Xu, Tao; Chen, Shuntai; Guo, Qiujun; Gao, Yebo; Hua, Baojin
2017-01-16
Fei-Liu-Ping ointment has been widely applied as adjunctive drug in the treatment of non-small cell lung cancer (NSCLC). However, there has been no systematic review of research findings regarding the efficacy of this treatment. Here, we provide a protocol for assessing the effectiveness and safety of Fei-Liu-Ping ointment in the treatment of NSCLC. The electronic databases to be searched will include MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, Excerpt Medica Database (EMBASE), China National Knowledge Infrastructure (CNKI), China Scientific Journal Database (VIP), Wanfang Database and Chinese Biomedical Literature Database (CBM). Papers in English or Chinese published from inception to 2016 will be included without any restrictions. We will conduct a meta-analysis of randomised controlled trial if possible. The therapeutic effects according to the standard for treatment of solid tumours by the WHO and the quality of life as evaluated by Karnofsky score and weight will be applied as the primary outcomes. We will also evaluate the data synthesis and risk of bias using Review Manager 5.3 software. The results of this review will offer implications for the use of Fei-Liu-Ping ointment as an adjunctive treatment for NSCLC. This knowledge will inform recommendations by surgeons and researchers who are interested in the treatment of NSCLC. The results of this systematic review will be disseminated through presentation at a conference and publication of the data in a peer-reviewed journal. PROSPERO CRD42016036911. 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/.
Ex-PRESS outcomes using mitomycin-C, Ologen alone, Ologen with 5-fluorouracil.
Menda, Shivali A; Lowry, Eugene A; Porco, Travis C; Stamper, Robert L; Rubin, Michel R; Han, Ying
2015-06-01
To compare the complication rate and effectiveness of mitomycin C (MMC), Ologen alone, and Ologen with 5-fluorouracil (5-FU) as adjunctives with Ex-PRESS mini shunt for medically uncontrolled glaucoma. Retrospective comparative study of 59 Ex-PRESS mini shunt trabeculectomy operations coupled with Ologen implantation alone, transient MMC application or Ologen implantation with 5-FU as adjunctive treatment. Eight eyes (7 patients) received Ologen alone, 37 eyes (34 patients) received MMC, and 14 eyes (14 patients) received Ologen with 5-FU as adjunctive therapy. Baseline characteristics, adjunctive used during operation, along with outcomes including intraocular pressure (IOP), number of anti-hypertensive drops, visual acuity, and complications were documented and compared. The primary outcome was IOP at 12 months. Variables were compared with r × c Fisher tests. The Ologen only group had a significantly higher IOP at 12 months (20.5 ± 10.23 mmHg) compared with Ologen combined with 5-FU (12.2 ± 1.47 mmHg) or MMC (13.8 ± 4.37 mmHg) (p = 0.015, linear mixed model). The Ologen only cohort also had a higher re-operation rate (p = 0.01, Fisher's Exact Test) and higher rate of bleb leak (p = 0.02, Fisher's Exact Test). Visual acuity was similar among all three groups. 5-FU with Ologen is as effective as MMC in maintaining IOP following Ex-PRESS shunt surgery at 1 year. However, Ologen alone may not be as effective as the other two adjunctive agents.
The Effects of Adjunct Questions on Prose Learning.
ERIC Educational Resources Information Center
Hamaker, Christiaan
1986-01-01
The research literature on the effects of factual and higher order adjunct questions is reviewed. The influence of 13 design variables on the direction and size of adjunct-questions effects is investigated. It is indicated that higher order adjunct questions may have a more general facilitative effect. (Author/JAZ)
Liao, Yueh-Hsiang; Li, Chia-Ing; Lin, Cheng-Chieh; Lin, Jaung-Geng; Chiang, Jen-Huai; Li, Tsai-Chung
2017-12-01
Traditional Chinese medicine is one of the popular alternative treatments for cancer, mainly enhancing host immune response and reducing adverse effect of chemotherapy. This study first explored traditional Chinese medicine treatment effect on long-term survival of lung cancer patients. This study evaluated whether traditional Chinese medicine combined with conventional cancer treatment improved overall survival of lung cancer patients. We had conducted a retrospective cohort study on 111,564 newly diagnosed lung cancer patients in 2000-2009 from National Health Insurance Program database. A total of 23,803 (21.31%) patients used traditional Chinese medicine for lung cancer care. Eligible participants were followed up until 2011 with a mean follow-up period of 1.96 years (standard deviation 2.55) for non-TCM users and 3.04 years (2.85) for traditional Chinese medicine users. Patients with traditional Chinese medicine utilization were significantly more likely to have a 32% decreased risk of death [hazard ratio = 0.62; 95% confidence interval = 0.61-0.63], compared with patients without traditional Chinese medicine utilization after multivariate adjustment. We also observed a similar significant reduction risk across various subgroups of chronic lung diseases. Qing Zao Jiu Fei Tang was the most effective traditional Chinese medicine agent for mortality reduction both in the entire lung cancer (0.81; 0.72-0.91) and matched populations (0.86; 0.78-0.95). This study demonstrated adjunctive therapy with traditional Chinese medicine may improve overall survival of lung cancer patients. This study also suggested traditional Chinese medicine may be used as an adjunctive therapy for cancer treatment. These observational findings need being validated by future randomized controlled trials to rule out the possibility of effect due to holistic care.
Clobazam : in patients with Lennox-Gastaut syndrome.
Yang, Lily P H; Scott, Lesley J
2012-11-01
Clobazam, as with other benzodiazepines, has a long history of use in the treatment of epilepsy. More recently, it was approved in the USA as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome in patients aged ≥2 years. In the pivotal, placebo-controlled CONTAIN trial in paediatric and adult patients with Lennox-Gastaut syndrome (n = 217 evaluable), adjunctive therapy with clobazam 5-40 mg/day for 12 weeks significantly reduced mean weekly drop seizure rates from baseline compared with adjunctive placebo (primary endpoint), with a significant dosage-dependent improvement in these rates. Results from a dosage-ranging, double-blind, multi-centre, phase II trial add further support for the efficacy of clobazam in paediatric and adult patients with Lennox-Gastaut syndrome (n = 61 evaluable). Improvements in mean weekly drop seizure rates with adjunctive clobazam treatment in these short-term trials was maintained in an ongoing, open-label extension study, with a 91.6 % reduction in mean weekly drop seizure rates from baseline (at randomization in the initial trials) to 24 months in the overall population. Treatment with adjunctive clobazam was generally well tolerated in these clinical trials and after at least 2 years of treatment in an open-label extension study. Most adverse events were mild or moderate and similar to those typically observed with other benzodiazepines.
Adjunctive Nutraceuticals for Depression: A Systematic Review and Meta-Analyses.
Sarris, Jerome; Murphy, Jenifer; Mischoulon, David; Papakostas, George I; Fava, Maurizio; Berk, Michael; Ng, Chee H
2016-06-01
There is burgeoning interest in augmentation strategies for improving inadequate response to antidepressants. The adjunctive use of standardized pharmaceutical-grade nutrients, known as nutraceuticals, has the potential to modulate several neurochemical pathways implicated in depression. While many studies have been conducted in this area, to date no specialized systematic review (or meta-analysis) has been conducted. A systematic search of PubMed, CINAHL, Cochrane Library, and Web of Science was conducted up to December 2015 for clinical trials using adjunctive nutrients for depression. Where sufficient data were available, a random-effects model analyzed the standard mean difference between treatment and placebo in the change from baseline to endpoint, combining the effect size data. Funnel plot and heterogeneity analyses were also performed. Primarily positive results were found for replicated studies testing S-adenosylmethionine (SAMe), methylfolate, omega-3 (primarily EPA or ethyl-EPA), and vitamin D, with positive isolated studies for creatine, folinic acid, and an amino acid combination. Mixed results were found for zinc, folic acid, vitamin C, and tryptophan, with nonsignificant results for inositol. No major adverse effects were noted in the studies (aside from minor digestive disturbance). A meta-analysis of adjunctive omega-3 versus placebo revealed a significant and moderate to strong effect in favor of omega-3. Conversely, a meta-analysis of folic acid revealed a nonsignificant difference from placebo. Marked study heterogeneity was found in a Higgins test for both omega-3 and folic acid studies; funnel plots also revealed asymmetry (reflecting potential study bias). Current evidence supports adjunctive use of SAMe, methylfolate, omega-3, and vitamin D with antidepressants to reduce depressive symptoms.
Outward Bound--An Adjunctive Psychiatric Therapy: Preliminary Research Findings.
ERIC Educational Resources Information Center
Stich, Thomas F.; Sussman, Lewis R.
According to a small study, Outward Bound can enhance the treatment of hospitalized psychiatric patients. Researchers measured the effect of a therapeutic Outward Bound program of prescribed physical and social tasks on the contentment and self-esteem of seven patients undergoing short-term treatment at the Veterans Administration Hospital in…
Hypnosis as an Adjunct to Cognitive-Behavioral Psychotherapy: A Meta-Analysis.
ERIC Educational Resources Information Center
Kirsch, Irving; And Others
1995-01-01
Performed a meta-analysis on 18 studies in which a cognitive-behavioral therapy was compared with the same therapy supplemented by hypnosis. Results indicated that hypnosis substantially enhanced treatment outcome, even though there were few procedural differences between the hypnotic and nonhypnotic treatments. Effects seemed particularly…
Hypnosis as an Adjunct Treatment for Distress Associated with Pediatric Cancer Procedures.
ERIC Educational Resources Information Center
White, Jerre Lee
This paper reviews research literature pertaining to the pain and anxiety associated with pediatric cancer and the use of hypnosis as an adjunct treatment. It is noted that pain and anxiety are most often associated with the procedural treatment of cancer, and that the literature suggests that both pain and anxiety are multi-faceted constructs.…
Criteria for choosing clinically effective glaucoma treatment: A discussion panel consensus
Thygesen, John; Burk, Reinhard; Carassa, Roberto; Crichton, Andrew; Goñi, Francisco Javier; Menage, Mitch; Miglior, Stefano; Montgomery, Donald; Nordmann, John-Philippe; Roberts, Tim; Singh, Kuldev
2007-01-01
Abstract Background: In the clinical management of patients at risk for or diagnosed with primary open-angle glaucoma (POAG), the aim of medical treatment is to reduce intraocular pressure (IOP) and then maintain it over time at a level that preserves both the structure and function of the optic nerve. Objective: The objective of this report was to establish a consensus on the criteria that should be used to determine the characteristics of IOP-lowering medication. Methods: Discussion was held among a panel of 12 physicians considered to be experts in glaucoma to develop a consensus on the criteria used by them to determine the characteristics of the IOP-lowering medication chosen for initial monotherapy and adjunctive treatment of ocular hypertension (OHT) or POAG. Consensus development combined available evidence and the impressions of these physicians regarding the clinical effectiveness of IOP-lowering medication for OHT and POAG. Once the panel identified the criteria, the order of priority and the relative importance of these criteria were then established in the setting of 3 risk categories (low, medium, and high) for a patient to experience significant visual disability from glaucoma over their expected life span. Results: The panel identified 5 criteria to determine the characteristics of IOP-lowering medication for OHT and POAG: IOP-lowering effect, systemic adverse events (AEs), ocular tolerability, compliance/administration, and cost of treatment. IOP-lowering effect was consistently ranked as the highest priority and cost as the lowest. The priority of compliance/administration did not vary by clinical situation. Systemic AEs and ocular tolerability were ranked as higher priorities in initial monotherapy than in adjunctive treatment and ranked lower as the risk for visual disability increased. The priority given to the criteria used to determine clinical effectiveness varied both with the risk for functional vision loss from glaucoma and whether initial monotherapy or adjunctive treatment was being considered. Conclusion: Glaucoma treatment should be assessed with regard to the need not only to lower IOP but also to minimize systemic and ocular AEs, promote patient compliance, and minimize cost. The order of priority and relative importance given to these treatment criteria will vary as part of individualizing patient care. PMID:24683204
Birang, Reza; Shahaboui, Mohammad; Kiani, Sima; Shadmehr, Elham; Naghsh, Narges
2015-01-01
Introduction: The optimum removal of bacteria and their toxins from periodontal pockets is not always obtained by conventional mechanical debridement. Adjunctive therapies may improve tissue healing through detoxification and bactericidal effects. The purpose of the present study was to evaluate the impact of adjunctive laser therapy (LT) and photodynamic therapy (PDT) on patients with chronic periodontitis. Methods: Twenty patients with at least three quadrants involved and each of them presenting pockets 4-8 mm deep were included in the study. Periodontal treatment comprising scaling and root planning (SRP) was accomplished for the whole mouth. Applying a split-mouth design, each quadrant was randomly treated with SRP alone (group A), SRP with LT (group B), and SRP with PDT (group C). The clinical indices were measured at baseline 6 weeks and 3 months after treatment. Microbiological samples were taken and evaluated at baseline and 3-month follow-up. Results: All groups showed statistically significant improvements in terms of clinical attachment level (CAL) gain, periodontal pocket depth (PPD) reduction, papilla bleeding index and microbial count compared to baseline (P < .05). The results showed more significant improvement in the 6-week evaluation in terms of CAL in groups B and C than in group A (P < .05). Group B also revealed a greater reduction in PPD than the other treatment modalities (P < .05). Conclusion: The obtained data suggested that adjunctive LT and PDT have significant short-term benefits in the treatment of chronic periodontitis. Furthermore, LT showed minimal additional advantages compared to PDT. PMID:26464778
Maa, Suh-Hwa; Wang, Chiu-Hua; Hsu, Kuang-Hung; Lin, Horng-Chyuan; Yee, Brian; MacDonald, Karen
2013-01-01
Background. Acupressure has been shown to improve respiratory parameters. We investigated the effects of acupressure on weaning indices in stable coma patients receiving mechanical ventilation. Methods. Patients were randomly allocated to one of three treatments: standard care with adjunctive acupressure on one (n = 32) or two days (n = 31) and standard care (n = 31). Acupressure in the form of 10 minutes of bilateral stimulation at five acupoints was administered per treatment session. Weaning indices were collected on two days before, right after, and at 0.5 hrs, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, and 4 hrs after the start of treatment. Results. There were statistically significant improvements in tidal volumes and index of rapid shallow breathing in the one-day and two-day adjunctive acupressure study arms compared to the standard care arm immediately after acupressure and persisting until 0.5, 1 hr, and 2 hrs after adjustment for covariates. Conclusions. In the stable ventilated coma patient, adjunctive acupressure contributes to improvements in tidal volumes and the index of rapid shallow breathing, the two indices most critical for weaning patients from mechanical ventilation. These effects tend to be immediate and likely to be sustained for 1 to 2 hours. PMID:23710234
An update on adjunctive treatment options for bipolar disorder.
Dean, Olivia M; Gliddon, Emma; Van Rheenen, Tamsyn E; Giorlando, Francesco; Davidson, Sandra K; Kaur, Manreena; Ngo, Trung T; Williams, Lana J
2018-03-01
Bipolar disorder is a complex illness often requiring combinations of therapies to successfully treat symptoms. In recent years, there have been significant advancements in a number of therapies for bipolar disorder. It is therefore timely to provide an overview of current adjunctive therapeutic options to help treating clinicians to inform their patients and work towards optimal outcomes. Publications were identified from PubMed searches on bipolar disorder and pharmacotherapy, nutraceuticals, hormone therapy, psychoeducation, interpersonal and social rhythm therapy, cognitive remediation, mindfulness, e-Health and brain stimulation techniques. Relevant articles in these areas were selected for further review. This paper provides a narrative review of adjunctive treatment options and is not a systematic review of the literature. A number of pharmacotherapeutic, psychological and neuromodulation treatment options are available. These have varying efficacy but all have shown benefit to people with bipolar disorder. Due to the complex nature of treating the disorder, combination treatments are often required. Adjunctive treatments to traditional pharmacological and psychological therapies are proving useful in closing the gap between initial symptom remission and full functional recovery. Given that response to monotherapy is often inadequate, combination regimens for bipolar disorder are typical. Correspondingly, psychiatric research is working towards a better understanding of the disorder's underlying biology. Therefore, treatment options are changing and adjunctive therapies are being increasingly recognized as providing significant tools to improve patient outcomes. Towards this end, this paper provides an overview of novel treatments that may improve clinical outcomes for people with bipolar disorder. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
John, Priya; Lazarus, Flemingson; Selvam, Arul; Prabhuji, Munivenkatappa Lakshmaiah Venkatesh
2015-01-01
Introduction PerioChip a bovine origin gelatine based CHX chip has shown beneficial effects in the management of Chronic Periodontitis. A new fish collagen based CHX chip similar to PerioChip is currently available; however this product has not been thoroughly researched. Aim The aim of the present study was to evaluate the effectiveness of a new Piscean collagen-based controlled-release chlorhexidine chip (CHX chip) as an adjunctive therapy to scaling and root planing (SRP). Settings and Design The study was conducted as a randomised, split-mouth, controlled clinical trial at Krishnadevaraya College of Dental Sciences, Bangalore, India. Materials and Methods In a split–mouth study involving 20 sites in 10 patients with chronic periodontitis, control sites received scaling and root planing and test sites received scaling and root planing (SRP) and the intrapocket CHX chip placement as an adjunct. Subgingival plaque samples were collected from both control and test sites at baseline, 11 days and 11 weeks and the anaerobic colony count were assessed. Clinical parameters that were recorded at baseline and 11 weeks were gingival index, Plaque index, Probing pocket depth (PPD), and Clinical attachment level (CAL). Plaque index was recorded additionally at 11 days. Results In the test group there was a statistically significant reduction in the total anaerobic colony count, gingival index and plaque scores from baseline as compared to control sites at all time intervals. An additional 0.8mm reduction in mean probing pocket depth was noted in the test group. Gain in Clinical attachment level was comparable in both groups. Conclusion The adjunctive use of the new collagen-based CHX chip yielded significant antimicrobial benefit accompanied by a reduction in probing depth and a clinical attachment level gain as compared to SRP alone. This suggests that it may be a useful treatment option of nonsurgical periodontal treatment of chronic periodontitis. PMID:26155567
Shao, Huikai; Zhao, Lingguo; Chen, Fuchao; Zeng, Shengbo; Liu, Shengquan; Li, Jiajia
2015-11-29
BACKGROUND In the past decades, a large number of randomized controlled trials (RCTs) on the efficacy of ligustrazine injection combined with conventional antianginal drugs for angina pectoris have been reported. However, these RCTs have not been evaluated in accordance with PRISMA systematic review standards. The aim of this study was to evaluate the efficacy of ligustrazine injection as adjunctive therapy for angina pectoris. MATERIAL AND METHODS The databases PubMed, Medline, Cochrane Library, Embase, Sino-Med, Wanfang Databases, Chinese Scientific Journal Database, Google Scholar, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, and the Chinese Science Citation Database were searched for published RCTs. Meta-analysis was performed on the primary outcome measures, including the improvements of electrocardiography (ECG) and the reductions in angina symptoms. Sensitivity and subgroup analysis based on the M score (the refined Jadad scores) were also used to evaluate the effect of quality, sample size, and publication year of the included RCTs on the overall effect of ligustrazine injection. RESULTS Eleven RCTs involving 870 patients with angina pectoris were selected in this study. Compared with conventional antianginal drugs alone, ligustrazine injection combined with antianginal drugs significantly increased the efficacy in symptom improvement (odds ratio [OR], 3.59; 95% confidence interval [CI]: 2.39 to 5.40) and in ECG improvement (OR, 3.42; 95% CI: 2.33 to 5.01). Sensitivity and subgroup analysis also confirmed that ligustrazine injection had better effect in the treatment of angina pectoris as adjunctive therapy. CONCLUSIONS The 11 eligible RCTs indicated that ligustrazine injection as adjunctive therapy was more effective than antianginal drugs alone. However, due to the low quality of included RCTs, more rigorously designed RCTs were still needed to verify the effects of ligustrazine injection as adjunctive therapy for angina pectoris.
Shao, Huikai; Zhao, Lingguo; Chen, Fuchao; Zeng, Shengbo; Liu, Shengquan; Li, Jiajia
2015-01-01
Background In the past decades, a large number of randomized controlled trials (RCTs) on the efficacy of ligustrazine injection combined with conventional antianginal drugs for angina pectoris have been reported. However, these RCTs have not been evaluated in accordance with PRISMA systematic review standards. The aim of this study was to evaluate the efficacy of ligustrazine injection as adjunctive therapy for angina pectoris. Material/Methods The databases PubMed, Medline, Cochrane Library, Embase, Sino-Med, Wanfang Databases, Chinese Scientific Journal Database, Google Scholar, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, and the Chinese Science Citation Database were searched for published RCTs. Meta-analysis was performed on the primary outcome measures, including the improvements of electrocardiography (ECG) and the reductions in angina symptoms. Sensitivity and subgroup analysis based on the M score (the refined Jadad scores) were also used to evaluate the effect of quality, sample size, and publication year of the included RCTs on the overall effect of ligustrazine injection. Results Eleven RCTs involving 870 patients with angina pectoris were selected in this study. Compared with conventional antianginal drugs alone, ligustrazine injection combined with antianginal drugs significantly increased the efficacy in symptom improvement (odds ratio [OR], 3.59; 95% confidence interval [CI]: 2.39 to 5.40) and in ECG improvement (OR, 3.42; 95% CI: 2.33 to 5.01). Sensitivity and subgroup analysis also confirmed that ligustrazine injection had better effect in the treatment of angina pectoris as adjunctive therapy. Conclusions The 11 eligible RCTs indicated that ligustrazine injection as adjunctive therapy was more effective than antianginal drugs alone. However, due to the low quality of included RCTs, more rigorously designed RCTs were still needed to verify the effects of ligustrazine injection as adjunctive therapy for angina pectoris. PMID:26615387
Effect of rasagiline as adjunct therapy to levodopa on severity of OFF in Parkinson's disease.
Stocchi, F; Rabey, J M
2011-12-01
The LARGO study demonstrated that rasagiline 1 mg/day as adjunct to levodopa significantly reduces OFF time to the same magnitude as adjunct entacapone. This substudy of LARGO aimed to assess the effect of rasagiline and entacapone on the motor symptoms of PD during the practically defined OFF state. LARGO was a randomized, double-blind, multicenter trial that assessed the efficacy and safety of rasagiline (1 mg/day), entacapone (200 mg with each levodopa dose), and placebo in 687 levodopa-treated PD patients with motor fluctuations. A substudy of LARGO measured UPDRS motor scores in the practically defined OFF state in 32 rasagiline, 36 entacapone, and 37 placebo patients. Treatment with rasagiline produced a significant improvement over placebo of 5.64 units in UPDRS motor OFF score (P = 0.013 vs. placebo). By contrast, the effect of adjunct entacapone was not significant (P = 0.14 vs. placebo). Whereas rasagiline also showed a trend in reducing the UPDRS-ADL OFF score (P = 0.058 vs. placebo), no such trend was noted for entacapone (P = 0.26 vs. placebo). Retrospective analysis, using the Bonferroni correction, of UPDRS motor subdomains further revealed that rasagiline, but not entacapone, significantly improved bradykinesia (P < 0.001) and showed trends for improvements in facial expression, speech, and axial impairment during OFF time. This study provides the first objectively measured evidence that adjunct rasagiline 1 mg/day is effective in reducing the severity of motor symptoms in the OFF state. This suggests a continuous effect of rasagiline 1 mg/day throughout the day and night and is consistent with its extended duration of therapeutic action. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.
Safety and Outcomes of Open-Label Deferasirox Iron Chelation Therapy for Mucormycosis▿
Spellberg, Brad; Andes, David; Perez, Mario; Anglim, Anne; Bonilla, Hector; Mathisen, Glenn E.; Walsh, Thomas J.; Ibrahim, Ashraf S.
2009-01-01
We sought to describe the safety profile of open-label, adjunctive deferasirox iron chelation therapy in eight patients with biopsy-proven mucormycosis. Deferasirox was administered for an average of 14 days (range, 7 to 21) at 5 to 20 mg/kg of body weight/day. The only adverse effects attributable to deferasirox were rashes in two patients. Deferasirox treatment was not associated with changes in renal or liver function, complete blood count, or transplant immunosuppressive levels. Thus, deferasirox appears safe as an adjunctive therapy for mucormycosis. PMID:19433555
Yılmaz, Selçuk; Algan, Serdar; Gursoy, Hare; Noyan, Ulku; Kuru, Bahar Eren; Kadir, Tanju
2013-06-01
The aim of this study was to evaluate the clinical and microbiological results of treatment with the Er:YAG laser and topical gaseous ozone application as adjuncts to initial periodontal therapy in chronic periodontitis (CP) patients. Although many studies have evaluated the effectiveness of the Er:YAG laser as an adjunct to initial periodontal therapy, few studies have focused on the use of gaseous ozone as an adjunct. Thirty patients with CP were randomly divided into three parallel groups, each composed of 10 individuals with at least four teeth having at least one approximal site with a probing depth (PD) of ≥5 mm and a sulcus bleeding index (SBI) ≥2 in each quadrant. Groups of patients received: (1) Scaling and root planing (SRP)+Er:YAG laser; (2) SRP+topical gaseous ozone; or (3) SRP alone. The microbiological and clinical parameters were monitored at day 0 and day 90. At the end of the observation period, statistically significant improvements in clinical parameters were observed within each group. Parallel to the clinical changes, all treatments reduced the number of total bacteria and the proportion of obligately anaerobic microorganisms. Although intergroup comparisons of microbiological parameters showed no significant differences, clinical findings, including attachment gain and PD reduction, were found to be statistically significant in favor of the SRP+Er:YAG laser group. Although statistically nonsignificant, the fact that the obligate anaerobic change was mostly observed in the SRP+Er:YAG laser group, and a similar decrease was noted in the SRP+topical gaseous ozone group, shows that ozone has an antimicrobial effect equivalent to that of the Er:YAG laser.
Web-based support as an adjunct to group-based smoking cessation for adolescents
Mermelstein, Robin; Turner, Lindsey
2008-01-01
Although group-based programs remain the most common treatment approach for adolescent smoking cessation, success rates for these programs have been relatively modest, and their reach may be limited. Web-based adjuncts may be one way to boost the efficacy and reach of group-based approaches. The purpose of this study was to evaluate the effectiveness of enhancing the American Lung Association’s Not on Tobacco program (NOT) with a Web-based adjunct (NOT Plus). Twenty-nine high schools were randomly assigned to either the NOT program alone or to the NOT Plus condition, which included access to a specially designed Web site for teens, along with proactive phone calls from the group facilitator to the participant. Self-reported smoking behavior was obtained at end-of-program and at a 3-month follow-up. Using hierarchical linear modeling, accounting for the clustering of students in schools, and controlling for student gender, grade, race, and baseline smoking rate, there was a marginally significant (p = .06) condition effect at end-of-treatment and a significant effect at 3-month follow-up (p < .05) favoring the NOT Plus condition. Approximately 57% of adolescents reported visiting the Web site, and among the NOT Plus condition, use of the Web site was associated with cessation significantly at end-of-program (p < .05), but not at 3 months. Adolescents in urban schools were more likely to access the Web site than those in rural schools. Participants who visited the Web site rated it positively on several dimensions. Reasons for not using the Web site will be discussed, as well as its value as an adjunct. PMID:17491173
Schmidt, Jennifer; Martin, Alexandra
2016-09-01
Brain-directed treatment techniques, such as neurofeedback, have recently been proposed as adjuncts in the treatment of eating disorders to improve therapeutic outcomes. In line with this recommendation, a cue exposure EEG-neurofeedback protocol was developed. The present study aimed at the evaluation of the specific efficacy of neurofeedback to reduce subjective binge eating in a female subthreshold sample. A total of 75 subjects were randomized to EEG-neurofeedback, mental imagery with a comparable treatment set-up or a waitlist group. At post-treatment, only EEG-neurofeedback led to a reduced frequency of binge eating (p = .015, g = 0.65). The effects remained stable to a 3-month follow-up. EEG-neurofeedback further showed particular beneficial effects on perceived stress and dietary self-efficacy. Differences in outcomes did not arise from divergent treatment expectations. Because EEG-neurofeedback showed a specific efficacy, it may be a promising brain-directed approach that should be tested as a treatment adjunct in clinical groups with binge eating. Copyright © 2016 John Wiley & Sons, Ltd and Eating Disorders Association. Copyright © 2016 John Wiley & Sons, Ltd and Eating Disorders Association.
Lachaine, Jean; Sikirica, Vanja; Mathurin, Karine
2016-01-16
Attention-deficit/hyperactivity disorder (ADHD) is a common psychiatric disorder in children, with worldwide prevalence of ADHD varying from 5.9 to 7.1 %, depending on the reporter. In case of inadequate response to stimulants, combination therapy of stimulants and an adjunctive medication may improve the control of ADHD symptoms, reduce the dose-limiting adverse events, and help control comorbidities. To date, the only medication to be used for adjunctive therapy to psychostimulants is guanfacine extended release (GXR). The aim of this study was to assess the economic impact of GXR as an adjunct therapy with long-acting stimulants (GXR + stimulant) compared to long-acting stimulant monotherapy (stimulant alone) in the treatment of children and adolescents with ADHD in Canada. A Markov model was developed using health states defined based on the clinician-reported Clinical Global Impression-Severity (CGI-S) score (normal, mild, moderate, severe). Transition probabilities were calculated based on patient-level data from a published study. Long-acting stimulants available in Canada were considered in the base-case model: amphetamine mixed salts, methylphenidate HCl formulations, and lisdexamfetamine dimesylate. Analyses were conducted from a Canadian Ministry of Health (MoH; Ontario) and a societal perspective over a 1-year time horizon with weekly cycles. Over a 1-year time horizon, GXR + stimulant was associated with 0.655 quality-adjusted life year (QALY), compared to 0.627 QALY with stimulant alone, for a gain of 0.028 QALY. From a MoH perspective, GXR+ stimulant and stimulant alone were associated with total costs of $CA1,617 and $CA949, respectively (difference of $CA668), which resulted in an incremental cost-effectiveness ratio (ICER) of $CA23,720/QALY. From a societal perspective, GXR + stimulant and stimulant alone were associated with total costs of $CA3,915 and $CA3,582, respectively (difference of $CA334), which resulted in an ICER of $CA11,845/QALY. Probabilistic sensitivity analysis (PSA) of GXR + stimulant showed that it remains a cost-effective strategy in 100 % of the simulations from both perspectives in numerous PSA and one-way sensitivity analyses, relative to a willingness to pay threshold of $50,000/QALY. This economic evaluation demonstrates that GXR + stimulant is cost-effective compared to stimulant alone in the treatment of children and adolescents with ADHD in Canada.
Omega-3 fatty acids as adjunctive therapy in Crohns disease.
Macdonald, Angie
2006-01-01
Crohns disease is an inflammatory bowel disease that can have a significant impact on the health of those afflicted. The etiology of the disease is unknown, but genetic, environmental, dietary, and immunological factors are thought to be involved. Multiple nutrients can become depleted during active disease due to inadequate intake or malabsorption. Preventing these deficiencies is paramount in the care of those suffering from Crohns disease. Often the traditional treatments (medications) have limited effectiveness and negative side effects that inhibit their use. Enteral nutrition has promising therapeutic benefits, but its use is often limited to the pediatric population due to poor patient acceptability. Omega-3 fatty acids have been investigated for their anti-inflammatory properties as an alternative to traditional care. This article reviews the etiology of Crohns disease, nutritional deficiencies, traditional treatments, and the use of omega-3 fatty acids in the prevention of Crohns recurrence. The results from clinical trials have been conflicting, but a new fish oil preparation that limits the side effects of traditional fish oil therapy shows promise as an adjunctive treatment for Crohns disease. Continued research is needed to validate these findings.
Sorensen, James C; Petersen, Aaron C; Timpani, Cara A; Campelj, Dean G; Cook, Jordan; Trewin, Adam J; Stojanovska, Vanesa; Stewart, Mathew; Hayes, Alan; Rybalka, Emma
2017-01-01
Chemotherapy is a leading intervention against cancer. Albeit highly effective, chemotherapy has a multitude of deleterious side-effects including skeletal muscle wasting and fatigue, which considerably reduces patient quality of life and survivability. As such, a defense against chemotherapy-induced skeletal muscle dysfunction is required. Here we investigate the effects of oxaliplatin (OXA) treatment in mice on the skeletal muscle and mitochondria, and the capacity for the Poly ADP-ribose polymerase (PARP) inhibitor, BGP-15, to ameliorate any pathological side-effects induced by OXA. To do so, we investigated the effects of 2 weeks of OXA (3 mg/kg) treatment with and without BGP-15 (15 mg/kg). OXA induced a 15% ( p < 0.05) reduction in lean tissue mass without significant changes in food consumption or energy expenditure. OXA treatment also altered the muscle architecture, increasing collagen deposition, neutral lipid and Ca 2+ accumulation; all of which were ameliorated with BGP-15 adjunct therapy. Here, we are the first to show that OXA penetrates the mitochondria, and, as a possible consequence of this, increases mtROS production. These data correspond with reduced diameter of isolated FDB fibers and shift in the fiber size distribution frequency of TA to the left. There was a tendency for reduction in intramuscular protein content, albeit apparently not via Murf1 (atrophy)- or p62 (autophagy)- dependent pathways. BGP-15 adjunct therapy protected against increased ROS production and improved mitochondrial viability 4-fold and preserved fiber diameter and number. Our study highlights BGP-15 as a potential adjunct therapy to address chemotherapy-induced skeletal muscle and mitochondrial pathology.
Janice Jimenez-Torres, G; Weinstein, Benjamin L; Walker, Cory R; Christopher Fowler, J; Ashford, Philippa; Borckardt, Jeffrey J; Madan, Alok
2017-03-01
Available treatments for chronic pain (CP) are modestly effective or associated with iatrogenic harm. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may be an effective, adjunctive treatment to non-opioid therapies. In this randomized control trial (RCT), we compare adjunctive active versus sham tDCS among patients in a multimodal inpatient pain management program. The primary objectives of the RCT are to improve pain tolerance and subjective pain experience. Patients admitted to the Pain Management Program at The Menninger Clinic in Houston, Texas are eligible for this trial. Eighty-four participants will be randomized (1:1) into a single-blind, 2×12 (group×time) controlled trial. A battery-powered direct and constant current stimulator (Soterix Medical Inc. 2014) delivers anodal stimulation over the left dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation over the right DLPFC. Active tDCS is applied by supplying a 2mA current for 20min/session over 10 sessions. Participants complete self-report and performance-based assessments on a weekly basis just prior to brain stimulation. Self-report assessments are collected via Chronic Pain Tracker version 3.6, an iPad interfaced application. The performance-based pain tolerance task is completed through the cold presser task. Interventions with cross-symptomatic therapeutic potential are absolutely essential in the context of CP, in which psychiatric comorbidity is the norm. Modalities that can be used in tandem with evidence-based, non-opioid therapies have the potential to have a synergistic effect, resulting in increased effectiveness of what have been modestly effective treatments to date. Copyright © 2017 Elsevier Inc. All rights reserved.
Eisendrath, Stuart J; Gillung, Erin; Delucchi, Kevin L; Segal, Zindel V; Nelson, J Craig; McInnes, L Alison; Mathalon, Daniel H; Feldman, Mitchell D
2016-01-01
Due to the clinical challenges of treatment-resistant depression (TRD), we evaluated the efficacy of mindfulness-based cognitive therapy (MBCT) relative to a structurally equivalent active comparison condition as adjuncts to treatment-as-usual (TAU) pharmacotherapy in TRD. This single-site, randomized controlled trial compared 8-week courses of MBCT and the Health Enhancement Program (HEP), comprising physical fitness, music therapy and nutritional education, as adjuncts to TAU pharmacotherapy for outpatient adults with TRD. The primary outcome was change in depression severity, measured by percent reduction in the total score on the 17-item Hamilton Depression Rating Scale (HAM-D17), with secondary depression indicators of treatment response and remission. We enrolled 173 adults; mean length of a current depressive episode was 6.8 years (SD = 8.9). At the end of 8 weeks of treatment, a multivariate analysis showed that relative to the HEP condition, the MBCT condition was associated with a significantly greater mean percent reduction in the HAM-D17 (36.6 vs. 25.3%; p = 0.01) and a significantly higher rate of treatment responders (30.3 vs. 15.3%; p = 0.03). Although numerically superior for MBCT than for HEP, the rates of remission did not significantly differ between treatments (22.4 vs. 13.9%; p = 0.15). In these models, state anxiety, perceived stress and the presence of personality disorder had adverse effects on outcomes. MBCT significantly decreased depression severity and improved treatment response rates at 8 weeks but not remission rates. MBCT appears to be a viable adjunct in the management of TRD. © 2016 S. Karger AG, Basel.
Shingleton, Rebecca M; Pratt, Elizabeth M; Gorman, Bernard; Barlow, David H; Palfai, Tibor P; Thompson-Brenner, Heather
2016-05-01
This study tested a motivational text message treatment adjunct for individuals with eating disorders (EDs) who exhibited high dietary restraint/restriction. A replicated single-case alternating treatment design was used to examine (a) the feasibility of combining a brief motivational interview with subsequent text messages and (b) the influence of the text messages on eating behaviors and motivation to change in individuals with EDs (N=12). The protocol was 8weeks and the text messages were adjunctive to cognitive-behavioral therapy. The intervention was well accepted (mean rating=7/10) and feasible within the context of monetary compensation (mean daily monitoring compliance =91%). Text messages did not impact behavioral outcomes: dietary restraint and kilocalorie intake. They had mixed effects on motivation to change dietary restraint, measured by the Readiness and Motivation Questionnaire (RMQ). When receiving text messages, RMQ precontemplation scores (desire to restrict) significantly increased, indicating decreased motivation; however, action scores (effort toward reducing dietary restraint) significantly increased, indicating increased motivation. These effects were moderated by weight status. Underweight individuals (n=4; body mass index [BMI]<19.0) reported increased ambivalence-that is, an increased desire to restrict and increased action toward reducing restriction-in response to the text messages. Normal weight participants (n=8; BMI>19.0) reported only increased action toward reducing restriction in response to the text messages. These data demonstrate text messages are a potentially feasible and acceptable treatment adjunct and may be effective at increasing motivation to change for normal weight individuals, while their influence on underweight patients is more complex. These findings provide a foundation for future research in technology-based motivational interventions for EDs and offer preliminary evidence for using these methods among normal weight individuals. Copyright © 2016. Published by Elsevier Ltd.
ERIC Educational Resources Information Center
Dukes, Denzel; And Others
1980-01-01
Frederic Leer's article "Running as an Adjunct to Psychotherapy" (January 1980 issue of this journal) is criticized by three authors. They focus on the psychological and social effects of running and its usefulness as a treatment for depressed adults. (LAB)
N-acetylcysteine for major depressive episodes in bipolar disorder.
Magalhães, Pedro V; Dean, Olívia M; Bush, Ashley I; Copolov, David L; Malhi, Gin S; Kohlmann, Kristy; Jeavons, Susan; Schapkaitz, Ian; Anderson-Hunt, Murray; Berk, Michael
2011-12-01
In this report, we aimed to evaluate the effect of add-on N-acetylcysteine (NAC) on depressive symptoms and functional outcomes in bipolar disorder. To that end, we conducted a secondary analysis of all patients meeting full criteria for a depressive episode in a placebo controlled trial of adjunctive NAC for bipolar disorder. Twenty-four week randomised clinical trial comparing adjunctive NAC and placebo in individuals with bipolar disorder experiencing major depressive episodes. Symptomatic and functional outcome data were collected over the study period. Seventeen participants were available for this report. Very large effect sizes in favor of NAC were found for depressive symptoms and functional outcomes at endpoint. Eight of the ten participants on NAC had a treatment response at endpoint; the same was true for only one of the seven participants allocated to placebo. These results indicate that adjunctive NAC may be useful for major depressive episodes in bipolar disorder. Further studies designed to confirm this hypothesis are necessary.
Social Networking Sites: An Adjunctive Treatment Modality for Psychological Problems
Menon, Indu S.; Sharma, Manoj Kumar; Chandra, Prabha S.; Thennarasu, K.
2014-01-01
Background: Social networking is seen as a way to enhance social support and feeling of well-being. The present work explores the potentials of social networking sites as an adjunctive treatment modality for initiating treatment contact as well as for managing psychological problems. Materials and Methods: Interview schedule, Facebook intensity questionnaire were administered on 28 subjects with a combination of 18 males and 10 females. They were taken from the in-patient and out-patient psychiatry setting of the hospital. Results: Facebook was the most popular sites and used to seek emotional support on the basis of the frequent updates of emotional content that users put in their profile; reconciliations, escape from the problems or to manage the loneliness; getting information about illness and its treatment and interaction with experts and also manifested as problematic use. Conclusions: It has implications for developing social networking based adjunctive treatment modality for psychological problems. PMID:25035548
Social networking sites: an adjunctive treatment modality for psychological problems.
Menon, Indu S; Sharma, Manoj Kumar; Chandra, Prabha S; Thennarasu, K
2014-07-01
Social networking is seen as a way to enhance social support and feeling of well-being. The present work explores the potentials of social networking sites as an adjunctive treatment modality for initiating treatment contact as well as for managing psychological problems. Interview schedule, Facebook intensity questionnaire were administered on 28 subjects with a combination of 18 males and 10 females. They were taken from the in-patient and out-patient psychiatry setting of the hospital. Facebook was the most popular sites and used to seek emotional support on the basis of the frequent updates of emotional content that users put in their profile; reconciliations, escape from the problems or to manage the loneliness; getting information about illness and its treatment and interaction with experts and also manifested as problematic use. It has implications for developing social networking based adjunctive treatment modality for psychological problems.
Al Hulami, Hassan; Babay, Nadir; Awartani, Fatin; Anil, Sukumaran
2011-01-01
Background Locally delivered doxycycline is found to be effective in managing periodontitis as an adjunct to scaling and root planing. Aim To evaluate the effect of locally delivered doxycycline (10%) with scaling and root planing in the periodontal treatment of smokers and to compare it with scaling and root planing alone. Methods Twelve smokers with chronic periodontitis and a pocket depth (⩾5 mm) on posterior teeth that bleed on probing were selected. Patients were randomly assigned to scaling and root planing (SRP) or scaling and root planing followed by local application of doxycycline (SRP-D). Plaque, bleeding on probing, gingival recession, clinical attachment level (CAL), and probing depth (PD) were recorded at the baseline, 6 and 12 weeks. Results Both groups showed a significant reduction in Plaque, Bleeding on Probing and pocket depth at 6th and 12th week from the baseline. A statistically significant gain of attachment was observed in both groups after treatment. Even though the doxycycline group showed slightly higher attachment gain it was not statistically significant compared to the control group. Conclusion The observations of the study reveal that the additional benefit of topical application of doxycycline as an adjunct to scaling and root planing in smokers is not convincing. However, further clinical studies may be necessary to substantiate the present observations. PMID:23960508
Local and systemic antimicrobial therapy in periodontics.
Herrera, David; Matesanz, Paula; Bascones-Martínez, Antonio; Sanz, Mariano
2012-09-01
This review aimed to update the current evidence on the efficacy of the adjunctive use of local and systemic antimicrobials in the treatment of periodontitis and to assess whether it might improve the clinical limitations and shortcomings of standard nonsurgical treatment in the management of periodontitis. Relevant randomized clinical trials (RCT) with more than 3 months of follow-up, published from 2010 to 2012 for systemic antimicrobials and from 2008 to 2012 for local antimicrobials, were searched in Medline and critically analyzed. Scientific evidence evaluated in different systematic reviews and reviews presented at European and World Workshops were also included. Only adjunctive therapies were considered in the present review: articles comparing debridement alone or plus placebo, versus debridement plus systemic or local antimicrobials were included. Adjunctive systemic antimicrobials have been evaluated both in aggressive and chronic periodontitis: in aggressive periodontitis, amoxicillin and metronidazole have been extensively studied, reporting clinical and microbiological benefits; in chronic periodontitis, different products are under scrutiny, such as azithromycin. The clinical efficacy of local antimicrobials, although extensively demonstrated, is still surrounded by a constant debate on the cost-effectiveness evaluation and on its adequate indications. Despite the clinical efficacy of the adjunctive use of local and systemic antimicrobials, demonstrated in RCTs and in systematic reviews, there is a lack of evidence to support well-defined clinical protocols, including products and dosages. Copyright © 2012 Elsevier Inc. All rights reserved.
Cieplik, Fabian; Buchalla, Wolfgang; Hellwig, Elmar; Al-Ahmad, Ali; Hiller, Karl-Anton; Maisch, Tim; Karygianni, Lamprini
2017-06-01
For deep carious lesions, a more conservative treatment modality ("selective caries removal") has been proposed, where only the heavily contaminated dentine is removed. In this regard, effective adjuncts for cavity disinfection such as the antimicrobial photodynamic therapy (aPDT) can be valuable clinically prior to definitive restoration. Therefore, the aim of this study was to systematically assess clinical studies on the effectiveness of aPDT as a supplementary tool in the treatment of deep caries lesions. Searches were performed in four databases (PubMed, EMBASE, ISI Web of Science, ClinicalTrials.gov) from 1st January, 2011 until 21st June, 2016 for search terms relevant to the observed parameters, pathological condition, intervention and anatomic entity. The pooled information was evaluated according to PRISMA guidelines. At first, 1651 articles were recovered, of which 1249 full-text articles were evaluated, 270 articles thereof were reviewed for eligibility and finally 6 articles met all inclusion criteria. The aPDT protocols involved Methylene Blue, Toluidine Blue and aluminium-chloride-phthalocyanine as photosensitizers and diode lasers, light-emitting diodes and halogen light-sources. The data from five reports, utilizing both culture-dependent and -independent methods, disclosed significant reduction of cariogenic bacterial load after mechanical caries removal with adjunct aPDT. As these studies exhibit some methodological limitations, e.g. lack of positive controls, this systematic review can support the application of aPDT to a limited extent only in terms of reducing the microbial load in deep carious lesions before restorative treatment. Copyright © 2017 Elsevier B.V. All rights reserved.
Legrand, Fabien D; Neff, Elise M
2016-02-01
Physical exercise as adjunctive treatment for hospitalized patients with major depressive disorder (MDD) has been of increasing interest in the past few years. While preliminary findings are promising, these prior studies have been plagued by inclusion of participants at different stages of medication use at study entry. The present study evaluates the effects of a short (10-days) add-on endurance-training intervention in hospitalized MDD patients on antidepressant medication for less than two weeks. Thirty-five participants were randomly assigned to one of three study groups: aerobic exercise (n=14), placebo (stretching) exercise (n=11), or no intervention (control; n=10). The study outcome was the change in the Beck Depression Inventory (BDI-II) total score from baseline to the end of the study period. The intent-to-treat analysis showed significant improvements in BDI-II scores for both the aerobic and the stretching groups. However, comparing pre- to post-study depression changes in these two groups, we found a large effect size in favor of aerobic exercise (Cohen's d=-1.06). No significant change in depressive symptoms was found in the control group. The nature of the intervention (i.e., exercise) meant blinding participants to treatments was not possible. Precise information on medication dosage was not available, and the short duration of interventions and lack of follow-up assessment were all limitations. Endurance-training can be a helpful adjunct treatment for hospitalized patients with severe affective disorders in the initial stages of pharmacotherapy. Copyright © 2015 Elsevier B.V. All rights reserved.
Utility of Adjunctive Procedures With Balloon Dilation of the Eustachian Tube.
Ashry, Yehia; Kawai, Kosuke; Poe, Dennis
2017-12-01
To assess the role and effect of concomitant adjunctive procedures when combined with balloon dilation of the Eustachian tube (BDET), including a new technique for treating obstructive disease within the bony Eustachian tube (ET). Retrospective case series. Tertiary medical center. Adults with persistent (≥2 years): 1) OME or non-fixed TM retraction AND type B or C tympanogram OR 2) Consistent symptoms of barochallenge with flights or diving, all despite medical treatment for ≥6 weeks. Balloon dilation of the cartilaginous ET (BDET) was performed under general anesthesia using concomitant myringotomy with or without tube placement if indicated. Adjunctive turbinectomy, adenoidectomy, and/or tympanoplasty were used in selected cases. For suspected disease in the bony ET, an illuminated guidewire was used for probing and clearing the lumen. Outcome measures were tympanogram, otomicroscopy, ET mucosal inflammation score, Valsalva maneuver, and PTA audiometry. 67 ETs (48 patients) underwent BDET: 1) 30/67 balloon w/wo myringotomy, w/wo tube, 2) 20/67 plus adjunctive procedure or 3) 17/67 plus guidewire. Follow-up was ranging from 0.4 to 3.4 years (mean 1.3 year, SD = 0.7). Significant improvement occurred in 79%. There was no significant difference in the failure rate comparing balloon dilation with adjunctive procedures 5/20 (25%) or without adjunctive procedures; 4/30 p = 0.45 (13%). Failure rate for BDET plus guide wire was 5/17 (29%) and resistance within the bony ET occurred in 8/17 (47%). Balloon dilation of the cartilaginous ET demonstrated significant improvement despite expansion of indications that necessitated the addition of adjunctive procedures. 4.
Nevitt, Benjamin N; Robinson, Narda; Kratz, Gail; Johnston, Matthew S
2015-03-01
Management of trauma-induced chronic torticollis in raptors has historically been challenging. Euthanasia is common in affected birds because of their inability to maintain normal cervical position, although they may be able to function normally. To assess effectiveness of physical therapy of the neck and head as an adjunct treatment for this condition, a case-control study was done in raptors admitted to the Rocky Mountain Raptor Program from 2003 to 2010. Eleven cases were identified with a diagnosis of chronic torticollis resulting from traumatic brain injury. Five cases were treated with physical therapy of the head and neck, and 6 control cases did not receive any physical therapy for the torticollis. Of the control cases, 0 of 6 had resolution of the torticollis, 0 of 6 were released, and 5 of 6 were euthanatized. Of the treated cases, 4 of 5 had complete resolution of the torticollis and 5 of 5 were released. Resolution of torticollis differed significantly between cases receiving physical therapy and controls. These results indicate that physical therapy should be used as an adjunctive therapy in cases of chronic torticollis induced by trauma in raptors because it results in better resolution of the torticollis and increased likelihood of release.
Nikitovic-Jokic, Milica; Holubowich, Corinne
2016-01-01
Background Screening with mammography can detect breast cancer early, before clinical symptoms appear. Some cancers, however, are not captured with mammography screening alone. Among women at high risk for breast cancer, magnetic resonance imaging (MRI) has been suggested as a safe adjunct (supplemental) screening tool that can detect breast cancers missed on screening mammography, potentially reducing the number of deaths associated with the disease. However, the use of adjunct screening tests may also increase the number of false-positive test results, which may lead to unnecessary follow-up testing, as well as patient stress and anxiety. We investigated the benefits and harms of MRI as an adjunct to mammography compared with mammography alone for screening women at less than high risk (average or higher than average risk) for breast cancer. Methods We searched Ovid MEDLINE, Ovid Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), Centre for Reviews and Dissemination (CRD) Health Technology Assessment Database, and National Health Service (NHS) Economic Evaluation Database, from January 2002 to January 2016, for evidence of effectiveness, harms, and diagnostic accuracy. Only studies evaluating the use of screening breast MRI as an adjunct to mammography in the specified populations were included. Results No studies in women at less than high risk for breast cancer met our inclusion criteria. Conclusions It remains uncertain if the use of adjunct screening breast MRI in women at less than high risk (average or higher than average risk) for breast cancer will reduce breast cancer–related mortality without significant increases in unnecessary follow-up testing and treatment. PMID:27990198
Pseudomonas aeruginosa keratitis: outcomes and response to corticosteroid treatment.
Sy, Aileen; Srinivasan, Muthiah; Mascarenhas, Jeena; Lalitha, Prajna; Rajaraman, Revathi; Ravindran, Meenakshi; Oldenburg, Catherine E; Ray, Kathryn J; Glidden, David; Zegans, Michael E; McLeod, Stephen D; Lietman, Thomas M; Acharya, Nisha R
2012-01-25
To compare the clinical course and effect of adjunctive corticosteroid therapy in Pseudomonas aeruginosa with those of all other strains of bacterial keratitis. Subanalyses were performed on data collected in the Steroids for Corneal Ulcers Trial (SCUT), a large randomized controlled trial in which patients were treated with moxifloxacin and were randomly assigned to 1 of 2 adjunctive treatment arms: corticosteroid or placebo (4 times a day with subsequent reduction). Multivariate analysis was used to determine the effect of predictors, organism, and treatment on outcomes, 3-month best-spectacle-corrected visual acuity (BSCVA), and infiltrate/scar size. The incidence of adverse events over a 3-month follow-up period was compared using Fisher's exact test. SCUT enrolled 500 patients. One hundred ten patients had P. aeruginosa ulcers; 99 of 110 (90%) enrolled patients returned for follow-up at 3 months. Patients with P. aeruginosa ulcers had significantly worse visual acuities than patients with other bacterial ulcers (P = 0.001) but showed significantly more improvement in 3-month BSCVA than those with other bacterial ulcers, adjusting for baseline characteristics (-0.14 logMAR; 95% confidence interval, -0.23 to -0.04; P = 0.004). There was no significant difference in adverse events between P. aeruginosa and other bacterial ulcers. There were no significant differences in BSCVA (P = 0.69), infiltrate/scar size (P = 0.17), and incidence of adverse events between patients with P. aeruginosa ulcers treated with adjunctive corticosteroids and patients given placebo. Although P. aeruginosa corneal ulcers have a more severe presentation, they appear to respond better to treatment than other bacterial ulcers. The authors did not find a significant benefit with corticosteroid treatment, but they also did not find any increase in adverse events. (ClinicalTrials.gov number, NCT00324168.).
Pseudomonas aeruginosa Keratitis: Outcomes and Response to Corticosteroid Treatment
Sy, Aileen; Srinivasan, Muthiah; Mascarenhas, Jeena; Lalitha, Prajna; Rajaraman, Revathi; Ravindran, Meenakshi; Oldenburg, Catherine E.; Ray, Kathryn J.; Glidden, David; Zegans, Michael E.; McLeod, Stephen D.; Lietman, Thomas M.
2012-01-01
Purpose. To compare the clinical course and effect of adjunctive corticosteroid therapy in Pseudomonas aeruginosa with those of all other strains of bacterial keratitis. Methods. Subanalyses were performed on data collected in the Steroids for Corneal Ulcers Trial (SCUT), a large randomized controlled trial in which patients were treated with moxifloxacin and were randomly assigned to 1 of 2 adjunctive treatment arms: corticosteroid or placebo (4 times a day with subsequent reduction). Multivariate analysis was used to determine the effect of predictors, organism, and treatment on outcomes, 3-month best-spectacle-corrected visual acuity (BSCVA), and infiltrate/scar size. The incidence of adverse events over a 3-month follow-up period was compared using Fisher's exact test. Results. SCUT enrolled 500 patients. One hundred ten patients had P. aeruginosa ulcers; 99 of 110 (90%) enrolled patients returned for follow-up at 3 months. Patients with P. aeruginosa ulcers had significantly worse visual acuities than patients with other bacterial ulcers (P = 0.001) but showed significantly more improvement in 3-month BSCVA than those with other bacterial ulcers, adjusting for baseline characteristics (−0.14 logMAR; 95% confidence interval, −0.23 to −0.04; P = 0.004). There was no significant difference in adverse events between P. aeruginosa and other bacterial ulcers. There were no significant differences in BSCVA (P = 0.69), infiltrate/scar size (P = 0.17), and incidence of adverse events between patients with P. aeruginosa ulcers treated with adjunctive corticosteroids and patients given placebo. Conclusions. Although P. aeruginosa corneal ulcers have a more severe presentation, they appear to respond better to treatment than other bacterial ulcers. The authors did not find a significant benefit with corticosteroid treatment, but they also did not find any increase in adverse events. (ClinicalTrials.gov number, NCT00324168.) PMID:22159005
Soczynska, Joanna K; Kennedy, Sidney H; Alsuwaidan, Mohammad; Mansur, Rodrigo B; Li, Madeline; McAndrews, Mary Pat; Brietzke, Elisa; Woldeyohannes, Hanna O; Taylor, Valerie H; McIntyre, Roger S
2017-05-01
The objectives of the study were to determine if adjunctive minocycline mitigates depressive symptom severity and improves cognitive function in individuals with bipolar I/II disorder (BD). The study also aimed to determine if changes in depressive and/or cognitive symptoms over the course of treatment were associated with changes in circulating inflammatory cytokine levels. A total of 29 (intention-to-treat: n=27) adults meeting DSM-IV-TR criteria for a major depressive episode as part of bipolar I or II disorder (i.e. Hamilton Depression Rating Scale 17-item [HAMD-17] ≥20) were enrolled in an 8-week, open-label study with adjunctive minocycline (100 mg bid). The primary outcome measure was the Montgomery-Åsberg Depression Rating Scale (MADRS). The HAMD-17, Clinical Global Impression-Severity (CGI-S), cognitive test composite scores and plasma cytokines were secondary outcome measures. Plasma cytokines were measured with the 30 V-Plex Immunoassay from Meso Scale Discovery. Adjunctive minocycline was associated with a reduction in depressive symptom severity from baseline to week 8 on the MADRS (P<.001, d=0.835), HAMD-17 (P<.001, d=0.949) and CGI-S (P<.001, d=1.09). Improvement in psychomotor speed, but not verbal memory or executive function, was observed only amongst individuals exhibiting a reduction in depression severity (P=.007, d=0.826). Levels of interleukin (IL)-12/23p40 (P=.002) were increased, while levels of IL-12p70 (P=.001) and C-C motif chemokine ligand 26 (CCL26) (P<.001) were reduced from baseline to week 8. A reduction in CCL26 levels was associated with a less favourable treatment response (P<.001). Results from the pilot study suggest that adjunctive minocycline may exert antidepressant effects in individuals with bipolar depression, possibly by targeting inflammatory cytokines. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Current trends in antithyroid drug treatment of Graves' disease.
Okosieme, Onyebuchi E; Lazarus, John H
2016-10-01
Graves' hyperthyroidism is associated with significant morbidity and mortality risk. The thionamides, methimazole, its pro-drug derivative carbimazole, and propylthiouracil, remain a cornerstone of management. Yet despite decades of use, optimal strategies for maximising treatment response and curtailing adverse effect risk remains uncertain. We reviewed the current literature on the evidence based medical management of Graves' disease. Specifically, we evaluated current approaches to the use of thionamides, adjunctive therapies, and potential novel agents for controlling Graves' hyperthyroidism. Primary medical therapy is successful in less than 50% of cases and so careful selection of patients for medical treatment based on a combination of pathological and pragmatic considerations is essential. Carbimazole or methimazole is the treatment of choice in the non-pregnant population driven by its more favourable pharmacokinetic and adverse effect profile over propylthiouracil. In pregnancy the choice of treatment is less straightforward and an approach that minimises undue fetal exposure to all thionamides should be adopted. Additional data is needed on the value of adjunctive therapies including potassium perchlorate, iodides, glucocorticoids, lithium, and cholestyramine. Novel agents directed against pathogenetic targets including TSH receptor blocking monoclonal antibodies and small molecule antagonists may hold promise for the future.
[Efficiency of brimonidine 0.2% and dorzolamide 2% as adjunctive therapy to beta-blockers].
Carrasco Font, C; Arias Puente, A; García Sáenz, M C; Villarejo Díaz-Maroto, I
2004-04-01
To evaluate the clinical efficiency and tolerability of brimonidine and dorzolamide twice daily as an adjunctive therapy for glaucoma patients with an inadequate response to beta-blockers therapy. This multicenter prospective analysis included 92 patients (180 eyes) with primary open-angle glaucoma or ocular hypertension on therapy beta-blockers and with intraocular pressure (IOP) greater than or equal to 18mmHg. The patients were randomly treated either with brimonidine 0.2% or dorzolamide 2% added for three months. Efficiency was determined by the reduction in 15% IOP from baseline at the first and the third month. Mean pre-treatment IOP was 22.37 DE 2.8 mmHg in the brimonidine group and 22.38 DE 2.6 mmHg in the dorzolamide group; mean post-treatment IOP decrease was 4.39 mmHg in the brimonidine group and 3.29 mmHg in the dorzolamide group. Clinical control at the first month was achieved in 78.3% and 71% of cases respectively (p=0.05). No statistical differences existed between groups for systemic adverse events. Four patients on brimonidine discontinued treatment due to local side effects. In the dorzolamide group, two patients left the treatment referring itching and three others left due to ocular allergy. This study found similar efficiency and safety when treating with brimonidine or dorzolamide as an adjunctive therapy for patients with hypertension or primary open-angle glaucoma.
Memantine in the Treatment of Executive Function Deficits in Adults With ADHD.
Biederman, Joseph; Fried, Ronna; Tarko, Laura; Surman, Craig; Spencer, Thomas; Pope, Amanda; Grossman, Rebecca; McDermott, Katie; Woodworth, K Yvonne; Faraone, Stephen V
2017-02-01
To evaluate the efficacy and safety of memantine hydrochloride as an adjunct to stimulant pharmacotherapy for treating executive function deficits (EFDs) in adults with ADHD. This was a 12-week, double-blind, placebo-controlled, randomized clinical trial of memantine added to open-label treatment with stimulant medication. Because of the small sample size, we considered a standardized mean difference (equivalent to effect size) of ≥0.5 and odds ratios ≥2 as indicators of trend improvements. Twelve participants received memantine and 14 received a placebo. Trend improvements favoring memantine were observed on Behavior Rating Inventory of Executive Functions-Adult Inhibition and Self-Monitor subscales when compared with Placebo. No significant changes were noted on the Cambridge Neuropsychological Test Automated Battery. Among adults with ADHD and EFDs, adjunct treatment with memantine to osmotic release oral system-methylphenidate (OROS-MPH) was associated with improvements in selective areas of executive functioning, supporting the need for further research.
Enhancing Women's Lives: The Role of Support Groups among Breast Cancer Patients.
ERIC Educational Resources Information Center
Gore-Felton, Cheryl; Spiegel, David
1999-01-01
Reviews research indicating that group psychotherapy is an effective adjunctive therapy to medical treatment for women with breast cancer. States that Supportive-Expressive group therapy has been effective in assisting patients in reducing anxiety related to death and dying, strengthening interpersonal relationships, and improving the quality of…
Zhou, Tian-Hang; Dang, Wei-Min; Ma, Yan-Tao; Hu, Chang-Qing; Wang, Ning; Zhang, Guo-Yi; Wang, Gang; Shi, Chuan; Zhang, Hua; Guo, Bin; Zhou, Shu-Zhe; Feng, Lei; Geng, Shu-Xia; Tong, Yu-Zhen; Tang, Guan-Wen; He, Zhong-Kai; Zhen, Long; Yu, Xin
2018-02-01
Bright light therapy (BLT) is an effective treatment for seasonal affective disorder and non- seasonal depression. The efficacy of BLT in treating patients with bipolar disorder is still unknown. The aim of this study is to examine the efficacy, onset time and clinical safety of BLT in treating patients with acute bipolar depression as an adjunctive therapy (trial registration at ClinicalTrials.gov: NCT02009371). This was a multi-center, single blind, randomized clinical trial. Seventy-four participants were randomized in one of two treatment conditions: BLT and control (dim red light therapy, dRLT). Sixty-three participants completed the study (33 BLT, 30 dRLT). Light therapy lasted for two weeks, one hour every morning. All participants were required to complete several scales assessments at baseline, and at the end of weeks 1 and 2. The primary outcome measures were the clinical efficacy of BLT which was assessed by the reduction rate of HAMD-17 scores, and the onset time of BLT which was assessed by the reduction rate of QIDS-SR16 scores. The secondary outcome measures were rates of switch into hypomania or mania and adverse events. 1) Clinical efficacy: BLT showed a greater ameliorative effect on bipolar depression than the control, with response rates of 78.19% vs. 43.33% respectively (p < 0.01). 2) Onset day: Median onset day was 4.33 days in BLT group. 3) BLT-emergent hypomania: No participants experienced symptoms of hypomania. 4) Side effects: No serious adverse events were reported. BLT can be considered as an effective and safe adjunctive treatment for patients with acute bipolar depression. Copyright © 2017 Elsevier B.V. All rights reserved.
Toniolo, Ricardo Alexandre; Fernandes, Francy de Brito Ferreira; Silva, Michelle; Dias, Rodrigo da Silva; Lafer, Beny
2017-12-15
Depressive episodes and cognitive impairment are major causes of morbidity and dysfunction in individuals suffering from bipolar disorder (BD). Novel treatment approaches that target clinical and cognitive aspects of bipolar depression are needed, and research on pathophysiology suggests that mitochondrial modulators such as the nutraceutical creatine monohydrate might have a therapeutic role for this condition. Eighteen (N=18) patients with bipolar depression according to DSM-IV criteria who were enrollled in a 6-week, randomized, double-blind, placebo-controlled trial of creatine monohydrate 6g daily as adjunctive therapy were submitted to neuropsychological assessments (Wisconsin Card Sorting Test, Digit Span subtest of the Wechsler Adult Intelligence Scale-Third Edition, Stroop Color-Word Test, Rey-Osterrieth complex figure test, FAS Verbal Fluency Test) at baseline and week 6. There was a statistically significant difference between the treatment groups of the change on the total scores after 6 weeks in the verbal fluency test, with improvement in the group receiving adjunctive treatment with creatine. We did not find significant differences between the groups of the changes on other neuropsychological tests. Small sample and lack of a control group of healthy subjects. Our trial, which was the first to investigate the cognitive effects of creatine monohydrate on bipolar depression, indicates that supplementation with this nutraceutical for 6 weeks is associated with improvement in verbal fluency tests in patients with this condition. Copyright © 2016 Elsevier B.V. All rights reserved.
Shorvon, S D; Trinka, E; Steinhoff, B J; Holtkamp, M; Villanueva, V; Peltola, J; Ben-Menachem, E
2017-03-01
Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug that is approved as adjunctive therapy in adults with focal-onset seizures. Following oral administration, ESL is rapidly metabolized to its active metabolite, eslicarbazepine, which acts primarily by enhancing slow inactivation of voltage-gated sodium channels. The efficacy and safety/tolerability of ESL in the adjunctive setting were established in a comprehensive Phase III program (n = 1702 randomized patients) and this evidence has been supported by several open studies (n = 864). ESL treatment has demonstrated improvements in health-related quality of life, in both randomized clinical trials and open studies. ESL has also been shown to be usually well tolerated and efficacious when used in the adjunctive setting in elderly patients. The effectiveness of ESL as the only add-on to antiepileptic drug monotherapy has been demonstrated in a multinational study (n = 219), subgroup analyses of which have also shown it to be efficacious and generally well tolerated in patients who had previously not responded to carbamazepine therapy. Open studies have also demonstrated improvements in tolerability in patients switched overnight from oxcarbazepine to ESL. Due to differences in pharmacokinetics, pharmacodynamics, and metabolism, there may be clinical situations in which it is appropriate to consider switching patients from oxcarbazepine or carbamazepine to ESL.
Karr, Jeffrey C
2017-11-01
A percutaneous antibiotic delivery technique (PAD-T) used for the adjunctive management of osteomyelitis is presented. This surgical technique incorporates a calcium sulfate and hydroxyapatite (calcium phosphate) bone void filler acting as a carrier vehicle with either an antibiotic or an antifungal medicine, delivering this combination directly into the area of osteomyelitis. The benefit of the PAD-T is reviewed with a case presentation of a successfully treated calcaneal osteomyelitis. No previously reported PAD-T using a simple bone cortex incision in the adjunctive treatment of osteomyelitis has been reported. The PAD-T safely and effectively uses a calcium sulfate and hydroxyapatite bone void filler carrier vehicle to deliver either an antibiotic or an antifungal medicine directly into the area of osteomyelitis.
Dialectical Behavior Therapy Group Skills Training for Bipolar Disorder.
Eisner, Lori; Eddie, David; Harley, Rebecca; Jacobo, Michelle; Nierenberg, Andrew A; Deckersbach, Thilo
2017-07-01
There is growing evidence that the capacity for emotion regulation is compromised in individuals with bipolar disorder. Dialectical behavior therapy (DBT), an empirically supported treatment that specifically targets emotion dysregulation, may be an effective adjunct treatment for improving emotion regulation and residual mood symptoms in patients with bipolar disorder. In this open, proof-of-concept pilot study, 37 participants engaged in a 12-week DBT group skills training program, learning mindfulness, emotion regulation, and distress tolerance skills. Repeated measures mixed models revealed skill acquisition in the areas of mindfulness, emotion regulation and distress tolerance, as well as improved psychological well-being and decreased emotion reactivity. The results of this study support a burgeoning literature that DBT is a feasible adjunct intervention for patients with bipolar disorder. Copyright © 2017. Published by Elsevier Ltd.
ERIC Educational Resources Information Center
Chang, Kiki; Saxena, Kirti; Howe, Meghan
2006-01-01
Objective: The treatment of pediatric bipolar depression has not been well studied. The authors wished to prospectively study the efficacy of lamotrigine as adjunctive or monotherapy in adolescents with bipolar disorder who were experiencing a depressive episode. Method: This was an 8-week open-label trial of lamotrigine with 20 adolescents ages…
Williams, David M; Ussher, Michael; Dunsiger, Shira; Miranda, Robert; Gwaltney, Chad J; Monti, Peter M; Emerson, Jessica
2014-01-01
Aerobic exercise has been proposed as a stand-alone or adjunct smoking cessation treatment, but findings have been mixed. Laboratory studies have shown that individual exercise sessions lead to decreases in withdrawal symptoms and cigarette cravings, but findings are limited by lack of follow-up and artificial settings. On the other hand, smoking cessation treatment RCTs have generally failed to show positive effects of exercise on smoking cessation, but have been plagued by poor and/or unverified compliance with exercise programs. This paper describes the rationale and design for Quit for Health (QFH)--an RCT designed to determine the efficacy of aerobic exercise as an adjunct smoking cessation treatment among women. To overcome limitations of previous research, compliance with the exercise (and wellness contact control) program is incentivized and directly observed, and ecological momentary assessment is used to examine change over time in withdrawal symptoms and cigarette cravings in participants' natural environments. Copyright © 2013 Elsevier Inc. All rights reserved.
Williams, David M.; Ussher, Michael; Dunsiger, Shira; Miranda, Robert; Gwaltney, Chad J.; Monti, Peter M.; Emerson, Jessica
2013-01-01
Aerobic exercise has been proposed as a stand-alone or adjunct smoking cessation treatment, but findings have been mixed. Laboratory studies have shown that individual exercise sessions lead to decreases in withdrawal symptoms and cigarette cravings, but findings are limited by lack of follow-up and artificial settings. On the other hand, smoking cessation treatment RCTs have generally failed to show positive effects of exercise on smoking cessation, but have been plagued by poor and/or unverified compliance with exercise programs. This paper describes the rationale and design for Quit for Health (QFH)—an RCT designed to determine the efficacy of aerobic exercise as an adjunct smoking cessation treatment among women. To overcome limitations of previous research, compliance with the exercise (and wellness contact control) program is incentivized and directly observed, and ecological momentary assessment is used to examine change over time in withdrawal symptoms and cigarette cravings in participants’ natural environments. PMID:24246818
Brewerton, Timothy D; D'Agostino, Meredith
2017-12-01
There is little information about the pharmacological treatment of avoidant and restrictive food intake disorder (ARFID), a challenging feeding disorder associated with marked impairment and developmental arrest. This brief clinical report seeks to fill this gap. A retrospective chart review of nine patients with ARFID treated in an eating disorder (ED) program (residential, partial hospital, and intensive outpatient levels of care) with adjunctive olanzapine was undertaken. The mean initial and final olanzapine doses were 0.9 + 0.63 mg/day and 2.8 + 1.47 mg/day, respectively. There was a statistically significant difference in weight gain pre- versus post-olanzapine treatment (3.3 ± 7.3 lbs vs. 13.1 ± 7.9 lbs [2.99 ± 6.62 lb SI vs. 11.88 ± 7.17 lb SI], paired t-test (p < 0.04, t = -2.48). Clinically, adjunctive olanzapine was helpful for not only weight gain but also reduction of associated anxious, depressive, and cognitive symptoms. Clinical Global Impressions scale scores indicated marked improvement in patients receiving adjunctive olanzapine. These cases illustrate that judicious use of low-dose olanzapine, when used as an adjunct to other treatment modalities, may facilitate eating, weight gain, and the reduction of anxious, depressive, and cognitive symptoms in ARFID patients. Future randomized, placebo-controlled studies in ARFID are warranted.
Schorr, Ethlynn S; Sidou, Farzi; Kerrouche, Nabil
2012-09-01
To assess the benefit of adjunctive use of a SPF 30 moisturizing lotion in reducing local side effects associated with atopical tretinoin cream. This was a randomized, investigator/evaluator-blinded, split-face comparison in subjects with healthy skin. Subjects applied tretinoin cream 0.05% once daily to the whole face and Cetaphil 174; Dermacontrol Moisturizer (CDM) once daily to one side of the face based on randomization. Tolerability, perference and skin hydration were evaluated at each week, and a cosmetic acceptability questionnaire regarding CDM was completed at the end of the study. The majority (about 83% to 86%) of subjects experienced skin irritations on both sides of their face, though predominantly mild for the CDM + tretinoin treated side. Tolerability preferences favored the CDM+tretinoin sides. Adjunctive use of CDM with a topical tretinoin cream improves tolerance of the treatment.
Adjunctive hyperbaric oxygen for necrotizing fasciitis.
Levett, Denny; Bennett, Michael H; Millar, Ian
2015-01-15
Hyperbaric oxygen therapy (HBOT) involves the therapeutic administration of 100% oxygen in a pressure chamber at pressures above one atmosphere absolute. This therapy has been used as an adjunct to surgery and antibiotics in the treatment of patients with necrotizing fasciitis with the aim of reducing morbidity and mortality. To review the evidence concerning the use of HBOT as an adjunctive treatment for patients with necrotizing fasciitis (NF). Specifically, we wish to address the following questions.1. Does administration of HBOT reduce mortality or morbidity associated with NF?2. What adverse effects are associated with use of HBOT in the treatment of individuals with NF? We searched the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid (1966 to September 2014); the Cumulative Index to Nursing and Allied Health Literature (CINAHL) Ovid (1982 to September 2014); EMBASE Ovid (1980 to September 2014); and the Database of Randomised Controlled Trials in Hyperbaric Medicine (DORCTHIM, M Bennett) (from inception to September 2014). In addition, we performed a systematic search of specific hyperbaric literature sources. This included handsearching of relevant hyperbaric textbooks; hyperbaric journals (Hyperbaric Medicine Review, South Pacific Underwater Medicine Society Journal, European Journal of Underwater and Hyperbaric Medicine, Aviation Space and Environmental Medicine Journal); and conference proceedings of the major hyperbaric societies (Undersea and Hyperbaric Medical Society, South Pacific Underwater Medicine Society, European Underwater and Baromedical Society, International Congress of Hyperbaric Medicine). We included all randomized and pseudo-randomized trials (trials in which an attempt at randomization has been made but the method was inappropriate, for example, alternate allocation) that compared the effects of HBOT with the effects of no HBOT (no treatment or sham) in the treatment of children and adults with necrotizing fasciitis. We planned independent data collection by two review authors using standardized forms. We found no trials that met the inclusion criteria. This systematic review failed to locate relevant clinical evidence to support or refute the effectiveness of HBOT in the management of necrotizing fasciitis. Good quality clinical trials are needed to define the role, if any, of HBOT in the treatment of individuals with necrotizing fasciitis.
Na, Kyoung-Sae; Lee, Kang Joon; Lee, Ji Sung; Cho, Young Sung; Jung, Han-Yong
2014-01-03
Numerous studies have reported that inflammation is closely associated with depression, and adjunctive non-steroidal anti-inflammatory drug (NSAID) treatment has been suggested as a novel therapeutic approach for depression. We searched electronic databases including Medline, Embase, and the Cochrane Central Register of Controlled Trials. We only included randomized controlled trials comparing adjunctive NSAIDs with placebos for treating depressive episodes. Of the 654 retrieved entries, we identified four relevant studies with a total of 150 patients (75 NSAID patients and 75 placebo patients) with depressive episodes. All four studies used celecoxib as the NSAID. The patients receiving adjunctive celecoxib had significantly higher mean changes in the Hamilton Rating Scale for Depression scores between baseline and endpoint measurements compared with those receiving placebo (weighted mean difference=3.26, 95% confidence interval; CI=1.81 to 4.71). The adjunctive celecoxib group also showed better remission (odds ratio; OR=6.58, 95% CI=2.55 to 17.00) and response rates (OR=6.49, 95% CI=2.89 to 14.55) than the placebo group. The all-cause drop-out rate was more favorable for the celecoxib group than for the placebo group (OR=0.45, 95% CI=0.18 to 1.13), although the statistical significance was not statistically significant (p=0.09). Adjunctive treatment with NSAIDs, particularly celecoxib, can be a promising strategy for patients with depressive disorder. Future studies with a larger sample size and longer study duration are needed to confirm the efficacy and tolerability of NSAIDs for depression. © 2013.
Utility of Adjunctive Procedures With Balloon Dilation of the Eustachian Tube
Ashry, Yehia; Kawai, Kosuke
2017-01-01
Objective To assess the role and effect of concomitant adjunctive procedures when combined with balloon dilation of the Eustachian tube (BDET), including a new technique for treating obstructive disease within the bony Eustachian tube (ET). Study Design Retrospective case series. Setting Tertiary medical center. Subjects Adults with persistent (≥2 years): 1) OME or non‐fixed TM retraction AND type B or C tympanogram OR 2) Consistent symptoms of barochallenge with flights or diving, all despite medical treatment for ≥6 weeks. Methods Balloon dilation of the cartilaginous ET (BDET) was performed under general anesthesia using concomitant myringotomy with or without tube placement if indicated. Adjunctive turbinectomy, adenoidectomy, and/or tympanoplasty were used in selected cases. For suspected disease in the bony ET, an illuminated guidewire was used for probing and clearing the lumen. Outcome measures were tympanogram, otomicroscopy, ET mucosal inflammation score, Valsalva maneuver, and PTA audiometry. Results 67 ETs (48 patients) underwent BDET: 1) 30/67 balloon w/wo myringotomy, w/wo tube, 2) 20/67 plus adjunctive procedure or 3) 17/67 plus guidewire. Follow‐up was ranging from 0.4 to 3.4 years (mean 1.3 year, SD = 0.7). Significant improvement occurred in 79%. There was no significant difference in the failure rate comparing balloon dilation with adjunctive procedures 5/20 (25%) or without adjunctive procedures; 4/30 p = 0.45 (13%). Failure rate for BDET plus guide wire was 5/17 (29%) and resistance within the bony ET occurred in 8/17 (47%). Conclusion Balloon dilation of the cartilaginous ET demonstrated significant improvement despite expansion of indications that necessitated the addition of adjunctive procedures. Level of Evidence 4 PMID:29299505
Cognitive behavioral therapy for schizophrenia: an empirical review.
Rector, Neil A; Beck, Aaron T
2012-10-01
Early case studies and noncontrolled trial studies focusing on the treatment of delusions and hallucinations have laid the foundation for more recent developments in comprehensive cognitive behavioral therapy (CBT) interventions for schizophrenia. Seven randomized, controlled trial studies testing the efficacy of CBT for schizophrenia were identified by electronic search (MEDLINE and PsychInfo) and by personal correspondence. After a review of these studies, effect size (ES) estimates were computed to determine the statistical magnitude of clinical change in CBT and control treatment conditions. CBT has been shown to produce large clinical effects on measures of positive and negative symptoms of schizophrenia. Patients receiving routine care and adjunctive CBT have experienced additional benefits above and beyond the gains achieved with routine care and adjunctive supportive therapy. These results reveal promise for the role of CBT in the treatment of schizophrenia although additional research is required to test its efficacy, long-term durability, and impact on relapse rates and quality of life. Clinical refinements are needed also to help those who show only minimal benefit with the intervention.
Mycophenolate Mofetil for the Treatment of Multiple Sclerosis-associated Uveitis.
Hedayatfar, Alireza; Falavarjani, Khalil Ghasemi; Soheilian, Masoud; Elmi Sadr, Navid; Modarres, Mehdi; Parvaresh, Mohammad Mehdi; Naseripour, Masood; Rohani, Mohammad; Almasi, Mostafa; Chee, Soon-Phaik
2017-06-01
To report the efficacy of mycophenolate mofetil (MMF) as adjunctive therapy for the treatment of multiple sclerosis (MS)-associated uveitis. In this retrospective, interventional case series, patients with MS-associated uveitis who were treated by MMF as an adjunct therapy to systemic corticosteroid were studied. Patients' demographics, clinical course, response to treatment, and complications were assessed. A total of 30 eyes of 15 patients with a mean age of 34.5 ± 8.3 years were studied. In three patients (20%), onset of uveitis preceded the diagnosis of MS. The course of MS was relapsing-remitting in 11 patients (73.3%) and secondary progressive in four patients (26.7%). At 1 year after institution of MMF, all the patients were on oral prednisolone ≤ 7.5 mg/day, all eyes were quiet without macular edema, and 53.3% of eyes gained visual improvement. Supplemental periocular and intraocular injections were needed during the first 6 months after starting MMF therapy. The systemic adverse effects were transient and minor in severity. MMF had beneficial effects on vision and intraocular inflammation with an acceptable safety profile.
Short-course oral steroids as an adjunct therapy for chronic rhinosinusitis.
Head, Karen; Chong, Lee Yee; Hopkins, Claire; Philpott, Carl; Schilder, Anne G M; Burton, Martin J
2016-04-26
This review is one of a suite of six Cochrane reviews looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is a common condition involving inflammation of the lining of the nose and paranasal sinuses. It is characterised by nasal blockage and nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Oral corticosteroids are used to control the inflammatory response and improve symptoms. To assess the effects of a short course of oral corticosteroids as an adjunct ('add-on') therapy in people with chronic rhinosinusitis who are already on standard treatments. The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 7); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015. Randomised controlled trials (RCTs) comparing a short course (up to 21 days) of oral corticosteroids to placebo or no treatment, where all patients were also receiving pharmacological treatment for chronic rhinosinusitis. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity, and the adverse event of mood or behavioural disturbances. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score, and the adverse events of insomnia, gastrointestinal disturbances and osteoporosis. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. Two trials with a total of 78 participants met the inclusion criteria. Both the populations and the 'standard' treatments differed in the two studies. Oral steroids as an adjunct to intranasal corticosteroids One trial in adults with nasal polyps included 30 participants. All participants used intranasal corticosteroids and were randomised to either short-course oral steroids (oral methylprednisolone, 1 mg/kg and reduced progressively over a 21-day treatment course) or no additional treatment. None of the primary outcome measures of interest in this review were reported by the study. There may have been an important reduction in the size of the polyps (measured by the nasal polyps score, a secondary outcome measure) in patients receiving oral steroids and intranasal corticosteroids, compared to intranasal corticosteroids alone (mean difference (MD) -0.46, 95% confidence interval (CI) -0.87 to -0.05; 30 participants; scale 1 to 4) at the end of treatment (21 days). This corresponds to a large effect size, but we are very uncertain about this estimate as we judged the study to be at high risk of bias. Moreover, longer-term data were not available and the other outcomes of interest were not reported. Oral steroids as an adjunct to antibiotics One trial in children (mean age of eight years) without nasal polyps included 48 participants. The trial compared oral corticosteroids (oral methylprednisolone, 1 mg/kg and reduced progressively over a 15-day treatment course) with placebo in participants who also received a 30-day course of antibiotics. This study addressed one of the primary outcome measures (disease severity) and one secondary outcome (CT score). For disease severity the four key symptoms used to define chronic rhinosinusitis in children (nasal blockage, nasal discharge, facial pressure, cough) were combined into one score. There was a greater improvement in symptom severity 30 days after the start of treatment in patients who received oral steroids and antibiotics compared with placebo and antibiotics (MD -7.10, 95% CI -9.59 to -4.61; 45 participants; scale 0 to 40). The observed mean difference corresponds to a large effect size. At the same time point there was a difference in CT scan score (MD -2.90, 95% CI -4.91 to -0.89; 45 participants; scale 0 to 24). We assessed the quality of the evidence to be low.There were no data available for the longer term (three months). There might be an improvement in symptom severity, polyps size and condition of the sinuses when assessed using CT scans in patients taking oral corticosteroids when these are used as an adjunct therapy to antibiotics or intranasal corticosteroids, but the quality of the evidence supporting this is low or very low (we are uncertain about the effect estimate; the true effect may be substantially different from the estimate of the effect). It is unclear whether the benefits of oral corticosteroids as an adjunct therapy are sustained beyond the short follow-up period reported (up to 30 days), as no longer-term data were available.There were no data in this review about the adverse effects associated with short courses of oral corticosteroids as an adjunct therapy.More research in this area, particularly research evaluating longer-term outcomes and adverse effects, is required.
Lo, Jessica W; Bunce, Catey; Charteris, David; Banerjee, Philip; Phillips, Rachel; Cornelius, Victoria R
2016-08-02
Open globe ocular trauma complicated by intraocular scarring (proliferative vitreoretinopathy) is a relatively rare, blinding, but potentially treatable condition for which, at present, surgery is often unsatisfactory and visual results frequently poor. To date, no pharmacological adjuncts to surgery have been proven to be effective. The aim of the Adjunctive Steroid Combination in Ocular Trauma (ASCOT) randomised controlled trial is to determine whether adjunctive steroid (triamcinolone acetonide), given at the time of surgery, can improve the outcome of vitreoretinal surgery in patients with open globe ocular trauma. This article presents the statistical analysis plan for the main publication as approved and signed off by the Trial Steering Committee prior to the first data extraction for the Data Monitoring Committee meeting report. ASCOT is a pragmatic, multi-centre, parallel-group, double-masked randomised controlled trial. The aim of the study is to recruit from 20-25 centres in the United Kingdom and randomise 300 eyes (from 300 patients) into two treatment arms. Both groups will receive standard surgical treatment and care; the intervention arm will additionally receive a pre-operative steroid combination (triamcinolone acetonide) into the vitreous cavity consisting of 4 mg/0.1 ml and 40 mg/1 ml sub-Tenon's. Participants will be followed for 6 months post-surgery. The primary outcome is the proportion of patients achieving a clinically meaning improvement in visual acuity in the study eye at 6 months after initial surgery, defined as a 10 letter score improvement in the ETDRS (the standard scale to test visual acuity). ISRCTN30012492 . Registered on 5 September 2014. EudraCT2014-002193-37 . Registered on 5 September 2014.
Lancman, Marcelo E; Fertig, Evan J; Trobliger, Robert W; Perrine, Kenneth; Myers, Lorna; Iyengar, Sloka S; Malik, Munazza
2016-08-01
The objective of this study was to examine cognitive and quality-of-life measures/quality of life outcomes with adjunctive lacosamide therapy in patients with treatment-resistant partial epilepsy. This was a prospective, open-label, nonblinded, adjunctive therapy test-retest (within subjects) study of patients with treatment-resistant partial epilepsy in which outcome (cognitive functioning and mood/quality of life) was measured in the same subject before and after adjunctive lacosamide administration for 24weeks. The cognitive assessment included the following: Controlled Oral Word Association Test, Buschke Selective Reminding Test, Brief Visuospatial Memory Test-Revised, Stroop Color Word Test, Symbol Digit Modalities Test, Digit Span, Digit Cancellation, and Trails A and B. The quality-of-life measures/quality-of-life assessment included the following: Beck Depression Inventory-II, Profile of Mood States, and Quality of Life Inventory-89. Lacosamide was started at 100mg (50mg twice daily) and could be titrated as needed up to 400mg/day (200mg twice daily). Baseline concomitant AEDs were kept constant. Composite scores were calculated for a pre-post difference score for the cognitive and mood/quality-of-life measures separately and used in regression analyses to correct for the effects of age, education, seizure frequency, seizure severity, dose of lacosamide, and number of AEDs at baseline. Thirty-four patients were enrolled (13 males, 21 females). Mean age was 38.8±2.43years. Mean seizure frequency decreased significantly from 2.0±2.55 seizures per week at baseline to 1.02±1.72 seizures per week at posttreatment (t=4.59, p<.0001) with a 50% responder rate seen in 18 patients (52.9%). No significant differences were found on the composite scores of the cognitive or the mood/quality-of-life measures after 6months of lacosamide. Lacosamide appeared to have low risks of significant changes in cognition or mood/quality of life. In addition, the present study supports prior studies that have proven lacosamide as an effective adjunctive therapy for the treatment of resistant partial epilepsy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
Shorey, Ryan C; Elmquist, Joanna; Gawrysiak, Michael J; Strauss, Catherine; Haynes, Ellen; Anderson, Scott; Stuart, Gregory L
2017-09-19
Substance use disorders are understood as a chronically relapsing condition that is difficult to treat. However, in recent years there have been promising developments in the treatment of substance use disorders, specifically with interventions based on mindfulness and acceptance and commitment therapy. Little research has examined whether these types of interventions may positively impact residential substance use treatment outcomes. Thus, in the current study we developed and examined, in a randomized controlled trial, a 4-week, eight-session, adjunctive mindfulness and acceptance group therapy for patients in residential substance use treatment. Our primary outcomes were substance use cravings, psychological flexibility, and dispositional mindfulness at treatment discharge. Patients (N = 117) from a private residential substance use facility were randomized to receive the adjunctive mindfulness and acceptance group or treatment-as-usual. Patients were assessed at treatment intake and at discharge from a 28-30-day residential program. Although treatment groups did not statistically differ at discharge on any primary outcome, small effect sizes favored the mindfulness and acceptance group on cravings and psychological flexibility. Conclusions/Importance: Continued research is needed to determine whether the addition of mindfulness and acceptance-based interventions improve outcomes long term following residential substance use treatment.
Karmazyn, Morris; Gan, Xiaohong Tracey
2017-10-01
Heart failure is a major medical and economic burden throughout the world. Although various treatment options are available to treat heart failure, death rates in both men and women remain high. Potential adjunctive therapies may lie with use of herbal medications, many of which possess potent pharmacological properties. Among the most widely studied is ginseng, a member of the genus Panax that is grown in many parts of the world and that has been used as a medical treatment for a variety of conditions for thousands of years, particularly in Asian societies. There are a number of ginseng species, each possessing distinct pharmacological effects due primarily to differences in their bioactive components including saponin ginsenosides and polysaccharides. While experimental evidence for salutary effects of ginseng on heart failure is robust, clinical evidence is less so, primarily due to a paucity of large-scale well-controlled clinical trials. However, there is evidence from small trials that ginseng-containing Chinese medications such as Shenmai can offer benefit when administered as adjunctive therapy to heart failure patients. Substantial additional studies are required, particularly in the clinical arena, to provide evidence for a favourable effect of ginseng in heart failure patients.
Safinamide in the treatment of Parkinson's disease.
Schapira, Anthony H V
2010-09-01
Current therapy for Parkinson's disease (PD) is primarily directed at reversing the motor symptoms that are the consequence of dopamine deficiency and includes levodopa, dopamine agonists and monoamine oxidase (MAO) B inhibitors. New drugs offering both dopaminergic and non-dopaminergic actions could offer a significant advantage. This review surveys the current treatment strategies for PD. Defining unmet needs and how a new compound - safinamide, which has both dopaminergic and non-dopaminergic actions - might address these. The reader will gain an understanding of safinamide and its mechanisms of action, including reversible MAOB inhibition and reduced dopamine reuptake with antiglutamatergic effects, and how it may potentially provide improvement of PD motor symptoms with an antidyskinetic effect through its effect on glutamate release. The clinical trial profile of safinamide is reviewed. Early results are promising in terms of improved motor function and reduced 'OFF' time. Additional Phase III trials are now in progress for this adjunctive indication. Finally, the reader will understand the potential role for safinamide in the selection and sequencing of drugs for PD. safinamide combines both dopaminergic and non-dopaminergic actions that may add a new dimension to PD treatment options as an adjunct to current drugs. Its efficacy is under active evaluation in Phase III clinical trials.
Dahan-Oliel, Noémi; Kasaai, Bahar; Montpetit, Kathleen; Hamdy, Reggie
2012-01-01
Children with musculoskeletal conditions experience muscle weakness, difficulty walking and limitations in physical activities. Standard treatment includes physiotherapy, casting, and surgery. The use of botulinum toxins appears as a promising treatment on its own, but usually as an adjunct to other treatment modalities and as an alternative to surgery. The objectives were to establish the evidence on the effectiveness, safety and functional outcome of BTX-A in children with musculoskeletal conditions. A literature search using five electronic databases identified 24 studies that met our inclusion criteria. Two randomized clinical trials were included; most studies were case studies with small sample sizes and no control group. Improvements in gait pattern, function, range of motion, reduction of co-contractions, and avoidance of surgical procedures were found following BTX-A injections. Adverse events were not reported in 10 studies, minor adverse events were reported in 13 children and there were no severe adverse events. Additional doses appear safe. BTX-A is a promising treatment adjunct in improving functional outcomes in children with musculoskeletal conditions. Future studies including larger samples, longer follow-up periods and a comparison group are required to provide evidence on the effectiveness and safety of this drug in children with musculoskeletal conditions. PMID:22548088
Breen, Annamarie; Blankley, Kory; Fine, Julie
2017-02-01
Nightmares associated with posttraumatic stress disorder (PTSD) are a hallmark symptom among U.S. military veterans who have seen combat. Management of combat-related nightmares can be difficult and current pharmacologic options are limited and tend to have adverse side effects. The aim of this review is to explore recent literature regarding the efficacy of prazosin for the treatment of nightmare disorder in the veteran population. Recent literature consisting of three systematic reviews was reviewed, as well as current clinical guidelines published by The Department of Veterans Affairs (VA) and The Department of Defense (DoD) and the American Academy of Sleep Medicine (AASM). Prazosin has been shown to be effective in the treatment of PTSD trauma-related nightmares. As a result of its low side effect profile and abilities to improve both sleep and reduce trauma nightmares, prazosin has been recommended as an adjunct therapy. Prazosin should be initiated as an adjunctive treatment to promote sleep in those suffering from PTSD nightmares. It should be initiated at 1 mg and then titrated upward until absence or desired reduction of nightmares is achieved, with a maximum dosage recommendation of 20 mg at bedtime and 5 mg midmorning. ©2016 American Association of Nurse Practitioners.
Williams, David M; Whiteley, Jessica A; Dunsiger, Shira; Jennings, Ernestine G; Albrecht, Anna E; Ussher, Michael H; Ciccolo, Joseph T; Parisi, Alfred F; Marcus, Bess H
2010-06-01
Previous randomized controlled trials have not supported moderate intensity exercise as an efficacious adjunct to smoking cessation treatments for women; however, compliance with exercise programs in these studies has been poor. The purpose of this pilot study was to estimate the effects of moderate intensity exercise on smoking cessation outcomes under optimal conditions for exercise program compliance. Sixty previously sedentary, healthy, female smokers were randomized to an 8-week program consisting of brief baseline smoking cessation counseling and the nicotine patch plus either 150 min/week of moderate intensity exercise or contact control. Participants attended a median of 86.4% and 95.5% of prescribed exercise/control sessions, respectively. There was a moderate, though statistically nonsignificant, effect of exercise at post-treatment for objectively verified 7-day point prevalence abstinence (48.3% vs. 23.3%; OR = 3.07, 95% CI: 0.89-11.07) and prolonged abstinence (34.5% vs. 20.0%; OR = 2.11, 95% CI: 0.56-8.32). Effects were attenuated when controlling for potential confounders, and after a 1-month, no-treatment period. The findings provide a preliminary indication that, given adequate compliance, moderate intensity exercise may enhance short-term smoking cessation outcomes for women; however, a larger trial is warranted. (PsycINFO Database Record (c) 2010 APA, all rights reserved).
Trevithick, Liam; McAllister-Williams, R Hamish; Blamire, Andrew; Branton, Tim; Clark, Ross; Downey, Darragh; Dunn, Graham; Easton, Andrew; Elliott, Rebecca; Ellwell, Clare; Hayden, Katherine; Holland, Fiona; Karim, Salman; Lowe, Jo; Loo, Colleen; Nair, Rajesh; Oakley, Timothy; Prakash, Antony; Sharma, Parveen K; Williams, Stephen R; Anderson, Ian M
2015-10-21
There is a robust empirical evidence base supporting the acute efficacy of electroconvulsive therapy (ECT) for severe and treatment resistant depression. However, a major limitation, probably contributing to its declining use, is that ECT is associated with impairment in cognition, notably in anterograde and retrograde memory and executive function. Preclinical and preliminary human data suggests that ketamine, used either as the sole anaesthetic agent or in addition to other anaesthetics, may reduce or prevent cognitive impairment following ECT. A putative hypothesis is that ketamine, through antagonising glutamate receptors, protects from excess excitatory neurotransmitter stimulation during ECT. The primary aim of the ketamine-ECT study is to investigate whether adjunctive ketamine can attenuate the cognitive impairment caused by ECT. Its secondary aim is to examine if ketamine increases the speed of clinical improvement with ECT. The ketamine ECT study is a multi-site randomised, placebo-controlled, double blind trial. It was originally planned to recruit 160 moderately to severely depressed patients who had been clinically prescribed ECT. This recruitment target was subsequently revised to 100 patients due to recruitment difficulties. Patients will be randomly allocated on a 1:1 basis to receive either adjunctive ketamine or saline in addition to standard anaesthesia for ECT. The primary neuropsychological outcome measure is anterograde verbal memory (Hopkins Verbal Learning Test-Revised delayed recall task) after 4 ECT treatments. Secondary cognitive outcomes include verbal fluency, autobiographical memory, visuospatial memory and digit span. Efficacy is assessed using observer and self-report efficacy measures of depressive symptomatology. The effects of ECT and ketamine on cortical activity during cognitive tasks will be studied in a sub-sample using functional near-infrared spectroscopy (fNIRS). The ketamine-ECT study aims to establish whether or not adjunctive ketamine used together with standard anaesthesia for ECT will significantly reduce the adverse cognitive effects observed after ECT. Potential efficacy benefits of increased speed of symptom improvement and a reduction in the number of ECT treatments required will also be assessed, as will safety and tolerability of adjunctive ketamine. This study will provide important evidence as to whether adjunctive ketamine is routinely indicated for ECT given for depression in routine NHS clinical practice. Current Controlled Trials: ISRCTN14689382 (assigned 30/07/2012); EudraCT Number: 2011-005476-41.
Hypnosis for treatment of pain in children
Rogovik, Alex L.; Goldman, Ran D.
2007-01-01
QUESTION Many children suffer from chronic and painful illnesses. Hypnosis was found to be effective for analgesia in adults. Is it effective for managing pain in children? ANSWER Children can be easier to hypnotize than adults. Studies have shown clinical hypnosis and self-hypnosis to be effective as adjunct treatments for children in pain. Examples include painful medical procedures, such as bone marrow aspiration and lumbar puncture in pediatric cancer patients, postoperative pain and anxiety in children undergoing surgery, and chronic headache. PMID:17872743
Lee, Yongeun; Kang, Seungbum; Park, Young-Hoon
2013-02-01
To evaluate the effect of adjunctive subtenon injection of triamcinolone acetonide (TA) in gas-filled eyes after vitrectomy for complicated proliferative diabetic retinopathy (PDR). This nonrandomized comparative study included 27 patients (27 eyes) who underwent pars plana vitrectomy and gas tamponade for treatment of PDR with tractional or combined tractional-rhegmatogenous retinal detachment and who received subtenon injection of TA (40 mg) at the end of surgery. The study group was compared with the control group (29 eyes), which was matched with the study group for preoperative and intraoperative parameters, but underwent pars plana vitrectomy and gas tamponade without a subtenon injection of TA. Retinal reattachments without reoperation were achieved in 25 eyes (92.6%) and 26 eyes (89.7%) at 6 months (p = 1.000) in the study and control groups, respectively. The study group and the control group did not differ significantly in the frequency of postoperative proliferative vitreoretinopathy, retinal redetachment rate, reoperation rate, macular pucker formation, postoperative vitreous hemorrhage, gain in visual acuity, intraocular pressure, and intraocular inflammation (p > 0.05). The clinical results of pars plana vitrectomy for complicated PDR are not improved significantly by an adjunctive subtenon TA injection in gas-filled eyes.
High-Dose Vitamin D3 during Tuberculosis Treatment in Mongolia. A Randomized Controlled Trial.
Ganmaa, Davaasambuu; Munkhzul, Baatar; Fawzi, Wafaie; Spiegelman, Donna; Willett, Walter C; Bayasgalan, Purev; Baasansuren, Erkhembayar; Buyankhishig, Burneebaatar; Oyun-Erdene, Sereeter; Jolliffe, David A; Xenakis, Theodoros; Bromage, Sabri; Bloom, Barry R; Martineau, Adrian R
2017-09-01
Existing trials of adjunctive vitamin D in the treatment of pulmonary tuberculosis (PTB) are variously limited by small sample sizes, inadequate dosing regimens, and high baseline vitamin D status among participants. Comprehensive analyses of the effects of genetic variation in the vitamin D pathway on response to vitamin D supplementation are lacking. To determine the effect of high-dose vitamin D 3 on response to antimicrobial therapy for PTB and to evaluate the influence of single-nucleotide polymorphisms (SNPs) in vitamin D pathway genes on response to adjunctive vitamin D 3 . We conducted a clinical trial in 390 adults with PTB in Ulaanbaatar, Mongolia, who were randomized to receive four biweekly doses of 3.5 mg (140,000 IU) vitamin D 3 (n = 190) or placebo (n = 200) during intensive-phase antituberculosis treatment. The intervention elevated 8-week serum 25-hydroxyvitamin D concentrations (154.5 nmol/L vs. 15.2 nmol/L in active vs. placebo arms, respectively; 95% confidence interval for difference, 125.9-154.7 nmol/L; P < 0.001) but did not influence time to sputum culture conversion overall (adjusted hazard ratio, 1.09; 95% confidence interval, 0.86-1.36; P = 0.48). Adjunctive vitamin D 3 accelerated sputum culture conversion in patients with one or more minor alleles for SNPs in genes encoding the vitamin D receptor (rs4334089, rs11568820) and 25-hydroxyvitamin D 1α-hydroxylase (CYP27B1: rs4646536) (adjusted hazard ratio ≥ 1.47; P for interaction ≤ 0.02). Vitamin D 3 did not influence time to sputum culture conversion in the study population overall. Effects of the intervention were modified by SNPs in VDR and CYP27B1. Clinical trial registered with www.clinicaltrials.gov (NCT01657656).
Stauffer, Virginia L; Liu, Peng; Goldberger, Celine; Marangell, Lauren B; Nelson, Craig; Gorwood, Philip; Fava, Maurizio
2017-03-01
To identify symptoms potentially representative of a noradrenergic symptom cluster as possible predictors of response to the selective norepinephrine reuptake inhibitor (NRI) edivoxetine when used as monotherapy or adjunctive treatment in patients with DSM-IV-TR major depressive disorder (MDD). Pooled data from 4 adjunctive treatment trials (selective serotonin reuptake inhibitor [SSRI] + edivoxetine 6-18 mg/d vs SSRI + placebo; N = 2,066) and data from 1 monotherapy trial (edivoxetine 6-18 mg/d versus placebo; N = 495) were used to identify predictors of response related to noradrenergic symptoms using a resampling-based ensemble tree method. The trials were conducted from 2008 to 2013. In the pooled adjunctive trials, no subgroup was identified that demonstrated a greater edivoxetine-placebo treatment difference than the overall patient cohort. In the edivoxetine monotherapy trial, no subgroup showing greater mean edivoxetine-placebo differences on the Montgomery-Asberg Depression Rating Scale versus the overall patient cohort was identified; a subgroup (67%) with high baseline Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) total score (≥ 28) showed statistically significantly (P = .02) greater mean edivoxetine-placebo differences on the Sheehan Disability Scale versus the overall patient cohort, and subgroups with baseline CPFQ total score ≥ 28 (65%), CPFQ cognition dimension score ≥ 16 (63%), or CPFQ physical dimension score ≥ 13 (59%) showed statistically significantly (P ≤ .025) greater mean edivoxetine-placebo differences on the CPFQ total score versus the overall patient cohort. While we could not identify symptoms predictive of response to the selective NRI edivoxetine used as adjunctive treatment, impaired cognition and physical symptoms may predict greater improvement during monotherapy. ClinicalTrials.gov identifiers: NCT00840034, NCT01173601, NCT01187407, NCT01185340, NCT00795821. © Copyright 2017 Physicians Postgraduate Press, Inc.
Lulic, Martina; Leiggener Görög, Isabelle; Salvi, Giovanni E; Ramseier, Christoph A; Mattheos, Nikolaos; Lang, Niklaus P
2009-08-01
Single photodynamic therapy (PDT) has been effective in initial periodontal therapy, but only improved bleeding on probing (BoP) in maintenance patients after a single use. Repeated PDT has not been addressed. To study the possible added benefits of repeated adjunctive PDT to conventional treatment of residual pockets in patients enrolled in periodontal maintenance. Ten maintenance patients with 70 residual pockets [probing pocket depth (PPD)>or=5 mm] were randomly assigned for treatment five times in 2 weeks (Days 0, 1, 2, 7, 14) with PDT (test) or non-activated laser (control) following debridement. The primary outcome variable was PPD, and the secondary variables were clinical attachment level (CAL) and BoP. These were assessed at 3, 6 and 12 months following the interventions. Greater PPD reductions were observed in the test (-0.67 +/- 0.34; p=0.01) compared with the control patients (-0.04 +/- 0.33; NS) after 6 months. Significant CAL gain (+0.52 +/- 0.31; p=0.01) was noted for the test, but not in the control (-0.27 +/- 0.52; NS) patients after 6 months. BoP percentages decreased significantly in test (97-64%, 67%, 77%), but not control patients after 3, 6 and 12 months. Repeated (five times) PDT adjunctive to debridement yielded improved clinical outcomes in residual pockets in maintenance patients. The effects were best documented after 6 months.
Nevile, Jessica C; Hurn, Simon D; Turner, Andrew G; McCowan, Christina
2015-05-01
To report three cases of canine corneal squamous cell carcinoma (SCC) treated with strontium 90 beta radiation as an adjunct to surgical excision. Corneal SCC was excised with lamellar keratectomy. This was followed by local application of strontium 90 beta radiation. Available case follow-up times range from 3 to 50 months. One case suffered a recurrence 5 months following initial excision and strontium 90 treatment. Strontium 90 beta radiation has been used extensively as an adjunctive treatment for equine corneal SCC and in other canine ocular tumors; however, there is a paucity of information regarding use in canine corneal SCC. The cases presented here suggest its use following keratectomy may be helpful in preventing disease recurrence. At the dosage used, severe adverse effects were not observed. © 2014 American College of Veterinary Ophthalmologists.
Jaggumantri, Sravan; Dunbar, Mary; Edgar, Vanessa; Mignone, Cristina; Newlove, Theresa; Elango, Rajavel; Collet, Jean Paul; Sargent, Michael; Stockler-Ipsiroglu, Sylvia; van Karnebeek, Clara D M
2015-10-01
Creatine transporter (SLC6A8) deficiency is an X-linked inborn error of metabolism characterized by cerebral creatine deficiency, behavioral problems, seizures, hypotonia, and intellectual developmental disability. A third of patients are amenable to treatment with high-dose oral creatine, glycine, and L-arginine supplementation. Given the limited treatment response, we initiated an open-label observational study to evaluate the effect of adjunct S-adenosyl methionine to further enhance intracerebral creatine synthesis. Significant and reproducible issues with sleep and behavior were noted in both male patients on a dose of 50/mg/kg. One of the two patients stopped S-adenosyl methionine and did not come for any follow-up. A safe and tolerable dose (17 mg/kg/day) was identified in the other patient. On magnetic resonance spectroscopy, this 8-year-old male did not show an increase in intracerebral creatine. However, significant improvement in speech/language skills, muscle mass were observed as well as in personal outcomes as defined by the family in activities related to communication and decision making. Further research is needed to assess the potential of S-adenosyl methionine as an adjunctive therapy for creatine transporter deficiency patients and to define the optimal dose. Our study also illustrates the importance of pathophysiology-based treatment, individualized outcome assessment, and patient/family participation in rare diseases research. Copyright © 2015 Elsevier Inc. All rights reserved.
Ruppen, Corinne; Decosterd, Laurent; Sendi, Parham
2017-03-01
According to expert opinions, gentamicin should be administered as an adjunct to penicillin against severe group B streptococcal (GBS) infections. Whether the adjunct is important is of particular interest for elderly patients. Not only is the risk of aminoglycoside nephrotoxicity higher in elderly persons, but their immune defence to bacterial infections may also be impaired. Time-kill assays with human blood products, such as serum, neutrophilic granulocytes (opsonophagocytic assays) and whole blood from healthy, elderly volunteers were performed to evaluate the effect of gentamicin in combination with penicillin. In time-kill assays with human serum and in opsonophagocytic assays, we saw a trend for faster killing with the penicillin-gentamicin combination therapy. This effect was seen 4 and 6 h after antibiotic exposure but not at time points evaluated at ≥8 h. In whole blood killing assays, no difference in killing rates was observed with adjunctive gentamicin therapy. The criteria for synergism were not fulfilled when the effect of penicillin-gentamicin combinations was compared with that of penicillin monotherapy. Rapid killing of GBS within the first few hours was observed in time-kill assays with human blood products. Considering that elderly people are prone to gentamicin nephrotoxicity and that in severe GBS infection a high penicillin dose is administered every 4-6 h, the prolonged use of adjunctive aminoglycosides in these infections requires caution.
Chen, Chao-Yang; Lu, Ling-Yan; Chen, Peng; Ji, Kang-Ting; Lin, Jia-Feng; Yang, Peng-Lin; Tang, Ji-Fei; Wang, Yan
2013-01-01
Intradialytic hypotension (IDH) is a global public health problem. A rising number of IDH sufferers resort to Chinese patent medicine, Shengmai Injection (SMI) in China. The objectives of present study are to assess the effectiveness and safety of SMI as an adjunct therapy for IDH. A systematic search of 6 medical databases was performed up to December 2011. Randomized trials involving SMI adjuvant therapy versus conventional therapy were identified. RevMan 5.0 was used for data analysis. Ten randomized clinical trials with 437 participants were identified. Methodological quality was considered inadequate in all trials. Compared with conventional therapy, SMI adjunct therapy showed significant effects in improving the clinic effective rate (P < 0.01), decreasing the incidence of IDH episode (P < 0.01), decreasing the frequency of nursing interventions (P < 0.01), and increasing diastolic blood pressure (P < 0.01). There was no statistical significance in the improvement of mean arterial pressure (P = 0.22) and systolic blood pressure (P = 0.08) between two groups. Four studies had mentioned adverse events, but no serious adverse effects were reported in any of the included trials. In conclusion, SMI adjunct therapy appears to be potentially effective in treatment of IDH and is generally safe. However, further rigorous designed trials are needed.
Ordonez, Alvaro A; Pokkali, Supriya; Kim, Sunhwa; Carr, Brian; Klunk, Mariah H; Tong, Leah; Saini, Vikram; Chang, Yong S; McKevitt, Matthew; Smith, Victoria; Gossage, David L; Jain, Sanjay K
2018-01-01
Matrix metalloproteinase (MMP)-9 is a zinc-dependent protease associated with early immune responses to Mycobacterium tuberculosis infection, macrophage recruitment and granuloma formation. We evaluated whether adjunctive inhibition of MMP-9 could improve the response to standard TB treatment in a mouse model that develops necrotic lesions. Six weeks after an aerosol infection with M. tuberculosis, C3HeB/FeJ mice received standard TB treatment (12 weeks) comprising rifampin, isoniazid and pyrazinamide alone or in combination with either anti-MMP-9 antibody, etanercept (positive control) or isotype antibody (negative control) for 6 weeks. Anti-MMP-9 and the isotype control had comparable high serum exposures and expected terminal half-life. The relapse rate in mice receiving standard TB treatment was 46.6%. Compared to the standard TB treatment, relapse rates in animals that received adjunctive treatments with anti-MMP-9 antibody or etanercept were significantly decreased to 25.9% (P = 0.006) and 29.8% (P = 0.019) respectively, but were not different from the arm that received the isotype control antibody (25.9%). Immunostaining demonstrated localization of MMP-9 primarily in macrophages in both murine and human lung tissues infected with M. tuberculosis, suggesting the importance of MMP-9 in TB pathogenesis. These data suggest that the relapse rates in M. tuberculosis-infected mice may be non-specifically improved by administration of antibodies in conjunction with standard TB treatments. Future studies are needed to evaluate the mechanism(s) leading to improved outcomes with adjunctive antibody treatments.
Kim, Sunhwa; Carr, Brian; Klunk, Mariah H.; Tong, Leah; Saini, Vikram; Chang, Yong S.; McKevitt, Matthew; Smith, Victoria; Gossage, David L.; Jain, Sanjay K.
2018-01-01
Matrix metalloproteinase (MMP)-9 is a zinc-dependent protease associated with early immune responses to Mycobacterium tuberculosis infection, macrophage recruitment and granuloma formation. We evaluated whether adjunctive inhibition of MMP-9 could improve the response to standard TB treatment in a mouse model that develops necrotic lesions. Six weeks after an aerosol infection with M. tuberculosis, C3HeB/FeJ mice received standard TB treatment (12 weeks) comprising rifampin, isoniazid and pyrazinamide alone or in combination with either anti-MMP-9 antibody, etanercept (positive control) or isotype antibody (negative control) for 6 weeks. Anti-MMP-9 and the isotype control had comparable high serum exposures and expected terminal half-life. The relapse rate in mice receiving standard TB treatment was 46.6%. Compared to the standard TB treatment, relapse rates in animals that received adjunctive treatments with anti-MMP-9 antibody or etanercept were significantly decreased to 25.9% (P = 0.006) and 29.8% (P = 0.019) respectively, but were not different from the arm that received the isotype control antibody (25.9%). Immunostaining demonstrated localization of MMP-9 primarily in macrophages in both murine and human lung tissues infected with M. tuberculosis, suggesting the importance of MMP-9 in TB pathogenesis. These data suggest that the relapse rates in M. tuberculosis-infected mice may be non-specifically improved by administration of antibodies in conjunction with standard TB treatments. Future studies are needed to evaluate the mechanism(s) leading to improved outcomes with adjunctive antibody treatments. PMID:29758082
Schmitt, Yuko S; Hoffman, Hunter G; Blough, David K; Patterson, David R; Jensen, Mark P; Soltani, Maryam; Carrougher, Gretchen J; Nakamura, Dana; Sharar, Sam R
2011-02-01
This randomized, controlled, within-subjects (crossover design) study examined the effects of immersive virtual reality as an adjunctive analgesic technique for hospitalized pediatric burn inpatients undergoing painful physical therapy. Fifty-four subjects (6-19 years old) performed range-of-motion exercises under a therapist's direction for 1-5 days. During each session, subjects spent equivalent time in both the virtual reality and the control conditions (treatment order randomized and counterbalanced). Graphic rating scale scores assessing the sensory, affective, and cognitive components of pain were obtained for each treatment condition. Secondary outcomes assessed subjects' perception of the virtual reality experience and maximum range-of-motion. Results showed that on study day one, subjects reported significant decreases (27-44%) in pain ratings during virtual reality. They also reported improved affect ("fun") during virtual reality. The analgesia and affect improvements were maintained with repeated virtual reality use over multiple therapy sessions. Maximum range-of-motion was not different between treatment conditions, but was significantly greater after the second treatment condition (regardless of treatment order). These results suggest that immersive virtual reality is an effective nonpharmacologic, adjunctive pain reduction technique in the pediatric burn population undergoing painful rehabilitation therapy. The magnitude of the analgesic effect is clinically meaningful and is maintained with repeated use. Copyright © 2010 Elsevier Ltd and ISBI. All rights reserved.
Schmitt, Yuko S.; Hoffman, Hunter G.; Blough, David K.; Patterson, David R.; Jensen, Mark P.; Soltani, Maryam; Carrougher, Gretchen J.; Nakamura, Dana; Sharar, Sam R.
2010-01-01
This randomized, controlled, within-subjects (crossover design) study examined the effects of immersive virtual reality as an adjunctive analgesic technique for hospitalized pediatric burn inpatients undergoing painful physical therapy. Fifty-four subjects (6–19 years old) performed range-of-motion exercises under a therapist’s direction for one to five days. During each session, subjects spent equivalent time in both the virtual reality and the control conditions (treatment order randomized and counterbalanced). Graphic rating scale scores assessing the sensory, affective, and cognitive components of pain were obtained for each treatment condition. Secondary outcomes assessed subjects’ perception of the virtual reality experience and maximum range-of-motion. Results showed that on study day one, subjects reported significant decreases (27–44%) in pain ratings during virtual reality. They also reported improved affect (“fun”) during virtual reality. The analgesia and affect improvements were maintained with repeated virtual reality use over multiple therapy sessions. Maximum range-of-motion was not different between treatment conditions, but was significantly greater after the second treatment condition (regardless of treatment order). These results suggest that immersive virtual reality is an effective nonpharmacologic, adjunctive pain reduction technique in the pediatric burn population undergoing painful rehabilitation therapy. The magnitude of the analgesic effect is clinically meaningful and is maintained with repeated use. PMID:20692769
Lemongrass essential oil gel as a local drug delivery agent for the treatment of periodontitis
Warad, Shivaraj B.; Kolar, Sahana S.; Kalburgi, Veena; Kalburgi, Nagaraj B.
2013-01-01
Background: It has been long recognized that periodontal diseases are infections of the periodontium, comprising the bacterial etiology, an immune response, and tissue destruction. Treatment strategies aiming primarily at suppressing or eliminating specific periodontal pathogens include adjunct use of local and systemic antibiotics as part of nonsurgical periodontal therapy. Unwanted side effects and resistance of microorganisms toward antibiotics due to their widespread use have modified the general perception about their efficacy. Research in phytosciences has revealed various medicinal plants offering a new choice of optional antimicrobial therapy. Cymbopogon citratus, Stapf. (lemongrass) is a popular medicinal plant. At a concentration ≤2%, lemongrass essential oil inhibits the growth of several kinds of microorganisms including periodontal pathogens, especially the reference strains Actinomyces naeslundii and Porphyromonas gingivalis, which were resistant to tetracycline hydrochloride. Aims: To evaluate the efficacy of locally delivered 2% lemongrass essential oil in gel form as an adjunct to scaling and root planing, as compared to scaling and root planing alone for the treatment of chronic periodontitis. Materials and Methods: 2% Lemongrass essential oil gel was prepared and placed in moderate to deep periodontal pockets after scaling and root planing. Results: Statistically significant reduction in probing depth and gingival index and gain in relative attachment level were noted in the experimental group as compared to the control group at 1 and 3 months. Conclusion: Locally delivered 2% lemongrass essential oil gel offers a new choice of safe and effective adjunct to scaling and root planing in periodontal therapy. PMID:24991068
Usall, Judith; López-Carrilero, Raquel; Iniesta, Raquel; Roca, Mercedes; Caballero, Montserrat; Rodriguez-Jimenez, Roberto; Oliveira, Cristina; Bernardo, Miguel; Corripio, Iluminada; Sindreu, Santiago Durán; González Piqueras, Jose Carlos; Felipe, Ana Espliego; Fernandez de Corres, Blanca; Ibáñez, Angela; Huerta, Raúl
2014-06-01
In this study, we assessed the efficacy of 2 pharmacodynamically different antidepressants, citalopram (a selective serotonin reuptake inhibitor) and reboxetine (a norepinephrine reuptake inhibitor), as adjunctive therapy to risperidone and olanzapine for the treatment of negative symptoms in schizophrenia. We performed a 6-month, multicenter, double-blind, randomized, placebo-controlled clinical trial. The recruitment period was from November 2008 to December 2011.The sample comprised 90 patients with a diagnosis of schizophrenia (DSM-IV criteria) who exhibited negative symptoms. The patients were recruited from 10 centers in different cities of the Spanish State. The primary efficacy measure was change in score on the negative subscale of the Positive and Negative Syndrome Scale (PANSS) between baseline and 6-month assessment. Other efficacy measures were changes in the PANSS subscales and total score, as well as the Scale for the Assessment of Negative Symptoms (SANS) subscales and total score. For statistical analysis, we employed mixed-effects models. We did not find statistically significant differences between the placebo group and the 2 treatment groups at 6-month assessments for the PANSS total (P=.6511), any PANSS subscale (negative [P=.5533], positive [P=.1723], or general psychopathology [P=.2083]), or the SANS (P= .5884). Cohen d measure showed a small effect size below the 0.5 threshold for all comparisons. In conclusion, our results do not support adjunctive use of citalopram or reboxetine with risperidone or olanzapine for the treatment of negative symptoms in schizophrenia. ClinicalTrials.gov identifier: NCT01300364. © Copyright 2014 Physicians Postgraduate Press, Inc.
Kumari, Minal; Martande, Santosh S; Pradeep, Avani R
2017-05-01
Statins are known to have a beneficial effect in the treatment of chronic periodontitis (CP). The current study was designed to investigate the effectiveness of a 1.2% atorvastatin (ATV) local drug delivery system as an adjunct to scaling and root planing (SRP) in the treatment of intrabony defects (IBD) in CP among smokers. Seventy-one smokers with CP were categorized into two treatment groups: SRP + 1.2% ATV gel and SRP + placebo gel. Clinical parameters, modified sulcus bleeding index, probing depth, and clinical attachment level were recorded at baseline before SRP and at 3, 6, and 9 months. At baseline, 6 months, and 9 months, the percentage of radiographic defect depth reduction was determined using computer-aided software. The mean probing depth reduction and mean clinical attachment level gain were found to be greater in the ATV group than the placebo group at 3, 6, and 9 months. A significantly greater mean percentage of radiographic defect depth reduction was found in the ATV group compared to the placebo group after 9 months. The ATV local drug delivery as an adjunct to SRP can be used in the treatment of IBD in CP among smokers. © 2016 John Wiley & Sons Australia, Ltd.
2011-01-01
Introduction Neuroinflammation is thought to be important in Alzheimer's disease pathogenesis. Mast cells are a key component of the inflammatory network and participate in the regulation of the blood-brain barrier's permeability. Masitinib, a selective oral tyrosine kinase inhibitor, effectively inhibits the survival, migration and activity of mast cells. As the brain is rich in mast cells, the therapeutic potential of masitinib as an adjunct therapy to standard care was investigated. Methods A randomised, placebo-controlled, phase 2 study was performed in patients with mild-to-moderate Alzheimer's disease, receiving masitinib as an adjunct to cholinesterase inhibitor and/or memantine. Patients were randomly assigned to receive masitinib (n = 26) (starting dose of 3 or 6 mg/kg/day) or placebo (n = 8), administered twice daily for 24 weeks. The primary endpoint was change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog) to assess cognitive function and the related patient response rate. Results The rate of clinically relevant cognitive decline according to the ADAS-Cog response (increase >4 points) after 12 and 24 weeks was significantly lower with masitinib adjunctive treatment compared with placebo (6% vs. 50% for both time points; P = 0.040 and P = 0.046, respectively). Moreover, whilst the placebo treatment arm showed worsening mean ADAS-Cog, Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory, and Mini-Mental State Examination scores, the masitinib treatment arm reported improvements, with statistical significance between treatment arms at week 12 and/or week 24 (respectively, P = 0.016 and 0.030; P = 0.035 and 0.128; and P = 0.047 and 0.031). The mean treatment effect according to change in ADAS-Cog score relative to baseline at weeks 12 and 24 was 6.8 and 7.6, respectively. Adverse events occurred more frequently with masitinib treatment (65% vs. 38% of patients); however, the majority of events were of mild or moderate intensity and transitory. Severe adverse events occurred at a similar frequency in the masitinib and placebo arms (15% vs. 13% of patients, respectively). Masitinib-associated events included gastrointestinal disorders, oedema, and rash. Conclusions Masitinib administered as add-on therapy to standard care during 24 weeks was associated with slower cognitive decline in Alzheimer's disease, with an acceptable tolerance profile. Masitinib may therefore represent an innovative avenue of treatment in Alzheimer's disease. This trial provides evidence that may support a larger placebo-controlled investigation. Trial registration Clinicaltrials.gov NCT00976118 PMID:21504563
Ghaleiha, Ali; Asadabadi, Mahtab; Mohammadi, Mohammad-Reza; Shahei, Maryam; Tabrizi, Mina; Hajiaghaee, Reza; Hassanzadeh, Elmira; Akhondzadeh, Shahin
2013-05-01
Autism is a neurodevelopmental disorder that causes significant impairment in socialization and communication. It is also associated with ritualistic and stereotypical behaviour. Recent studies propose both hyper-and hypoglutamatergic ideologies for autism. The objective of this study was to assess the effects of memantine plus risperidone in the treatment of children with autism. Children with autism were randomly allocated to risperidone plus memantine or placebo plus risperidone for a 10-wk, double-blind, placebo-controlled study. The dose of risperidone was titrated up to 3 mg/d and memantine was titrated to 20 mg/d. Children were assessed at baseline and after 2, 4, 6, 8 and 10 wk of starting medication protocol. The primary outcome measure was the irritability subscale of Aberrant Behavior Checklist-Community (ABC-C). Difference between the two treatment arms was significant as the group that received memantine had greater reduction in ABC-C subscale scores for irritability, stereotypic behaviour and hyperactivity. Eight side-effects were observed over the trial, out of the 25 side-effects that the checklist included. The difference between the two groups in the frequency of side-effects was not significant. The present study suggests that memantine may be a potential adjunctive treatment strategy for autism and it was generally well tolerated. This trial is registered with the Iranian Clinical Trials Registry (IRCT1138901151556N10; www.irct.ir).
Bhatia, Triptish; Mazumdar, Sati; Wood, Joel; He, Fanyin; Gur, Raquel E; Gur, Ruben C; Nimgaonkar, Vishwajit L; Deshpande, Smita N
2017-04-01
Yoga and physical exercise have been used as adjunctive intervention for cognitive dysfunction in schizophrenia (SZ), but controlled comparisons are lacking. Aims A single-blind randomised controlled trial was designed to evaluate whether yoga training or physical exercise training enhance cognitive functions in SZ, based on a prior pilot study. Consenting, clinically stable, adult outpatients with SZ (n=286) completed baseline assessments and were randomised to treatment as usual (TAU), supervised yoga training with TAU (YT) or supervised physical exercise training with TAU (PE). Based on the pilot study, the primary outcome measure was speed index for the cognitive domain of 'attention' in the Penn computerised neurocognitive battery. Using mixed models and contrasts, cognitive functions at baseline, 21 days (end of training), 3 and 6 months post-training were evaluated with intention-to-treat paradigm. Speed index of attention domain in the YT group showed greater improvement than PE at 6 months follow-up (p<0.036, effect size 0.51). In the PE group, 'accuracy index of attention domain showed greater improvement than TAU alone at 6-month follow-up (p<0.025, effect size 0.61). For several other cognitive domains, significant improvements were observed with YT or PE compared with TAU alone (p<0.05, effect sizes 0.30-1.97). Both YT and PE improved attention and additional cognitive domains well past the training period, supporting our prior reported beneficial effect of YT on speed index of attention domain. As adjuncts, YT or PE can benefit individuals with SZ.
Rashid, Haroon; Khan, Akif A; Fineberg, Naomi A
2015-06-01
A retrospective naturalistic case note study to determine the frequency, co-morbidity and treatment-response of body dysmorphic disorder (BDD). Records from 280 patients attending a highly specialised obsessive-compulsive disorder (OCD)/BDD service were analysed. The clinical outcome was measured either through scoring of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) for OCD/BDD, or textual analysis of case notes for evidence of symptomatic improvement, treatment tolerability, and premature disengagement. A total of 32 patients (11.43%) were diagnosed with BDD. Of these, 28 (87.5%) had at least one co-morbidity. All patients were offered cognitive behavioural therapy (CBT) and selective serotonin reuptake inhibitor (SSRI). Adjunctive low-dose antipsychotic was prescribed for 21 (66%) patients. Overall, 18/32 (56%) responded, and 7/32 (22%) disengaged prematurely. Patients offered antipsychotic, SSRI and CBT (n = 21) were compared with those offered SSRI and CBT only (n = 11). The treatment was well-tolerated. Whereas there was no significant inter-group difference in the clinical response rate, premature disengagement occurred less frequently in the antipsychotic-treated patients (9.5% versus 45%; Fisher's Exact Test P = 0.0318). BDD frequently presents with co-morbidity, treatment-resistance and premature disengagement. Adjunctive antipsychotic was associated with significantly better treatment adherence, but responder rates did not differ significantly, possibly related to the small sample-size. A well-powered randomised controlled study is warranted, to determine clinical outcomes with adjunctive antipsychotic in BDD.
Narcotic antagonists. Treatment tool for addiction.
Valentine, N M; Meyer, R E
1976-09-01
Narcotic antagonists have recently gained attention through research aimed at evaluating both biochemical effects and treatment potential for opiate addiction. Narcotic antagonists are a classification of drugs which block the euphoric (and all other) effects of opiates. Naltrexone is the most promising narcotic antagonist based on ability to produce blockade, length of duration, and relative absence of side effects. The narcotic antagonists offer an adjunctive or alternative method of treatment for opiate addicts based on Wikler's biobehavioral theory of conditioned abstinence. Narcotic antagonists are presently being investigated at seven research centers throughout the United States and may be available for clinical use in the future.
Rasagiline: a review of its use in the treatment of idiopathic Parkinson's disease.
Hoy, Sheridan M; Keating, Gillian M
2012-03-26
Rasagiline (Azilect®), a selective, irreversible, monoamine oxidase-B inhibitor, is available in the EU, the US and in several other countries worldwide, including Canada and Israel. It is indicated for the treatment of idiopathic Parkinson's disease as monotherapy or as adjunctive therapy to levodopa in patients [corrected]with end-of-dose fluctuations in the EU and for the treatment of adult patients with the signs and symptoms of idiopathic Parkinson's disease in the US. This article reviews the pharmacological properties, therapeutic efficacy and tolerability of rasagiline as monotherapy or as adjunctive therapy to levodopa in patients with Parkinson's disease. Oral rasagiline as monotherapy or as adjunctive therapy to levodopa was effective in the symptomatic treatment of adult patients with Parkinson's disease participating in double-blind, placebo-controlled, multinational studies. In patients with early Parkinson's disease, monotherapy with rasagiline 1 mg/day (recommended dosage) significantly slowed the rate of worsening (i.e. an increase in the Unified Parkinson's Disease Rating Scale [UPDRS] score) in the ADAGIO and TEMPO studies, with the results from the ADAGIO study for rasagiline 1 mg/day suggesting a slowing of clinical progression. However, at the higher dosage of 2 mg/day, rasagiline met the primary endpoint in the TEMPO study and the first, but not the second, of three hierarchical primary endpoints in the ADAGIO study. Compared with delayed-start rasagiline monotherapy, early initiation was associated with a slower long-term progression of the clinical signs and symptoms of Parkinson's disease in the TEMPO study. As adjunctive therapy to levodopa in the LARGO and PRESTO studies, rasagiline 0.5 and/or 1 mg/day significantly reduced the total daily 'off' time (primary efficacy endpoint) and significantly improved the Clinical Global Impression score, the UPDRS activities of daily living subscale score during 'off' time and the UPDRS motor subscale score during 'on' time compared with placebo in patients with advanced Parkinson's disease. Although rasagiline showed neuroprotective properties both in vitro and in vivo, identifying its potential to slow clinical progression in the clinical setting has been elusive to date and was not definitively demonstrated in the studies discussed in this article. Additional rasagiline studies specifically designed to assess the clinical progression of Parkinson's disease while addressing the potentially confounding factors of the delayed-start study design would therefore be of interest. As monotherapy or as adjunctive therapy to levodopa, rasagiline was generally well tolerated, with the frequency and nature of treatment-emergent adverse events generally similar across clinical studies and between rasagiline and placebo groups. Therapy with rasagiline appears to be associated with a low incidence of cognitive and behavioural adverse events. Thus, oral rasagiline as monotherapy or as adjunctive therapy to levodopa provides a useful option in the treatment of adult patients with Parkinson's disease.
Adjunctive cholestyramine therapy for thyrotoxicosis.
Solomon, B L; Wartofsky, L; Burman, K D
1993-01-01
Initial therapy of thyrotoxicosis usually includes beta-blockade for symptom relief and thionamides to block new thyroid hormone synthesis. In view of the increased enterohepatic circulation of thyroxine (T4) and triiodothyronine (T3) in thyrotoxicosis, we proposed that cholestyramine, an anion exchange resin which binds iodothyronines, when used adjunctively with thionamides and a beta-blocker, would lower serum iodothyronine levels faster than would standard therapy alone. A double blind placebo-controlled cross-over design was used with patients randomly assigned to either the treatment or control groups. They received their initial treatment for two weeks (Phase 1) followed by a one-week washout period, and then crossed to the opposite treatment for two weeks (Phase 2). Standard therapy included atenolol 50 mg daily, individualized dosages of methimazole and either 4 g of cholestyramine or 4 g of placebo powder four times per day. Fifteen patients with thyrotoxicosis (14 Graves' disease, 1 toxic adenoma) participated in this study. Total and free thyroxine and triiodothyronine, as well as thyroid-stimulating immunoglobulin and thyrotrophin-binding inhibitory immunoglobulin, were measured weekly. Seven patients received cholestyramine and eight patients received placebo during Phase 1. A more rapid decline in all thyroid hormone levels was seen in the cholestyramine-treated group (F = 4-7, P < 0.01) than in the placebo group (F = 2-3.1, P = 0.05). In Phase 2, the eight patients who received cholestyramine showed an additional decline in free thyroxine from weeks one to two, but the overall rate of decline in hormone levels was not different between the groups. Immunoglobulin levels remained unaffected regardless of group, treatment, or time. We conclude that cholestyramine is a safe and effective adjunctive agent in the treatment of thyrotoxicosis and that its greatest efficacy may be during the first few weeks of treatment.
Meza-Mauricio, Jonathan; Soto-Peñaloza, David; Peñarrocha-Oltra, David; Montiel-Company, Jose Maria; Peruzzo, Daiane Cristina
2018-06-12
This review aimed at evaluating the effects of chronic periodontitis (CP) treatment with local statins as adjuncts to scaling and root planing (SRP), compared with SRP alone or with placebo. Electronic and hand searches were conducted in three databases to select randomized controlled trials (RCTs) comparing SRP + statins versus SRP alone. Random effects models were conducted to determine the clinical attachment level (CAL) gain as the primary outcome variable, and probing pocket depth (PPD) reduction, modified sulcus bleeding index (mSBI), and intrabony defect depth (IBD) as the secondary outcomes. Of the 526 papers identified, 15 articles met the criteria for inclusion in this systematic review, and 13 in the meta-analysis. The meta-analysis showed a statistically significant CAL gain (mean differences [MD] = 1.84 mm, 95% confidence interval [CI] = 1.45 to 2.23; p = 0.000), PPD reduction (MD = 1.69 mm, 95% CI = 1.37 to 2.04; p = 0.000), mSBI change (MD = 0.70, 95% CI = 0.57 to 0.84; p = 0.000), and IBD (MD = 1.48, 95% CI = 1.30 to 1.67; p = 0.000) attributed to SRP + statin treatment (6 months). Within the limitations of this study, the collective evidence emerging from this systematic review and meta-analysis may support the use of locally applied statins as adjuncts to SRP in CP treatment, based on being an easy, low-cost alternative, with lesser adverse effects on bacterial resistance. These results should be interpreted with caution. Clinicians might consider the use of SRP + statins as an adjunct over other alternative approaches, based on the results of the present review. The informed decision should be taken, considering the patient's values and preferences, and the intervention to be implemented by the clinician.
Research on hypnosis as an adjunct to cognitive-behavioral psychotherapy.
Schoenberger, N E
2000-04-01
There is a growing body of research evaluating the use of hypnosis with cognitive-behavioral techniques in the treatment of psychological disorders. The central question for research is whether the addition of hypnosis enhances the efficacy of cognitive-behavioral treatments. Overall, studies demonstrate a substantial benefit from the addition of hypnosis; however, the number of published studies is relatively small, and many of them have methodological limitations. For cognitive-behavioral hypnotherapies to be recognized as empirically supported treatments, a number of well-designed, randomized clinical trials are necessary. Currently, the efficacy of hypnosis as an adjunctive treatment remains unresolved.
Adjunctive Treatment in Juvenile Nasopharyngeal Angiofibroma: How Should We Approach Recurrence?
Scholfield, Daniel W; Brundler, Marie-Anne; McDermott, Ann-Louise; Mussai, Francis; Kearns, Pamela
2016-04-01
A recent case of advanced, recurrent juvenile nasopharyngeal angiofibroma (JNA) at our institution has highlighted the limited evidence regarding adjunctive treatment. We present the case of a 10-year-old boy who is the first to undergo multiple-staged surgical resections alongside vincristine treatment. We performed a review of the literature analyzing the roles of radiation therapy, cytotoxic drugs, and novel targeted agents in JNA relapse. Small cohort studies suggest radiotherapy and flutamide are the most rational treatment options for residual and recurrent JNA. Our review highlights the need for further research into the management of primary and recurrent JNA.
Smagula, Stephen F; Wallace, Meredith L; Anderson, Stewart J; Karp, Jordan F; Lenze, Eric J; Mulsant, Benoit H; Butters, Meryl A; Blumberger, Daniel M; Diniz, Breno S; Lotrich, Francis E; Dew, Mary Amanda; Reynolds, Charles F
2016-10-01
Personalizing treatment for late-life depression requires identifying and integrating information from multiple factors that influence treatment efficacy (moderators). We performed exploratory moderator analyses using data from a multi-site, randomized, placebo-controlled, double-blind trial of aripiprazole augmentation. Patients (n = 159) aged ≥60 years had major depressive disorder that failed to remit with venlafaxine monotherapy. We examined effect sizes of 39 potential moderators of aripiprazole (vs. placebo) augmentation efficacy using the outcome of percentage reduction in depressive symptom after 12 weeks. We then incorporated information from the individually relevant variables in combined moderators. A larger aripiprazole treatment effect was related to: white race, better physical function, better performance on Trail-Making, attention, immediate, and delayed memory tests, greater psychomotor agitation and suicidality symptoms, and a history of adequate antidepressant pharmacotherapy. A smaller aripiprazole treatment effect was observed in patients with: more pain and more work/activity impairment and libido symptoms. Combining information from race and Trail-Making test performance (base combined moderator (Mb*)) produced a larger effect size (Spearman effect size = 0.29 (95% confidence interval (CI): 0.15, 0.42)) than any individual moderator. Adding other individually relevant moderators in the full combined moderator (Mf*) further improved effect size (Spearman effect size = 0.39 (95% CI: 0.25, 0.52)) and identified a sub-group benefiting more from placebo plus continuation venlafaxine monotherapy than adjunctive aripiprazole. Combining moderators can help clinicians personalize depression treatment. We found the majority of our patients benefited from adjunctive aripiprazole, but a smaller subgroup that is identifiable using clinical measures appeared to benefit more from continuation venlafaxine plus placebo. Copyright © 2016 Elsevier Ltd. All rights reserved.
Smagula, Stephen F.; Wallace, Meredith L.; Anderson, Stewart J.; Karp, Jordan F.; Lenze, Eric J.; Mulsant, Benoit H.; Butters, Meryl A.; Blumberger, Daniel M.; Diniz, Breno S.; Lotrich, Francis; Dew, Mary Amanda; Reynolds, Charles F.
2016-01-01
Personalizing treatment for late-life depression requires identifying and integrating information from multiple factors that influence treatment efficacy (moderators). We performed exploratory moderator analyses using data from a multi-site, randomized, placebo-controlled, double-blind trial of aripiprazole augmentation. Patients (n=159) aged ≥60 years had major depressive disorder that failed to remit with venlafaxine monotherapy. We examined effect sizes of 39 potential moderators of aripiprazole (vs. placebo) augmentation efficacy using the outcome of percentage reduction in depressive symptom after 12 weeks. We then incorporated information from the individually relevant variables in combined moderators. A larger aripiprazole treatment effect was related to: white race, better physical function, better performance on Trail-Making, attention, immediate, and delayed memory tests, greater psychomotor agitation and suicidality symptoms, and a history of adequate antidepressant pharmacotherapy. A smaller aripiprazole treatment effect was observed in patients with: more pain and more work/activity impairment and libido symptoms. Combining information from race and Trail-Making test performance (base combined moderator (Mb*)) produced a larger effect size (Spearman effect size=0.29 (95% confidence interval (CI): 0.15, 0.42)) than any individual moderator. Adding other individually relevant moderators in the full combined moderator (Mf*) further improved effect size (Spearman effect size=0.39 (95% CI: 0.25, 0.52)) and identified a sub-group benefiting more from placebo plus continuation venlafaxine monotherapy than adjunctive aripiprazole. Combining moderators can help clinicians personalize depression treatment. We found the majority of our patients benefited from adjunctive aripiprazole, but a smaller subgroup that is identifiable using clinical measures appeared to benefit more from continuation venlafaxine plus placebo. PMID:27438687
Management and recurrence of keratocystic odontogenic tumor: a systematic review.
Johnson, Nigel R; Batstone, Martin D; Savage, Neil W
2013-10-01
The objective of this study was to evaluate the most up-to-date treatment modalities and respective recurrence rates for keratocystic odontogenic tumor (KCOT). A systematic review of the literature from 1999 to 2010 was undertaken examining treatment and recurrence rates for KCOT. Four inclusion criteria were defined for articles to then be analyzed against 8 standards. Of the 2736 published articles, 8 met the inclusion criteria. When merging the data, enucleation and enucleation with adjunctive measures (other than Carnoy's solution) had recurrence rates of 25.6% and 30.3%, respectively. Marsupialization with adjunctive measures produced a recurrence rate of 15.8%, whereas enucleation with Carnoy's solution presented a recurrence rate of 7.9%. Only one resection case had recurrence (6.3%). The enucleation technique with the use of adjunctive procedures (other than Carnoy's solution) provides a higher recurrence rate than any other treatment modality. Copyright © 2013 Elsevier Inc. All rights reserved.
Kast, RE
2010-01-01
Glioblastoma treatment as now constituted offers increased survival measured in months over untreated patients. Because glioblastomas are active in synthesizing a bewildering variety of growth factors, a systematic approach to inhibiting these is being undertaken as treatment adjunct. The serotonin 7 receptor is commonly overexpressed in glioblastoma. Research documentation showing agonists at serotonin receptor 7 cause increased extracellular regulated kinase 1/2 activation, increased interleukin-6 synthesis, increased signal transducer and activator of transcription-3 activation, increased resistance to apoptosis and other growth enhancing changes in glioblastoma is reviewed in this paper. Because three drugs in wide use to treat thought disorders – paliperidone, pimozide and risperidone – are also potent and well-tolerated inhibitors at serotonin receptor 7, these drugs should be studied for growth factor deprivation in an adjunctive role in glioblastoma treatment. PMID:20880389
Dose-response effects of atropine and HI-6 treatment of organophosphorus poisoning in guinea pigs
DOE Office of Scientific and Technical Information (OSTI.GOV)
Koplovitz, I.; Menton, R.; Matthews, C.
1995-12-31
H1-6 (1-2-hydrnxyiminomethyl-1 pyridino-3-(4-carbameyl- 1--pyddino)-2- oxaprnpane dichioride) has been evaluated as an oxime alternative to pralidoxime, and toxogonin in the treatment of organophosphorus (OP) poisoning. The dose response effects of atropine (ATR) and HI-6 were investigated to more fully explore the interaction of these compounds in the treatment of OP poisoning. ATR, HI-6 and various combinations of the two drugs were evaluated against lethal poisoning by soman (GD) and tabun (GA) in guinea pigs. The effect of adjunctive diazepam treatment on the efficacy of atropine and HI-6 against soman was also investigated. Animals of either sex were challenged s.c. with OPmore » and treated i.m. 1 min later with ATR and/or HI-6. When used, diazepam was injected immediately after ATR+HI6. LD50s of each treatment were calculated from probit models based on 24-hour survival against 5 levels of nerve agent and 6 animals per challenge level. A protective index (PI) was calculated by dividing the nerve agent LD50 in the presence of treatment by the LD50 in the absence of treatment. Treatment with HI-6 alone had little effect on the toxicity of either OP. Treatment with ATR alone was more effective than HI-6 alone and was significantly more effective against soman than against tabun. When used in combination atropine and HI-6 had a strong synergistic effect against both agents. The dose of atropine used with HI-6 was critical in determining the efficacy of HI-6 against either agent. The slopes of the dose-lethality curves were minimally affected by the dose of ATR or HI-6. Adjunctive treatment with diazepam enhanced the efficacy of HI-6 and atropine against soman.« less
A current review of core decompression in the treatment of osteonecrosis of the femoral head.
Pierce, Todd P; Jauregui, Julio J; Elmallah, Randa K; Lavernia, Carlos J; Mont, Michael A; Nace, James
2015-09-01
The review describes the following: (1) how traditional core decompression is performed, (2) adjunctive treatments, (3) multiple percutaneous drilling technique, and (4) the overall outcomes of these procedures. Core decompression has optimal outcomes when used in the earliest, precollapse disease stages. More recent studies have reported excellent outcomes with percutaneous drilling. Furthermore, adjunct treatment methods combining core decompression with growth factors, bone morphogenic proteins, stem cells, and bone grafting have demonstrated positive results; however, larger randomized trial is needed to evaluate their overall efficacy.
Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice.
Lin, Jen-Cheng; Lee, Mei-Yi; Chan, Ming-Huan; Chen, Yi-Chyan; Chen, Hwei-Hsien
2016-09-01
Ketamine is emerging as a new hope against depression, but ketamine-associated psychotomimetic effects limit its clinical use. An adjunct therapy along with ketamine to alleviate its adverse effects and even potentiate the antidepressant effects might be an alternative strategy. Betaine, a methyl derivative of glycine and a dietary supplement, has been shown to have antidepressant-like effects and to act like a partial agonist at the glycine site of N-methyl-D-aspartate receptors (NMDARs). Accordingly, betaine might have potential to be an adjunct to ketamine treatment for depression. The antidepressant-like effects of ketamine and betaine were evaluated by forced swimming test and novelty suppressed feeding test in mice. Both betaine and ketamine produced antidepressant-like effects. Furthermore, we determined the effects of betaine on ketamine-induced antidepressant-like and psychotomimetic behaviors, motor incoordination, hyperlocomotor activity, and anesthesia. The antidepressant-like responses to betaine combined with ketamine were stronger than their individual effects. In contrast, ketamine-induced impairments in prepulse inhibition, novel object recognition test, social interaction, and rotarod test were remarkably attenuated, whereas ketamine-induced hyperlocomotion and loss of righting reflex were not affected by betaine. These findings revealed that betaine could enhance the antidepressant-like effects, yet block the psychotomimetic effects of ketamine, suggesting that betaine can be considered as an add-on therapy to ketamine for treatment-resistant depression and suitable for the treatment of depressive symptoms in patients with schizophrenia.
Adjunctive minocycline for schizophrenia: A meta-analysis of randomized controlled trials.
Xiang, Ying-Qiang; Zheng, Wei; Wang, Shi-Bin; Yang, Xin-Hu; Cai, Dong-Bin; Ng, Chee H; Ungvari, Gabor S; Kelly, Deanna L; Xu, Wei-Ying; Xiang, Yu-Tao
2017-01-01
This study aimed to conduct a meta-analysis of the efficacy and safety of adjunctive minocycline for schizophrenia. Randomized controlled trials (RCTs) comparing adjunctive minocycline with placebo in patients with schizophrenia were included in the meta-analysis. Two independent investigators extracted and synthesized data. Standard mean differences (SMDs), risk ratio (RR) ±95% confidence intervals (CIs) and the number-needed-to-harm (NNH) were calculated. Eight RCTs with 548 schizophrenia patient including 286 (52.2%) patients on minocycline (171.9±31.2mg/day) and 262 (47.8%) on placebo completed 18.5±13.4 weeks of treatment. Meta-analyses of Positive and Negative Syndrome Scale (PANSS) (7 RCTs with 8 treatment arms)/Brief Psychiatric Rating Scale (BPRS) (1 RCT) total score [SMD: -0.64, (95%CI: -1.02, -0.27), P=0.0008; I 2 =74%], positive, negative and general symptom scores [SMD: -0.69 to -0.22 (95%CI: -0.98, -0.03), P=0.02-0.00001; I 2 =7-63%] revealed a significant superiority of adjunctive minocycline treatment over the placebo. There was no significant difference regarding neurocognitive function, discontinuation rate and adverse drug reactions between the two groups. This meta-analysis showed that adjunctive minocycline appears to be efficacious and safe for schizophrenia. Due to significant heterogeneity, future studies with a large sample size are needed to confirm these findings. Copyright © 2016 Elsevier B.V. and ECNP. All rights reserved.
Dowsing, Paul; Murray, Alison; Sandler, Jonathan
2015-04-01
In the second of two papers, management of orthodontic emergencies involving appliances other than Fixed appliances will be detailed. Problems relating to removable appliances, as well as other orthodontic adjuncts, will be discussed. Unfortunately, orthodontic appliance breakage does occur, despite the clinicians giving clear and concise instructions to the patients and their parents at fitting. If general dental practitioners have a practical knowledge of how to diagnose problems and to provide appropriate advice or timely 'emergency' treatment, this will significantly reduce the inconvenience for all parties concerned. It should also ensure that treatment progresses in the most efficient and comfortable manner for their patients. In specific situations the early, accurate identification of the problem and instigation of its appropriate management can avoid more serious consequences. Clinical Relevance: Appropriate handling of an orthodontic 'emergency' by the dentist can, on many occasions, provide immediate relief to the patient. This will, in turn, allow treatment to continue in the right direction, thus allowing more efficient and effective use of valuable resources.
Community-acquired bacterial meningitis.
Costerus, Joost M; Brouwer, Matthijs C; Bijlsma, Merijn W; van de Beek, Diederik
2017-02-01
Bacterial meningitis is a medical emergency and is associated with a high disease burden. We reviewed recent progress in the management of patients with community-acquired bacterial meningitis. The worldwide burden of disease of bacterial meningitis remains high, despite the decreasing incidence following introduction of routine vaccination campaigns. Delay in diagnosis and treatment remain major concerns in the management of acute bacterial meningitis. European Society of Clinical Microbiology and Infectious Diseases guidelines strive for a door-to-antibiotic-time less than 1 h. Polymerase chain reaction (PCR) has emerged as an important diagnostic tool to identify the causative organism. Point-of-care tests using fast multiplex PCR have been developed, but additional value has not been proven. Although anecdotal observations advocate pressure-based management, a randomized controlled trial will need to be performed first to determine efficacy and safety of such an aggressive treatment approach. Adjunctive dexamethasone remains the only adjunctive therapy with proven efficacy. The incidence of bacterial meningitis has been decreasing after the implementation of effective vaccines. Treatment should be administered as soon as possible and time to treatment should not exceed 1 h.
Bast, F; Risteska, K; Jovanovic, S; Sedlmaier, B
2009-08-01
The antibiotic und antitumoral effect of Mitomycin C (MMC), a derivative of Streptomyces caespitosus, has been known since 1956. Besides its use as an adjunction in the treatment of breast, lung and prostate cancer, or as a second-line cytostatic drug for head and neck squamous cell carcinoma (HNSCC), since 1963, MMC has also been successfully used in the suppression of post-operative scar formation, particularly in the field of ophthalmology. This is due to its modulation of fibroblast activity, which enables decreased scarring and fibrosis. In this résumé, we wish to recapitulate our long years of experience in the topical application of Mitomycin C in the treatment of scar formation and stenosis in head and neck organs. A retrospective analysis on the basis of clinical disease courses and findings (image documentation, questionnaires, pulmonary function tests) covering an examination period of 10 years, was performed on 40 patients with stenosising lesions and a mean age of 54 years. The fields of application included laryngeal, tracheal, oesophageal stenosis and stenosis of the external ear canal and the choane. After combined application of MMC and surgical intervention in cases of recurrent stenosising processes in head and neck organs, especially the larynx and the trachea, a sustained improvement was achieved in the pre-operative stenosis level as well as in the pre-operative, severely limited, forced inspiratory volume in 1 second (F1V1). The topical application of MMC appears to be an effective adjunction as a concept of treatment for stenosising, scar-forming lesions. This topical application, however, is not a substitute for correct diagnosis and appropriate surgical treatment. It must be regarded as a purely adjunctive manoeuvre. During the 10 years in which it was used, the clinical findings confirmed an enhancement in the containment of complex cases without the occurrence of any complications. Georg Thieme Verlag KG Stuttgart, New York.
Host modulation therapeutics in periodontics: role as an adjunctive periodontal therapy.
Shinwari, Muhammad Saad; Tanwir, Farzeen; Hyder, Pakiza Raza; Bin Saeed, Muhammad Humza
2014-09-01
Host Modulation Therapy (HMT) is a treatment concept that reduces tissue destruction and stabilizes or even regenerates inflammatory tissue by modifying host response factors. It has been used for treating osteoporosis and arthritis for several decades. However, its use in dentistry has only been recently reported. The objective of this article is to present a review of the various literatures available on HMT and also its role as adjunct therapy in periodontics. For identifying studies for this review, a PUBMED search was carried out in 2013 for all articles published till December 2012. The search was restricted to English language publications only. Longitudinal prospective and retrospective studies were included in the search. The key words used were: Host Modulation Therapy; Sub antimicrobial dose doxycycline and Non-Surgical Periodontal Therapy. The main outcomes sought were host modulation therapeutics in periodontics. Exclusion criteria included cross sectional studies, short case series as well as studies with short follow-up periods. There is a paucity of literature on HMT in periodontics although the only drug approved by United States Food and Drug Administration (FDA) is a subantimicrobial dose of doxycycline (SDD) with highly predictable results as a host modulating agent in periodontal diseases and also an effective adjunctive therapy in various diseases of periodontium. However, more randomized controlled trials are needed to obtain clinical guidelines on the usage of other host modulating agents as adjunct as well as definite therapy for periodontal diseases. SDD is an effective adjunct therapy when used in dosage of 20mg twice daily for minimum 3 months duration in various periodontal diseases with predictable clinical outcomes. It is also recommended that future clinical research on anti cytokine drugs, chemically modified tetracycline and other HMT agents should be conducted so that new drugs are available with highly predictable results.
Vagus nerve stimulation therapy in partial epilepsy: a review.
Panebianco, Mariangela; Zavanone, Chiara; Dupont, Sophie; Restivo, Domenico A; Pavone, Antonino
2016-09-01
Epilepsy is a chronic neurological disorder characterized by recurrent, unprovoked epileptic seizures. The majority of people given a diagnosis of epilepsy have a good prognosis, but 20-30 % will develop drug-resistant epilepsy. Vagus nerve stimulation (VNS) is a neuromodulatory treatment that is used as an adjunctive therapy for treating people with medically refractory epilepsy. It consists of chronic intermittent electrical stimulation of the vagus nerve, delivered by a programmable pulse generator (Neuro-Cybernetic Prosthesis). In 1997, the Food and Drug Administration approved VNS as adjunctive treatment for medically refractory partial-onset seizures in adults and adolescents. This article reviews the literature from 1988 to nowadays. We discuss thoroughly the anatomy and physiology of vagus nerve and the potential mechanisms of actions and clinical applications involved in VNS therapy, as well as the management, safety, tolerability and effectiveness of VNS therapy. VNS for partial seizures appears to be an effective and well tolerated treatment in adult and pediatric patients. People noted improvements in feelings of well-being, alertness, memory and thinking skills, as well as mood. The adverse effect profile is substantially different from the adverse effect profile associated with antiepileptic drugs, making VNS a potential alternative for patients with difficulty tolerating antiepileptic drug adverse effects. Despite the passing years and the advent of promising neuromodulation technologies, VNS remains an efficacy treatment for people with medically refractory epilepsy. Past and ongoing investigations in other indications have provided signals of the therapeutic potential in a wide variety of conditions.
Needle Acupuncture for Substance Use Disorders: A Systematic Review
2015-01-01
RCTs). We did identify statistically significant, clinically medium effects in favor of acupuncture (as an adjunctive or monotherapy) versus any...statistically significant, clinically medium effects in favor of acupuncture (as an adjunctive or monotherapy) versus any comparator at...at postintervention. We did identify statistically significant, clinically medium effects in favor of acupuncture (as an adjunctive or monotherapy
Guiding periodontal pocket recolonization: a proof of concept.
Teughels, W; Newman, M G; Coucke, W; Haffajee, A D; Van Der Mei, H C; Haake, S Kinder; Schepers, E; Cassiman, J-J; Van Eldere, J; van Steenberghe, D; Quirynen, M
2007-11-01
The complexity of the periodontal microbiota resembles that of the gastro-intestinal tract, where infectious diseases are treatable via probiotics. In the oropharyngeal region, probiotic or replacement therapies have shown some benefit in the prevention of dental caries, otitis media, and pharyngitis, but their effectiveness in the treatment of periodontitis is unknown. Therefore, this study addressed the hypothesis that the application of selected beneficial bacteria, as an adjunct to scaling and root planing, would inhibit the periodontopathogen recolonization of periodontal pockets. Analysis of the data showed, in a beagle dog model, that when beneficial bacteria were applied in periodontal pockets adjunctively after root planing, subgingival recolonization of periodontopathogens was delayed and reduced, as was the degree of inflammation, at a clinically significant level. The study confirmed the hypothesis and provides a proof of concept for a guided pocket recolonization (GPR) approach in the treatment of periodontitis.
Metformin as adjunct antituberculosis therapy.
Singhal, Amit; Jie, Liu; Kumar, Pavanish; Hong, Gan Suay; Leow, Melvin Khee-Shing; Paleja, Bhairav; Tsenova, Liana; Kurepina, Natalia; Chen, Jinmiao; Zolezzi, Francesca; Kreiswirth, Barry; Poidinger, Michael; Chee, Cynthia; Kaplan, Gilla; Wang, Yee Tang; De Libero, Gennaro
2014-11-19
The global burden of tuberculosis (TB) morbidity and mortality remains immense. A potential new approach to TB therapy is to augment protective host immune responses. We report that the antidiabetic drug metformin (MET) reduces the intracellular growth of Mycobacterium tuberculosis (Mtb) in an AMPK (adenosine monophosphate-activated protein kinase)-dependent manner. MET controls the growth of drug-resistant Mtb strains, increases production of mitochondrial reactive oxygen species, and facilitates phagosome-lysosome fusion. In Mtb-infected mice, use of MET ameliorated lung pathology, reduced chronic inflammation, and enhanced the specific immune response and the efficacy of conventional TB drugs. Moreover, in two separate human cohorts, MET treatment was associated with improved control of Mtb infection and decreased disease severity. Collectively, these data indicate that MET is a promising candidate host-adjunctive therapy for improving the effective treatment of TB. Copyright © 2014, American Association for the Advancement of Science.
Bul, Kim C M; Kato, Pamela M; Van der Oord, Saskia; Danckaerts, Marina; Vreeke, Leonie J; Willems, Annik; van Oers, Helga J J; Van Den Heuvel, Ria; Birnie, Derk; Van Amelsvoort, Thérèse A M J; Franken, Ingmar H A; Maras, Athanasios
2016-02-16
The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called "Plan-It Commander") as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV).
2016-01-01
Background The need for accessible and motivating treatment approaches within mental health has led to the development of an Internet-based serious game intervention (called “Plan-It Commander”) as an adjunct to treatment as usual for children with attention-deficit/hyperactivity disorder (ADHD). Objective The aim was to determine the effects of Plan-It Commander on daily life skills of children with ADHD in a multisite randomized controlled crossover open-label trial. Methods Participants (N=170) in this 20-week trial had a diagnosis of ADHD and ranged in age from 8 to 12 years (male: 80.6%, 137/170; female: 19.4%, 33/170). They were randomized to a serious game intervention group (group 1; n=88) or a treatment-as-usual crossover group (group 2; n=82). Participants randomized to group 1 received a serious game intervention in addition to treatment as usual for the first 10 weeks and then received treatment as usual for the next 10 weeks. Participants randomized to group 2 received treatment as usual for the first 10 weeks and crossed over to the serious game intervention in addition to treatment as usual for the subsequent 10 weeks. Primary (parent report) and secondary (parent, teacher, and child self-report) outcome measures were administered at baseline, 10 weeks, and 10-week follow-up. Results After 10 weeks, participants in group 1 compared to group 2 achieved significantly greater improvements on the primary outcome of time management skills (parent-reported; P=.004) and on secondary outcomes of the social skill of responsibility (parent-reported; P=.04), and working memory (parent-reported; P=.02). Parents and teachers reported that total social skills improved over time within groups, whereas effects on total social skills and teacher-reported planning/organizing skills were nonsignificant between groups. Within group 1, positive effects were maintained or further improved in the last 10 weeks of the study. Participants in group 2, who played the serious game during the second period of the study (weeks 10 to 20), improved on comparable domains of daily life functioning over time. Conclusions Plan-It Commander offers an effective therapeutic approach as an adjunct intervention to traditional therapeutic ADHD approaches that improve functional outcomes in daily life. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 62056259; http://www.controlled-trials.com/ISRCTN62056259 (Archived by WebCite at http://www.webcitation.org/6eNsiTDJV). PMID:26883052
Flow control techniques for Onyx embolization of intracranial dural arteriovenous fistulae.
Shi, Zhong-Song; Loh, Yince; Gonzalez, Nestor; Tateshima, Satoshi; Feng, Lei; Jahan, Reza; Duckwiler, Gary; Viñuela, Fernando
2013-07-01
Experience of flow control techniques during endovascular treatment of intracranial dural arteriovenous fistulas (DAVFs) using the Onyx liquid embolic system is reported, with an emphasis on high flow shunts. Data were evaluated in patients with DAVFs treated endovascularly with Onyx. Adjunctive techniques with coils, acrylics and balloon assistance were utilized to reduce the rate of flow with transarterial and transvenous approaches. The following types of adjunctive techniques were used in 58 patients who underwent a total of 84 embolization sessions with Onyx: transvenous coiling with transvenous or transarterial Onyx embolization in 36 patients, transarterial coiling with transarterial Onyx embolization in eight patients, arterial or venous balloon assisted technique with transarterial or transvenous Onyx embolization in 11 patients, transarterial high concentration acrylics with transarterial Onyx embolization in one patient and staged transarterial or transvenous coiling and Onyx embolization in two patients. Complete obliteration of the fistulae was achieved in 41 patients (70.7%) and 27 patients (65.9%) with high flow fistulae after endovascular treatment alone. Periprocedural complications were encountered in 16 patients, and 13 complications were associated with the adjunctive techniques. There were four neurologic and two non-neurologic clinical sequelae. Distal Onyx migration occurred in four, microcatheter retention in three and cranial neuropathy in three patients. There was one instance each of cerebellar hemorrhage, thromboembolism, coil stretching and retention, and dissection. 56 survivors experienced complete resolution or significant improvement of their symptoms on follow-up. Flow control techniques are safe and effective adjunctive methods in primary endovascular Onyx embolization of high flow DAVFs.
Delsignore, Aba; Rufer, Michael; Emmerich, Juliane; Weidt, Steffi; Brühl, Annette Beatrix; Moergeli, Hanspeter
2016-10-30
The present study evaluates the impact of semi-individualized e-mail support as an adjunct to cognitive behavioral group therapy (CBGT) for social anxiety disorder (SAD) on dropout and outcome. The effectiveness of additional semi-individualized e-mail support was evaluated for the whole sample and for a subsample of patients at risk of dropping out of therapy. A total of 91 patients with SAD were allocated either to the intervention condition (CBGT with e-mail support), or to the control condition (CBGT without e-mail support). Anxiety symptoms, depression, global symptomatology and life satisfaction were assessed at pretreatment, post-treatment and follow-up (3, 6 and 12 months). From pre-treatment to post-treatment, both groups improved significantly on all symptom measures. Therapy gains were maintained at the 1-year follow-up. Subsample analyses showed that CBGT+e-mail was more effective than CGBT alone in reducing symptom severity among patients missing at least two therapy sessions. Additionally, in this subgroup, those receiving additional e-mail support showed a tendency towards lower dropout rates. Based on the results of this study, semi-individualized e-mail support between sessions seems to enhance the effectiveness of CBGT for SAD patients at risk of dropping out of treatment and should be considered as an additional tool in clinical practice. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Potential Efficacy of Citicoline as Adjunct Therapy in Treatment of Cerebral Malaria
El-Assaad, Fatima; Combes, Valery; Grau, Georges Emile Raymond
2014-01-01
Cerebral malaria (CM) is characterized by a dysregulated immune response that results in endothelial membrane destabilization and increased microparticle (MP) production. Citicoline (CTC) is a membrane stabilizer used for the treatment of neurological disorders. We evaluated the efficacy of CTC as adjunct therapy to aid recovery from experimental CM. We show that CTC reduces MP production in vitro; in combination with artesunate in vivo, confers partial protection against CM; and prolongs survival. PMID:24165175
Role of Antidiarrhoeal Drugs as Adjunctive Therapies for Acute Diarrhoea in Children
Faure, Christophe
2013-01-01
Acute diarrhoea is a leading cause of child mortality in developing countries. Principal pathogens include Escherichia coli, rotaviruses, and noroviruses. 90% of diarrhoeal deaths are attributable to inadequate sanitation. Acute diarrhoea is the second leading cause of overall childhood mortality and accounts for 18% of deaths among children under five. In 2004 an estimated 1.5 million children died from diarrhoea, with 80% of deaths occurring before the age of two. Treatment goals are to prevent dehydration and nutritional damage and to reduce duration and severity of diarrhoeal episodes. The recommended therapeutic regimen is to provide oral rehydration solutions (ORS) and to continue feeding. Although ORS effectively mitigates dehydration, it has no effect on the duration, severity, or frequency of diarrhoeal episodes. Adjuvant therapy with micronutrients, probiotics, or antidiarrhoeal agents may thus be useful. The WHO recommends the use of zinc tablets in association with ORS. The ESPGHAN/ESPID treatment guidelines consider the use of racecadotril, diosmectite, or probiotics as possible adjunctive therapy to ORS. Only racecadotril and diosmectite reduce stool output, but no treatment has yet been shown to reduce hospitalisation rate or mortality. Appropriate management with validated treatments may help reduce the health and economic burden of acute diarrhoea in children worldwide. PMID:23533446
Pharmaceutical management of the childhood glaucomas.
Talbot, A W; Russell-Eggitt, I
2000-05-01
Glaucoma in childhood is a diverse, blinding group of conditions, which presents a major therapeutic challenge. Treatment is primarily surgical with medical treatments used as an adjunct. None of these drugs has been granted approval by the regulatory agencies for use in children, but they are used on a compassionate basis. Issues of efficacy and safety of these medications in children are discussed. beta-adrenoceptor blockers have been employed as first line pharmaceutical therapy for many years. Recently three new classes of drugs have been developed for use in glaucoma in adults. beta-blockers remain first line therapy if there are no contraindications such as asthma. Topical carbonic anhydrase inhibitors (CAI) appear to be less effective than beta-blockers, but seem safe systemically, although associated with local irritation. They are useful as an adjunct to beta-blockers or as first line therapy when beta-blockers are contraindicated. Prostaglandins have not proved as effective in childhood glaucoma as in adult glaucoma, although it works well in some patients with juvenile open angle glaucoma (JOAG) and others with aphakic glaucoma. alpha-adrenergic agonists, although effective at least in the short-term, have serious, potential systemic side effects, which demand close observation when used in neonates and young infants.
Bucior, Iwona; Abbott, Jason; Song, Yuanlin; Matthay, Michael A.
2013-01-01
Treatment of acute and chronic pulmonary infections caused by opportunistic pathogen Pseudomonas aeruginosa is limited by the increasing frequency of multidrug bacterial resistance. Here, we describe a novel adjunctive therapy in which administration of a mix of simple sugars—mannose, fucose, and galactose—inhibits bacterial attachment, limits lung damage, and potentiates conventional antibiotic therapy. The sugar mixture inhibits adhesion of nonmucoid and mucoid P. aeruginosa strains to bronchial epithelial cells in vitro. In a murine model of acute pneumonia, treatment with the sugar mixture alone diminishes lung damage, bacterial dissemination to the subpleural alveoli, and neutrophil- and IL-8-driven inflammatory responses. Remarkably, the sugars act synergistically with anti-Pseudomonas antibiotics, including β-lactams and quinolones, to further reduce bacterial lung colonization and damage. To probe the mechanism, we examined the effects of sugars in the presence or absence of antibiotics during growth in liquid culture and in an ex vivo infection model utilizing freshly dissected mouse tracheas and lungs. We demonstrate that the sugar mixture induces rapid but reversible formation of bacterial clusters that exhibited enhanced susceptibility to antibiotics compared with individual bacteria. Our findings reveal that sugar inhalation, an inexpensive and safe therapeutic, could be used in combination with conventional antibiotic therapy to more effectively treat P. aeruginosa lung infections. PMID:23792737
Martins, Sérgio H L; Novaes, Arthur B; Taba, Mario; Palioto, Daniela B; Messora, Michel R; Reino, Danilo M; Souza, Sérgio L S
2017-07-01
This randomized controlled clinical trial evaluated the effects of an adjunctive single application of antimicrobial photodynamic therapy (aPDT) in Surgical Periodontal Treatment (ST) in patients with severe chronic periodontitis (SCP). In a split-mouth design, 20 patients with SCP were treated with aPDT+ST (Test Group, TG) or ST only (Control Group, CG). aPDT was applied in a single episode, using a diode laser and a phenothiazine photosensitizer. All patients were monitored until 90 days after surgical therapy. Levels of 40 subgingival species were measured by checkerboard DNA-DNA hybridization at baseline, 60 and 150 days. Clinical and microbiological parameters were evaluated. In deep periodontal pockets depth (PPD ≥5 mm), Test Group presented a significantly higher decrease in PPD than Control Group at 90 days after surgical therapy (p < .05). Test Group also demonstrated significantly less periodontal pathogens of red complex (Treponema denticola) (p < .05). A single episode of aPDT used in adjunct to open flap debridement of the root surface in the surgical treatment of SCP: i) significantly improved clinical periodontal parameters; ii) eliminates periodontal pathogens of the red complex more effectively (NCT02734784). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Kondo, Douglas G; Sung, Young-Hoon; Hellem, Tracy L; Fiedler, Kristen K; Shi, Xianfeng; Jeong, Eun-Kee; Renshaw, Perry F
2011-12-01
Adolescent major depressive disorder (MDD) is a life-threatening brain disease with limited interventions. Treatment resistance is common, and the illness burden is disproportionately borne by females. 31-Phosphorus magnetic resonance spectroscopy ((31)P MRS) is a translational method for in vivo measurement of brain energy metabolites. We recruited 5 female adolescents who had been on fluoxetine (Prozac®) for ≥ 8 weeks, but continued meet diagnostic criteria for MDD with a Children's Depression Rating Scale-Revised (CDRS-R) raw score ≥ 40. Treatment response was measured with the CDRS-R. (31)P MRS brain scans were performed at baseline, and repeated following adjunctive creatine 4 g daily for 8 weeks. For comparison, 10 healthy female adolescents underwent identical brain scans performed 8 weeks apart. The mean CDRS-R score declined from 69 to 30.6, a decrease of 56%. Participants experienced no Serious Adverse Events, suicide attempts, hospitalizations or intentional self-harm. There were no unresolved treatment-emergent adverse effects or laboratory abnormalities. MDD participants' baseline CDRS-R score was correlated with baseline pH (p=0.04), and was negatively correlated with beta-nucleoside triphosphate (β-NTP) concentration (p=0.03). Compared to healthy controls, creatine-treated adolescents demonstrated a significant increase in brain Phosphocreatine (PCr) concentration (p=0.02) on follow-up (31)P MRS brain scans. Lack of placebo control; and small sample size. Further study of creatine as an adjunctive treatment for adolescents with SSRI-resistant MDD is warranted. Copyright © 2011 Elsevier B.V. All rights reserved.
Role of Hematopoietic Growth Factors as Adjuncts in the Treatment of Chronic Hepatitis C Patients
Danish, Fazal A.; Koul, Salman S.; Subhani, Fazal R.; Rabbani, Ahemd E.; Yasmin, Saeeda
2008-01-01
Drug-induced hematotoxicity is the most common reason for reducing the dose or withdrawing ribavirin (RBV) and interferon (IFN) therapy in chronic hepatitis C, which leads to the elimination of a possible cure for the patient. Traditionally, severe anemia and neutropenia have been considered as absolute contraindications to start antiviral therapy. This has not however, been the case since the advent of adjunct therapy with hematopoietic growth factors (erythropoietin (EPO) and granulocyte-colony stimulating factor (G-CSF)). Some recent landmark studies have used this adjunct therapy to help avoid antiviral dose reductions. Although the addition of this adjunct therapy has been shown to significantly increase the overall cost of the treatment, this extra cost is worth bearing if the infection is cured at the end of the day. Although more studies are needed to refine the true indications of this adjunct therapy, determine the best dose regimen, quantify the average extra cost and determine whether or not the addition of this therapy increases the sustained virological response rates achieved, the initial reports are encouraging. Therefore, although not recommended on a routine basis, some selected patients may be given the benefits of these factors. This article reviews the current literature on this subject and makes a few recommendations to help develop local guidelines. PMID:19568529
Physical Exercise for Treatment of Mood Disorders: A Critical Review
Hearing, CM; Chang, WC; Szuhany, KL; Deckersbach, T; Nierenberg, AA; Sylvia, LG
2016-01-01
Purpose of the review The purpose of this review is to critically assess the evidence for exercise as an adjunct intervention for major depressive disorder and bipolar disorder, chronic conditions characterized by frequent comorbid conditions as well as interepisodic symptoms with poor quality of life and impaired functioning. Individuals with these mood disorders are at higher risk of cardiovascular disease and premature death in part because of increased rates of obesity, inactivity, and diabetes mellitus compared to the general population. Exercise may not only mitigate the increased risk of cardiovascular disease, but could also potentially improve the long term outcomes of mood disorders. Recent findings We conducted a literature review on the impact of exercise on mood disorders and associated comorbid conditions as well as possible biological mechanisms. We found that exercise impacts both the physical health parameters of mood disorders as well as mental health outcomes. Exercise also positively impacts conditions frequently comorbid with mood disorders (i.e. anxiety, pain, and insomnia). There are multiple candidate biomarkers for exercise, with brain-derived neurotrophic factor and oxidative stress as two main promising components of exercise’s anti-depressant effect. Summary Exercise appears to be a promising adjunct treatment for mood disorders. We conclude with recommendations for future research of exercise as an adjunct intervention for mood disorders. PMID:28503402
Physical Exercise for Treatment of Mood Disorders: A Critical Review.
Hearing, C M; Chang, W C; Szuhany, K L; Deckersbach, T; Nierenberg, A A; Sylvia, L G
2016-12-01
The purpose of this review is to critically assess the evidence for exercise as an adjunct intervention for major depressive disorder and bipolar disorder, chronic conditions characterized by frequent comorbid conditions as well as interepisodic symptoms with poor quality of life and impaired functioning. Individuals with these mood disorders are at higher risk of cardiovascular disease and premature death in part because of increased rates of obesity, inactivity, and diabetes mellitus compared to the general population. Exercise may not only mitigate the increased risk of cardiovascular disease, but could also potentially improve the long term outcomes of mood disorders. We conducted a literature review on the impact of exercise on mood disorders and associated comorbid conditions as well as possible biological mechanisms. We found that exercise impacts both the physical health parameters of mood disorders as well as mental health outcomes. Exercise also positively impacts conditions frequently comorbid with mood disorders (i.e. anxiety, pain, and insomnia). There are multiple candidate biomarkers for exercise, with brain-derived neurotrophic factor and oxidative stress as two main promising components of exercise's anti-depressant effect. Exercise appears to be a promising adjunct treatment for mood disorders. We conclude with recommendations for future research of exercise as an adjunct intervention for mood disorders.
Stenman, J; Wennström, J L; Abrahamsson, K H
2018-05-01
To evaluate (ii) whether inclusion of a single motivational interviewing (MI) session, as an adjunct to periodontal therapy, might be beneficial for preventing relapse in oral hygiene behaviours among patients treated for chronic periodontitis and (ii) whether individual and clinical characteristics can be of predictive value for retention of sufficient oral hygiene behaviours. This 3-year follow-up of a previously reported randomized controlled trial (RCT) study of 6-month duration included 26 patients. Patients in the test group had received one MI session by a clinical psychologist before initiation of the periodontal treatment. Otherwise, all patients followed the same treatment protocol for conventional educational intervention and non-surgical periodontal therapy. Efficacy variables assessed for evaluation of the standard of self-performed periodontal infection control were marginal bleeding index (MBI; primary efficacy variable) and plaque score (PI). The patterns of change in MBI and PI scores were similar for test and control groups over the observation period. At 3 years, both groups showed a desirable mean full-mouth MBI of 15%, a figure that was comparable to that at the short-term evaluation after active periodontal treatment. The post-treatment MBI was the only variable identified as a predictor of retained adequate oral hygiene behaviours. A single MI session as an adjunct to conventional periodontal therapy could not be proven to be of long-term beneficial additive effect with regard to prevention of relapse in oral hygiene behaviour. Desirable standard of self-performed infection control after active periodontal treatment predicted the retention of sufficient oral hygiene behaviour over time. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Non-Steroidal Anti-inflammatory Drugs As Host-Directed Therapy for Tuberculosis: A Systematic Review
Kroesen, Vera M.; Gröschel, Matthias I.; Martinson, Neil; Zumla, Alimuddin; Maeurer, Markus; van der Werf, Tjip S.; Vilaplana, Cristina
2017-01-01
Lengthy, antimicrobial therapy targeting the pathogen is the mainstay of conventional tuberculosis treatment, complicated by emerging drug resistances. Host-directed therapies, including non-steroidal anti-inflammatory drugs (NSAIDs), in contrast, target host factors to mitigate disease severity. In the present Systematic Review, we investigate whether NSAIDs display any effects as therapy of TB and discuss possible mechanisms of action of NSAIDs as adjunctive therapy of TB. Ten studies, seven preclinical studies in mice and three clinical trials, were included and systematically reviewed. Our results point toward a beneficial effect of NSAIDs as adjunct to current TB therapy regimens, mediated by decreased lung pathology balancing host-immune reaction. The determination of the best timing for their administration in order to obtain the potential beneficial effects needs further investigation. Even if the preclinical evidence requires clinical evaluation, NSAIDs might represent a potential safe, simple, and cheap improvement in therapy of TB. PMID:28713389
Avellar, Ariane B C C; Carvalho, Luciane B C; Prado, Gilmar F; Prado, Lucila B F
2016-12-01
Pharmacotherapy has been used as an adjunct to CPAP for treatment of residual excessive sleepiness in patients with a diagnosis of obstructive sleep apnea syndrome (OSAS). However, no studies with a high level of evidence have been conducted to support this practice and confirm its effectiveness. We conducted a meta-analysis to summarize and quantify the effects of pharmacological treatment in adults with OSAS who experience residual excessive sleepiness despite adequate CPAP use. We reviewed clinical trials that compared medications to placebo and evaluated the outcomes residual excessive sleepiness, cognition, and quality of life, as well as treatment effectiveness and safety. The MEDLINE, EMBASE, LILACS, Cochrane Central Register of Controlled Trials - CENTRAL, and PsycINFO electronic databases were searched using highly sensitive search strategies. Trials were only included if measures were taken to ensure effective CPAP treatment. Eight randomized clinical trials were included. Pharmacotherapy with modafinil and armodafinil led to improvement of excessive daytime sleepiness, attention/alertness, and clinical condition as measured with the CGI-C. No improvements in quality of life or other cognitive domains (including memory, executive function, and language) could be confirmed. Pharmacotherapy did not cause any severe adverse effects, but was associated with significant dropout rates as compared with placebo. In conclusion, although our results demonstrate the effectiveness of pharmacological treatment as an adjunct to CPAP, further investigation is necessary to improve confidence in its effects. Many findings on the impact of pharmacotherapy on cognition and quality of life were evaluated through analysis of single studies, with heterogeneity in tests and absence of standardization, which reduced certainty as to whether actual improvement occurred in these outcomes. Copyright © 2015 Elsevier Ltd. All rights reserved.
Kerling, A; Kück, M; Tegtbur, U; Grams, L; Weber-Spickschen, S; Hanke, A; Stubbs, B; Kahl, K G
2017-06-01
Brain derived neurotrophic factor (BDNF) has been implicated in the pathogenesis of major depressive disorder (MDD). Existing data on exercise treatment in people with MDD are inconsistent concerning the effect of exercise on BDNF pointing either to increased or unaltered BDNF concentrations. However, studies in non-depressed persons demonstrated a significant effect on resting peripheral BDNF concentrations in aerobic training interventions. Given the lack of clarity mentioned above, the current study aimed at examining the effect of adjunctive exercise on serum BDNF levels in guideline based treated patients with MDD. 42 depressed inpatients were included, and randomized either to a 6 week structured and supervised exercise intervention plus treatment as usual (EXERCISE, n=22), or to treatment as usual (TAU, n=20). BDNF serum concentrations were assessed before and after the intervention in both study groups with established immunoassays. Serum BDNF slightly decreased in the TAU group, whilst there was an increase in BDNF levels in the exercise group. There was a significant time x group effect concerning sBDNF (p=0.030) with repeated ANOVA measures with age and BMI as covariates, suggesting an increase in BDNF concentrations in the EXERCISE group compared to TAU. Though there was no statistic difference in the antidepressant medication between EXERCISE and TAU potential interactions between exercise and medication on the effects of exercise in BDNF cannot be excluded. Gender was not considered as a covariate in ANOVA due to the small number of objects. Exercise training given as adjunct to standard guideline based treatment appears to have additional effects on BDNF serum concentrations in people with MDD. Our results add further evidence to the beneficial effects of exercise in the treatment of MDD. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.
Adjunctive pregabalin in partial responders with major depressive disorder and residual anxiety.
Vitali, Mario; Tedeschini, Enrico; Mistretta, Martino; Fehling, Kiki; Aceti, Franca; Ceccanti, Mauro; Fava, Maurizio
2013-02-01
Anxiety symptoms in depression result often in treatment resistance, residual symptoms, and persistent functional impairment. To assess the effectiveness and safety of adjunctive pregabalin to antidepressants for residual anxiety in patients with major depressive disorder (MDD). A retrospective chart review was conducted to identify partial responders among patients with MDD with residual anxiety. Twenty such patients (age, 58.4 ± 11.2 years; 15 women; baseline Hamilton Depression Rating Scale [HDRS], 17.1 ± 3.5) who received adjunctive pregabalin for residual anxiety were included. Antidepressants augmented were the selective serotonin reuptake inhibitors (n = 12), mirtazapine (n = 2), and selective serotonin-norepinephrine reuptake inhibitors (n = 6). Twenty patients received at least 4 weeks of pregabalin treatment after 8 weeks of antidepressant therapy. At week 1 (9 weeks after initiating treatment), pregabalin was prescribed at a mean ± SD dose of 71.2 ± 31.7 mg, and the mean maximum pregabalin dose prescribed was 156.2 ± 76.5 mg (range, 75-300 mg). At week 8, there were 13 responders (13/20 [65%]), and 7 of these 13 patients achieved remission (HDRS17 < 8). There were significant decreases in HDRS scores (13.5 ± 3.1 vs 9.1 ± 2.9, P < 0.000), and HDRS anxiety/somatization subscale scores (6.3 ± 2 to 3.6 ± 1.7, P < 0.000). Adverse effects included somnolence (n = 7), weight gain (n = 3), dizziness (n = 4), dry mouth (n = 6), edema (n = 3), blurred vision (n = 3), difficulty with concentration/attention (n = 8), headache (n = 6), and diarrhea (n = 5). The results suggest a possible augmentation role for pregabalin when used in conjunction with conventional antidepressants for residual anxiety in MDD.
Cook, Ian A; Abrams, Michelle; Leuchter, Andrew F
2016-04-01
External stimulation of the trigeminal nerve (eTNS) is an emerging neuromodulation therapy for epilepsy and depression. Preliminary studies suggest it has an excellent safety profile and is associated with significant improvements in seizures and mood. Neuroanatomical projections of the trigeminal system suggest eTNS may alter activity in structures regulating mood, anxiety, and sleep. In this proof-of-concept trial, the effects of eTNS were evaluated in adults with posttraumatic stress disorder (PTSD) and comorbid unipolar major depressive disorder (MDD) as an adjunct to pharmacotherapy for these commonly co-occurring conditions. Twelve adults with PTSD and MDD were studied in an eight-week open outpatient trial (age 52.8 [13.7 sd], 8F:4M). Stimulation was applied to the supraorbital and supratrochlear nerves for eight hours each night as an adjunct to pharmacotherapy. Changes in symptoms were monitored using the PTSD Patient Checklist (PCL), Hamilton Depression Rating Scale (HDRS-17), Quick Inventory of Depressive Symptomatology (QIDS-C), and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Over the eight weeks, eTNS treatment was associated with significant decreases in PCL (p = 0.003; median decrease of 15 points; effect size d 1.5), HDRS-17 (p < 0.001; 42% response rate, 25% remission; d 2.1), and QIDS-C scores (p < 0.001; d 1.8), as well as an improvement in quality of life (Q-LES-Q, p < 0.01). eTNS was well tolerated with few treatment emergent adverse events. Significant improvements in PTSD and depression severity were achieved in the eight weeks of acute eTNS treatment. This novel approach to wearable brain stimulation may have use as an adjunct to pharmacotherapy in these disorders if efficacy and tolerability are confirmed with additional studies. © 2016 International Neuromodulation Society.
2010-11-01
particular nerve agent and oxime uti- lized in the treatment regimen. Atropine is the universal treatment for organophospho- rus anticholinesterase poisoning...general, to the recovery of AChE activity either through decarbamylation of PB protected enzyme or by use of an effective oxime. The results against...this protected enzyme in the first few minutes after intoxication and treat- ment provides sufficient enzyme activity to sustain survival.̂ ’"* A
Seite, Sophie; Benech, Florence; Berdah, Sandrine; Bayer, Muriel; Veyrat, Sophie; Segot, Evelyne; Sakalikova, Marcela; Gibejova, Lucia; Zelenkova, Hana
2013-08-01
The objective of these studies was to investigate whether a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay thermal spring water formulated in a highly protective packaging can have an impact in the management of rosacea-prone skin subjects. Several studies were performed to evaluate the efficacy of this product in the management of rosacea prone skin, as either monotherapy or adjunctive therapy or to maintain the efficacy of a Metronidazole treatment. The first study was performed on 37 women aged 18-45 with added stage 2 erythro-couperosis, who applied test formula as monotherapy twice a day for 4 weeks. During a second study, a dermatological evaluation was performed on patients with stage I or II rosacea, a questionnaire containing information about patient characteristics, tolerance, clinical signs, symptoms and skin reactivity to "trigger factors" was completed by dermatologists at baseline and 2 months after treatment with the test formula as either monotherapy or adjunctive therapy. Finally, in a third study, 65 patients finishing a Metronidazole treatment applied once daily and the tested formula twice daily were divided into 2 groups using the test formula or vehicle control, twice a day for 8 weeks for the evaluation of efficacy as adjunctive therapy. We noted that the test formula, as an adjunctive therapy, helped prolong the efficacy of a Metronidazole treatment. In monotherapy, there was a significant efficacy of the test formula associated with an excellent tolerance. A significant improvement of all the clinical signs and symptoms of rosacea and a reduction of the skin reactivity to "trigger factors" were shown. These studies highlight the interest value and impact of a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay thermal spring water formulated in a highly protective packaging in monotherapy or in combination with or after a therapeutic treatment in the management of patients suffering from rosacea.
Nguyen, Naomi-Trang; Byarlay, Matthew R; Reinhardt, Richard A; Marx, David B; Meinberg, Trudy A; Kaldahl, Wayne B
2015-10-01
Numerous studies have documented the clinical outcomes of laser therapy for untreated periodontitis, but very few have reported on lasers treating inflamed pockets during maintenance therapy. The aim of this study is to compare the effectiveness of scaling and root planing (SRP) plus the adjunctive use of diode laser therapy to SRP alone on changes in the clinical parameters of disease and on the gingival crevicular fluid (GCF) inflammatory mediator interleukin-1β (IL-1β) in patients receiving regular periodontal maintenance therapy. This single-masked and randomized, controlled, prospective study includes 22 patients receiving regular periodontal maintenance therapy who had one or more periodontal sites with a probing depth (PD) ≥ 5 mm with bleeding on probing (BOP). Fifty-six sites were treated with SRP and adjunctive laser therapy (SRP + L). Fifty-eight sites were treated with SRP alone. Clinical parameters, including PD, clinical attachment level (CAL), and BOP, and GCF IL-1β levels were measured immediately before treatment (baseline) and 3 months after treatment. Sites treated with SRP + L and SRP alone resulted in statistically significant reductions in PD and BOP and gains in CAL. These changes were not significantly different between the two therapies. Similarly, differences in GCF IL-1β levels between SRP + L and SRP alone were not statistically significant. In periodontal maintenance patients, SRP + L did not enhance clinical outcomes compared to SRP alone in the treatment of inflamed sites with ≥ 5 mm PD.
Melatonin and Melatonin Agonists as Adjunctive Treatments in Bipolar Disorders.
Geoffroy, Pierre Alexis; Etain, Bruno; Franchi, Jean-Arthur Micoulaud; Bellivier, Frank; Ritter, Philipp
2015-01-01
Bipolar disorders (BD) present with abnormalities of circadian rhythmicity and sleep homeostasis, even during phases of remission. These abnormalities are linked to the underlying neurobiology of genetic susceptibility to BD. Melatonin is a pineal gland secreted neurohormone that induces circadian-related and sleep-related responses. Exogenous melatonin has demonstrated efficacy in treating primary insomnia, delayed sleep phase disorder, improving sleep parameters and overall sleep quality, and some psychiatric disorders like autistic spectrum disorders. In order to evaluate the efficacy of melatonin among patients with BD, this comprehensive review emphasizes the abnormal melatonin function in BD, the rationale of melatonin action in BD, the available data about the exogenous administration of melatonin, and melatonin agonists (ramelteon and tasimelteon), and recommendations of use in patients with BD. There is a scientific rationale to propose melatonin-agonists as an adjunctive treatment of mood stabilizers in treating sleep disorders in BD and thus to possibly prevent relapses when administered during remission phases. We emphasized the need to treat insomnia, sleep delayed latencies and sleep abnormalities in BD that are prodromal markers of an emerging mood episode and possible targets to prevent future relapses. An additional interesting adjunctive therapeutic effect might be on preventing metabolic syndrome, particularly in patients treated with antipsychotics. Finally, melatonin is well tolerated and has little dependence potential in contrast to most available sleep medications. Further studies are expected to be able to produce stronger evidence-based therapeutic guidelines to confirm and delineate the routine use of melatonin-agonists in the treatment of BD.
Johnstone, Ainslie; Levenstein, Jacob M; Hinson, Emily L; Stagg, Charlotte J
2017-01-01
Stroke is a leading cause of long-term disability, with around three-quarters of stroke survivors experiencing motor problems. Intensive physiotherapy is currently the most effective treatment for post-stroke motor deficits, but much recent research has been targeted at increasing the effects of the intervention by pairing it with a wide variety of adjunct therapies, all of which aim to increase cortical plasticity, and thereby hope to maximize functional outcome. Here, we review the literature describing neurochemical changes underlying plasticity induction following stroke. We discuss methods of assessing neurochemicals in humans, and how these measurements change post-stroke. Motor learning in healthy individuals has been suggested as a model for stroke plasticity, and we discuss the support for this model, and what evidence it provides for neurochemical changes. One converging hypothesis from animal, healthy and stroke studies is the importance of the regulation of the inhibitory neurotransmitter GABA for the induction of cortical plasticity. We discuss the evidence supporting this hypothesis, before finally summarizing the literature surrounding the use of adjunct therapies such as non-invasive brain stimulation and SSRIs in post-stroke motor recovery, both of which have been show to influence the GABAergic system.
Fan, Xiaoduo; Liu, Emily; Freudenreich, Oliver; Copeland, Paul; Hayden, Douglas; Ghebremichael, Musie; Cohen, Bruce; Ongur, Dost; Goff, Donald C.; Henderson, David C.
2015-01-01
Objective This study examined the effect of adjunctive intranasal insulin therapy on psychopathology and cognition in patients with schizophrenia. Methods Each subject had a DSM-IV diagnosis of schizophrenia or schizoaffective disorder and been on stable antipsychotics for at least one month. In an 8-week randomized, double blind, placebo controlled study, subjects received either intranasal insulin (40 IU 4 times per day) or placebo. Psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS). A neuropsychological battery was used to assess cognitive performance. The assessment for psychopathology and cognition was conducted at baseline, week 4 and week 8. Results A total number of 45 subjects were enrolled in the study (21 in the insulin group, 24 in the placebo group). The mixed model analysis showed that there were no significant differences between the two groups at week 8 on various psychopathology and cognitive measures (p’s > 0.1). Conclusion Adjunctive therapy with intranasal insulin did not seem to be beneficial in improving schizophrenia symptoms or cognition in the present study. The implications for future studies were discussed. PMID:23422397
2014-01-01
Background This post hoc analysis assessed the safety, tolerability and effectiveness of long-term treatment with aripiprazole adjunctive to either bupropion or selective serotonin reuptake inhibitors (SSRIs)/serotonin–norepinephrine reuptake inhibitors (SNRIs) in patients with major depressive disorder (MDD). Methods Data from de novo patients (did not participate in 2 previous studies) in a 52-week, open-label safety study of adjunctive aripiprazole after documented inadequate response to 1–4 antidepressant treatments (ADTs; SSRI, SNRI, or bupropion) were analyzed post hoc. Assessments included safety and tolerability, sexual functioning (Massachusetts General Hospital Sexual Functioning Inventory [MGH-SFI]) and Clinical Global Impressions–Severity (CGI-S). Results Forty-seven patients received bupropion plus aripiprazole and 245 received an SSRI/SNRI plus aripiprazole; 19 (40.4%) and 78 (31.8%), respectively, completed 52 weeks of treatment, and 46 and 242, respectively, received ≥1 dose of study medication (safety sample). Median time to discontinuation (any reason) was 184.0 days. Overall, 97.8% of patients in the bupropion group and 93.8% in the SSRI/SNRI group experienced ≥1 adverse event. The most common treatment-emergent adverse events were fatigue (26.1%) and somnolence (21.7%) with bupropion and fatigue (23.6%) and akathisia (23.6%) with an SSRI/SNRI. Mean change in body weight at week 52 (observed cases) was +3.1 kg for bupropion and +2.4 kg for an SSRI/SNRI. Treatment-emergent, potentially clinically relevant abnormalities in fasting glucose occurred in 8.3% of patients with bupropion and 17.4% with an SSRI/SNRI; for abnormalities in fasting total cholesterol, the incidence was 25.0% and 34.7%, respectively. Mean (SE) change from baseline in fasting glucose was 1.4 (1.9) mg/dL with bupropion and 2.7 (1.5) mg/dL with an SSRI/SNRI. Baseline MGH-SFI item scores indicated less severe impairment with bupropion versus an SSRI/SNRI; in both groups most MGH-SFI items exhibited improvement at week 52. Mean CGI-S improvement at week 52 (last observation carried forward) was -1.4 with bupropion and -1.5 with an SSRI/SNRI (efficacy sample). Conclusions There were no unexpected AEs with long-term adjunctive aripiprazole therapy when added to either bupropion or SSRIs/SNRIs, and symptom improvement was similar between ADT groups. Sexual functioning in patients with MDD on antidepressants was also modestly improved after adding aripiprazole. Trial registration ClinicalTrials.gov: NCT00095745 (November 9, 2004). PMID:25037144
Acupuncture for the Management of Postdural Puncture Headache: A Case Report
Chang, Alexandra; Acquah, Joseph; Reddy, Sanjay
2016-01-01
Postdural puncture headache (PDPH) is a recognized complication of neuraxial anesthesia. This case report documents 1 patient who developed PDPH following epidural anesthesia for postoperative pain control. The patient declined conventional treatments, including an epidural blood patch and intravenous caffeine. This report documents successful use of adjunct acupuncture for the management of PDPH. Additional research on acupuncture as a potential adjunctive therapy for PDPH is needed, particularly for patients who are reluctant to receive more invasive treatments. PMID:26937320
Overprompting Science Students Using Adjunct Study Questions.
ERIC Educational Resources Information Center
Holliday, William G.
Described is an investigation of the hypothesis that students presented with strong hints or prompts to answers of comprehension questions adjunct to a flow diagram would understand less than students presented with no prompts. Also described is the study of the hypotheses that a diagram-only treatment group would outperform the prompted group and…
So, Suzanne Ho-Wai; Chan, Arthur P.; Chong, Catherine Shiu-Yin; Wong, Melissa Hiu-Mei; Lo, William Tak-Lam; Chung, Dicky Wai-Sau; Chan, Sandra S.
2015-01-01
Metacognitive training (MCT) was developed to promote awareness of reasoning biases among patients with schizophrenia. While MCT has been translated into 31 languages, most MCT studies were conducted in Europe, including newer evidence recommending an individualized approach of delivery. As reasoning biases covered in MCT are separable processes and are associated with different symptoms, testing the effect of selected MCT modules would help to develop a targeted and cost-effective intervention for specific symptoms and associated mechanisms. This study tested the efficacy of a four-session metacognitive training for delusions, MCTd (in Traditional Chinese with cultural adaptations, provided individually), as an adjunct to antipsychotics in reducing severity and conviction of delusions, jumping to conclusions (JTC) bias and belief inflexibility. Forty-four patients with delusions were randomized into the MCTd or the wait-list control condition. Patients on wait-list received the same MCTd after 4 weeks of treatment as usual (TAU). Assessment interviews took place before and after the treatment, and at 4-week follow-up. There was an additional baseline assessment for the controls. JTC and belief flexibility were measured by the beads tasks and the Maudsley Assessment of Delusions Scale. Attendance rate of the MCTd was satisfactory (84.5%). Compared to TAU, there was a greater reduction in psychotic symptoms, delusional severity and conviction following MCTd. There was a large treatment effect size in improvement in belief flexibility. Improvement in reaction to hypothetical contradiction predicted treatment effect in positive symptoms and delusions. JTC bias was reduced following MCTd, although the treatment effect was not significantly larger than TAU. Our results support the use of process-based interventions that target psychological mechanisms underlying specific psychotic symptoms as adjuncts to more conventional approaches. PMID:26124726
Routines for interocclusal appliance therapy among general dental practitioners in a Swedish county.
Gnauck, Maja; Helkimo, Martti; Magnusson, Tomas
2012-01-01
The aims of this study were to investigate what kind of interocclusal appliances that were chosen among Swedish dentists when treating temporomandibular disorders (TMD), the clinical rationale for the treatment, the diagnoses that warranted the appliance treatment, the use of adjunct TMD treatments and prognostic considerations, and possible differences in these respects between children/adolescents and adults with TMD, and, finally, possible differences between private practitioners and general practitioners in the public dental service. During the 12-months-period April 2009-March 2010 all general dental practitioners in the county of Jönköping, Sweden, were asked to fill in a questionnaire when performing a TMD treatment with an interocclusal appliance. A total of 394 questionnaires were filled in and returned, 216 (55%) from dentists in public dental service and 178 (45%) from private practitioners. It was found that in 40% of the cases, no pre-treatment recording of the functional status in the masticatory system had been made. The commonest reasons for the treatment were bruxism, headache, and replacement of a previous appliance. Less than half of the appliances made were hard acrylic appliances. Some kind of adjunct therapy had been made in 22% of the cases treated in public dental service. The corresponding figure for those treated by private practitioners was 25%. Therapeutic jaw exercises was the commonest adjunct therapy followed by selective occlusal adjustment. In the vast majority of cases, the dentists judged the prognosis of the treatment to be good. It is concluded that a large number of appliances made to treat TMD were soft appliances, especially in public dental service. This reflects a possible overuse of soft appliances at the expense of hard acrylic appliances. Furthermore, in a large number of cases, the treatment was performed without any pre-treatment registrations, and adjunct therapies were rarely used. In all these respects,there is an improvement potential for the treatment of TMD in general dental practice.
Relapse Prevention for Alcohol and Drug Problems: That Was Zen, This Is Tao
ERIC Educational Resources Information Center
Witkiewitz, Katie; Marlatt, Alan G.
2004-01-01
Relapse prevention, based on the cognitive-behavioral model of relapse, has become an adjunct to the treatment of numerous psychological problems, including (but not limited to) substance abuse, depression, sexual offending, and schizophrenia. This article provides an overview of the efficacy and effectiveness of relapse prevention in the…
Epidural cortical stimulation as adjunctive treatment for non-fluent aphasia: preliminary findings.
Cherney, Leora R; Erickson, Robert K; Small, Steven L
2010-09-01
This study evaluated the safety and feasibility of targeted epidural cortical stimulation delivered concurrently with intensive speech-language therapy for treatment of chronic non-fluent aphasia. Eight stroke survivors with non-fluent aphasia received intensive behavioural therapy for 3 h daily for 6 weeks using a combination of articulation drills, oral reading and conversational practice. Four of these participants (investigational participants) also underwent functional MRI guided surgical implantation of an epidural stimulation device which was activated only during therapy sessions. Behavioural data were collected before treatment, immediately after treatment and at 6 and 12 weeks following termination of therapy. Imaging data were collected before and after treatment. Investigational participants showed a mean Aphasia Quotient change of 8.0 points immediately post-therapy and at the 6 week follow-up, and 12.3 points at 12 weeks. The control group had changes of 4.6, 5.5 and 3.6 points, respectively. Similar changes were noted on subjective caregiver ratings. Functional imaging suggested increased consolidation of activity in interventional participants. Behavioural speech-language therapy improves non-fluent aphasia, independent of cortical stimulation. However, epidural stimulation of the ipsilesional premotor cortex may augment this effect, with the largest effects after completion of therapy. The neural mechanisms underlying these effects are manifested in the brain by decreases in the volume of activity globally and in particular regions. Although the number of participants enrolled in this trial precludes definitive conclusions, targeted epidural cortical stimulation appears safe and may be a feasible adjunctive treatment for non-fluent aphasia, particularly when the aphasia is more severe.
Effect of Level of Adjunct Questions on Achievement of Field Independent/Field Dependent Learners
ERIC Educational Resources Information Center
Pi-Sui-Hsu; Dwyer, Francis
2004-01-01
Adjunct questions inserted in text requires that an individual is retrieving known concepts and constructing the new meaning. In this process, the individual has to recall the knowledge just studied and locate exactly the location of the information. This study attempts to examine the (a) instructional effects of varied types of adjunct questions…
ERIC Educational Resources Information Center
Betts, Kristen S.; Sikorski, Bernadine
2008-01-01
Turnover and attrition of online faculty and adjunct faculty is a reality. While there are no reported national statistics or data on annual turnover/attrition for online faculty/adjunct, the overall costs of recruiting, training, and replacing faculty/adjunct can be staggering. Moreover, the short and long term effects of online faculty/adjunct…
2009-01-01
Background In Vitro Fertilisation (IVF) is now an accepted and effective treatment for infertility, however IVF is acknowledged as contributing to, rather than lessening, the overall psychosocial effects of infertility. Psychological and counselling interventions have previously been widely recommended in parallel with infertility treatments but whilst in many jurisdictions counselling is recommended or mandatory, it may not be widely used. Acupuncture is increasingly used as an adjunct to IVF, in this preliminary study we sought to investigate the experience of infertile women who had used acupuncture to improve their fertility. Methods A sample of 20 women was drawn from a cohort of women who had attended for a minimum of four acupuncture sessions in the practices of two acupuncturists in South Australia. Eight women were interviewed using a semi-structured questionnaire. Six had sought acupuncture during IVF treatment and two had begun acupuncture to enhance their fertility and had later progressed to IVF. Descriptive content analysis was employed to analyse the data. Results Four major categories of perceptions about acupuncture in relation to reproductive health were identified: (a) Awareness of, and perceived benefits of acupuncture; (b) perceptions of the body and the impact of acupuncture upon it; (c) perceptions of stress and the impact of acupuncture on resilience; and (d) perceptions of the intersection of medical treatment and acupuncture. Conclusion This preliminary exploration, whilst confined to a small sample of women, confirms that acupuncture is indeed perceived by infertile women to have an impact to their health. All findings outlined here are reported cautiously because they are limited by the size of the sample. They suggest that further studies of acupuncture as an adjunct to IVF should systematically explore the issues of wellbeing, anxiety, personal and social resilience and women's identity in relation to sexuality and reproduction. PMID:20003370
Abdollahi, Abbas; LeBouthillier, Daniel M; Najafi, Mahmoud; Asmundson, Gordon J G; Hosseinian, Simin; Shahidi, Shahriar; Carlbring, Per; Kalhori, Atefeh; Sadeghi, Hassan; Jalili, Marzieh
2017-09-01
Suicidal ideation and depression are prevalent and costly conditions that reduce quality of life. This study was designed to determine the efficacy of exercise as an adjunct to cognitive behavioural therapy (CBT) for suicidal ideation and depression among depressed individuals. In a randomized clinical trial, 54 mildly to moderately depressed patients (54% female, mean age=48.25) were assigned to a combined CBT and exercise group or to a CBT only group. Both groups received one weekly session of therapy for 12 weeks, while the combined group also completed exercise three times weekly over the same period. Self-reported suicidal ideation, depression, and activities of daily living were measured at the beginning and the end of treatment. Multilevel modelling revealed greater improvements in suicidal ideation, depression, and activities of daily living in the combined CBT and exercise group, compared to the CBT only group. No follow-up data were collected, so the long-term effects (i.e., maintenance of gains) is unclear. The findings revealed that exercise adjunct to CBT effectively decreases both depressive symptoms and suicidal ideation in mildly to moderately depressed individuals. Copyright © 2017 Elsevier B.V. All rights reserved.
Sylvia, Louisa G.; Rabideau, Dustin J.; Nierenberg, Andrew A.; Bowden, Charles L.; Friedman, Edward S.; Iosifescu, Dan V.; Thase, Michael E.; Ketter, Terence; Greiter, Elizabeth A.; Calabrese, Joseph R.; Leon, Andrew C.; Ostacher, Michael J.; Reilly-Harrington, Noreen
2014-01-01
Objectives The aims of this study were to evaluate correlates and predictors of life functioning and quality of life in bipolar disorder during a comparative effectiveness trial of moderate doses of lithium. Methods In the Lithium treatment moderate-dose use study (LiTMUS), 283 symptomatic outpatients with bipolar disorder type I or II were randomized to receive lithium plus ”optimal personalized treatment (OPT), or OPT alone. Participants were assessed using structured diagnostic interviews, clinician-rated blinded assessments, and questionnaires. We employ linear mixed effects models to test the effect of treatment overall and adjunct lithium specifically on quality of life or functioning. Similar models are used to examine the association of baseline demographics and clinical features with quality of life and life functioning. Results Quality of life and impaired functioning at baseline were associated with lower income, higher depressive severity, and more psychiatric comorbid conditions. Over six months, patients in both treatment groups improved in quality of life and life functioning (p-values < 0.0001); without a statistically significant difference between the two treatment groups (p-values > 0.05). Within the lithium group, improvement in quality of life and functioning were not associated with concurrent lithium levels at week 12 or week 24 (p-values > 0.05). Lower baseline depressive severity and younger age of onset predicted less improvement in functioning over six months. Conclusions Optimized care for bipolar disorder improves overall quality of life and life functioning, with no additional benefit from adjunct moderate doses of lithium. Illness burden and psychosocial stressors were associated with worse quality of life and lower functioning in individuals with bipolar disorder. PMID:25194782
Gualberto, Erivan Clementino; Theodoro, Letícia Helena; Longo, Mariellén; Novaes, Vivian Cristina Noronha; Nagata, Maria José Hitomi; Ervolino, Edilson; Garcia, Valdir Gouveia
2016-01-01
The aim of this study was to compare the use of antimicrobial photodynamic therapy (aPDT) as an adjunct to scaling and root planing (SRP) in the treatment of experimentally induced periodontitis in female rats that were systemically treated with or without nicotine. Female rats (n = 180) were divided into two groups: vehicle administration (Veh) and nicotine administration (Nic). Mini-pumps containing either vehicle or nicotine were implanted in the rats 30 days before the induction of experimental periodontitis (EP). EP was induced by placing a cotton ligature around the left mandibular first molar. After 7 days, the ligature was removed, and the rats were randomly divided into three treatment subgroups: SRP (only SRP), DL (SRP plus diode laser), and aPDT (SRP plus aPDT). The aPDT consisted of phenothiazine photosensitizer deposition followed by diode laser irradiation. Ten rats from each subgroup were euthanized at 7, 15, and 30 days after treatment. Alveolar bone loss (ABL) in the furcation region was evaluated using histological, histometric, and immunohistochemical analyses. The rats that were treated with nicotine showed more ABL compared to those treated with vehicle. In both the Veh and Nic groups, SRP plus aPDT treatment resulted in reduced ABL, smaller numbers of both TRAP- and RANKL-positive cells, and higher numbers of PCNA-positive cells compared to SRP treatment alone. aPDT was an effective adjunctive therapy for the treatment of periodontitis in female rats regardless of whether they received nicotine.
Orthodontic–periodontics interdisciplinary approach
Vinod, K.; Reddy, Y. Giridhar; Reddy, Vinay P.; Nandan, Hemant; Sharma, Meenakshi
2012-01-01
In this present era, when a significant number of patients seeking orthodontic treatment are adults, importance of multidisciplinary treatment approach cannot be overemphasized. Higher susceptibility of plaque accumulation in patients undergoing orthodontic treatment makes involvement of periodontist almost unavoidable. Also, orthodontic treatment frequently results in undesirable periodontal changes which require immediate attention. More recently, orthodontics has been used as an adjunct to periodontics to increase connective tissue support and alveolar bone height. The purpose of this article is to review the adverse effects of orthodontic treatment on the periodontal tissues and to discuss the mutually beneficial relationship shared between the two specialties. PMID:22628956
Mischoulon, David; Shelton, Richard C; Baer, Lee; Bobo, William V; Curren, Laura; Fava, Maurizio; Papakostas, George I
2017-04-01
To examine motoric, cardiovascular, endocrine, and metabolic effects of adjunctive ziprasidone in adults with major depressive disorder (MDD) and prior nonresponse to 8 weeks of open-label escitalopram. A multicenter, parallel, randomized, double-blind, placebo-controlled trial was conducted at 3 US academic medical centers from July 2008 to October 2013. Recruited were 139 outpatients with persistent DSM-IV MDD following an 8-week open-label trial of escitalopram. Subjects were then randomized to adjunctive ziprasidone (escitalopram + ziprasidone, n = 71) or placebo (escitalopram + placebo, n = 68) for 8 additional weeks. Cardiac and metabolic measures were obtained at each treatment visit. Barnes Akathisia Scale and Abnormal Involuntary Movement Scale (AIMS) scores were also obtained. Changes in outcome measures for each treatment group were compared by independent-samples t test. A trend toward significance (P = .06) in corrected QT interval (QTc) increase was observed for ziprasidone (mean [SD] = 8.8 [20.2] milliseconds) versus placebo (-0.02 [25.5] milliseconds). Ziprasidone-treated patients had a significantly greater increase in global akathisia scores (P = .01) and significant weight increase (mean [SD] = 3.5 [11.8] kg, or 7.7 [26.1] lb) compared to placebo (1.0 [6.4] kg, or 2.2 [14.1] lb) (P = .03). No significant changes in AIMS scores were observed for either treatment group. Adjunctive ziprasidone, added to escitalopram, led to a greater weight gain and greater but modest akathisia compared to placebo. The effect of ziprasidone on QTc showed a trend toward significance, and therefore caution should be used in the administration of ziprasidone. While ziprasidone augmentation in patients with MDD appears safe, precautions should be taken in practice, specifically regular monitoring of electrocardiogram, weight, extrapyramidal symptoms, and involuntary movements. ClinicalTrials.gov identifier: NCT00633399. © Copyright 2016 Physicians Postgraduate Press, Inc.
Rutkofsky, Ian Hunter; Khan, Anser Saeed; Sahito, Sindhu; Kumar, Vikram
2017-01-01
Context • Psychoneuroimmunology is the interdisciplinary study that links behavioral health with the neuroendocrinal system and investigates that link's bidirectional impact on the human immune system. Mechanistic studies have shown how omega-3 polyunsaturated fatty acids (PUFAs), like those found in fish oil, can modulate key pathways involved in inflammation, sympathetic activity, oxidative stress, transcription factors, and inflammatory cytokine production. Objective • The research team intended to investigate the effects that PUFAs have on the brain and the immune system, including the effects of proinflammatory cytokines and oxidative stress, and their therapeutic benefits in major depressive disorder (MDD) and bipolar disorder, either as an alternative monotherapy or a complementary adjunct treatment. Design • A literature search was conducted through PubMed and Google Scholar, with no restrictions on the publication dates or geographically. Setting • The research occurred at research facilities in Washington, DC, and Davis, California. Results • Well-described links between inflammation and MDD and bipolar disorder have been established. Similarly, a highly inflammatory state is a contributing factor to many significant health complications, and omega-3 PUFAs can help treat those issues. Conclusions • The research team concluded that omega-3 fatty acids have therapeutic benefits in the treatment of both MDD and bipolar disorder and are effective as a monotherapy and, particularly, as an adjunct therapy. The efficacy of omega-3 supplementation is clearly useful in promoting better health overall and supplementation should be encouraged in the primary care setting. A meta-analysis exploring an adjunct treatment of supplemental eicosapentaenoic acid or docosahexaenoic acid is likely to yield the greatest benefits to psychiatric conditions and provide an answer to proper dosing regimens. The team also created a chart of the supplements' salient features, demonstrating the overall health benefits of omega-3 fatty acids.
Chung, Chih-Ling; Wang, Shih-Wei; Sun, Wei-Chih; Shu, Chih-Wen; Kao, Yu-Chen; Shiao, Meng-Shin; Chen, Chun-Lin
2018-04-18
Sorafenib is the only FDA approved drug for the treatment of advanced hepatocellular carcinoma (HCC) and other malignancies. Studies indicate that TGF-β signalling is associated with tumour progression in HCC. Autocrine and paracrine TGF-β promotes tumour growth and malignancy by inducing epithelial-mesenchymal transition (EMT). Sorafenib is believed to antagonize tumour progression by inhibiting TGF-β-induced EMT. It improves survival of patients but HCC later develops resistance and relapses. The underlying mechanism of resistance is unknown. Understanding of the molecular mechanism of sorafenib inhibition of TGF-β-induced signalling or responses in HCC may lead to development of adjunctive effective therapy for HCC. In this study, we demonstrate that sorafenib suppresses TGF-β responsiveness in hepatoma cells, hepatocytes, and animal liver, mainly by downregulating cell-surface type II TGF-β receptors (TβRII) localized in caveolae/lipid rafts and non-lipid raft microdomains via caveolae/lipid rafts-mediated internalization and degradation. Furthermore, sorafenib-induced downregulation and degradation of cell-surface TβRII is prevented by simultaneous treatment with a caveolae disruptor or lysosomal inhibitors. On the other hand, sorafenib only downregulates cell-surface TβRII localized in caveolae/lipid rafts but not localized in non-lipid raft microdomains in hepatic stellate cells. These results suggest that sorafenib inhibits TGF-β signalling mainly by inducing caveolae/lipid raft-mediated internalization and degradation of cell-surface TβR-II in target cells. They may also imply that treatment with agents which promote formation of caveolae/lipid rafts, TGF-β receptor kinase inhibitors (e.g., LY2157299) or TGF-β peptide antagonists (by liver-targeting delivery) may be considered as effective adjunct therapy with sorafenib for HCC. Copyright © 2018 Elsevier Inc. All rights reserved.
Corticosteroids for Bacterial Keratitis
Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; Glidden, David V.; Ray, Kathryn J.; Hong, Kevin C.; Oldenburg, Catherine E.; Lee, Salena M.; Zegans, Michael E.; McLeod, Stephen D.; Lietman, Thomas M.; Acharya, Nisha R.
2013-01-01
Objective To determine whether there is a benefit in clinical outcomes with the use of topical corticosteroids as adjunctive therapy in the treatment of bacterial corneal ulcers. Methods Randomized, placebo-controlled, double-masked, multicenter clinical trial comparing prednisolone sodium phosphate, 1.0%, to placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and received topical moxifloxacin for at least 48 hours before randomization. Main Outcome Measures The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months from enrollment. Secondary outcomes included infiltrate/scar size, reepithelialization, and corneal perforation. Results Between September 1, 2006, and February 22, 2010, 1769 patients were screened for the trial and 500 patients were enrolled. No significant difference was observed in the 3-month BSCVA (−0.009 logarithm of the minimum angle of resolution [logMAR]; 95% CI, −0.085 to 0.068; P = .82), infiltrate/scar size (P = .40), time to reepithelialization (P = .44), or corneal perforation (P > .99). A significant effect of corticosteroids was observed in subgroups of baseline BSCVA (P = .03) and ulcer location (P = .04). At 3 months, patients with vision of counting fingers or worse at baseline had 0.17 logMAR better visual acuity with corticosteroids (95% CI, −0.31 to −0.02; P = .03) compared with placebo, and patients with ulcers that were completely central at baseline had 0.20 logMAR better visual acuity with corticosteroids (−0.37 to −0.04; P = .02). Conclusions We found no overall difference in 3-month BSCVA and no safety concerns with adjunctive corticosteroid therapy for bacterial corneal ulcers. Application to Clinical Practice Adjunctive topical corticosteroid use does not improve 3-month vision in patients with bacterial corneal ulcers. PMID:21987582
Corticosteroids for bacterial keratitis: the Steroids for Corneal Ulcers Trial (SCUT).
Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; Glidden, David V; Ray, Kathryn J; Hong, Kevin C; Oldenburg, Catherine E; Lee, Salena M; Zegans, Michael E; McLeod, Stephen D; Lietman, Thomas M; Acharya, Nisha R
2012-02-01
To determine whether there is a benefit in clinical outcomes with the use of topical corticosteroids as adjunctive therapy in the treatment of bacterial corneal ulcers. Randomized, placebo-controlled, double-masked, multicenter clinical trial comparing prednisolone sodium phosphate, 1.0%, to placebo as adjunctive therapy for the treatment of bacterial corneal ulcers. Eligible patients had a culture-positive bacterial corneal ulcer and received topical moxifloxacin for at least 48 hours before randomization. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months from enrollment. Secondary outcomes included infiltrate/scar size, reepithelialization, and corneal perforation. Between September 1, 2006, and February 22, 2010, 1769 patients were screened for the trial and 500 patients were enrolled. No significant difference was observed in the 3-month BSCVA (-0.009 logarithm of the minimum angle of resolution [logMAR]; 95% CI, -0.085 to 0.068; P = .82), infiltrate/scar size (P = .40), time to reepithelialization (P = .44), or corneal perforation (P > .99). A significant effect of corticosteroids was observed in subgroups of baseline BSCVA (P = .03) and ulcer location (P = .04). At 3 months, patients with vision of counting fingers or worse at baseline had 0.17 logMAR better visual acuity with corticosteroids (95% CI, -0.31 to -0.02; P = .03) compared with placebo, and patients with ulcers that were completely central at baseline had 0.20 logMAR better visual acuity with corticosteroids (-0.37 to -0.04; P = .02). We found no overall difference in 3-month BSCVA and no safety concerns with adjunctive corticosteroid therapy for bacterial corneal ulcers. Adjunctive topical corticosteroid use does not improve 3-month vision in patients with bacterial corneal ulcers. clinicaltrials.gov Identifier: NCT00324168.
Tolosa, E; Stern, M B
2012-02-01
Rasagiline, an MAO-B inhibitor, is indicated for the treatment of Parkinson's disease (PD). In this post hoc analysis, the efficacy, safety and tolerability of rasagiline as an adjunct to levodopa were compared with placebo in elderly (≥70 years) and younger (<70 years) patients with PD. Data were pooled from the Parkinson's Rasagiline: Efficacy and Safety on the Treatment of 'OFF' and Lasting effect in Adjunct therapy with Rasagiline Given Once daily randomized, double-blind, placebo-controlled trials with the primary efficacy end-point being the reduction from baseline in daily OFF time. Secondary efficacy end-points included scores for Clinical Global Improvement (CGI)-Examiner during ON time, Unified Parkinson's Disease Rating Scale (UPDRS)-ADL during OFF time, UPDRS-Motor during ON time and total daily ON time with and without troublesome dyskinesia. Tolerability was evaluated from adverse events (AEs) in the two age groups. Rasagiline decreased daily OFF time versus placebo (P<0.01) and improved CGI-Examiner score (P=0.001) and UPDRS-Motor ON score (P<0.05). Changes in UPDRS-ADL OFF score and total daily ON time without dyskinesia also favoured rasagiline but were not significant. Between-group comparisons (≥70 vs. <70 years) showed that efficacy was unaffected by age for all end-points (P>0.1), and rasagiline was well tolerated amongst both groups of patients with a comparable incidence of total and dopaminergic AEs (P>0.1). Adjunct rasagiline is efficacious and well tolerated in elderly non-demented patients (≥70 years) with moderate to advanced PD. Confirmation of the efficacy and safety of rasagiline in the elderly patient subgroup is especially relevant because of the increasing number of elderly patients with PD. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.
Hochman, Eldar; Krivoy, Amir; Schaffer, Ayal; Weizman, Abraham; Valevski, Avi
2016-12-01
Antipsychotic adjunctive therapy to mood stabilizers (MSs) may improve relapse prevention; however, only a few naturalistic studies, reflecting more generalizable bipolar disorder (BD) samples, support this notion. We compared the 1-year rehospitalization rates of manic patients with bipolar I disorder (BD-I) who were discharged with MS (lithium or valproate) monotherapy or with adjunctive atypical or typical antipsychotic therapy. A total of 201 patients with BD-I who were hospitalized with manic episodes between 2005 and 2013 were retrospectively followed for 1-year rehospitalization rates according to treatment at discharge: MS monotherapy, MS with atypical antipsychotics, and MS with typical antipsychotics. Additionally, time to rehospitalization during the 1-year period after discharge was compared between treatment groups. Multivariable survival analyses adjusted for covariates known to influence rehospitalization were conducted. Rehospitalization rates within 1 year were significantly lower in the MS with atypical antipsychotics group (6.3%) compared to the MS monotherapy group (24.3%, P=.008) and to the MS with typical antipsychotics group (20.6%, P=.02). Time to rehospitalization was significantly longer for the MS with atypical antipsychotics group (345.5 days) compared to the MS monotherapy group (315.1 days, P=.006) and to the MS with typical antipsychotics group (334.1 days, P=.02). The MS with atypical antipsychotics group had a significantly reduced adjusted risk of rehospitalization (hazard ratio=0.17, 95% confidence interval: 0.05-0.61, P=.007) compared to the MS monotherapy group. Atypical antipsychotic adjunctive therapy to MSs may be more effective than MS monotherapy in preventing rehospitalization during the 1-year period after a BD manic episode. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Chen, Yukun; Evola, Marianne
2013-01-01
Rationale Memantine is a N-methyl-d-aspartic acid receptor (NMDAR) channel blocker that binds to dizocilpine sites and appears well tolerated during chronic use. Published studies suggest NMDAR antagonists prevent development of tolerance to effects of morphine by blocking NMDAR hyperactivation. Objectives We sought to compare effects of memantine to those of the more frequently studied dizocilpine and to evaluate memantine as a potential adjunct to modify tolerance to mu-opioid receptor agonists. Methods Sprague–Dawley rats were trained to discriminate morphine (3.2 mg/kg) and saline under fixed ratio 15 schedules of food delivery. Potency and maximal stimulus or rate-altering effects of cumulative doses of morphine were examined 30 min after pretreatment with dizocilpine (0.032–0.1 mg/kg) or memantine (5–10 mg/kg) and after chronic treatment with combinations of dizocilpine or memantine and morphine, 10 mg/kg twice daily, for 6 to 14 days. Effects of dizocilpine or memantine on morphine antinociception were examined in a 55 °C water tail-withdrawal assay with drug treatments parallel to those in discrimination studies. Results Acutely, memantine attenuated while dizocilpine potentiated the stimulus and antinociceptive effects of morphine. Neither chronic dizocilpine nor memantine blocked tolerance to the stimulus effects of morphine. In contrast, combined-treatment with dizocilpine (0.1 mg/kg) blocked tolerance to antinociceptive effects of lower (0.1∼3.2 mg/kg) but not higher doses of morphine, whereas memantine did not block tolerance. Conclusions Memantine and dizocilpine interacted differently with morphine, possibly due to different NMDAR binding profiles. The lack of memantine-induced changes in morphine tolerance suggests memantine may not be a useful adjunct in chronic pain management. PMID:22864944
[Calcitonin as an alternative treatment for root resorption].
Pierce, A; Berg, J O; Lindskog, S
1989-01-01
Inflammatory root resorption is a common finding following trauma and will cause eventual destruction of the tooth root if left untreated. This study examined the effects of intrapulpal application of calcitonin, a hormone known to inhibit osteoclastic bone resorption, on experimental inflammatory root resorption induced in monkeys. Results were histologically evaluated using a morphometric technique and revealed that calcitonin was an effective medicament for the treatment of inflammatory root resorption. It was concluded that this hormone could be a useful therapeutic adjunct in difficult cases of external root resorption.
Celik, Istemi Han; Oguz, Serife Suna; Demirel, Gamze; Erdeve, Omer; Dilmen, Ugur
2012-02-01
Multidrug-resistant (MDR) gram-negative bacteria-related nosocomial infections and ventilator-associated pneumonia (VAP) presents an emerging challenge to clinicians. Older antimicrobial agents such as colistin have become life-saving drugs because of the susceptibility of these pathogens. We report our experience with aerosolized colistin in two preterm and one term neonate with Acinetobacter baumannii and Pseudomonas aeruginosa-related VAP who were unresponsiveness to previous antimicrobial treatment. All pathogens were isolated from tracheal aspirate. We used 5 mg/kg (base activity) aerosolized colistin methanesulfonate sodium in every 12 h as an adjunctive therapy for VAP. VAP was treated by 14, 14, and 16-day courses of aerosolized colistin in these patients, respectively. No adverse effect such as nephrotoxicity or neurotoxicity was observed. We found that aerosolized colistin was tolerable and safe, and it may be an adjunctive treatment option for MDR gram-negative bacterial VAP in neonates. Further studies are needed to determine appropriate doses for aerosolized colistin and its eligibility as an alternative treatment choice in newborns.
Bean, Melanie K.; Jeffers, Amy J.; Tully, Carrie B.; Thornton, Laura M.; Mazzeo, Suzanne E.
2014-01-01
There is an urgent need for innovative approaches to pediatric obesity treatment. There is also a demand for targeted strategies that reduce attrition and improve treatment adherence. Intervening exclusively with parents of overweight children is a novel approach with demonstrated efficacy in reducing child body mass index (BMI) percentile. Motivational interviewing (MI), a brief communication style for exploring and resolving ambivalence about behavior change, might enhance treatment engagement when implemented as part of obesity interventions. The aim of this report is to provide the rationale and methods for a novel study of MI with parents in the treatment of their children’s overweight. We designed and are currently implementing NOURISH+MI, a randomized controlled trial examining the feasibility and efficacy of an adjunct values-based MI intervention, implemented within a culturally-tailored parent intervention for overweight children ages 5-11 years, NOURISH+ (Nourishing Our Understanding of Role modeling to Improve Support and Health). Specifically, we are randomly assigning 60 parents to this adjunctive treatment, and investigating if adding two MI sessions prior to the NOURISH+ group intervention will enhance treatment effects. We will be able to compare NOURISH+MI participants with those from the two NOURISH+ treatment conditions (NOURISH+ and control). We hypothesize that children whose parents participate in NOURISH+MI will demonstrate lower attrition and greater adherence with NOURISH+, ultimately leading to greater treatment effects, compared with children whose parents are randomized to NOURISH+ or a control group. Findings will contribute to the emerging literature examining the efficacy of MI within pediatric obesity interventions. PMID:24530488
Howie, Stephen; Bottomley, Christian; Chimah, Osaretin; Ideh, Readon; Ebruke, Bernard; Okomo, Uduak; Onyeama, Charles; Donkor, Simon; Rodrigues, Onike; Tapgun, Mary; Janneh, Marie; Oluwalana, Claire; Kuti, Bankole; Enwere, Godwin; Esangbedo, Pamela; Doherty, Conor; Mackenzie, Grant; Greenwood, Brian; Corrah, Tumani; Prentice, Andrew; Adegbola, Richard; Zaman, Syed
2018-06-01
The benefit of zinc as an adjunct therapy for severe pneumonia is not established. We assessed the benefit of adjunct zinc therapy for severe pneumonia in children and determined whether the study children were zinc deficient. This was a randomized, parallel group, double-blind, placebo-controlled trial with an allocation ratio of 1:1 conducted in children with severe pneumonia to evaluate the efficacy of daily zinc as an adjunct treatment in preventing 'treatment failure' (presence of any sign of severe pneumonia) on day-5 and day-10 and in reducing the time to resolution of signs of severe pneumonia. Six hundred and four children 2-59 months of age presenting with severe pneumonia at six urban and rural health care facilities in The Gambia were individually randomised to receive placebo (n = 301) or zinc (n = 303) for seven days. To determine if the study children were zinc deficient, supplementation was continued in a randomly selected subgroup of 121 children from each arm for six months post-enrolment, and height-gain, nutritional status, plasma zinc concentrations, and immune competence were compared. Percentage of treatment failure were similar in placebo and zinc arms both on day 5 (14.0% vs 14.1%) and day 10 (5.2% vs 5.9%). The time to recovery from lower chest wall indrawing and sternal retraction was longer in the placebo compared to zinc arm (24.4 vs 23.0 hours; P = 0.011 and 18.7 vs 11.0 hours; P = 0.006 respectively). The time to resolution for all respiratory symptoms of severity was not significantly different between placebo and zinc arms (42.3 vs 30.9 hours respectively; P = 0.242). In the six months follow-up sub-group, there was no significant difference in height gain, height-for-age and weight-for-height Z-scores, mid upper arm circumference, plasma zinc concentrations, and anergy at six months post-enrolment. In this population, zinc given as an adjunct treatment for severe pneumonia showed no benefit in treatment failure rates, or clinically important benefit in time to recovery from respiratory symptoms and showed marginal benefit in rapidity of resolution of some signs of severity. This finding does not support routine use of zinc as an adjunct treatment in severe pneumonia in generally zinc replete children. ISRCTN33548493.
Palm, Nicole; Floroff, Catherine; Hassig, Tanna B; Boylan, Alice; Kanter, Julie
2018-05-23
The optimal management of recurrent painful episodes in individuals living with sickle cell disease (SCD) remains unclear. Currently, the primary treatment for these episodes remains supportive, using fluids and intravenous opioid and anti-inflammatory medications. Few reports have described the use of adjunct subanesthetic doses of ketamine to opioids for treatment of refractory pain in SCD. This article reports a retrospective case series of five patients admitted to the intensive care unit (ICU) with prolonged vaso-occlusive episodes (VOEs). Patients were treated with a continuous-infusion of low-dose ketamine (up to 5 µg/kg/min) after insufficient pain control with opioid analgesic therapy. Outcomes studied included impact on opioid analgesic use, a description of ketamine dosing strategy, and an analysis of adverse events due to opioid or ketamine analgesia. Descriptive statistics are provided. During ketamine infusion, patients experienced a lower reported pain score (mean numeric rating scale [NRS] score 7.2 vs. 6.4), reduced opioid-induced adverse effects, and decreased opioid dosing requirements (median reduction of 90 mg morphine equivalents per patient). The average duration of severe pain during admission prior to ketamine therapy was 8 days. Only one of five patients reported an adverse effect (vivid dreams) secondary to ketamine infusion. The Richmond Agitation Sedation Scale (RASS) was assessed throughout therapy, with only one patient experiencing light drowsiness. Low-dose ketamine infusion may be considered as an adjunct analgesic agent in patients with vaso-occlusive episodes who report continued severe pain despite high-dose opioid therapy, particularly those experiencing opioid-induced adverse effects.
McLean, Brian
2015-09-10
To perform a quality assurance and performance improvement project through review of our single center data on the safety and patient acceptability of the stellate ganglion blockade (SGB) procedure for the relief of symptoms related to chronic post-traumatic stress disorder. Our interventional pain management service has been offering trials of SGB therapy to assist with the management of the sympathetically mediated anxiety and hyperarousal symptoms of severe and treatment-refractory combat-related PTSD. There have been multiple case series in the literature describing the potential impact of this procedure for PTSD symptom management as well as the safety of image-guided procedures. We wished to ensure that we were performing this procedure safely and that patients were tolerating and accepting of this adjunctive treatment option. We conducted a review of our quality assurance and performance improvement data over the past 18 months during which we performed 250 stellate ganglion blocks for the management of PTSD symptoms to detect any potential complications or unanticipated side effects. We also analyzed responses from an anonymous patient de-identified survey collected regarding the comfort and satisfaction associated with the procedure. We did not identify any immediate post-procedural complications or delayed complications from any of the 250 procedures performed from November 2013 to April 2015. Of the 110 surveys that were returned and tabulated, 100% of the patients surveyed were overall satisfied with our process and with the procedure, 100% said they would recommend the procedure to a friend, and 95% stated that they would be willing to undergo as many repeat procedures as necessary based on little discomfort and tolerable side effects. Our quality assurance assessment suggests that in our center the SGB procedure for PTSD is a safe, well-tolerated, and acceptable treatment adjunct in the management of severe symptoms associated with chronic treatment-refractory PTSD. Patient satisfaction responses are strongly suggestive of high therapeutic value, and further studies are indicated to determine the effectiveness, duration of action, and optimal treatment regimen.
Efficacy of subantimicrobial-dose doxycycline against nitrosative stress in chronic periodontitis.
Pârvu, Alina Elena; Alb, Sandu Florin; Crăciun, Alexandra; Taulescu, Marian Aurel
2013-02-01
To evaluate the effectiveness of subantimicrobial-dose doxycycline (SDD) as an adjunct to scaling and root planing (SRP) treatment against the nitrosative stress of moderate to advanced chronic periodontitis. Adults with untreated chronic periodontitis (n=174) were randomly administered SRP+SDD (n=87) (20 mg of doxycycline twice daily) or SRP+placebo (n=87) treatment for 3 months. At baseline and after 3 months, the probing depths (PD), bleeding on probing (BOP) and clinical attachment level (CAL) were measured, and a gingivomucosal biopsy was collected to assay the induction of nitric oxide synthase (iNOS) and 3-nitrotyrosine (3NT), and blood was collected to assay for total nitrites and nitrates (NO(x)) and 3NT. Compared to baseline, at the completion of treatment, significant decreases in the levels of tissue iNOS and 3NT and serum NO(x) and 3NT were observed in both groups. SRP+SDD yielded a greater reduction in the gingivomucosal and serum nitrosative stress markers than did SRP+placebo. PD, BOP, and CAL reduction were correlated with the nitrosative stress parameters. On a short-term basis, SDD therapy may be used as an adjunct to SRP treatment against nitrosative stress in moderate to advanced chronic periodontitis.
Bronchoscopic cryotherapy treatment of isolated endoluminal typical carcinoid tumor.
Bertoletti, Laurent; Elleuch, Rami; Kaczmarek, David; Jean-François, Rita; Vergnon, Jean Michel
2006-11-01
Bronchial typical carcinoid tumors are rare. The "gold standard" treatment is surgery, but there is literature to support bronchoscopic therapy with curative intent. Based on the efficacy of cryotherapy for in situ lung cancer, we studied the safety and efficacy of rigid bronchoscopic treatment with cryotherapy on isolated endoluminal typical carcinoid tumors. All the patients from the Department of Pulmonary Diseases and Thoracic Oncology of St. Etienne University Hospital (France), and of Hôpital Notre Dame, University Hospital of Montreal referred with typical carcinoid were screened. Inclusion criteria included the following: proven typical carcinoid, strictly endoluminal disease amenable to bronchoscopic therapy, and no evidence of lymph node invasion. All patients had a complete removal of the tumor, and all patients received cryotherapy to the implantation base. Twenty-nine patients were screened, and 18 were included. Mean age was 47 years, and study population included 11 women. Median follow-up was 55 months. There was a single recurrence 7 years after the initial bronchoscopic treatment. Cryotherapy is a safe and effective adjunct to endobronchial mechanical resection of typical carcinoids. Unlike other adjuncts that have been proposed, cryotherapy is not associated with long-term complications including bronchial stenosis.
Weinstock, Jeremiah; Farney, Margaret R; Elrod, Noel M; Henderson, Craig E; Weiss, Edward P
2017-01-01
Substance use disorders (SUDs) are maladaptive patterns of substance use that are associated with psychiatric comorbidity, unhealthy lifestyle choices, and high rates of relapse. Exercise is associated with a wide range of acute and long-term benefits for both mental and physical health and is presently being investigated as a promising adjunctive treatment for SUD. Despite positive effects of regular physical activity on treatment outcomes and risk factors for relapse, low adherence and high attrition rates limit the benefits derived from exercise interventions. Lack of motivation is one of many perceived barriers to initiating exercise that contributes to poor adherence to interventions. In the present article, we describe the protocol for a novel, integrated exercise intervention that combines motivational interviewing (MI), a client-centered approach designed to enhance intrinsic motivation and resolve ambivalence toward change, and contingency management (CM), a behavioral treatment that provides monetary incentives for the completion of target behaviors. The protocol seeks to address the challenges surrounding initiation and maintenance of an exercise program at a level consistent with public health guidelines, particularly for sedentary patients. We conclude with considerations for the implementation of the intervention in SUD specific clinics. Copyright © 2016 Elsevier Inc. All rights reserved.
Cost-utility model of rasagiline in the treatment of advanced Parkinson's disease in Finland.
Hudry, Joumana; Rinne, Juha O; Keränen, Tapani; Eckert, Laurent; Cochran, John M
2006-04-01
The economic burden of Parkinson's disease (PD) is high, especially in patients experiencing motor fluctuations. Rasagiline has demonstrated efficacy against symptoms of PD in early and advanced stages of the disease. To assess the cost-utility of rasagiline and entacapone as adjunctive therapies to levodopa versus standard levodopa care in PD patients with motor fluctuations in Finland. A 2 year probabilistic Markov model with 3 health states: "25% or less off-time/day," "greater than 25% off-time/day," and "dead" was used. Off-time represents time awake with poor or absent motor function. Model inputs included transition probabilities from randomized clinical trials, utilities from a preference measurement study, and costs and resources from a Finnish cost-of-illness study. Effectiveness measures were quality-adjusted life years (QALYs) and number of months spent with 25% or less off-time/day. Uncertainty around parameters was taken into account by Monte Carlo simulations. Over 2 years from a societal perspective, rasagiline or entacapone as adjunctive therapies to levodopa showed greater effectiveness than levodopa alone at no additional costs. Benefits after 2 years were 0.13 (95% CI 0.08 to 0.17) additional QALYs and 5.2 (3.6 to 6.7) additional months for rasagiline and 0.12 (0.08 to 0.17) QALYs and 5.1 (3.5 to 6.6) months for entacapone, both in adjunct to levodopa compared with levodopa alone. The results of this study support the use of rasagiline and entacapone as adjunctive cost-effective alternatives to levodopa alone in PD patients with motor fluctuations in Finland. With a different mode of action, rasagiline is a valuable therapeutic alternative to entacapone at no additional charge to society.
Ma, Min; Ren, Qian; Yang, Chun; Zhang, Ji-Chun; Yao, Wei; Dong, Chao; Ohgi, Yuta; Futamura, Takashi; Hashimoto, Kenji
2017-02-01
Addition of low doses of atypical antipsychotic drugs with selective serotonin reuptake inhibitors (SSRIs) could promote a rapid antidepressant effect in treatment-resistant patients with major depression. Brexpiprazole, a new atypical antipsychotic drug, has been used as adjunctive therapy for the treatment of major depression. The present study was undertaken to examine whether brexpiprazole could augment antidepressant effects of the SSRI fluoxetine in an inflammation model of depression. We examined the effects of fluoxetine (10 mg/kg), brexpiprazole (0.1 mg/kg), or the combination of the two drugs on depression-like behavior, alterations in the brain-derived neurotrophic factor (BDNF) - TrkB signaling, and dendritic spine density in selected brain regions after administration of lipopolysaccharide (LPS) (0.5 mg/kg). Combination of brexpiprazole and fluoxetine promoted a rapid antidepressant effect in inflammation model although brexpipazole or fluoxetine alone did not show antidepressant effect. Furthermore, the combination significantly improved LPS-induced alterations in the BDNF - TrkB signaling and dendritic spine density in the prefrontal cortex, CA3 and dentate gyrus, and nucleus accumbens. These results suggest that add-on of brexpiprazole to fluoxetine can produce a rapid antidepressant effect in the LPS inflammation model of depression, indicating that adjunctive therapy of brexpiprazole to SSRIs could produce a rapid antidepressant effect in depressed patients with inflammation.
Panda, Saurav; Sankari, Malaiappan; Satpathy, Anurag; Jayakumar, Doraiswamy; Mozzati, Marco; Mortellaro, Carmen; Gallesio, Giorgia; Taschieri, Silvio; Del Fabbro, Massimo
2016-05-01
Autologous platelet-rich fibrin (PRF) and barrier membranes in the treatment of intrabony defects in chronic periodontitis patients have shown significant clinical benefits. This study evaluates the additive effect of autologous PRF in combination with a barrier membrane versus the use of barrier membrane alone for the treatment of intrabony defects in chronic periodontitis patients. A randomized split-mouth design was used. Sixteen patients with 32 paired intrabony defects were included. In each patient 1 defect was treated using a resorbable collagen membrane along with PRF (test group) and the other defect by guided tissue regeneration alone (control group). The following clinical parameters were measured at baseline and after 9 months: plaque index, modified sulcus bleeding index, probing pocket depth, clinical attachment level, and gingival marginal level. The radiographic defect depth was also assessed at baseline and after 9 months. Test group showed a statistically significant improvement for probing depth (P = 0.002), clinical attachment level (P = 0.001), and radiographic defect depth (P < 0.001) after 9 months as compared with the control sites. Radiographic defect depth reduction was 58.19 ± 13.24% in the test group as compared with 24.86 ± 9.94% reduction in the control group. The adjunctive use of PRF in combination with barrier membrane is more effective in the treatment of intrabony defects in chronic periodontitis as compared with barrier membrane alone.
The use of atypical antipsychotics beyond psychoses: efficacy of quetiapine in bipolar disorder.
Mundo, Emanuela; Cattaneo, Elisabetta; Zanoni, Silvia; Altamura, A Carlo
2006-06-01
Atypical antpsychotics have been sucessfully used in the treatment of bipolar disorder (BD), either as adjunctive or as monotherapy. Quetiapine is an atypical antipsychotic extensively used in the treatment of psychotic disorders. It has serotonergic and dopaminergic activity and it appears to be selective for the mesolimbic and mesocortical dopamine system. The aim of this paper was to review the recent literature on the use of quetiapine in the treatment of BD. The literature databases currently available online were searched for papers on quetiapine and BD. Papers and reports published between January 1995 and June 2005 were selected and reviewed critically. Augmentative low dose quetiapine was found to be effective in BD partially responsive to conventional mood-stabilizers. Manic and mixed episodes have been the best studied, and quetiapine was found to be effective either as monotherapy or as adjunctive therapy in both randomized clinical trials and open-label studies. Data on the use of quetiapine in bipolar depression showed a significant efficacy and high remission rates. Maintenance data suggested a role of quetiapine as a good alternative to classical mood stabilizers in reducing recurrence rates of BD. A few studies on the efficacy in rapid cycling BD have also been published. Quetiapine is an effective agent for the short- and long-term treatment of BD. The mechanism of action of quetiapine as a mood stabilizer is still unknown. Some preliminary data suggest the involvement of glutamate pathways but further studies are needed to clarify this issue.
Papakostas, George I; Fava, Maurizio; Baer, Lee; Swee, Michaela B; Jaeger, Adrienne; Bobo, William V; Shelton, Richard C
2015-12-01
The authors sought to test the efficacy of adjunctive ziprasidone in adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram. This was an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial conducted at three academic medical centers. Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1), randomly assigned in a 1:1 ratio to receive adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo, N=68), with 8 weekly follow-up assessments. The primary outcome measure was clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D). The Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain were defined a priori as key secondary outcome measures. Rates of clinical response (35.2% compared with 20.5%) and mean improvement in HAM-D total scores (-6.4 [SD=6.4] compared with -3.3 [SD=6.2]) were significantly greater for the escitalopram plus ziprasidone group. Several secondary measures of antidepressant efficacy also favored adjunctive ziprasidone. The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score. Ten (14%) patients in the escitalopram plus ziprasidone group discontinued treatment because of intolerance, compared with none in the escitalopram plus placebo group. Ziprasidone as an adjunct to escitalopram demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.
Isehed, Catrine; Holmlund, Anders; Renvert, Stefan; Svenson, Björn; Johansson, Ingegerd; Lundberg, Pernilla
2016-10-01
This randomized clinical trial aimed at comparing radiological, clinical and microbial effects of surgical treatment of peri-implantitis alone or in combination with enamel matrix derivative (EMD). Twenty-six subjects were treated with open flap debridement and decontamination of the implant surfaces with gauze and saline preceding adjunctive EMD or no EMD. Bone level (BL) change was primary outcome and secondary outcomes were changes in pocket depth (PD), plaque, pus, bleeding and the microbiota of the peri-implant biofilm analyzed by the Human Oral Microbe Identification Microarray over a time period of 12 months. In multivariate modelling, increased marginal BL at implant site was significantly associated with EMD, the number of osseous walls in the peri-implant bone defect and a Gram+/aerobic microbial flora, whereas reduced BL was associated with a Gram-/anaerobic microbial flora and presence of bleeding and pus, with a cross-validated predictive capacity (Q(2) ) of 36.4%. Similar, but statistically non-significant, trends were seen for BL, PD, plaque, pus and bleeding in univariate analysis. Adjunctive EMD to surgical treatment of peri-implantitis was associated with prevalence of Gram+/aerobic bacteria during the follow-up period and increased marginal BL 12 months after treatment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Acarbose is an effective adjunct to dietary therapy in the treatment of hypertriglyceridaemias
Malaguarnera, M; Giugno, I; Ruello, P; Rizzo, M; Motta, M; Mazzoleni, G
1999-01-01
Aims In diabetics, acarbose causes a reduction of blood glucose and triglyceride levels. The aim of this study was to assess the effect of this drug in non diabetic subjects with hypertriglyceridaemia. Methods Thirty non diabetic patients with hypertriglyceridaemia type IIb or IV (24 males, six females; mean age 51.1 ±10.2 years) were studied. They were stratified into two groups depending on their basal triglyceride concentration (group A: triglyceride values ≤4.5 mmol l−1; group B triglyceride values > 4.5 mmol l− 1). Treatment consisted of 4 week courses of diet plus acarbose (50 mg twice daily) alternating with 4 weeks of diet alone for a total period of 16 weeks. Results Mean triglyceride values decreased significantly during the first and third cycles of therapy, i.e. diet plus acarbose treatment cycles in both patient groups. Group A also had significant reductions in total cholesterol and HDL cholesterol concentrations after completion of the acarbose treatment. Reduction of triglyceride levels was observed after both acarbose courses in patients affected by hypertriglyceridaemia type IIb. A marked reduction of triglyceride concentrations was achieved by patients affected by hypertriglyceridaemia type IV after the second acarbose course only. Conclusions Diet alone did not reduce triglyceride concentrations to normal values in our patients. The data suggest that acarbose is a useful adjunct to dietary control in non-diabetic patients affected by severe hypertriglyceridaemia. PMID:10583032
Kaneko, Yuji; Cortes, Lourdes; Sanberg, Cyndy; Acosta, Sandra; Bickford, Paula C.; Borlongan, Cesar V.
2012-01-01
Stroke remains the number one cause of disability in the adult population. Despite scientific progress in our understanding of stroke pathology, only one treatment (tissue plasminogen activator or tPA) is able to afford benefits but to less than 3% of ischemic stroke patients. The development of experimental dietary supplement therapeutics designed to stimulate endogenous mechanisms that confer neuroprotection is likely to open new avenues for exploring stroke therapies. The present review article evaluates the recent literature supporting the benefits of dietary supplementation for the therapy of ischemic stroke. This article focuses on discussing the medical benefits of NT-020 as an adjunct agent for stroke therapy. Based on our preliminary data, a pre-stroke treatment with dietary supplementation promotes neuroprotection by decreasing inflammation and enhancing neurogenesis. However, we recognize that a pre-stroke treatment holds weak clinical relevance. Thus, the main goal of this article is to provide information about recent data that support the assumption of natural compounds as neuroprotective and to evaluate the therapeutic effects of a dietary supplement called NT-020 as in a stroke model. We focus on a systematic assessment of practical treatment parameters so that NT-020 and other dietary supplementations can be developed as an adjunct agent for the prevention or treatment of chronic diseases. We offer rationale for determining the optimal dosage, therapeutic window, and mechanism of action of NT-020 as a dietary supplement to produce neuroprotection when administered immediately after stroke onset. We highlight our long-standing principle in championing both translational and basic science approaches in an effort to fully reveal the therapeutic potential of NT-020 as dietary supplementation in the treatment of stroke. We envision dietary supplementation as an adjunct therapy for stroke at acute, subacute, and even chronic periods. PMID:22837703
Cranial electrotherapy stimulation for treatment of anxiety, depression, and insomnia.
Kirsch, Daniel L; Nichols, Francine
2013-03-01
Cranial electrotherapy stimulation is a prescriptive medical device that delivers a mild form of electrical stimulation to the brain for the treatment of anxiety, depression, and insomnia. It is supported by more than 40 years of research demonstrating its effectiveness in several mechanistic studies and greater than 100 clinical studies. Adverse effects are rare (<1%), mild, and self-limiting, consisting mainly of skin irritation under the electrodes and headaches. Often used as a stand-alone therapy, because results are usually seen from the first treatment, cranial electrotherapy stimulation may also be used as an adjunctive therapy. Copyright © 2013 Elsevier Inc. All rights reserved.
ERIC Educational Resources Information Center
Alkahtani, Keetam D. F.
2013-01-01
Children's challenging behaviors can be addressed with effective interventions that can meet children's emotional needs and support their families. Positive Behavioral Interventions and Supports (PBIS) value the family involvement in the process of their child treatment. The intention of this study was to use concept mapping as an adjunct to PBIS…
[Ivermectin as an adjunct in the treatment of refractory epilepsy].
Diazgranados-Sanchez, J A; Mejia-Fernandez, J L; Chan-Guevara, L S; Valencia-Artunduaga, M H; Costa, J L
2017-10-01
Ivermectin, a 22'23 dihydro derivative of avermectins beta-1a, is a highly effective veterinary and human anti parasitic, used to treat endoparasites of difficult control such as filariasis and onchocerciasis, with a median plasma life of at least of 16 hours. The recommended therapeutic doses range from 0.05 to 0.40 mg/kg, without undesirable effects or risk to human life. It went from being a great success in animal health to its application in humans, where it has had great impact. Studies in basic sciences have shown that ivermectin has anticonvulsive effects in different epileptic animal models, where five different mechanisms of action have been described. Descriptive, prospective observational study, performed between 2013 and 2015, with 32 refractory epileptic patients, who received ivermectin as an a dose of adjunctive treatment of 10 mg/day three or seven times a week, controlled every three months, followed by 12-24 months, without withdrawal of anticonvulsant medications that they received previously. Progressively, patients entered into crisis control, at the end of the programmed follow-up period, the total percentage of crisis reduction was 97%, of which 57% did not return to crisis from the beginning of treatment, all patients being free of crisis according to International League Against Epilepsy criteria. Ivermectin has been useful as an adjuvant, achieving a significant decrease in seizures in this group of drug resistant patients.
Meta-analysis of Huangqi injection for the adjunctive therapy of aplastic anemia
Zhu, Changtai; Gao, Yulu; Jiang, Ting; Hao, Cao; Gao, Zongshuai; Sun, Yongning
2015-01-01
Aplastic anemia therapy remains difficult, due to lack of effective treatment regimens. In recent years, Huangqi injection for the adjunctive therapy of aplastic anemia has been reported in many clinical trials. Considering that Huangqi injection may be a novel approach to aplastic anemia treatment, we conducted a meta-analysis of clinical controlled trials to assess the clinical value of Huangqi injection in the treatment of aplastic anemia. We searched the Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Full-text Database (VIP), Wanfang Database, PubMed and EMBASE database to collect the data about the trials of Huangqi injection combined with androgens for treating aplastic anemia. A total of ten studies involving 720 patients with aplastic anemia were included in this study. The meta-analysis showed significant increases in the pool effectiveness rate, white blood cells (WBC), haematoglobin (Hb), platelets (PLT), and reticulocytes (Ret) between the experimental group versus the control group. No severe side effects were found in this study. However, the lower Jadad scores and asymmetric funnel plot degrades the validity of the meta-analysis as the clinical evidence. Therefore, Huangqi injection may significantly enhance the efficacy of androgens for aplastic anemia, suggesting that the novel approach of Chinese traditional medicine combined with Western medicine is promising. The exact outcome required confirmation with rigorously well-designed multi-center trials. PMID:26379817
Raj, K Ravi; Musalaiah, Svvs; Nagasri, M; Kumar, P Aravind; Reddy, P Indeevar; Greeshma, M
2016-01-01
Photodynamic therapy (PDT) is a local noninvasive treatment modality without side effects caused by antibiotics. The aim of this study was to evaluate the efficacy of adjunctive use of PDT with scaling and root planing as compared with SRP alone in the treatment of chronic periodontitis. Twenty participants with chronic periodontitis having probing pocket depths (PDs) of ≥5 mm were selected for the study. Patients were randomly divided into control group and test group with ten patients in each group. Full-mouth SRP was performed in both the groups, followed by PDT in test group. Assessment of plaque index (PI), gingival index (GI), PD, and clinical attachment level (CAL) was done at baseline and after 3 months. Microbiological assessment of Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola was done by polymerase chain reaction (PCR) at baseline and 3 months after the therapy. There was a significant reduction in PI, GI, PD, CAL, and microbiologic parameters in test group, following SRP and PDT, when compared with SRP alone in control group. PDT in conjunction with SRP has shown additional improvement in periodontal parameters when compared to SRP alone and has a beneficial effect in chronic periodontitis patients.
NASA Astrophysics Data System (ADS)
Durkee, Heather A.; Relhan, Nidhi; Arboleda, Alejandro; Halili, Francisco; De Freitas, Carolina; Alawa, Karam; Aguilar, Mariela C.; Amescua, Guillermo; Miller, Darlene; Parel, Jean-Marie
2016-03-01
Keratitis associated with Pseudomonas aeruginosa is difficult to manage. Treatment includes antibiotic eye drops, however, some strains of Pseudomonas aeruginosa are resistant. Current research efforts are focused on finding alternative and adjunct therapies to treat multi-drug resistant bacteria. One promising alternate technique is photodynamic therapy (PDT). The purpose of this study was to evaluate the effect of riboflavin- and rose bengal-mediated PDT on Pseudomonas aeruginosa keratitis isolates in vitro. Two isolates (S+U- and S-U+) of Pseudomonas aeruginosa were derived from keratitis patients and exposed to five experimental groups: (1) Control (dark, UV-A irradiation, 525nm irradiation); (2) 0.1% riboflavin (dark, UV-A irradiation); and (3) 0.1% rose bengal, (4) 0.05% rose bengal and (5) 0.01% rose bengal (dark, 525nm irradiation). Three days after treatment, in dark conditions of all concentration of riboflavin and rose bengal showed no inhibition in both S+U- and S-U+ strains of Pseudomonas aeruginosa. In 0.1% and 0.05% rose bengal irradiated groups, for both S+U- and S-U+ strains, there was complete inhibition of bacterial growth in the central 50mm zone corresponding to the diameter of the green light source. These in vitro results suggest that rose bengal photodynamic therapy may be an effective adjunct treatment for Pseudomonas aeruginosa keratitis.
Adjunctive low-dose docosahexaenoic acid (DHA) for major depression: An open-label pilot trial.
Smith, Deidre J; Sarris, Jerome; Dowling, Nathan; O'Connor, Manjula; Ng, Chee H
2018-04-01
Whilst the majority of evidence supports the adjunctive use of eicosapentaenoic acid (EPA) in improving mood, to date no study exists using low-dose docosahexaenoic acid (DHA) alone as an adjunctive treatment in patients with mild to moderate major depressive disorder (MDD). A naturalistic 8-week open-label pilot trial of low-dose DHA, (260 mg or 520 mg/day) in 28 patients with MDD who were non-responsive to medication or psychotherapy, with a Hamilton Depression Rating Scale (HAM-D) score of greater than 17, was conducted. Primary outcomes of depression, clinical severity, and daytime sleepiness were measured. After 8 weeks, 54% of patients had a ≥50% reduction on the HAM-D, and 45% were in remission (HAM-D ≤ 7). The eta-squared statistic (0.59) indicated a large effect size for the reduction of depression (equivalent to Cohen's d of 2.4). However confidence in this effect size is tempered due to the lack of a placebo. The mean score for the Clinical Global Impression Severity Scale was significantly improved by 1.28 points (P < 0.05). Despite a significant reduction in the HAM-D score for middle insomnia (P = 0.02), the reduction in excessive daytime somnolence on the total Epworth Sleepiness Scale (ESS) did not reach significance. No significant adverse reactions to DHA were found. Within the major limits of this open-label pilot study, the results suggest that DHA may provide additional adjunctive benefits in patients with mild- to -moderate depression.
Hua, L.; Cohen, T. S.; Shi, Y.; Datta, V.; Hilliard, J. J.; Tkaczyk, C.; Suzich, J.; Stover, C. K.
2015-01-01
Immunocompromised individuals are at increased risk of Staphylococcus aureus pneumonia. Neutralization of alpha-toxin (AT) with the monoclonal antibody (MAb) MEDI4893* protects normal mice from S. aureus pneumonia; however, the effects of the MAb in immunocompromised mice have not been reported. In this study, passive immunization with MEDI4893* increased survival rates and reduced bacterial numbers in the lungs in an immunocompromised murine S. aureus pneumonia model. Lungs from infected mice exhibited alveolar epithelial damage, protein leakage, and bacterial overgrowth, whereas lungs from mice passively immunized with MEDI4893* retained a healthy architecture, with an intact epithelial barrier. Adjunctive therapy or prophylaxis with a subtherapeutic MEDI4893* dose combined with subtherapeutic doses of vancomycin or linezolid improved survival rates, compared with the monotherapies. Furthermore, coadministration of MEDI4893* with vancomycin or linezolid extended the antibiotic treatment window. These data suggest that MAb-mediated neutralization of AT holds promise in strategies for prevention and adjunctive therapy among immunocompromised patients. PMID:25987629
Slot, Dagmar E; Timmerman, Mark F; Versteeg, Paula A; van der Velden, Ubele; van der Weijden, Fridus A
2012-12-01
Various laser systems are currently available for intra-oral use. Neodymium:Yttrium-Aluminium Garnet lasers(Nd:YAG) have been approved by the US Food and Drug Administration for soft tissue treatment in the oral cavity. The aim of this study was to test whether the use of a water-cooled Nd:YAG laser during a maintenance care programme as an adjunct to supragingival and subgingival debridement (scaling and root planing, SRP) with hand and ultrasonic instruments results in clinical improvement compared with SRP alone. This study was an examiner-blind, randomized and controlled clinical trial using a split-mouth design. Thirty subjects were selected, originally diagnosed with moderate to severe generalized periodontitis, following a periodontal maintenance care programme (PMC). Immediately after SRP in two randomly assigned contra-lateral quadrants, all pockets ≥5 mm were additionally treated with a Nd:YAG laser (1064 nm, 4W, 250-μsec pulse). Clinical assessments [probing pocket depth PPD, bleeding on pocket probing (BOPP)] were performed pre-treatment and at 6 months. Based on these assessments, the periodontal inflamed surface area (PISA) was calculated. At 6 months, the clinical parameters had significantly improved for both regimens. No statistically significant differences between treatment modalities were observed for PPD and BOPP scores at any time. PISA scores supported these findings. In residual pockets ≥5 mm, treated in a PMC, the adjunctive use of an Nd:YAG laser does not provide a clinically significant additional advantage. © 2012 John Wiley & Sons A/S.
Kim, Jon Soo; Lee, Jeong Ho; Ryu, Hye Won; Lim, Byung Chan; Hwang, Hee; Chae, Jong-Hee; Choi, Jieun; Kim, Ki Joong; Hwang, Yong Seung; Kim, Hunmin
2014-08-01
Intravenous levetiracetam (LEV) has been shown to be effective and safe in treating adults with refractory status epilepticus (SE). We sought to investigate the efficacy and safety of intravenous LEV for pediatric patients with refractory SE. We performed a retrospective medical-record review of pediatric patients who were treated with intravenous LEV for refractory SE. Clinical information regarding age, sex, seizure type, and underlying neurological status was collected. We evaluated other anticonvulsants that were used prior to administration of intravenous LEV and assessed loading dose, response to treatment, and any adverse events from intravenous LEV administration. Fourteen patients (8 boys and 6 girls) received intravenous LEV for the treatment of refractory SE. The mean age of the patients was 4.4 ± 5.5 years (range, 4 days to 14.6 years). Ten of the patients were neurologically healthy prior to the refractory SE, and the other 4 had been previously diagnosed with epilepsy. The mean loading dose of intravenous LEV was 26 ± 4.6 mg/kg (range, 20-30 mg/kg). Seizure termination occurred in 6 (43%) of the 14 patients. In particular, 4 (57%) of the 7 patients younger than 2 years showed seizure termination. No immediate adverse events occurred during or after infusions. The current study demonstrated that the adjunctive use of intravenous LEV was effective and well tolerated in pediatric patients with refractory SE, even in patients younger than 2 years. Intravenous LEV should be considered as an effective and safe treatment option for refractory SE in pediatric patients.
Wiles, Nicola; Thomas, Laura; Abel, Anna; Ridgway, Nicola; Turner, Nicholas; Campbell, John; Garland, Anne; Hollinghurst, Sandra; Jerrom, Bill; Kessler, David; Kuyken, Willem; Morrison, Jill; Turner, Katrina; Williams, Chris; Peters, Tim; Lewis, Glyn
2013-02-02
Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone. This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611. Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001). Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population. National Institute for Health Research Health Technology Assessment. Copyright © 2013 Elsevier Ltd. All rights reserved.
Enhancing learning using questions, adjunct to science charts
NASA Astrophysics Data System (ADS)
Holliday, William G.; Benson, Garth
This study supported two hypotheses. First, adjunct questions interacted with a science chart so powerfully that content established as difficult to learn in the pilot and in this study's control groups became easier to learn when charted. Second, students familiar with the chart test before instruction (test exposure) were better prepared to take this test after instruction. This adjunct-question study examined the generalizability of selective-attention and academic-studying hypotheses to a modified science chart medium. About 300 high school students were randomly assigned to four conditions each including a vitamin chart (chart only, test exposure, importance of questions emphasized to students by teachers, and combinational conditions - test exposure and question importance) across 16 biology classrooms. Then these same students were again randomly assigned within each classroom to a control and to four question treatments no questions, questions focusing on easy-to-learn charted content, questions focusing on difficult-to-learn charted content, and a combinational treatment.
Enhancing learning using questions adjunct to science charts
NASA Astrophysics Data System (ADS)
Holliday, William G.; Benson, Garth
This study supported two hypotheses. First, adjunct questions interacted with a science chart so powerfully that content established as difficult to learn in the pilot and in this study's control groups became easier to learn when charted. Second, students familiar with the chart test before instruction (test exposure) were better prepared to take this test after instruction. This adjunct-question study examined the generalizability of selective-attention and academic-studying hypotheses to a modified science chart medium. About 300 high school students were randomly assigned to four conditions each including a vitamin chart (chart only, test exposure, importance of questions emphasized to students by teachers, and combinational conditions--test exposure and question importance) across 16 biology classrooms. Then these same students were again randomly assigned within each classroom to a control and to four question treatments (no questions, questions focusing on easy-to-learn charted content, questions focusing on difficult-to-learn charted content, and a combinational treatment).
Starcevic, Vladan
2017-08-01
This article addresses some of the controversies about the role of benzodiazepines in the treatment of posttraumatic stress disorder. Benzodiazepines have been admonished in treatment guidelines for posttraumatic stress disorder, but this is based on very little solid evidence. Although benzodiazepines do not seem to be effective in the treatment of the core posttraumatic stress disorder symptoms, their careful use as adjunctive agents for the symptoms such as anxiety and sleep disturbance may be useful. Future research needs to identify predictors of improved treatment outcomes in posttraumatic stress disorder with use of benzodiazepines.
Dell'Osso, Bernardo; Cremaschi, Laura; Palazzo, Maria Carlotta; Spagnolin, Gregorio; Cattaneo, Alma; Grancini, Benedetta; Maggi, Matteo; Altamura, Alfredo Carlo
2014-09-01
Several randomized controlled trials (RCTs), conducted in schizophrenic and bipolar patients, have documented the efficacy and tolerability of asenapine as monotherapy both for short- and long-term treatment. However, evidence on its augmentative use is more limited and related to the manic/mixed phase of bipolar disorder (BD). The present article reviews augmentative asenapine efficacy and safety/tolerability in the treatment of BD. It also includes some original cases of bipolar patients treated with add-on asenapine in the short- and long-term. To date, only a single RCT with manic/mixed patients with partial response to mood-stabilizer monotherapy supports the efficacy and safety/tolerability of augmentative asenapine to lithium/valproate, both in acute and long-term treatment. Additionally, two case reports confirm the overall effectiveness of augmentative asenapine to clozapine and valproate. Our case series, consisting of 4 bipolar patients treated with adjunctive asenapine to mood stabilizers and atypical antipsychotics - with treatment duration ranging from 1 to 14 months - provided clinical results that are consistent with literature data. Taken as a whole, available evidence seems to support the efficacy and safety of adjunctive asenapine in bipolar patients, though additional studies with active comparators are requested to confirm the current body of evidence.
Once-daily USL255 as adjunctive treatment of partial-onset seizures: Randomized phase III study
Chung, Steve S; Fakhoury, Toufic A; Hogan, R Edward; Nagaraddi, Venkatesh N; Blatt, Ilan; Lawson, Balduin; Arnold, Stephan; Anders, Bob; Clark, Annie M; Laine, Dawn; Meadows, R Shawn; Halvorsen, Mark B
2014-01-01
Objective To evaluate the efficacy and safety of USL255, Qudexy™ XR (topiramate) extended-release capsules, as an adjunctive treatment for refractory partial-onset seizures (POS) in adults taking one to three concomitant antiepileptic drugs. Methods In this global phase III study (PREVAIL; NCT01142193), 249 adults with POS were randomized 1:1 to once-daily USL255 (200 mg/day) or placebo. The primary and key secondary efficacy endpoints were median percent reduction in weekly POS frequency and responder rate (proportion of patients with ≥50% reduction in seizure frequency). Seizure freedom was also assessed. Safety (adverse events, clinical and laboratory findings), as well as treatment effects on quality of life (QOLIE-31-P) and clinical global impression of change (CGI-C), were evaluated. Results Across the entire 11-week treatment phase, USL255 significantly reduced the median percent seizure frequency and significantly improved responder rate compared with placebo. Efficacy over placebo was observed early in treatment, in patients with highly refractory POS, and in those with the most debilitating seizure types (i.e., complex partial, partial secondarily generalized). USL255 was safe and generally well tolerated with a low incidence of neurocognitive adverse events. USL255 was associated with significant clinical improvement without adversely affecting quality of life. Significance The PREVAIL phase III clinical study demonstrated that once-daily USL255 (200 mg/day) significantly improved seizure control and was safe and generally well tolerated with few neurocognitive side effects. PMID:24902983
The effect of low-level diode laser on COX-2 gene expression in chronic periodontitis patients.
Pesevska, Snezana; Gjorgoski, Icko; Ivanovski, Kiro; Soldatos, Nikolaos K; Angelov, Nikola
2017-09-01
Adjunctive treatments to scaling and root planing (SRP) such as lasers, have been utilized in the treatment of chronic periodontitis, mainly aiming to suppress and eliminate the bacteria, as well as enhancing the healing response. Eighty gingival papilla biopsy samples were obtained from 60 patients diagnosed with chronic advanced periodontitis; randomly assigned to three treatment groups (n = 20), as well as 20 subjects with no periodontal disease [group A]. Group B received SRP on a single quadrant/day for four consecutive days. On day 5, all quadrants were rescaled. Groups C and D received the same treatment as group B plus laser application with the low-level diode laser (630-670 nm, 1.875 J/cm2) for five and ten consecutive days, respectively. Papilla biopsies were obtained from subjects and evaluated by RT-PCR for expression of COX-2. The values in the control group were 0.028 0.014 and baseline values for the examined groups were 0.16 0.18. Significantly decreased level of COX-2 expression for groups C and D was found after treatment, while lowest average expression was found in the group that had the 10 laser treatments supplemental to SRP (0,035 0,014). The results of this study show suppression of COX-2 in gingival tissue after low-level laser treatment as adjunct to SRP.
Wadhwa, Nitya; Basnet, Sudha; Natchu, Uma Chandra Mouli; Shrestha, Laxman P; Bhatnagar, Shinjini; Sommerfelt, Halvor; Strand, Tor A; Ramji, Siddarth; Aggarwal, K C; Chellani, Harish; Govil, Anuradha; Jajoo, Mamta; Mathur, N B; Bhatt, Meenakshi; Mohta, Anup; Ansari, Imran; Basnet, Srijana; Chapagain, Ram H; Shah, Ganesh P; Shrestha, Binod M
2017-07-10
An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality. This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment. A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants. Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017.
Grover, Shilpa; Tewari, Shikha; Sharma, Rajinder K; Singh, Gajendra; Yadav, Aparna; Naula, Satish C
2016-06-01
Emblica officinalis fruit possesses varied medicinal properties including cytoprotective antimicrobial, antioxidant, antiresorptive and antiinflammatory activity. The present study aimed to investigate the effect of subgingival application of indigenously prepared E. officinalis (Amla) sustained-release gel adjunctive to scaling and root planing (SRP) on chronic periodontitis. Forty-six patients (528 sites) were randomly assigned to control group (23;264): SRP +placebo gel and test group (23;264): SRP + 10% E. officinalis gel application. Periodontal parameters: plaque index, gingival index, probing pocket depth (PPD), clinical attachment level (CAL) and modified sulcus bleeding index (mSBI) were assessed at baseline, 2 and 3-month post-therapy. Forty patients (470 sites) completed the trial. When test and control sites were compared, significantly more reduction in mean PPD, mSBI, number of sites with PPD = 5-6 mm, PPD ≥ 7 mm, CAL ≥ 6 mm and greater CAL gain were achieved in test sites at 2- and 3-month post-therapy (p < 0.05). Locally delivered 10% E. officinalis sustained-release gel used as an adjunct to SRP may be more effective in reducing inflammation and periodontal destruction in patients with chronic periodontitis when compared with SRP alone. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.
Li, Jie; Li, Xue; Liu, Emily; Copeland, Paul; Freudenreich, Oliver; Goff, Donald C.; Henderson, David C.; Song, Xueqin; Fan, Xiaoduo
2013-01-01
Objective This study examined the effect of adjunctive intranasal insulin therapy on body metabolism in patients with schizophrenia. Method Each subject had a DSM-IV diagnosis of schizophrenia or schizoaffective disorder and had been on stable dose of antipsychotic agent for at least one month. In an 8-week randomized, double-blind, placebo-controlled study, subjects received either intranasal insulin (40IU 4 times per day) or placebo. The whole body dual-energy X-ray absorptiometry (DXA) was used to assess body composition. Lipid particles were assessed using nuclear magnetic resonance (NMR) spectroscopy. All assessments were conducted at baseline, and repeated at week 8. Results A total number of 39 subjects completed the study (18 in the insulin group, 21 in the placebo group). There were no significant differences between the two groups in week 8 changes for body weight, body mass index, waist circumference, as well as various measures of lipid particles (p′s > 0.100). The DXA assessment showed no significant differences between the two groups in week 8 changes for fat mass, lean mass or total mass (p's > 0.100). Conclusion In the present study, adjunctive therapy of intranasal insulin did not seem to improve body metabolism in patients with schizophrenia. The implications for future studies were discussed. PMID:23434504
Responsive cortical stimulation for the treatment of medically intractable partial epilepsy.
Morrell, Martha J
2011-09-27
This multicenter, double-blind, randomized controlled trial assessed the safety and effectiveness of responsive cortical stimulation as an adjunctive therapy for partial onset seizures in adults with medically refractory epilepsy. A total of 191 adults with medically intractable partial epilepsy were implanted with a responsive neurostimulator connected to depth or subdural leads placed at 1 or 2 predetermined seizure foci. The neurostimulator was programmed to detect abnormal electrocorticographic activity. One month after implantation, subjects were randomized 1:1 to receive stimulation in response to detections (treatment) or to receive no stimulation (sham). Efficacy and safety were assessed over a 12-week blinded period and a subsequent 84-week open-label period during which all subjects received responsive stimulation. Seizures were significantly reduced in the treatment (-37.9%, n = 97) compared to the sham group (-17.3%, n = 94; p = 0.012) during the blinded period and there was no difference between the treatment and sham groups in adverse events. During the open-label period, the seizure reduction was sustained in the treatment group and seizures were significantly reduced in the sham group when stimulation began. There were significant improvements in overall quality of life (p < 0.02) and no deterioration in mood or neuropsychological function. Responsive cortical stimulation reduces the frequency of disabling partial seizures, is associated with improvements in quality of life, and is well-tolerated with no mood or cognitive effects. Responsive stimulation may provide another adjunctive treatment option for adults with medically intractable partial seizures. This study provides Class I evidence that responsive cortical stimulation is effective in significantly reducing seizure frequency for 12 weeks in adults who have failed 2 or more antiepileptic medication trials, 3 or more seizures per month, and 1 or 2 seizure foci.
ERIC Educational Resources Information Center
Ritzhaupt, Albert Dieter; Barron, Ann
2008-01-01
The purpose of this study was to investigate the effect of time-compressed narration and representational adjunct images on a learner's ability to recall and recognize information. The experiment was a 4 Audio Speeds (1.0 = normal vs. 1.5 = moderate vs. 2.0 = fast vs. 2.5 = fastest rate) x Adjunct Image (Image Present vs. Image Absent) factorial…
Bhavsar, N V; Trivedi, S R; Dulani, K; Brahmbhatt, N; Shah, S; Chaudhri, D
2016-08-01
Bisphosphonates are beneficial to women, after menopause, in treatment of gum diseases. In this study, significant improvement in the disease condition was found and that no further progress was noted, and no side effects were reported. Bisphosphonates can be safely and successfully be used to support oral health procedures. The purpose of this study was to evaluate host modulating effect of bisphosphonate adjunct with the treatment of chronic periodontitis in osteopenic and osteoporotic postmenopausal women. Twenty-two osteopenic and osteoporotic postmenopausal women with moderate to severe chronic periodontitis were selected for the study. On intraoral examination, periodontal parameters like probing depth (PD), clinical attachment level (CAL), Plaque Index (PI) and Gingival Index (GI) were recorded. Scaling and root planing were done. Intraoral periapical X-rays were taken, and alveolar bone density (ABD) was measured with cone beam computed tomography (CBCT), and then, medications (risedronate 5 mg once daily (OD), calcium citrate 250 mg OD, vitamin D 400 IU OD) were given. Patients were recalled for follow-up at 3, 6 and 12 months. Intraoral periapical (IOPA) X-rays were taken at 6 and 12 months and ABD was measured at baseline and 12 months. There was a significant improvement in all the parameters. There was an increase of 0.02 ± 0.001 cm on CT scan and 0.38 ± 0.005 mm on IOPA in bone height over 12 months from baseline. Bone density increased by 118.56 ± 3.251 Hounsfield units (HU). There was no progress in the disease, and further bone loss was not noticed. This is in correlation with clinical parameters which showed highly significant gain in CAL (3.57 ± 0.234 mm) and reduction in PD (2.20 ± 0.229 mm) Bisphosphonate therapy as an adjunct to scaling and root planing may have significant beneficial clinical effects on the periodontium of postmenopausal women with moderate to severe chronic periodontitis.
Development of lacosamide for the treatment of partial-onset seizures
Doty, Pamela; Hebert, David; Mathy, Francois-Xavier; Byrnes, William; Zackheim, James; Simontacchi, Kelly
2013-01-01
Lacosamide is an antiepileptic drug (AED) available in multiple formulations that was first approved in 2008 as adjunctive therapy for partial-onset seizures (POS) in adults. Unlike traditional sodium channel blockers affecting fast inactivation, lacosamide selectively enhances sodium channel slow inactivation. This mechanism of action results in stabilization of hyperexcitable neuronal membranes, inhibition of neuronal firing, and reduction in long-term channel availability without affecting physiological function. Lacosamide has a well-characterized and favorable pharmacokinetic profile, including a fast absorption rate, minimal or no interaction with cytochrome P-450 izoenzymes, and a low potential for drug–drug interactions. Lacosamide clinical development included three placebo-controlled, double-blind, randomized trials conducted in more than 1300 patients, each demonstrating safety and efficacy of lacosamide compared to placebo as adjunctive therapy for adults with POS. The clinical use of lacosamide may broaden, pending results of trials evaluating its use as monotherapy for POS in adults, as treatment for epilepsy in pediatric subjects, and as adjunctive treatment for uncontrolled primary generalized tonic–clonic seizures in those with idiopathic generalized epilepsy. PMID:23859801
Piezosurgery®-assisted periodontally accelerated osteogenic orthodontics.
Pakhare, Vikas Vilas; Khandait, Chinmay Harishchandra; Shrivastav, Sunita Satish; Dhadse, Prasad Vijayrao; Baliga, Vidya Sudhindhra; Seegavadi, Vasudevan Dwarkanathan
2017-01-01
Periodontally accelerated osteogenic orthodontic procedure has become useful adjunct to reduce orthodontic treatment time as compared with conventional orthodontics. This case demonstrates the use of Piezosurgery ® to facilitate rapid tooth movement with relatively shorter treatment time. A 23-year-old male with Angles Class I malocclusion having spaced anterior teeth and protrusion requested orthodontic treatment with reduced time period. Before surgery, presurgical orthodontic treatment was done to do initial alignment of the teeth. This was followed by piezosurgical corticotomy and final space closure was achieved by active orthodontic tooth movement. The total treatment time required to complete the orthodontic treatment was 5 months. 1-year follow-up revealed no evidence of any adverse periodontal effects or relapse. Thus, Piezosurgery ® -assisted corticotomy may prove to be a noble and effective treatment approach to decrease the orthodontic treatment time.
Piezosurgery®-assisted periodontally accelerated osteogenic orthodontics
Pakhare, Vikas Vilas; Khandait, Chinmay Harishchandra; Shrivastav, Sunita Satish; Dhadse, Prasad Vijayrao; Baliga, Vidya Sudhindhra; Seegavadi, Vasudevan Dwarkanathan
2017-01-01
Periodontally accelerated osteogenic orthodontic procedure has become useful adjunct to reduce orthodontic treatment time as compared with conventional orthodontics. This case demonstrates the use of Piezosurgery® to facilitate rapid tooth movement with relatively shorter treatment time. A 23-year-old male with Angles Class I malocclusion having spaced anterior teeth and protrusion requested orthodontic treatment with reduced time period. Before surgery, presurgical orthodontic treatment was done to do initial alignment of the teeth. This was followed by piezosurgical corticotomy and final space closure was achieved by active orthodontic tooth movement. The total treatment time required to complete the orthodontic treatment was 5 months. 1-year follow-up revealed no evidence of any adverse periodontal effects or relapse. Thus, Piezosurgery®-assisted corticotomy may prove to be a noble and effective treatment approach to decrease the orthodontic treatment time. PMID:29491592
Pain management in the geriatric population.
Borsheski, Robert; Johnson, Quinn L
2014-01-01
Pain is a highly prevalent and clinically important problem in the elderly. Unfortunately, due to difficulties in assessing pain in geriatric patients, the complexities of multiple comorbidities, and the high prevalence of polypharmacy, many practitioners are reluctant to treat pain aggressively in this unique patient population. Safe and effective treatment therefore, requires a working knowledge of the physiologic changes associated with aging, the challenges of accurately assessing pain, the unique effects of common therapeutic agents upon the elderly as well as the importance of adjunctive therapies. The following review is intended to provide the practitioner with practical knowledge for safer and more effective treatment of pain.
Jahanbakhsh, Seyedeh Pardis; Manteghi, Ali Akhondpour; Emami, Seyed Ahmad; Mahyari, Saman; Gholampour, Beheshteh; Mohammadpour, Amir Hooshang; Sahebkar, Amirhossein
2016-08-01
Obsessive-compulsive disorder (OCD) is a chronic psychiatric disorder that is causally linked to dysregulation of the serotonergic system. The aim of this study is to investigate the efficacy of Withania somnifera (W. somnifera) root extract as an adjunct therapy to standard OCD treatment. Thirty patients with a confirmed diagnosis of OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria participated in this randomized double-blind placebo-controlled trial and were randomly assigned to the treatment group (W. somnifera extract, 120mg/day; n=15) or the placebo group (n=15). All patients were under treatment with Selective Serotonin Re-uptake Inhibitors (SSRIs), and were instructed to take 4 capsules of the extract or placebo per day, preferably after meals, for a period of six weeks. The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) was used in order to assess the severity of OCD symptoms at baseline and at the end of the trial. Statistical analyses were performed using SPSS software and Y-BOCS values were presented as median and range (Min-Max). Comparison of the change in Y-BOCS score during the course of the trial revealed a significantly greater effect of W. somnifera (26 (14-40) [pre-treatment] versus 14 (4-40) [post-treatment]; change: -8 (-23 to 0)) versus placebo (18 (11-33) [pre-treatment] versus 16 (10-31) [post-treatment]; change: -2 (-4 to 0)) (P<0.001). The extract was safe and no adverse event was reported during the trial. W. somnifera extract may be beneficial as a safe and effective adjunct to SSRIs in the treatment of OCD. Copyright © 2016. Published by Elsevier Ltd.
Treating the sibling subsystem: an adjunct of divorce therapy.
Schibuk, M
1989-04-01
Sibling therapy, frequently overlooked as a method of treatment, is particularly appropriate in situations that require a deliberate focus on the "unit of continuity," or the subsystem that remains intact during a process of family reorganization. For this and other reasons it can be an effective tool in treating children of divorce. A case illustrating this use of sibling therapy is presented.
ERIC Educational Resources Information Center
Hasanzadeh, Elmira; Mohammadi, Mohammad-Reza; Ghanizadeh, Ahmad; Rezazadeh, Shams-Ali; Tabrizi, Mina; Rezaei, Farzin; Akhondzadeh, Shahin
2012-01-01
"Ginkgo biloba" has been reported to affect the neurotransmitter system and to have antioxidant properties that could impact the pathogenesis of Autism Spectrum Disorder. Based on these studies, we decided to assess the effectiveness of "Ginkgo biloba" extract (Ginko T.D., Tolidaru, Iran) as an adjunctive agent to risperidone in the treatment of…
The Effects of a Structured Art Group Experience on Wellness Levels of University Students
ERIC Educational Resources Information Center
Jahimiak, Sarah Anne Eikelberg
2016-01-01
Although art therapy has been used for over 100 years as an adjunctive treatment method for physical and mental health disorders, the research findings regarding the efficacy of this approach have been mixed and inconclusive. Reviews of the current literature on the efficacy of art therapy have noted the field lacks well-controlled studies.…
Dean, Olivia M; Turner, Alyna; Malhi, Gin S; Ng, Chee; Cotton, Sue M; Dodd, Seetal; Sarris, Jerome; Samuni, Yuval; Tanious, Michelle; Dowling, Nathan; Waterdrinker, Astrid; Smith, Deidre; Berk, Michael
2015-01-01
Bipolar disorder places a significant burden on individuals, caregivers and family, and the broader community. Current treatments are believed to be more effective against manic symptoms, leaving a shortfall in recovery during the depressive phase of the illness. The current study draws on recent evidence suggesting that, in addition to increased oxidative load, alterations in mitochondrial function occur in bipolar disorder. This 16-week study aims to explore the potential benefits of N-acetylcysteine (NAC) alone or in combination (CT) with selected nutraceuticals believed to enhance mitochondrial function. The study includes adults diagnosed with bipolar disorder currently experiencing an episode of depression. Participants are asked to take NAC, CT, or placebo in addition to any usual treatments. A post-discontinuation visit is conducted 4 weeks following the treatment phase. The primary outcome of the study will be mean change on the Montgomery-Asberg Depression Rating Scale. Secondary outcomes include functioning, substance use, mania ratings, and quality of life. Blood samples will be collected at baseline and week 16 to explore biochemical alterations following treatment. This study may provide a novel adjunctive treatment for bipolar depression. Analysis of biological samples may assist in understanding the therapeutic benefits and the underlying etiology of bipolar depression. Australian and New Zealand Clinical Trial Registry ACTRN12612000830897.
EEG neurofeedback effects in the treatment of adolescent anorexia nervosa.
Lackner, Nina; Unterrainer, Human-Friedrich; Skliris, Dimitris; Shaheen, Sandra; Dunitz-Scheer, Marguerite; Wood, Guilherme; Scheer, Peter Jaron Zwi; Wallner-Liebmann, Sandra Johanna; Neuper, Christa
2016-01-01
A pre-post design including 22 females was used to evaluate the effectiveness of neurofeedback in the treatment of adolescent anorexia nervosa. Resting EEG measures and a psychological test-battery assessing eating behavior traits, clinical symptoms, emotionality, and mood were obtained. While both the experimental (n = 10) and control group (n = 12) received their usual maintenance treatment, the experimental group received 10 sessions of individual alpha frequency training over a period of 5 weeks as additional treatment. Significant training effects were shown in eating behavior traits, emotion regulation, and in relative theta power in the eyes closed condition. Although the results are limited due to the small sample size, these are the first empirical data demonstrating the benefits of neurofeedback as a treatment adjunct in individuals with anorexia nervosa.
Tripicchio, Gina L; Ammerman, Alice S; Neshteruk, Cody; Faith, Myles S; Dean, Kelsey; Befort, Christie; Ward, Dianne S; Truesdale, Kimberly P; Burger, Kyle S; Davis, Ann
2017-12-01
Strategies to treat pediatric obesity are needed, especially among high-need populations. Technology is an innovative approach; however, data on technology as adjuncts to in-person treatment programs are limited. A total of 64 children [body mass index (BMI) ≥85th percentile, mean age = 9.6 ± 3.1 years, 32.8% female, 84.4% Hispanic] were recruited to participate in one of three cohorts of a family-based behavioral group (FBBG) treatment program: FBBG only, TECH1, and TECH2. Rolling, nonrandomized recruitment was used to enroll participants into three cohorts from May 2014 to February 2015. FBBG began in May 2014 and received the standard, in-person 12-week treatment only (n = 21); TECH1 began in September 2014 and received FBBG plus a digital tablet equipped with a fitness app (FITNET) (n = 20); TECH2 began in February 2015 and received FBBG and FITNET, plus five individually tailored TeleMed health-coaching sessions delivered via Skype (n = 23). Child BMI z-score (BMI-z) was assessed at baseline and postintervention. Secondary aims examined weekly FBBG attendance, feasibility/acceptability of FITNET and Skype, and the effect of technology engagement on BMI-z. FBBG and TECH1 participants did not show significant reductions in BMI-z postintervention [FBBG: β = -0.05(0.04), p = 0.25; TECH1: β = -0.006(0.06), p = 0.92], but TECH2 participants did [β = -0.09(0.02), p < 0.001] and TeleMed session participation was significantly associated with BMI-z reduction [β = -0.04(0.01), p = 0.01]. FITNET use and FBBG attendance were not associated with BMI-z in any cohort. Overall, participants rated the technology as highly acceptable. Technology adjuncts are feasible, used by hard-to-reach participants, and show promise for improving child weight status in obesity treatment programs.
Jepsen, Karin; Jepsen, Søren
2016-06-01
This review gives an update of the current scientific evidence on the efficacy of the adjunctive use of systemic and local antibiotics/antimicrobials in the treatment of periodontitis. In particular, it addresses whether their use can improve the results of nonsurgical mechanical therapy in mild-to-moderate forms of the disease. Large numbers of randomized clinical trials and systematic reviews with meta-analyses have clearly established that adjunctive systemic antibiotics, combined with mechanical debridement, offer clinical improvements additional to those obtained with scaling and root planing alone. These effects are more pronounced in aggressive periodontitis and in initially deep pockets, whereas more limited additional improvements, of 0.3 mm for additional pocket reduction and 0.2 mm for additional clinical attachment gain, have been documented for moderately deep sites (4-6 mm) in patients with chronic periodontitis. The marginal clinical benefit in patients with moderate disease has to be balanced against possible side effects. Notably, it has to be realized that an increasing number of warnings have been articulated against the unrestricted use of antibiotics in treating periodontal diseases because of the emerging global public health issue of bacterial resistance. The effects of the adjunctive local administration of antimicrobials have also been very well documented in several systematic reviews. Overall, in persistent or recurrent localized deep sites, the application of antimicrobials by sustained-delivery devices may offer a benefit of an additional 0.4 mm in pocket depth reduction and 0.3 mm in clinical attachment level gain. In conclusion, the slight additional benefits of adjunctive antimicrobials, which were shown for moderate forms of periodontitis, have to be balanced against their side effects and therefore their prescription should be limited as much as possible. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Chiropractic management of a patient with persistent headache
West, Jason; Phillips, Reed B.
2013-01-01
Objective The purpose of this case report is to describe chiropractic care of a patient with persistent headache treated using chiropractic manipulative therapy and adjunct treatments. Clinical features A 54-year-old multiparous woman had chronic debilitating headaches for 11 months. Previous care from a variety of specialties had brought no appreciable relief. Intervention and outcome The patient was managed with chiropractic manipulative therapy, injections, and electromagnetic therapy. Five treatments over 6 weeks brought resolution of the headaches. Conclusion This patient with persistent headache responded favorably to a course of chiropractic and adjunctive care. PMID:24396331
Wolfe, Tammy Culpepper; Stringer, Elizabeth; Krauss, Sue; Trout, Tim
2015-03-01
This case report describes a new physical therapy technique, specifically the Wolfe Kinetic Technique, as adjunctive therapy in the treatment of severe osteoarthritis in a 20-yr-old Komodo dragon (Varanus komodoensis). This animal was managed with oral analgesics for 3 yr with fair to minimal response over time. Due to worsening of lameness and mobility, physical therapy was initiated. Ten treatment sessions were administered at 1-wk intervals. Within 1 mo the Komodo dragon exhibited marked improvement in gait and function, increased responsiveness to his environment, and increased mobility which continued to improve over the subsequent sessions. Although outcomes could not be measured by standardized objective measures, this study provides a reference for treatment of future cases and a foundation for future research substantiating treatment practices in animal physical therapy.
Roos-Jansåker, Ann-Marie; Almhöjd, Ulrica S; Jansson, Henrik
2017-01-01
To evaluate the adjunctive clinical effects of a chloramine to non-surgical treatment of peri-implantitis. Eighteen individuals diagnosed with peri-implantitis (clinical signs of inflammation and progressive bone loss) on at least two implants were included. Clinical variables; plaque accumulation (Pl), probing depth (PD), clinical attachment level (CAL) and bleeding on probing (BoP), were recorded at baseline and at 3-month follow-up. Primary clinical efficacy variable was the change in the number of sites with BoP. The implants were randomized into two different treatment groups: test and control. Both implants received supra- and submucosal debridement by ultrasonic instrumentation supplemented with hand instruments. The implants assigned to the test group first received local applications of a chloramine gel (Perisolv ™ ; RLS Global AB, Gothenburg, Sweden) followed by mechanical instrumentation. The oral hygiene was checked at 6 weeks. After 3 months, implants of both groups showed statistically significant reduction (P < 0.001) in the number of BoP-positive sites compared with baseline. The reduction of BoP-positive sites in the test group changed from 0.97 (SD ± 0.12) to 0.38 (SD ± 0.46), and in the control group from 0.97 (SD ± 0.12) to 0.31 (SD ± 0.42). Between-group comparisons revealed no statistically significant differences at baseline and after 3 months, for BoP or any of the other variables. In the present randomized clinical trial of peri-implantitis therapy; non-surgical mechanical debridement with adjunctive use of a chloramine is equally effective in the reduction of mucosal inflammation as conventional non-surgical mechanical debridement up to 3 months. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Naylor, Jennifer C; Kilts, Jason D; Bradford, Daniel W; Strauss, Jennifer L; Capehart, Bruce P; Szabo, Steven T; Smith, Karen D; Dunn, Charlotte E; Conner, Kathryn M; Davidson, Jonathan R T; Wagner, Henry Ryan; Hamer, Robert M; Marx, Christine E
2015-05-01
Many individuals with post-traumatic stress disorder (PTSD) experience persistent symptoms despite pharmacological treatment with antidepressants. Several open-label monotherapy and adjunctive studies have suggested that aripiprazole (a second-generation antipsychotic) may have clinical utility in PTSD. However, there have been no randomized placebo-controlled trials of aripiprazole use for PTSD. We thus conducted a pilot randomized controlled trial of adjunctive aripiprazole versus placebo among Veterans with chronic PTSD serving in the US military since 11 September 2001 to assess the feasibility, safety, tolerability, and therapeutic potential of aripiprazole. Sixteen Veterans were randomized, and 14 completed at least 4 weeks of the study; 12 completed the entire 8-week trial. Outcome measures included the Clinician-Administered PTSD Scale (CAPS), PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores. Aripiprazole was well-tolerated in this cohort, and improvements in CAPS, PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores were as hypothesized. Although CAPS change scores did not reach statistical significance, aripiprazole outperformed placebo by 9 points on the CAPS in the last observation carried forward analysis compared with the placebo group (n = 7 per group), and by 20 points in the group randomized to aripiprazole that completed the entire study (n = 5) compared with the placebo group (n = 7). Results suggest promise for aripiprazole as an adjunctive strategy for the treatment of PTSD.
Khanfour, Ashraf A
2013-05-01
When choosing the Ilizarov technique for the treatment of recurrent or neglected clubfeet deformity, there was a consensus on the treatment of 3-8-year-old children by the soft-tissue distraction 'bloodless method' either alone or with an adjunctive-limited soft tissue release; whereas, in older children, adjunctive osteotomies were required. Major foot osteotomies such as V, U, Y, or supramalleolar types were established for patients after puberty when the foot bones become fully ossified. So, children falling in the age group between 8 and 13 years (preadolescents) represents a transitional growing stage that has its identity that makes carrying out major foot osteotomies unsuitable. Twenty-five feet in 21 patients with a mean age at the time of operation of 10.9 years (range, 9-13 years) with recurrent or neglected clubfeet deformity who presented to the orthopedic department at Alexandria (Egypt) between February 2004 and December 2008 were treated with the Ilizarov technique combined with adjunctive limited bony and/or soft-tissue procedures as will be discussed. After a mean follow-up period of 3.6 years (range, 2-7 years), 21 children showed good results, four children showed fair results, and no poor results were recorded. No major complications were reported. The Ilizarov technique with limited bony and/or soft-tissue procedures can be considered as a suitable, convenient, efficient, and successful salvage procedure for preadolescent recurrent or neglected clubfeet.
Paliperidone Palmitate for Schizoaffective Disorder: A Review of the Clinical Evidence.
Greenberg, William M; Citrome, Leslie
2015-12-01
Despite being frequently diagnosed, there has been very limited study of efficacious treatments for schizoaffective disorder. Paliperidone had been approved for the treatment of schizoaffective disorder, and a recently completed relapse prevention study of the use of a once-monthly injectable paliperidone formulation has also led to an indication for that preparation to treat schizoaffective disorder. To review the efficacy and tolerability of paliperidone for schizoaffective disorder, we conducted a systematic literature search of studies of paliperidone in the treatment of schizoaffective disorder, and briefly reviewed evidence regarding the somewhat controversial nature of that diagnostic entity. We located several studies of the use of paliperidone extended release in the treatment of schizoaffective disorder, but only one completed study of the use of paliperidone palmitate, which demonstrated efficacy in preventing relapse. Three other studies are currently recruiting participants. Efficacy and tolerability were similar to the profile of oral paliperidone in the treatment of individuals with schizophrenia. These results were similar for both individuals treated with paliperidone palmitate alone, and for those treated with paliperidone palmitate with adjunctive mood stabilizers and/or antidepressants. The use of paliperidone palmitate does not require initial co-administration of oral paliperidone, has relatively little risk of drug-drug interactions, and its pharmacokinetics are favorable for once-monthly administration, an important treatment option for individuals with psychotic disorders, who may often be non-adherent to effective medication regimens. Paliperidone palmitate is an approved treatment for schizoaffective disorder, and can be efficacious with or without commonly employed adjunctive treatments.
Detrimental Effects of Immediate Explanation Feedback
ERIC Educational Resources Information Center
Roelle, Julian; Rahimkhani-Sagvand, Natalie; Berthold, Kirsten
2017-01-01
Adjunct questions are a common means to foster learning from instructional explanations. As the benefit of adjunct questions is mitigated if learner performance on them is low, it is also common to provide feedback as an add-on if learners fail to correctly respond to them. However, if adjunct questions are highly demanding, feedback might not…
Present and Future: Pharmacologic Treatment of Obesity
Glandt, Mariela; Raz, Itamar
2011-01-01
Obesity now presents one of the biggest health problems of our times. Diet and exercise are best for both prevention and treatment; unfortunately, both require much discipline and are difficult to maintain. Medications offer a possible adjunct, but their effect is modest, they are limited by side effects, and the weight loss lasts only as long as the drug is being taken, since as soon as treatment is stopped, the weight is regained. Sibutramine, a sympathomimetic medication which was available for long-term treatment, is the most recent of the drugs to be withdrawn from the market due to side effects; in this case it was an increased risk of cardiovascular events. This paper reviews those medications which are available for treatment of obesity, including many of those recently taken off the market. It also discusses some of the newer treatments that are currently being investigated. PMID:21331293
The use of atypical antipsychotics beyond psychoses: efficacy of quetiapine in bipolar disorder
Mundo, Emanuela; Cattaneo, Elisabetta; Zanoni, Silvia; Altamura, A Carlo
2006-01-01
Background and rationale Atypical antpsychotics have been sucessfully used in the treatment of bipolar disorder (BD), either as adjunctive or as monotherapy. Quetiapine is an atypical antipsychotic extensively used in the treatment of psychotic disorders. It has serotonergic and dopaminergic activity and it appears to be selective for the mesolimbic and mesocortical dopamine system. The aim of this paper was to review the recent literature on the use of quetiapine in the treatment of BD. Methods The literature databases currently available online were searched for papers on quetiapine and BD. Papers and reports published between January 1995 and June 2005 were selected and reviewed critically. Results Augmentative low dose quetiapine was found to be effective in BD partially responsive to conventional mood-stabilizers. Manic and mixed episodes have been the best studied, and quetiapine was found to be effective either as monotherapy or as adjunctive therapy in both randomized clinical trials and open-label studies. Data on the use of quetiapine in bipolar depression showed a significant efficacy and high remission rates. Maintenance data suggested a role of quetiapine as a good alternative to classical mood stabilizers in reducing recurrence rates of BD. A few studies on the efficacy in rapid cycling BD have also been published. Conclusions Quetiapine is an effective agent for the short- and long-term treatment of BD. The mechanism of action of quetiapine as a mood stabilizer is still unknown. Some preliminary data suggest the involvement of glutamate pathways but further studies are needed to clarify this issue. PMID:19412458
Hypnosis as an adjunct to cognitive-behavioral psychotherapy: a meta-analysis.
Kirsch, I; Montgomery, G; Sapirstein, G
1995-04-01
A meta-analysis was performed on 18 studies in which a cognitive-behavioral therapy was compared with the same therapy supplemented by hypnosis. The results indicated that the addition of hypnosis substantially enhanced treatment outcome, so that the average client receiving cognitive-behavioral hypnotherapy showed greater improvement than at least 70% of clients receiving nonhypnotic treatment. Effects seemed particularly pronounced for treatments of obesity, especially at long-term follow-up, indicating that unlike those in nonhypnotic treatment, clients to whom hypnotic inductions had been administered continued to lose weight after treatment ended. These results were particularly striking because of the few procedural differences between the hypnotic and nonhypnotic treatments.
Recommendations for the nutrition management of phenylalanine hydroxylase deficiency
Singh, Rani H.; Rohr, Fran; Frazier, Dianne; Cunningham, Amy; Mofidi, Shideh; Ogata, Beth; Splett, Patricia L.; Moseley, Kathryn; Huntington, Kathleen; Acosta, Phyllis B.; Vockley, Jerry; Van Calcar, Sandra C.
2014-01-01
The effectiveness of a phenylalanine-restricted diet to improve the outcome of individuals with phenylalanine hydroxylase deficiency (OMIM no. 261600) has been recognized since the first patients were treated 60 years ago. However, the treatment regime is complex, costly, and often difficult to maintain for the long term. Improvements and refinements in the diet for phenylalanine hydroxylase deficiency have been made over the years, and adjunctive therapies have proven to be successful for certain patients. Yet evidence-based guidelines for managing phenylalanine hydroxylase deficiency, optimizing outcomes, and addressing all available therapies are lacking. Thus, recommendations for nutrition management were developed using evidence from peer-reviewed publications, gray literature, and consensus surveys. The areas investigated included choice of appropriate medical foods, integration of adjunctive therapies, treatment during pregnancy, monitoring of nutritional and clinical markers, prevention of nutrient deficiencies, providing of access to care, and compliance strategies. This process has not only provided assessment and refinement of current nutrition management and monitoring recommendations but also charted a direction for future studies. This document serves as a companion to the concurrently published American College of Medical Genetics and Genomics guideline for the medical treatment of phenylalanine hydroxylase deficiency. Genet Med 16 2, 121–131. PMID:24385075
Cook, Jeremy J; Summers, N Jake; Cook, Emily A
2015-01-01
Electromagnetic fields and their uses in bone healing have been fairly well studied, with most results showing improvement in healing of both bone and cartilage. Most supportive data are found in relation to the spine, femur, and tibia, but there is increasing evidence for its use in the foot and ankle for treatment of nonunions and as an adjunctive device in arthrodeses, particularly in high-risk populations. There are varying data and a significant variety of quality in the current research and publications concerning the use of electrical bone stimulation in the treatment of the foot and ankle. Thus, there is a definite need for further investigation and high-quality study designs to determine the most effective treatment modalities and pathologies best used with bone stimulation. Bone stimulation should be viewed as an adjunctive procedure in which the surgeon optimizes the high-risk patient both medically or surgically whenever possible. But when used appropriately, bone stimulation has the potential to influence outcomes and aid in bone healing when complications arise and in high-risk populations. Copyright © 2015 Elsevier Inc. All rights reserved.
Rosenbaum, Simon; Tiedemann, Anne; Stanton, Robert; Parker, Alexandra; Waterreus, Anna; Curtis, Jackie; Ward, Philip B
2016-02-01
Physical activity (PA) and exercise is increasingly being recognised as an efficacious component of treatment for various mental disorders. The association between PA and cardiometabolic disease is well established, as is the strong link between mental illness, sedentary behaviour and poor cardiometabolic health. Examples of successful integration of clinical PA programs within mental health treatment facilities are increasing. The aim of this review was to summarise the evidence regarding PA and mental illness, and to present examples of clinical exercise programs within Australian mental health facilities. A narrative synthesis of systematic reviews and clinical trials was conducted. Evidence supporting the inclusion of PA programs as an adjunct to treatment for various conditions was presented; including depression, schizophrenia, anxiety disorders, post-traumatic stress disorder and substance abuse. In light of the available evidence, the inclusion of clinical PA programs within mental health treatment, facilitated by dedicated clinicians (exercise physiologists / physiotherapists) was justified. PA is a feasible, effective and acceptable adjunct to usual care for a variety of mental disorders. There is a clear need for greater investment in initiatives aiming to increase PA among people experiencing mental illness, given the benefits to both mental and physical health outcomes. © The Royal Australian and New Zealand College of Psychiatrists 2015.
Husain, Muhammad I; Chaudhry, Imran B; Husain, Nusrat; Khoso, Ameer B; Rahman, Raza R; Hamirani, Munir M; Hodsoll, John; Qurashi, Inti; Deakin, John Fw; Young, Allan H
2017-09-01
Evidence suggests that anti-inflammatory medication may be effective in the treatment of depressive symptoms. In this study, we aimed to investigate whether minocycline added to treatment as usual (TAU) for 3 months in patients with treatment-resistant depression will lead to an improvement in depressive symptoms. Multi-site, 12-week, double-blind, placebo-controlled, pilot trial of minocycline added to TAU for patients suffering from DSM-5 major depressive disorder, whose current episode has failed to respond to at least two antidepressants. The primary outcome measure was mean change in Hamilton Depression Rating Scale (HAMD-17) scores from baseline to week 12. Secondary measures were the Clinical Global Impression scale (CGI), Patient Health Questionnaire-9 (PHQ-9), the Generalised Anxiety Disorder scale (GAD-7) and EuroQoL (EQ-5D) quality-of-life questionnaire. Side-effect checklists were also used. Minocycline was started at 100 mg once daily (OD) and increased to 200 mg after 2 weeks. A total of 41 participants were randomised, with 21 in the minocycline group and 20 in the placebo group. A large decrease in HAMD scores was observed in the minocycline group compared to the placebo group (standardised effect size (ES) -1.21, p < 0.001). CGI scores in the minocycline group also showed a large improvement compared with placebo (odds ratio (OR): 17.6, p < 0.001). PHQ-9, GAD-7 and EQ-5D total showed more moderate improvements (ES ~ 0.4-0.5). The findings indicate that adjunctive minocycline leads to improvement in symptoms of treatment-resistant depression. However, our findings require replication in a larger sample. ClinicalTrials.gov identifier: NCT02263872, registered October 2014.
Psychodramatic Treatment for Deaf People.
ERIC Educational Resources Information Center
Swink, David F.
1985-01-01
The article describes how psychodrama is used in group psychotherapy and in social skills groups with deaf persons. In addition, videotape replay is described as an adjunct to psychodramatic treatment. (Author/CL)
Effect of Photo-Fenton Bleaching on Tetracycline-stained Dentin in vitro.
Bennett, Zackary Yale; Walsh, Laurence James
2015-02-01
Tetracycline-stained tooth structure is difficult to bleach using nightguard tray methods. The possible benefits of in-office light-accelerated bleaching systems based on the photo-Fenton reaction are of interest as possible adjunctive treatments. This study was a proof of concept for possible benefits of this approach, using dentine slabs from human tooth roots stained in a reproducible manner with the tetracycline antibiotic demeclocycline hydrochloride. Color changes overtime in tetra-cycline stained roots from single rooted teeth treated using gel (Zoom! WhiteSpeed(®)) alone, blue LED light alone, or gel plus light in combination were tracked using standardized digital photography. Controls received no treatment. Changes in color channel data were tracked overtime, for each treatment group (N = 20 per group). Dentin was lighter after bleaching, with significant improvements in the dentin color for the blue channel (yellow shade) followed by the green channel and luminosity. The greatest changes occurred with gel activated by light (p < 0.0001), which was superior to effects seen with gel alone. Use of the light alone did not significantly alter shade. This proof of concept study demonstrates that bleaching using the photo-Fenton chemistry is capable of lightening tetracycline-stained dentine. Further investigation of the use of this method for treating tetracycline-stained teeth in clinical settings appears warranted. Because tetracycline staining may respond to bleaching treatments based on the photo-Fenton reaction, systems, such as Zoom! WhiteSpeed, may have benefits as adjuncts to home bleaching for patients with tetracycline-staining.
Xiong, Xing-Jiang; Wang, Zhong; Wang, Jie
2015-01-01
Coronary heart disease (CHD) is one of the leading causes of death worldwide. Moreover, angina pectoris is one of the most important types of CHD. Therefore, prevention and effective treatment of angina pectoris is of utmost importance in both China and western countries. However, undesirable effects of antianginal therapy do influence treatment adherence to a certain extent. Therefore, it's not surprising that, complementary and alternative medicine (CAM), including Chinese medicine (CM), are widely welcomed among patients with CHD, hoping that it might complement western medicine. In our previous studies, blood stasis syndrome (BSS) (Xueyu Zheng) was the main syndrome (Zheng-hou) of angina pectoris. Currently, China Food and Drug Administration authoritatively recommended more than 200 Chinese patent medicines (CPMs) as complementary or adjunctive therapies for symptom management and enhancing quality of life along with mainstream care on angina pectoris management in mainland China. This paper reviewed 4 kinds of most frequently-used CPMs by promoting blood circulation and removing blood stasis in the treatment of angina pectoris. It aims to evaluate the current evidence of CPMs in combination therapy for angina pectoris. This review indicated that CPMs as adjunctive treatment to routine antianginal therapy play an active role in reducing the incidence of primary endpoint events, decreasing anginal attack rate, and improving electrocardiogram. Additionally, CPMs have been proven relatively safe. Further rigorously designed clinical trials should be conducted to confirm the results.
Molecular actions and clinical pharmacogenetics of lithium therapy
Can, Adem; Schulze, Thomas G.; Gould, Todd D.
2014-01-01
Mood disorders, including bipolar disorder and depression, are relatively common human diseases for which pharmacological treatment options are often not optimal. Among existing pharmacological agents and mood stabilizers used for the treatment of mood disorders, lithium has a unique clinical profile. Lithium has efficacy in the treatment of bipolar disorder generally, and in particular mania, while also being useful in the adjunct treatment of refractory depression. In addition to antimanic and adjunct antidepressant efficacy, lithium is also proven effective in the reduction of suicide and suicidal behaviors. However, only a subset of patients manifests beneficial responses to lithium therapy and the underlying genetic factors of response are not exactly known. Here we discuss preclinical research suggesting mechanisms likely to underlie lithium’s therapeutic actions including direct targets inositol monophosphatase and glycogen synthase kinase-3 (GSK-3) among others, as well as indirect actions including modulation of neurotrophic and neurotransmitter systems and circadian function. We follow with a discussion of current knowledge related to the pharmacogenetic underpinnings of effective lithium therapy in patients within this context. Progress in elucidation of genetic factors that may be involved in human response to lithium pharmacology has been slow, and there is still limited conclusive evidence for the role of a particular genetic factor. However, the development of new approaches such as genome-wide association studies (GWAS), and increased use of genetic testing and improved identification of mood disorder patients sub-groups will lead to improved elucidation of relevant genetic factors in the future. PMID:24534415
Ultrasound as an Adjunct to Mammography for Breast Cancer Screening: A Health Technology Assessment
Nikitovic-Jokic, Milica; Tu, Hong Anh; Palimaka, Stefan; Higgins, Caroline; Holubowich, Corinne
2016-01-01
Background Screening with mammography can detect breast cancer early, before clinical symptoms appear. Some cancers, however, are not captured with mammography screening alone. Ultrasound has been suggested as a safe adjunct screening tool that can detect breast cancers missed on mammography. We investigated the benefits, harms, cost-effectiveness, and cost burden of ultrasound as an adjunct to mammography compared with mammography alone for screening women at average risk and at high risk for breast cancer. Methods We searched Ovid MEDLINE, Ovid Embase, EBM Reviews, and the NHS Economic Evaluation Database, from January 1998 to June 2015, for evidence of effectiveness, harms, diagnostic accuracy, and cost-effectiveness. Only studies evaluating the use of ultrasound as an adjunct to mammography in the specified populations were included. We also conducted a cost analysis to estimate the costs in Ontario over the next 5 years to fund ultrasound as an adjunct to mammography in breast cancer screening for high-risk women who are contraindicated for MRI, the current standard of care to supplement mammography. Results No studies in average-risk women met the inclusion criteria of the clinical review. We included 5 prospective, paired cohort studies in high-risk women, 4 of which were relevant to the Ontario context. Adjunct ultrasound identified between 2.3 and 5.9 additional breast cancers per 1,000 screens. The average pooled sensitivity of mammography and ultrasound was 53%, a statistically significant increase relative to mammography alone (absolute increase 13%; P < .05). The average pooled specificity of the combined test was 96%, an absolute increase in the false-positive rate of 2% relative to mammography screening alone. The GRADE for this body of evidence was low. Additional annual costs of using breast ultrasound as an adjunct to mammography for high-risk women in Ontario contraindicated for MRI would range from $15,500 to $30,250 in the next 5 years. Conclusions We found no evidence that evaluated the comparative effectiveness or diagnostic accuracy of screening breast ultrasound as an adjunct to mammography among average-risk women aged 50 years and over. In women at high risk of developing breast cancer, there is low-quality evidence that screening with mammography and adjunct ultrasound detects additional cases of disease, with improved sensitivity compared to mammography alone. Screening with adjunct ultrasound also increases the number of false-positive findings and subsequent biopsy recommendations. It is unclear if the use of screening breast ultrasound as an adjunct to mammography will reduce breast cancer–related mortality among high-risk women. The annual cost burden of using adjunct ultrasound to screen high-risk women who cannot receive MRI in Ontario would be small. PMID:27468326
Kim, Carole H; Chen, Monica F; Coleman, Anne L
2017-02-22
Endophthalmitis refers to severe infection within the eye that involves the aqueous humor or vitreous humor, or both, and threatens vision. Most cases of endophthalmitis are exogenous (i.e. due to inoculation of organisms from an outside source), and most exogenous endophthalmitis is acute and occurs after an intraocular procedure. The mainstay of treatment is emergent administration of broad-spectrum intravitreous antibiotics. Due to their anti-inflammatory effects, steroids in conjunction with antibiotics have been proposed to be beneficial in endophthalmitis management. To assess the effects of antibiotics combined with steroids versus antibiotics alone for the treatment of acute endophthalmitis following intraocular surgery or intravitreous injection. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 11), MEDLINE Ovid (1946 to 8 December 2016), Embase Ovid (1980 to 8 December 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 8 December 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 8 December 2016, ClinicalTrials.gov (www.clinicaltrials.gov); searched 8 December 2016, and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 8 December 2016. We did not use any date or language restrictions in the electronic searches for trials. We included randomized controlled trials comparing the effectiveness of adjunctive steroids with antibiotics alone in the management of acute, clinically diagnosed endophthalmitis following intraocular surgery or intravitreous injection. We excluded trials with participants with endogenous endophthalmitis unless outcomes were reported by source of infection. We imposed no restrictions on the method or order of administration, dose, frequency, or duration of antibiotics and steroids. Two review authors independently screened the search results, assessed risk of bias, and extracted data using methods expected by Cochrane. We contacted study authors to try to obtain missing information or information to clarify risk of bias. We conducted a meta-analysis for any outcomes that were reported by at least two studies. Outcomes reported from single studies were summarized in the text. We assessed the certainty of the evidence using GRADE. We included three trials with a total of 95 randomized participants in this review and identified one ongoing trial. The studies were conducted in South Africa, India, and the Netherlands. Out of the 92 analyzed participants, 91 participants were diagnosed with endophthalmitis following cataract surgery. In the remaining participant, endophthalmitis was attributable to penetrating keratoplasty. All studies used intravitreous dexamethasone for adjunctive steroid therapy and a combination of two intravitreous antibiotics that provided gram-positive and gram-negative coverage for the antibiotic therapy. We judged one trial to be at overall low risk of bias and two studies to be at overall unclear risk of bias due to lack of reporting of study methods. None of the three trials had been registered in a clinical trial register.While none of the included studies reported the primary outcome of complete resolution of endophthalmitis as defined in our protocol, one study reported combined anatomical and functional success (i.e. proportion of participants with intraocular pressure of at least 5 mmHg and visual acuity of at least 6/120). Very low-certainty evidence suggested no difference in combined success when comparing adjunctive steroid antibiotics alone (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.80 to 1.45; 32 participants). Low-certainty evidence from two studies showed that a higher proportion of participants who received adjunctive dexamethasone had a good visual outcome (Snellen visual acuity 6/6 to 6/18) at three months compared with those in the antibiotics-alone group (RR 1.95, 95% CI 1.05 to 3.60; 60 participants). Similarly, low-certainty evidence from one study suggested that more participants in the dexamethasone group had a good visual outcome at 12 months compared to those who did not receive dexamethasone (RR 2.00, 95% CI 0.98 to 4.08; 28 participants). Investigators of one study reported improvement in visual acuity, but we could not estimate the effect of adjunctive steroid therapy because the study investigators did not provide standard deviations or standard errors. Two studies reported adverse events (retinal detachment, hypotony, proliferative vitreoretinopathy, and seclusion of pupil). The total numbers of adverse events were 8 out of 30 (26.7%) for those who received dexamethasone versus 6 out of 30 (20.0%) for those who did not. We could only perform a pooled analysis for the occurrence of retinal detachment; any difference between the two treatment groups was uncertain (RR 1.57, 95% CI 0.50 to 4.90; 60 participants) (very low-certainty evidence). No study reported intraocular pressure or cost outcomes. Current evidence on the effectiveness of adjunctive steroid therapy versus antibiotics alone in the management of acute endophthalmitis after intraocular surgery is inadequate. We found no studies that had enrolled cases of acute endophthalmitis following intravitreous injection. A combined analysis of two studies suggests adjunctive steroids may provide a higher probability of having a good visual outcome at three months than not using adjunctive steroids. However, considering that most of the confidence intervals crossed the null and that this review was limited in scope and applicability to clinical practice, it is not possible to conclude whether the use adjunctive steroids is effective at this time. Any future trials should examine whether adjunctive steroids may be useful in certain clinical settings such as type of causative organism or etiology. These studies should include outcomes that take patient's symptoms and clinical examination into account, report outcomes in a uniform and consistent manner, and follow up at short- and long-term intervals.
Kim, Carole H; Chen, Monica F; Coleman, Anne L
2017-01-01
Background Endophthalmitis refers to severe infection within the eye that involves the aqueous humor or vitreous humor, or both, and threatens vision. Most cases of endophthalmitis are exogenous (i.e. due to inoculation of organisms from an outside source), and most exogenous endophthalmitis is acute and occurs after an intraocular procedure. The mainstay of treatment is emergent administration of broad-spectrum intravitreous antibiotics. Due to their anti-inflammatory effects, steroids in conjunction with antibiotics have been proposed to be beneficial in endophthalmitis management. Objectives To assess the effects of antibiotics combined with steroids versus antibiotics alone for the treatment of acute endophthalmitis following intraocular surgery or intravitreous injection. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 11), MEDLINE Ovid (1946 to 8 December 2016), Embase Ovid (1980 to 8 December 2016), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 8 December 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 8 December 2016, ClinicalTrials.gov (www.clinicaltrials.gov); searched 8 December 2016, and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 8 December 2016. We did not use any date or language restrictions in the electronic searches for trials. Selection criteria We included randomized controlled trials comparing the effectiveness of adjunctive steroids with antibiotics alone in the management of acute, clinically diagnosed endophthalmitis following intraocular surgery or intravitreous injection. We excluded trials with participants with endogenous endophthalmitis unless outcomes were reported by source of infection. We imposed no restrictions on the method or order of administration, dose, frequency, or duration of antibiotics and steroids. Data collection and analysis Two review authors independently screened the search results, assessed risk of bias, and extracted data using methods expected by Cochrane. We contacted study authors to try to obtain missing information or information to clarify risk of bias. We conducted a meta-analysis for any outcomes that were reported by at least two studies. Outcomes reported from single studies were summarized in the text. We assessed the certainty of the evidence using GRADE. Main results We included three trials with a total of 95 randomized participants in this review and identified one ongoing trial. The studies were conducted in South Africa, India, and the Netherlands. Out of the 92 analyzed participants, 91 participants were diagnosed with endophthalmitis following cataract surgery. In the remaining participant, endophthalmitis was attributable to penetrating keratoplasty. All studies used intravitreous dexamethasone for adjunctive steroid therapy and a combination of two intravitreous antibiotics that provided gram-positive and gram-negative coverage for the antibiotic therapy. We judged one trial to be at overall low risk of bias and two studies to be at overall unclear risk of bias due to lack of reporting of study methods. None of the three trials had been registered in a clinical trial register. While none of the included studies reported the primary outcome of complete resolution of endophthalmitis as defined in our protocol, one study reported combined anatomical and functional success (i.e. proportion of participants with intraocular pressure of at least 5 mmHg and visual acuity of at least 6/120). Very low-certainty evidence suggested no difference in combined success when comparing adjunctive steroid antibiotics alone (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.80 to 1.45; 32 participants). Low-certainty evidence from two studies showed that a higher proportion of participants who received adjunctive dexamethasone had a good visual outcome (Snellen visual acuity 6/6 to 6/18) at three months compared with those in the antibiotics-alone group (RR 1.95, 95% CI 1.05 to 3.60; 60 participants). Similarly, low-certainty evidence from one study suggested that more participants in the dexamethasone group had a good visual outcome at 12 months compared to those who did not receive dexamethasone (RR 2.00, 95% CI 0.98 to 4.08; 28 participants). Investigators of one study reported improvement in visual acuity, but we could not estimate the effect of adjunctive steroid therapy because the study investigators did not provide standard deviations or standard errors. Two studies reported adverse events (retinal detachment, hypotony, proliferative vitreoretinopathy, and seclusion of pupil). The total numbers of adverse events were 8 out of 30 (26.7%) for those who received dexamethasone versus 6 out of 30 (20.0%) for those who did not. We could only perform a pooled analysis for the occurrence of retinal detachment; any difference between the two treatment groups was uncertain (RR 1.57, 95% CI 0.50 to 4.90; 60 participants) (very low-certainty evidence). No study reported intraocular pressure or cost outcomes. Authors’ conclusions Current evidence on the effectiveness of adjunctive steroid therapy versus antibiotics alone in the management of acute endophthalmitis after intraocular surgery is inadequate. We found no studies that had enrolled cases of acute endophthalmitis following intravitreous injection. A combined analysis of two studies suggests adjunctive steroids may provide a higher probability of having a good visual outcome at three months than not using adjunctive steroids. However, considering that most of the confidence intervals crossed the null and that this review was limited in scope and applicability to clinical practice, it is not possible to conclude whether the use adjunctive steroids is effective at this time. Any future trials should examine whether adjunctive steroids may be useful in certain clinical settings such as type of causative organism or etiology. These studies should include outcomes that take patient’s symptoms and clinical examination into account, report outcomes in a uniform and consistent manner, and follow up at short- and long-term intervals. PMID:28225198
Exercise in the Treatment of Youth Substance Use Disorders: Review and Recommendations.
More, Alissa; Jackson, Ben; Dimmock, James A; Thornton, Ashleigh L; Colthart, Allan; Furzer, Bonnie J
2017-01-01
Substance use disorders among youth represent a significant public health concern. It is well established that regular exercise provides important physical and mental health benefits; however, evidence for the role of exercise as an adjunct component within substance use disorder treatment is scarce. In this review, we identify factors associated with the development and persistence of substance use disorders among youth, identify current treatment modalities, and present evidence to support the efficacy of incorporating exercise participation during rehabilitation. We also provide a series of recommendations for future research that explores the feasibility and effectiveness of exercise participation as a complement to substance use disorder treatment among youth.
Prior elicitation and Bayesian analysis of the Steroids for Corneal Ulcers Trial.
See, Craig W; Srinivasan, Muthiah; Saravanan, Somu; Oldenburg, Catherine E; Esterberg, Elizabeth J; Ray, Kathryn J; Glaser, Tanya S; Tu, Elmer Y; Zegans, Michael E; McLeod, Stephen D; Acharya, Nisha R; Lietman, Thomas M
2012-12-01
To elicit expert opinion on the use of adjunctive corticosteroid therapy in bacterial corneal ulcers. To perform a Bayesian analysis of the Steroids for Corneal Ulcers Trial (SCUT), using expert opinion as a prior probability. The SCUT was a placebo-controlled trial assessing visual outcomes in patients receiving topical corticosteroids or placebo as adjunctive therapy for bacterial keratitis. Questionnaires were conducted at scientific meetings in India and North America to gauge expert consensus on the perceived benefit of corticosteroids as adjunct treatment. Bayesian analysis, using the questionnaire data as a prior probability and the primary outcome of SCUT as a likelihood, was performed. For comparison, an additional Bayesian analysis was performed using the results of the SCUT pilot study as a prior distribution. Indian respondents believed there to be a 1.21 Snellen line improvement, and North American respondents believed there to be a 1.24 line improvement with corticosteroid therapy. The SCUT primary outcome found a non-significant 0.09 Snellen line benefit with corticosteroid treatment. The results of the Bayesian analysis estimated a slightly greater benefit than did the SCUT primary analysis (0.19 lines verses 0.09 lines). Indian and North American experts had similar expectations on the effectiveness of corticosteroids in bacterial corneal ulcers; that corticosteroids would markedly improve visual outcomes. Bayesian analysis produced results very similar to those produced by the SCUT primary analysis. The similarity in result is likely due to the large sample size of SCUT and helps validate the results of SCUT.
Sidbury, Robert; Tom, Wynnis L.; Bergman, James N.; Cooper, Kevin D.; Silverman, Robert A.; Berger, Timothy G.; Chamlin, Sarah L.; Cohen, David E.; Cordoro, Kelly M.; Davis, Dawn M.; Feldman, Steven R.; Hanifin, Jon M.; Krol, Alfons; Margolis, David J.; Paller, Amy S.; Schwarzenberger, Kathryn; Simpson, Eric L.; Williams, Hywel C.; Elmets, Craig A.; Block, Julie; Harrod, Christopher G.; Begolka, Wendy Smith; Eichenfield, Lawrence F.
2015-01-01
Atopic dermatitis (AD) is a common, chronic inflammatory dermatosis that can affect all age groups. This evidence-based guideline addresses important clinical questions that arise in its management. In this final section, treatments for flare prevention and adjunctive and complementary therapies and approaches are reviewed. Suggestions on utilization are given based on available evidence. PMID:25264237
Plourde, Brian D; Vallez, Lauren J; Sun, Biyuan; Nelson-Cheeseman, Brittany B; Abraham, John P; Staniloae, Cezar S
2016-09-01
Simulations were made of the pressure and velocity fields throughout an artery before and after removal of plaque using orbital atherectomy plus adjunctive balloon angioplasty or stenting. The calculations were carried out with an unsteady computational fluid dynamic solver that allows the fluid to naturally transition to turbulence. The results of the atherectomy procedure leads to an increased flow through the stenotic zone with a coincident decrease in pressure drop across the stenosis. The measured effect of atherectomy and adjunctive treatment showed decrease the systolic pressure drop by a factor of 2.3. Waveforms obtained from a measurements were input into a numerical simulation of blood flow through geometry obtained from medical imaging. From the numerical simulations, a detailed investigation of the sources of pressure loss was obtained. It is found that the major sources of pressure drop are related to the acceleration of blood through heavily occluded cross sections and the imperfect flow recovery downstream. This finding suggests that targeting only the most occluded parts of a stenosis would benefit the hemodynamics. The calculated change in systolic pressure drop through the lesion was a factor of 2.4, in excellent agreement with the measured improvement. The systolic and cardiac-cycle-average pressure results were compared with measurements made in a multi-patient study treated with orbital atherectomy and adjunctive treatment. The agreements between the measured and calculated systolic pressure drop before and after the treatment were within 3%. This excellent agreement adds further confidence to the results. This research demonstrates the use of orbital atherectomy to facilitate balloon expansion to restore blood flow and how pressure measurements can be utilized to optimize revascularization of occluded peripheral vessels.
Perampanel: A Review in Drug-Resistant Epilepsy.
Frampton, James E
2015-09-01
Perampanel (Fycompa®), an orally-active, selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist, is a first-in-class antiepileptic drug (AED) offering the convenience of once-daily administration. In the EU and US, perampanel is approved in patients with epilepsy aged ≥12 years for the adjunctive treatment of primary generalized tonic-clonic seizures (GTCS) and partial-onset seizures (POS; with or without secondary generalization). In phase III trials of 17 or 19 weeks' duration, add-on perampanel ≤12 mg/day significantly improved seizure control in patients aged ≥12 years who were experiencing either primary GTCS or POS (with or without secondary generalization), despite ongoing treatment with stable dosages of one to three AEDs. Improvements in seizure control were maintained for up to 2 years in extensions of these core studies. Perampanel also provided sustained seizure control for up to ≈4 years in an extension of two phase II studies in patients aged ≥18 years with drug-resistant POS. Adjunctive perampanel therapy was generally well tolerated. Treatment-emergent adverse events were most commonly CNS-related (e.g. dizziness, somnolence, fatigue and irritability) and dose-related; however, most were of mild to moderate intensity. Clinical experience with perampanel is accumulating, although comparative studies and pharmacoeconomic data that could assist in positioning it relative to other AEDS that are approved and/or recommended as adjunctive therapy are lacking. Nonetheless, on the basis of its overall clinical profile and unique mechanism of action, perampanel is a useful additional adjunctive treatment option for patients with drug-resistant POS, with or without secondary generalization, and primary GTCS.
Fox, Susan H; Katzenschlager, Regina; Lim, Shen-Yang; Ravina, Bernard; Seppi, Klaus; Coelho, Miguel; Poewe, Werner; Rascol, Olivier; Goetz, Christopher G; Sampaio, Cristina
2011-10-01
The objective was to update previous evidence-based medicine reviews of treatments for motor symptoms of Parkinson's disease published between 2002 and 2005. Level I (randomized, controlled trial) reports of pharmacological, surgical, and nonpharmacological interventions for the motor symptoms of Parkinson's disease between January 2004 (2001 for nonpharmacological) and December 2010 were reviewed. Criteria for inclusion, clinical indications, ranking, efficacy conclusions, safety, and implications for clinical practice followed the original program outline and adhered to evidence-based medicine methodology. Sixty-eight new studies qualified for review. Piribedil, pramipexole, pramipexole extended release, ropinirole, rotigotine, cabergoline, and pergolide were all efficacious as symptomatic monotherapy; ropinirole prolonged release was likely efficacious. All were efficacious as a symptomatic adjunct except pramipexole extended release, for which there is insufficient evidence. For prevention/delay of motor fluctuations, pramipexole and cabergoline were efficacious, and for prevention/delay of dyskinesia, pramipexole, ropinirole, ropinirole prolonged release, and cabergoline were all efficacious, whereas pergolide was likely efficacious. Duodenal infusion of levodopa was likely efficacious in the treatment of motor complications, but the practice implication is investigational. Entacapone was nonefficacious as a symptomatic adjunct to levodopa in nonfluctuating patients and nonefficacious in the prevention/delay of motor complications. Rasagiline conclusions were revised to efficacious as a symptomatic adjunct, and as treatment for motor fluctuations. Clozapine was efficacious in dyskinesia, but because of safety issues, the practice implication is possibly useful. Bilateral subthalamic nucleus deep brain stimulation, bilateral globus pallidus stimulation, and unilateral pallidotomy were updated to efficacious for motor complications. Physical therapy was revised to likely efficacious as symptomatic adjunct therapy. This evidence-based medicine review updates the field and highlights gaps for research. Copyright © 2011 Movement Disorder Society.
A randomized trial of adjunct testosterone for cancer‐related muscle loss in men and women
Wright, Traver J.; Dillon, E. Lichar; Durham, William J.; Chamberlain, Albert; Randolph, Kathleen M.; Danesi, Christopher; Horstman, Astrid M.; Gilkison, Charles R.; Willis, Maurice; Richardson, Gwyn; Hatch, Sandra S.; Jupiter, Daniel C.; McCammon, Susan; Urban, Randall J.
2018-01-01
Abstract Background Cancer cachexia negatively impacts cancer‐related treatment options, quality of life, morbidity, and mortality, yet no established therapies exist. We investigated the anabolic properties of testosterone to limit the loss of body mass in late stage cancer patients undergoing standard of care cancer treatment. Methods A randomized, double‐blind, placebo‐controlled phase II clinical trial was undertaken to assess the potential therapeutic role of adjunct testosterone to limit loss of body mass in patients with squamous cell carcinoma of the cervix or head and neck undergoing standard of care treatment including chemotherapy and chemoradiation. Patients were randomly assigned in blocks to receive weekly injections of either 100 mg testosterone enanthate or placebo for 7 weeks. The primary outcome was per cent change in lean body mass, and secondary outcomes included assessment of quality of life, tests of physical performance, muscle strength, daily activity levels, resting energy expenditure, nutritional intake, and overall survival. Results A total of 28 patients were enrolled, 22 patients were studied to completion, and 21 patients were included in the final analysis (12 placebo, nine testosterone). Adjunct testosterone increased lean body mass by 3.2% (95% confidence interval [CI], 0–7%) whereas those receiving placebo lost 3.3% (95% CI, −7% to 1%, P = 0.015). Although testosterone patients maintained more favourable body condition, sustained daily activity levels, and showed meaningful improvements in quality of life and physical performance, overall survival was similar in both treatment groups. Conclusions In patients with advanced cancer undergoing the early phase of standard of care therapy, adjunct testosterone improved lean body mass and was also associated with increased quality of life, and physical activity compared with placebo. PMID:29654645
Vitamin D Treatment for the Prevention of Falls in Older Adults: Systematic Review and Meta-Analysis
Kalyani, Rita Rastogi; Stein, Brady; Valiyil, Ritu; Manno, Rebecca; Maynard, Janet W.; Crews, Deidra
2010-01-01
Objectives To systematically review and quantitatively synthesize the effect of vitamin D therapy on fall prevention in older adults. Design Systematic review and meta-analysis. Setting MEDLINE, CINAHL,Web of Science, EMBASE, Cochrane Library, LILACS, bibliographies of selected articles, and previous systematic reviews through February 2009 were searched for eligible studies. Participants Older adults (aged ≥60 years) who participated in randomized controlled trials that investigated the effectiveness of vitamin D therapy in the prevention of falls and used an explicit fall definition. Measurements Two authors independently extracted data including study characteristics, quality assessment, and outcomes. The I2 statistic was used to assess heterogeneity in a randomeffects model. Results Of 1,679 potentially relevant articles, 10 studies met inclusion criteria. In pooled analysis, vitamin D therapy (200-1000IU) reduced falls by 14% (relative risk [RR] 0.86;95% confidence interval 0.79-0.93;I2=7%) compared to calcium or placebo; number needed to treat=15. The following subgroups had significant fall reductions: community-dwelling (age<80 years), adjunctive calcium supplementation, no history of fractures/falls, duration>6 months, cholecalciferol, and dose≥800 IU. Meta-regression demonstrated no linear association of vitamin D dose or duration with treatment effect. Post-hoc analysis, including 7 additional studies (17 total) without explicit fall definitions, yielded smaller benefit (RR 0.92,0.87-0.98) and more heterogeneity (I2=36%) but found significant intergroup differences favoring adjunctive calcium versus none (p=0.001). Conclusion Vitamin D treatment effectively reduces the risk of falls in older adults. Future studies should investigate whether particular populations or treatment regimens may have greater benefit. PMID:20579169
Qi, Fanghua; Zhao, Lin; Zhou, Aiyan; Zhang, Bo; Li, Anyuan; Wang, Zhixue; Han, Junqing
2015-02-01
Recent studies indicate that Traditional Chinese medicine (TCM) can play an important role in the whole course of cancer treatment such as recovery stages of post-operative, radiotherapy or chemotherapy stages instead of only terminal stage of cancer. In this review, we have summarized current evidence for using TCM as adjuvant cancer treatment in different stages of cancer lesions. Some TCMs (e.g., TJ-41, Liu-jun-zi-tang, PHY906, Coumarin, and Aescine) are capable of improving the post-operative symptoms such as fatigue, pain, appetite, diarrhea, nausea, vomiting, and lymphedema. Some TCMs (e.g., Ginseng, Huang-Qi, BanZhiLian, TJ-48, Huachansu injection, Shenqi fuzheng injection, and Kanglaite injection) in combination with chemo- or radio-therapy are capable of enhancing the efficacy of and diminishing the side effects and complications caused by chemo- and radiotherapy. Taken together, they have great advantages in terms of suppressing tumor progression, relieving surgery complications, increasing the sensitivity of chemo- and radio- therapeutics, improving an organism's immune system function, and lessening the damage caused by surgery, chemo- or radio-therapeutics. They have significant effects on relieving breast cancer-related lymphedema, reducing cancer-related fatigue and pain, improving radiation pneumonitis and gastrointestinal side effects, protecting liver function, and even ameliorating bone marrow suppression. This review of those medicines should contribute to an understanding of Chinese herbal medicines as an adjunctive therapy in the whole course of cancer treatment instead of only terminal stage of cancer, by providing useful information for development of more effective anti-cancer drugs and making more patients "survival with cancer" for a long time.
Kim, Nam Wook; Song, Yul-Mai; Kim, Eosu; Cho, Hyun-Sang; Cheon, Keun-Ah; Kim, Su Jin; Park, Jin Young
2016-09-01
α-Lipoic acid (ALA) has been reported to be effective in reducing body weight in rodents and obese patients. Our previous open trial showed that ALA may play a role in reducing weight gain in patients with schizophrenia on atypical antipsychotics. The present study evaluated the efficacy of ALA in reducing weight and BMI in patients with schizophrenia who had experienced significant weight gain since taking atypical antipsychotics. In a 12-week, double-blind randomized placebo-controlled study, 22 overweight and clinically stable patients with schizophrenia were randomly assigned to receive ALA or placebo. ALA was administered at 600-1800 mg, as tolerated. Weight, BMI, abdomen fat area measured by computed tomography, and metabolic values were determined. Adverse effects were also assessed to examine safety. Overall, 15 patients completed 12 weeks of treatment. There was significant weight loss and decreased visceral fat levels in the ALA group compared with the placebo group. There were no instances of psychopathologic aggravation or severe ALA-associated adverse effects. ALA was effective in reducing weight and abdominal obesity in patients with schizophrenia who had experienced significant weight gain since beginning an atypical antipsychotic regimen. Moreover, ALA was well tolerated throughout this study. ALA might play an important role as an adjunctive treatment in decreasing obesity in patients who take atypical antipsychotics.
Glasser, Seth A; Charney, Sarah; Dervisis, Nikolaos G; Witten, Matthew R; Ettinger, Susan; Berg, Jason; Joseph, Richard
2014-01-01
An image-guided robotic stereotactic radiosurgery (SRS) system can be used to deliver curative-intent radiation in either single fraction or hypofractionated doses. Medical records for 19 dogs with nonlymphomatous nasal tumors treated with hypofractionated image-guided robotic stereotactic body radiotherapy (SBRT), either with or without adjunctive treatment, were retrospectively analyzed for survival and prognostic factors. Median survival time (MST) was evaluated using Kaplan-Meier survival curves. Age, breed, tumor type, stage, tumor size, prescribed radiation dose, and heterogeneity index were analyzed for prognostic significance. Dogs were treated with three consecutive-day, 8-12 gray (Gy) fractions of image-guided robotic SBRT. Overall MST was 399 days. No significant prognostic factors were identified. Acute side effects were rare and mild. Late side effects included one dog with an oronasal fistula and six dogs with seizures. In three of six dogs, seizures were a presenting complaint prior to SBRT. The cause of seizures in the remaining three dogs could not be definitively determined due to lack of follow-up computed tomography (CT) imaging. The seizures could have been related to either progression of disease or late radiation effect. Results indicate that image-guided robotic SBRT, either with or without adjunctive therapy, for canine nonlymphomatous nasal tumors provides comparable survival times (STs) to daily fractionated megavoltage radiation with fewer required fractions and fewer acute side effects.
Mancini, Marcio C; de Melo, Maria Edna
2017-01-01
The prevalence of obesity increases worldwide. Treating obesity and its associated health problems has a significant economic impact on health care systems. The unsatisfactory long-term outcomes observed in the obesity treatment are due to its complex pathophysiology and the inherent difficulties associated with maintenance of lifestyle modifications. Determined by genetic and environmental factors, obesity has been officially recognized as a chronic disease, an action that allowed the recognition of anti-obesity drugs as legitimate therapeutic options to address the growing obesity endemic. Like other chronic diseases, obesity requires long-term treatment. Pharmacological interventions, when used as an adjunct to lifestyle changes, are useful to facilitate clinically meaningful weight loss, which may impact on obesity-associated comorbid conditions. In the past, medications for weight reduction were limited. However, the landscape has changed and new drugs provide additional options for weight management. Among the new drugs, liraglutide is the most studied, especially regarding its effects on the limbic system. As an adjunct to a reduced-calorie diet and increased physical activity, treatment with liraglutide 3.0 mg provides a statistically significant and clinically meaningful weight loss. Liraglutide is a glucagon-like peptide 1 (GLP-1) receptor agonist that shares 97% homology to native GLP-1. Receptor agonists of GLP-1, including liraglutide, have emerged as effective therapies for type 2 diabetes and obesity. This review will address the major findings concerning the central regulation of appetite and the main studies that evaluated new drugs for obesity treatment, with a greater focus on liraglutide 3.0 mg.
Physical Activity in Depressed Elderly. A Systematic Review
Mura, Gioia; Carta, Mauro Giovanni
2013-01-01
Background: exercise may reduce depressive symptoms both in healthy aged populations and in old patients diagnosed with MDD, but few specific analysis were conducted on the efficacy of exercise as an adjunctive treatment with antidepressants, which may be probably more useful in clinical practice, considered the high prevalence of treatment resistant depression in late life, the low cost and safety of physical activity interventions. Objective: to establish the new findings on the effectiveness of exercise on depression in elderlies, with particular focus on the efficacy of the exercise as an adjunctive treatment with antidepressants drug therapy. Method: the search of significant articles was carried out in PubMed/Medline with the following key words: “exercise”, “physical activity”, “physical fitness”, “depressive disorder”, “depression”, “depressive symptoms”, “late life”, “old people”, and “elderly”. Results: 44 papers were retrieved by the search. Among the 10 included randomized controlled trials, treatment allocation was adequately conceived in 4 studies, intention-to-treat analysis was performed in 6 studies, but no study had a double-blinded assessment. We examined and discussed the results of all these trials. Conclusion: in the last 20 years, few progresses were done in showing the efficacy of exercise on depression, due in part to the persistent lack of high quality research, in part to clinical issues of management of depression in late life, in part to the difficult to establish the real effectiveness of exercise on depressive symptoms in elderlies. However, there are some promising findings on physical activity combined with antidepressants in treatment resistant late life depression. PMID:24009640
Efficacy of Adjunctive Tofacitinib Therapy in Mouse Models of Tuberculosis
Maiga, Mamoudou; Ahidjo, Bintou Ahmadou; Maiga, Mariama C.; Cheung, Laurene; Pelly, Shaaretha; Lun, Shichun; Bougoudogo, Flabou; Bishai, William R.
2015-01-01
The global tuberculosis (TB) epidemic and the spread of multi- and extensively-drug resistant strains of Mycobacterium tuberculosis (M.tb) have been fueled by low adherence to following lengthy treatment protocols, and the rapid spread of HIV (Human Immunodeficiency Virus). Persistence of the infection in immunocompetent individuals follows from the ability of M.tb to subvert host immune responses in favor of survival within macrophages. Alternative host-directed strategies are therefore being currently sought to improve treatment efficacy and duration. In this study, we evaluated tofacitinib, a new oral Janus kinase (JAK) blocker with anti-inflammatory properties, in shortening tuberculosis treatment. BALB/c mice, which are immunocompetent, showed acceleration of M.tb clearance achieving apparent sterilization after 16 weeks of adjunctive tofacitinib therapy at average exposures higher than recommended in humans, while mice receiving standard treatment alone did not achieve clearance until 24 weeks. True sterilization with tofacitinib was not achieved until five months. C3HeB/FeJ mice, which show reduced pro-inflammatory cytokines during M.tb infection, did not show improved clearance with adjunctive tofacitinib therapy, indicating that the nature of granulomatous lesions and host immunity may influence responsiveness to tofacitinib. Our findings suggest that the JAK pathway could be explored further for host-directed therapy in immunocompetent individuals. PMID:26425693
Kocaoglu-Vurma, N A; Harper, W J; Drake, M A; Courtney, P D
2008-08-01
The effect of nonstarter Lactobacillus adjunct cultures on the microbial, chemical, and sensory characteristics of Swiss cheese manufactured using the "kosher make procedure" was investigated. The kosher make procedure, which uses a lower cooking temperature than traditional Swiss cheese making, is used by many American cheese manufacturers to allow for kosher-certified whey. Cheeses were manufactured using a commercial starter culture combination and 1 of 3 non-starter Lactobacillus strains previously isolated from Swiss cheeses, Lactobacillus casei A26, L. casei B21, and Lactobacillus rhamnosus H2, as an adjunct. Control cheeses lacked the adjunct culture. Cheeses were analyzed during ripening for microbial and chemical composition. Adjunct strain L. casei A26, which utilized citrate most readily in laboratory medium, dominated the Lactobacillus population within 30 d, faster than the other adjunct cultures. There were no significant differences in Propionibacterium counts, Streptococcus thermophilus counts, protein, fat, moisture, salt, and pH among the cheeses. Free amino acid concentration ranged from 5 to 7 mmol/100 g of cheese at 90 d of ripening and was adjunct strain dependent. Lactic, acetic, and propionic acid concentrations were not significantly different among the cheeses after a 90-d ripening period; however differences in propionic acid concentrations were apparent at 60 d, with the cheeses made with L. casei adjuncts containing less propionic acid. Citric acid was depleted by the end of warm room ripening in cheeses manufactured with adjunct L. casei strains, but not with adjunct L. rhamnosus. Cheeses made with L. casei A26 were most similar to the control cheeses in diacetyl and butyric/isobutyric acid abundance as evaluated by electronic nose during the first 3 mo of ripening. The 4 cheese types differed in their descriptive sensory profiles at 8 mo of age, indicating an adjunct strain-dependent effect on particular flavor attributes. Adjunct Lactobacillus spp. affected the flavor profile and concentration of some flavor compounds in Swiss cheeses produced with the kosher make procedure. Use of adjunct Lactobacillus cultures provides Swiss cheese makers using a low cooking temperature with a means to control the dominant Lactobacillus strain during ripening, reduce citrate concentration, and modify cheese flavor.
ERIC Educational Resources Information Center
Jackson, Paul C.
2012-01-01
Adjunct faculty members make up an increasing percentage of the faculty in the community colleges. By some estimates, the percentage may be as high as seventy percent (70%). Many of these adjunct faculty members are practitioners, individuals who work full-time in business, industry or government, or who have recently retired. Practitioners bring…
ERIC Educational Resources Information Center
Pilieci, Kimberly M.
2016-01-01
The majority of faculty in higher education, including secular and biblical institutions, are adjunct faculty. The literature suggests that adjunct faculty are less effective and satisfied, and have weaker organizational sense of belonging (OSB) and affective organizational commitment (AOC). Denominational affiliation (DA) and religious commitment…
The Case for Adjunctive Monoclonal Antibody Immunotherapy in Schizophrenia.
Miller, Brian J; Buckley, Peter F
2016-06-01
This article presents the case in favor of clinical trials of adjunctive monoclonal antibody immunotherapy in schizophrenia. Evidence for prenatal and premorbid immune risk factors for the development of schizophrenia in the offspring is highlighted. Then key evidence for immune dysfunction in patients with schizophrenia is considered. Next, previous trials of adjunctive anti-inflammatory or other immunotherapy in schizophrenia are discussed. Then evidence for psychosis as a side effect of immunotherapy for other disorders is discussed. Also presented is preliminary evidence for adjunctive monoclonal antibody immunotherapy in psychiatric disorders. Finally, important considerations in the design and implementation of clinical trials of adjunctive monoclonal antibody immunotherapy in schizophrenia are discussed. Copyright © 2016 Elsevier Inc. All rights reserved.
The benefit of lithium carbonate adjunct in refractory depression--fact or fiction?
Kantor, D; McNevin, S; Leichner, P; Harper, D; Krenn, M
1986-06-01
Our group attempted to validate previous claims of rapid success with lithium carbonate adjunct therapy in antidepressant-resistant depression. Seven depressed patients volunteered for a study of placebo controlled, double-blind design. During their treatment on general hospital psychiatric wards, these patients received antidepressant medication for a period of at least 21 days. While continuing to receive antidepressant medication after the 21 day period, four of the patients then received lithium carbonate, and three received placebo. This combination pharmacological therapy continued for a 48 hour period. After this time, six of the seven patients showed no significant improvement. The remaining patient, who had received lithium carbonate, improved markedly over the 48 hour period. However, this patient relapsed within one week. A review of the two most extensive studies claiming significant results with the lithium carbonate adjunct therapy was performed. We feel that they, as presented, leave serious doubt as to the validity of their conclusions. We conclude that on the basis of our work up to this point in time and the analysis of previous reports claiming otherwise, no valid evidence exists for a consistent therapeutic effect of lithium carbonate adjunct in antidepressant-resistant depression. It was also found that methodologic contamination necessitated the exclusion of an additional six patients from the double-blind trial. We conclude that in order to objectively examine the rapidly expanding field of biological psychiatry, teaching of clinical staff in basic research procedure should be stressed as a part of routine ward orientation.
Complex ankle arthrodesis: Review of the literature
Rabinovich, Remy V; Haleem, Amgad M; Rozbruch, S Robert
2015-01-01
Complex ankle arthrodesis is defined as an ankle fusion that is at high risk of delayed and nonunion secondary to patient comorbidities and/or local ankle/hindfoot factors. Risk factors that contribute to defining this group of patients can be divided into systemic factors and local factors pertaining to co-existing ankle or hindfoot pathology. Orthopaedic surgeons should be aware of these risk factors and their association with patients’ outcomes after complex ankle fusions. Both external and internal fixations have demonstrated positive outcomes with regards to achieving stable fixation and minimizing infection. Recent innovations in the application of biophysical agents and devices have shown promising results as adjuncts for healing. Both osteoconductive and osteoinductive agents have been effectively utilized as biological adjuncts for bone healing with low complication rates. Devices such as pulsed electromagnetic field bone stimulators, internal direct current stimulators and low-intensity pulsed ultrasound bone stimulators have been associated with faster bone healing and improved outcomes scores when compared with controls. The aim of this review article is to present a comprehensive approach to the management of complex ankle fusions, including the use of biophysical adjuncts for healing and a proposed algorithm for their treatment. PMID:26396936
PROLACTIN LEVELS DO NOT RISE AMONG TRANSGENDER WOMEN TREATED WITH ESTRADIOL AND SPIRONOLACTONE.
Bisson, Jason R; Chan, Kelly J; Safer, Joshua D
2018-04-30
Existing transgender treatment guidelines suggest that for transfeminine hormone treatment there is a need to monitor prolactin levels. Also, recent studies suggest that use of cyproterone acetate as an adjunctive anti-androgen during transgender hormone treatment may elevate serum prolactin. We sought to determine whether the reported relationship between transfeminine estradiol treatment and hyperprolactinemia would be evident when the regimen used spironolactone as the adjunctive anti-androgen. Estradiol levels, testosterone levels, prolactin levels, and BMI as well as prescribed spironolactone dosage were extracted from the electronic medical records of 98 de-identified transgender women treated with estrogen therapy at the Endocrinology Clinic at Boston Medical Center. Up to 6 years of data were available for some patients. We found no statistically significant relationship between prolactin and any of the other measures. No estrogen dose associated elevations in prolactin were found. None of the patients were diagnosed with prolactinoma. Our data suggest that there may be no significant rise in prolactin when transgender women are treated with estrogen along with spironolactone as the adjunct anti-androgen, and that it may be unnecessary to monitor prolactin in women on this treatment combination. BMI = body mass index; BMC = Boston Medical Center; HT = hormone therapy; ENIGI = European Network for the Investigation of Gender Incongruence; E2 = estradiol; LCMS/MS = liquid chromatography tandem mass spectrometry; T = testosterone.
Notay, Manisha; Foolad, Negar; Vaughn, Alexandra R; Sivamani, Raja K
2017-12-01
Probiotic, prebiotic, and synbiotic supplementation is becoming more prevalent nowadays. Clinical studies have demonstrated some of the medical benefits of probiotics, prebiotics, and synbiotics within dermatology but an evidence-based review of their effects in adults is needed. The aim of this study was to identify evidence for the use of supplementation with probiotics, prebiotics, or synbiotics for the prevention and treatment of dermatological diseases in adults. We conducted a search of the Ovid MEDLINE, Cochrane Central Register of Controlled trials and EMBASE electronic databases from 1 January 1946 to 11 January 2017. Trials examining supplementation in the treatment of dermatological diseases using oral or topical probiotics, synbiotics, and prebiotics in adults over the age of 18 years were selected. Of 315 articles, 12 met the inclusion criteria. Nutritional supplementation with probiotics and prebiotics was shown to improve atopic dermatitis (AD) symptomatology, quality of life, or clinical severity in six of nine studies. One study in psoriasis was shown to improve inflammatory markers, and one study suggested that probiotics could be used as adjunctive therapy in the treatment of acne. Preliminary studies are optimistic for the use of some strains of probiotics for symptomatic and clinical improvement in AD, and as adjunctive treatment with antibiotics for acne. Further research is necessary to better assess how probiotics and prebiotics may be used within dermatology.
Metronidazole with Lactacyd vaginal gel in bacterial vaginosis.
Decena, Ditas Cristina D; Co, Jennifer T; Manalastas, Ricardo M; Palaypayon, Evelyn P; Padolina, Christia S; Sison, Judith M; Dancel, Louella A; Lelis, Marievi A
2006-04-01
To assess the efficacy and tolerability of lactic acid (Lactacyd vaginal gel; LVG) when given as an adjunct to metronidazole in the treatment of bacterial vaginosis (BV) among Filipino patients. A multicenter, open-labeled, controlled, randomized, three-arm comparative study on 90 women aged 18 years or over with clinically and microbiologically proven BV. The lactobacilli colony count significantly increased over time in all three arms. At day 14, growth of lactobacilli was significantly higher among patients in the lactic acid gel and combination treatment arms. Significant reduction of malodorous vaginal discharge (whiff test) and lowest recurrence of BV were noted in the metronidazole plus lactic acid gel arm. Regarding disappearance of signs of BV, there was significant decrease in the pH level and frequency of clue cell positive patients across time but was not significantly different across treatment groups. Only one patient (3%, 1/60) among those who received lactic acid gel complained of increased curd-like discharge. Six patients (10%, 6/60) who received metronidazole complained of epigastric pain/discomfort, dizziness and dyspnea. Lactic acid gel (LVG) is safe and as efficacious as metronidazole in the treatment of BV. There is evidence that LVG when combined with metronidazole is superior to metronidazole alone in promoting lactobacilli colonization. LVG as an adjunct to metronidazole, having the least number of recurrent BV, appears to result in better long-term treatment effect on bacterial vaginosis.
Sodium benzoate for treatment of hepatic encephalopathy.
Misel, Michael L; Gish, Robert G; Patton, Heather; Mendler, Michel
2013-04-01
Hepatic encephalopathy (HE) is a serious but usually reversible neuropsychiatric complication of cirrhosis, inborn errors of metabolism involving disorders of the urea cycle, and noncirrhotic portosystemic shunting that most commonly arises from a transjugular intrahepatic portosystemic shunting procedure. Symptoms can include alterations in cognitive function, neuromuscular activity, and consciousness, as well as sleep disorders and mood changes. HE is associated with significant morbidity and mortality and, if not properly treated, will lead to increased hospital admissions and healthcare costs. Although the standard therapies of lactulose and rifaximin (Xifaxan, Salix) are effective for most patients, these drugs may be associated with significant adverse effects and expense and, in some patients, inadequate therapeutic response. A need for adjunctive therapies exists. Drugs that target serum and tissue ammonia metabolism and elimination may be important adjuncts to drugs that reduce ammonia production and absorption from the gastrointestinal tract for patients with severe or persistent overt symptoms of HE. Sodium benzoate is an inexpensive adjunctive agent that can be used in addition to lactulose and rifaximin and may provide an option for some select patients with refractory HE who have failed to respond to standard therapies or who cannot afford them. Although sodium benzoate does not share the same adverse effect profiles of standard therapies for HE, its efficacy has not been well established. Given the significant dose-dependent sodium content of this therapy, it may not be appropriate for patients with significant fluid retention or kidney dysfunction.
Sodium Benzoate for Treatment of Hepatic Encephalopathy
Misel, Michael L.; Patton, Heather; Mendler, Michel
2013-01-01
Hepatic encephalopathy (HE) is a serious but usually reversible neuropsychiatric complication of cirrhosis, inborn errors of metabolism involving disorders of the urea cycle, and noncirrhotic portosystemic shunting that most commonly arises from a transjugular intrahepatic portosystemic shunting procedure. Symptoms can include alterations in cognitive function, neuromuscular activity, and consciousness, as well as sleep disorders and mood changes. HE is associated with significant morbidity and mortality and, if not properly treated, will lead to increased hospital admissions and healthcare costs. Although the standard therapies of lactulose and rifaximin (Xifaxan, Salix) are effective for most patients, these drugs may be associated with significant adverse effects and expense and, in some patients, inadequate therapeutic response. A need for adjunctive therapies exists. Drugs that target serum and tissue ammonia metabolism and elimination may be important adjuncts to drugs that reduce ammonia production and absorption from the gastrointestinal tract for patients with severe or persistent overt symptoms of HE. Sodium benzoate is an inexpensive adjunctive agent that can be used in addition to lactulose and rifaximin and may provide an option for some select patients with refractory HE who have failed to respond to standard therapies or who cannot afford them. Although sodium benzoate does not share the same adverse effect profiles of standard therapies for HE, its efficacy has not been well established. Given the significant dose-dependent sodium content of this therapy, it may not be appropriate for patients with significant fluid retention or kidney dysfunction. PMID:24711766
Albèr, Anders; Brønden, Andreas; Knop, Filip K
2017-07-01
A large proportion of patients with type 1 diabetes do not reach their glycaemic target of glycated hemoglobin (HbA1c) <7.0% (53 mmol/mol) and, furthermore, an increasing number of patients with type 1 diabetes are overweight and obese. Treatment of type 1 diabetes is based on insulin therapy, which is associated with well-described and unfortunate adverse effects such as hypoglycaemia and increased body weight. Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) are the focus of increasing interest as a possible adjunctive treatment to insulin in type 1 diabetes because of their glucagonostatic and extrapancreatic effects. So far, the focus has mainly been on the long-acting GLP-1RAs, but the risk-benefit ratio emerging from studies evaluating the effect of long-acting GLP-1RAs as adjunctive therapy to insulin therapy in patients with type 1 diabetes has been disappointing. This might be attributable to a lack of glucagonostatic effect of these long-acting GLP-1RAs in type 1 diabetes, alongside development of tachyphylaxis to GLP-1-induced retardation of gastric emptying. In contrast, the short-acting GLP-1RAs seem to have a preserved and sustained effect on glucagon secretion and gastric emptying in patients with type 1 diabetes, which could translate into effective lowering of postprandial glucose excursions; however, these observations regarding short-acting GLP-1RAs are all derived from small open-label trials and should thus be interpreted with caution. In the present paper we review the potential role of GLP-1RAs, in particular short-acting GLP-1RAs, as add-on to insulin in the treatment of type 1 diabetes. © 2017 John Wiley & Sons Ltd.
Development of lacosamide for the treatment of partial-onset seizures.
Doty, Pamela; Hebert, David; Mathy, Francois-Xavier; Byrnes, William; Zackheim, James; Simontacchi, Kelly
2013-07-01
Lacosamide is an antiepileptic drug (AED) available in multiple formulations that was first approved in 2008 as adjunctive therapy for partial-onset seizures (POS) in adults. Unlike traditional sodium channel blockers affecting fast inactivation, lacosamide selectively enhances sodium channel slow inactivation. This mechanism of action results in stabilization of hyperexcitable neuronal membranes, inhibition of neuronal firing, and reduction in long-term channel availability without affecting physiological function. Lacosamide has a well-characterized and favorable pharmacokinetic profile, including a fast absorption rate, minimal or no interaction with cytochrome P-450 izoenzymes, and a low potential for drug-drug interactions. Lacosamide clinical development included three placebo-controlled, double-blind, randomized trials conducted in more than 1300 patients, each demonstrating safety and efficacy of lacosamide compared to placebo as adjunctive therapy for adults with POS. The clinical use of lacosamide may broaden, pending results of trials evaluating its use as monotherapy for POS in adults, as treatment for epilepsy in pediatric subjects, and as adjunctive treatment for uncontrolled primary generalized tonic-clonic seizures in those with idiopathic generalized epilepsy. © 2013 The Authors. Annals of the New York Academy of Sciences published by Wiley Periodicals Inc. on behalf of The New York Academy of Sciences.
Verrotti, Alberto; Loiacono, Giulia; Rossi, Alessandra; Tartaro, Armando; Delli Pizzi, Andrea; Coppola, Giangennaro
2015-07-01
Schizencephaly is an uncommon malformation of cortical development. Patients with schizencephaly present with a broad range of severe neurologic symptoms including pharmacoresistant epilepsy. Rufinamide is a new antiepileptic drug approved for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome and it is also effective for refractory partial seizures. We report 3 cases of pediatric patients aged 7.2, 8.1, and 10.1 years, respectively, with intractable epilepsy associated with bilateral open-lip schizencephaly and septo-optic dysplasia. The follow-up ranged from 3.8 to 4.1 years. In our patients, the introduction of rufinamide as adjunctive drug led to a dramatic decline in the number of seizures and an improvement in EEG epileptic activity without side effects. Rufinamide seems to be efficacious and safe in patients with epileptic encephalopathies associated with pharmacoresistant epilepsy; further and larger clinical reports and controlled studies could confirm the usefulness of this anticonvulsant drug. © The Author(s) 2014.
Hua, L; Cohen, T S; Shi, Y; Datta, V; Hilliard, J J; Tkaczyk, C; Suzich, J; Stover, C K; Sellman, B R
2015-08-01
Immunocompromised individuals are at increased risk of Staphylococcus aureus pneumonia. Neutralization of alpha-toxin (AT) with the monoclonal antibody (MAb) MEDI4893* protects normal mice from S. aureus pneumonia; however, the effects of the MAb in immunocompromised mice have not been reported. In this study, passive immunization with MEDI4893* increased survival rates and reduced bacterial numbers in the lungs in an immunocompromised murine S. aureus pneumonia model. Lungs from infected mice exhibited alveolar epithelial damage, protein leakage, and bacterial overgrowth, whereas lungs from mice passively immunized with MEDI4893* retained a healthy architecture, with an intact epithelial barrier. Adjunctive therapy or prophylaxis with a subtherapeutic MEDI4893* dose combined with subtherapeutic doses of vancomycin or linezolid improved survival rates, compared with the monotherapies. Furthermore, coadministration of MEDI4893* with vancomycin or linezolid extended the antibiotic treatment window. These data suggest that MAb-mediated neutralization of AT holds promise in strategies for prevention and adjunctive therapy among immunocompromised patients. Copyright © 2015, American Society for Microbiology. All Rights Reserved.
Fibrin glue for local haemostasis in haemophilia surgery.
Rodriguez-Merchan, E Carlos
2017-12-01
Local fibrin glue (FG) appears to be a useful local haemostatic agent for severe haemorrhage in people with haemophilia (PWH) undergoing surgical procedures. To evaluate the role of local FG in PWH. A review of the literature on the topic has been performed. Local FG is not always necessary to achieve haemostasis in all surgical procedures performed in PWH. However, it could be a good adjunct therapy, primarily when a surgical field will bleed more than expected (e.g. patients with inhibitors), and also for circumcisions, dental extractions, and surgical treatment of pseudotumours. Although correct surgical haemostasis can typically be achieved by the infusion of factor concentrate at the adequate dose, my recommendation for surgeons is always to have local FG by their side. Local FG appears to be an effective adjunctive therapy for cases in which bleeding is likely (e.g. patients with inhibitors), and for circumcisions, oral surgery, and treatment of pseudotumours. Through the use of local FG, the doses of factor concentrate necessary to prevent bleeding could be reduced, providing considerable cost savings.
Alves, Flávio R F; Andrade-Junior, Carlos V; Marceliano-Alves, Marília F; Pérez, Alejandro R; Rôças, Isabela N; Versiani, Marco A; Sousa-Neto, Manoel D; Provenzano, José C; Siqueira, José F
2016-11-01
This study evaluated the disinfecting ability of chemomechanical preparation with rotary nickel-titanium instruments, followed by 2 distinct adjunctive procedures in the root canals of extracted mandibular molars by means of a correlative analytical approach. Twenty-two extracted mandibular molars were selected and anatomically matched between groups on the basis of micro-computed tomographic analysis. In the first phase of the experiment, root canals were contaminated with Enterococcus faecalis and subjected to chemomechanical preparation with BT RaCe instruments and 2.5% NaOCl irrigation. Then either XP-Endo Finisher instrument or passive ultrasonic irrigation was used to supplement disinfection. Micro-computed tomography was used to show whether the percentage of unprepared areas correlated to bacterial counts. In the second phase, the same teeth were contaminated once again, and the adjunctive procedures were used. Samples from the isthmus area of mesial roots and the apical 5-mm fragment of distal roots were obtained by cryopulverization. Samples taken before and after treatment steps in both phases were evaluated by quantitative polymerase chain reaction and statistically analyzed. In phase 1, preparation in both groups resulted in substantial decrease of bacterial counts (P < .001). The adjunctive approaches led to a further small bacterial reduction, which was significant for XP-Endo Finisher (P < .05). No significant differences were observed between groups for persisting bacterial counts. Correlative analysis revealed no statistically significant relationship between bacterial reduction and the percentage of unprepared areas (P > .05). In phase 2, both methods had significant antibacterial effects in the main canal, but none of them could predictably disinfect the isthmus/recess areas. Both XP-Endo Finisher and passive ultrasonic irrigation exhibited antibacterial effectiveness, but only the former caused a significant reduction in the bacterial counts after chemomechanical preparation. None of them were effective in predictably disinfecting the isthmus/recess areas. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.
Jurič, Ivona Bago; Plečko, Vanda; Pandurić, Dragana Gabrić; Anić, Ivica
2014-12-01
The purpose of the study was to evaluate the efficacy of antimicrobial photodynamic therapy (aPDT) used as an adjunct to the endodontic re-treatment in the eradication of microorganisms from previously filled root canals. The study sample consisted of 21 randomly selected patients with root filled and infected root canal system with chronic apical periodontitis on incisors or canines, who have had previously endodontic treatment. Microbiological samples from the root canals were collected after accessing the canal, following the endodontic re-treatment and after the aPDT procedure. During instrumentation, the root canals were irrigated with 2.5% sodium hypochlorite (NaOCl), and the final irrigation protocol included 17% ethylenediaminetetraacetic acid followed by NaOCl. Root canals were filled with a phenothiazinium chloride and irradiated with a diode laser (λ=660 nm, 100 mW) for 1 min. Microbiological samples from the root canals were cultivated on selective plates, and the identification was done by micromorphology, macromorphology and different API strips as well as bacterial counts (colony forming units). Fourteen bacteria species were isolated from the root canals initially, with a mean value of 4.57 species per canal. Although endodontic re-treatment alone produced a significant reduction in the number of bacteria species (p<0.001), the combination of endodontic treatment and aPDT was statistically more effective (p<0.001). No bacteria were cultivated from the main root canals of 11 teeth. The results indicated that the aPDT used as an adjunct to the conventional endodontic therapy achieved a significant further reduction of intracanal microbial load. Copyright © 2014 Elsevier B.V. All rights reserved.
More Antisepsis, Less Antibiotics Whenever Possible.
Grzybowski, Andrzej; Turczynowska, Magdalena
2018-01-01
Increasing bacterial resistance to antibiotics has recently become an important medical challenge. In ophthalmology antibiotics are widely used for treatment and prophylaxis of ocular infections. In many cases antiseptics may be a valuable adjunct and sometimes even an alternative to antibiotics for the prevention and treatment of infections, reducing the overuse of antibiotics. This review aims to highlight the available literature on the subject of antibiotic resistance in ophthalmology. Full understanding of this growing problem is necessary for tailoring effective pre-, intra-, and postoperative management to improve antibiotic stewardship programs. Copyright 2017 Asia-Pacific Academy of Ophthalmology.
Dynamic Distraction External Fixation for Contracture of the Metacarpophalangeal Joint.
Seigerman, Daniel A; Tan, Virak
2015-12-01
Metacarpophalangeal (MP) joint contractures are common after traumatic injury, and can be difficult to manage. After surgical capsulectomy, it remains challenging to maintain motion that was obtained at the time of surgery. Our group uses a novel, prefabricated digital external fixator to provide both distraction, and motion therapy across the MP joint after surgical treatment of MP contracture. The purpose of this technique is to demonstrate the effectiveness of an adjunctive dynamic distraction external fixator for the maintenance of joint motion after surgical treatment of MP contractures of the border digits.
Effects of incidental pictorial and verbal adjuncts on text learning.
Terry, W S; Howe, D C
1988-01-01
In this study, college students read and studied texts on historical figures in psychology, which were supplemented by drawings and/or brief biographies of these persons. In Experiment 1, a 2 x 2 between-groups design was conducted in which students received one adjunct with each text, both adjuncts, or neither. In Experiment 2, a single group of students received a within-subjects manipulation of the same adjunct conditions. In the between-groups comparison, students receiving biographies learned less of the target text passages, with the group receiving illustrations and biographies performing least accurately. In the within-subject conditions, texts accompanied by an illustration were better learned, with these students doing best on the text with both picture and biography. The results suggest that adjuncts may emphasize some texts, at the expense of learning from the other texts, but that too much adjunct material interferes with the learning of the target passages.
Zhao, Jingyuan; Song, Xueqin; Ai, Xiaoqing; Gu, Xiaojing; Huang, Guangbiao; Li, Xue; Pang, Lijuan; Ding, Minli; Ding, Shuang; Lv, Luxian
2015-01-01
Objective The present study aimed to evaluate the efficacy and safety of adjunctive aripiprazole treatment in schizophrenia patients with risperidone-induced hyperprolactinemia. Methods One hundred and thirteen patients who were receiving a stable dose of risperidone were randomly assigned to either adjunctive aripiprazole treatment (10 mg/day) (aripiprazole group) or no additional treatment (control group) at a 1:1 ratio for 8 weeks. Schizophrenia symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Rating scales and safety assessments (RSESE, BARS, UKU) were performed at baseline and at weeks 4 and 8. Serum levels of prolactin were determined at baseline and at weeks 2, 4, 6 and 8. Metabolic parameters were determined at baseline and again at weeks 4 and 8. Results One hundred and thirteen patients were enrolled in this study, and 107 patients completed the study (54 in the aripiprazole group, and 53 in the control group). PANSS-total scores in the aripiprazole group decreased significantly at week 4 (P = 0.003) and week 8 (P = 0.007) compared with the control group. PANSS-negative scores in the aripiprazole group also decreased significantly at week 4 (P = 0.005) and week 8 (P< 0.001) compared with the control group. Serum levels of prolactin in the aripiprazole group decreased significantly at week 2 (P< 0.001), week 4 (P< 0.001), week 6 (P< 0.001) and week 8 (P< 0.001) compared with the control group. There were no significant differences in changes of Fasting Plasma Glucose, Total cholesterol, Triglycerides and High Density Lipoprotein within each group at week 4 and 8 execpt low density lipoproteins. There was no significant difference in the incidence of adverse reactions between the two groups. Conclusions Adjunctive aripiprazole treatment may be beneficial in reducing serum levels of prolactin and improving negative symptoms in schizophrenia patients with risperidone-induced hyperprolactinemia. Trial Registration chictr.org ChiCTR-IOR-15006278 PMID:26448615
Early addition of topical corticosteroids in the treatment of bacterial keratitis.
Ray, Kathryn J; Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Glidden, David V; Oldenburg, Catherine E; Sun, Catherine Q; Zegans, Michael E; McLeod, Stephen D; Acharya, Nisha R; Lietman, Thomas M
2014-06-01
Scarring from bacterial keratitis remains a leading cause of visual loss. To determine whether topical corticosteroids are beneficial as an adjunctive therapy for bacterial keratitis if given early in the course of infection. The Steroids for Corneal Ulcers Trial (SCUT) was a randomized, double-masked, placebo-controlled trial that overall found no effect of adding topical corticosteroids to topical moxifloxacin hydrochloride in bacterial keratitis. Here, we assess the timing of administration of corticosteroids in a subgroup analysis of the SCUT. We define earlier administration of corticosteroids (vs placebo) as addition after 2 to 3 days of topical antibiotics and later as addition after 4 or more days of topical antibiotics. We assess the effect of topical corticosteroids (vs placebo) on 3-month best spectacle-corrected visual acuity in patients who received corticosteroids or placebo earlier vs later. Further analyses were performed for subgroups of patients with non-Nocardia keratitis and those with no topical antibiotic use before enrollment. Patients treated with topical corticosteroids as adjunctive therapy within 2 to 3 days of antibiotic therapy had approximately 1-line better visual acuity at 3 months than did those given placebo (-0.11 logMAR; 95% CI, -0.20 to -0.02 logMAR; P = .01). In patients who had 4 or more days of antibiotic therapy before corticosteroid treatment, the effect was not significant; patients given corticosteroids had 1-line worse visual acuity at 3 months compared with those in the placebo group (0.10 logMAR; 95% CI, -0.02 to 0.23 logMAR; P = .14). Patients with non-Nocardia keratitis and those having no topical antibiotic use before the SCUT enrollment showed significant improvement in best spectacle-corrected visual acuity at 3 months if corticosteroids were administered earlier rather than later. There may be a benefit with adjunctive topical corticosteroids if application occurs earlier in the course of bacterial corneal ulcers.
Berk, Michael; Dean, Olivia M; Cotton, Sue M; Gama, Clarissa S; Kapczinski, Flavio; Fernandes, Brisa; Kohlmann, Kristy; Jeavons, Susan; Hewitt, Karen; Moss, Kirsteen; Allwang, Christine; Schapkaitz, Ian; Cobb, Heidi; Bush, Ashley I; Dodd, Seetal; Malhi, Gin S
2012-08-14
N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).
Camardese, Giovanni; Leone, Beniamino; Serrani, Riccardo; Walstra, Coco; Di Nicola, Marco; Della Marca, Giacomo; Bria, Pietro; Janiri, Luigi
2015-01-01
Objectives We investigated the clinical benefits of bright light therapy (BLT) as an adjunct treatment to ongoing psychopharmacotherapy, both in unipolar and bipolar difficult-to-treat depressed (DTD) outpatients. Methods In an open-label study, 31 depressed outpatients (16 unipolar and 15 bipolar) were included to undergo 3 weeks of BLT. Twenty-five completed the treatment and 5-week follow-up. Main outcome measures Clinical outcomes were evaluated by the Hamilton Depression Rating Scale (HDRS). The Snaith–Hamilton Pleasure Scale and the Depression Retardation Rating Scale were used to assess changes in anhedonia and psychomotor retardation, respectively. Results The adjunctive BLT seemed to influence the course of the depressive episode, and a statistically significant reduction in HDRS scores was reported since the first week of therapy. The treatment was well-tolerated, and no patients presented clinical signs of (hypo)manic switch during the overall treatment period. At the end of the study (after 5 weeks from BLT discontinuation), nine patients (36%, eight unipolar and one bipolar) still showed a treatment response. BLT augmentation also led to a significant improvement of psychomotor retardation. Conclusion BLT combined with the ongoing pharmacological treatment offers a simple approach, and it might be effective in rapidly ameliorating depressive core symptoms of vulnerable DTD outpatients. These preliminary results need to be confirmed in placebo-controlled, randomized, double-blind clinical trial on larger samples. PMID:26396517
Microwave ablation for treatment of hepatic neoplasia in five dogs.
Yang, Toni; Case, J Brad; Boston, Sarah; Dark, Michael J; Toskich, Beau
2017-01-01
CASE DESCRIPTION 5 dogs between 9 and 11 years of age were evaluated for treatment of primary (n = 2) or metastatic (3) hepatic neoplasia. CLINICAL FINDINGS Patients were evaluated on an elective (n = 3) or emergency (2) basis. Two dogs with primary hepatic neoplasia were evaluated because of lethargy and inappetence. One dog was referred after an enlarged anal sac was detected via palpation per rectum during a routine physical examination. Two dogs were evaluated on an emergency basis because of lethargy and weakness, and hemoabdomen in the absence of a history of trauma was detected. All 5 dogs underwent thoracic radiography and abdominal ultrasonography, with CT performed in both dogs with primary hepatic neoplasia. All dogs had preoperative evidence of abdominal neoplasia, and none had evidence of thoracic metastasis. TREATMENT AND OUTCOME All dogs underwent ventral midline laparotomy and had diffuse hepatic neoplasia that precluded complete resection. Locoregional treatment with MWA was applied to hepatic lesions (0.5 to 2.5 cm diameter) without procedural complications. Histopathologic diagnoses were biliary adenocarcinoma (n = 1), hemangiosarcoma (2), hepatocellular carcinoma (1), and apocrine gland adenocarcinoma (1). CLINICAL RELEVANCE MWA is being increasingly used as an adjunct in the surgical treatment of human patients with primary and metastatic liver disease. Results of the present small case series suggested that MWA is feasible and potentially effective as an adjunctive treatment for appropriately selected dogs with nonresectable hepatic tumors. Further investigation is indicated.
Dopamine agonists in the treatment of Parkinson's disease.
Bonuccelli, Ubaldo; Pavese, Nicola
2006-01-01
Dopamine agonists are highly effective as adjunctive therapy to levodopa in advanced Parkinson's disease and have rapidly gained popularity as a monotherapy in the early stages of Parkinson's disease for patients less than 65-70 years old. In the latter case, dopamine agonists are about as effective as levodopa but patients demonstrate a lower tendency to develop motor complications. However, dopamine agonists lose efficacy over time and the number of patients remaining on agonist monotherapy decreases to less than 50% after 3 years of treatment. Thus, after a few years of treatment the majority of patients who started on dopamine agonists will be administered levodopa, in a combined dopaminergic therapy, in order to achieve a better control of motor symptoms.
Wells, Elizabeth A.; Donovan, Dennis M.; Brooks, Marissa
2012-01-01
Abstract Objectives The purpose of this study was to examine the implementation and acceptability of Mindful Awareness in Body-oriented Therapy (MABT), a novel adjunctive approach to substance use disorder (SUD) treatment. The primary aims of the study were to examine implementation of MABT as an adjunct to addiction treatment, and MABT acceptability to study participants and treatment staff. Methods MABT was delivered to participants randomly assigned to the intervention in a larger ongoing trial. This study focuses only on the implementation and acceptability of the intervention, as outcomes are not yet available. MABT was delivered once weekly for 8 weeks (1.5-hour sessions) and spanned inpatient and outpatient programs at a women-only treatment facility. Descriptive statistics were used to examine participant recruitment and retention to the intervention. To measure MABT acceptability, survey and written questionnaires were administered; analysis involved descriptive statistics and content analysis using Atlas.ti software. Results Thirty-one (31) of the women enrolled in the study were randomized to MABT. Eighteen (18) participants completed 75%–100% of the MABT sessions. Intervention implementation required flexibility on the part of both the researchers and the clinic staff, and minor changes were made to successfully implement MABT as an adjunct to usual care. MABT was perceived to increase emotional awareness and provide new tools to cope with stress, and to positively influence SUD treatment by facilitating emotion regulation. Conclusions It was feasible to implement MABT and to recruit and retain women to MABT in women's chemical-dependency treatment. MABT acceptability and perceived benefit was high. PMID:22524991
Íbias, Javier; Miguéns, Miguel; Pellón, Ricardo
2016-09-01
The spontaneously hypertensive rat (SHR) has been proposed as an animal model for attention deficit hyperactivity disorder (ADHD), and typically develops excessive patterns of response under most behavioural protocols. Schedule-induced polydipsia (SIP) is the excessive water consumption that occurs as a schedule effect when food is intermittently delivered and animals are partially food- but not water-deprived. SIP has been used as a model of excessive behaviour, and considerable evidence has involved the dopaminergic system in its development and maintenance. The aim of this study was to evaluate the effects of the most common psychostimulants used in ADHD treatment on SIP, comparing their effects in SHRs with rats from control populations. SHR, Wistar Kyoto (WKY) and Wistar rats were submitted to a multiple fixed time (FT) food schedule with two components: 30 s and 90 s. The acute effects of different dopaminergic compounds were evaluated after 40 sessions of SIP acquisition. All animals showed higher adjunctive drinking under FT 30 s than FT 90 s, and SHRs displayed higher asymptotic SIP levels in FT 90 s compared to WKY and Wistar rats. SHRs were less sensitive to dopaminergic agents than control rats in terms of affecting rates of adjunctive drinking. These differences point to an altered dopaminergic system in the SHR and provide new insights into the neurobiological basis of ADHD pharmacological treatments. © The Author(s) 2016.
Steinhoff, Bernhard J; Eckhardt, Klaus; Doty, Pamela; De Backer, Marc; Brunnert, Marcus; Schulze-Bonhage, Andreas
2016-05-01
This noninterventional, observational, postauthorization safety study (SP0942, NCT00771927) evaluated the incidence of predefined cardiovascular- (CV) and psychiatric-related treatment-emergent adverse events (TEAEs), in patients with epilepsy and uncontrolled partial-onset seizures, when initiating adjunctive therapy with lacosamide or another approved antiepileptic drug (AED) according to standard medical practice. Active recording of predefined TEAEs of interest took place at three-monthly recommended visits for up to 12months. Of 1004 patients who received at least one dose of adjunctive AEDs, 511 initially added lacosamide therapy, 493 added another AED, 69 were ≥65years of age, and 72 took concomitant antiarrhythmic drugs. Patients in the lacosamide cohort had a higher median frequency of partial-onset seizures (6.0 versus 3.5 per 28days) despite taking more concomitant AEDs (84.9% versus 66.9% took ≥2) at baseline. Patients who added lacosamide took a modal dose of 200mg/day over the treatment period (n=501), and 50.1% (256/511) completed 12months of treatment. Fifty-one point nine percent (256/493) of patients who added another AED completed the study, with the most commonly added AED being levetiracetam (28.4%). Four patients (0.8%) in each cohort, all <65years of age, reported predefined CV-related TEAEs. None were considered serious or led to discontinuation. One event each of sinus bradycardia (lacosamide), atrioventricular block first degree (lacosamide), and syncope (other AED) were judged to be treatment-related. Another patient in the other AED cohort reported bradycardia while taking concomitant antiarrhythmic drugs. Predefined psychiatric-related TEAEs were reported by 21 patients (4.1%) in the lacosamide cohort and 27 patients (5.5%) in the other AED cohort. Depression was the most common to be treatment-related (7/11 and 12/18 of patients reporting treatment-related psychiatric TEAEs, respectively). Serious psychiatric-related TEAEs were reported by four patients who added lacosamide (two cases of depression, two of suicide attempt) and one who added another AED (depression). Seven deaths occurred, all of which were considered unrelated/unlikely related to study medication. This thorough evaluation revealed a low incidence of predefined CV- and psychiatric-related TEAEs in patients taking adjunctive AED therapy according to standard medical practice. No specific safety concerns related to adjunctive lacosamide therapy were noted. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.
2012-01-01
Background Staphylococcus aureus bacteraemia is a common and serious infection, with an associated mortality of ~25%. Once in the blood, S. aureus can disseminate to infect almost any organ, but bones, joints and heart valves are most frequently affected. Despite the infection’s severity, the evidence guiding optimal antibiotic therapy is weak: fewer than 1,500 patients have been included in 16 randomised controlled trials investigating S. aureus bacteraemia treatment. It is uncertain which antibiotics are most effective, their route of administration and duration, and whether antibiotic combinations are better than single agents. We hypothesise that adjunctive rifampicin, given in combination with a standard first-line antibiotic, will enhance killing of S. aureus early in the treatment course, sterilise infected foci and blood faster, and thereby reduce the risk of dissemination, metastatic infection and death. Our aim is to determine whether adjunctive rifampicin reduces all-cause mortality within 14 days and bacteriological failure or death within 12 weeks from randomisation. Methods We will perform a parallel group, randomised (1:1), blinded, placebo-controlled trial in NHS hospitals across the UK. Adults (≥18 years) with S. aureus (meticillin-susceptible or resistant) grown from at least one blood culture who have received ≤96 h of active antibiotic therapy for the current infection and do not have contraindications to the use of rifampicin will be eligible for inclusion. Participants will be randomised to adjunctive rifampicin (600-900mg/day; orally or intravenously) or placebo for the first 14 days of therapy in combination with standard single-agent antibiotic therapy. The co-primary outcome measures will be all-cause mortality up to 14 days from randomisation and bacteriological failure/death (all-cause) up to 12 weeks from randomisation. 940 patients will be recruited, providing >80% power to detect 45% and 30% reductions in the two co-primary endpoints of death by 14 days and bacteriological failure/death by 12 weeks respectively. Discussion This pragmatic trial addresses the long-standing hypothesis that adjunctive rifampicin improves outcome from S. aureus bacteraemia through enhanced early bacterial killing. If proven correct, it will provide a paradigm through which further improvements in outcome from S. aureus bacteraemia can be explored. Trial registration Current Controlled Trial ISRCTN 37666216 PMID:23249501
Thwaites, Guy; Auckland, Cressida; Barlow, Gavin; Cunningham, Richard; Davies, Gerry; Edgeworth, Jonathan; Greig, Julia; Hopkins, Susan; Jeyaratnam, Dakshika; Jenkins, Neil; Llewelyn, Martin; Meisner, Sarah; Nsutebu, Emmanuel; Planche, Tim; Read, Robert C; Scarborough, Matthew; Soares, Marta; Tilley, Robert; Török, M Estée; Williams, John; Wilson, Peter; Wyllie, Sarah; Walker, A Sarah
2012-12-18
Staphylococcus aureus bacteraemia is a common and serious infection, with an associated mortality of ~25%. Once in the blood, S. aureus can disseminate to infect almost any organ, but bones, joints and heart valves are most frequently affected. Despite the infection's severity, the evidence guiding optimal antibiotic therapy is weak: fewer than 1,500 patients have been included in 16 randomised controlled trials investigating S. aureus bacteraemia treatment. It is uncertain which antibiotics are most effective, their route of administration and duration, and whether antibiotic combinations are better than single agents. We hypothesise that adjunctive rifampicin, given in combination with a standard first-line antibiotic, will enhance killing of S. aureus early in the treatment course, sterilise infected foci and blood faster, and thereby reduce the risk of dissemination, metastatic infection and death. Our aim is to determine whether adjunctive rifampicin reduces all-cause mortality within 14 days and bacteriological failure or death within 12 weeks from randomisation. We will perform a parallel group, randomised (1:1), blinded, placebo-controlled trial in NHS hospitals across the UK. Adults (≥ 18 years) with S. aureus (meticillin-susceptible or resistant) grown from at least one blood culture who have received ≤ 96 h of active antibiotic therapy for the current infection and do not have contraindications to the use of rifampicin will be eligible for inclusion. Participants will be randomised to adjunctive rifampicin (600-900 mg/day; orally or intravenously) or placebo for the first 14 days of therapy in combination with standard single-agent antibiotic therapy. The co-primary outcome measures will be all-cause mortality up to 14 days from randomisation and bacteriological failure/death (all-cause) up to 12 weeks from randomisation. 940 patients will be recruited, providing >80% power to detect 45% and 30% reductions in the two co-primary endpoints of death by 14 days and bacteriological failure/death by 12 weeks respectively. This pragmatic trial addresses the long-standing hypothesis that adjunctive rifampicin improves outcome from S. aureus bacteraemia through enhanced early bacterial killing. If proven correct, it will provide a paradigm through which further improvements in outcome from S. aureus bacteraemia can be explored.
Ayorech, Ziada; Tracy, Derek K; Baumeister, David; Giaroli, Giovanni
2015-03-15
Inflammation has emerged as a potentially important factor - and thus putative pharmacological target - in the pathology of bipolar disorders. However to date no systematic evaluations of the efficacy of add on anti-inflammatory treatment for the depressive and manic episodes have been carried out. Sixteen articles were ultimately identified - by computer searches of databases (including PsycINFO, MEDLINE, and EMBASE), supplemented by hand searches and personal communication - as meeting study inclusion criteria. Anti-manic effects were evaluated in two trials, one of adjunctive n-acetyl cysteine (NAC), one of omega-3 fatty acids (O3FA), and significant improvements only emerged for NAC. Celecoxib had a rapid but short-lived antidepressant effect. Despite limited effects of O3FA on symptoms, imaging data demonstrated alterations in neuronal functioning that might have longer-term therapeutic effects. Evidence was strongest for adjunctive NAC in bipolar depression though conclusions are limited by small sample sizes. Definitive conclusions are limited by the paucity of data, small study sizes, and the variability in methodology used. Current evidence for aspirin or celecoxib is insufficient though further investigation of the potential of celecoxib in early illness onset is warranted. Variable evidence exists for add-on O3FA though an indication of short-term treatment effects on membrane fluidity and neuronal activity suggest longer follow-up assessment is needed. The strongest evidence emerged for NAC in depression and future studies must address the role of illness duration and patients׳ baseline medications on outcomes. Careful consideration of lithium toxicity in the elderly and renal impaired is essential. Copyright © 2014 Elsevier B.V. All rights reserved.
McLoughlin, Benjamin C; Pushpa-Rajah, Jonathan A; Gillies, Donna; Rathbone, John; Variend, Hannele; Kalakouti, Eliana; Kyprianou, Katerina
2014-10-14
Schizophrenia is a mental illness causing disordered beliefs, ideas and sensations. Many people with schizophrenia smoke cannabis, and it is unclear why a large proportion do so and if the effects are harmful or beneficial. It is also unclear what the best method is to allow people with schizophrenia to alter their cannabis intake. To assess the effects of specific psychological treatments for cannabis reduction in people with schizophrenia.To assess the effects of antipsychotics for cannabis reduction in people with schizophrenia.To assess the effects of cannabinoids (cannabis related chemical compounds derived from cannabis or manufactured) for symptom reduction in people with schizophrenia. We searched the Cochrane Schizophrenia Group Trials Register, 12 August 2013, which is based on regular searches of BIOSIS, CINAHL, EMBASE, MEDLINE, PUBMED and PsycINFO.We searched all references of articles selected for inclusion for further relevant trials. We contacted the first author of included studies for unpublished trials or data. We included all randomised controlled trials involving cannabinoids and schizophrenia/schizophrenia-like illnesses, which assessed:1) treatments to reduce cannabis use in people with schizophrenia;2) the effects of cannabinoids on people with schizophrenia. We independently inspected citations, selected papers and then re-inspected the studies if there were discrepancies, and extracted data. For dichotomous data we calculated risk ratios (RR) and for continuous data, we calculated mean differences (MD), both with 95% confidence intervals (CI) on an intention-to-treat basis, based on a fixed-effect model. We excluded data if loss to follow-up was greater than 50%. We assessed risk of bias for included studies and used GRADE to rate the quality of the evidence. We identified eight randomised trials, involving 530 participants, which met our selection criteria.For the cannabis reduction studies no one treatment showed superiority for reduction in cannabis use. Overall, data were poorly reported for many outcomes of interest. Our main outcomes of interest were medium-term data for cannabis use, global state, mental state, global functioning, adverse events, leaving the study early and satisfaction with treatment. 1. Reduction in cannabis use: adjunct psychological therapies (specifically about cannabis and psychosis) versus treatment as usualResults from one small study showed people receiving adjunct psychological therapies specifically about cannabis and psychosis were no more likely to reduce their intake than those receiving treatment as usual (n = 54, 1 RCT, MD -0.10, 95% CI -2.44 to 2.24, moderate quality evidence). Results for other main outcomes at medium term were also equivocal. No difference in mental state measured on the PANSS positive were observed between groups (n = 62, 1 RCT, MD -0.30 95% CI -2.55 to 1.95, moderate quality evidence). Nor for the outcome of general functioning measured using the World Health Organization Quality of Life BREF (n = 49, 1 RCT, MD 0.90 95% CI -1.15 to 2.95, moderate quality evidence). No data were reported for the other main outcomes of interest 2. Reduction in cannabis use: adjunct psychological therapy (specifically about cannabis and psychosis) versus adjunct non-specific psychoeducation One study compared specific psychological therapy aimed at cannabis reduction with general psychological therapy. At three-month follow-up, the use of cannabis in the previous four weeks was similar between treatment groups (n = 47, 1 RCT, RR 1.04 95% CI 0.62 to 1.74, moderate quality evidence). Again, at a medium-term follow-up, the average mental state scores from the Brief Pscychiatric Rating Scale-Expanded were similar between groups (n = 47, 1 RCT, MD 3.60 95% CI - 5.61 to 12.81, moderate quality evidence). No data were reported for the other main outcomes of interest: global state, general functioning, adverse events, leaving the study early and satisfaction with treatment. 3. Reduction in cannabis use: antipsychotic versus antipsychotic In a small trial comparing effectiveness of olanzapine versus risperidone for cannabis reduction, there was no difference between groups at medium-term follow-up (n = 16, 1 RCT, RR 1.80 95% CI 0.52 to 6.22, moderate quality evidence). The number of participants leaving the study early at medium term was also similar (n = 28, 1 RCT, RR 0.50 95% CI 0.19 to 1.29, moderate quality evidence). Mental state data were reported, however they were reported within the short term and no difference was observed. No data were reported for global state, general functioning, and satisfaction with treatment.With regards to adverse effects data, no study reported medium-term data. Short-term data were presented but overall, no real differences between treatment groups were observed for adverse effects. 4. Cannabinoid as treatment: cannabidiol versus amisulprideAgain, no data were reported for any of the main outcomes of interest at medium term. There were short-term data reported for mental state using the BPRS and PANSS, no overall differences in mental state were observed between treatment groups. Results are limited and inconclusive due to the small number and size of randomised controlled trials available and quality of data reporting within these trials. More research is needed to a) explore the effects of adjunct psychological therapy that is specifically about cannabis and psychosis as currently there is no evidence for any novel intervention being better than standard treatment,for those that use cannabis and have schizophrenia b) decide the most effective drug treatment in treating those that use cannabis and have schizophrenia, and c) assess the effectiveness of cannabidiol in treating schizophrenia. Currently evidence is insufficient to show cannabidiol has an antipsychotic effect.
Nasra, Maha M A; Khiri, Heba M; Hazzah, Heba A; Abdallah, Ossama Y
2017-11-01
This study aimed to develop syringeable in-situ curcumin (cur) gel for the treatment of periodontal pockets as well as to evaluate the clinical efficacy of Cur in-situ gel formulation. Different in-situ gel formulations of Cur were prepared using 30% of pluronic F127, and 1% of carbopol P934. The formulations were evaluated regarding gelation temperature, pH, viscosity, syringeability study, in-vitro release and chemical stability of cur. The effect of aging of gel formulations for 3months in refrigerator was investigated. The selected formulation was clinically evaluated through the determination of probing depth, plaque index, and bleeding index at baseline and 1 month after application. The formulations showed accepted gelation temperature ranging from 28 to 34 °C and all had pH value of 4. The viscosity of the formulations at 4 °C ranged from 19 000 to 37 000 cP. All formulations were easily syringeable through 21 gauge needle at cold temperature. Curcumin stability during the release study was maintained. Aging showed no significant effect on release profile, drug content, or the pH after 3 months, while it showed a slight increase in viscosity with concomitant decrease in gelation temperature. Selected formulations delivered into periodontal pocket evaluated clinically showed to be effective. The treated group revealed that the adjunctive use of intracrevicular 2% curcumin in-situ gel adjunct to mechanical treatment in patients with adult periodontitis could aid in significant clinical reduction of probing depth, bleeding index, and to less extent of plaque. This indicates that curcumin in this novel drug delivery system is an excellent candidate for periodontal disease treatment.
Faulkner, Michele A
2017-01-01
Perampanel is a first-in-class antiepileptic medication approved for the treatment of partial (focal) seizures, and as adjunctive treatment for primarily generalized tonic-clonic seizures. The pharmacology, efficacy data, adverse-effect profile, pharmacokinetics and place in therapy are reviewed. Perampanel is indicated for use in patients with epilepsy who are 12 years of age or older. It is the first medication designed specifically to be a non-competitive antagonist at post-synaptic α-amino-3-hydroxyl-5-methyl-4-isoxazole-propionate receptors. Efficacy in refractory seizures has been established, and ongoing efficacy demonstrated by post-marketing data. The drug is completely absorbed, and exhibits a half-life that allows for once-daily administration in doses up to 12 mg/day. Drug interactions are minimal, but increased doses may be necessary when given with strong inducers of cytochrome P450 enzymes, including when perampanel is co-administered with other antiepileptics that exhibit this property. The most common adverse effects noted in both clinical trials and post-marketing are dizziness and somnolence. Psychiatric and behavioral adverse events have been documented in both adult and pediatric patients, including those with no corresponding diagnostic history. Perampanel is a novel adjunctive antiepileptic medication that is an effective option for adolescents and adults with partial seizures, and primarily generalized tonic-clonic seizures uncontrolled with other medications.
Faulkner, Michele A
2017-01-01
Purpose Perampanel is a first-in-class antiepileptic medication approved for the treatment of partial (focal) seizures, and as adjunctive treatment for primarily generalized tonic–clonic seizures. The pharmacology, efficacy data, adverse-effect profile, pharmacokinetics and place in therapy are reviewed. Summary Perampanel is indicated for use in patients with epilepsy who are 12 years of age or older. It is the first medication designed specifically to be a non-competitive antagonist at post-synaptic α-amino-3-hydroxyl-5-methyl-4-isoxazole-propionate receptors. Efficacy in refractory seizures has been established, and ongoing efficacy demonstrated by post-marketing data. The drug is completely absorbed, and exhibits a half-life that allows for once-daily administration in doses up to 12 mg/day. Drug interactions are minimal, but increased doses may be necessary when given with strong inducers of cytochrome P450 enzymes, including when perampanel is co-administered with other antiepileptics that exhibit this property. The most common adverse effects noted in both clinical trials and post-marketing are dizziness and somnolence. Psychiatric and behavioral adverse events have been documented in both adult and pediatric patients, including those with no corresponding diagnostic history. Conclusion Perampanel is a novel adjunctive antiepileptic medication that is an effective option for adolescents and adults with partial seizures, and primarily generalized tonic–clonic seizures uncontrolled with other medications. PMID:29042752
The role of metabolic therapy in treating glioblastoma multiforme
Maroon, Joseph C.; Seyfried, Thomas N.; Donohue, Joseph P.; Bost, Jeffrey
2015-01-01
Glioblastoma multiforme (GBM) is an aggressive and nearly uniformly fatal malignancy of the central nervous system. Despite extensive research and clinical trials over the past 50 years, very little progress has been made to significantly alter its lethal prognosis. The current standard of care (SOC) includes maximal surgical resection, radiation therapy and chemotherapy and temozolomide (TMZ), including the selective use of glucocorticoids for symptom control. These same treatments, however, have the potential to create an environment that may actually facilitate tumor growth and survival. Research investigating the unique metabolic needs of tumor cells has led to the proposal of a new metabolic treatment for various cancers including GBMs that may enhance the effectiveness of the SOC. The goal of metabolic cancer therapy is to restrict GBM cells of glucose, their main energy substrate. By recognizing the underlying energy production requirements of cancer cells, newly proposed metabolic therapy is being used as an adjunct to standard GBM therapies. This review will discuss the calorie restricted ketogenic diet (CR-KD) as a promising potential adjunctive metabolic therapy for patients with GBMs. The effectiveness of the CR-KD is based on the “Warburg Effect” of cancer metabolism and the microenvironment of GBM tumors. We will review recent case reports, clinical studies, review articles, and animal model research using the CR-KD and explain the principles of the Warburg Effect as it relates to CR-KD and GBMs. PMID:25949849
The Role of Pharmacotherapy in the Treatment of Adolescent Substance Use Disorders.
Hammond, Christopher J
2016-10-01
Adolescent substance use disorders (SUDs) are a significant public health issue due to the associated morbidity, mortality, and societal cost. While effective for some adolescents, psychosocial interventions generally produce small-to-moderate reductions in substance use. Most youth relapse within 12 months of treatment. One approach to improve outcomes is through adjunctive pharmacotherapy. Medication assisted treatments have been shown to improve adult SUD treatment outcomes, and preliminary studies in adolescents suggest that combining medication with psychosocial interventions may also enhance SUD outcomes for youth. This article presents a comprehensive review and grading of the evidence from studies conducted in adolescents with SUDs. Copyright © 2016 Elsevier Inc. All rights reserved.
Exercise in the Treatment of Youth Substance Use Disorders: Review and Recommendations
More, Alissa; Jackson, Ben; Dimmock, James A.; Thornton, Ashleigh L.; Colthart, Allan; Furzer, Bonnie J.
2017-01-01
Substance use disorders among youth represent a significant public health concern. It is well established that regular exercise provides important physical and mental health benefits; however, evidence for the role of exercise as an adjunct component within substance use disorder treatment is scarce. In this review, we identify factors associated with the development and persistence of substance use disorders among youth, identify current treatment modalities, and present evidence to support the efficacy of incorporating exercise participation during rehabilitation. We also provide a series of recommendations for future research that explores the feasibility and effectiveness of exercise participation as a complement to substance use disorder treatment among youth. PMID:29089915
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
Advances in the development of new tuberculosis drugs and treatment regimens.
Zumla, Alimuddin; Nahid, Payam; Cole, Stewart T
2013-05-01
Despite the introduction 40 years ago of the inexpensive and effective four-drug (isoniazid, rifampicin, pyrazinamide and ethambutol) treatment regimen, tuberculosis (TB) continues to cause considerable morbidity and mortality worldwide. For the first time since the 1960s, new and novel drugs and regimens for all forms of TB are emerging. Such regimens are likely to utilize both repurposed drugs and new chemical entities, and several of these regimens are now progressing through clinical trials. This article covers current concepts and recent advances in TB drug discovery and development, including an update of ongoing TB treatment trials, newer clinical trial designs, TB biomarkers and adjunct host-directed therapies.
Effective Leadership of Online Adjunct Faculty
ERIC Educational Resources Information Center
Tipple, Robert
2010-01-01
Post secondary education leaders and administrators are currently facing two separate but inter-related trends: the growth in online education, and the significant increase in adjunct (part-time) faculty. In order to maximize the educational quality and institutional effectiveness, education leaders must develop an approach that levers the…
Adjuncts to colonic cleansing before colonoscopy.
Park, Sanghoon; Lim, Yun Jeong
2014-03-21
Pre-procedural cleansing of the bowel can maximize the effectiveness and efficiency of colonoscopy. Yet, efficacy of the current gold standard colonic preparation method - high-volume oral administration of purgative agents 12-24 h prior to the procedure - is limited by several factors, such as patient compliance (due to poor palatability and inconvenience of the dosing regimen) and risks of complications (due to drug interactions or intolerance). Attempts to resolve these limitations have included providing adjunctive agents and methods to promote the colonic cleansing ability of the principal purgative agent, with the aim of lessening unpleasant side effects (such as bloating) and reducing the large ingested volume requirement. Several promising adjunctive agents are bisacodyl, magnesium citrate, senna, simethicone, metoclopramide, and prokinetics, and each are being investigated for their potential. This review provides an up to date summary of the reported investigations into the potencies and weaknesses of the key adjuncts currently being applied in clinic as supplements to the traditional bowel preparation agents. While the comparative analysis of these adjuncts showed that no single agent or method has yet achieved the goal of completely overcoming the limitations of the current gold standard preparation method, they at least provide endoscopists with an array of alternatives to help improve the suboptimal efficacy of the main cleansing solutions when used alone. To aid in this clinical endeavor, a subjective grade was assigned to each adjunct to indicate its practical value. In addition, the systematic review of the currently available agents and methods provides insight into the features of each that may be overcome or exploited to create novel drugs and strategies that may become adopted as effective bowel cleansing adjuncts or alternatives.
Adjuncts to colonic cleansing before colonoscopy
Park, Sanghoon; Lim, Yun Jeong
2014-01-01
Pre-procedural cleansing of the bowel can maximize the effectiveness and efficiency of colonoscopy. Yet, efficacy of the current gold standard colonic preparation method - high-volume oral administration of purgative agents 12-24 h prior to the procedure - is limited by several factors, such as patient compliance (due to poor palatability and inconvenience of the dosing regimen) and risks of complications (due to drug interactions or intolerance). Attempts to resolve these limitations have included providing adjunctive agents and methods to promote the colonic cleansing ability of the principal purgative agent, with the aim of lessening unpleasant side effects (such as bloating) and reducing the large ingested volume requirement. Several promising adjunctive agents are bisacodyl, magnesium citrate, senna, simethicone, metoclopramide, and prokinetics, and each are being investigated for their potential. This review provides an up to date summary of the reported investigations into the potencies and weaknesses of the key adjuncts currently being applied in clinic as supplements to the traditional bowel preparation agents. While the comparative analysis of these adjuncts showed that no single agent or method has yet achieved the goal of completely overcoming the limitations of the current gold standard preparation method, they at least provide endoscopists with an array of alternatives to help improve the suboptimal efficacy of the main cleansing solutions when used alone. To aid in this clinical endeavor, a subjective grade was assigned to each adjunct to indicate its practical value. In addition, the systematic review of the currently available agents and methods provides insight into the features of each that may be overcome or exploited to create novel drugs and strategies that may become adopted as effective bowel cleansing adjuncts or alternatives. PMID:24659864
Psychiatric side effects and antiepileptic drugs: Observations from prospective audits.
Stephen, Linda J; Wishart, Abbie; Brodie, Martin J
2017-06-01
Psychiatric comorbidities are common in people with epilepsy. A retrospective study of characteristics associated with withdrawal due to psychiatric side effects was undertaken in patients with treated epilepsy participating in prospective audits with new antiepileptic drugs (AEDs). A total of 1058 treated patients with uncontrolled seizures (942 focal-onset seizures, 116 generalized genetic epilepsies [GGEs]) participated in eight prospective, observational audits from 1996 to 2014. These patients were prescribed adjunctive topiramate (n=170), levetiracetam (n=220), pregabalin (n=135), zonisamide (n=203), lacosamide (n=160), eslicarbazepine acetate (n=52), retigabine (n=64), or perampanel (n=54). Doses were titrated according to efficacy and tolerability to optimize zeizure outcomes and reduce side effects. Psychiatric comorbidities were recorded prior to and after the addition of each AED. At baseline, patients with focal-onset seizures (189 of 942; 20.1%) were statistically more likely to have psychiatric diagnoses compared to patients with GGEs (14 of 116, 12.1%; p=0.039). Following adjunctive AED treatment, neuropsychiatric adverse effects led to AED withdrawal in 1.9-16.7% of patients. Patients with a pre-treatment psychiatric history (22 of 209; 10.5%) were statistically more likely to discontinue their new AED due to psychiatric issues compared to patients with no previous psychiatric diagnosis (50 of 849; 5.9%; p=0.017). Patients receiving sodium channel blocking AEDs (4 of 212, 1.9%) were statistically less likely to develop intolerable psychiatric problems, compared to those on AEDs possessing other mechanisms of action (68 of 846, 8.0%; p=0.012). Depression was the commonest problem, leading to discontinuation of AEDs in 2.8% (n=30) patients. Aggression was statistically more common in men (11 of 527, 2.1%) compared to women (1 of 531, 0.2%; p=0.004). Patients with learning disability (12 of 122, 9.8%; p=0.0015) were statistically less likely to have psychiatric issues prior to adjunctive AED treatment compared to other patients (208 of 936, 22.2%), but there were no statistically significant differences once the new AEDs were added (8 of 122 patients with learning disability, 6.6%; 64 of 936 other patients, 6.8%). Awareness of these issues may assist clinicians in avoiding, identifying and treating psychiatric comorbidities in people with epilepsy. Copyright © 2017 Elsevier Inc. All rights reserved.
Runge, Uwe; Arnold, Stephan; Brandt, Christian; Reinhardt, Fritjof; Kühn, Frank; Isensee, Kathleen; Ramirez, Francisco; Dedeken, Peter; Lauterbach, Thomas; Noack-Rink, Matthias; Mayer, Thomas
2015-12-01
Evidence for the efficacy and safety of adjunctive lacosamide in the treatment of partial-onset seizures (POS) was gained during placebo-controlled clinical trials in patients with treatment-resistant seizures who were taking one to three concomitant antiepileptic drugs (AEDs). The VITOBA study (NCT01098162) evaluated the effectiveness and tolerability of adjunctive lacosamide added to one baseline AED in real-world clinical practice. We conducted a 6-month observational study at 112 sites across Germany. Adult patients (≥ 16 years) with POS received lacosamide adjunctive to only one baseline AED. Seizure frequency reduction at the end of the observation period was compared with a 3-month retrospective baseline period. Five hundred seventy-one patients received lacosamide at least once (Safety Set [SS]); 520 provided evaluable seizure records (Full Analysis Set [FAS]); and 499 took in-label dosages of lacosamide (up to 400 mg) and were evaluated for effectiveness (modified FAS). Median baseline seizure frequency was 2.0 per 28 days: 47.1% of patients (235/499, mFAS) took a concomitant sodium channel-blocking (SCB) AED; 38.1% (190/499) had only one lifetime AED; and 18.4% (92/499) were aged ≥ 65 years (mFAS). At the final visit, 72.5% (358/494) of patients showed a ≥ 50% reduction in seizure frequency from baseline, 63.8% (315/494) showed a ≥ 75% reduction, and 45.5% (225/494) were seizure-free. Seizure freedom rates were higher in patients aged ≥ 65 years (56.7%) compared with patients aged <65 years (43.1%), in patients with ≤ 5 years epilepsy duration (52.5%) versus >5 years duration (41.0%), and when added to first monotherapy (60.5%) rather than as a later therapy option. Treatment-emergent adverse events (TEAEs) were reported by 48.5% (277/571) of patients (SS), with a profile similar to that observed in pivotal trials; 466 of patients (81.6%, SS) continued lacosamide therapy after the trial. These results suggest that lacosamide use, added to one concomitant AED, was effective at improving seizure control and was well tolerated in patients treated in routine clinical practice. © 2015 The Authors. Epilepsia published by Wiley Periodicals, Inc. on behalf of International League Against Epilepsy.
Paliperidone for the treatment of schizoaffective disorder.
Alphs, Larry; Fu, Dong-Jing; Turkoz, Ibrahim
2016-01-01
Schizoaffective disorder (SCA) is a complex mental illness characterized by psychosis and affective symptoms. Treatment usually involves concomitant therapy with antipsychotics, mood stabilizers, and/or antidepressants. Effective treatment must address acute symptoms, maintain long-term stability, promote recovery, and improve patient functioning. Data from 3 pivotal studies evaluating the acute and maintenance treatment of SCA with paliperidone are reviewed. Two formulations of paliperidone have been studied for these indications: an extended-release oral formulation (NCT00397033, NCT00412373) and long-acting injectable once-monthly paliperidone palmitate (NCT01193153). The reported effects of these formulations on psychotic, depressive, and manic symptoms are discussed. Both formulations were found to be safe and effective for the acute and maintenance treatment of SCA. Of critical importance for this treatment population is that rapid improvement was seen in all major symptoms of SCA, including psychosis, depression, and mania. Mediation analyses suggest that the known antipsychotic effects of paliperidone occur independently of its antidepressant effects. Both formulations of the drug are effective when used as monotherapy or adjunctively with antidepressants or mood stabilizers. Beyond symptom control, both formulations improved patient functioning and increased patient satisfaction.
Status epilepticus developing during lacosamide monotherapy
Papacostas, Savvas S
2015-01-01
Two cases with partial onset epilepsy who developed status epilepticus (SE) on lacosamide (LCM) monotherapy are reported. LCM is an effective adjunctive antiepileptic drug (AED) for partial-onset epilepsy and as infusion in SE. It has also shown efficacy in monotherapy. The reported cases achieved control of seizures with adjunctive LCM treatment and were afterwards converted to monotherapy. Both patients subsequently developed SE while on LCM monotherapy. They were on monotherapy for at least 2 months after withdrawal of concomitant AEDs precluding the possibility of withdrawal-induced SE. Pharmacovigilance is indicated when LCM is administered in monotherapy in order to assess its proper therapeutic potential and its putative limitations especially in cases where it may prove ineffective. Moreover, vigilance is necessary whenever any concomitant antiepileptic is tapered regardless of the substances used. Higher doses may be needed when an AED is used in monotherapy. PMID:25628098
[Hypnotherapy of atopic dermatitis in an adult. Case report].
Perczel, Kristóf; Gál, János
2016-01-17
Hypnosis is well known for its modulatory effects on immune and inflammatory processes, and it is a therapeutic option for certain diseases of such pathogenesis. The authors report treatment of an adult patient with extensive atopic dermatitis, who was only minimally responsive to conservative treatment. In a 15 session hypnotherapy the authors combined the use of direct, symptom-oriented suggestive techniques with hypnotic procedures to identify and modify comorbid psychological issues. To monitor the effect of the treatment, patient diaries (quality and quantity of sleep, intensity of pain and itch) and repeated psychometric tests were used. At the end of treatment there were improvements in all measured dimensions (itch, pain, insomnia, activity, anxiety and emotional state) both clinically and psychometrically. The authors conclude, that hypnosis can be an effective adjunctive therapy in atopic dermatitis, and in certain severe cases may constitute a salvage therapy.
Use of atypical antipsychotics for treatment-resistant major depressive disorder.
Papakostas, George I; Shelton, Richard C
2008-12-01
Despite the progressive increase in the number of pharmacologic agents with potential antidepressant activity, many patients suffering from major depressive disorder (MDD) continue to be symptomatic. Clearly, an urgent need exists to develop safer, better tolerated, and more effective treatments for MDD. Use of atypical antipsychotic agents as adjunctive treatment for treatment-resistant MDD (TRD) represents one such effort toward novel pharmacotherapy development. Atypical antipsychotic agents have been hypothesized to be beneficial in treating mood disorders, including TRD, as a result of their complex mechanisms of action. After an initial series of positive case reports, series, and small clinical trials, subsequent larger-scale projects have yielded conflicting results. However, more recently, larger-scale clinical trials have supported the effectiveness of at least some of these medications. This review summarizes the existing data regarding the effectiveness of these medications in treating TRD, including biochemical rationale and clinical data.
Loh, Jeffrey; Gulati, Amitabh
2015-06-01
Cancer pain is difficult to treat, often requiring a multimodal approach. While medication management remains the mainstay for the treatment of cancer pain, medications are often associated with undesired side effects. Transcutaneous electrical nerve stimulation (TENS) provides a potential adjunctive method for treating cancer pain with minimal side effects. Few studies have been performed evaluating the efficacy of TENS on cancer pain. We sought to examine the usefulness of TENS on all cancer patients and to specifically look at the use of TENS as a goal-directed therapy to improve functionality. Retrospective cohort study. Since 2008, patients with chronic cancer pain and on multimodal pain regimens were trialed with TENS. Those patients who showed an improvement in pain symptoms or severity were educated about and provided with a TENS unit for use at home. Pain symptoms and scores were monitored with the visual analog scale (VAS), the numerical rating pain (NRP) scale, and Short-Form McGill Questionnaire at the start of TENS treatment and at 2 months follow-up. TENS proved beneficial in 69.7% of patients over the course of 2 months. In TENS responsive patients, VAS scores decreased by 9.8 on a 0-100 mm scale (P < 0.001), and NRP scores decreased by 0.8 on a 1-10 scale (P < 0.001). Lack of placebo and lack of blinding of physician and patient. TENS provides a beneficial adjunct for the treatment of cancer pain, especially when utilized as a goal-directed therapy. Wiley Periodicals, Inc.
Alivizatos, Vassilos; Felekis, Dimitrios; Zorbalas, Athanasios
2002-01-01
The aim of this study was to evaluate the effectiveness of Octreotide as an adjunct treatment to total parenteral nutrition in the spontaneous closure of postoperative enterocutaneous fistulas. Medical records of 39 patients with postoperative enterocutaneous fistulas treated in our Department between January 1988 and August 2000 were reviewed. Sixteen patients had duodenal fistulas and 23 had jejunal or ileal fistulas. According to the daily output, there were 20 low fistula output and 19 high fistula output. Conservative treatment consisted of nutritional support with total parenteral nutrition in all the patients. Administration of Octreotide (100 micrograms every 8 hours, subcutaneously) was done in 21 consecutive patients until spontaneous closure of the fistulas or their subsequent surgical closure. The occurrence of fistulas closure was compared using the Fisher's exact test. A mean reduction of 50% of fistula output was noted in all the patients who received Octreotide, within 24 hours of its administration. Spontaneous closure was achieved in 13 patients of the Octreotide group (mean closure time: 15.3 days, range: 6-35) and in 12 patients treated only with total parenteral nutrition (mean closure time: 13.9 days, range: 7-25); this difference was not significant (P = 0.5). Also, the fistula closure rate was not influenced by the anatomic site, the high or low output, and the age of the patient. The results of this study suggest that, as an adjunct treatment to total parenteral nutrition, Octreotide reduces rapidly the fistula output without significant influence in the spontaneous closure rate.
Evidence for S-adenosyl-L-methionine (SAM-e) for the treatment of major depressive disorder.
Papakostas, George I
2009-01-01
Despite the increasingly large array of antidepressants available to treat major depressive disorder, patients continue to experience relatively modest response and remission rates. In addition, patients may experience adverse side effects from pharmacotherapy that not only hinder treatment compliance and adherence but, in some cases, may also contribute to increased disability, patient suffering, morbidity, and mortality. In order to enhance treatment efficacy and tolerability, patients and clinicians have become increasingly interested in nonpharmaceutical supplements for treating depression. One of the best-studied of these supplements is S-adenosyl-L-methionine (SAM-e), a naturally occurring molecule present in all living cells and a major methyl group donor in the human body. Controlled trials have found SAM-e to be more efficacious than placebo and equal in efficacy to the tricyclic antidepressants for treating major depressive disorder (MDD) when administered parenterally (either intravenously or intramuscularly). Less evidence supports the use of oral SAM-e, although some trials have demonstrated its efficacy as well. In addition, there is a paucity of evidence examining whether oral forms of SAM-e can be safe, well tolerated, and efficacious when used as adjunctive treatment for antidepressant nonresponders with MDD. Although preliminary data suggest SAM-e may be useful as an adjunctive therapy to antidepressants, controlled studies are needed to confirm or refute these preliminary findings. (c) Copyright 2009 Physicians Postgraduate Press, Inc.
Prior Elicitation and Bayesian Analysis of the Steroids for Corneal Ulcers Trial
See, Craig W.; Srinivasan, Muthiah; Saravanan, Somu; Oldenburg, Catherine E.; Esterberg, Elizabeth J.; Ray, Kathryn J.; Glaser, Tanya S.; Tu, Elmer Y.; Zegans, Michael E.; McLeod, Stephen D.; Acharya, Nisha R.; Lietman, Thomas M.
2013-01-01
Purpose To elicit expert opinion on the use of adjunctive corticosteroid therapy in bacterial corneal ulcers. To perform a Bayesian analysis of the Steroids for Corneal Ulcers Trial (SCUT), using expert opinion as a prior probability. Methods The SCUT was a placebo-controlled trial assessing visual outcomes in patients receiving topical corticosteroids or placebo as adjunctive therapy for bacterial keratitis. Questionnaires were conducted at scientific meetings in India and North America to gauge expert consensus on the perceived benefit of corticosteroids as adjunct treatment. Bayesian analysis, using the questionnaire data as a prior probability and the primary outcome of SCUT as a likelihood, was performed. For comparison, an additional Bayesian analysis was performed using the results of the SCUT pilot study as a prior distribution. Results Indian respondents believed there to be a 1.21 Snellen line improvement, and North American respondents believed there to be a 1.24 line improvement with corticosteroid therapy. The SCUT primary outcome found a non-significant 0.09 Snellen line benefit with corticosteroid treatment. The results of the Bayesian analysis estimated a slightly greater benefit than did the SCUT primary analysis (0.19 lines verses 0.09 lines). Conclusion Indian and North American experts had similar expectations on the effectiveness of corticosteroids in bacterial corneal ulcers; that corticosteroids would markedly improve visual outcomes. Bayesian analysis produced results very similar to those produced by the SCUT primary analysis. The similarity in result is likely due to the large sample size of SCUT and helps validate the results of SCUT. PMID:23171211
Effectiveness of adjunct psychotherapy for cancer treatment: a review.
Chen, YokeYong; Ahmad, Mahadir
2018-05-16
Psychotherapies were offered to alleviate psychological and physical symptoms; however, most psychological interventions were only delivered after cancer treatment. Newly diagnosed cancer patients experienced psychological distress while waiting for treatments. This review paper focused on randomized control trial studies, aimed to investigate the effectiveness of psychological intervention among newly diagnosed cancer patients. Eight randomized control trial papers were found in recent 10 years period through electronic database. A moderate to large effect size was detected on the outcomes, ranging from 0.43 to 0.89. This indicated that psychological-based prehabilitation with standard care yielded better outcomes than standard care alone. Psychological-based prehabilitation provides evidence in its effectiveness to reduce psychological distress, functional impairment, recurrence of cancer, numbers of immune reactivity and sleeping quality; however, inconsistent with longer survival result among cancer patients. In conclusion, psychological-based prehabilitation before cancer treatment is necessary for better treatment outcome, and future research is needed to investigate more directly the outcome.
Evaluation of open-label topiramate as primary or adjunctive therapy in infantile spasms.
Zou, Li-Ping; Lin, Qing; Qin, Jiong; Cai, Fang-Cheng; Liu, Zhi-Sheng; Mix, Eilhard
2008-01-01
A multicenter open-label clinical trial was conducted to evaluate the clinical usefulness of topiramate (TPM) as primary or adjunctive therapy for infantile spasms in the postmarketing period in China. Thirty-four centers participated in the trial. Patients included in the study had 1 or more seizures per day before treatment. One hundred twenty (22.1%) very young patients with an age younger than 6 month and 64.2% of patients were younger than 1 year at start of treatment. All patients received a starting dose of 0.5 to 1 mg kg d TPM twice daily. The dosage was increased by 0.5 to 1 mg kg d every 5 to 7 days up to 3 to 5 mg kg d. The resulting range of the total TPM dosage was 25 to 200 mg d (3.57-20 mg kg d), with a median value of 73.9 mg d. Seizure outcomes were measured by intention-to-treat analysis. Patients were seen by a neurologist, and their data were evaluated at the day of inclusion and after 4, 8, 12, 16, and 20 weeks (from visit 1 to visit 5) of treatment. Five hundred forty-four patients entered the study. After 20 weeks of TPM treatment, 239 patients (43.9%) were seizure-free. A higher proportion of patients in the monotherapy group than in the add-on therapy group showed a seizure rate reduction. An increase in seizure frequency was observed in 8 patients (1.5%) during the 20-week treatment period. Nineteen patients were withdrawn before completing the study, and in 46 cases, some data of the structured data files and questionnaires were missing. No efficacy of TPM treatment was recorded in these cases. Adverse effects occurred in 211 patients (38.8%). Most frequent side effects were anorexia and somnolence. Topiramate proved to be an effective and safe monotherapy and add-on therapy in patients with infantile spasms younger than 1 year.
2015-01-01
The impressive but sad list of over forty clinical studies using various cytotoxic chemotherapies published in the last few years has failed to increase median survival of glioblastoma beyond two years after diagnosis. In view of this apparent brick wall, adjunctive non-cytotoxic growth factor blocking drugs are being tried, as in the CUSP9* protocol. A related theme is searching for agonists at growth inhibiting receptors. One such dataset is that of melatonin agonism at M1 or M2 receptors found on glioblastoma cells, being a negative regulator of these cells’ growth. Melatonin itself is an endogenous hormone, but when used as an exogenously administered drug it has many disadvantages. Agomelatine, marketed as an antidepressant, and ramelteon, marketed as a treatment for insomnia, are currently-available melatonin receptor agonists. These melatonin receptor agonists have significant advantages over the natural ligand: longer half-life, better oral absorption, and higher affinity to melatonin receptors. They have an eminently benign side effect profile. As full agonists they should function to inhibit glioblastoma growth, as demonstrated for melatonin. A potentially helpful ancillary attribute of melatonergic agonists in glioblastoma treatment is an increase in interleukin-2 synthesis, expected, at least partially, to reverse some of the immunosuppression associated with glioblastoma. PMID:26034396
Kast, Richard E
2015-01-01
The impressive but sad list of over forty clinical studies using various cytotoxic chemotherapies published in the last few years has failed to increase median survival of glioblastoma beyond two years after diagnosis. In view of this apparent brick wall, adjunctive non-cytotoxic growth factor blocking drugs are being tried, as in the CUSP9* protocol. A related theme is searching for agonists at growth inhibiting receptors. One such dataset is that of melatonin agonism at M1 or M2 receptors found on glioblastoma cells, being a negative regulator of these cells' growth. Melatonin itself is an endogenous hormone, but when used as an exogenously administered drug it has many disadvantages. Agomelatine, marketed as an antidepressant, and ramelteon, marketed as a treatment for insomnia, are currently-available melatonin receptor agonists. These melatonin receptor agonists have significant advantages over the natural ligand: longer half-life, better oral absorption, and higher affinity to melatonin receptors. They have an eminently benign side effect profile. As full agonists they should function to inhibit glioblastoma growth, as demonstrated for melatonin. A potentially helpful ancillary attribute of melatonergic agonists in glioblastoma treatment is an increase in interleukin-2 synthesis, expected, at least partially, to reverse some of the immunosuppression associated with glioblastoma.
Adjunctive traditional Chinese medicine therapy improves survival of liver cancer patients.
Liao, Yueh-Hsiang; Lin, Cheng-Chieh; Lai, Hsueh-Chou; Chiang, Jen-Huai; Lin, Jaung-Geng; Li, Tsai-Chung
2015-12-01
Traditional Chinese medicine (TCM) is an alternative treatment for cancer with its effect by stimulating host immune response for cytotoxic activity against liver cancer. No studies evaluated TCM treatment on survival of liver cancer patients. This study determined whether the combination of TCM and conventional cancer treatment affects the survival of liver cancer patients. A retrospective cohort study was conducted in 127 237 newly diagnosed liver cancer patients from 2000 to 2009 in the National Health Insurance Program database. Among these patients, 30 992 (24.36%) used TCM for liver cancer care. All patients were followed up until 2011. The mean follow-up was 5.67 years (SD 1.47) for TCM users and 5.49 years (SD 3.64) for non-TCM users. Compared with patients without TCM use, patients with TCM use were significantly associated with a decreased risk of death [hazard ratio (HR) = 0.65, 95% confidence interval (CI) = 0.64-0.66] with multivariate adjustment. A similar significant protective effect of TCM use across various subgroups of chronic liver diseases was also observed. Jia Wei Xiao Yao San (HR = 0.89, 95% CI = 0.81-0.96) and Chai Hu Shu Gan Tang (HR = 0.86, 95% CI = 0.78-0.95) were the most effective TCM agents that improved survival. This cohort study provided information that adjunctive therapy with TCM may improve the survival in liver cancer patients. Further studies are needed to confirm the potential role of TCM in HCC. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Tomé-Carneiro, Joao; Visioli, Francesco
2016-10-15
In addition to prescription drugs, nutraceuticals/functional foods/medical foods are being increasingly added as adjunct treatment of cardiovascular disease (CVD), even though most of them have been exclusively studied in vitro. We review the available evidence (focusing on when the amount of polyphenols' intake was measured) coming from randomized controlled trials (RCTs) of (poly)phenol-based supplements. We conclude that (poly)phenol-based nutraceuticals and functional foods might be indeed used as adjunct therapy of CVD, but additional long-term RCTs with adequate numerosity and with clinically relevant end points are needed to provide unequivocal evidence of their clinical usefulness. Copyright © 2015. Published by Elsevier GmbH.
Pharmacogenetics in electroconvulsive therapy and adjunctive medications.
Mirzakhani, Hooman; van Noorden, Martijn S; Swen, Jesse; Nozari, Ala; Guchelaar, Henk-Jan
2015-01-01
Electroconvulsive therapy (ECT) has shown apparent efficacy in treatment of patients with depression and other mental illnesses who do not respond to psychotropic medications or need urgent control of their symptoms. Pharmacogenetics contributes to an individual's sensitivity and response to a variety of drugs. Clinical insights into pharmacogenetics of ECT and adjunctive medications not only improves its safety and efficacy in the indicated patients, but can also lead to the identification of novel treatments in psychiatric disorders through understanding of potential molecular and biological mechanisms involved. In this review, we explore the indications of pharmacogenetics role in safety and efficacy of ECT and present the evidence for its role in patients with psychiatric disorders undergoing ECT.
Cognitive behavioral treatment for narcolepsy: can it complement pharmacotherapy?
Marín Agudelo, Hernán Andrés; Jiménez Correa, Ulises; Carlos Sierra, Juan; Pandi-Perumal, Seithikurippu R.; Schenck, Carlos H.
2014-01-01
Sleep medicine in general and psychology in particular have recently developed cognitive behavioral treatment for narcolepsy (CBT-N). Despite a growing interest in this topic, most studies since 2007 have reviewed CBT applications for other sleep disorders. Currently, 6 reviews have been published on narcolepsy, with an expert consensus being reached that CBT represented an important adjunctive treatment for the disease. The current paper reviews the need for CBT applications for narcolepsy by generalizing the application of multicomponent treatments and performing studies that extrapolate the results obtained from multicenter studies. Nineteen studies were found in which the need-for-treatment guidelines identified the use of CBT for narcolepsy. Three additional studies were identified that evaluated the effectiveness of cognitive behavioral measures and multicomponent treatments for which treatment protocols have been proposed. PMID:26483898
H., Ari; N., Emlek; S., Ari; S., Coşar; K., Doğanay; C., Aydin; E., Tenekecioğlu; A., Tütüncü; O.C., Yontar; M., Gürdoğan; T., Bozat; M., Melek
2015-01-01
Background The aim of our study was to assess the effect of pretreatment with cilostazol and rosuvastatin combination before elective percutaneous coronary intervention (PCI) on peri-procedural myocardial injury (PPMIJ). Methods We randomly assigned 172 patients with stable angina pectoris scheduled for elective PCI to pre- treatment with Cilostazol 200mg and Rosuvastatin 40 mg (group 1), or to pretreatment with Rosuvastatin 40 mg group (group 2). The primary end-point was the occurrence of PPMIJ defined as any cardiac troponin I (Tn I) level elevated above the upper normal limit (UNL). The occurrence of peri-procedural myocardial infarction (PPMIN) was defined as a post-procedural increase in cTnI level ≥ 5 times above the UNL. Results There was no significant difference in baseline characteristics between group 1 (n = 86) and group 2 (n = 86). The rate of PPMIJ (21% vs. 24%, p = 0.58) and PPMIN (2.3% vs. 7%, p = 0.27) were similar between the two study groups. Subgroup analysis performed on those patients without statin therapy before PCI (53 patients in group 1 and 50 patients in group 2) showed that the incidence of PPMIJ was significantly lower in the group 1 patients without chronic statin treatment [17% (9/53) versus 34% (17/50); p = 0.04], but the rate of PPMIN was similar between the two groups for those patients without chronic statin treatment [1.9% (1/53) versus 10% (5/50); p = 0.07]. Conclusions We found that adjunct cilostazol and rosuvastatin pre-treatment did not significantly reduce PPMIJ after elective PCI in patients with stable angina pectoris. However, adjunct cilostazol pre-treatment could reduce PPMIJ in patients without chronic statin therapy before elective PCI. PMID:27122885
Christodoulides, Nicos; Nikolidakis, Dimitris; Chondros, Panagiotis; Becker, Jürgen; Schwarz, Frank; Rössler, Ralf; Sculean, Anton
2008-09-01
Recent preclinical and clinical data have suggested a potential benefit of photodynamic therapy (PDT) in the treatment of periodontitis. However, there are very limited data from controlled clinical trials evaluating the effect of PDT in the treatment of periodontitis. The aim of this study was to evaluate the clinical and microbiologic effects of the adjunctive use of PDT to non-surgical periodontal treatment. Twenty-four subjects with chronic periodontitis were randomly treated with scaling and root planing followed by a single episode of PDT (test) or scaling and root planing alone (control). Full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), gingival recession, and clinical attachment level (CAL) were measured at baseline and 3 and 6 months after therapy. Primary outcome variables were changes in PD and CAL. Microbiologic evaluation of Aggregatibacter actinomycetemcomitans (previously Actinobacillus actinomycetemcomitans), Porphyromonas gingivalis, Prevotella intermedia, Tannerella forsythia (previously T. forsythensis), Treponema denticola, Parvimonas micra (previously Peptostreptococcus micros or Micromonas micros), Fusobacterium nucleatum, Campylobacter rectus, Eubacterium nodatum, Eikenella corrodens, and Capnocytophaga spp. was performed at baseline and 3 and 6 months following therapy by using a commercially available polymerase chain reaction test. At 3 and 6 months after treatment, there were no statistically significant differences between the groups with regard to CAL, PD, FMPS, or microbiologic changes. At 3 and 6 months, a statistically significantly greater improvement in FMBS was found in the test group. The additional application of a single episode of PDT to scaling and root planing failed to result in an additional improvement in terms of PD reduction and CAL gain, but it resulted in a significantly higher reduction in bleeding scores compared to scaling and root planing alone.
Dymarek, Robert; Halski, Tomasz; Ptaszkowski, Kuba; Slupska, Lucyna; Rosinczuk, Joanna; Taradaj, Jakub
2014-07-01
Standard care procedures for complex wounds are sometimes supported and reinforced by physical treatment modalities such as extracorporeal shock wave therapy (ESWT). To evaluate available evidence of ESWT effectiveness in humans, a systematic review of the literature was conducted using MEDLINE, PubMed, Scopus, EBSCOhost, and PEDro databases. Of the 393 articles found, 13 met the publication date (year 2000-2013), study type (clinical study), language (English only), and abstract availability (yes) criteria. The 13 studies (n = 919 patients with wounds of varying etiologies) included seven randomized controlled trials that were evaluated using Cochrane Collaboration Group standards. Only studies with randomization, well prepared inclusion/exclusion criteria protocol, written in English, and full version available were analyzed. An additional six publications reporting results of other clinical studies including a total of 523patients were identified and summarized. ESWT was most commonly applied once or twice a week using used low or medium energy, focused or defocused generator heads (energy range 0.03 to 0.25 mJ/mm2; usually 0.1 mJ/mm2), and electrohydraulic or electromagnetic sources. Few safety concerns were reported, and in the controlled clinical studies statistically significant differences in rates of wound closure were reported compared to a variety of standard topical treatment modalities, sham ESWT treatment, and hyperbaric oxygen therapy. Based on this analysis, ESWT can be characterized as noninvasive, mostly painless, and safe. Controlled, randomized, multicenter, blind clinical trials still are required to evaluate the efficacy and cost-effectiveness of ESWT compared to sham control, other adjunctive treatments, and commonly used moisture-retentive dressings. In the future, ESWT may play an important role in wound care once evidence-based practice guidelines are developed.
H, Ari; N, Emlek; S, Ari; S, Coşar; K, Doğanay; C, Aydin; E, Tenekecioğlu; A, Tütüncü; O C, Yontar; M, Gürdoğan; T, Bozat; M, Melek
2015-07-01
The aim of our study was to assess the effect of pretreatment with cilostazol and rosuvastatin combination before elective percutaneous coronary intervention (PCI) on peri-procedural myocardial injury (PPMIJ). We randomly assigned 172 patients with stable angina pectoris scheduled for elective PCI to pre- treatment with Cilostazol 200mg and Rosuvastatin 40 mg (group 1), or to pretreatment with Rosuvastatin 40 mg group (group 2). The primary end-point was the occurrence of PPMIJ defined as any cardiac troponin I (Tn I) level elevated above the upper normal limit (UNL). The occurrence of peri-procedural myocardial infarction (PPMIN) was defined as a post-procedural increase in cTnI level ≥ 5 times above the UNL. There was no significant difference in baseline characteristics between group 1 (n = 86) and group 2 (n = 86). The rate of PPMIJ (21% vs. 24%, p = 0.58) and PPMIN (2.3% vs. 7%, p = 0.27) were similar between the two study groups. Subgroup analysis performed on those patients without statin therapy before PCI (53 patients in group 1 and 50 patients in group 2) showed that the incidence of PPMIJ was significantly lower in the group 1 patients without chronic statin treatment [17% (9/53) versus 34% (17/50); p = 0.04], but the rate of PPMIN was similar between the two groups for those patients without chronic statin treatment [1.9% (1/53) versus 10% (5/50); p = 0.07]. We found that adjunct cilostazol and rosuvastatin pre-treatment did not significantly reduce PPMIJ after elective PCI in patients with stable angina pectoris. However, adjunct cilostazol pre-treatment could reduce PPMIJ in patients without chronic statin therapy before elective PCI. Cilostazol; Myocardial injury; Percutaneous coronary intervention; Statin.
Jentsch, Holger F R; Buchmann, Andreas; Friedrich, Abel; Eick, Sigrun
2016-09-01
The objective of the present study is to compare the effect of systemic adjunctive use of azithromycin with amoxicillin/metronidazole to scaling and root planing (SRP) in a clinical study. Data from 60 individuals with chronic periodontitis were evaluated after full-mouth SRP. Antibiotics were given from the first day of SRP, in the test group (n = 29), azithromycin for 3 days and, in the control group (n = 31), amoxicillin/metronidazole for7 days. Probing depth (PD), attachment level (AL), and bleeding on probing (BOP) were recorded at baseline and after 3 and 12 months. Gingival crevicular fluid was analyzed for matrix metalloprotease (MMP)-8 and interleukin (IL)-1beta levels. Subgingival plaque was taken for assessment of the major bacteria associated with periodontitis. In both groups, PD, AL, and BOP were significantly reduced (p < 0.001). A few significant differences between the groups were found; AL and BOP were significantly better in the test than in the control group at the end of the study (p = 0.020 and 0.009). Periodontopathogens were reduced most in the test group. A noninferiority of the treatment with azithromycin in comparison with amoxicillin/metronidazole can be stated. The administration of azithromycin could be an alternative to the use of amoxicillin/metronidazole adjunctive to SRP in patients with moderate or severe chronic periodontitis; however, a randomized placebo-controlled multicenter study is needed. Application of azithromycin as a single antibiotic for 3 days might be considered as an additional adjunctive antibiotic to SRP in selected patients.
Adjunctive use of the diode laser in non-surgical periodontal therapy: exploring the controversy.
Porteous, Mary Sornborger; Rowe, Dorothy J
2014-04-01
Despite the controversy regarding clinical efficacy, dental hygienists use the diode laser as an adjunct to non-surgical periodontal therapy. The technique to maximize successful laser therapy outcome is controversial as well. The purpose of this review is to explore the scientific foundation of the controversy surrounding the use of the diode laser as an adjunct to non-surgical periodontal therapy. Further, this paper addresses the weaknesses in study design, the heterogeneity of methodology in the published clinical studies, especially the laser parameters, and how these issues impact the collective clinical and microbial data, and thus conclusions regarding clinical efficacy. Evaluation of the literature identifies possible mechanisms that could contribute to the varied, often conflicting results among laser studies that are the foundation of the controversy surrounding clinical efficacy. These mechanisms include current paradigms of periodontal biofilm behavior, tissue response to laser therapy being dependent on tissue type and health, and that the successful therapeutic treatment window is specific to the target tissue, biofilm composition, laser wavelength, and laser energy delivered. Lastly, this paper discusses laser parameters used in the various clinical studies, and how their diversity contributes to the controversy. Although this review does not establish clinical efficacy, it does reveal the scientific foundation of the controversy and the need for standardized, well designed randomized controlled clinical trials to develop specific guidelines for using the laser as an adjunct to non-surgical periodontal therapy. Using evidence-based laser guidelines would allow dental hygienists to provide more effective non-surgical periodontal care.
Johannsen, Annsofi; Tellefsen, Monica; Wikesjö, Ulf; Johannsen, Gunnar
2009-09-01
The aim of the present study was to evaluate the adjunctive effect of the local application of a hyaluronan gel to scaling and root planing in the treatment of chronic periodontitis. Twelve patients with chronic periodontitis were recruited to participate in a study with a split-mouth design and provided informed consent. Plaque formation and bleeding on probing were evaluated pretreatment (baseline) and at 1, 4, and 12 weeks post-treatment. Probing depths and attachment levels were evaluated at baseline and at 12 weeks. The patients received full-mouth scaling and root planing. A hyaluronan gel was administered subgingivally in the test sites at baseline and after 1 week. Significant differences between test and control were evaluated using the paired t test, repeated-measures analysis of variance (Wilks lambda), and a non-parametric Wilcoxon signed-rank test. A significant reduction in bleeding on probing scores and probing depths was observed in both groups at 12 weeks (P <0.05). Significantly lower bleeding on probing scores were observed in the hyaluronan group compared to control at 12 weeks (P <0.05). Mean probing depth reductions between baseline and 12 weeks were 1.0 +/- 0.3 mm and 0.8 +/- 0.2 mm for the hyaluronan and control groups, respectively. The difference between the groups was statistically significant (P <0.05). The local application of hyaluronan gel in conjunction with scaling and root planing may have a beneficial effect on periodontal health in patients with chronic periodontitis.
Barik, Kanai Lal; Paul, Uttam Kumar; Bhattacharyya, Anup Kumar; Adhikary, Amit; Agarwal, Gajanand; Rana, Kriti Sundar
2014-02-01
Epilepsy is a common paediatric neurologic disorder that is difficult to manage in a substantial portion of children, highlighting the continued need for more effective and better tolerated drugs. A multicentric study was conducted from August, 2011 to July, 2013 using levetiracetam (LEV) in newely diagnosed epilepsy in 122 young children of 1-5 years age group to find its role in practical scenario depending upon the knowledge from prior literature available. It has been demonstrated effective as adjunctive therapy as well as monotherapy for new-onset partial seizures and generalised tonic-clonic seizures (GTCS) but it acts better as adjunctive therapy than the monotherapy. When LEV was used as adjunctive therapy 15.4% children with partial seizure were seizure-free as compared to 11.12% in GTCS and when LEV was used as monotherapy 16.17% children with partial seizure were seizure-free as compared to 15.38% in GTCS. When LEV was used as add on therapy 16.67% children < 2 years were seizure-free as compared to 17.85% in > 2 years. When LEV was used as monotherapy 25.00% children < 2 years were seizure-free as compared to 18.18% > 2 years. So, it was found more efficacious in partial group of seizures than the GTCS variety. It also shows more efficacy in older age group (> 2 years) than the younger ones (< 2 years). Somnolence and behavioural changes were noted as ad- verse effects in a few cases. So, LEV is an important addition to the treatment of paediatric epilepsy.
Review of adjunctive dexmedetomidine in the management of severe acute alcohol withdrawal syndrome.
Wong, Adrian; Smithburger, Pamela L; Kane-Gill, Sandra L
2015-01-01
The primary management of alcohol withdrawal involves the administration of a γ-aminobutyric acid agonist, such as benzodiazepines, for management of symptoms and to prevent further progression to seizure or delirium tremens. Despite escalating doses of benzodiazepines, published literature indicates that some patient's alcohol withdrawal syndrome symptoms do not respond, and that the use of adjunctive agents may be beneficial in these patients. Dexmedetomidine, an α2-agonist, serves as a potential adjunctive agent through management of associated autonomic symptoms. Understanding of recent literature evaluating its use is necessary for appropriate selection. To review available literature supporting the use of adjunctive dexmedetomidine for management of severe alcohol withdrawal syndrome. A total of 13 published articles evaluating the efficacy and safety of dexmedetomidine as an adjunctive agent for the treatment of alcohol withdrawal in adult patients were identified from a MEDLINE search using the key words alcohol withdrawal, delirium tremens and dexmedetomidine. Evaluation of the literature indicates that dexmedetomidine is associated with a decrease in short-term benzodiazepine requirements after initiation, and improvement in hemodynamic parameters in relation to the adrenergic drive present in alcohol withdrawal. The use of dexmedetomidine in the management of severe alcohol withdrawal should be considered as an adjunctive agent. Dexmedetomidine appears to be well tolerated, with an expected decrease in blood pressure and heart rate. Seizures have occurred in patients with alcohol withdrawal despite the use of dexmedetomidine, with and without benzodiazepines, due to lack of γ-aminobutyric acid agonist administration.
Bio-Thiersch as an Adjunct to Perineal Proctectomy Reduces Rates of Recurrent Rectal Prolapse.
Eftaiha, Saleh M; Calata, Jed F; Sugrue, Jeremy J; Marecik, Slawomir J; Prasad, Leela M; Mellgren, Anders; Nordenstam, Johan; Park, John J
2017-02-01
The rates of recurrent prolapse after perineal proctectomy vary widely in the literature, with incidences ranging between 0% and 50%. The Thiersch procedure, first described in 1891 for the treatment of rectal prolapse, involves encircling the anus with a foreign material with the goal of confining the prolapsing rectum above the anus. The Bio-Thiersch procedure uses biological mesh for anal encirclement and can be used as an adjunct to perineal proctectomy for rectal prolapse to reduce recurrence. The aim of this study was to evaluate the Bio-Thiersch procedure as an adjunct to perineal proctectomy and its impact on recurrence compared with perineal proctectomy alone. A retrospective review of consecutive patients undergoing perineal proctectomy with and without Bio-Thiersch was performed. Procedures took place in the Division of Colon and Rectal Surgery at a tertiary academic teaching hospital. Patients who had undergone perineal proctectomy and those who received perineal proctectomy with Bio-Thiersch were evaluated and compared. All of the patients with rectal prolapse received perineal proctectomy with levatorplasty, and a proportion of those patients had a Bio-Thiersch placed as an adjunct. The incidence of recurrent rectal prolapse after perineal proctectomy alone or perineal proctectomy with Bio-Thiersch was documented. Sixty-two patients underwent perineal proctectomy (8 had a previous prolapse procedure), and 25 patients underwent perineal proctectomy with Bio-Thiersch (12 had a previous prolapse procedure). Patients who received perineal proctectomy with Bio-Thiersch had a lower rate of recurrent rectal prolapse (p < 0.05) despite a higher proportion of them having had a previous prolapse procedure (p < 0.01). Perineal proctectomy with Bio-Thiersch had a lower recurrence over time versus perineal proctectomy alone (p < 0.05). This study was limited by nature of being a retrospective review. Bio-Thiersch as an adjunct to perineal proctectomy may reduce the risk for recurrent rectal prolapse and can be particularly effective in patients with a history of previous failed prolapse procedures.
Lichter-Konecki, Uta; Nadkarni, Vinay; Moudgil, Asha; Cook, Noah; Poeschl, Johannes; Meyer, Michael T; Dimmock, David; Baumgart, Stephen
2013-08-01
Children with urea cycle disorders (UCDs) or organic acidemias (OAs) and acute hyperammonemia and encephalopathy are at great risk for neurological injury, developmental delay, intellectual disability, and death. Nutritional support, intravenous alternative pathway therapy, and dialysis are used to treat severe hyperammonemia associated with UCDs and nutritional support and dialysis are used to treat severe hyperammonemia in OAs. Brain protective treatment while therapy is initiated may improve neurological and cognitive function for the lifetime of the child. Animal experiments and small clinical trials in hepatic encephalopathy caused by acute liver failure suggest that therapeutic hypothermia provides neuroprotection in hyperammonemia associated encephalopathy. We report results of an ongoing pilot study that assesses if whole body cooling during rescue treatment of neonates with acute hyperammonemia and encephalopathy is feasible and can be conducted safely. Adjunct whole body therapeutic hypothermia was conducted in addition to standard treatment in acutely encephalopathic, hyperammonemic neonates with UCDs and OAs requiring dialysis. Therapeutic hypothermia was initiated using cooling blankets as preparations for dialysis were underway. Similar to standard therapeutic hypothermia treatment for neonatal hypoxic ischemic encephalopathy, patients were maintained at 33.5°C±1°C for 72h, they were then slowly rewarmed by 0.5°C every 3h over 18h. In addition data of age-matched historic controls were collected for comparison. Seven patients were cooled using the pilot study protocol and data of seven historic controls were reviewed. All seven patients survived the initial rescue and cooling treatment, 6 patients were discharged home 2-4weeks after hospitalization, five of them feeding orally. The main complication observed in a majority of patients was hypotension. Adjunct therapeutic hypothermia for neonates with UCDs and OAs receiving standard treatment was feasible and could be conducted safely in pediatric and neonatal intensive care units experienced in the application of therapeutic hypothermia in critically ill neonates. However, including adjunct therapeutic hypothermia in the already involved treatment regimen of critically ill patients with hyperammonemia and encephalopathy adds to the complexity of care and should not be done unless it is proven efficacious in a randomized clinical trial. Copyright © 2013 Elsevier Inc. All rights reserved.
Brigo, Francesco; Bragazzi, Nicola Luigi; Nardone, Raffaele; Trinka, Eugen
2016-11-01
Brivaracetam (BRV), eslicarbazepine acetate (ESL), lacosamide (LCM), and perampanel (PER) have been recently marketed as adjunctive treatments for focal onset seizures. To date, no randomized controlled trial (RCT) has directly compared BRV with ESL, LCM, or PER. To compare BRV with the other add-on AEDs in patients with uncontrolled focal epilepsy, estimating their efficacy and tolerability through an adjusted, common-reference based indirect comparison meta-analysis. We systematically searched RCTs in which add-on treatment with ESL or LCM in patients with focal onset seizures have been compared with placebo. Efficacy and tolerability outcomes were considered. Random-effects Mantel-Haenszel meta-analyses were performed to obtain odds ratios (ORs) for the efficacy of BRV, LCM, ESL, or PER versus placebo. Adjusted indirect comparisons were then made between BRV and the other three AEDs using the obtained results, comparing the minimum and the highest effective recommended daily dose of each drug. Seventeen RCTs, with a total of 4971 patients were included. After adjusting for dose-effects, indirect comparisons showed no difference between BRV and LCM, ESL, or PER for responder rate and seizure freedom. Lower adverse events were observed with high dose BRV compared to high dose ESL or PER, but no difference was found in withdrawing because of adverse events. Indirect comparisons do not demonstrate a significant difference in efficacy between add-on BRV and LCM, ESL, or PER in focal epilepsy, and might suggest a better tolerability of BRV than ESL, and possibly also PER, at the highest effective recommended dose. Copyright © 2016 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
Hermeto, Larissa C.; DeRossi, Rafael; Marques, Beatriz C.; Jardim, Paulo H.A.
2015-01-01
This study investigated the analgesic and systemic effects of intramuscular (IM) versus epidural (EP) administration of tramadol as an adjunct to EP injection of lidocaine in cats. Six healthy, domestic, shorthair female cats underwent general anesthesia. A prospective, randomized, crossover trial was then conducted with each cat receiving the following 3 treatments: EP injection of 2% lidocaine [LEP; 3.0 mg/kg body weight (BW)]; EP injection of a combination of lidocaine and 5% tramadol (LTEP; 3.0 and 2.0 mg/kg BW, respectively); or EP injection of lidocaine and IM injection of tramadol (LEPTIM; 3.0 and 2.0 mg/kg BW, respectively). Systemic effects, spread and duration of analgesia, behavior, and motor blockade were determined before treatment and at predetermined intervals afterwards. The duration of analgesia was 120 ± 31 min for LTEP, 71 ± 17 min for LEPTIM, and 53 ± 6 min for LEP (P < 0.05; mean ± SD). The cranial spread of analgesia obtained with LTEP was similar to that with LEP or LEPTIM, extending to dermatomic region T13–L1. Complete motor blockade was similar for the 3 treatments. It was concluded that tramadol produces similar side effects in cats after either EP or IM administration. Our findings indicate that EP and IM tramadol (2 mg/kg BW) with EP lidocaine produce satisfactory analgesia in cats. As an adjunct to lidocaine, EP tramadol provides a longer duration of analgesia than IM administration. The adverse effects produced by EP and IM administration of tramadol were not different. Further studies are needed to determine whether EP administration of tramadol could play a role in managing postoperative pain in cats when co-administered with lidocaine after painful surgical procedures. PMID:26130854
Bergemann, Niels; Parzer, Peter; Jaggy, Susanne; Auler, Beatrice; Mundt, Christoph; Maier-Braunleder, Sabine
2008-01-01
Objective: The effects of estrogen on comprehension of metaphoric speech, word fluency, and verbal ability were investigated in women suffering from schizophrenia. The issue of estrogen-dependent neuropsychological performance could be highly relevant because women with schizophrenia frequently suffer from hypoestrogenism. Method: A placebo-controlled, double-blind, crossover study using 17β-estradiol for replacement therapy and as an adjunct to a naturalistic maintenance antipsychotic treatment was carried out over a period of 8 months. Nineteen women (mean age = 38.0 years, SD = 9.9 years) with schizophrenia were included in the study. Comprehension of metaphoric speech was measured by a lexical decision paradigm, word fluency, and verbal ability by a paper-and-pencil test. Results: Significant improvement was seen for the activation of metaphoric meaning during estrogen treatment (P = .013); in contrast, no difference was found for the activation of concrete meaning under this condition. Verbal ability and word fluency did not improve under estrogen replacement therapy either. Conclusions: This is the very first study based on estrogen intervention instead of the physiological hormone changes to examine the estrogen effects on neuropsychological performance in women with schizophrenia. In addition, it is the first time that the effect of estrogen on metaphoric speech comprehension was investigated in this context. While in a previous study estrogen therapy as adjunct to a naturalistic maintenance treatment with antipsychotics did not show an effect on psychopathology measured by a rating scale, a significant effect of estrogen on the comprehension of metaphoric speech and/or concretism, a main feature of schizophrenic thought and language disturbance, was found in the present study. Because the improvement of formal thought disorders and language disturbances is crucial for social integration of patients with schizophrenia, the results may have implications for the treatment of these individuals. PMID:18156639
[Noninvasive alternatives to CPAP in therapy of obstructive sleep apnea syndrome].
Fritsch, K; Bloch, K E
2000-07-01
Non-surgical treatment of the sleep apnea syndrome comprises behavioral modification such as sleep hygiene, weight reduction, and positional training as an adjunct to standard therapy with continuous positive airway pressure (CPAP) applied via a nasal mask. For patients who cannot tolerate or are not willing to use CPAP for psychological or other reasons, removable intraoral appliances that advance the mandible during sleep are a valuable treatment alternative. Randomised controlled trials have confirmed effectiveness of intraoral appliances in relieving symptoms and measured sleep and respiratory disturbances. Side effects including hypersalivation, mucosal dryness, tooth and temporo-mandibular joint discomfort are common but usually mild. To timely detect effects of oral appliances on occlusion and on the temporo-mandibular joint longterm orthodontic monitoring is advisable.
Fallon, Marie T; Albert Lux, Eberhard; McQuade, Robert; Rossetti, Sandro; Sanchez, Raymond; Sun, Wei; Wright, Stephen; Lichtman, Aron H; Kornyeyeva, Elena
2017-08-01
Opioids are critical for managing cancer pain, but may provide inadequate relief and/or unacceptable side effects in some cases. To assess the analgesic efficacy of adjunctive Sativex (Δ 9 -tetrahydrocannabinol (27 mg/mL): cannabidiol (25 mg/mL)) in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy. This report describes two phase 3, double-blind, randomized, placebo-controlled trials. Eligible patients had advanced cancer and average pain numerical rating scale (NRS) scores ≥4 and ≤8 at baseline, despite optimized opioid therapy. In Study-1, patients were randomized to Sativex or placebo, and then self-titrated study medications over a 2-week period per effect and tolerability, followed by a 3-week treatment period. In Study-2, all patients self-titrated Sativex over a 2-week period. Patients with a ≥15% improvement from baseline in pain score were then randomized 1:1 to Sativex or placebo, followed by 5-week treatment period (randomized withdrawal design). The primary efficacy endpoint (percent improvement (Study-1) and mean change (Study-2) in average daily pain NRS scores) was not met in either study. Post hoc analyses of the primary endpoints identified statistically favourable treatment effect for Sativex in US patients <65 years (median treatment difference: 8.8; 95% confidence interval (CI): 0.00-17.95; p = 0.040) that was not observed in patients <65 years from the rest of the world (median treatment difference: 0.2; 95% CI: -5.00 to 7.74; p = 0.794). Treatment effect in favour of Sativex was observed on quality-of-life questionnaires, despite the fact that similar effects were not observed on NRS score. The safety profile of Sativex was consistent with earlier studies, and no evidence of abuse or misuse was identified. Sativex did not demonstrate superiority to placebo in reducing self-reported pain NRS scores in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy, although further exploration of differences between United States and patients from the rest of the world is warranted.
Reichmann, Heinz; Cooper, James; Rolfe, Katie; Martinez-Martin, Pablo
2011-01-01
Patients undergoing long-term therapy for PD often experience motor fluctuations and nocturnal disturbances. In a post-hoc analysis, we explored effects of ropinirole prolonged release on sleep, night-time awakenings, and “on” time over 24 hours. Patients with advanced PD suboptimally controlled with L-dopa were randomized to adjunctive ropinirole prolonged release (2–24 mg/day) or placebo for 24 weeks. Awake/asleep and, if awake, “on”/“off” status was recorded via diary cards. At week 24 last observation carried forward, changes in nighttime or daytime sleep duration were not significantly different between treatments. Of patients with baseline awakenings, a significantly higher proportion in the ropinirole prolonged release group had a reduction in awakenings versus placebo. Patients receiving ropinirole prolonged release had a significantly greater increase in amount/percentage of awake time “on”/“on” without troublesome dyskinesia during all periods assessed (including night-time and early morning), versus placebo, and higher odds for being “on” on waking. Adjunctive once-daily ropinirole prolonged release may help provide 24-hour symptom control in patients with advanced PD not optimally controlled with L-dopa. PMID:21687750
Mipomersen as a potential adjunctive therapy for hypercholesterolemia.
Patel, Neeraj; Hegele, Robert A
2010-10-01
Mipomersen, an antisense oligonucleotide directed against apolipoprotein B-100 (apoB), was investigated for its safety and efficacy in reducing low-density lipoprotein (LDL) cholesterol (C) as adjunctive treatment for patients with homozygous familial hypercholesterolemia (HoFH) in a Phase III, double-blind, randomized, controlled trial. HoFH patients are very rare in the general population (∼ 1:1,000,000) and have very high risk for cardiovascular events. HoFH patients respond poorly to statins and most other existing lipid-lowering therapies. Mipomersen (200 or 160 mg) administered subcutaneously to 34 HoFH patients for 26 weeks significantly reduced LDL-C by 24.7% from baseline. In addition, mipomersen lowered plasma lipoprotein (a). In most patients, mipomersen administration was most associated with injection-site reactions; influenza-like symptoms were also more common in mipomersen-treated patients. Four patients had elevated serum alanine aminotransferase (ALT) concentrations, one of whom also had a significant increase in intrahepatic triglyceride content. Another patient met the stopping rules for increased ALT concentrations. No patient developed steatohepatitis during the study. Thus, so far short-term data indicate that mipomersen is safe and effective as an adjunctive drug for lowering LDL-C. Despite these promising results, the longer-term safety and efficacy of mipomersen still needs to be determined.
Treatment of personality disorder.
Bateman, Anthony W; Gunderson, John; Mulder, Roger
2015-02-21
The evidence base for the effective treatment of personality disorders is insufficient. Most of the existing evidence on personality disorder is for the treatment of borderline personality disorder, but even this is limited by the small sample sizes and short follow-up in clinical trials, the wide range of core outcome measures used by studies, and poor control of coexisting psychopathology. Psychological or psychosocial intervention is recommended as the primary treatment for borderline personality disorder and pharmacotherapy is only advised as an adjunctive treatment. The amount of research about the underlying, abnormal, psychological or biological processes leading to the manifestation of a disordered personality is increasing, which could lead to more effective interventions. The synergistic or antagonistic interaction of psychotherapies and drugs for treating personality disorder should be studied in conjunction with their mechanisms of change throughout the development of each. Copyright © 2015 Elsevier Ltd. All rights reserved.
The use of hyperbaric oxygen therapy and LED therapy in diabetic foot
NASA Astrophysics Data System (ADS)
Marques, Cristiane R. S.; Martin, Airton A.; Lima, Carlos J.; Conrado, Luis A. L.; Silveira, Fabricio L.; Carvalho, Marcos V.
2004-07-01
Chronic foot ulcers are common ailments presented in diabetes, which offer severe complications and are often unresponsive to therapy. In this work it was evaluated the effects of adjunctive Hyperbaric Oxygen Therapy (HBO) treatment and LEDtherapy irradiation on ulcer healing (HBO) in addition to conventional treatment. In ulcers of diabetic foot these treatments lead to a reduction in the probability of amputation up to almost four times compared with patients not receiving such co-adjutant treatment. The LEDtherapy irradiation was given concurrently using an energy density of 4J/cm2 for 5 min. During the experiment nine patients with diabetic foot ulcers were submitted for HBO sessions with 2,5 ATM for two hours. The experiment demonstrated the effectiveness of HBO + LEDtherapy treatment by favoring the ulcer healing through an increased fibroblastic response, collagen synthesis and neo-vascularization of the ischaemia, as well as increases in the leukocytic bactericidal activity.
Onaolapo, Olakunle James; Ademakinwa, Olayemi Quyyom; Olalekan, Temitayo Opeyemi; Onaolapo, Adejoke Yetunde
2017-09-01
We studied the influence of zinc, haloperidol or olanzapine on neurobehaviour (open-field, radial arm maze and elevated plus maze) and brain antioxidant status in vehicle- or ketamine-treated mice, with the aim of ascertaining the potentials of zinc in counteracting ketamine's effects. Experiment 1 assessed the effects of zinc in healthy animals and the relative degrees of modulation of ketamine's effects by zinc, haloperidol or olanzapine, respectively. Experiment 2 assessed the modulation of ketamine's effects following co-administration of zinc with haloperidol or olanzapine. Male mice weighing 18-20 g each were used. Animals were pretreated with ketamine (except vehicle, zinc, haloperidol and olanzapine controls) for 10 days before commencement of 14-day treatment (day 11-24) with vehicle, zinc, haloperidol or olanzapine (alone or in combination). Ketamine injection also continued alongside zinc and/or standard drugs in the ketamine-treated groups. Zinc, haloperidol and olanzapine were administered by gavage. Treatments were given daily and behaviours assessed on days 11 and 24. On day 24, animals were sacrificed and whole brain homogenates used for estimation of glutathione, nitric oxide and malondialdehyde (MDA) levels. Ketamine increased open-field behaviours, nitric oxide and MDA levels, while it decreased working memory, social interaction and glutathione. Administration of zinc alone or in combination with haloperidol or olanzapine was associated with variable degrees of reversal of these effects. Zinc may have the potential of a possible therapeutic agent and/or adjunct in the reversal of schizophrenia-like changes in behaviour and brain oxidative status.
Grasso, M C; Button, B M; Allison, D J; Sawyer, S M
2000-05-01
Routine chest physiotherapy (CPT) is an important component of prophylactic therapy in children with cystic fibrosis (CF) and requires a significant commitment of time and energy. It is important, therefore, to establish CPT as a positive experience. In this study, we evaluated the effect of recorded music as an adjunct to CPT. Specifically, we compared the use of newly composed music, familiar music, and the family's usual routine on children's and parents' enjoyment of CPT and the parents' perception of time taken to complete CPT. Enjoyment and perception of time were evaluated via questionnaires designed specifically for this study. Participants were caregivers of one or more children with CF who were aged between 4(1/2) months and 24 months at the commencement of the clinical trial and required CPT on a daily basis. Participants were randomly allocated into control and treatment groups. Control group participants experienced two conditions consecutively: no audiotape (NT; control) and familiar music tape (FT; placebo control). Treatment group participants were given the treatment music tape (TT), which was composed and compiled by a music therapist. After baseline assessment, evaluation occurred at two 6-weekly intervals. Children's enjoyment increased significantly after use of the TT (+1. 25 units) compared to NT (-0.5 units; P = 0.03), as did parents' enjoyment (+1.0 vs. 0.0 units, P = 0.02). Children's enjoyment did not change significantly after use of the FT (+0.75 units) compared to NT (n.s.). Likewise, parents' enjoyment did not change significantly after use of the FT (+1.0 units, n.s.). There was no change in perception of time after use of the TT (-4.5 vs. +0.2 min, n.s.) or the FT (+3.3 min, n.s.). These results indicate that children's and parents' enjoyment of CPT significantly increased after the use of specifically composed and recorded music as an adjunct. We therefore recommend that recorded music, such as that provided in this study, be given to parents to use as an adjunct to CPT when their young children are diagnosed with CF, in order to assist the establishment of a positive routine. Copyright 2000 Wiley-Liss, Inc.
Present and future drug treatment for Parkinson's disease
Schapira, A
2005-01-01
Considerable advances made in defining the aetiology, pathogenesis, and pathology of Parkinson's disease (PD) have resulted in the development and rapid expansion of the pharmacopoeia available for treatment. Anticholinergics were used before the introduction of levodopa which is now the drug most commonly used. Dopamine agonists are effective when used alone or as an adjunct to levodopa, while monoamine oxidase B inhibitors improve motor function in early and advanced PD. However, treatment mainly addresses the dopaminergic features of the disease and leaves its progressive course unaffected; the drug treatment available for the management of non-motor symptoms is limited. This article seeks to set current treatment options in context, review emerging and novel drug treatments for PD, and assess the prospects for disease modification. Surgical therapies are not considered. PMID:16227533
A randomized trial of adjunct testosterone for cancer-related muscle loss in men and women.
Wright, Traver J; Dillon, E Lichar; Durham, William J; Chamberlain, Albert; Randolph, Kathleen M; Danesi, Christopher; Horstman, Astrid M; Gilkison, Charles R; Willis, Maurice; Richardson, Gwyn; Hatch, Sandra S; Jupiter, Daniel C; McCammon, Susan; Urban, Randall J; Sheffield-Moore, Melinda
2018-06-01
Cancer cachexia negatively impacts cancer-related treatment options, quality of life, morbidity, and mortality, yet no established therapies exist. We investigated the anabolic properties of testosterone to limit the loss of body mass in late stage cancer patients undergoing standard of care cancer treatment. A randomized, double-blind, placebo-controlled phase II clinical trial was undertaken to assess the potential therapeutic role of adjunct testosterone to limit loss of body mass in patients with squamous cell carcinoma of the cervix or head and neck undergoing standard of care treatment including chemotherapy and chemoradiation. Patients were randomly assigned in blocks to receive weekly injections of either 100 mg testosterone enanthate or placebo for 7 weeks. The primary outcome was per cent change in lean body mass, and secondary outcomes included assessment of quality of life, tests of physical performance, muscle strength, daily activity levels, resting energy expenditure, nutritional intake, and overall survival. A total of 28 patients were enrolled, 22 patients were studied to completion, and 21 patients were included in the final analysis (12 placebo, nine testosterone). Adjunct testosterone increased lean body mass by 3.2% (95% confidence interval [CI], 0-7%) whereas those receiving placebo lost 3.3% (95% CI, -7% to 1%, P = 0.015). Although testosterone patients maintained more favourable body condition, sustained daily activity levels, and showed meaningful improvements in quality of life and physical performance, overall survival was similar in both treatment groups. In patients with advanced cancer undergoing the early phase of standard of care therapy, adjunct testosterone improved lean body mass and was also associated with increased quality of life, and physical activity compared with placebo. © 2018 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of the Society on Sarcopenia, Cachexia and Wasting Disorders.
Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies
Mameniškienė, Rūta; Quarato, Pier Paolo; Klein, Pavel; Gamage, Jessica; Schiemann, Jimmy; Johnson, Martin E.; Whitesides, John; McDonough, Belinda; Eckhardt, Klaus
2016-01-01
Objective: To assess the efficacy, safety, and tolerability of adjunctive brivaracetam (BRV), a selective, high-affinity ligand for SV2A, for treatment of partial-onset (focal) seizures (POS) in adults. Methods: Data were pooled from patients (aged 16–80 years) with POS uncontrolled by 1 to 2 antiepileptic drugs receiving BRV 50, 100, or 200 mg/d or placebo, without titration, in 3 phase III studies of BRV (NCT00490035, NCT00464269, and NCT01261325, ClinicalTrials.gov, funded by UCB Pharma). The studies had an 8-week baseline and a 12-week treatment period. Patients receiving concomitant levetiracetam were excluded from the efficacy pool. Results: In the efficacy population (n = 1,160), reduction over placebo (95% confidence interval) in baseline-adjusted POS frequency/28 days was 19.5% (8.0%–29.6%) for 50 mg/d (p = 0.0015), 24.4% (16.8%–31.2%) for 100 mg/d (p < 0.00001), and 24.0% (15.3%–31.8%) for 200 mg/d (p < 0.00001). The ≥50% responder rate was 34.2% (50 mg/d, p = 0.0015), 39.5% (100 mg/d, p < 0.00001), and 37.8% (200 mg/d, p = 0.00003) vs 20.3% for placebo (p < 0.01). Across the safety population groups (n = 1,262), 90.0% to 93.9% completed the studies. Treatment-emergent adverse events (TEAEs) were reported by 68.0% BRV overall (n = 803) and 62.1% placebo (n = 459). Serious TEAEs were reported by 3.0% (BRV) and 2.8% (placebo); 3 patients receiving BRV and one patient receiving placebo died. TEAEs in ≥5% patients taking BRV (vs placebo) were somnolence (15.2% vs 8.5%), dizziness (11.2% vs 7.2%), headache (9.6% vs 10.2%), and fatigue (8.7% vs 3.7%). Conclusions: Adjunctive BRV was effective and generally well tolerated in adults with POS. Classification of evidence: This analysis provides Class I evidence that adjunctive BRV is effective in reducing POS frequency in adults with epilepsy and uncontrolled seizures. PMID:27335114
Pemphigus vulgaris: approach to treatment.
Sinha, Animesh A; Hoffman, Melissa B; Janicke, Elise C
2015-04-01
The therapeutic management of pemphigus vulgaris (PV) is centered around immunosuppression, which can be generalized, as in the use of corticosteroids or steroid sparing agents, or specific, as in therapeutic blockage of autoantibody production, certain cytokines, or signaling pathways. Currently, the backbone of treatment for PV, particularly, first line therapy, remains systemic corticosteroids. Although very effective, the significant side effects of long-term corticosteroid usage are well documented. Adjunctive therapies aim to eliminate, or at least decrease, the necessary dose of corticosteroids. Specifically, azathioprine, cyclophosphamide, methotrexate, cyclosporine, mycophenolate mofetil and dapsone are now widely used in PV. Intravenous immunoglobulin (IVIG), plasmapheresis, immunoadsorption, and most recently, rituximab, are other members of the therapeutic armamentarium. However, despite the widening range of treatment options in PV, well-controlled clinical trials and consensus guidelines are lacking.
Fujikura, Yuji; Manabe, Toshie; Kawana, Akihiko; Kohno, Shigeru
2017-02-01
The clinical benefits of adjunctive corticosteroids for Pneumocystis jirovecii (P. jirovecii) pneumonia in patients not infected with the human immunodeficiency virus (HIV) has not been evaluated by meta-analysis. We conducted a systematic review of published studies describing the effects of adjunctive corticosteroids on outcome in non-HIV P. jirovecii pneumonia patients. Two investigators independently searched the PubMed and Cochrane databases for eligible articles written in English. A meta-analysis was performed using a random-effects model for measuring mortality as the primary outcome, and the need for intubation or mechanical ventilation as the secondary outcome. Seven observational studies were eligible. In these studies, adjunctive corticosteroids did not affect mortality in non-HIV patients (odds ratio [OR] 1.26; 95% CI 0.60-2.67) and there was no beneficial effect in patients with severe hypoxemia (PaO 2 <70mmHg) (OR 0.90; 95% CI 0.44-1.83). No significant effect on the secondary outcome was observed (OR 1.34; 95% CI 0.44-4.11). Although the studies were observational, meta-analysis showed that adjunctive corticosteroids did not improve the outcome of P. jirovecii pneumonia in non-HIV patients. The results warrant a randomized controlled trial. Copyright © 2016 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.
Maehara, Akiko; Mintz, Gary S; Shimshak, Thomas M; Ricotta, Joseph J; Ramaiah, Venkatesh; Foster, Malcolm T; Davis, Thomas P; Gray, William A
2015-05-01
Endovascular treatment of calcified femoral-popliteal disease is challenging. We sought to evaluate the mechanism of lumen gain when using the JETSTREAM Atherectomy System to treat calcified peripheral artery lesions. The JETSTREAM Calcium Study was a prospective, single-arm, multicentre study to evaluate the JETSTREAM Atherectomy System for severely calcified femoral-popliteal artery lesions, i.e., patients with claudication and lesions with superficial calcium >90° and >5 mm in length as determined by intravascular ultrasound (IVUS). The 2.1 mm catheter was used in this study without distal protection. Fifty-five patients underwent angiographic screening: 26 (45%) met IVUS inclusion criteria. Angiographic calcium was moderate in eight cases and severe in 14, with no available data for four cases. Visual diameter stenosis was 86±9% pre-treatment, 37±13% post atherectomy, and 10±6% post adjunctive treatment (adjunctive PTA+stenting in eight and adjunct PTA alone in 16). IVUS showed lumen area increased from 6.6±3.7 mm2 to 10.0±3.6 mm2 (p=0.001): calcium reduction was responsible for 86±23% of the lumen increase. Although the superficial calcium arc did not change (151±70° to 146±71°, p=0.83), the arc of reverberation increased (23±20° to 65±40°, p=0.006), indicating device-related modification of calcium. Adjunctive balloon angioplasty was performed in 62% of the lesions, and stent implantation in 31%. In 11 cases with adjunctive balloon dilation, the MLA increased from 7.1 (6.4, 7.8) mm2 post atherectomy to 11.9 (10.3, 13.5) mm2 post balloon (p<0.001) without flow-limiting dissection. No major adverse events occurred up to 30 days post procedure in either the study group or the patients who were excluded from the analysis. The JETSTREAM Atherectomy System increased lumen dimensions in moderately or severely calcified femoral-popliteal lesions by removing superficial calcium without major complications.
2012-01-01
Background N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. Method The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. Results There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. Conclusions There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. Trial Registration The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493). PMID:22891797
Garner, Bryan R; Zehner, Mark; Roosa, Mathew R; Martino, Steve; Gotham, Heather J; Ball, Elizabeth L; Stilen, Patricia; Speck, Kathryn; Vandersloot, Denna; Rieckmann, Traci R; Chaple, Michael; Martin, Erika G; Kaiser, David; Ford, James H
2017-11-17
Improving the extent to which evidence-based practices (EBPs)-treatments that have been empirically shown to be efficacious or effective-are integrated within routine practice is a well-documented challenge across numerous areas of health. In 2014, the National Institute on Drug Abuse funded a type 2 effectiveness-implementation hybrid trial titled the substance abuse treatment to HIV Care (SAT2HIV) Project. Aim 1 of the SAT2HIV Project tests the effectiveness of a motivational interviewing-based brief intervention (MIBI) for substance use as an adjunct to usual care within AIDS service organizations (ASOs) as part of its MIBI Experiment. Aim 2 of the SAT2HIV Project tests the effectiveness of implementation and sustainment facilitation (ISF) as an adjunct to the Addiction Technology Transfer Center (ATTC) model for training staff in motivational interviewing as part of its ISF Experiment. The current paper describes the study protocol for the ISF Experiment. Using a cluster randomized design, case management and leadership staff from 39 ASOs across the United States were randomized to receive either the ATTC strategy (control condition) or the ATTC + ISF strategy (experimental condition). The ATTC strategy is staff-focused and includes 10 discrete strategies (e.g., provide centralized technical assistance, conduct educational meetings, provide ongoing consultation). The ISF strategy is organization-focused and includes seven discrete strategies (e.g., use an implementation advisor, organize implementation team meetings, conduct cyclical small tests of change). Building upon the exploration-preparation-implementation-sustainment (EPIS) framework, the effectiveness of the ISF strategy is examined via three staff-level measures: (1) time-to-proficiency (i.e., preparation phase outcome), (2) implementation effectiveness (i.e., implementation phase outcome), and (3) level of sustainment (i.e., sustainment phase outcome). Although not without limitations, the ISF experiment has several strengths: a highly rigorous design (randomized, hypothesis-driven), high-need setting (ASOs), large sample size (39 ASOs), large geographic representation (23 states and the District of Columbia), and testing along multiple phases of the EPIS continuum (preparation, implementation, and sustainment). Thus, study findings will significantly improve generalizable knowledge regarding the best preparation, implementation, and sustainment strategies for advancing EBPs along the EPIS continuum. Moreover, increasing ASO's capacity to address substance use may improve the HIV Care Continuum. Trial registration ClinicalTrials.gov: NCT03120598.
Patient Susceptibility to Candidiasis—A Potential for Adjunctive Immunotherapy
Davidson, Linda; Netea, Mihai G.; Kullberg, Bart Jan
2018-01-01
Candida spp. are colonizing fungi of human skin and mucosae of the gastrointestinal and genitourinary tract, present in 30–50% of healthy individuals in a population at any given moment. The host defense mechanisms prevent this commensal fungus from invading and causing disease. Loss of skin or mucosal barrier function, microbiome imbalances, or defects of immune defense mechanisms can lead to an increased susceptibility to severe mucocutaneous or invasive candidiasis. A comprehensive understanding of the immune defense against Candida is essential for developing adjunctive immunotherapy. The important role of underlying genetic susceptibility to Candida infections has become apparent over the years. In most patients, the cause of increased susceptibility to fungal infections is complex, based on a combination of immune regulation gene polymorphisms together with other non-genetic predisposing factors. Identification of patients with an underlying genetic predisposition could help determine which patients could benefit from prophylactic antifungal treatment or adjunctive immunotherapy. This review will provide an overview of patient susceptibility to mucocutaneous and invasive candidiasis and the potential for adjunctive immunotherapy. PMID:29371502
Therapeutic Use of Botulinum Toxin in Neurorehabilitation
Intiso, Domenico
2012-01-01
The botulinum toxins (BTX), type A and type B by blocking vesicle acetylcholine release at neuro-muscular and neuro-secretory junctions can result efficacious therapeutic agents for the treatment of numerous disorders in patients requiring neuro-rehabilitative intervention. Its use for the reduction of focal spasticity following stroke, brain injury, and cerebral palsy is provided. Although the reduction of spasticity is widely demonstrated with BTX type A injection, its impact on the improvement of dexterity and functional outcome remains controversial. The use of BTX for the rehabilitation of children with obstetrical brachial plexus palsy and in treating sialorrhea which can complicate the course of some severe neurological diseases such as amyotrophic lateral sclerosis and Parkinson's disease is also addressed. Adverse events and neutralizing antibodies formation after repeated BTX injections can occur. Since impaired neurological persons can have complex disabling feature, BTX treatment should be viewed as adjunct measure to other rehabilitative strategies that are based on the individual's residual ability and competence and targeted to achieve the best functional recovery. BTX therapy has high cost and transient effect, but its benefits outweigh these disadvantages. Future studies must clarify if this agent alone or adjunctive to other rehabilitative procedures works best on functional outcome. PMID:21941544
Rotundo, Roberto; Nieri, Michele; Cairo, Francesco; Franceschi, Debora; Mervelt, Jana; Bonaccini, Daniele; Esposito, Marco; Pini-Prato, Giovanpaolo
2010-06-01
This split-mouth, randomized, clinical trial aimed to evaluate the efficacy of erbium-doped:yttrium-aluminium-garnet (Er:YAG) laser application in non-surgical periodontal treatment. A total of 27 patients underwent four modalities of non-surgical therapy: supragingival debridement; scaling and root planing (SRP)+Er:YAG laser; Er:YAG laser; and SRP. Each strategy was randomly assigned and performed in one of the four quadrants. Clinical outcomes were evaluated at 3 and 6 months. Subjective benefits of patients have been evaluated by means of questionnaires. Six months after therapy, Er:YAG laser showed no statistical difference in clinical attachment gain with respect to supragingival scaling [0.15 mm (95% CI -0.16; 0.46)], while SRP showed a greater attachment gain than the supragingival scaling [0.37 mm (95% CI 0.05; 0.68)]. No difference resulted between Er:YAG laser+SRP and SRP alone [0.05 mm (95% CI -0.25; 0.36)]. The adjunctive use of Er:YAG laser to conventional SRP did not reveal a more effective result than SRP alone. Furthermore, the sites treated with Er:YAG laser showed similar results of the sites treated with supragingival scaling.
McMain, Shelley F; Guimond, Tim; Barnhart, Ryan; Habinski, Liat; Streiner, David L
2017-02-01
Evidence-based therapies for borderline personality disorder (BPD) are lengthy and scarce. Data on brief interventions are limited, and their role in the treatment of BPD is unclear. Our aim was therefore to evaluate the clinical effectiveness of brief dialectical behaviour therapy (DBT) skills training as an adjunctive intervention for high suicide risk in patients with BPD. Eighty-four out-patients were randomized to 20 weeks of DBT skills (n = 42) or a waitlist (WL; n = 42). The primary outcome was frequency of suicidal or non-suicidal self-injurious (NSSI) episodes. Assessments were conducted at baseline 10, 20 and 32 weeks. DBT participants showed greater reductions than the WL participants on suicidal and NSSI behaviours between baseline and 32 weeks (P < 0.0001). DBT participants showed greater improvements than controls on measures of anger, distress tolerance and emotion regulation at 32 weeks. This abbreviated intervention is a viable option that may be a useful adjunctive intervention for the treatment of high-risk behaviour associated with the acute phase of BPD. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Assenza, G; Mecarelli, O; Lanzone, J; Assenza, F; Tombini, M; Di Lazzaro, V; Pulitano, P
2018-05-01
Eslicarbazepine acetate (ESL) is a third-generation member of the dibenzazepine family approved in 2009 by the European Medicines Agency with the indication of adjunctive therapy in adult people with partial-onset seizures (PPOS). We aimed at assessing the ESL impact on seizure frequency and quality of life in PPOS with a particular attention to sleepiness and depression. We evaluated 50 adult PPOS (>18 years; 48 ± 14 years-old; 23 males) treated with adjunctive ESL for ≥2months with a retrospective multi-centric design. Clinical files of the last 2 years were reviewed checking for monthly seizure frequency, treatment retention rate, adverse drug reactions (ADRs), concomitant anti-epileptic drugs and behavioural scales for sleepiness (Stanford Sleepiness Scale, SSS, and Epworth Sleepiness Scale, ESS), depression (Beck Depression Inventory-II, BDI) and overall quality of life (QOLIE-31). At the end of 96 ± 28 days of ESL treatment, the mean seizure reduction was 56%; 60% of patients had seizure reduction above 50%, with a 31% of the whole population becoming seizure free. We reported 16 ADRs with 4 hyponatremia. Retention rate was 76%. Patient reported less sleepiness after ESL (SSS, p = 0.031; ESS, p = 0.0000002). Before ESL, 38% of patients had pathologic BDI scores, which normalized in most of them (73%) after ESL (BDI improvement, p = 0.000012). These scores resulted in an amelioration of quality of life (QOLIE-31, p = 0.000002). ESL is a safe and effective anti-epileptic drug in a real life scenario, with an excellent behavioural profile for the overall quality of life and, in particular, for sleepiness and depression. Copyright © 2018 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
Chan, W Y Wandy; Frampton, Christopher M; Crozier, Ian G; Troughton, Richard W; Richards, A Mark
2013-10-01
The purpose of this study is to investigate the effects of urocortin-2 as adjunct therapy in acute decompensated heart failure (ADHF). Urocortin-2 produced favorable integrated effects in experimental heart failure but there are no equivalent human data. We describe the first therapeutic study of urocortin-2 infusion in ADHF. Fifty-three patients with ADHF were randomly assigned to 5 ng/kg/min of urocortin-2 or placebo infusion for 4 h as an adjunct therapy. Changes in vital signs, plasma neurohormonal and renal indices during treatment were compared using repeated-measures analysis of covariance. Ten patients in each arm underwent more detailed invasive hemodynamic evaluation. Urocortin-2 produced greater falls in systolic blood pressure compared to placebo (16 ± 5.8 mm Hg, p < 0.001) with nonsignificant increases in heart rate (5.7 ± 3.8 beats/min, p = 0.07) and increased cardiac output (2.1 ± 0.4 l/min vs. -0.1 ± 0.4 l/min, p < 0.001) associated with a 47% reduction in calculated total peripheral resistance (p = 0.015). Falls in pulmonary artery and pulmonary capillary wedge pressures did not differ significantly between groups. Urocortin-2 reduced urine volume and creatinine clearance during infusion but these returned to above baseline level in the 8 h after infusion. Plasma renin activity rose briefly with urocortin-2 coinciding with reductions in blood pressure (p < 0.001). B-type natriuretic peptide levels fell significantly over 24 h with urocortin-2 (p < 0.01) but not with placebo. Urocortin-2 infusion in ADHF markedly augmented cardiac output without significant reflex tachycardia. Renal indices fell transiently concurrent with urocortin-2-induced reductions in blood pressure. Further investigations are required to uncover the full potential of urocortin-2 in treating ADHF. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Xue, Dong; Tang, Lu; Bai, Yuhao; Ding, Qian; Wang, Pengcheng; Zhao, Ying
2017-06-01
To evaluate the clinical efficacy of photodynamic therapy (PDT) adjunctive to scaling and root planing (SRP) in patients with untreated chronic periodontitis based on up-to-date evidence. MEDLINE and the Cochrane Library were systematically searched to identify eligible randomized controlled trials (RCTs), supplemented by a manual literature search. Mean differences (MD) and the corresponding 95% confidence intervals (CI) of probing depth (PD) reduction and clinical attachment level (CAL) gain were synthesized. The I 2 test and Q statistics were used to determine the inter-study heterogeneity. Subgroup analysis based on smoking status was performed. Eleven RCTs with a total of 243 subjects were included. Significant improvement in PD reduction (MD=0.13, CI:0.02-0.24, p=0.02) and marginal significant improvement in CAL gain (MD=0.18, CI:-0.005-0.363, p=0.056) were observed in favor of SRP+PDT at 3months. When evaluated at 6months after baseline, the association of PDT with SRP resulted in a significant benefit in PD reduction (MD=0.40, CI:0.05-0.74, p=0.03), but not in CAL gain (MD=0.37, CI:-0.18-0.93, p=0.18). Subgroup analysis revealed that the combined therapy produced no significant improvements in PD and CAL at neither 3months nor 6months for studies with smokers. No treatment-related adverse events or side effects had been reported by the included studies. Pooled analysis suggests a short-term benefit of PDT as an adjunct to SRP in clinical outcome variables. However, evidence regarding its long-term efficacy is still insufficient and no significant effect has been confirmed in terms of CAL gain at 6months. Future clinical trials of high methodological quality are needed to establish the optimal combination of photosensitizer and laser configuration. Copyright © 2017 Elsevier B.V. All rights reserved.
Aortic anatomic severity grade correlates with resource utilization.
Rasheed, Khurram; Cullen, John P; Seaman, Matthew J; Messing, Susan; Ellis, Jennifer L; Glocker, Roan J; Doyle, Adam J; Stoner, Michael C
2016-03-01
Potential cost effectiveness of endovascular aneurysm repair (EVAR) compared with open aortic repair (OAR) is offset by the use of intraoperative adjuncts (components) or late reinterventions. Anatomic severity grade (ASG) can be used preoperatively to assess abdominal aortic aneurysms, and provide a quantitative measure of anatomic complexity. The hypothesis of this study is that ASG is directly related to the use of intraoperative adjuncts and cost of aortic repair. Patients who undergo elective OAR and EVAR for abdominal aortic aneurysms were identified over a consecutive 3-year period. ASG scores were calculated manually using three-dimensional reconstruction software by two blinded reviewers. Statistical analysis of cost data was performed using a log transformation. Regression analyses, with a continuous or dichotomous outcome, used a generalized estimating equations approach with the sandwich estimator, being robust with respect to deviations from model assumptions. One hundred forty patients were identified for analysis, n = 33 OAR and n = 107 EVAR. The mean total cost (± standard deviation) for OAR was per thousand (k) $38.3 ± 49.3, length of stay (LOS) 13.5 ± 14.2 days, ASG score 18.13 ± 3.78; for EVAR, mean total cost was k $24.7 ± 13.0 (P = .016), LOS 3.0 ± 4.4 days (P = .012), ASG score 15.9 ± 4.13 (P = .010). In patients who underwent EVAR, 25.2% required intraoperative adjuncts, and analysis of this group revealed a mean total cost of k $31.5 ± 15.9, ASG score 18.48 ± 3.72, and LOS 3.9 ± 4.5, which were significantly greater compared with cases without adjunctive procedures. An ASG score of ≥15 correlated with an increased propensity for requirement of intraoperative adjuncts; odds ratio, 5.75 (95% confidence interval, 1.82-18.19). ASG >15 was also associated with chronic kidney disease, end stage renal disease, hypertension, female sex, increased cost, and use of adjunctive procedures. Complex aneurysm anatomy correlates with increased total cost and need for adjunctive procedures during EVAR. Preoperative assessment with ASG scores can delineate patients at greater risk for increased resource use. Patient comorbid factors are associated with anatomic complexity defined according to ASG. A critical examination of the relationship between anatomic complexity and finances is required within the context of aggressive endovascular treatment strategies and shifts toward value-based reimbursement. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.
Heckenberg, Sebastiaan G B; Brouwer, Matthijs C; van de Beek, Diederik
2014-01-01
Bacterial meningitis is a neurologic emergency. Vaccination against common pathogens has decreased the burden of disease. Early diagnosis and rapid initiation of empiric antimicrobial and adjunctive therapy are vital. Therapy should be initiated as soon as blood cultures have been obtained, preceding any imaging studies. Clinical signs suggestive of bacterial meningitis include fever, headache, meningismus, and an altered level of consciousness but signs may be scarce in children, in the elderly, and in meningococcal disease. Host genetic factors are major determinants of susceptibility to meningococcal and pneumococcal disease. Dexamethasone therapy has been implemented as adjunctive treatment of adults with pneumococcal meningitis. Adequate and prompt treatment of bacterial meningitis is critical to outcome. In this chapter we review the epidemiology, pathophysiology, and management of bacterial meningitis. © 2014 Elsevier B.V. All rights reserved.
Carreño, Mar; Benbadis, Selim; Rocha, Francisco; Blum, David; Cheng, Hailong
2017-12-01
To investigate whether adjunctive eslicarbazepine acetate (ESL) could lead to exacerbation of seizures in some patients. Post-hoc analysis of data pooled from three Phase III trials of adjunctive ESL (studies 301, 302, and 304) for refractory partial-onset seizures (POS). Following an 8-week baseline period, patients were randomized to receive placebo or ESL 400, 800, or 1,200 mg once daily (2-week titration, 12-week maintenance, 2-4 week tapering-off periods). Patient seizure diary data and seizure treatment-emergent adverse event (TEAE) reports were pooled for analysis. The modified intent-to-treat and safety populations comprised 1,410 patients and 1,447 patients, respectively. Titration period : Compared with placebo (32/21%), significantly smaller proportions of patients taking ESL 800 mg (20/15%) and 1,200 mg (22/12%) had a ≥25/≥50% increase in standardized seizure frequency (SSF) from baseline; there was no significant difference between placebo and ESL 400 mg. Maintenance period : Compared with placebo (20%), significantly smaller proportions of patients taking ESL (400 mg, 12%; 800 mg, 12%; 1,200 mg, 14%) had an increase in SSF ≥25%. When evaluating ≥50% increases in SSF, only ESL 800 mg (7%) was significantly different from placebo (12%). Some patients had no secondarily generalized tonic-clonic (sGTC) seizures during baseline but had ≥1 sGTC seizure during maintenance treatment (placebo, 11%; ESL 400 mg, 5%; 800 mg, 10%; 1,200 mg, 5%). Fewer patients had a ≥25% increase in sGTC seizure frequency with ESL (400 mg, 11%; 800 mg, 9%; 1,200 mg, 14%) versus placebo (19%). The incidence of seizures reported as TEAEs was low in all treatment groups; incidences were generally lower with ESL versus placebo. Tapering-off period : Similar proportions of patients taking ESL and placebo had a ≥25/≥50% increase in SSF. Seizure TEAE incidence was numerically higher with ESL versus placebo. Treatment with adjunctive ESL does not appear to aggravate POS or sGTC seizures.
Bacterial meningitis - principles of antimicrobial treatment.
Jawień, Miroslaw; Garlicki, Aleksander M
2013-01-01
Bacterial meningitis is associated with significant morbidity and mortality despite the availability of effective antimicrobial therapy. The management approach to patients with suspected or proven bacterial meningitis includes emergent cerebrospinal fluid analysis and initiation of appropriate antimicrobial and adjunctive therapies. The choice of empirical antimicrobial therapy is based on the patient's age and underlying disease status; once the infecting pathogen is isolated, antimicrobial therapy can be modified for optimal treatment. Successful treatment of bacterial meningitis requires the knowledge on epidemiology including prevalence of antimicrobial resistant pathogens, pathogenesis of meningitis, pharmacokinetics and pharmacodynamics of antimicrobial agents. The emergence of antibiotic-resistant bacterial strains in recent years has necessitated the development of new strategies for empiric antimicrobial therapy for bacterial meningitis.
(Non-)Arguments in Long-Distance Extractions.
Nyvad, Anne Mette; Kizach, Johannes; Christensen, Ken Ramshøj
2015-10-01
Previous research has shown that in fully grammatical sentences, response time increases and acceptability decreases when the filler in a long-distance extraction is incompatible with the matrix verb. This effect could potentially be due to a difference between argument and adjunct extraction. In this paper we investigate the effect of long extraction of arguments and adjuncts where incompatibility is kept constant. Based on the results from two offline surveys and an online experiment, we argue that the argument/adjunct asymmetry in terms of acceptability is due to differences in processing difficulty, but that both types of extraction involve the same intermediate attachment sites in the online processing.
Francio, Vinicius T; Boesch, Ron; Tunning, Michael
2015-03-01
Posterior cortical atrophy (PCA) is a rare progressive neurodegenerative syndrome which unusual symptoms include deficits of balance, bodily orientation, chronic pain syndrome and dysfunctional motor patterns. Current research provides minimal guidance on support, education and recommended evidence-based patient care. This case reports the utilization of chiropractic spinal manipulation, dynamic neuromuscular stabilization (DNS), and other adjunctive procedures along with medical treatment of PCA. A 54-year-old male presented to a chiropractic clinic with non-specific back pain associated with visual disturbances, slight memory loss, and inappropriate cognitive motor control. After physical examination, brain MRI and PET scan, the diagnosis of PCA was recognized. Chiropractic spinal manipulation and dynamic neuromuscular stabilization were utilized as adjunctive care to conservative pharmacological treatment of PCA. Outcome measurements showed a 60% improvement in the patient's perception of health with restored functional neuromuscular pattern, improvements in locomotion, posture, pain control, mood, tolerance to activities of daily living (ADLs) and overall satisfactory progress in quality of life. Yet, no changes on memory loss progression, visual space orientation, and speech were observed. PCA is a progressive and debilitating condition. Because of poor awareness of PCA by physicians, patients usually receive incomplete care. Additional efforts must be centered on the musculoskeletal features of PCA, aiming enhancement in quality of life and functional improvements (FI). Adjunctive rehabilitative treatment is considered essential for individuals with cognitive and motor disturbances, and manual medicine procedures may be consider a viable option.
Safarinejad, Mohammad Reza
2010-09-01
To determine the safety and efficacy of adjunctive bupropion sustained-release (SR) on male sexual dysfunction (SD) induced by a selective serotonin reuptake inhibitor (SSRI), as SD is a common side-effect of SSRIs and the most effective treatments have yet to be determined. The randomized sample consisted of 234 euthymic men who were receiving some type of SSRI. The men were randomly assigned to bupropion SR (150 mg twice daily, 117) or placebo (twice daily, 117) for 12 weeks. Efficacy was evaluated using the Clinical Global Impression-Sexual Function (CGI-SF; the primary outcome measure), the International Index of Erectile Function (IIEF), Arizona Sexual Experience Scale (ASEX), and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) (secondary outcome measures). Participants were followed biweekly during study period. After 12 weeks of treatment, the mean (sd) scores for CGI-SF were significantly lower, i.e. better, in patients on bupropion SR, at 2.4 (1.2), than in the placebo group, at 3.9 (1.1) (P= 0.01). Men who received bupropion had a significant increase in the total IIEF score (54.4% vs 1.2%; P= 0.003), and in the five different domains of the IIEF. Total ASEX scores were significantly lower, i.e. better, among men who received bupropion than placebo, at 15.5 (4.3) vs 21.5 (4.7) (P= 0.002). The EDITS scores were 67.4 (10.2) for the bupropion and 36.3 (11.7) for the placebo group (P= 0.001). The ASEX score and CGI-SF score were correlated (P= 0.003). In linear regression analyses the CGI-SF score was not affected significantly by the duration of SD, type of SSRI used and age. Bupropion is an effective treatment for male SD induced by SSRIs. These results provide empirical support for conducting a further study of bupropion.
Perampanel: a new add-on treatment for epilepsy.
2013-02-01
Perampanel (Fycompa - Eisai) is a new antiepileptic drug marketed in the EU. It is licensed for use as adjunctive treatment of partial-onset seizuresi with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.2 Here we discuss the place of perampanel in the treatment of epilepsy.
2010-01-01
Background The Multicenter Osteopathic Pneumonia Study in the Elderly (MOPSE) is a registered, double-blinded, randomized, controlled trial designed to assess the efficacy of osteopathic manipulative treatment (OMT) as an adjunctive treatment in elderly patients with pneumonia. Methods 406 subjects aged ≥ 50 years hospitalized with pneumonia at 7 community hospitals were randomized using concealed allocation to conventional care only (CCO), light-touch treatment (LT), or OMT groups. All subjects received conventional treatment for pneumonia. OMT and LT groups received group-specific protocols for 15 minutes, twice daily until discharge, cessation of antibiotics, respiratory failure, death, or withdrawal from the study. The primary outcomes were hospital length of stay (LOS), time to clinical stability, and a symptomatic and functional recovery score. Results Intention-to-treat (ITT) analysis (n = 387) found no significant differences between groups. Per-protocol (PP) analysis (n = 318) found a significant difference between groups (P = 0.01) in LOS. Multiple comparisons indicated a reduction in median LOS (95% confidence interval) for the OMT group (3.5 [3.2-4.0] days) versus the CCO group (4.5 [3.9-4.9] days), but not versus the LT group (3.9 [3.5-4.8] days). Secondary outcomes of duration of intravenous antibiotics and treatment endpoint were also significantly different between groups (P = 0.05 and 0.006, respectively). Duration of intravenous antibiotics and death or respiratory failure were lower for the OMT group versus the CCO group, but not versus the LT group. Conclusions ITT analysis found no differences between groups. PP analysis found significant reductions in LOS, duration of intravenous antibiotics, and respiratory failure or death when OMT was compared to CCO. Given the prevalence of pneumonia, adjunctive OMT merits further study. PMID:20302619
Adjunctive Therapy to Improve Functional Recovery after Limb Ischemia Reperfusion Injury
2017-10-01
end-point for the operative procedure that reads as follows: “If an animal is observed on preparation for surgery to have an elevated exhaled end...protocol, e.g. the agent is effective even when administered after the leg has become ischemic. Given that small animal studies have been performed and...in a large animal model that better simulates the way the human body responds to treatment of this important injury process. 15. SUBJECT TERMS
Chiang, I-Han; Chen, Shyi-Gen; Huang, Kun-Lun; Chou, Yu-Ching; Dai, Niann-Tzyy; Peng, Chung-Kan
2017-06-01
Despite major advances in therapeutic strategies for the management of patients with severe burns, significant morbidity and mortality is observed. Hyperbaric oxygen therapy (HBOT) increases the supply of oxygen to burn areas. The aim of this study was to determine whether HBOT is effective in the treatment of major thermal burns. On June 27, 2015 in New Taipei, Taiwan, a mass casualty disaster occurred as fire erupted over a large crowd, injuring 499 people. Fifty-three victims (20 women and 33 men) were admitted to Tri-Service General Hospital. Thirty-eight patients underwent adjunctive HBOT (HBOT group), and 15 patients received routine burn therapy (control group). Serum procalcitonin (PCT) level, a sepsis biomarker, was measured until it reached normal levels (<0.5μg/L). The records of all patients from June 2015 to March 2016 were analyzed retrospectively. Outcome measures that were compared between the groups included the use of tracheostomy and hemodialysis, total body surface area (TBSA) and the number of skin graft operations, length of hospital stay, infection status, and mortality. The mean age of the patients was 22.4 years, and the mean TBSA was 43%. All the patients survived and were discharged without requiring limb amputation or being permanently disabled. Patient characteristics did not differ significantly between the groups. PCT levels returned to normal significantly faster (p=0.007) in the HBOT group. Multidisciplinary burn care combined with adjunctive HBOT improves sepsis control compared with standard treatment without HBOT. Prospective studies are required to define the role of HBOT in extensive burns. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.
Lacosamide cardiac safety: clinical trials in patients with partial-onset seizures.
Rudd, G D; Haverkamp, W; Mason, J W; Wenger, T; Jay, G; Hebert, D; Doty, P; Horstmann, R
2015-11-01
To evaluate the cardiac safety of adjunctive lacosamide in a large pool of adults with partial-onset seizures (POS). Post-randomization changes from baseline for electrocardiographic (ECG) measurements, diagnostic findings, and relevant adverse events (AEs) were compared for pooled data from three randomized, placebo-controlled trials of adjunctive lacosamide for the treatment of POS. Lacosamide did not prolong the QTc interval or affect heart rate as determined by an analysis of data from patients randomized to lacosamide 200, 400, or 600 mg/day (n = 944) compared with placebo (n = 364). After 12-week maintenance treatment, mean changes from baseline for QRS duration were similar between the placebo and lacosamide 200 and 400 mg/day groups (0.0, -0.2, and 0.4 ms), but slightly increased for lacosamide 600 mg/day (2.3 ms). A small, dose-related mean increase in PR interval was observed (-0.3, 1.4, 4.4, and 6.6 ms for the placebo and lacosamide 200, 400, and 600 mg/day groups, respectively). First-degree atrioventricular (AV) block was reported as a non-serious AE in 0.0%, 0.7%, 0.2%, and 0.5% of patients in the same respective groups. Second- or higher degree AV block was not observed. There was no evidence of a PR-interval-related pharmacodynamic interaction of lacosamide with either carbamazepine or lamotrigine. Evaluation of the pooled cardiac safety data from patients with POS showed that adjunctive lacosamide at the maximum recommended dose (400 mg/day) was not clearly associated with any cardiac effect other than a small, dose-related increase in PR interval that had no evident symptomatic consequence. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Usall, Judith; Huerta-Ramos, Elena; Labad, Javier; Cobo, Jesús; Núñez, Christian; Creus, Marta; Parés, Gemma García; Cuadras, Daniel; Franco, José; Miquel, Eva; Reyes, Julio César; Roca, Mercedes
2016-01-01
The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator, appears to act similarly to estrogens on dopamine and serotonin brain systems. One previous trial by our team found that raloxifene was useful to improve negative, positive, and general psychopathological symptoms, without having the negative side effects of estrogens. In this study, we assess the utility of raloxifene in treating negative and other psychotic symptoms in postmenopausal women with schizophrenia exhibiting prominent negative symptoms. This was a 24-week, randomized, parallel, double-blind, placebo-controlled study. Patients were recruited from the inpatient and outpatient departments of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy postmenopausal women with schizophrenia (DSM-IV) were randomized to either adjunctive raloxifene (38 women) or adjunctive placebo (32 women). Psychopathological symptoms were assessed at baseline and at weeks 4, 12, and 24 with the Positive and Negative Syndrome Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS). The addition of raloxifene (60mg/d) to regular antipsychotic treatment significantly reduced negative (P = .027), general (P = .003), and total symptomatology (P = .005) measured with the PANSS during the 24-week trial, as compared to women receiving placebo. Also Alogia SANSS subscale improved more in the raloxifene (P = .048) than the placebo group. In conclusion, raloxifene improved negative and general psychopathological symptoms, compared with antipsychotic medication alone, in postmenopausal women with schizophrenia. These data replicate our previous results with a larger sample and a longer follow-up. Trial registration: NCT01573637. PMID:26591005
Nunes, Luciana Vargas Alves; Lacaz, Fernando Sargo; Bressan, Rodrigo Affonseca; Nunes, Sandra Odebrecht Vargas Alves; Mari, Jair de Jesus
2013-04-01
INTRODUCTION.: Evidence is accumulating to support the presence of erectile dysfunction in patients with schizophrenia. This dysregulation may be amenable to therapeutic intervention to improve adherence and quality of life of patients who suffer from schizophrenia and schizoaffective disorders. AIM.: We aimed to evaluate the use of adjunctive medication lodenafil for the treatment of erectile dysfunction in outpatients with schizophrenia and spectrum. METHODS.: The design was a randomized, double-blind, crossover, placebo-controlled trial with lodenafil and it was carried at the Schizophrenia Outpatients Program. MAIN OUTCOME MEASURES.: The measures used to assess sexual dysfunction were Arizona Sexual Experiences Scale (ASEX) and International Index of Erectile Function (IIEF). The Positive and Negative Syndrome Scale (PANSS) and the Quality of Life Scale (QLS) were also used. The measures included the levels of prolactin, estradiol, luteinizing hormone, sex hormone-binding globulin, free testosterone, and total testosterone at baseline and end point. Lodenafil and placebo pills were used by the patients for 16 weeks. RESULTS.: Fifty male outpatients fulfilled the criteria and 94% of the participants completed the study. Lodenafil and placebo produced improvement in ASEX, IIEF scale, PANSS, and QLS, and there was no statistical difference between lodenafil and placebo groups in all sexual domains in the results of PANSS and QLS and in the results of hormone levels. CONCLUSION.: These results indicate that both lodenafil and placebo were effective in the treatment of erectile dysfunction for schizophrenia. Placebo effect is very important in patients with schizophrenia and this study showed the importance of discussing sexuality and trying to treat these patients. Further studies designed to test treatments of erectile dysfunction in patients who suffer from schizophrenia are necessary. © 2013 International Society for Sexual Medicine.
Role of paliperidone extended-release in treatment of schizoaffective disorder
Canuso, Carla M; Turkoz, Ibrahim; Fu, Dong Jing; Bossie, Cynthia A
2010-01-01
Schizoaffective disorder is characterized by the presence of symptoms of both schizophrenia and a major mood disorder. The coexistence of these symptoms can be difficult to manage, and these patients are generally treated with antipsychotics as well as mood stabilizers and/or antidepressants. Additionally, no established treatment guidelines exist for this disorder. This review describes the combined results of two international, double-blind, placebo-controlled clinical studies of paliperidone extended-release (ER), an atypical antipsychotic recently approved in the US for the treatment of schizoaffective disorder. Subjects in these six-week trials were aged 18–65 years, had a diagnosis of schizoaffective disorder based on the Structural Clinical Interview for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) Disorders, and were experiencing an acute exacerbation. The subjects from these studies had significant symptomatology as evidenced by a mean (standard deviation) baseline Positive and Negative Syndrome Scale total score of 92.8 (13.0). Based on Young Mania Rating Scale and/or a 21-item Hamilton Rating Scale for Depression score of ≥16 at baseline, 79.5% and 66.9% of subjects presented with prominent manic and depressive symptoms, respectively, and 46.4% presented with mixed symptoms. Approximately half (45%) of subjects were taking adjunctive mood stabilizers and/or antidepressants. Paliperidone ER was found to be effective in improving psychotic and mood symptoms in these subjects. Paliperidone ER was also effective as monotherapy or adjunctive to mood stabilizers and/or antidepressants for subjects with prominent manic, depressive, or mixed symptoms at baseline. No new tolerability signals were observed in this population. To the best of our awareness, these pooled data provide the largest data set of patients with schizoaffective disorder, and extend our knowledge of disease characteristics and treatment response. PMID:20957127
Role of paliperidone extended-release in treatment of schizoaffective disorder.
Canuso, Carla M; Turkoz, Ibrahim; Fu, Dong Jing; Bossie, Cynthia A
2010-10-05
Schizoaffective disorder is characterized by the presence of symptoms of both schizophrenia and a major mood disorder. The coexistence of these symptoms can be difficult to manage, and these patients are generally treated with antipsychotics as well as mood stabilizers and/or antidepressants. Additionally, no established treatment guidelines exist for this disorder. This review describes the combined results of two international, double-blind, placebo-controlled clinical studies of paliperidone extended-release (ER), an atypical antipsychotic recently approved in the US for the treatment of schizoaffective disorder. Subjects in these six-week trials were aged 18-65 years, had a diagnosis of schizoaffective disorder based on the Structural Clinical Interview for DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) Disorders, and were experiencing an acute exacerbation. The subjects from these studies had significant symptomatology as evidenced by a mean (standard deviation) baseline Positive and Negative Syndrome Scale total score of 92.8 (13.0). Based on Young Mania Rating Scale and/or a 21-item Hamilton Rating Scale for Depression score of ≥16 at baseline, 79.5% and 66.9% of subjects presented with prominent manic and depressive symptoms, respectively, and 46.4% presented with mixed symptoms. Approximately half (45%) of subjects were taking adjunctive mood stabilizers and/or antidepressants. Paliperidone ER was found to be effective in improving psychotic and mood symptoms in these subjects. Paliperidone ER was also effective as monotherapy or adjunctive to mood stabilizers and/or antidepressants for subjects with prominent manic, depressive, or mixed symptoms at baseline. No new tolerability signals were observed in this population. To the best of our awareness, these pooled data provide the largest data set of patients with schizoaffective disorder, and extend our knowledge of disease characteristics and treatment response.
Faramarzi, Masumeh; Goharfar, Zahra; Pourabbas, Reza; Kashefimehr, Atabak; Shirmohmmadi, Adileh
2015-08-01
The purpose of this study was to compare the microbial and clinical effects of mechanical debridement (MD) alone or in combination with the application of enamel matrix derivative (EMD) and sustained-release micro-spherical minocycline (MSM) for treatment of peri-implant mucosal infl ammation (PIMI). Subjects with at least one implant with PIMI were included and divided into control and two different test groups. In all three groups, MD was performed. In the MSM group, following MD, MSM was placed subgingivally around the implants. In the EMD group, after MD, EMD was placed in the sulcus around the implants. Sampling of peri-implant crevicular fl uid for microbial analysis with real-time polymerase chain reaction and recording of probing depth (PD) and bleeding on probing (BOP) were performed prior to as well as two weeks and three months after treatment. Median values and interquartile range were estimated for each variable during the various assessment intervals of the study. In all groups, at two weeks and three months, the counts of Porphyromonas gingivalis decreased significantly compared to baseline. Levels of P. gingivalis were significantly reduced in MSM (P<0.001) and EMD (P=0.026) groups compared to the control group. Also, clinical parameters improved significantly at two weeks and three months. Reduction of PD was significant in MSM (P<0.001) and EMD (P<0.001) groups. The decrease in BOP in the MSM, EMD, and control groups was 60%, 50%, and 20%, respectively. The use of MSM and EMD can be an adjunctive treatment for management of PIMI and improves clinical parameters and reduces P. gingivalis burden three months after treatment.
Rapid eye movement sleep behavior disorder.
Gugger, James J; Wagner, Mary L
2007-11-01
To describe the clinical features of rapid eye movement (REM) sleep behavior disorder (RBD), evaluate treatment options, and discuss management of patients with comorbid diseases. A MEDLINE search (1977-April 2007) using the terms REM sleep behavior disorder, narcolepsy, parkinsonian disorders, levodopa, dopamine agonists, clonazepam, benzodiazepines, and melatonin was used to retrieve relevant articles. The reference sections of all articles and texts were scanned for additional literature. All articles published in English were evaluated. There were no specific criteria for inclusion of articles in this review. RBD is characterized by enactment of dream content resulting from the loss of normal skeletal muscle atonia during REM sleep. RBD occurs mainly in geriatric patients and in patients with neurodegenerative diseases, especially parkinsonian diseases. The presence of idiopathic RBD may be a sign of an underlying parkinsonian syndrome. Development of RBD may be one of the first manifestations of Parkinson's disease or other parkinsonian syndromes. An acute form of RBD can be drug-induced or occur on drug withdrawal. The potential for injury to the patient and his or her bed partner is as high as 96%. Controlled trials are unavailable for most agents used in the treatment of RBD, although clonazepam is an effective first-line agent and can provide rapid and complete symptom remission based on evidence from 3 large case series. Patients who cannot tolerate clonazepam or who have a suboptimal response may benefit from melatonin alone or as an adjunct. Both drugs are generally well tolerated when taken at bedtime. Management of patients with RBD becomes complicated due to the high incidence of neurologic comorbidity. Clonazepam is the treatment of choice for patients with RBD. The drug is efficacious and has a low incidence of adverse effects. Melatonin is a viable second-line or adjunctive treatment.
Nutritional interventions for the adjunctive treatment of schizophrenia: a brief review.
Arroll, Megan Anne; Wilder, Lorraine; Neil, James
2014-09-16
Schizophrenia is a chronic condition that impacts significantly not only on the individual and family, but the disorder also has wider consequences for society in terms of significant costs to the economy. This highly prevalent condition affects approximately 1% of the worldwide population, yet there are few therapeutic options. The predominant treatment strategy for schizophrenia is anti-psychotic medication (with or without additional talking therapy) even though this approach lacks efficacy in managing the negative symptoms of the condition, is not effective in one-third of the patient group and the side effects of the medication can be severe and debilitating. In recent years, a number of pathophysiological processes have been identified in groups of people with schizophrenia including oxidative stress, one-carbon metabolism and immune-mediated responses. A number of studies have shown that these altered physiological mechanisms can be ameliorated by nutritional interventions in some individuals with schizophrenia. This review briefly describes the aforementioned processes and outlines research that has investigated the utility of nutritional approaches as an adjunct to anti-psychotic medication including antioxidant and vitamin B supplementation, neuroprotective and anti-inflammatory nutrients and exclusion diets. Whilst none of these interventions provides a 'one-size-fits-all' therapeutic solution, we suggest that a personalised approach warrants research attention as there is growing agreement that schizophrenia is a spectrum disorder that develops from the interplay between environmental and genetic factors.
Makhlouf, Mona; Dahaba, Mushira M; Tunér, Jan; Eissa, Sohair A; Harhash, Tarek A-H
2012-03-01
The aim of this split-mouth, double blinded, short-term, controlled clinical trial was to study the effect of low-level laser therapy (LLLT) as an adjunct to scaling and root planing (SRP) for treatment of chronic periodontitis. LLLT is reported to improve the outcome of traditional SRP, but the evidence is still weak. Sixteen patients with a probing pocket depth (PPD) of 4-6 mm involving at least three teeth in each quadrant were recruited for the study. Afterwards, SRP quadrants were randomly assigned for 10 sessions of LLLT. Results showed that when compared to sites treated with SRP alone, those treated with SRP+LLLT (10 sessions, 830 nm, 100 mW, 3 J per point, 3 J/cm(2)) exhibited greater reductions in PPD at 5 weeks and 3 months but not at 6 months. Further, SRP+LLLT-treated sites had a statistically significant increase in mean radiographic bone density when comparing 6- and 12-month data and overall from baseline to 12 months. There was a trend to reduce interleukin (IL)-1β but the difference between control and laser sites was not statistically significant. SRP combined with LLLT improved radiographic bone density and short-term PPD reduction in patients with chronic periodontitis, but did not significantly affect either the gingival crevicular fluid of IL-1β or the gingival or plaque index.
Li, Mouduo; Qiao, Cuixia; Qin, Liping; Zhang, Junyong; Ling, Changquan
2012-09-01
To investigate the application of Traditional Chinese Medicine Injections (TCMIs) for treatment of primary liver cancer (PLC). A literature review was conducted using PubMed/Medline, Cochrane Library Controlled Clinical Trials Database, China National Knowledge Infrastructure (CNKI), China Scientific Journal Database (CSJD) and China Biology Medicine (CBM). Online websites including journal websites and databases of ongoing trials, as well as some Traditional Chinese Medicine journals that are not indexed in the electronic databases were also searched. as adjunctive medication for the treatment of PLC could regulate patient immunity, reduce bone marrow suppression, relieve clinical symptoms, and improve quality of life, as well as control disease progression and prolong survival time. Within the limitations of this review, we conclude that application of TCMIs as adjunctive medication may provide benefits for patients with PLC. Further large, high-quality trials are warranted.
Askovic, Mirjana; Watters, Anna J; Aroche, Jorge; Harris, Anthony W F
2017-08-01
The objective of this study was to describe the use of neurofeedback for refugee-related chronic posttraumatic stress disorder (PTSD) in two case studies. We describe the assessment and application of neurofeedback integrated into the treatment of two clients with chronic PTSD. We include details of our treatment schedule, symptoms and quantitative electrophysiological data for each case. Results All clients achieved significant reduction in symptoms of PTSD and improvement in daily functioning post-neurofeedback therapy. Quantitative electroencephalogric (EEG) measures indicate a normalisation of EEG markers relating to trauma, including overarousal at rest and working memory function. Conclusions Neurofeedback as an adjunct to trauma-informed therapy may help to remediate chronic PTSD relating to refugee experiences. If replicated then improvements demonstrated in this population would be generalisable to all chronic PTSD.
Development of perampanel in epilepsy.
Satlin, A; Kramer, L D; Laurenza, A
2013-01-01
Alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA)-type glutamate receptors play a key role in mediating glutamatergic transmission in the cortex. Perampanel (2-[2-oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl] benzonitrile) is a potent, orally active, highly selective, non-competitive AMPA-type glutamate receptor antagonist, identified via a focused discovery program at Eisai Research Laboratories. Development of perampanel as adjunctive therapy for the treatment of partial-onset seizures was planned in keeping with regulatory guidance and guidelines on antiepileptic drug (AED) development. This is the first AED with a specific action on glutamate-mediated excitatory neurotransmission to show evidence of efficacy and tolerability in reducing treatment-refractory partial-onset seizures in Phase III clinical trials. Perampanel (Fycompa(®)) has been approved in the EU and the United States for adjunctive treatment of partial-onset seizures. © 2013 John Wiley & Sons A/S.
Piezocision as an adjunct to orthodontic treatment of unilateral posterior crossbite
Bakathir, Manal A.; Hassan, Ali H.; Bahammam, Maha A.
2017-01-01
Piezocision (corticotomy) is a minimally invasive approach that involves micro-incisions, piezoelectric incisions, and selective tunnelling for soft or hard tissue grafting. Piezocision has many uses in orthodontics, but its uses in cross-bite cases are limited. This case report illustrates the outcomes of a 19-year-old female patient with unilateral cross-bite that was treated with a minimally invasive piezocision with bone grafting in the affected side. In addition, she also had a functional shift, severe crowding, and mid-line shift. Therefore, the shift was eliminated using a quad helix expansion, she was treated with a fixed appliance, and a bimaxillary extraction of the first premolars was performed. The patient followed-up at 18 months, and the occlusion was stable with a pleasant profile. Piezocision can be used as an adjunct to the orthodontic treatment of adults to facilitate the treatment of complicated cases. PMID:28397951
Dysphagia in Stroke: A New Solution
Langdon, Claire; Blacker, David
2010-01-01
Dysphagia is extremely common following stroke, affecting 13%–94% of acute stroke sufferers. It is associated with respiratory complications, increased risk of aspiration pneumonia, nutritional compromise and dehydration, and detracts from quality of life. While many stroke survivors experience a rapid return to normal swallowing function, this does not always happen. Current dysphagia treatment in Australia focuses upon prevention of aspiration via diet and fluid modifications, compensatory manoeuvres and positional changes, and exercises to rehabilitate paretic muscles. This article discusses a newer adjunctive treatment modality, neuromuscular electrical stimulation (NMES), and reviews the available literature on its efficacy as a therapy for dysphagia with particular emphasis on its use as a treatment for dysphagia in stroke. There is a good theoretical basis to support the use of NMES as an adjunctive therapy in dysphagia and there would appear to be a great need for further well-designed studies to accurately determine the safety and efficacy of this technique. PMID:20721336
NASA Astrophysics Data System (ADS)
Cruz, Raul M.; Izdebski, Krzysztof; Yan, Yuling
2012-02-01
Recurrent Respiratory Papillomatosis (RRP) is a devastating disorder- especially in a performing professional voice user. The mainstay of treatment is based on immaculate serial removal of regrowing papillomas, usually with a laser. Repetitive laser excisions can cause significant scarring and webbing. The risks of post-operative sequela are exponentially increased with anterior location of papilloma clusters. The resultant dysphonia is not amenable to physiological voice therapy protocols. Additional or adjunctive treatments are eagerly sought by patients to avoid complications. Many of these treatments remain unproven. Recently, bevacizumab (Avastin) has been advocated as potentially useful. Consequently, we report a case treated with KTP lasering of papillomas with adjunctive intralesional bevacizumab injections. Current outcome of the case is analyzed with both traditional LVS and High Speed Digital Imaging (HSDI).
Treatment of tension-type headache: from old myths to modern concepts.
Barbanti, P; Egeo, G; Aurilia, C; Fofi, L
2014-05-01
Tension-type headache (TTH) is the second most common human disease, accounting for intense disability, high costs and numerous workdays lost. Tension-type headache is less simple and easy-to-treat than commonly thought. Antidepressants, despite their poor tolerability, are still the first-choice drugs for preventing TTH. The most widely studied non-pharmacological approach to TTH, cognitive-behavioral techniques, effectively relieve pain only in selected patients. The most frequently used and recommended treatments for acute TTH, NSAIDs and paracetamol have scarce efficacy as documented by their low therapeutic gain over placebo in the 2-h pain-free response. Their effectiveness may be increased by a more proper use and by the adjunction of caffeine, antiemetics, myorelaxants or tranquillizers but the risk of medication-overuse headache must be considered. Hence, the need for more effective and tailored treatments in TTH remains.
Desai, Rajen U; Singh, Kuldev; Lin, Shan C
2013-03-01
To determine the safety and efficacy of intravitreal ranibizumab therapy before and after Ahmed tube insertion for open-angle glaucoma as a means of optimizing postoperative intraocular pressure control. Randomized, controlled trial. Open-angle glaucoma patients scheduled for Ahmed tube insertion, randomized to ranibizumab or control groups. Ranibizumab (0.5 mg in 0.05 mL) was administered intravitreally at three time points: 9 days prior to surgery, 1 month post-surgery and 2 months post-surgery. Control patients underwent the same procedure without ranibizumab. Success at 6 months postoperatively was defined as intraocular pressure <18 mmHg with no adjunctive medications or intraocular pressure <15 mmHg with one adjunctive medication. The study and control arms included six and five subjects, respectively, with four in each arm undergoing combined cataract surgery. In the ranibizumab arm, the preoperative and postoperative intraocular pressure/medication usage was 21.0 ± 6.7 mmHg on 3.2 ± 1.5 medications and 14.7 ± 1.9 mmHg on 0.5 ± 0.8 medications, respectively. In the control arm, preoperative and postoperative intraocular pressure/medication usage was 18.8 ± 3.8 mmHg on 2.8 ± 1.3 medications and 16.2 ± 3.6 mmHg with 1.8 ± 1.6 medications, respectively. Success was achieved in 83% of subjects in the ranibizumab group compared with 40% in the control group (two-tailed Fisher's exact test, P = 0.24). The findings from this small pilot comparative study suggest that intravitreal ranibizumab use may be a safe and potentially effective adjunctive treatment modality in improving success after Ahmed tube placement. © 2012 The Authors. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists.
Digital health intervention as an adjunct to a workplace health program in hypertension.
Senecal, Conor; Widmer, R Jay; Johnson, Matthew P; Lerman, Lilach O; Lerman, Amir
2018-05-30
Hypertension is a common and difficult-to-treat condition; digital health tools may serve as adjuncts to traditional pharmaceutical and lifestyle-based interventions. Using a retrospective observational study we sought to evaluate the effect of a desktop and mobile digital health intervention (DHI) as an adjunct to a workplace health program in those previously diagnosed with hypertension. As part of a workplace health program, 3330 patients were identified as previously diagnosed with hypertension. A DHI was made available to participants providing motivational and educational materials assisting in the management of hypertension. We evaluated changes in blood pressure, weight, and body mass index (BMI) between users and nonusers based on login frequency to the DHI using multivariate regression through the five visits over the course of 1 year. One thousand six hundred twenty-two (49%) participants logged into the application at least once. DHI users had significant greater improvements in systolic blood pressure (SBP; -2.79 mm Hg), diastolic blood pressure (-2.12 mm Hg), and BMI (-0.23 kg/m 2 ) at 1 year. Increased login frequency was significantly correlated with reductions in SBP, diastolic blood pressure, weight, and BMI (P ≤ .014). This large, observational study provides evidence that a DHI as an adjunct to a workplace health program is associated with greater improvement in blood pressure and BMI at 1 year. This study adds to the growing body of evidence that DHIs may be useful in augmenting the treatment of hypertension in addition to traditional management with pharmaceuticals and lifestyle changes. Copyright © 2018 American Heart Association. Published by Elsevier Inc. All rights reserved.
Juvenile Fibromyalgia: A Multidisciplinary Approach to Treatment.
Tesher, Melissa S
2015-06-01
A 14-year-old boy presented with months of severe widespread musculoskeletal pain. He was profoundly fatigued and unable to attend school. Laboratory evaluation, including complete blood count, comprehensive metabolic panel, inflammatory markers, and thyroid function, was unrevealing. Physical examination was also normal except for multiple tender points. The patient was diagnosed with juvenile primary fibromyalgia syndrome and referred for multidisciplinary treatment including physical therapy, exercise, and counseling, and his daily functioning gradually improves. Juvenile fibromyalgia is a complex syndrome that often severely limits patients' activities and can impede normal adolescent development. Effective treatment requires an understanding of the biologic, psychologic, and social factors contributing to the perpetuation of chronic pain. The author reviews the diagnostic criteria, pathophysiology, and treatment of juvenile fibromyalgia. Medications, particularly antidepressants and anticonvulsants, can be useful adjuncts to therapy. However, multimodal pain management including intensive physical therapy, exercise, counseling, and sleep hygiene is most effective in treating fibromyalgia. Copyright 2015, SLACK Incorporated.
Coussens, Anna K.; Wilkinson, Robert J.; Martineau, Adrian R.
2015-01-01
Adjunctive vitamin D treatment for pulmonary tuberculosis enhances resolution of inflammation but has modest effects on bacterial clearance. Sodium 4-phenylbutyrate (PBA) is in clinical use for a range of conditions and has been shown to synergise with vitamin D metabolites to upregulate cathelicidin antimicrobial peptide (CAMP) expression. We investigated whether clinically attainable plasma concentrations of PBA (0.4-4mM) directly affect Mycobacterium tuberculosis (Mtb) growth and human macrophage and PBMC response to infection. We also tested the ability of PBA to enhance the immunomodulatory actions of the vitamin D metabolite 25(OH)D3 during infection and synergistically inhibit intracellular Mtb growth. PBA inhibited Mtb growth in broth with an MIC99 of 1mM, which was reduced to 0.25mM by lowering pH. During human macrophage infection, PBA treatment restricted Mtb uptake, phagocytic receptor expression and intracellular growth in a dose-dependent manner. PBA independently regulated CCL chemokine secretion and induced expression of the antimicrobial LTF (lactoferrin), the anti-inflammatory PROC (protein C) and multiple genes within the NLRP3 inflammasome pathway. PBA co-treatment with 25(OH)D3 synergistically modulated expression of numerous vitamin D-response genes, including CAMP, CYP24A1, CXCL10 and IL-37. This synergistic effect was dependent on MAPK signalling, while the effect of PBA on LTF, PROC and NLRP3 was MAPK-independent. During PBA and 25(OH)D3 co-treatment of human macrophages, in the absence of exogenous proteinase 3 (PR3) to activate cathelicidin, Mtb growth restriction was dominated by the effect of PBA, while the addition of PR3 enhanced growth restriction by 25(OH)D3 and PBA co-treatment. This suggests that PBA augments vitamin D–mediated cathelicidin-dependent Mtb growth restriction by human macrophages and independently induces antimicrobial and anti-inflammatory action. Therefore through both host-directed and bacterial-directed mechanisms PBA and vitamin D may prove an effective combinatorial adjunct therapy for tuberculosis to both resolve immunopathology and enhance bacterial clearance. PMID:26133770
Coussens, Anna K; Wilkinson, Robert J; Martineau, Adrian R
2015-07-01
Adjunctive vitamin D treatment for pulmonary tuberculosis enhances resolution of inflammation but has modest effects on bacterial clearance. Sodium 4-phenylbutyrate (PBA) is in clinical use for a range of conditions and has been shown to synergise with vitamin D metabolites to upregulate cathelicidin antimicrobial peptide (CAMP) expression. We investigated whether clinically attainable plasma concentrations of PBA (0.4-4 mM) directly affect Mycobacterium tuberculosis (Mtb) growth and human macrophage and PBMC response to infection. We also tested the ability of PBA to enhance the immunomodulatory actions of the vitamin D metabolite 25(OH)D3 during infection and synergistically inhibit intracellular Mtb growth. PBA inhibited Mtb growth in broth with an MIC99 of 1 mM, which was reduced to 0.25 mM by lowering pH. During human macrophage infection, PBA treatment restricted Mtb uptake, phagocytic receptor expression and intracellular growth in a dose-dependent manner. PBA independently regulated CCL chemokine secretion and induced expression of the antimicrobial LTF (lactoferrin), the anti-inflammatory PROC (protein C) and multiple genes within the NLRP3 inflammasome pathway. PBA co-treatment with 25(OH)D3 synergistically modulated expression of numerous vitamin D-response genes, including CAMP, CYP24A1, CXCL10 and IL-37. This synergistic effect was dependent on MAPK signalling, while the effect of PBA on LTF, PROC and NLRP3 was MAPK-independent. During PBA and 25(OH)D3 co-treatment of human macrophages, in the absence of exogenous proteinase 3 (PR3) to activate cathelicidin, Mtb growth restriction was dominated by the effect of PBA, while the addition of PR3 enhanced growth restriction by 25(OH)D3 and PBA co-treatment. This suggests that PBA augments vitamin D-mediated cathelicidin-dependent Mtb growth restriction by human macrophages and independently induces antimicrobial and anti-inflammatory action. Therefore through both host-directed and bacterial-directed mechanisms PBA and vitamin D may prove an effective combinatorial adjunct therapy for tuberculosis to both resolve immunopathology and enhance bacterial clearance.
Biedermann, Falko; Fleischhacker, W Wolfgang; Kemmler, Georg; Ebenbichler, Christoph F; Lechleitner, Monika; Hofer, Alex
2014-05-01
Weight gain represents a frequent side effect of antipsychotic drug treatment. The current trial investigated the effect of add-on treatment with sibutramine in schizophrenia outpatients who had gained more than 7% of weight during the course of treatment. This 24-week placebo-controlled study evaluated the effects of sibutramine added to ongoing antipsychotic treatment. Weight, waist-hip ratio, BMI, blood pressure/pulse and ECG were monitored regularly. In addition, several laboratory tests were performed. Psychopathological symptoms and side effects were assessed frequently. Fifteen patients were assigned randomly to add-on treatment with sibutramine 10 mg or placebo. The two groups did not differ in weight, sociodemographic, or clinical data. Eleven patients were considered for statistical analysis. Significant weight loss was observed in the sibutramine group (mean = -6.1 kg), whereas patients on placebo experienced a mean weight gain of 1.9 kg. A reduction in HbA1c was apparent in the sibutramine but not in the placebo group. No significant between-group differences were found in changes in psychopathology or drug safety. This pilot trial suggests that adjunctive treatment with sibutramine may be safe and effective in schizophrenic patients with antipsychotic-induced weight gain.
Mandel, David R; Eichas, Katy; Holmes, Judith
2010-01-12
Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. ACTRN12609000435280.
2010-01-01
Background Lactic acid-producing bacteria (LAB) probiotics demonstrate immunomodulating and anti-inflammatory effects and the ability to lessen the symptoms of arthritis in both animals and humans. This randomized, double-blind, placebo-controlled, parallel-design, clinical pilot trial was conducted to evaluate the effects of the LAB probiotic preparation, Bacillus coagulans GBI-30, 6086, on symptoms and measures of functional capacity in patients with rheumatoid arthritis (RA) in combination with pharmacological anti-arthritic medications. Methods Forty-five adult men and women with symptoms of RA were randomly assigned to receive Bacillus coagulans GBI-30, 6086 or placebo once a day in a double-blind fashion for 60 days in addition to their standard anti-arthritic medications. Arthritis activity was evaluated by clinical examination, the American College of Rheumatology (ACR) criteria, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI), and laboratory tests for erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Results Subjects who received Bacillus coagulans GBI-30, 6086 experienced borderline statistically significant improvement in the Patient Pain Assessment score (P = .052) and statistically significant improvement in Pain Scale (P = .046) vs placebo. Compared with placebo, Bacillus coagulans GBI-30, 6086 treatment resulted in greater improvement in patient global assessment and self-assessed disability; reduction in CRP; as well as the ability to walk 2 miles, reach, and participate in daily activities. There were no treatment-related adverse events reported throughout this study. Conclusions Results of this pilot study suggest that adjunctive treatment with Bacillus coagulans GBI-30, 6086 LAB probiotic appeared to be a safe and effective for patients suffering from RA. Because of the low study population size, larger trials are needed to verify these results. Trial registration ACTRN12609000435280 PMID:20067641
Kucyi, Aaron; Alsuwaidan, Mohammad T; Liauw, Samantha S; McIntyre, Roger S
2010-11-01
Neurocognitive dysfunction associated with bipolar disorder (BD) is pervasive, persistent across illness phases, and is demonstrated to predispose and portend psychosocial impairment. Moreover, no approved therapies for various phases of BD have been shown to reliably improve any dimension of neurocognitive performance. In this article, we emphasize that aerobic physical exercise is a viable neurocognitive-enhancing adjunctive treatment for patients with BD. The overarching aim of this review is to emphasize that aerobic physical exercise is a viable neurocognitive-enhancing adjunctive treatment for patients with BD. We conducted PubMed and Google Scholar searches of all English-language articles published between January 1966 and February 2010 using the search terms bipolar disorder, major depressive disorder, depression, exercise, and physical activity cross-referenced with each other and the following terms: cognition, executive function, learning, memory, attention, emotion, and behavior. Articles selected for review were based on adequacy of sample size, use of standardized experimental procedures, validated assessment measures, and overall quality. Available studies have documented an array of persisting neurocognitive deficits across disparate bipolar populations. Abnormalities in verbal working memory are highly replicated; deficits in executive function, learning, attention, and processing speed are also a consistent abnormality. The effect sizes of neurocognitive deficits in BD are intermediate between those reported in schizophrenia and major depressive disorder. Several original reports and reviews have documented the neurocognitive-enhancing effects of aerobic exercise in the general population as well as across diverse medical populations and ages. Proposed mechanisms involve nonexclusive effects on neurogenesis, neurotrophism, immunoinflammatory systems, insulin sensitivity, and neurotransmitter systems. Each of these effector systems are implicated in both normal and abnormal neurocognitive processes in BD. Available evidence provides a rationale for empirically evaluating the neurocognitive benefits of aerobic exercise in BD.
Randomized controlled trial of zonisamide for the treatment of refractory partial-onset seizures.
Faught, E; Ayala, R; Montouris, G G; Leppik, I E
2001-11-27
Zonisamide is a sulfonamide antiepilepsy drug with sodium and calcium channel-blocking actions. Experience in Japan and a previous European double-blind study have demonstrated its efficacy against partial-onset seizures. A randomized, double-blind, placebo-controlled trial enrolling 203 patients was conducted at 20 United States sites to assess zonisamide efficacy and dose response as adjunctive therapy for refractory partial-onset seizures. Zonisamide dosages were elevated by 100 mg/d each week. The study design allowed parallel comparisons with placebo for three dosages and a final crossover to 400 mg/d of zonisamide for all patients. The primary efficacy comparison was change in seizure frequency from a 4-week placebo baseline to weeks 8 through 12 on blinded therapy. At 400 mg/d, zonisamide reduced the median frequency of all seizures by 40.5% from baseline, compared with a 9% reduction (p = 0.0009) with placebo treatment, and produced a > or =50% seizure reduction (responder rate) in 42% of patients. A dosage of 100 mg/d produced a 20.5% reduction in median seizure frequency (p = 0.038 compared with placebo) and a dosage of 200 mg/d produced a 24.7% reduction in median seizure frequency (p = 0.004 compared with placebo). Dropouts from adverse events (10%) did not differ from placebo (8.2%, NS). The only adverse event differing significantly from placebo was weight loss, though somnolence, anorexia, and ataxia were slightly more common with zonisamide treatment. Serum zonisamide concentrations rose with increasing dose. Zonisamide is effective and well tolerated as an adjunctive agent for refractory partial-onset seizures. The minimal effective dosage was 100 mg/d, but 400 mg/d was the most effective dosage.
Evaluation of synergistic activity of bovine lactoferricin with antibiotics in corneal infection.
Oo, Thein Zaw; Cole, Nerida; Garthwaite, Linda; Willcox, Mark D P; Zhu, Hua
2010-06-01
The objectives of this study were to determine whether a synergistic effect could be obtained in vitro between bovine lactoferricin (B-LFcin) and antibiotics against Pseudomonas aeruginosa and Staphylococcus aureus isolates from ocular infections, and to evaluate the use of B-LFcin as an adjunct to the antibiotic treatment of corneal infection in vivo. Chequerboard and time-kill assays were performed to investigate the combined effects of B-LFcin and conventional antibiotics, including ciprofloxacin, ceftazidime and gentamicin, against 17 strains of P. aeruginosa (8) and S. aureus (9) isolated from ocular infection and inflammation, and 1 reference strain of S. aureus. Corneas of C57BL/6 mice were topically challenged with a multidrug-resistant strain of P. aeruginosa. Nine hours post-challenge, mice were treated topically and hourly with either vehicle, B-LFcin, ciprofloxacin or ciprofloxacin containing B-LFcin for 8 h. Corneas were then clinically examined, and bacterial numbers and levels of myeloperoxidase (MPO) evaluated. Synergy between B-LFcin and ciprofloxacin or ceftazidime was identified in most P. aeruginosa isolates, including multidrug-resistant strains, whereas no synergistic effect was seen between B-LFcin and gentamicin. Synergy was only observed with B-LFcin and ciprofloxacin against 2/10 S. aureus strains, and there was no synergy between B-LFcin and any of the other antibiotics tested. Combined B-LFcin and ciprofloxacin treatment significantly improved the clinical outcome, and reduced bacterial numbers and MPO in infected mouse corneas. B-LFcin alone was also able to reduce levels of MPO in infected corneas. These findings indicate that B-LFcin may have advantages as an adjunct therapy with both antimicrobial and anti-inflammatory properties in the treatment of corneal infection.
Photodynamic application in neurosurgery: present and future
NASA Astrophysics Data System (ADS)
Kostron, Herwig
2009-06-01
Photodynamic techniques such as photodynamic diagnosis (PDD), fluorescence guided tumor resection (FGR) and photodynamic therapy (PDT) are currently undergoing intensive clinical investigations as adjunctive treatment for malignant brain tumours. This review provides an overview on the current clinical data and trials as well as on photosensitisers, technical developments and indications for photodynamic application in Neurosurgery. Furthermore new developments and clinical significance of FGR for neurosurgery will be discussed. Over 1000 patients were enrolled in various clinical phase I/II trials for PDT for malignant brain tumours. Despite various treatment protocols, variation of photosensitisers and light dose there is a clear trend towards prolonging median survival after one single PDT as compared to conventional therapeutic modalities. The median survival after PDT for primary glioblastoma multiforme WHO IV was 19 months and for recurrent GBM 9 months as compared to standard convential treatment which is 15 months and 3 months, respectively. FGR in combination with adjunctive radiation was significantly superior to standard surgical resection followed by radiation. The combination of FGR/PDD and intraoperative PDT increased significantly survival in recurrent glioblastoma patients. The combination of PDD/ FGR and PDT offers an exciting approach to the treatment of malignant brain tumours "to see and to treat." PDT was generally well tolerated and side effects consisted of occasionally increased intracranial pressure and prolonged skin sensitivity against direct sunlight. This review covers the current available data and draws the future potential of PDD and PDT for its application in neurosurgery.
West, Amy E; Weinstein, Sally M; Peters, Amy T; Katz, Andrea C; Henry, David B; Cruz, Rick A; Pavuluri, Mani N
2014-11-01
Previous studies have found that family-based psychosocial treatments are effective adjuncts to pharmacotherapy among adults and adolescents with bipolar disorder (BD). The objective of this study was to compare the efficacy of adjunctive child- and family-focused cognitive-behavioral therapy (CFF-CBT) to psychotherapy as usual (control) for mood symptom severity and global functioning in children with BD. Sixty-nine youth, aged 7 to 13 years (mean = 9.19, SD = 1.61) with DSM-IV-TR bipolar I, II, or not otherwise specified (NOS) disorder were randomly assigned to CFF-CBT or control groups. Both treatments consisted of 12 weekly sessions followed by 6 monthly booster sessions delivered over a total of 9 months. Independent evaluators assessed participants at baseline, week 4, week 8, week 12 (posttreatment), and week 39 (6-month follow-up). Participants in CFF-CBT attended more sessions, were less likely to drop out, and reported greater satisfaction with treatment than controls. CFF-CBT demonstrated efficacy compared to the control treatment in reducing parent-reported mania at posttreatment and depression symptoms at posttreatment and follow-up. Global functioning did not differ at posttreatment but was higher among CFF-CBT participants at follow-up. CFF-CBT may be efficacious in reducing acute mood symptoms and improving long-term psychosocial functioning among children with BD. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.