[Mirtazapine versus other antidepressive agents for depression].

PubMed

Knud Larsen, Jens

2012-11-12

A Cochrane analysis compared efficacy and side effects of mirtazapine with other antidepressants. After six weeks of treatment no reliable difference of efficacy between mirtazapine, selective serotonin reuptake inhibitors (SSRI), noradrenaline reuptake inhibitors or tricyclic antidepressants was found. The side effects like increased sleep and weight gain were compared by treatment with mirtazapine and treatment with SSRI antidepressants. The very fact of the sleep effect and the fast onset of action have probably increased the effect size compared with SSRI antidepressants. The results of the Cochrane analysis cannot for certain be generalized to inpatients, as other studies have found tricyclic antidepressants to be especially effective.

Efficacy and safety of prophylactic levetiracetam in supratentorial brain tumour surgery: a systematic review and meta‐analysis

PubMed Central

Tsaousi, Georgia; Apostolidou, Eirini; Karakoulas, Konstantinos; Kouvelas, Dimitrios; Amaniti, Ekaterini

2016-01-01

Aims The aim of this study was to perform an up‐to‐date systematic review and meta‐analysis on the efficacy and safety of prophylactic administration of levetiracetam in brain tumour patients. Method A systematic review of studies published until April 2015 was conducted using Scopus/Elsevier, EMBASE and MEDLINE. The search was limited to articles reporting results from adult patients, suffering from brain tumour, undergoing supratentorial craniotomy for tumour resection or biopsy and administered levetiracetam in the perioperative period for seizure prophylaxis. Outcomes included the efficacy and safety of levetiracetam, as well as the tolerability of the specific regimen, defined by the discontinuation of the treatment due to side effects. Results The systematic review included 1148 patients from 12 studies comparing levetiracetam with no treatment, phenytoin and valproate, while only 243 patients from three studies, comparing levetiracetam vs phenytoin efficacy and safety, were included in the meta‐analysis. The combined results from the meta‐analysis showed that levetiracetam administration was followed by significantly fewer seizures than treatment with phenytoin (OR = 0.12 [0.03–0.42]: χ2 = 1.76: I2 = 0%). Analysis also showed significantly fewer side effects in patients receiving levetiracetam, compared to other groups (P < 0.05). The combined results showed fewer side effects in the levetiracetam group compared to the phenytoin group (OR = 0.65 [0.14–2.99]: χ2 = 8.79: I2 = 77%). Conclusions The efficacy of prophylaxis with levetiracetam seems to be superior to that with phenytoin and valproate administration. Moreover, levetiracetam use demonstrates fewer side effects in brain tumour patients. Nevertheless, high risk of bias and moderate methodological quality must be taken into account when considering these results. PMID:26945547

The Effects of Augmented Reality-based Otago Exercise on Balance, Gait, and Falls Efficacy of Elderly Women.

PubMed

Yoo, Ha-Na; Chung, Eunjung; Lee, Byoung-Hee

2013-07-01

[Purpose] The purpose of this study was to determine the effects of augmented reality-based Otago exercise on balance, gait, and falls efficacy of elderly women. [Subjects] The subjects were 21 elderly women, who were randomly divided into two groups: an augmented reality-based Otago exercise group of 10 subjects and an Otago exercise group of 11 subjects. [Methods] All subjects were evaluated for balance (Berg Balance Scale, BBS), gait parameters (velocity, cadence, step length, and stride length), and falls efficacy. Within 12 weeks, Otago exercise for muscle strengthening and balance training was conducted three times, for a period of 60 minutes each, and subjects in the experimental group performed augmented reality-based Otago exercise. [Results] Following intervention, the augmented reality-based Otago exercise group showed significant increases in BBS, velocity, cadence, step length (right side), stride length (right side and left side) and falls efficacy. [Conclusion] The results of this study suggest the feasibility and suitability of this augmented reality-based Otago exercise for elderly women.

Assessment of the efficacy and safety of a combination of 2 topical retinoids (RetinSphere) in maintaining post-treatment response of acne to oral isotretinoin.

PubMed

Truchuelo, M T; Jiménez, N; Mavura, D; Jaén, P

2015-03-01

The high rate of relapse of acne lesions following oral isotretinoin treatment is a common problem which remains unsolved. To avoid or minimize relapses, topical retinoids have been used for many years as maintenance treatment. However, adverse effects frequently occur. To determine the efficacy and safety of a new retinoid combination (Retinsphere technology) in maintaining post-treatment response to oral isotretinoin. Prospective, randomized, double-blind and vehicle-controlled study of 30 patients with acne previously treated with isotretinoin. Treatment with the retinoid combination was applied to one side of the face and vehicle was applied to the other, once daily, for 3 months. Standardized photographs were taken using RBX technology at baseline, 1.5 months and 3 months. The primary efficacy endpoint was the appearance of relapse on the treated side compared to the vehicle-treated side. Other endpoints included lesion count, investigator-reported improvement, patient-reported improvement, impact on quality-of-life, and side effects. Although the majority of patients did not reach the total target dose of oral isotretinoin, the relapse rate was significantly lower on the retinoid-treated side compared to the vehicle-treated side. Likewise, improved lesion count and excellent tolerance were observed. This new retinoid combination (Retinsphere technology) were effective and safe as maintenance therapy after post-treatment response to oral isotretinoin in patients with acne. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

Perceptions on efficacy and side effects of conventional depot antipsychotics (CDA) and atypical depot antipsychotics (ADA): Psychiatrists versus patients in Hong Kong.

PubMed

Tsang, Hector W H; Fong, Mandy W M; Fung, Kelvin M T; Chung, Raymond C K

2010-03-01

Abstract Objectives. We compared the satisfaction level of psychiatrists and psychiatric patients towards conventional (CDA) and atypical (ADA) depot antipsychotics on symptom management, role functioning, and side effects. Method. Patients from an out-patient clinic of a public hospital and psychiatrists from public hospitals participated in the survey in 2007-2008. A total of 153 patients were interviewed by a tailor-made questionnaire and 72 psychiatrists self-administered a similar questionnaire. Results. Both groups shared similar attitudes towards clinical effectiveness and treatment efficacy of ADA and CDA. More patients were ambivalent towards relapse prevention of CDA than psychiatrists (30.7 vs. 16.7%, P<0.044) and three quarters of psychiatrists believed that ADA are associated with less side effects. More than half of the patients showed negative attitudes towards the effectiveness of CDA on improving quality of life (52.40%), work (57.50%), and recreation (55.50%). Psychiatrists were more aware of the limitation of CDA and severity of side effects of CDA. They did not, however, seem to incorporate patients' opinions and research findings into their clinical practice. Conclusion. Evidence-based practice and shared decision-making model between clinicians and mental patients should be advocated. More investigations should be devoted to examine the efficacy of ADA as the alternative to CDA.

Efficacy and side-effect profiles of lactulose, docusate sodium, and sennosides compared to PEG in opioid-induced constipation: a systematic review.

PubMed

Ruston, Teresa; Hunter, Kathleen; Cummings, Greta; Lazarescu, Adriana

2013-01-01

Opioid-induced constipation (OIC) is a side effect of opioid therapy that can affect quality of life, adherence to treatment, and morbidity and possibly mortality. To investigate whether docusate sodium, sennosides, and lactulose have equal efficacy and side effect profiles compared to PEG in the management of OIC in adults. A systematic review was undertaken. Randomized controlled trials of adults taking opioids for cancer or non-cancer pain were considered if they met inclusion criteria. Statistical pooling was not possible as no studies met inclusion criteria. Large, well-powered, randomized controlled trials are feasible. Standard definitions of OIC would assist with the execution of these studies and contribute to their internal and external validity. Further research is strongly encouraged.

[Initial experiences with amisulpride, an in Germany novel, atypical neuroleptic drug in treatment of adolescents with psychiatric disorders].

PubMed

Göpel, C; Marcus, A

2001-08-01

In addition to conventional antipsychotic drugs, during the past decade an increasing number of atypical neuroleptics has been introduced in the treatment of juvenile schizophrenic and schizoaffective disorders. In 1999 Germany legalized the benzamide amisulpride for the treatment of acute and chronic schizophrenic symptoms. Preliminary treatment results are reported here. Ten adolescent cases are presented with regard to the efficacy, side effects and dosage of amisulpride. Preliminary results on the use of amisulpride are promising. The rate of side effects is tolerable. Amisulprise seems to constitute a useful alternative in the treatment of juvenile schizophrenia for those who suffer from intolerable side effects of classical or atypical neuroleptics. Controlled studies are warranted to further clarify its efficacy and safety in the treatment of adolescents.

Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study.

PubMed

Tanglertsampan, Chuchai

2012-10-01

Topical minoxidil and oral finasteride have been used to treat men with androgenetic alopecia (AGA). There are concerns about side effects of oral finasteride especially erectile dysfunction. To compare the efficacy and safety of the 24 weeks application of 3% minoxidil lotion (MNX) versus combined 3% minoxidil and 0.1% finasteride lotion (MFX) in men with AGA. Forty men with AGA were randomized treated with MNX or MFX. Efficacy was evaluated by hair counts and global photographic assessment. Safety assessment was performed by history and physical examination. At week 24, hair counts were increased from baseline in both groups. However paired t-test revealed statistical difference only in MFX group (p = 0.044). Unpaired t-test revealed no statistical difference between two groups with respect to change of hair counts at 24 weeks from baseline (p = 0.503). MFX showed significantly higher efficacy than MNX by global photographic assessment (p = 0.003). There was no significant difference in side effects between both groups. Although change of hair counts was not statistically different between two groups, global photographic assessment showed significantly greater improvement in the MFX group than the MNX group. There was no sexual side effect. MFX may be a safe and effective treatment option.

Analysis of opioid efficacy, tolerance, addiction and dependence from cell culture to human.

PubMed

Morgan, Michael M; Christie, MacDonald J

2011-10-01

Opioid agonists are the most effective treatment for pain, but their use is limited by side effects, tolerance and fears of addiction and dependence. A major goal of opioid research is to develop agonists that have high analgesic efficacy and a low profile for side effects, tolerance, addiction and dependence. Unfortunately, there is a serious lack of experimental data comparing the degree to which different opioids produce these effects in humans. In contrast, a wide range of experimental techniques from heterologous expression systems to behaviour assessment in whole animals have been developed to study these problems. The objective of this review is to describe and evaluate these techniques as they are used to study opioid efficacy, tolerance, addiction and dependence. © 2011 The Authors. British Journal of Pharmacology © 2011 The British Pharmacological Society.

A Systematic Review and Meta-Analysis of Brief Versus Ultrabrief Right Unilateral Electroconvulsive Therapy for Depression.

PubMed

Tor, Phern-Chern; Bautovich, Alison; Wang, Min-Jung; Martin, Donel; Harvey, Samuel B; Loo, Colleen

2015-09-01

Electroconvulsive therapy (ECT) is an effective depression treatment, but it has potential cognitive side effects. Ultrabrief pulse (UBP) right unilateral (RUL) ECT is an increasingly used treatment option that can potentially combine efficacy with lesser cognitive side effects. However, current trials are underpowered or have conflicting results. A systematic review and meta-analysis was conducted to evaluate the relative efficacy and cognitive effects of brief pulse (BP) and UBP RUL ECT. MEDLINE, EMBASE, PsycINFO, CENTRAL, DARE, and the International Clinical Trials Registry Platform were searched with the search terms ECT, electroconvulsive therapy, electroconvulsive shock, electroconvulsive shock therapy, electrical stimulation, electroconvulsive combined with brief, ultra*, pulse, and trial in English, all fields including title, abstract, subject heading, and full text up to June 20, 2013, for studies comparing BP and UBP RUL ECT in depressed patients that reported formalized mood ratings for depression. Six studies met the inclusion criteria, comprising a total of 689 patients. Efficacy, cognitive, response, and remission outcomes were extracted from each publication or obtained directly from authors. BP RUL ECT was significantly more efficacious in treating depression than UBP RUL ECT (standardized mean difference = 0.25; 95% CI, 0.08–0.41; P = .004) but showed significantly more cognitive side effects in all cognitive domains examined (global cognition, anterograde learning and recall, retrograde memory) (P < .01). The mean number of treatment sessions given was 8.7 for BP ECT and 9.6 for UBP ECT (P < .001). UBP had a lower remission rate (OR = 0.71; 95% CI, 0.51–0.99; P = .045), with a number needed to treat of 12.1. BP compared with UBP RUL ECT was slightly more efficacious in treating depression and required fewer treatment sessions, but led to greater cognitive side effects. The decision of whether to use BP or UBP RUL ECT should be made on an individual patient basis and should be based on a careful weighing of the relative priorities of efficacy versus minimization of cognitive impairment.

Fractional ablative laser skin resurfacing: a review.

PubMed

Tajirian, Ani L; Tarijian, Ani L; Goldberg, David J

2011-12-01

Ablative laser technology has been in use for many years now. The large side effect profile however has limited its use. Fractional ablative technology is a newer development which combines a lesser side effect profile along with similar efficacy. In this paper we review fractional ablative laser skin resurfacing.

Development of Antidepressants as Novel Agents to Treat Small Cell Lung Cancer

DTIC Science & Technology

2015-10-01

in patients based on the recommendation of a psychiatrist that Desipramine would have fewer side - effects than Imipramine and on very early... side effects and no obvious efficacy, even though very few patients were treated), we re-examined the effects of Desipramine in vivo. This took a...imipramine (10mg/kg), Tretament with daily IP inejctions for 30 days at 10mg/kg did not lead to any obvious side effects in mice but did not have a

Emergency contraception: which is the best?

PubMed

Mittal, Suneeta

2016-12-01

Emergency contraception is a safe and effective method to prevent an unwanted pregnancy after an unprotected or inadequately protected sexual intercourse. Several methods for emergency contraception (EC) are currently registered in many countries for use in an emergency to prevent a pregnancy following an unprotected, possibly fertile intercourse or after a contraceptive accident like condom rupture. Different methods have varying modes of action, time frame of efficacy, dosage schedule and unwanted effects. Since several methods are available it is important to decide the best method. In this article the available literature on emergency contraception has been reviewed and an attempt has been made to discuss the need for emergency contraception and compare different options for emergency contraception in terms of their efficacy in pregnancy prevention, their safety profile and unwanted side effects. EC repeated use and initiating a regular method after EC use are also discussed. Emergency contraceptive methods include copper Intra-uterine devices (IUD) and different types of pills like estrogen progestin combination pill (Yuzpe Regimen), Progestin only pill (LNG), antiprogestin pill (Mifepristone), and progesterone modulator Uripristal Acetate (UPA). There is a marginal difference in the mechanism of action, efficacy including time frame and ability to protect from pregnancy with regular doses in obese women, drug interactions and side effects. These are discussed in detail. Copper IUD is the most effective emergency contraceptive with advantage of providing continued contraception. However, it cannot be used universally due to lack of infrastructure and a trained provider as well as not being suitable option for women at risk of sexually transmitted infections. Amongst different pills LNG is more effective with fewer side effects than Yuzpe regimen. LNG and UPA are comparable with similar efficacy and side effect profile. UPA has a wider window of efficacy, in LNG efficacy declines after 72 hours. UPA is more suitable for obese women. Mifepristone is effective but is registered as EC pill only in few countries and use is limited as it is also used as an abortion pill. Yuzpe regimen is the least effective of all contraceptive pills as EC, and works only till 72 hours of unprotected sex, but is useful in places where dedicated methods are not available, as it is easily accessible. Any combined pill can be used in this regimen except triphasic pill.

Increasing AR by HIF-2α inhibitor (PT-2385) overcomes the side-effects of sorafenib by suppressing hepatocellular carcinoma invasion via alteration of pSTAT3, pAKT and pERK signals

PubMed Central

Xu, Junjie; Zheng, Longbo; Chen, Jiang; Sun, Yin; Lin, Hui; Jin, Ren-an; Tang, Minyue; Liang, Xiao; Cai, Xiujun

2017-01-01

Although sorafenib is currently used as a standard treatment for advanced hepatocellular carcinoma, low response rate, transient and limited efficacy, primary and acquired resistance and negative side-effects gain increasing attentions, suggesting the need for better efficacious combination therapy. Here, we demonstrated that the sorafenib-induced or hypoxia-induced hypoxia inducible factor (HIF)-2α could bind to an hypoxia responsive element within 500 bp region of androgen receptor (AR) promoter and thus transcriptionally suppress AR. Importantly, In vitro and In vivo studies suggested a specific and potent HIF-2α inhibitor, PT-2385, could significantly enhance sorafenib efficacy by suppressing HIF-2α, increasing AR and suppressing downstream pSTAT3/pAKT/pERK pathways. Clinical samples further confirmed the role of HIF-2α and AR. It is promising that PT-2385 could alleviate the undesirable side-effects of sorafenib treatment by sorafenib-PT-2385 combination therapy, which may shed light for late-stage HCC patients. PMID:29022906

Increasing AR by HIF-2α inhibitor (PT-2385) overcomes the side-effects of sorafenib by suppressing hepatocellular carcinoma invasion via alteration of pSTAT3, pAKT and pERK signals.

PubMed

Xu, Junjie; Zheng, Longbo; Chen, Jiang; Sun, Yin; Lin, Hui; Jin, Ren-An; Tang, Minyue; Liang, Xiao; Cai, Xiujun

2017-10-12

Although sorafenib is currently used as a standard treatment for advanced hepatocellular carcinoma, low response rate, transient and limited efficacy, primary and acquired resistance and negative side-effects gain increasing attentions, suggesting the need for better efficacious combination therapy. Here, we demonstrated that the sorafenib-induced or hypoxia-induced hypoxia inducible factor (HIF)-2α could bind to an hypoxia responsive element within 500 bp region of androgen receptor (AR) promoter and thus transcriptionally suppress AR. Importantly, In vitro and In vivo studies suggested a specific and potent HIF-2α inhibitor, PT-2385, could significantly enhance sorafenib efficacy by suppressing HIF-2α, increasing AR and suppressing downstream pSTAT3/pAKT/pERK pathways. Clinical samples further confirmed the role of HIF-2α and AR. It is promising that PT-2385 could alleviate the undesirable side-effects of sorafenib treatment by sorafenib-PT-2385 combination therapy, which may shed light for late-stage HCC patients.

Clinical efficacy and safety of cisapride and clebopride in the management of chronic functional dyspepsia: a double-blind, randomized study.

PubMed

Sabbatini, F; Minieri, M; Manzi, G; Piai, G; D'Angelo, V; Mazzacca, G

1991-01-01

The clinical efficacy and the safety of chronic oral administration of cisapride, a new gastrointestinal prokinetic agent, (10 mg tid) and clebopride (0.5 mg tid) was assayed in 48 outpatients affected with functional dyspepsia, in a randomized double-blind study. Each of the drugs induced a significant reduction in dyspeptic symptoms after 2 and 4 weeks (p less than 0.001). Two patients, given clebopride, dropped out of the study because of severe side effects during the first week of treatment. Mild adverse reactions were reported in 6 out of 23 cisapride-treated patients and in 10 out of 20 clebopride-treated patients who completed the study. The most common side effect of cisapride was diarrhoea and that of clebopride was drowsiness. Cisapride appears to be as effective as clebopride in reducing dyspeptic symptoms and seems to induce less severe side effects.

Effect of relative head position on the anesthetic efficacy of inferior alveolar nerve block during endodontic treatment of patients with irreversible pulpitis.

PubMed

Aggarwal, Vivek; Singla, Mamta; Miglani, Sanjay

2018-02-01

The purpose of this prospective randomized single-blind clinical trial was to evaluate the effect of tilting the head on the anesthetic efficacy of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. Ninety-two patients were divided into two groups: the first group received IANB and the head was tilted in the direction of the block for 15 min, whereas the second group received IANB and the head was tilted to the opposite side. Access cavity preparation was initiated after 15 min. Success was defined as no pain or faint/weak/mild pain during endodontic access preparation and instrumentation. The anesthetic success rates were analyzed by Pearson chi-square test at 5% significance levels. The same side position and opposite side position yielded 41% and 30% anesthetic success rates, respectively; there was no significant difference between the two sides. Relative head position has no effect on the anesthetic success rate of IANB.

Effect of relative head position on the anesthetic efficacy of inferior alveolar nerve block during endodontic treatment of patients with irreversible pulpitis

PubMed Central

2018-01-01

Background The purpose of this prospective randomized single-blind clinical trial was to evaluate the effect of tilting the head on the anesthetic efficacy of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. Methods Ninety-two patients were divided into two groups: the first group received IANB and the head was tilted in the direction of the block for 15 min, whereas the second group received IANB and the head was tilted to the opposite side. Access cavity preparation was initiated after 15 min. Success was defined as no pain or faint/weak/mild pain during endodontic access preparation and instrumentation. The anesthetic success rates were analyzed by Pearson chi-square test at 5% significance levels. Results The same side position and opposite side position yielded 41% and 30% anesthetic success rates, respectively; there was no significant difference between the two sides. Conclusions Relative head position has no effect on the anesthetic success rate of IANB. PMID:29556558

Central nervous system side effects associated with zolpidem treatment.

PubMed

Toner, L C; Tsambiras, B M; Catalano, G; Catalano, M C; Cooper, D S

2000-01-01

Zolpidem is one of the newer medications developed for the treatment of insomnia. It is an imidazopyridine agent that is an alternative to the typical sedative-hypnotic agents. Zolpidem use is gaining favor because of its efficacy and its side effect profile, which is milder and less problematic than that of the benzodiazepines and barbiturates used to treat insomnia. Still, side effects are not uncommon with zolpidem use. We report a series of cases in which the patients developed delirium, nightmares and hallucinations during treatment with zolpidem. We will review its pharmacology, discuss previous reports of central nervous system side effects, examine the impact of drug interactions with concurrent use of antidepressants, examine gender differences in susceptibility to side effects, and explore the significance of protein binding in producing side effects.

Prophylactic Therapy for Hereditary Angioedema.

PubMed

Longhurst, Hilary; Zinser, Emily

2017-08-01

Long-term prophylaxis is needed in many patients with hereditary angioedema and poses many challenges. Attenuated androgens are effective in many but are limited by side effect profiles. There is less evidence for efficacy of tranexamic acid and progestagens; however, the small side effect profile makes tranexamic acid an option for prophylaxis in children and progestagens an option for women. C1 inhibitor is beneficial, but at present requires intravenous delivery and may need dose titration for maximum efficacy. Short-term prophylaxis should be considered for all procedures. New therapies are promising in overcoming many problems encountered with current options for long-term prophylaxis. Copyright © 2017 Elsevier Inc. All rights reserved.

Open-label trial of atomoxetine hydrochloride in adults with ADHD.

PubMed

Johnson, Mats; Cederlund, Mats; Råstam, Maria; Areskoug, Björn; Gillberg, Christopher

2010-03-01

While atomoxetine is an established treatment for attention-deficit/hyperactivity disorder in children, few studies have examined its efficacy for adults. Open-label trial of atomoxetine in 20 individuals with ADHD, aged 19-47 years, for 10 weeks, and a total of one year for responders. Ten patients met primary efficacy criteria at 10 weeks. Only one patient completed the whole study. Six patients discontinued before 10 weeks and thirteen at 10 weeks or later, mainly because of side-effects (aggression, depressed mood, raised liver enzymes, thyroid hormones, diastolic blood pressure), decreasing efficacy or non-compliance. Fifty percent responded to treatment, but only one patient (5%) felt sufficient improvement to continue for one year. Dosage may have been too low, and baseline impairment too high, for atomoxetine to have sufficient effect on ADHD symptoms in our group of adults. The majority had few side-effects, but several terminated treatment because of adverse effects.

Efficacy and side-effects of a semi-individualized Chinese herb mixture "Tiáo Gēng Tāng" for menopausal syndrome in China.

PubMed

Jia, Man; Kluwe, Lan; Liu, Hui-Cong; Tang, Qian-Jue; Liu, Lian; Wang, Zhen-Zhen; Tian, Li-Xia; Zhao, Li; Chen, Ying-Chao; Friedrich, Reinhard E; Sun, Zhuo-Jun; Xu, Lian-Wei

2015-01-01

Chinese herbal medicine is an alternative therapy for menopausal problems and is widely practiced in China and many other Asian countries. However, efficacies and side-effects are rarely assessed according to the standards of evidence-based medicine. This is a prospective observatory study following efficacy and side-effects of a semi-individualized Chinese herbal mixture "Tiáo Gēng Tāng (TGT)" in 30 patients for 3 months. Another group of 30 patients receiving hormone therapy with tibolone was included as a positive comparison. Common questionnaire-based measuring instruments were: modified Kupperman index, menopause rating scale, life quality and Chinese medical symptom scale (CMSS). Follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) were determined before and three months after the treatments. Significant improvement was seen in overall scores of all the four measurements in both groups. For some symptoms, including dry mouth, tinnitus, poor appetite and constipation, TGT was more effective than tibolone. For psychosocial and sexual sub-scales of life quality, tibolone has a slightly higher remedy rate than TGT. TGT lowered FSH and LH significantly, as tibolone did, but elevated E2 significantly less than tibolone. Various adverse events, including body weight increase, abdomen discomfort, nausea/vomiting, emotional instability, pressure in breasts and dizziness, were reported by patients treated with tibolone, whereas only diarrhea was observed in two patients treated with TGT. TGT alleviates menopausal symptoms with similar efficacy as tibolone but has fewer side effects. Copyright © 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

Efficacy and safety of novel antipsychotics: a critical review.

PubMed

Balestrieri, Matteo; Vampini, Claudio; Bellantuono, Cesario

2000-10-01

Efficacy and safety of novel antipsychotic (AP) drugs (amisulpride, olanzapine, quetiapine, ziprasidone and zotepine) have been reviewed. Data on their antipsychotic efficacy and side effects profile have been evaluated only on the basis of controlled trials so far published. Overall, all these drugs have shown an antipsychotic efficacy on positive symptoms of schizophrenia similar to that of the conventional AP drugs. On negative symptoms, all novel AP drugs, except quetiapine and ziprasidone, demonstrated a better efficacy than haloperidol. Long-term efficacy of these AP drugs in the maintenance treatment of schizophrenia needs to be explored by further, better-designed, epidemiological studies. The safety profile shows that the novel AP drugs are generally well-tolerated and induce significantly less acute extrapyramidal side effects in comparison with haloperidol. Some methodological flaws in the experimental design of the clinical trials analysed are discussed. Although these novel AP drugs have potential clinical advantages, a number of relevant questions still remain to be addressed, in order to establish the impact of these drugs in the overall treatment of schizophrenia. Copyright 2000 John Wiley & Sons, Ltd.

Neuromodulation Treatments for Geriatric Mood and Cognitive Disorders.

PubMed

McDonald, William M

2016-12-01

There is increasing evidence for the efficacy of neuromodulation in the treatment of resistant mood disorders and emerging data supporting the use of neuromodulation in cognitive disorders. A significant minority of depressed elders do not respond to pharmacotherapy and/or psychotherapy. This has led clinicians to recommend the increasing use of electroconvulsive therapy (ECT) in the treatment of medication-resistant or life-threatening geriatric depression. Multiple studies have supported the safety and efficacy of ECT in the elderly, yet ECT is associated with side effects including cardiovascular and cognitive side effects. Neuromodulation therapies have the potential for providing effective treatment for treatment-resistant older adults with reduced side effects and this review will outline the risks and benefits of neuromodulation treatment in geriatric psychiatry. There is also emerging evidence of the efficacy of neuromodulation devices in the treatment of cognitive disorders. Pharmacotherapy has been largely ineffective in changing the course of neurodegenerative diseases causing dementia and other treatments are clearly needed. This review will outline the available evidence for neuromodulation in the treatment of mood and cognitive disorders in the elderly. Copyright © 2016 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Comparing the effects of repetitive transcranial magnetic stimulation and electroconvulsive therapy in the treatment of depression: a systematic review and meta-analysis.

PubMed

Micallef-Trigona, Beppe

2014-01-01

Electroconvulsive therapy (ECT) is the longest standing psychiatric treatment available and has unequivocal benefit in severe depression. However this treatment comes with a number of side effects such as memory impairment. On the other hand, Repetitive Transcranial Magnetic Stimulation (rTMS) is a relatively new form of treatment which has been shown to be efficacious in patients suffering from a number of psychopathologies, including severe depression, with few reported side effects. Due to its potential therapeutic efficacy and lack of side effects, rTMS has gained traction in the treatment of depression, with a number of authors keen to see it take over from ECT. However, it is not clear whether rTMS represents a therapeutic alternative to ECT. This meta-analysis will therefore compare the "gold standard" treatment for severe depression, with the relatively new but promising rTMS. A literature search will be performed with the intention to include all randomised clinical trials. The null hypothesis is that there is no difference in the antidepressant efficacy between the two types of treatment modalities. Statistical analysis of Hamilton Depression Rating Scale (HDRS) scores will be performed.

Assessment of the efficacy and tolerance of a new combination of retinoids and depigmenting agents in the treatment of melasma.

PubMed

Truchuelo, Maria Teresa; Jiménez, Natalia; Jaén, Pedro

2014-12-01

Melasma is a dermatosis with significant repercussions on patients' quality of life, and there is currently no standard treatment. Hydroquinone is deemed the treatment of choice, but its safety has been questioned in certain cases. To determine the efficacy and safety of a new combination of retinoids in the improvement of melasma. Prospective, double-blind, vehicle-controlled, and randomized study in 30 patients with melasma. The product was applied on one side of the face and the vehicle on the other, twice daily during 3 months. Standardized photographs were taken using RBX technology on the three visits (basal, at one and a half months and at 3 months). The main variable to determine the efficacy was the improvement of the hemifacial Melasma Area Severity Index (MASI). Other variables were determined such as improvement perceived by the investigator, improvement perceived by the patient, impact on quality of life or side effects. The MASI improvement at 3 months of treatment was significant on the treated side vs. the vehicle side, reaching an improvement of 70%, which is comparable to the percentage of improvement described with hydroquinone. No notable side effects were detected, in spite of a significant percentage of patients included in the study citing a history that could be compatible with sensitive skin. This new combination of retinoids and depigmenting agents proved to be effective and safe in the treatment of melasma. © 2014 Wiley Periodicals, Inc.

Enhancing Clinical Trials by Incorporating Side Effects

ERIC Educational Resources Information Center

Schrag, Francis

2009-01-01

Evidence-based medicine is often seen as a model for evidence-based education, and deservedly so, but evaluators in education have been slow to adopt one of its salient features, attention to side effects. Many education evaluations focus almost exclusively on efficacy, that is on achievement test scores. Regardless of domain, all interventions…

Counseling issues and management of side effects for women using depot medroxyprogesterone acetate contraception.

PubMed

Nelson, A L

1996-05-01

Patients satisfaction is crucial to maximizing long-term utilization and efficacy of any contraceptive method. Satisfaction is enhanced when appropriate preutilization counseling is offered and when side effects are successfully managed. This article provides a conceptual model for patient counseling, highlights the significant points that should be included in counseling patients about depot medroxyprogesterone acetate (DMPA) and offers clinical suggestions to help evaluate and treat the more common side effects associated with DMPA use.

Adjuvant endocrine therapy after breast cancer: a qualitative study of factors associated with adherence

PubMed Central

Boulton, Mary; Fenlon, Debbie; Hulbert-Williams, Nick J; Walter, Fiona M; Donnelly, Peter; Lavery, Bernadette A; Morgan, Adrienne; Morris, Carolyn; Watson, Eila K

2018-01-01

Introduction Despite evidence of the efficacy of adjuvant endocrine therapy (AET) in reducing the risk of recurrence and mortality after treatment for primary breast cancer, adherence to AET is suboptimal. This study aimed to explore factors that influence adherence and nonadherence to AET following breast cancer to inform the development of supportive interventions. Methods Interviews were conducted with 32 women who had been prescribed AET, 2–4 years following their diagnosis of breast cancer. Both adherers (n=19) and nonadherers (n=13) were recruited. The analysis was conducted using the Framework approach. Results Factors associated with adherence were as follows: managing side effects including information and advice on side effects and taking control of side effects, supportive relationships, and personal influences. Factors associated with nonadherence were as follows: burden of side effects, feeling unsupported, concerns about long-term AET use, regaining normality, including valuing the quality of life over length of life, and risk perception. Conclusion Provision of timely information to prepare women for the potential side effects of AET and education on medication management strategies are needed, including provision of timely and accurate information on the efficacy of AET in reducing breast cancer recurrence and on potential side effects and ways to manage these should they arise. Trust in the doctor–patient relationship and clear patient pathways for bothersome side effects and concerns with AET are important. Training and education on AET for GPs should be considered alongside novel care pathways such as primary care nurse cancer care review and community pharmacist follow-up. PMID:29497284

Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study.

PubMed

Lee, Saridpong; Tanglertsampan, Chuchai; Tanchotikul, Mingkwan; Worapunpong, Nigun

2014-02-01

Topical minoxidil has been successfully used to treat androgenetic alopecia. It can also be applied to enhance eyebrows. However, there is no study comparing minoxidil lotion with placebo for eyebrow enhancement. In this trial, we determined the efficacy and safety of minoxidil 2% lotion for eyebrow enhancement compared with placebo. Forty patients were randomized for minoxidil on the eyebrow on one side of the face and placebo on the other. Efficacy was evaluated by global photographic assessment, eyebrow diameter, eyebrow count and subject's satisfaction. Side-effects were also evaluated. Thirty-nine patients (97.5%) completed the study. After 16 weeks, the minoxidil group achieved significantly better results in all measured outcomes compared to the placebo group. Side-effects were minor and did not preclude patients from continuing the study. Our study suggests that minoxidil 2% lotion is a safe and effective treatment for eyebrow hypotrichosis. © 2014 Japanese Dermatological Association.

Outcomes from switching from rotigotine patch to alternate therapies in Parkinson's disease.

PubMed

Chitnis, Shilpa; Jaffery, Manall; Dewey, Richard B

2012-01-01

When rotigotine patch was withdrawn from the US market, we prospectively gathered data on efficacy, side effects, and daytime sedation on patients while taking rotigotine and following the switch to alternate therapies. Patients rated the efficacy of rotigotine on a scale of 0-5 (ineffective to extremely effective) and completed the Epworth Sleepiness Scale. At a follow-up visit a mean of 3 months later, patients rated their change in efficacy and side effects on a scale of -3 to +3 (much worse to much better) and again completed the Epworth Sleepiness Scale. Thirty-three patients were switched to a single alternate treatment. On rotigotine, the average efficacy score was 3.5, and after switching, the average change in efficacy was -0.67 (worsening). Average change scores for efficacy and adverse effects were 0.25 and 0.38 for levodopa, -0.88 and -0.25 for ropinirole IR, -1.2 and -0.83 for ropinirole XL, -0.80 and 1.0 for pramipexole, and -1.0 and 0.50 for rasagiline, respectively. Average change in Epworth score on each alternate agent was -3.9, -2.3, 1.3, 3.0, and 1. Rotigotine was an effective treatment with all groups deteriorating after switch except for the levodopa group. Fifty-eight percent of patients preferred rotigotine versus 36% preferring the alternate treatment.

Double Pass 595 nm Pulsed Dye Laser Does Not Enhance the Efficacy of Port Wine Stains Compared with Single Pass: A Randomized Comparison with Histological Examination.

PubMed

Yu, Wenxin; Zhu, Jiafang; Wang, Lizhen; Qiu, Yajing; Chen, Yijie; Yang, Xi; Chang, Lei; Ma, Gang; Lin, Xiaoxi

2018-03-27

To compare the efficacy and safety of double-pass pulsed dye laser (DWL) and single-pass PDL (SWL) in treating virgin port wine stain (PWS). The increase in the extent of vascular damage attributed to the use of double-pass techniques for PWS remains inconclusive. A prospective, side-by-side comparison with a histological study for virgin PWS is still lacking. Twenty-one patients (11 flat PWS, 10 hypertrophic PWS) with untreated PWS underwent 3 treatments at 2-month intervals. Each PWS was divided into three treatment sites: SWL, DWL, and untreated control. Chromametric and visual evaluation of the efficacy and evaluation of side effects were conducted 3 months after final treatment. Biopsies were taken at the treated sites immediately posttreatment. Chromametric and visual evaluation suggested that DWL sites showed no significant improvement compared with SWL (p > 0.05) in treating PWS. The mean depth of photothermal damage to the vessels was limited to a maximum of 0.36-0.41 mm in both SWL and DWL sides. Permanent side effects were not observed in any patients. Double-pass PDL does not enhance PWS clearance. To improve the clearance of PWS lesions, either the depth of laser penetration should be increased or greater photothermal damage to vessels should be generated.

Low-fluence Q-switched Nd: YAG 1064-nm laser and intense pulsed light for the treatment of melasma.

PubMed

Vachiramon, V; Sirithanabadeekul, P; Sahawatwong, S

2015-07-01

Low-fluence Q-switched Nd:YAG 1064 nm laser (LFQS) and intense pulsed light (IPL) have been shown to be effective in the treatment of melasma. LFQS can target deeper pigment, while IPL can target a wide range of cutaneous structures. However, there is limited information on efficacy and side-effects of the combined treatment. To compare the efficacy and safety of combined LFQS and IPL therapy with LFQS monotherapy in the treatment of melasma. Twenty female patients with mixed-type melasma on both cheeks were treated with LFQS on full face for five sessions at 1-week intervals. One side of the face was randomly assigned to receive additional three sessions of IPL treatments at 2-week intervals. Patients were evaluated 12 weeks after the last treatment. Outcome measures include the assessment by colorimeter and calculated as relative lightness index (R*LI), modified Melasma Area and Severity Index (mMASI), patient satisfaction and adverse effects. Eighteen patients completed the study. Both sides of the face showed significant improvement of R*LI and mMASI. A more rapid improvement of R*LI and mMASI was observed on combined side. At the end of treatment, 55% improvement and 37% improvement of R*LI was observed on combined side and monotherapy side respectively. The overall patients' satisfaction was in favour of the combined side. Recurrence occurred on both sides but there was still a significant decrease compared to baseline. No serious side effect was noted. The combination of LFQS and IPL results in faster clearance of melasma and is more effective than LFQS alone for melasma treatment. However, recurrence is still inevitable. © 2014 European Academy of Dermatology and Venereology.

Transdermal scopolamine in the prevention of motion sickness - Evaluation of the time course of efficacy

NASA Technical Reports Server (NTRS)

Homick, J. L.; Reschke, M. F.; Degioanni, J.; Cintron-Trevino, N. M.; Kohl, R. L.

1983-01-01

This study evaluated the time course of efficacy of transdermal scopolamine in the prevention of motion sickness induced by exposure to coriolis stimulation in a rotating chair. We measured levels of efficacy, quantified side effects and symptoms, and determined inter- and intra-subject variability following use of transdermal scopolamine. The response to transdermal scopolamine was highly variable, although overall we recorded a 40 percent improvement in test scores 16-72 h after application of the transdermal system. This variability could not be explained solely by the levels of scopolamine present in the blood. The improvement was not due to the artifactual repression by scopolamine of selected symptoms of motion sickness. An unexpectedly high incidence of side effects was reported. It was concluded that the therapeutic use of transdermal scopolamine be evaluated individually and that individuals be cautioned that subsequent usage may not always be effective.

Objective Analysis of Poly-L-Lactic Acid Injection Efficacy in Different Settings.

PubMed

Byun, Sang-Young; Seo, Koo-Il; Shin, Jung-Won; Kwon, Soon-Hyo; Park, Mi-Sook; Lee, Joshua; Park, Kyoung-Chan; Na, Jung-Im; Huh, Chang-Hun

2015-12-01

Poly-L-lactic acid (PLLA) filler is known to have continuous volume effect. The objective of this study is to analyze objective volume effect of PLLA in different settings of injection schedule on the cheek. A split-face, evaluator-blind randomized study in 24 volunteers was conducted. One side was injected 3 times with 4 cc dose and the other side was injected 2 times with 6 cc dose per visit. Facial volume loss scale (FVLS) and Vectra were evaluated. Measured average FVLS showed statistically significant improvement both in 3 and 2 times injection sides and maintained efficacy until 12 months. Vectra showed volume difference (cc) between before and after injection. In 3 times injection side, it was increased 2.12 (after 1 month) to 3.17 (after 12 months). In 2 times injection side, it was increased 2.26 (after 1 month) to 3.19 (after 12 months). Gradual volume improvement over 12 months was statistically significant in both sides. There was no statistically significant difference between 3 and 2 times injection in FVLS and Vectra. There was no severe adverse event. Poly-L-lactic acid has continuous volume effect and there was no significant difference by injection times at the same total injection volume.

Efficacy of side air bags in reducing driver deaths in driver-side collisions.

PubMed

Braver, Elisa R; Kyrychenko, Sergey Y

2004-03-15

Side air bags, a relatively new technology designed to protect the head and/or torso in side-impact collisions, are becoming increasingly common in automobiles. Their efficacy in preventing US driver deaths among cars struck on the near (driver's) side was examined using data from the Fatality Analysis Reporting System and the General Estimates System. Risk ratios for driver death per nearside collision during 1999-2001 were computed for head/torso and torso-only side air bags in cars from model years 1997-2002, relative to cars without side air bags. Confounding was addressed by adjusting nearside risk ratios for front- and rear-impact mortality, which is unaffected by side air bags. Risk ratios were 0.55 (95% confidence interval: 0.43, 0.71) for head/torso air bags and 0.89 (95% confidence interval: 0.79, 1.01) for torso-only air bags. Risk was reduced when cars with head/torso air bags were struck by cars/minivans (significant) or pickup trucks/sport utility vehicles (nonsignificant). Risk was reduced in two-vehicle collisions and among male drivers and drivers aged 16-64 years. Protective effects associated with torso-only air bags were observed in single-vehicle crashes and among male and 16- to 64-year-old drivers. Head/torso side air bags appear to be very effective in reducing nearside driver deaths, whereas torso-only air bags appear less protective.

Discovery of Boolean metabolic networks: integer linear programming based approach.

PubMed

Qiu, Yushan; Jiang, Hao; Ching, Wai-Ki; Cheng, Xiaoqing

2018-04-11

Traditional drug discovery methods focused on the efficacy of drugs rather than their toxicity. However, toxicity and/or lack of efficacy are produced when unintended targets are affected in metabolic networks. Thus, identification of biological targets which can be manipulated to produce the desired effect with minimum side-effects has become an important and challenging topic. Efficient computational methods are required to identify the drug targets while incurring minimal side-effects. In this paper, we propose a graph-based computational damage model that summarizes the impact of enzymes on compounds in metabolic networks. An efficient method based on Integer Linear Programming formalism is then developed to identify the optimal enzyme-combination so as to minimize the side-effects. The identified target enzymes for known successful drugs are then verified by comparing the results with those in the existing literature. Side-effects reduction plays a crucial role in the study of drug development. A graph-based computational damage model is proposed and the theoretical analysis states the captured problem is NP-completeness. The proposed approaches can therefore contribute to the discovery of drug targets. Our developed software is available at " http://hkumath.hku.hk/~wkc/APBC2018-metabolic-network.zip ".

Field efficacy of moxidectin in dogs and rabbits naturally infested with Sarcoptes spp., Demodex spp. and Psoroptes spp. mites.

PubMed

Wagner, R; Wendlberger, U

2000-11-10

The efficacy of moxidectin 1% injectable for cattle was evaluated in dogs and rabbits with naturally acquired sarcoptic, demodectic or psoroptic mites. Twenty-two dogs with generalised demodicosis were orally treated with 0.4mg/kg moxidectin daily. Forty-one dogs suffering from sarcoptic mange were treated with 0.2-0.25mg/kg moxidectin either orally or subcutaneously every week for three to six times. Seven rabbits were treated orally with 0.2mg/kg moxidectin twice 10 days apart. Of the 22 dogs with demodicosis, 14% were stopped treatment because of side effects, 14% were lost and of the remaining 72% all were cured (mean therapy duration 2.4 months). Thirty-seven of the sarcoptic mange-infected dogs finished treatment and were cured. In 17% of dogs, side effects were noted. All seven rabbits treated for psoroptic mange were cured and did not show any side effect. Our results indicate that moxidectin is effective and a good alternative for the treatment of demodicosis and scabies in dogs and psoroptic mange in rabbits. Side effects seem to occur more frequently if applied subcutaneously, therefore the oral route should be preferred.

Topical tranexamic acid as an adjuvant treatment in melasma: Side-by-side comparison clinical study.

PubMed

Chung, Jong Yoon; Lee, Jong Hee; Lee, Joo Heung

2016-08-01

Tranexamic acid (TNA) is a novel therapeutic agent for hyperpigmented skin disorders. The efficacy and safety of topical TNA in patients with melasma has not been heretofore studied. The main objective of this study is to evaluate the efficacy and safety of topical TNA combined with intense pulsed light (IPL) treatment in Asians with melasma. A randomized, split-face (internally controlled) study was conducted in 15 women who received four monthly sessions of IPL to both sides of the face. Topical TNA or vehicle was applied to a randomly assigned side during and after IPL treatment. Patients were followed up for 12 weeks after completing the IPL treatments. Baseline and follow-up melanin index (MI; measured by Mexameter®, Courage and Khazaka, Cologne, Germany) and modified melasma area and severity index (mMASI) scores were determined. Thirteen subjects completed the study without serious adverse events. MI and mMASI decreased significantly from baseline to 12 weeks after the last IPL treatment on the topical TNA side but not on the vehicle side. The efficacy of topical TNA in preventing rebound pigmentation after IPL treatment was also statistically significant. Topical TNA can be considered an effective and safe adjuvant to conventional treatment for melasma.

Efficacy of Intense Pulsed Light Therapy in the Treatment of Facial Acne Vulgaris: Comparison of Two Different Fluences

PubMed Central

Patidar, Monika V; Deshmukh, Ashish Ramchandra; Khedkar, Maruti Yadav

2016-01-01

Background: Acne vulgaris is the most common disease of the skin affecting adolescents and young adults causing psychological distress. The combination of antibiotic resistance, adverse effects of topical and systemic anti acne medications and desire for high tech approaches have all led to new enthusiasm for light based acne treatment. Intense pulse light (IPL) therapy has three modes of action in acne vulgaris i.e., photochemical, photo thermal and photo immunological. Aims: (1) to study efficacy of IPL therapy in facial acne vulgaris. (2) To compare two fluences - one normal and other subnormal on right and left side of face respectively. Methods: (Including settings and design and statistical analysis used). Total 45 patients in age group 16 to 28 years with inflammatory facial acne vulgaris were included in prospective study. Baseline data for each patient was recorded. All patients were given 4 sittings of IPL at 2 weeks interval and were followed for 2 months every 2 weeks. Fluence used was 35J/cm2 on right and 20J/cm2 on left side. Percentage reduction in lesion count was calculated at each sitting and follow up and graded as mild (0-25%), moderate (26-50%), good (51-75%) and excellent (76-100%). Side effects were noted. The results were analysed using Mann-Whitney Test. Results: On right side, excellent results were achieved in 10(22%), good in 22(49%) and moderate in 13(29%) patients. On left side excellent were results achieved in 7(15%), good in 19(42%) and moderate in 16(43%) patients. There was no statically significant difference noted in efficacy of two fluences used in treatment of facial acne vulgaris. Conclusions: IPL is a effective and safe option for inflammatory acne vulgaris with minimal reversible side effects. Subnormal fluence is as effective as normal fluence in Indian skin. PMID:27688446

Efficacy of Intense Pulsed Light Therapy in the Treatment of Facial Acne Vulgaris: Comparison of Two Different Fluences.

PubMed

Patidar, Monika V; Deshmukh, Ashish Ramchandra; Khedkar, Maruti Yadav

2016-01-01

Acne vulgaris is the most common disease of the skin affecting adolescents and young adults causing psychological distress. The combination of antibiotic resistance, adverse effects of topical and systemic anti acne medications and desire for high tech approaches have all led to new enthusiasm for light based acne treatment. Intense pulse light (IPL) therapy has three modes of action in acne vulgaris i.e., photochemical, photo thermal and photo immunological. (1) to study efficacy of IPL therapy in facial acne vulgaris. (2) To compare two fluences - one normal and other subnormal on right and left side of face respectively. (Including settings and design and statistical analysis used). Total 45 patients in age group 16 to 28 years with inflammatory facial acne vulgaris were included in prospective study. Baseline data for each patient was recorded. All patients were given 4 sittings of IPL at 2 weeks interval and were followed for 2 months every 2 weeks. Fluence used was 35J/cm(2) on right and 20J/cm(2) on left side. Percentage reduction in lesion count was calculated at each sitting and follow up and graded as mild (0-25%), moderate (26-50%), good (51-75%) and excellent (76-100%). Side effects were noted. The results were analysed using Mann-Whitney Test. On right side, excellent results were achieved in 10(22%), good in 22(49%) and moderate in 13(29%) patients. On left side excellent were results achieved in 7(15%), good in 19(42%) and moderate in 16(43%) patients. There was no statically significant difference noted in efficacy of two fluences used in treatment of facial acne vulgaris. IPL is a effective and safe option for inflammatory acne vulgaris with minimal reversible side effects. Subnormal fluence is as effective as normal fluence in Indian skin.

Bone mineral density in relation to efficacy and side effects of budesonide and prednisolone in Crohn's disease.

PubMed

Schoon, Erik J; Bollani, Simona; Mills, Peter R; Israeli, Eran; Felsenberg, Dieter; Ljunghall, Sverker; Persson, Tore; Haptén-White, Louise; Graffner, Hans; Bianchi Porro, Gabriele; Vatn, Morten; Stockbrügger, Reinhold W

2005-02-01

Osteoporosis frequently occurs in Crohn's disease, often because of corticosteroids. Budesonide as controlled release capsules is a locally acting corticosteroid with low systemic bioavailability. We investigated its effects on bone compared with prednisolone. In 34 international centers, 272 patients with Crohn's disease involving ileum and/or colon ascendens were randomized to once daily treatment with budesonide or prednisolone for 2 years at doses adapted to disease activity. One hundred eighty-one corticosteroid-free patients had active disease (98 had never received corticosteroids, corticosteroid naive; 83 had received corticosteroids previously, corticosteroid exposed), and 90 had quiescent disease, receiving long-term low doses of corticosteroids, corticosteroid-dependent; in 1 patient, no efficacy data were obtained. Bone mineral density and fractures were assessed in a double-blinded fashion; disease activity, side effects, and quality of life were monitored. Neither the corticosteroid-free nor the corticosteroid-dependent patients treated with budesonide differed significantly in bone mineral density from those receiving prednisolone. However, corticosteroid-naive patients receiving budesonide had smaller reductions in bone mineral density than those on prednisolone (mean, -1.04% vs -3.84%; P = .0084). Treatment-emergent corticosteroid side effects were less frequent with budesonide. Efficacy was similar in both groups. Treatment with budesonide is associated with better preserved bone mass compared with prednisolone in only the corticosteroid-naive patients with active ileocecal Crohn's disease. In both the corticosteroid-free and corticosteroid-dependent groups, budesonide and prednisolone were equally effective for up to 2 years, but budesonide caused fewer corticosteroid side effects.

Theranostic Nanoseeds for Efficacious Internal Radiation Therapy of Unresectable Solid Tumors

NASA Astrophysics Data System (ADS)

Moeendarbari, Sina; Tekade, Rakesh; Mulgaonkar, Aditi; Christensen, Preston; Ramezani, Saleh; Hassan, Gedaa; Jiang, Ruiqian; Öz, Orhan K.; Hao, Yaowu; Sun, Xiankai

2016-02-01

Malignant tumors are considered “unresectable” if they are adhere to vital structures or the surgery would cause irreversible damages to the patients. Though a variety of cytotoxic drugs and radiation therapies are currently available in clinical practice to treat such tumor masses, these therapeutic modalities are always associated with substantial side effects. Here, we report an injectable nanoparticle-based internal radiation source that potentially offers more efficacious treatment of unresectable solid tumors without significant adverse side effects. Using a highly efficient incorporation procedure, palladium-103, a brachytherapy radioisotope in clinical practice, was coated to monodispersed hollow gold nanoparticles with a diameter about 120 nm, to form 103Pd@Au nanoseeds. The therapeutic efficacy of 103Pd@Au nanoseeds were assessed when intratumorally injected into a prostate cancer xenograft model. Five weeks after a single-dose treatment, a significant tumor burden reduction (>80%) was observed without noticeable side effects on the liver, spleen and other organs. Impressively, >95% nanoseeds were retained inside the tumors as monitored by Single Photon Emission Computed Tomography (SPECT) with the gamma emissions of 103Pd. These findings show that this nanoseed-based brachytherapy has the potential to provide a theranostic solution to unresectable solid tumors.

Switching long acting antipsychotic medications to aripiprazole long acting once-a-month: expert consensus by a panel of Italian and Spanish psychiatrists.

PubMed

Fagiolini, Andrea; Alfonsi, Emilia; Amodeo, Giovanni; Cenci, Mario; Di Lella, Michele; Farinella, Francesco; Ferraiuolo, Fabrizio; Fraguas, David; Loparco, Natale; Gutierrez-Rojas, Luis; Mignone, Maria Laura; Pataracchia, Giuseppe; Pillai, Gianluca; Russo, Felicia; Sanchez-Gistau, Vanessa; Spinogatti, Franco; Toscano, Marco; Villari, Vincenzo; De Filippis, Sergio

2016-01-01

Aripiprazole long acting once-monthly (AOM) is a long acting atypical antipsychotic with proven efficacy in schizophrenia and with a pharmacological and a side effect profile that is different from other antipsychotics. These and other characteristics make AOM a possible alternative in patients requiring a change in long acting antipsychotic treatment due to issues such as lack of efficacy or persistent side effects. Both clinical and pharmacological factors should be considered when switching antipsychotics, and specific guidelines for long acting antipsychotic switching that address all these factors are needed. A panel of Italian and Spanish experts in psychiatry met to discuss the strategies for the switch to AOM in patients with schizophrenia. Real life clinical experiences were shared and the clinical strategies to improve the likelihood of success were discussed. Due to its specific pharmacological and tolerability profile, AOM represents a suitable alternative for patients with schizophrenia requiring a switch to a new LAI treatment because of lack of efficacy or persistent side effects from another LAI. Possible strategies for the switch to AOM are presented in this expert consensus paper in an attempt to provide guidance throughout the entire switching process.

Reiki and related therapies in the dialysis ward: an evidence-based and ethical discussion to debate if these complementary and alternative medicines are welcomed or banned.

PubMed

Ferraresi, Martina; Clari, Roberta; Moro, Irene; Banino, Elena; Boero, Enrico; Crosio, Alessandro; Dayne, Romina; Rosset, Lorenzo; Scarpa, Andrea; Serra, Enrica; Surace, Alessandra; Testore, Alessio; Colombi, Nicoletta; Piccoli, Barbara Giorgina

2013-06-21

Complementary and Alternative Medicines (CAMs) are increasingly practiced in the general population; it is estimated that over 30% of patients with chronic diseases use CAMs on a regular basis. CAMs are also used in hospital settings, suggesting a growing interest in individualized therapies. One potential field of interest is pain, frequently reported by dialysis patients, and seldom sufficiently relieved by mainstream therapies. Gentle-touch therapies and Reiki (an energy based touch therapy) are widely used in the western population as pain relievers.By integrating evidence based approaches and providing ethical discussion, this debate discusses the pros and cons of CAMs in the dialysis ward, and whether such approaches should be welcomed or banned. In spite of the wide use of CAMs in the general population, few studies deal with the pros and cons of an integration of mainstream medicine and CAMs in dialysis patients; one paper only regarded the use of Reiki and related practices. Widening the search to chronic pain, Reiki and related practices, 419 articles were found on Medline and 6 were selected (1 Cochrane review and 5 RCTs updating the Cochrane review). According to the EBM approach, Reiki allows a statistically significant but very low-grade pain reduction without specific side effects. Gentle-touch therapy and Reiki are thus good examples of approaches in which controversial efficacy has to be balanced against no known side effect, frequent free availability (volunteer non-profit associations) and easy integration with any other pharmacological or non pharmacological therapy. While a classical evidence-based approach, showing low-grade efficacy, is likely to lead to a negative attitude towards the use of Reiki in the dialysis ward, the ethical discussion, analyzing beneficium (efficacy) together with non maleficium (side effects), justice (cost, availability and integration with mainstream therapies) and autonomy (patients' choice) is likely to lead to a permissive-positive attitude. This paper debates the current evidence on Reiki and related techniques as pain-relievers in an ethical framework, and suggests that physicians may wish to consider efficacy but also side effects, contextualization (availability and costs) and patient's requests, according also to the suggestions of the Society for Integrative Oncology (tolerate, control efficacy and side effects).

Reiki and related therapies in the dialysis ward: an evidence-based and ethical discussion to debate if these complementary and alternative medicines are welcomed or banned

PubMed Central

2013-01-01

Background Complementary and Alternative Medicines (CAMs) are increasingly practiced in the general population; it is estimated that over 30% of patients with chronic diseases use CAMs on a regular basis. CAMs are also used in hospital settings, suggesting a growing interest in individualized therapies. One potential field of interest is pain, frequently reported by dialysis patients, and seldom sufficiently relieved by mainstream therapies. Gentle-touch therapies and Reiki (an energy based touch therapy) are widely used in the western population as pain relievers. By integrating evidence based approaches and providing ethical discussion, this debate discusses the pros and cons of CAMs in the dialysis ward, and whether such approaches should be welcomed or banned. Discussion In spite of the wide use of CAMs in the general population, few studies deal with the pros and cons of an integration of mainstream medicine and CAMs in dialysis patients; one paper only regarded the use of Reiki and related practices. Widening the search to chronic pain, Reiki and related practices, 419 articles were found on Medline and 6 were selected (1 Cochrane review and 5 RCTs updating the Cochrane review). According to the EBM approach, Reiki allows a statistically significant but very low-grade pain reduction without specific side effects. Gentle-touch therapy and Reiki are thus good examples of approaches in which controversial efficacy has to be balanced against no known side effect, frequent free availability (volunteer non-profit associations) and easy integration with any other pharmacological or non pharmacological therapy. While a classical evidence-based approach, showing low-grade efficacy, is likely to lead to a negative attitude towards the use of Reiki in the dialysis ward, the ethical discussion, analyzing beneficium (efficacy) together with non maleficium (side effects), justice (cost, availability and integration with mainstream therapies) and autonomy (patients’ choice) is likely to lead to a permissive-positive attitude. Summary This paper debates the current evidence on Reiki and related techniques as pain-relievers in an ethical framework, and suggests that physicians may wish to consider efficacy but also side effects, contextualization (availability and costs) and patient’s requests, according also to the suggestions of the Society for Integrative Oncology (tolerate, control efficacy and side effects). PMID:23799960

Medical use of cannabis in the Netherlands.

PubMed

Gorter, Robert W; Butorac, Mario; Cobian, Eloy Pulido; van der Sluis, Willem

2005-03-08

The authors investigated the indications for cannabis prescription in the Netherlands and assessed its efficacy and side effects. A majority (64.1%) of patients reported a good or excellent effect on their symptoms. Of these patients, approximately 44% used cannabis for >/=5 months. Indications were neurologic disorders, pain, musculoskeletal disorders, and cancer anorexia/cachexia. Inhaled cannabis was perceived as more effective than oral administration. Reported side effects were generally mild.

Buspirone versus methylphenidate in the treatment of attention deficit hyperactivity disorder: a double-blind and randomized trial.

PubMed

Davari-Ashtiani, Rozita; Shahrbabaki, Mahin Eslami; Razjouyan, Katayoon; Amini, Homayoun; Mazhabdar, Homa

2010-12-01

The efficacy and side effects of buspirone compared with methylphenidate (MPH) in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). A total of 34 children with ADHD as defined by DSM-IV-TR were randomized to buspirone or methylphenidate dosed on weight-adjusted basis at buspirone (0.5 mg/kg/day) and methylphenidate (0.3-1 mg/kg/day) for a 6-week double-blind clinical trial. The principle measures of outcome were the teacher and parent ADHD Rating Scale. The side effects were assessed by the special side effect checklist of each drug. In both groups, the scores of teacher and parent ADHD Rating Scale significantly declined on the 6th week as compared to baseline (p = 0.001). These effects were observed in the subscales too. No significant differences were observed between the two protocols on the total scores of parent and teacher ADHD Rating Scale, but methylphenidate was superior to buspirone in decreasing the symptoms of inattention. The side effects of buspirone were mild and rare in comparison with MPH. Buspirone has a favorable side-effects profile. It also has clinically and statistically significant impacts on improving the ADHD symptoms in children. These preliminary findings of the efficacy of buspirone in children with ADHD need large and cross-over studies.

Maternal side effects & fetal neuroprotection according to body mass index after magnesium sulfate in a multicenter randomized controlled trial.

PubMed

Vilchez, Gustavo; Dai, Jing; Lagos, Moraima; Sokol, Robert J

2018-01-01

Evidence supports the need of dose-adjustment of several drugs according to body mass index (BMI) to prevent toxicity in the underweight, and ensure efficacy in obese women. However, for MgSO 4 neuroprotection, the effect of BMI on maternal toxicity and fetal neuroprotection is understudied. We analyze the effect of BMI on maternal/infant outcomes after MgSO 4 . Secondary analysis of a clinical trial that studied MgSO 4 neuroprotection. Maternal side effects, magnesium cord levels, and offspring cerebral palsy/death were analyzed along BMI strata using ANOVA and chi-square test. Logistic regression was used to calculate adjusted odds ratios according to the treatment and BMI, using nonobese that received placebo as reference. Interaction analyses were performed to validate differential efficacy of BMI. From 2241 women, more side effects and higher magnesium cord levels were seen in underweight women (p = 0.05). MgSO 4 neuroprotection was effective in the non-obese (p = 0.02), but not in obese women (p = 1.00). In multivariate analyses, MgSO 4 significantly reduced cerebral palsy only in nonobese women. Interaction analyses showed the moderator effect of BMI (p = 0.169). Increasing MgSO 4 dose in obese mothers may ensure neuroprotective efficacy without representing increased maternal risks. Considering costs of studying this association, current analysis may form the basis for reasonable practice.

Advances in Pharmacotherapeutics of Space Motion Sickness

NASA Technical Reports Server (NTRS)

Putcha, Lakshmi

2006-01-01

Space Motion Sickness (SMS) is common occurrence in the U.S. manned space flight program and nearly 2/3 of Shuttle crewmembers experience SMS. Several drugs have been prescribed for therapeutic management of SMS. Typically, orally-administered SMS medications (scopolamine, promethazine) have poor bioavailability and often have detrimental neurocognitive side effects at recommended doses. Intramuscularly administered promethazine (PMZ) is perceived to have optimal efficacy with minimal side effects in space. However, intramuscular injections are painful and the sedating neurocognitive side effects of promethazine, significant in controlled ground testing, may be masked in orbit because injections are usually given prior to crew sleep. Currently, EVAs cannot be performed by symptomatic crew or prior to flight day three due to the lack of a consistently efficacious drug, concern about neurocognitive side effects, and because an in-suit vomiting episode is potentially fatal. NASA has long sought a fast acting, consistently effective anti-motion sickness medication which has only minor neurocognitive side effects. Development of intranasal formulations of scopolamine and promethazine, the two commonly used SMS drugs at NASA for both space and reduced gravity environment medical operations, appears to be a logical alternative to current treatment modalities for SMS. The advantages are expected to be fast absorption, reliable and high bioavailability, and probably reduced neurocognitive side effects owing to dose reduction. Results from clinical trials with intranasal scopolamine gel formulation and pre-clinical testing of a prototype microcapsule intranasal gel dosage form of PMZ (INPMZ) will be discussed. These formulations are expected to offer a dependable and effective noninvasive treatment option for SMS.

[Treatment side effects and compliance in patients with depression].

PubMed

Petrova, N N; Kucher, E O

2012-01-01

The impact of treatment side-effects on the compliance was studied in 85 depressive patients with different mental disorders - recurrent depressive disorder, postschizophrenic depression and organic affective disorder. The comparison of objective and subjective evaluations of compliance and a comparative analysis of the level of compliance, with its dependence on the treatment specifics, in different diseases were done. A significant role of efficacy and treatment side-effects was identified. The levels of "mental" and "autonomous" side-effects were highest in the treatment of depression: patients with postschizophrenic depression had the highest risk in respect of maintenance treatment; patients with recurrent depressive disorder and organic (affective) disorder were more tolerant to the treatment side-effects and their treatment, including the maintenance therapy, was rather effective. The compliance of all patients with depression was negatively correlated with the severity of side-effects of pharmacotherapy. The greatest side-effects and the lowest level of compliance were observed in the complex treatment with antidepressants and atypical neuroleptics. The effect of side-effects on the compliance was dependent on their severity and subjective tolerability and, to a lesser extent, on the amount of drugs.

Terbinafine: novel formulations that potentiate antifungal activities.

PubMed

Ma, Y; Chen, X; Guan, S

2015-03-01

Terbinafine, an orally and topically active antifungal agent, has been available for the treatment of dermatophytic infections and onychomycosis for more than a decade. In addition, oral administration has been shown to be associated with drug-drug interactions, hepatotoxicity, low concentration at the infected sites, gastrointestinal and systemic side effects and other adverse effects. Since topical drug delivery can provide higher patient compliance, allow immediate access to the infected site and reduce unwanted systemic drug exposure, an improved topical drug delivery approach with high permeability, sustained release and prolonged retainment could overcome the limitations and side effects caused by oral administration. Conventional topical formulations cannot keep the drug in the targeted sites for a long duration of time and hence a novel drug delivery that can avoid the side effects while still providing sustained efficacy in treatment should be developed. This brief review of novel formulations based on polymers and nanostructure carriers provides insight into the efficacy and topical delivery of terbinafine. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

Analysis of opioid efficacy, tolerance, addiction and dependence from cell culture to human

PubMed Central

Morgan, Michael M; Christie, MacDonald J

2011-01-01

Opioid agonists are the most effective treatment for pain, but their use is limited by side effects, tolerance and fears of addiction and dependence. A major goal of opioid research is to develop agonists that have high analgesic efficacy and a low profile for side effects, tolerance, addiction and dependence. Unfortunately, there is a serious lack of experimental data comparing the degree to which different opioids produce these effects in humans. In contrast, a wide range of experimental techniques from heterologous expression systems to behaviour assessment in whole animals have been developed to study these problems. The objective of this review is to describe and evaluate these techniques as they are used to study opioid efficacy, tolerance, addiction and dependence. LINKED ARTICLES This article is part of a themed issue on Translational Neuropharmacology. To view the other articles in this issue visit http://dx.doi.org/10.1111/bph.2011.164.issue-4 PMID:21434879

Cannabidiol monotherapy for treatment-resistant schizophrenia.

PubMed

Zuardi, Antonio Waldo; Hallak, Jaime E C; Dursun, Serdar Murat; Morais, Sílvio L; Sanches, Rafael Faria; Musty, Richard E; Crippa, José Alexandre S

2006-09-01

Cannabidiol (CBD), one of the major products of the marijuana plant, is devoid of marijuana's typical psychological effects. In contrast, potential antipsychotic efficacy has been suggested based on preclinical and clinical data (Zuardi et al., 2002). In this report, we further investigated the efficacy and safety of CBD monotherapy in three patients with treatment-resistant schizophrenia (TRS). This was an in-patient study. All patients were given placebo for the initial 5 days, and from the 6th to 35th day (inclusive) they received CBD (initial oral dose of 40 mg reaching 1280 mg/day). On the 36th day, CBD treatment was discontinued and replaced by placebo for 5 days, which was subsequently switched to olanzapine for over 15 days. Efficacy, tolerability and side effects were assessed. One patient showed mild improvement, but two patients didn't show any improvement during CBD monotherapy. All patients tolerated CBD very well and no side effects were reported. These preliminary data suggest that CBD monotherapy may not be effective for TRS.

Aidi injection combined with radiation in the treatment of non-small cell lung cancer: A meta-analysis evaluation the efficacy and side effects.

PubMed

Zhang, Hongzhi; Jiang, Huijuan; Hu, Xigang; Jia, Zongling

2015-08-01

The purpose of this meta-analysis was to assess the clinical efficacy and side effects of Aidi injection combined with radiation in the treatment of non-small cell lung cancer (NSCLC). By searching PubMed, the Cochrane central register of controlled trials, EMBSE and CNKI databases, the efficacy and side effect data of Aidi injection combined with radiation in the treatment of NSCLC from the published clinical studies were collected. The data were pooled using Stata version 11.0 software (http://www.stata.com; Stata Corporation, College Station, TX). Ten clinical studies with 1084 subjects were included in this meta-analysis. The combined data showed the clinical efficacy in experiment group was higher than that of control group (risk ratio [RR] = 1.72, 95% confidence interval [CI]: 1.52-1.96, P = 0.00); four articles reported the life quality improvement. The pooled data showed that the use of Aidi can significantly improve the quality of life in the procedure of radiation (RR = 2.29, 95% CI: 1.76-2.98, P = 0.00); six studies reported the radiation toxicities. The pooled data showed that Aidi injection can significant decrease the radiation pneumonia (OR = 0.46, 95% CI: 0. 34-0.63), radiation esophagitis (OR = 0.53, 95% CI: 0.40-0.71), and marrow suppression (OR = 0.50, 95% CI: 0.42-0.59). Aidi injection can improve the clinical efficacy, quality of life, and decrease the radiation-related toxicities in NSCLC patients who received radiation.

Combination of glycolic acid peel and topical 20% azelaic acid cream in melasma patients: efficacy and improvement in quality of life.

PubMed

Dayal, Surabhi; Sahu, Priyadarshini; Dua, Ruchika

2017-03-01

Glycolic acid (GA) peel is one of the most versatile agents in the treatment of melasma. GA peeling alone or in combination with topical hypopigmenting agents has shown encouraging results. However, there is paucity of controlled trial demonstrating the efficacy of glycolic peel in conjunction with topical azelaic acid (AA). We therefore sought to highlight the efficacy and safety of this combination in melasma. To assess the clinical efficacy, safety and reduction in melasma quality of life (MELASQOL) scores on combining serial GA peels with topical 20% AA cream in epidermal melasma. Sixty patients of epidermal melasma were enrolled for 24 weeks. Patients were divided into two groups: (1) Study group received serial GA peel every 3 weeks with twice daily 20% AA cream, and (2) control group received only 20% AA cream. Clinical improvement was assessed objectively using Melasma Area Severity Index (MASI). Melasma-related quality of life was measured by MELASQOL scale in both groups. Side effects were observed at each visit. The improvement in MASI and percentage decrease in MASI scoring were statistically significant 12 weeks onwards in study group as compared to control group. There was also a significant reduction in MELASQOL scores in study group as compared to control group after treatment. Minor reversible side effects were observed in both groups, which did not require cessation of therapy. GA peel enhances therapeutic efficacy of topical AA cream for treatment of melasma, with improvement in quality of life without serious side effects. © 2016 Wiley Periodicals, Inc.

Non-injection routes for allergen immunotherapy: focus on sublingual immunotherapy.

PubMed

Passalacqua, Giovanni; Guerra, Laura; Pasquali, Mercedes; Canonica, Giorgio Walter

2006-01-01

Allergen specific immunotherapy, together with drugs and allergen avoidance, is a cornerstone in the management of respiratory allergy. The non-injection or local routes were developed with the main goal of improving the safety and minimizing the risk of those side effects, which can accompany the injection route. The pure oral route and the bronchial route showed, in the clinical trials, only a marginal efficacy with not negligible side effects. Therefore, these routes are no longer recommended for clinical use. The nasal route proved effective and safe, but its efficacy is strictly limited to the nose. Moreover, the practical problems with administration have made the use of nasal immunotherapy progressively declining. The efficacy of the sublingual route is confirmed by numerous controlled trials, and a meta analysis (in allergic rhinitis). The safety profile, as derived from clinical trials and post marketing surveillance studies, is satisfactory, with mild gastrointestinal complaints being the more frequent side effect reported. Recent studies have also demonstrated that SLIT has a long-lasting effect and a preventive effect on the onset of new skin sensitizations, and interesting data on adherence and mechanisms of action have become recently available. Based on these experimental data, SLIT is now officially accepted as a viable alternative to the subcutaneous route in adults and children. Several points still need to be elucidated, including: mechanisms of action, optimal dosages, and indications in pediatric patients.

Actions of the dual FAAH/MAGL inhibitor JZL195 in a murine neuropathic pain model

PubMed Central

Adamson Barnes, Nicholas S.; Mitchell, Vanessa A.; Kazantzis, Nicholas P.

2015-01-01

Background and Purpose While cannabinoids have been proposed as a potential treatment for neuropathic pain, they have limitations. Cannabinoid receptor agonists have good efficacy in animal models of neuropathic pain; they have a poor therapeutic window. Conversely, selective fatty acid amide hydrolase (FAAH) inhibitors that enhance the endocannabinoid system have a better therapeutic window, but lesser efficacy. We examined whether JZL195, a dual inhibitor of FAAH and monacylglycerol lipase (MAGL), could overcome these limitations. Experimental Approach C57BL/6 mice underwent the chronic constriction injury (CCI) model of neuropathic pain. Mechanical and cold allodynia, plus cannabinoid side effects, were assessed in response to systemic drug application. Key Results JZL195 and the cannabinoid receptor agonist WIN55212 produced dose‐dependent reductions in CCI‐induced mechanical and cold allodynia, plus side effects including motor incoordination, catalepsy and sedation. JZL195 reduced allodynia with an ED50 at least four times less than that at which it produced side effects. By contrast, WIN55212 reduced allodynia and produce side effects with similar ED50s. The maximal anti‐allodynic effect of JZL195 was greater than that produced by selective FAAH, or MAGL inhibitors. The JZL195‐induced anti‐allodynia was maintained during repeated treatment. Conclusions and Implications These findings suggest that JZL195 has greater anti‐allodynic efficacy than selective FAAH, or MAGL inhibitors, plus a greater therapeutic window than a cannabinoid receptor agonist. Thus, dual FAAH/MAGL inhibition may have greater potential in alleviating neuropathic pain, compared with selective FAAH and MAGL inhibitors, or cannabinoid receptor agonists. PMID:26398331

Stimulant Use in Patients with Sturge-Weber Syndrome: Safety and Efficacy

PubMed Central

Lance, Eboni I.; Lanier, Kira E.; Zabel, T. Andrew; Comi, Anne M.

2015-01-01

BACKGROUND Sturge Weber Syndrome (SWS) is characterized by a facial port-wine birthmark, vascular eye abnormalities, and a leptomeningeal angioma. Attention and behavioral issues are common in SWS; however, literature evidence for stimulant treatment is minimal. This study evaluates stimulant medication safety and efficacy in SWS patients. METHODS The research database of the Hunter Nelson Sturge-Weber Center (n = 210 subjects with SWS brain involvement) was reviewed for stimulant use. Twelve subjects (mean age 10.5 years, age range 4 to 21 years) on stimulants were seen between 2003 and 2012. A retrospective chart review obtained co-morbid diagnoses, stimulant type and dosage, medication side effects, vital signs, and medication efficacy. RESULTS All twelve subjects had brain involvement (unilateral - nine; bilateral – three). Additional co-morbidities included epilepsy (twelve), hemi-paresis (eight), headaches (eight), and vision deficits (seven). Eight subjects reported side effects, primarily appetite suppression (four) and headaches (three). There were no statistically significant changes in weight or blood pressure six months after medication initiation. Medication efficacy was subjectively reported in eleven subjects. Seven patients remained on stimulants at their most recent follow up visit. CONCLUSIONS This study preliminarily evaluates stimulant medication use in a small group of SWS patients. Stimulants were tolerated and effective in most subjects. Side effects were mostly minor and medication did not negatively impact growth or vital signs. Stimulant medication may be a safe and effective intervention for SWS children with attention issues/attention deficit hyperactivity disorder (ADHD). Further studies with larger sample sizes are needed. PMID:25439578

An update on analgesics.

PubMed

Power, I

2011-07-01

Recent introduction of new analgesics into the clinic is best described as a slow process with activity classified into two main areas: improving analgesic efficacy/potency and reducing side-effect profile. This review article describes some of the recent advances with an emphasis on use in the acute setting. In this respect, opioids continue to be the mainstay (but not the only) analgesic and there have been important improvements in their clinical effect profile. For example, tapentadol has been introduced as a mixed opioid and norepinephrine uptake inhibitor which, unlike tramadol, does not require metabolic activation and does not suffer from isomer-dependent pharmacodynamics. Opioid antagonists have received much attention recently either used alone, methylnaltrexone (s.c) or alvimopan (p.o), or in combination, Targinact (oxycodone/naloxone), and appear to be effective in reducing opioid side-effects such as those in the gastrointestinal tract. Other agents where there has been recent development include the use of gabapentin, methylxanthines, and local anaesthetics. An interesting area of translation of basic research is in the inhibition of breakdown of endogenous opioids with opiorphin, targeting of the endocannabinoid system, and the use of ampakines to obtund opioid-induced side-effects. It is clear that there is still much work to be done, but the need for highly efficacious analgesics with good side-effect profile remains.

Buspirone in the treatment of posttraumatic stress disorder.

PubMed

Wells, B G; Chu, C C; Johnson, R; Nasdahl, C; Ayubi, M A; Sewell, E; Statham, P

1991-01-01

Three patients with a DSM-III-R diagnosis of posttraumatic stress disorder were successfully treated with buspirone in final maximum dosages ranging from 35-60 mg daily. The onset of clinical efficacy ranged from 5-29 days. Symptoms that improved included anxiety, insomnia, flashbacks, and depressed mood. Patients experienced no side effects. Serotonin partial agonist effects are a possible mechanism underlying buspirone's efficacy.

Antiepileptic drug therapy: clinical laboratory significance.

PubMed

Naradzay, J F; Olshaker, J S

1996-01-01

When evaluating a patient who is taking an antiepileptic medication, it is important for the emergency physician to correlate the clinical presentation with the antiepileptic drug level. Therapeutic ranges have been suggested for most antiepileptic medications, but these must be interpreted in light of clinical efficacy and patient tolerance. When considering the efficacy of anti-epileptic medications, it is necessary to consider the patient's unique metabolism, side-effect tolerance, and overall response to therapy. Suggested therapeutic ranges should be the first reference for the emergency physician. The purpose of this report is to discuss the laboratory values of commonly prescribed antiepileptic medications. Therapeutic ranges, side-effects, and common medication interactions are discussed concerning phenytoin, phenobarbital, carbamezapine, and valproic acid.

[Clinical study on a concomitant therapy with fluconazole and human recombinant granulocyte colony stimulating factor in the treatment of systemic fungal infections with hematological disorders].

PubMed

Kitamura, K; Miyagawa, K; Urabe, A; Sato, H; Obayashi, Y; Aoki, I; Takaku, F; Togawa, A; Shindou, E; Wakabayashi, Y; Ohshima, T; Horikoshi, A; Nomura, T; Ohki, I; Suzuki, K; Kamakura, M; Oguchi, A; Toyama, K; Yaguchi, M; Aoki, N; Kato, A; Mizoguchi, H; Masuda, M; Irie, S; Fujioka, S

1996-12-01

The clinical efficacy and the safety of concomitant therapy with fluconazole and recombinant human granulocyte colony stimulating factor (rhG-CSF) was compared with fluconazole monotherapy in neutropenic patients with hematological disorders. The clinical efficacy rate was 73.5% (25/34) in the combination therapy and 48.1% (37/77) in monotherapy. The difference between the two is statistically significant. Side effects were not observed in the combination group, but laboratory abnormalities were found in 6 patients with an incident rate of 11%. The combination therapy with fluconazole and rhG-CSF may be selected as empiric therapy for systemic fungal infection associated with hematological disorders, since this combination therapy showed high efficacy and low incident of side effects. Some patients, however, did not show increased neutrophil counts in spite of rhG-CSF administration.

EMP-induced BBB-disruption enhances drug delivery to glioma and increases treatment efficacy in rats.

PubMed

Li, Kangchu; Zhang, Keying; Xu, Shenglong; Wang, Xiaowu; Zhou, Yongchun; Zhou, Yan; Gao, Peng; Lin, Jiajin; Ding, Guirong; Guo, Guozhen

2018-01-01

Chemotherapy on gliomas is not satisfactorily efficient because the presence of blood-brain barriers (BBB) leads to inadequate exposure of tumor cells to administered drugs. In order to facilitate chemotherapeutics to penetrate BBB and increase the treatment efficacy of gliomas, electromagnetic pulse (EMP) was applied and the 1-(2-Chlorethyl)-cyclohexyl-nitrosourea (CCNU) lomustine concentration in tumor tissue, tumor size, tumor apoptosis, and side effects were measured in glioma-bearing rat model. The results showed that EMP exposure could enhance the delivery of CCNU to tumor tissue, facilitate tumor apoptosis, and inhibit tumor growth without obvious side effects. The data indicated that EMP-induced BBB disruption could enhance delivery of CCNU to glioblastoma multiforme and increase treatment efficacy in glioma-bearing rats. Bioelectromagnetics. 39:60-67, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

The efficacy of a low dose combination of topiramate and naltrexone on ethanol reinforcement and consumption in rat models.

PubMed

Moore, Catherine F; Protzuk, Omar A; Johnson, Bankole A; Lynch, Wendy J

2014-01-01

Combined medication approaches, by targeting multiple neurotransmitter systems involved in alcohol use disorders (AUDs), may be more efficacious than single-medication approaches. We examined, in animal models of consumption and reinforcement, the combined effects of naltrexone (an opioid antagonist) and topiramate (a GABA/glutamate modulator), two medications that have shown promise for treating AUDs, hypothesizing that their combination would be more efficacious than either alone. The effects of naltrexone and topiramate on ethanol consumption were examined in alcohol preferring (P) rats (N=10) and in rats from their background strain (Wistar, N=9) using conditions that induce high levels of consumption (24-h, 3-bottle, free-choice procedure). Low doses of each medication (1mg/kg, naltrexone; 10mg/kg, topiramate) were selected in an attempt to maximize their combined efficacy while minimizing potential side-effects. Their effects on ethanol reinforcement were assessed under a progressive-ratio schedule in additional groups of (N=22) P rats. A moderate dose of topiramate (20mg/kg) was also included to verify topiramate's efficacy on its own. In P rats, but not in Wistar rats, the combination effectively and persistently reduced consumption; whereas, neither dose alone was effective. The combination and naltrexone alone were equally effective at reducing ethanol reinforcement; however, with the combination, but not naltrexone alone, this effect was selective for ethanol. All treatments produced a similar decrease in home-cage food consumption. The 20mg/kg dose of topiramate also effectively reduced ethanol consumption and reinforcement. With greater efficacy and fewer side-effects, the combination shows promise as a treatment for AUDs. Copyright © 2013 Elsevier Inc. All rights reserved.

The efficacy of a low dose combination of topiramate and naltrexone on ethanol reinforcement and consumption in rat models

PubMed Central

Moore, Catherine F; Protzuk, Omar A; Johnson, Bankole A; Lynch, Wendy J

2013-01-01

Rationale Combined medication approaches, by targeting multiple neurotransmitter systems involved in alcohol use disorders (AUDs), may be more efficacious than single-medication approaches. Objectives We examined, in animals models of consumption and reinforcement, the combined effects of naltrexone (an opioid antagonist) and topiramate (a GABA/glutamate modulator), two medications that have shown promise for treating AUDs, hypothesizing that their combination would be more efficacious than either alone. Methods The effects of naltrexone and topiramate on ethanol consumption were examined in alcohol preferring (P) rats (N=10) and in rats from their background strain (Wistar, N=9) using conditions that induce high levels of consumption (24-hr, 3-bottle, free-choice procedure). Low doses of each medication (1 mg/kg, naltrexone; 10 mg/kg, topiramate) were selected in an attempt to maximize their combined efficacy while minimizing potential side-effects. Their effects on ethanol reinforcement were assessed under a progressive-ratio schedule in additional groups of (N=22) P rats. A moderate dose of topiramate (20 mg/kg) was also included to verify topiramate’s efficacy on its own. Results In P rats, but not Wistar rats, the combination effectively and persistently reduced consumption; whereas, neither dose alone was effective. The combination and naltrexone alone were equally effective at reducing ethanol reinforcement; however, with the combination, but not naltrexone alone, this effect was selective for ethanol. All treatments produced a similar decrease in home-cage food consumption. The 20 mg/kg dose of topiramate also effectively reduced ethanol consumption and reinforcement. Conclusions With greater efficacy and fewer side-effects, the combination shows promise as a treatment for AUDs. PMID:24252444

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

PubMed

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

2016-04-01

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

Overview of clinical use and side effect profile of valsartan in Chinese hypertensive patients

PubMed Central

Huang, Qi-Fang; Li, Yan; Wang, Ji-Guang

2014-01-01

We reviewed the Chinese and English literature for the efficacy and safety data of valsartan monotherapy or combination therapy in Chinese hypertensive patients. According to the data of ten randomized controlled trials, valsartan monotherapy was as efficacious as another angiotensin receptor blocker or other classes of antihypertensive drugs, excepting the slightly inferior diastolic blood pressure-lowering effect in comparison with calcium channel blockers. According to the data of six randomized controlled trials, valsartan combination, with hydrochlorothiazide, amlodipine, or nifedipine gastrointestinal therapeutic system, was more efficacious than monotherapy of valsartan, amlodipine, or nifedipine gastrointestinal therapeutic system. According to these trials, valsartan had an acceptable tolerability, regardless of whether it was used as monotherapy or in combination therapy. Nonetheless, several rare side effects have been reported, indicating that it should still be used with caution. This is of particular importance given that there are millions of hypertensive patients, worldwide, currently exposed to the drug. PMID:24403822

Efficacy and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen.

PubMed

Ertzgaard, Per; Campo, Claudia; Calabrese, Alessandra

2017-03-06

Oral baclofen has long been a mainstay in the management of spasticity. This review looks at the clinical evidence for the efficacy and safety of oral baclofen in patients with spasticity of any origin or severity, to determine whether there is a rationale for the use of intrathecal baclofen. Results suggest that oral baclofen may be effective in many patients with spasticity, regardless of the underlying disease or severity, and that it is at least comparable with other antispasmodic agents. However, adverse effects, such as muscle weakness, nausea, somnolence and paraesthesia, are common with oral baclofen, affecting between 25% and 75% of patients, and limiting its usefulness. Intrathecal baclofen may be an effective alternative as the drug is delivered directly into the cerebrospinal fluid, thus bypassing the blood-brain barrier and thereby optimizing the efficacy of baclofen while minimizing drug-related side-effects. Intrathecal baclofen is a viable option in patients who experience intolerable side-effects or who fail to respond to the maximum recommended dose of oral baclofen.

[Ferrous sulfate in the treatment of iron deficiency anemia: The positions continue].

PubMed

Dvoretsky, L I

The paper discusses treatment strategy and tactics for iron deficiency anemia. It gives data on the comparative efficacy of different iron sulfate drugs, their bioavailability, effects on peroxidation processes, and side effects. The paper also considers the clinical significance of a dosage form of iron-containing drugs with a sustained iron release, as well as ways to reduce the frequency and magnitude of side effects when ferrous sulfate is used.

Slow infusion of low{\\hyphen}dose ketamine reduces bothersome side effects compared to IV push: a double{\\hyphen}blind, double dummy, randomized controlled trial.

PubMed

Clattenburg, Eben J; Hailozian, Christian; Haro, Daniel; Yoo, Tina; Flores, Stefan; Louie, Derex; Herring, Andrew A

2018-04-12

We compared the analgesic efficacy and incidence of side effects when low{\\hyphen}dose (0.3 mg{\\sol}kg) ketamine (LDK) is administered as a slow infusion (SI) over 15 minutes versus an intravenous push (IVP) over one minute. This was a prospective, randomized, double blind, double dummy, placebo{\\hyphen}controlled trial of adult ED patients presenting with moderate to severe pain (numerical rating score ≥ 5). Patients received ketamine 0.3mg{\\sol}kg administered either as a SI or IVP. Our primary outcome was the proportion of patients experiencing any psychoperceptual side effect over 60 minutes. A secondary outcome was incidence of moderate or greater psychoperceptual side effects. Additional outcomes included reduction in pain NRS scores at 60 minutes and percent maximum summed pain intensity difference ({\\percnt}SPID). Fifty{\\hyphen}nine participants completed the study. 86.2{\\percnt} of the IVP arm and 70.0{\\percnt} of the SI arm experienced any side effect (difference 16.2{\\percnt}, 95{\\percnt}CI {\\hyphen}5.4 - 37.8). We found a large reduction in moderate or greater psychoperceptual side effects with SI administration-75.9{\\percnt} reported moderate or greater side effects versus 43.4{\\percnt} in the SI arm (difference 32.5{\\percnt}, 95{\\percnt}CI 7.9 - 57.1). Additionally, the IVP arm experienced more hallucinations (n{\\equal}8, 27.6{\\percnt}) than the SI arm (SI n{\\equal}2, 6.7{\\percnt}; difference 20.9{\\percnt}, 95{\\percnt}CI 1.8 - 43.4). We found no significant differences in analgesic efficacy. At 60 minutes, the mean {\\percnt}SPID in the IVP and SI arms was 39.9{\\percnt} and 33.5{\\percnt}, respectively, with a difference of 6.5{\\percnt} (95{\\percnt}CI {\\hyphen}5.8 - 18.7). Most patients who are administered LDK experience a psychoperceptual side effect regardless of administration via SI or IVP. However, patients receiving LDK as a SI reported significantly fewer moderate or greater psychoperceptual side effects and hallucinations with equivalent analgesia. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Chronic cannabinoid CB2 activation reverses paclitaxel neuropathy without tolerance or CB1-dependent withdrawal

PubMed Central

Deng, Liting; Guindon, Josée; Cornett, Benjamin L.; Makriyannis, Alexandros; Mackie, Ken; Hohmann, Andrea G.

2014-01-01

Background Mixed cannabinoid CB1/CB2 agonists such as Δ9-tetrahydrocannabinol (Δ9-THC) can produce tolerance, physical withdrawal, and unwanted CB1-mediated central nervous system side effects. Whether repeated systemic administration of a CB2-preferring agonist engages CB1 receptors or produces CB1-mediated side effects is unknown. Methods We evaluated anti-allodynic efficacy, possible tolerance, and cannabimimetic side effects of repeated dosing with a CB2-preferring agonist AM1710 in a model of chemotherapy-induced neuropathy produced by paclitaxel using CB1KO, CB2KO, and WT mice. Comparisons were made with the prototypic classical cannabinoid Δ9-THC. We also explored the site and possible mechanism of action of AM1710. Results Paclitaxel-induced mechanical and cold allodynia developed equivalently in CB1KO, CB2KO, and WT mice. Both AM1710 and Δ9-THC suppressed established paclitaxel-induced allodynia in WT mice. Unlike Δ9-THC, chronic AM1710 did not engage CB1 activity or produce antinociceptive tolerance, CB1-mediated cannabinoid withdrawal, hypothermia, or motor dysfunction. Anti-allodynic efficacy of systemic AM1710 was absent in CB2KO mice or WT mice receiving the CB2 antagonist AM630, administered either systemically or intrathecally. Intrathecal AM1710 also attenuated paclitaxel-induced allodynia in WT but not CB2KO mice, implicating a possible role for spinal CB2 receptors in AM1710 anti-allodynic efficacy. Finally, both acute and chronic treatment with AM1710 decreased mRNA levels of tumor necrosis factor alpha and monocyte chemoattractant protein-1 in lumbar spinal cord of paclitaxel-treated WT mice. Conclusions Our results highlight the potential of prolonged use of CB2 agonists for managing chemotherapy-induced allodynia with a favorable therapeutic ratio marked by sustained efficacy and absence of tolerance, physical withdrawal, or CB1-mediated side effects. PMID:24853387

Comparison of efficacy and side-effect profile of oral PUVA vs. oral PUVA sol in the treatment of vitiligo: a 36-week prospective study.

PubMed

Singh, S; Khandpur, S; Sharma, V K; Ramam, M

2013-11-01

Both Oral PUVA and PUVA sol have been successfully used in vitiligo treatment. However, there is paucity of studies comparing the two therapies, especially under subtropical conditions of abundant sunlight where PUVA sol is more feasible. To compare the efficacy and side effects of oral PUVA versus oral PUVA sol therapy in generalized vitiligo. Comparative prospective clinical trial conducted on consecutive patients of generalized vitiligo. Response to treatment was assessed using change in Lund & Browder (L & B) score for assessment of reduction in body surface area of involvement, patient global assessment (PGA) of improvement in vitiligo, investigator's global assessment (IGA) of extent of repigmentation, and quality of life (QOL) assessment using Tjioe et al questionnaire. Thirty five patients were recruited- 18 in PUVA and 17 in PUVA sol group. Mean percentage change in L & B score at 36 weeks was 46.4% in PUVA and 26.1% in PUVA sol group (P = 0.06), mean PGA score in PUVA was 4.58 ± 2.23 and in PUVA sol group was 6 ± 2.08 (P = 0.13), mean IGA score was 3.08 ± 1.68 in PUVA and 1.79 ± 0.57 in PUVA sol group (P = 0.11). QOL scores were significantly higher in PUVA group as compared to the PUVA sol group (P = 0.04). Side effects were comparable in two groups except for phototoxic side effects which were significantly more in PUVA group. PUVA is more efficacious than PUVA sol and also provides greater psychological benefit in treatment of generalized vitiligo but is associated with more phototoxic adverse effects. © 2012 The Authors. Journal of the European Academy of Dermatology and Venereology © 2012 European Academy of Dermatology and Venereology.

Neural mechanisms associated with treatment decision making: An fMRI study.

PubMed

Abidi, Malek; Bruce, Jared; Le Blanche, Alain; Bruce, Amanda; Jarmolowicz, David P; Csillik, Antonia; Thai, N Jade; Lim, Seung-Lark; Heinzlef, Olivier; de Marco, Giovanni

2018-04-23

Great progress has been made in understanding how people make financial decisions. However, there is little research on how people make health and treatment choices. Our study aimed to examine how participants weigh benefits (reduction in disease progression) and probability of risk (medications' side effects) when making hypothetical treatment decisions, and to identify the neural networks implicated in this process. Fourteen healthy participants were recruited to perform a treatment decision probability discounting task using MRI. Behavioral responses and skin conductance responses (SCRs) were measured. A whole brain analysis were performed to compare activity changes between "mild" and "severe" medications' side effects conditions. Then, orbitofrontal cortex (OFC), ventral striatum (VS), amygdala and insula were chosen for effective connectivity analysis. Behavioral data showed that participants are more likely to refuse medication when side effects are high and efficacy is low. SCRs values were significantly higher when people made medication decisions in the severe compared to mild condition. Functionally, OFC and VS were activated in the mild condition and were associated with increased likehood of choosing to take medication (higher area under the curve "AUC" side effects/efficacy). These regions also demonstrated an increased effective connectivity when participants valued treatment benefits. By contrast, the OFC, insula and amygdala were activated in the severe condition and were associated with and increased likelihood to refuse treatment. These regions showed enhanced effective connectivity when participants were confronted with increased side effects severity. This is the first study to examine the behavioral and neural bases of medical decision making. Copyright © 2018 Elsevier B.V. All rights reserved.

Comparison of injectable molindone and haloperidol followed by oral dosage forms in acutely ill schizophrenics.

PubMed

Escobar, J I; Mann, J J; Keller, J; Wilkins, J; Mason, B; Mills, M J

1985-08-01

The comparative efficacy of molindone and haloperidol, given by injection for the first 2-3 days of hospitalization and then continued orally for up to 4 weeks, is reported from an ongoing double-blind study. Efficacy and side effects were assessed by the Brief Psychiatric Rating Scale, Clinical Global Impressions, Treatment Emergent Symptom Scale, and Target Symptom Ratings. Analyses based on the first 35 patients who entered the study indicate that both drugs were effective and well tolerated. There were slight advantages for molindone early during the injectable phase of treatment and for haloperidol late during the oral portion of the study, but these differences were not clinically significant. No significant differences in side effects were found between the two drugs.

Anma massage (Japanese massage) therapy for patients with Parkinson's disease in geriatric health services facilities: Effectiveness on limited range of motion of the shoulder joint.

PubMed

Suoh, Sachie; Donoyama, Nozomi; Ohkoshi, Norio

2016-04-01

To determine the efficacy of Anma massage therapy for patients with Parkinson's disease (PD) in geriatric health services facilities. (1) Immediate treatment effects: 10 PD patients, in the intervention period with Hoehn and Yahr (H&Y) scale at stage 5, received 30-40 min sessions of Anma massage therapy. In the non-intervention period, six PD patients did not undergo this therapy. The shoulder joint range of motion (ROM) was measured before and after each session. (2) Continuous treatment effects: Six PD patients in the intervention period received the same massage sessions once a week continuously for seven weeks. One week after the completion of the treatment, the ROM of the shoulder joints was measured. (1) Shoulder abduction on the more affected side showed immediate significant improvements. (2) Shoulder abduction on the more affected side and less affected side showed notable effects of continuous treatment procedure leading to significant improvement. The above results suggested the efficacy of successive Anma massage therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

Administration of ketamine for unipolar and bipolar depression.

PubMed

Kraus, Christoph; Rabl, Ulrich; Vanicek, Thomas; Carlberg, Laura; Popovic, Ana; Spies, Marie; Bartova, Lucie; Gryglewski, Gregor; Papageorgiou, Konstantinos; Lanzenberger, Rupert; Willeit, Matthäus; Winkler, Dietmar; Rybakowski, Janusz K; Kasper, Siegfried

2017-03-01

Clinical trials demonstrated that ketamine exhibits rapid antidepressant efficacy when administered in subanaesthetic dosages. We reviewed currently available literature investigating efficacy, response rates and safety profile. Twelve studies investigating unipolar, seven on bipolar depression were included after search in medline, scopus and web of science. Randomized, placebo-controlled or open-label trials reported antidepressant response rates after 24 h on primary outcome measures at 61%. The average reduction of Hamilton Depression Rating Scale (HAM-D) was 10.9 points, Beck Depression Inventory (BDI) 15.7 points and Montgomery-Asberg Depression Rating Scale (MADRS) 20.8 points. Ketamine was always superior to placebo. Most common side effects were dizziness, blurred vision, restlessness, nausea/vomiting and headache, which were all reversible. Relapse rates ranged between 60% and 92%. To provide best practice-based information to patients, a consent-form for application and modification in local language is included. Ketamine constitutes a novel, rapid and efficacious treatment option for patients suffering from treatment resistant depression and exhibits rapid and significant anti-suicidal effects. New administration routes might serve as alternative to intravenous regimes for potential usage in outpatient settings. However, long-term side effects are not known and short duration of antidepressant response need ways to prolong ketamine's efficacy.

Pulse duration settings in subthalamic stimulation for Parkinson's disease

PubMed Central

Steigerwald, Frank; Timmermann, Lars; Kühn, Andrea; Schnitzler, Alfons; Reich, Martin M.; Kirsch, Anna Dalal; Barbe, Michael Thomas; Visser‐Vandewalle, Veerle; Hübl, Julius; van Riesen, Christoph; Groiss, Stefan Jun; Moldovan, Alexia‐Sabine; Lin, Sherry; Carcieri, Stephen; Manola, Ljubomir

2017-01-01

ABSTRACT Background Stimulation parameters in deep brain stimulation (DBS) of the subthalamic nucleus for Parkinson's disease (PD) are rarely tested in double‐blind conditions. Evidence‐based recommendations on optimal stimulator settings are needed. Results from the CUSTOM‐DBS study are reported, comparing 2 pulse durations. Methods A total of 15 patients were programmed using a pulse width of 30 µs (test) or 60 µs (control). Efficacy and side‐effect thresholds and unified PD rating scale (UPDRS) III were measured in meds‐off (primary outcome). The therapeutic window was the difference between patients’ efficacy and side effect thresholds. Results The therapeutic window was significantly larger at 30 µs than 60 µs (P = ·0009) and the efficacy (UPDRS III score) was noninferior (P = .00008). Interpretation Subthalamic neurostimulation at 30 µs versus 60 µs pulse width is equally effective on PD motor signs, is more energy efficient, and has less likelihood of stimulation‐related side effects. © 2017 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. PMID:29165837

Drug Treatment for Androgenetic Alopecia: First Italian Questionnaire Survey on What Dermatologists Think about Finasteride.

PubMed

Sorbellini, Elisabetta; Pinto, Daniela; Marzani, Barbara; Rinaldi, Fabio

2018-06-01

Treatment with finasteride 1 mg/day represents the therapy of choice for androgenetic alopecia (AGA). We investigated how Italian dermatologists approach use of finasteride for treatment of AGA and common side effects reported by patients. A tablet-based survey was conducted from February 2017 to January 2018 in Italy to investigating use of 1 mg/day finasteride in the treatment of AGA. Approximately 1153 Italian dermatologists were surveyed about prescription frequency, therapy duration, treatment practices, and side effects eventually reported. Dermatologists considered treatment with 1 mg/day finasteride to be the most efficacious treatment for AGA, as reflecting by its long-term (5 years) prescription. Data on sexual side effects from our survey are in line with previous scientific evidence, especially regarding loss of libido, erectile dysfunction, and problems with ejaculation, but also in the psychological sphere and regarding physical impairments such as myalgia and loss of muscle tone. This is the first preliminary observational study on how Italian dermatologists approach use of finasteride to treat AGA. Although side effects have been reported, especially in the sexual sphere, lack of alternative treatments with the same efficacy leads dermatologists to prescribe 1 mg/day finasteride with a tendency to prolong therapy in the long term. Giuliani S.p.A.

The efficacy in melasma treatment using a 1410 nm fractional photothermolysis laser.

PubMed

Wanitphakdeedecha, R; Keoprasom, N; Eimpunth, S; Manuskiatti, W

2014-03-01

Melasma treatment modalities including topical and procedural therapy have been employed with variable results and high recurrence rate. To quantitatively assess improvement in melasma and side effects after 1410 nm fractional photothermolysis laser treatments and to determine efficacy at 1-, 2- and 3-month follow-up after treatment. Thirty volunteers with melasma were treated with 1410 nm fractional photothermolysis for four passes on full face and additional four passes on melasma area. They were randomly treated on one side of their face with 20 mJ at 5% coverage and the other side of their face with 20 mJ at 20% coverage. All subjects were treated monthly for five times. Melanin index, Visual analogue scale and Melasma Area and Severity Index score were measured at baseline and 1-, 2- and 3-month follow-up after complete treatment protocol. There was statistically significant improvement of Melanin index at 2- and 3-month follow-up visits, but not at 1-month follow-up visit. Visual analogue scale and Melasma Area and Severity Index score improved significantly on both sides at 1-, 2- and 3-month follow-ups. The overall patients' satisfaction was significantly higher on the side treated with 20 mJ, 5% coverage. Adverse reactions included erythema, dryness and post-inflammatory hyperpigmentation on melasma area. Those side effects were significantly more intense on the side treated with 20 mJ, 20% coverage. 1410 nm fractional photothermolysis laser treatment is a safe and temporary effective procedure for melasma; however, long-term follow-up is still needed. Only 5% coverage should be used to minimize risks of adverse effects. © 2013 The Authors Journal of the European Academy of Dermatology and Venereology © 2013 European Academy of Dermatology and Venereology.

Large-scale exploration and analysis of drug combinations.

PubMed

Li, Peng; Huang, Chao; Fu, Yingxue; Wang, Jinan; Wu, Ziyin; Ru, Jinlong; Zheng, Chunli; Guo, Zihu; Chen, Xuetong; Zhou, Wei; Zhang, Wenjuan; Li, Yan; Chen, Jianxin; Lu, Aiping; Wang, Yonghua

2015-06-15

Drug combinations are a promising strategy for combating complex diseases by improving the efficacy and reducing corresponding side effects. Currently, a widely studied problem in pharmacology is to predict effective drug combinations, either through empirically screening in clinic or pure experimental trials. However, the large-scale prediction of drug combination by a systems method is rarely considered. We report a systems pharmacology framework to predict drug combinations (PreDCs) on a computational model, termed probability ensemble approach (PEA), for analysis of both the efficacy and adverse effects of drug combinations. First, a Bayesian network integrating with a similarity algorithm is developed to model the combinations from drug molecular and pharmacological phenotypes, and the predictions are then assessed with both clinical efficacy and adverse effects. It is illustrated that PEA can predict the combination efficacy of drugs spanning different therapeutic classes with high specificity and sensitivity (AUC = 0.90), which was further validated by independent data or new experimental assays. PEA also evaluates the adverse effects (AUC = 0.95) quantitatively and detects the therapeutic indications for drug combinations. Finally, the PreDC database includes 1571 known and 3269 predicted optimal combinations as well as their potential side effects and therapeutic indications. The PreDC database is available at http://sm.nwsuaf.edu.cn/lsp/predc.php. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Efficacy and safety of rectal thiopental sedation in outpatient echocardiographic examination of children.

PubMed

Okutan, V; Lenk, M K; Sarici, S U; Dündaröz, R; Akin, R; Gökçay, E

2000-11-01

The efficacy and safety of rectal thiopental administration in sedation for paediatric echocardiographic examination were prospectively investigated in infants with known or suspected congenital heart disease in an outpatient manner. A total of 1150 patients (546F, 604M) were studied; 264 were 7 d to 6 mo old (group I), 572 were 6 mo to 2-y-old (group II), and 314 were 2 to 6-y-old (group III). Thiopental sodium dissolved in 10 ml of water in a syringe to which a 6-F feeding catheter was attached was administered prior to echocardiographic examination to patients in groups I, II and III with doses of 50, 35 and 25 mg/kg, respectively in an emergency care environment. Length of time to achieve sedation (induction time), duration of sedation, length of time to return to normal activity (recovery time), whether sedation was successful and side effects were recorded. In the overall study population, sedation was successful in 1094 (95.1%) of the patients, the induction time was 16.34 +/- 3.69 min, the duration of sedation was 35.07 +/- 7.04 min, the recovery time was 63.25 +/- 10.17 min and the overall side-effect prevalence was 2%. Sedation was significantly more successful, the induction time was significantly shorter, the recovery time was significantly longer and side effects significantly more prominent in groups I and II compared to group III. Rectally administered thiopental is a safe and efficacious agent for sedation of infants and young children with known or suspected congenital heart disease who are undergoing echocardiography in an outpatient cardiology clinic, provided that it is used in an emergency care setting considering the risk of respiratory depression even though the prevalence of this side effect is significantly low.

A survey of awareness related to the use of antibiotics for dental issues among non-medical female university students in Riyadh, Saudi Arabia.

PubMed

Abu-Mostafa, Nedal A; Al-Mejlad, Najmah J; Al-Yami, Amal S; Al-Sakhin, Fatimah Z; Al-Mudhi, Shahad A

Inappropriate use of antibiotics may lead to adverse side effects. This cross-sectional survey aimed to investigate the knowledge and attitude of female non-medical students regarding the medical and dental use of antibiotics. Four hundred validated self-administered questionnaires were distributed in Princess Norah Bint-Abdurrahman University, Riyadh, Saudi Arabia. The questionnaire included questions about accessibility, attitude toward usage, efficacy, side effects, resistance, and usage for dental issues. Knowledge was estimated for every respondent by counting the correct answers, which were considered as points. The scores were categorized as poor, moderate, and high. Of the respondents, 77.8% answered they get antibiotics according to a doctor's prescription; however, 31% stops taking antibiotics when they feel well. Only 38.8% of respondents knew that antibiotics may cause allergic reactions while 59.8% believed the human body can be resistant to antibiotics. The percentages of answers related to dental issues were: antibiotics relieve dental pain (68.8%), antibiotics can be harmful for children's teeth (27.3%), antibiotics are best avoided in pregnancy (56.7%) and no need for antibiotics after scaling (33.8%), root canal treatment (16%), or simple extraction (40.3%). Of respondents, 68% had poor scores about antibiotics efficacy, side effects, and resistance while 86.8% had poor scores related to dental problems. This study noticed a bad attitude related to antibiotics usage, with many misconceptions and poor knowledge. Moreover, the necessity of antibiotics for treatment of dental disease or after dental procedures was totally unclear for the respondents. Community campaigns are recommended every university semester to educate students about the indications, efficacy, and side effects of antibiotics. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

AN OBSERVATIONAL STUDY OF SOCIAL CONTROL, MOOD, AND SELF-EFFICACY IN COUPLES DURING TREATMENT FOR HEAD AND NECK CANCER

PubMed Central

BADR, HODA; YEUNG, CHI; LEWIS, MEGAN A.; MILBURY, KATHRIN; REDD, WILLIAM H.

2014-01-01

OBJECTIVE Head and neck cancer (HNC) patients experience debilitating side effects, including abnormally reduced salivation and difficulty swallowing. Intensive self-care protocols are prescribed to control side effects and minimize discomfort, but non-adherence rates are high. Although spouses are in a prime position to encourage adherence, studies have yet to examine how spouse social control (i.e., attempts to influence patient behavior to support adherence) affects HNC patient mood and self-efficacy for engaging in these self-care routines. METHODS One-hundred twenty-five HNC couples where the patient (86% male) was undergoing radiotherapy were recorded in the laboratory as they discussed a cancer-related issue that the patient identified as being a topic of concern. RESULTS Sixty-eight couples discussed side-effects and spouses engaged in social control in 61 of these discussions. Although oral complications and pain were frequently identified by patients as being topics of concern, dental/oral care and pain management were some of the least likely self-care behaviors to be targeted by spouses, who focused primarily on encouraging patients to maintain their weight and hydration. Although spouses engaged in an almost equal number of positive and negative control attempts, only positive control was significantly (p<.05) associated with patient positive mood and self-efficacy. CONCLUSION HNC couples may benefit from programs that emphasize the regular practice of self-care routines to control oral side effects, pain, and nutrition/hydration problems. Likewise, programs that encourage spouses to maximize their use of positive social control may also boost patients’ mood during treatment and empower them to engage in recommended self-care behaviors. PMID:25471820

Is pain relief equally efficacious and free of side effects with repeated doses of oral sucrose in preterm neonates?

PubMed

Gaspardo, Cláudia Maria; Miyase, Catia Isumi; Chimello, Juliana Thomazatti; Martinez, Francisco Eulógio; Martins Linhares, Maria Beatriz

2008-07-01

The aim of the present study was to examine the efficacy and potential side effects of repeated doses of oral sucrose for pain relief during procedures in NICU. Thirty-three preterm neonates were randomly allocated in blind fashion into two groups, the sucrose group (SG=17) and the control group (CG=16). The responses of neonates to pain and distress were assessed during blood collection on four consecutive assessment (ass.) days. For the first assessment, the neonates did not receive any solution before the blood collection procedure. During the next three days, the SG received oral sucrose (25%; 0.5 ml/kg) and the CG received sterile water, 2 min before each minor acute painful procedure. The neonates were evaluated during blood collection each morning. The assessment was divided into five phases: Baseline (BL), Antisepsis (A), Puncture (P), Dressing (D), and Recovery (R). The neonates' facial activity (NFCS), behavioral state, and heart rate were evaluated. The data analysis used cut-off scores for painful and distressful responses. No side effects of using sucrose were detected. There were significantly fewer SG neonates with facial actions signaling pain than CG neonates in P (ass.2) and in A (ass.3). We found significantly fewer SG neonates in the awake state than CG neonates in P (ass.2 and ass.4). There were significantly fewer SG neonates crying during A (ass.2), P (ass.2 and ass.4), and D (ass.3). There was no statistical difference between-groups for physiological response. The efficacy of sucrose was maintained for pain relief in preterm neonates with no side effects.

Nanotechnological advances for cutaneous release of tretinoin: an approach to minimize side effects and improve therapeutic efficacy.

PubMed

Raminelli, Ana Claudia Pompeu; Romero, Valeria; Semreen, Mohammad H; Leonardi, Gislaine Ricci

2018-03-12

The clinical efficacy of the topical tretinoin is widely studied and has been well established for many therapeutic interventions, among some, photoaging, acne, and melasma. However, the side effects, mainly cutaneous irritation, erythema, xerosis and peeling, remain major obstacle to the patient compliance. Besides, the insight regarding the drug delivery profile is essential to understand the therapeutic action of the drug. Herein we highlight further advances and an update on tretinoin delivery systems such as liposomes, niosomes, solid lipid nanoparticles, nanostructured lipid carriers, cyclodextrins, nanostructured polymers and other technological systems that reduce its side effects and improve the permeation profile to potentiate efficacy and drug safety on the skin. Pharmaceutical preparations were developed and evaluated for permeability in in vitro models using pig ear, snake, mouse and human skin, and potential for irritation was also verified using release systems for tretinoin and compared to available commercial formulations. Overall results indicated the composition, charge and size of the system influences the tretinoin delivery, modulating the type of release and its retention. Small unilamellar vesicles promoted greater cutaneous delivery of tretinoin. Negative charge, for both liposomes and niosomes, can improve pig skin hydration as well as the tretinoin retention. The quantity of solid lipids and the type of oil used in the composition of solid lipid nanoparticles and nanostructured lipid carriers affected percutaneous drug delivery. As evident from the literature, the tretinoin technological delivery systems consist an innovative and potential management for increasing the patient compliance presenting safety and efficacy. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A comparison of the efficacy and tolerability of oxcarbazepine oral suspension between infants and children with epilepsy: a retrospective chart review at a single medical center in Taiwan.

PubMed

Wei, Shu-Hao; Liu, Cheng-Chao; Fan, Pi-Chuan

2014-02-01

Few clinical studies have assessed the efficacy and safety of oxcarbazepine (OXC) oral suspension in Asian pediatric patients and particularly in infants. The aim of this study was to investigate and compare the efficacy, tolerability, and side effects of OXC oral suspension in Taiwanese infants and children with various types of epilepsy. A retrospective review of the efficacy, tolerability, and side effects of OXC oral suspension in a tertiary medical center in Taiwan was conducted and included children (1-9 years old) and infants (<1 year old) diagnosed with epilepsy, which was classified into idiopathic partial, symptomatic partial, or multifocal subtypes. The OXC oral suspension (Trileptal(®); Novartis) was given in a gradual dose titration, from an initial 7.5 mg/kg/day to 30 mg/kg/day within 1 month in all cases. A total of 20 infants and 38 children were identified. There were no statistically significant differences between the children and infants in efficacy (75 vs. 82 %, p = 0.734) and adverse effects (30 vs. 21 %, p = 0.525) after OXC oral suspension treatment. The efficacy was significantly correlated with the epilepsy subtype (p < 0.01) and the number of combined antiepileptic drugs (AEDs) before OXC treatment (p < 0.01) in both groups. The patients with idiopathic and symptomatic partial epilepsy responded better to OXC oral suspension than those with multifocal epilepsy. OXC oral suspension is effective and well tolerated in both infants and children with partial epilepsy in Taiwan. Treatment efficacy was related to epilepsy subtype and number of combined AEDs before OXC treatment. Monotherapy had an excellent therapeutic response in partial epilepsy but not in multifocal epilepsy.

A Partnership Training Program: Studying Targeted Drug Delivery Using Nanoparticles In Breast Cancer Diagnosis and Therapy

DTIC Science & Technology

2015-12-01

have been approved by FDA or are under development. Their use aims to minimize drug degradation, prevent undesirable side effects , and increase drug...efficacy, while simultaneously reducing side effects , owing to properties such as more targeted localization in tumors and active cellular uptake...with Dr. Vreeland suggested that the lipid was below the transition temperature of the lipid, which likely contributed to the poor size distribution

Unilateral ultra-brief pulse electroconvulsive therapy for depression in Parkinson's disease.

PubMed

Williams, N R; Bentzley, B S; Sahlem, G L; Pannu, J; Korte, J E; Revuelta, G; Short, E B; George, M S

2017-04-01

Electroconvulsive therapy (ECT) has demonstrated efficacy in treating core symptoms of Parkinson's disease (PD); however, widespread use of ECT in PD has been limited due to concern over cognitive burden. We investigated the use of a newer ECT technology known to have fewer cognitive side effects (right unilateral [RUL] ultra-brief pulse [UBP]) for the treatment of medically refractory psychiatric dysfunction in PD. This open-label pilot study included 6 patients who were assessed in the motoric, cognitive, and neuropsychiatric domains prior to and after RUL UBP ECT. Primary endpoints were changes in total score on the HAM-D-17 and GDS-30 rating scales. Patients were found to improve in motoric and psychiatric domains following RUL UBP ECT without cognitive side effects, both immediately following ECT and at 1-month follow-up. This study demonstrates that RUL UBP ECT is safe, feasible, and potentially efficacious in treating multiple domains of PD, including motor and mood, without clear cognitive side effects. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Efficacy of side airbags in reducing driver deaths in driver-side car and SUV collisions.

PubMed

McCartt, Anne T; Kyrychenko, Sergey Y

2007-06-01

To estimate the efficacy of side airbags in preventing driver deaths in passenger vehicles struck on the driver side. Risk ratios for driver deaths per driver-side collision were computed for side airbag-equipped cars and SUVs, relative to vehicles without side airbags. Driver fatality ratios also were calculated for the same vehicles in front and rear impacts, and these were used to adjust the side crash risk ratios for differences in fatality risk unrelated to side airbags. Risk ratios were calculated separately for side airbags providing torso-only protection and side airbags with head protection; almost all head protecting airbags also had airbags protecting the torso. Car driver death risk in driver-side crashes was reduced by 37 percent for head protecting airbags and 26 percent for torso-only side airbags. Car driver death risk was reduced for older and younger drivers, males and females, and drivers of small and midsize cars, and when the striking vehicle was an SUV/pickup or a car/minivan. Death risk for drivers of SUVs was reduced by 52 percent with head protecting side airbags and by 30 percent with torso-only airbags. The effectiveness of side airbags could not be assessed for pickups and minivans due to the small number of these vehicles with airbags involved in crashes. Side airbags substantially reduce the risk of car and SUV driver death in driver-side collisions. Making side airbags with head protection available to drivers and right front passengers in all passenger vehicles could reduce the number of fatalities in motor vehicle crashes in the United States by about 2,000 each year.

Long-term safety and efficacy of budesonide in the treatment of ulcerative colitis

PubMed Central

Iborra, Marisa; Álvarez-Sotomayor, Diego; Nos, Pilar

2014-01-01

Ulcerative colitis (UC) is a chronic, relapsing, and remitting inflammatory disease involving the large intestine (colon). Treatment seeks to break recurrent inflammation episodes by inducing and maintaining remission. Historically, oral systemic corticosteroids played an important role in inducing remission of this chronic disease; however, their long-term use is limited and can lead to adverse events. Budesonide is a synthetic steroid with potent local anti-inflammatory effects and low systemic bioavailability due to high first-pass hepatic metabolism. Several studies have demonstrated oral budesonide’s usefulness in treating active mild to moderate ileocecal Crohn’s disease and microscopic colitis and in an enema formulation for left sided UC. However, there is limited information regarding oral budesonide’s efficacy in UC. A novel oral budesonide formulation using a multimatrix system (budesonide-MMX) to extend drug release throughout the colon has been developed recently and seems to be an effective treatment in active left sided UC patients. This article summarizes budesonide’s long-term safety and efficacy in treating UC. PMID:24523594

Novel liposomal technology applied in esophageal cancer treatment

NASA Astrophysics Data System (ADS)

Yeh, Chia-Hsien; Hsieh, Yei-San; Yang, Pei-wen; Huang, Leaf; Hsu, Yih-Chih

2018-02-01

Cisplatin (CDDP) has been commonly used as a chemotherapeutic drug, mainly used for the treatment of malignant epithelial cell tumors. We have developed a new method based on innovative lipid calcium phosphate, which encapsulated hydrophobic drugs to form liposomal nanoparticles. Esophageal cancer xenograft model was used to investigate the efficacy of liposomal nanoparticles. and it showed good therapeutic efficacy with lower side effects. Liposomal nanoparticles exhibited a better therapeutic effect than that of conventional CDDP.

Chemical form of selenium affects its uptake, transport, and glutathione peroxidase activity in the human intestinal Caco-2 cell model.

PubMed

Zeng, Huawei; Jackson, Matthew I; Cheng, Wen-Hsing; Combs, Gerald F

2011-11-01

Determining the effect of selenium (Se) chemical form on uptake, transport, and glutathione peroxidase activity in human intestinal cells is critical to assess Se bioavailability at nutritional doses. In this study, we found that two sources of L-selenomethionine (SeMet) and Se-enriched yeast each increased intracellular Se content more effectively than selenite or methylselenocysteine (SeMSC) in the human intestinal Caco-2 cell model. Interestingly, SeMSC, SeMet, and digested Se-enriched yeast were transported at comparable efficacy from the apical to basolateral sides, each being about 3-fold that of selenite. In addition, these forms of Se, whether before or after traversing from apical side to basolateral side, did not change the potential to support glutathione peroxidase (GPx) activity. Although selenoprotein P has been postulated to be a key Se transport protein, its intracellular expression did not differ when selenite, SeMSC, SeMet, or digested Se-enriched yeast was added to serum-contained media. Taken together, our data show, for the first time, that the chemical form of Se at nutritional doses can affect the absorptive (apical to basolateral side) efficacy and retention of Se by intestinal cells; but that, these effects are not directly correlated to the potential to support GPx activity.

Botulinum toxin injections for the treatment of hemifacial spasm over 16 years.

PubMed

Sorgun, Mine Hayriye; Yilmaz, Rezzak; Akin, Yusuf Alper; Mercan, Fatma Nazli; Akbostanci, Muhittin Cenk

2015-08-01

The aim of this study was to investigate the efficacy and side effects of botulinum toxin (BTX) in the treatment of hemifacial spasm (HFS). We also focused on the divergence between different injection techniques and commercial forms. We retrospectively evaluated 470 sessions of BTX injections administered to 68 patients with HFS. The initial time of improvement, duration and degree of improvement, and frequency and duration of adverse effects were analysed. Pretarsal and preseptal injections and Botox (Allergan, Irvine, CA, USA) and Dysport (Ipsen Biopharmaceuticals, Paris, France) brands were compared in terms of efficacy and side effects, accompanied by a review of papers which reported BTX treatment of HFS. An average of 34.5 units was used per patient. The first improvement was felt after 8 days and lasted for 14.8 weeks. Patients experienced a 73.7% improvement. In 79.7% of injections, no adverse effect was reported, in 4.9% erythema, ecchymosis, and swelling in the injection area, in 3.6% facial asymmetry, in 3.4% ptosis, in 3.2% diplopia, and in 2.3% difficulty of eye closure was detected. Patients reported 75% improvement on average after 314 sessions of pretarsal injections and 72.7% improvement after 156 sessions of preseptal injections (p=0.001). The efficacy and side effects of Botox and Dysport were similar. BTX is an effective and safe treatment option for HFS. No difference was determined between Botox and Dysport, and pretarsal injection is better than preseptal injection regarding the reported degree of improvement. Copyright © 2015 Elsevier Ltd. All rights reserved.

Drug and Nondrug Treatment in Tension-type Headache

PubMed Central

2009-01-01

Tension-type headache (TTH) is a common primary headache with tremendous socioeconomic impact. Establishment of an accurate diagnosis is important before initiation of any treatment. Nondrug management is crucial. Information, reassurance and identification of trigger factors may be rewarding. Psychological treatments with scientific evidence for efficacy include relaxation training, EMG biofeedback and cognitive-behavioural therapy. Physical therapy and acupuncture are widely used, but the scientific evidence for efficacy is sparse. Simple analgesics are the mainstays for treatment of episodic TTH. Combination analgesics, triptans, muscle relaxants and opioids should not be used, and it is crucial to avoid frequent and excessive use of simple analgesics to prevent the development of medication-overuse headache. The tricyclic antidepressant amitriptyline is drug of first choice for the prophylactic treatment of chronic TTH. The efficacy is modest and treatment is often hampered by side effects. Thus, treatment of frequent TTH is often difficult and multidisciplinary treatment strategies can be useful. The development of specific nonpharmacological and pharmacological managements for TTH with higher efficacy and fewer side effects is urgently needed. Future studies should also examine the relative efficacy of the various treatment modalities; for example, psychological, physical and pharmacological treatments, and clarify how treatment programs should be optimized to best suit the individual patient. PMID:21179525

Is side-viewing endoscope assisted balloon dilatation better for corrosive gastric outlet obstruction?

PubMed

Katiyar, Prashant; Nijhawan, Sandeep; Saradava, Vimal; Nagaich, Neeraj; Gupta, Gaurav; Mathur, Amit; Nepalia, Subhash

2013-11-01

Endoscopic balloon dilatation (EBD) is an effective therapy for caustic-induced gastric outlet obstruction (GOO). Gaining access to the stricture site is the most important step. It is sometimes difficult to negotiate a balloon through the stricture with a front-viewing endoscope due to deformed anatomy of stomach. To overcome this technical difficulty, a side-viewing endoscope can be used. There is limited data regarding the use of side-viewing endoscopes in EBD. We here report on the short-term efficacy and safety of EBD in caustic-induced GOO. In technically difficult cases, a side-viewing endoscope was used for EBD and its efficacy and safety were assessed. The study included 25 patients with caustic-induced GOO. Patients underwent EBD using a through-the-scope balloon. Initial balloon dilatation was performed with a front-viewing endoscope. A side-viewing endoscope was used where negotiation across the stricture failed with a front-viewing endoscope. Dilatation was started at 8 mm diameter and was performed at 1-week intervals. The end point of dilatation was 15 mm diameter. In 18 patients successful balloon dilatation was possible with a front-viewing endoscope. A side-viewing endoscope was used in six patients as negotiation across the stricture was not possible with a front-viewing endoscope. In all six patients negotiation across the stricture followed by successful dilatation was successful with a side-viewing endoscope. Of the 25 patients included in this study, 24 (96%) achieved procedural success (18 with a front-viewing endoscope and 6 with a side-viewing endoscope) in 3-9 sessions. Our results show that EBD is a safe and effective option for caustic-induced GOO and in difficult cases a side-viewing endoscope can be used to achieve technical success.

Carbon dioxide laser versus erbium:YAG laser in treatment of epidermal verrucous nevus: a comparative randomized clinical study.

PubMed

Osman, Mai Abdel Raouf; Kassab, Ahmed Nazmi

2017-08-01

A verrucous epidermal nevus (VEN) is a skin disorder that has been treated using different treatment modalities with varying results. Ablative lasers such as carbon dioxide laser (CO 2 ) and erbium:yttrium-aluminum-garnet (Er:YAG) laser have been considered as the gold standard for the treatment of epidermal nevi. To evaluate and compare the efficacy, postoperative wound healing and side effects of pulsed CO 2 laser and Er:YAG laser for the treatment of verrucous epidermal nevi. Twenty patients with localized VEN were randomly divided into two groups. Group 1 was administered CO 2 laser and group 2 underwent Er:YAG laser treatment. A blinded physician evaluated the photographs and dermoscopic photomicrographs for the efficacy and possible side effects. All patients received one treatment session and were followed up over a 6-month period. Both lasers induced noticeable clinical improvement, but there were no significant differences between two lasers in treatment response, patient satisfaction, duration of erythema and side effects. The average time to re-epithelialization was 13.5 days with CO 2 and 7.9 days with Er:YAG laser (p< .0005). No scarring was observed in Er:YAG laser group and no lesional recurrence was detected in CO 2 laser group since treatment. Apart from re-epithelialization, both lasers showed equivalent outcomes with respect to treatment response, patient satisfaction, side effects and complications.

Combination of CO2 and Q-switched Nd:YAG lasers is more effective than Q-switched Nd:YAG laser alone for eyebrow tattoo removal.

PubMed

Radmanesh, Mohammad; Rafiei, Zohreh

2015-04-01

The eyebrow tattoo removal using Q-switched lasers is usually prolonged. Other modalities may be required to enhance the efficacy and shorten the treatment course. To compare the efficacy of Q-switched neodymium-doped yttrium aluminum garnet (Nd:YAG) laser alone versus combination of Q-switched Nd:YAG and Ultrapulse CO2 lasers for eyebrow tattoo removal after a single session. After local anesthesia, the right eyebrow of 20 patients was treated with Ultrapulse CO2 laser with the parameters of 4 J/cm(2) and 3.2 J/cm(2) for the first and the second passes. Both eyebrows were then treated with 1064-nm and 532-nm Q-switched Nd:YAG laser. The spot size and pulse duration were 3 mm and 5 nanoseconds for both wavelengths, and the fluence was 7 J/cm(2) for 1064 nm and 3 J/cm (2) for 532 nm. The side treated with combination of Q-switched Nd:YAG and CO2 lasers improved 75-100% in 6 of 20 patients versus only 1 of 20 in the side treated with Q-switched Nd:YAG alone. Similarly, the right side in 13 of 20 patients showed more than 50% improvement with combination therapy versus the left side (the monotherapy side), where only 6 of 20 cases showed more than 50% improvement. The Mann-Whitney test was 2.85 for the right side and 1.95 for the left side (P value = 0.007). Using Ultra pulse CO2 laser enhances the efficacy of Q-switched Nd:YAG laser in eyebrow tattoo removal.

Selective Cathepsin S Inhibition with MIV-247 Attenuates Mechanical Allodynia and Enhances the Antiallodynic Effects of Gabapentin and Pregabalin in a Mouse Model of Neuropathic Pain.

PubMed

Hewitt, Ellen; Pitcher, Thomas; Rizoska, Biljana; Tunblad, Karin; Henderson, Ian; Sahlberg, Britt-Louise; Grabowska, Urszula; Classon, Björn; Edenius, Charlotte; Malcangio, Marzia; Lindström, Erik

2016-09-01

Cathepsin S inhibitors attenuate mechanical allodynia in preclinical neuropathic pain models. The current study evaluated the effects when combining the selective cathepsin S inhibitor MIV-247 with gabapentin or pregabalin in a mouse model of neuropathic pain. Mice were rendered neuropathic by partial sciatic nerve ligation. MIV-247, gabapentin, or pregabalin were administered alone or in combination via oral gavage. Mechanical allodynia was assessed using von Frey hairs. Neurobehavioral side effects were evaluated by assessing beam walking. MIV-247, gabapentin, and pregabalin concentrations in various tissues were measured. Oral administration of MIV-247 (100-200 µmol/kg) dose-dependently attenuated mechanical allodynia by up to approximately 50% reversal when given as a single dose or when given twice daily for 5 days. No behavioral deficits were observed at any dose of MIV-247 tested. Gabapentin (58-350 µmol/kg) and pregabalin (63-377 µmol/kg) also inhibited mechanical allodynia with virtually complete reversal at the highest doses tested. The minimum effective dose of MIV-247 (100 µmol/kg) in combination with the minimum effective dose of pregabalin (75 µmol/kg) or gabapentin (146 µmol/kg) resulted in enhanced antiallodynic efficacy without augmenting side effects. A subeffective dose of MIV-247 (50 µmol/kg) in combination with a subeffective dose of pregabalin (38 µmol/kg) or gabapentin (73 µmol/kg) also resulted in substantial efficacy. Plasma levels of MIV-247, gabapentin, and pregabalin were similar when given in combination as to when given alone. Cathepsin S inhibition with MIV-247 exerts significant antiallodynic efficacy alone, and also enhances the effect of gabapentin and pregabalin without increasing side effects or inducing pharmacokinetic interactions. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

Standing Up for the Victim, Siding with the Bully or Standing By? Bystander Responses in Bullying Situations

ERIC Educational Resources Information Center

Poyhonen, Virpi; Juvonen, Jaana; Salmivalli, Christina

2012-01-01

In this study we examined children's self-efficacy, outcome expectations, and outcome values in relation to bystander responses in bullying situations. We proposed that beyond the effect of self-efficacy, the decision to defend the victim of bullying vs. remain passive vs. reinforce the bully depends on outcomes children expect from defending, and…

Use of probiotics in the fight against Helicobacter pylori

PubMed Central

Ruggiero, Paolo

2014-01-01

After the discovery of Helicobacter pylori (H. pylori), and the evidence of its relationship with gastric diseases, antibiotic-based therapies were developed, which efficacy was however limited by antibiotic resistance and lack of patient compliance. A vaccine would overcome these drawbacks, but currently there is not any H. pylori vaccine licensed. In the frame of the studies aimed at finding alternative therapies or at increasing the efficacy of the current ones and/or reducing their side effects, the investigation on the use of probiotics plays an interesting role. In vitro and preclinical studies have shown the feasibility of this approach. Several clinical trials indicated that administration of probiotics can reduce the side effects of H. pylori eradication treatment, increasing tolerability, and often increases the overall efficacy. The results of these trials vary, likely reflecting the variety of probiotics assessed and that of the eradication treatment, as well as the differences in the geographic area that imply different H. pylori strains distribution, host susceptibility, and therapy efficacy. In conclusion, the use of probiotics appears promising as an adjuvant for the current H. pylori eradication treatment, though it still requires optimization. PMID:25400981

A post marketing survey on the side-effects of loxoprofen.

PubMed

Waikakul, S; Waikakul, W

1999-07-01

A survey study of the efficacy and side-effects of loxoprofen in orthopaedic outpatient clinics was carried out from January 1995 to December 1997. There were 1206 patients (569 males and 637 females) with an average age of 56.4 +/- 14.9 years. The youngest was 43 and the oldest was 79 years. About 36 per cent of the patients had underlying diseases and 31 per cent were receiving other medications as well as loxoprofen. About 91 per cent of the patients were satisfied with loxoprofen in terms of pain control and decreased inflammation. However, 8.4 per cent had side-effects, the most common being GI and CNS disturbances. Some patients (0.24%) had GI bleeding and needed hospitalization. The high risk patients were female older than 60 years who had used loxoprofen continuously for more than 6 weeks. However, we conclude that loxoprofen is an effective NSAID with few side-effects.

Effect of Primary Tumor Location on Second- or Later-line Treatment Outcomes in Patients With RAS Wild-type Metastatic Colorectal Cancer and All Treatment Lines in Patients With RAS Mutations in Four Randomized Panitumumab Studies.

PubMed

Boeckx, Nele; Koukakis, Reija; Op de Beeck, Ken; Rolfo, Christian; Van Camp, Guy; Siena, Salvatore; Tabernero, Josep; Douillard, Jean-Yves; André, Thierry; Peeters, Marc

2018-03-08

The primary tumor location has a prognostic impact in metastatic colorectal cancer (mCRC). We report the results from retrospective analyses assessing the effect of tumor location on prognosis and efficacy of second- and later-line panitumumab treatment in patients with RAS wild-type (WT) mCRC and on prognosis in all lines of treatment in patients with RAS mutant (MT) mCRC. RAS WT data (n = 483) from 2 randomized phase III panitumumab trials (ClinicalTrials.gov identifiers, NCT00339183 and NCT00113763) were analyzed for treatment outcomes stratified by tumor location. The second analysis assessed the effect of tumor location in RAS MT patients (n = 1205) from 4 panitumumab studies (ClinicalTrials.gov identifiers, NCT00364013, NCT00819780, NCT00339183, and NCT00113763). Primary tumors located in the cecum to transverse colon were coded as right-sided; those located from the splenic flexure to the rectum were coded as left-sided. Of all patients, the tumor location was ascertained for 83% to 88%; 71% to 77% of patients had left-sided tumors. RAS WT patients with right-sided tumors did worse for all efficacy parameters compared with those with left-sided tumors. The patients with left-sided tumors had better outcomes with panitumumab than with the comparator treatment. Because of the low patient numbers, no conclusions could be drawn for right-sided mCRC. The prognostic effect of tumor location on survival was unclear for RAS MT patients. These retrospective analyses have confirmed that RAS WT right-sided mCRC is associated with a poor prognosis, regardless of the treatment. RAS WT patients with left-sided tumors benefitted from the addition of panitumumab in second or later treatment lines. Further research is warranted to determine the optimum management of right-sided mCRC and RAS MT tumors. Copyright © 2018 Elsevier Inc. All rights reserved.

Comparison of dexpanthenol and zinc oxide ointment with ointment base in the treatment of irritant diaper dermatitis from diarrhea: a multicenter study.

PubMed

Wananukul, Siriwan; Limpongsanuruk, Wanida; Singalavanija, Srisupalak; Wisuthsarewong, Wanee

2006-10-01

Severity of irritant diaper dermatitis (IDD) from diarrhea varies from patient to patient depending on the nature of feces and the number of bowel movements. The purpose of the present study was to compare the effectiveness of dexpanthenol and zinc oxide ointment with ointment base in the treatment of irritant diaper dermatitis from acute diarrhea in children by measuring transepidermal water loss (TEWL). Forty-six children with diarrhea were prospectively, block randomized, investigator-blinded to receive dexpanthenol and zinc oxide ointment on one side and ointment base on the other side. TEWL was measured before and on days 1, 3, and 7 of treatment together with the assessment of severity score. The efficacy of treatment was defined by complete clearance of the lesion. TEWL in the treated and control side was not different before the application of the topical medication. In the present study, the efficacy of 5% dexpanthenol and zinc oxide ointment on D3 was 39% (18from 46 patients) compared to 32% in the ointment base side. On D7, the efficacy of the treated side was 58.7% and the ointment base side was 56%. The patients who still had skin lesions were those who had prolonged diarrhea. On the treated side, the mean of TEWL was lower than the control side on DI (p = 0.18) and had significant improvement on D3 (p = 0. 002). At the end of the present study, TEWL on the treated side was less than TEWL of the control side but it did not have statistical significance (p = 0.07). There was no rash or sign of abnormality on the treated side at the end of D7. In the treatment of lDD from acute diarrhea, 5% dexpanthenol and zinc oxide ointment significantly decreased TEWL in the treated side more than the ointment base on day 3 but the severity score was not significantly different on days 1, 3 and 7.

Chronic cannabinoid receptor 2 activation reverses paclitaxel neuropathy without tolerance or cannabinoid receptor 1-dependent withdrawal.

PubMed

Deng, Liting; Guindon, Josée; Cornett, Benjamin L; Makriyannis, Alexandros; Mackie, Ken; Hohmann, Andrea G

2015-03-01

Mixed cannabinoid receptor 1 and 2 (CB1 and CB2) agonists such as Δ(9)-tetrahydrocannabinol (Δ(9)-THC) can produce tolerance, physical withdrawal, and unwanted CB1-mediated central nervous system side effects. Whether repeated systemic administration of a CB2-preferring agonist engages CB1 receptors or produces CB1-mediated side effects is unknown. We evaluated antiallodynic efficacy, possible tolerance, and cannabimimetic side effects of repeated dosing with a CB2-preferring agonist AM1710 in a model of chemotherapy-induced neuropathy produced by paclitaxel using CB1 knockout (CB1KO), CB2 knockout (CB2KO), and wild-type (WT) mice. Comparisons were made with the prototypic classic cannabinoid Δ(9)-THC. We also explored the site and possible mechanism of action of AM1710. Paclitaxel-induced mechanical and cold allodynia developed to an equivalent degree in CB1KO, CB2KO, and WT mice. Both AM1710 and Δ(9)-THC suppressed established paclitaxel-induced allodynia in WT mice. In contrast to Δ(9)-THC, chronic administration of AM1710 did not engage CB1 activity or produce antinociceptive tolerance, CB1-mediated cannabinoid withdrawal, hypothermia, or motor dysfunction. Antiallodynic efficacy of systemic administration of AM1710 was absent in CB2KO mice and WT mice receiving the CB2 antagonist AM630, administered either systemically or intrathecally. Intrathecal administration of AM1710 also attenuated paclitaxel-induced allodynia in WT mice, but not CB2KO mice, implicating a possible role for spinal CB2 receptors in AM1710 antiallodynic efficacy. Finally, both acute and chronic administration of AM1710 decreased messenger RNA levels of tumor necrosis factor-α and monocyte chemoattractant protein 1 in lumbar spinal cord of paclitaxel-treated WT mice. Our results highlight the potential of prolonged use of CB2 agonists for managing chemotherapy-induced allodynia with a favorable therapeutic ratio marked by sustained efficacy and absence of tolerance, physical withdrawal, or CB1-mediated side effects. Copyright © 2015 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

To switch from Botox to Dysport in children with CP, a real world, dose conversion, cost-effectiveness study.

PubMed

Tedroff, Kristina; Befrits, Gustaf; Tedroff, Carl Johan; Gantelius, Stefan

2018-05-01

Children with cerebral palsy (CP) are routinely treated with botulinum toxin A (BoNT-A). Two non dose-equivalent and differently priced products, Botox and Dysport are used. Depending on the conversion one of the products is considerably cheaper. However, the dose conversion factors studied to date have varied widely and relevant studies have not included children. Our objective here was to compare the efficacy and health economics of the switch from Botox to Dysport in children with CP when conversion was set to 1:2. Specifically were these treatments perceived as equivalent in terms of efficacy, duration and side-effects and were the drug cost lowered by using Dysport. This prospective, real-world, cost-effectiveness population-based observational study included all children with CP, (n = 159) mean age 9.4 years (SD, 4.3), in the larger Stockholm area who received BoNT-A between September 1, 2014, and December 31, 2015. Parents reported the efficacy, duration and side-effects of previous treatment while physicians reported doses and goals set by children and parents for the present treatment. Drug acquisition costs were provided by county administrators. In connection with 341 visits caregivers reported comparable effects of similar duration with these products, with few, similar and transient side-effects. The drug-cost per treatment was 4029 SEK for Botox and 2380 SEK in the case of Dysport. When Botox was replaced by a two-fold higher Unit dose of Dysport (conversion 1:2) parents perceived the treatment of their children with CP to be equally effective while the cost was 41% lower according to procured prices. Copyright © 2018 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

Fractional erbium-doped yttrium aluminum garnet laser-assisted drug delivery of hydroquinone in the treatment of melasma

PubMed Central

Badawi, Ashraf M; Osman, Mai Abdelraouf

2018-01-01

Background Melasma is a difficult-to-treat hyperpigmentary disorder. Ablative fractional laser (AFL)-assisted delivery of topically applied drugs to varied targets in the skin has been an area of ongoing study and research. Objective The objective of this study was to evaluate the efficacy and safety of fractional erbium-doped yttrium aluminum garnet (Er:YAG) laser as an assisted drug delivery for enhancing topical hydroquinone (HQ) permeation into the skin of melasma patients. Patients and methods Thirty female patients with bilateral melasma were randomly treated in a split-face controlled manner with a fractional Er:YAG laser followed by 4% HQ cream on one side and 4% HQ cream alone on the other side. All patients received six laser sessions with a 2-week interval. The efficacy of treatments was determined through photographs, dermoscopic photomicrographs and Melasma Area Severity Index (MASI) score, all performed at baseline and at 12 weeks of starting therapy. The patient’s level of satisfaction was also recorded. Results Er:YAG laser + HQ showed significantly better results (p<0.005) with regard to decrease in the degree of pigmentation as assessed on the 4-point scale than HQ alone. There was a significant decrease in MASI scores on Er:YAG laser + HQ side vs HQ side. Minor reversible side effects were observed on both sides. Conclusion AFL-assisted delivery of HQ is a safe and effective method for the treatment of melasma. PMID:29379308

Functional lesional neurosurgery for tremor-a protocol for a systematic review and meta-analysis.

PubMed

Schreglmann, Sebastian R; Krauss, Joachim K; Chang, Jin Woo; Bhatia, Kailash P; Kägi, Georg

2017-05-09

The recent introduction of incision-less lesional neurosurgery using Gamma Knife and MRI-guided focused ultrasound has revived interest in lesional treatment options for tremor disorders. Preliminary literature researches reveal that the consistency of treatment effects after lesional neurosurgery for tremor has not formally been assessed yet. Similarly, the efficacy of different targets for lesional treatment and incidence of persistent side effects of lesional neurosurgical interventions has not been comprehensively assessed. This work therefore aims to describe a suitable process how to review the existing literature on efficacy and persistent side effects of lesional neurosurgical treatment for tremor due to Parkinson's disease, essential tremor, multiple sclerosis and midbrain/rubral tremor. We will search electronic databases (Medline, Cochrane) and reference lists of included articles for studies reporting lesional interventions for tremor in cohorts homogeneous for tremor aetiology and intervention (technique and target). We will include cohorts with a minimum number of five subjects and follow-up of 2 months. One investigator will perform the initial literature search and two investigators then independently decide which references to include for final efficacy and safety analysis. After settling of disagreement, data will be extracted from articles using a standardised template. We will perform a random-effect meta-analysis calculating standardised mean differences (Hedge's g) for comparison in Forest plots and subgroup analysis after assessment of heterogeneity using I 2 statistics. This study will summarise the available evidence on the efficacy of lesional interventions for the most frequent tremor disorders, as well as for the incidence rate of persisting side effects after unilateral lesional treatment. This data will be useful to guide future work on incision-less lesional interventions for tremor. This study has been registered with the PROSPERO database (no. CRD42016048049). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

High versus moderate energy use of bipolar fractional radiofrequency in the treatment of acne scars: a split-face double-blinded randomized control trial pilot study.

PubMed

Phothong, Weeranut; Wanitphakdeedecha, Rungsima; Sathaworawong, Angkana; Manuskiatti, Woraphong

2016-02-01

Bipolar fractional radiofrequency (FRF) device was firstly FDA-approved for treating atrophic acne scar in 2008 through the process of dermal coagulation and minimal epidermal ablation. The average energy at 60 mJ/pin was widely used to treat atrophic acne scars. However, the higher energy was delivered, the deeper ablation and coagulation were found. At present, the new generation of a device with bipolar FRF technology with electrode-pin tip was developed to maximize ability to deliver energy up to 100 mJ/pin. The objective of the study was to explore and compare the efficacy of utilizing high energy (100 mJ/pin) and moderate energy (60 mJ/pin) of bipolar fractional radiofrequency in treatment of atrophic acne scar in Asians. This is a split-face, double-blinded, randomized control trial, pilot study by using parallel group design technique. Thirty healthy subjects with Fitzpatrick skin phototype III-IV diagnosed as atrophic acne scares were enrolled. All subjects received four monthly sessions of bipolar FRF treatment. Left and right facial sides of individual patients were randomly assigned for different energy (high energy at 100 mJ/pin versus moderate energy at 60 mJ/pin). Acne scars improvement was blinded graded by dermatologist using global acne scarring score (GASS) which was subjectively evaluated at baseline, 1-, 3-, and 6-month follow-up. Objective scar analysis was also done using UVA-light video camera to measure scar volume, skin smoothness, and wrinkle at baseline, 3-, and 6-month follow-up after the last treatment. Side effects including pain, erythema, swelling, and crusting were also recorded. Thirty subjects completed the study with full 4-treatment course. The mean GASS of high energy side and moderate energy side was significantly reduced at 1-, 3-, and 6-month follow-up visits. At 1 month follow-visit, high energy side demonstrated significant improvement compared with moderate energy side (p = 0.03). Postinflammatory hyperpigmentation (PIH) developed in 21/120 sessions in high energy side (17.5 %) and 16/120 sessions in moderate energy side (13.3 %). Pain score and the duration of erythema after treatments were significant higher on the side that was treated with high energy. Bipolar FRF device was safe and effective in the treatment of atrophic acne scars in Asians. High energy setting demonstrated significant higher efficacy at 1 month follow-visit. However, the efficacy of both energy settings was comparable at 3- and 6-month follow-up. In addition, side effects were significantly more intense on the side treated with high energy.

Advances in Medicinal Plants with Effects on Anxiety Behavior Associated to Mental and Health Conditions.

PubMed

Barreto, George E; Avila-Rodriguez, Marco; Foitzick, Madeline; Aliev, Gjumrakch; Echeverria, Valentina

2017-01-01

Many mental health conditions including psychiatric disorders and neurodegenerative conditions are poorly responsive for actual medications or have low patient adherence to treatment due to the side effects or costs associated with these treatments. The main goal of this review is to provide clinical providers and patients with actualized information about the efficacy of selected herbal medicines for anxiety disorders derived from mental and/or health conditions, and their associated side effects. In this review, actual scientific advances about the use of medicinal plants for anxiety disorders are presented. In recent years, the herbal therapies have reemerged as a source of efficacious natural treatments, at a lower cost and most of the time reduced side effects than currently prescribed pharmaceutical drugs. The herbs described mainly correspond to plants of traditional medicine from the American continent and near islands and Asia. Current evidence confirms the therapeutic effects of traditional medicine. Further clinical investigation is required to confirm these findings. The current understanding of the molecular mechanisms involved in psychiatric disorders, as well as the new advances in brain imaging permit a rapid and serious evaluation of anxiolytic compounds. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

A pilot study of the comparative efficacy of 100 Hz magnetic seizure therapy and electroconvulsive therapy in persistent depression.

PubMed

Fitzgerald, Paul B; Hoy, Kate E; Elliot, David; McQueen, Susan; Wambeek, Lenore E; Chen, Leo; Clinton, Anne Maree; Downey, Glenn; Daskalakis, Zafiris J

2018-05-01

Magnetic seizure therapy (MST) is a novel brain stimulation technique that uses a high-powered transcranial magnetic stimulation device to produce therapeutic seizures. Preliminary MST studies have found antidepressant effects in the absence of cognitive side effects but its efficacy compared to electroconvulsive therapy (ECT) remains unclear. The aim of this study was to investigate the therapeutic efficacy and cognitive profile of MST compared to standard right unilateral ECT treatment. Thirty-seven patients completed a course of at least nine ECT or MST treatments in a randomized double-blind protocol. Assessments of depression severity and cognition were performed before and after treatment. No difference in the antidepressant effectiveness between the treatments was seen across any of the clinical outcome measures, although the overall response rates in both groups were quite low. In regards to cognition, following MST there were significant improvements in tests of psychomotor speed, verbal memory, and cognitive inhibition, with no reductions in cognitive performance. Following ECT there was significant improvement in only one of the cognitive inhibition tasks. With respect to the between-group comparisons, the MST group showed a significantly greater improvement on psychomotor speed than ECT. MST showed similar efficacy to right unilateral ECT in patients with treatment-resistant depression without cognitive side effects but in a sample that was only of sufficient size to demonstrate relatively large differences in response between the two groups. Future research should aim to optimize the methods of MST administration and compare its efficacy to ECT in large randomized controlled trials. © 2018 Wiley Periodicals, Inc.

Current perspectives in NSAID-induced gastropathy.

PubMed

Sinha, Mau; Gautam, Lovely; Shukla, Prakash Kumar; Kaur, Punit; Sharma, Sujata; Singh, Tej P

2013-01-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most highly prescribed drugs in the world. Their analgesic, anti-inflammatory, and antipyretic actions may be beneficial; however, they are associated with severe side effects including gastrointestinal injury and peptic ulceration. Though several approaches for limiting these side effects have been adopted, like the use of COX-2 specific drugs, comedication of acid suppressants like proton pump inhibitors and prostaglandin analogs, these alternatives have limitations in terms of efficacy and side effects. In this paper, the mechanism of action of NSAIDs and their critical gastrointestinal complications have been reviewed. This paper also provides the information on different preventive measures prescribed to minimize such adverse effects and analyses the new suggested strategies for development of novel drugs to maintain the anti-inflammatory functions of NSAIDs along with effective gastrointestinal protection.

[Drug management for coronary artery disease in the elderly].

PubMed

Meune, C

2006-11-01

The incidence of side effects increases dramatically with age. It is estimated that almost one third of side effects could be avoided by an appropriate prescription. On the other hand, age is the main factor associated to the non-prescription of major pharmacological classes, which have evidenced their efficacy in younger patients with coronary artery disease. The estimation of the benefit/risk ratio is therefore highly important in the old/very old patient. It seems important to integrate the results of studies and registries including old patients, evidencing the efficacy of the majority of pharmacological classes validated in younger patients, especially antiplatelets, beta-blockers and statins. The assessment of the benefit/risk ratio should also take into account the tolerance profile of the drug and the patient. The prescription should be adapted to the "age-related" changes of pharmacokinetics and pharmacodynamics.

Tacrolimus treatment of atopic eczema/dermatitis syndrome.

PubMed

Thestrup-Pedersen, Kristian

2003-10-01

Atopic dermatitis is today the most common chronic disease of children in Europe, the US and Japan. The 'golden standard' of therapy is topical glucocorticosteroids and emollients. The steroids have been on the market for four decades, are efficacious, but only advised for short-term treatment due to their risks of side effects. More than 16,000 persons suffering from atopic dermatitis have been enrolled in clinical studies of tacrolimus. One third of patients with moderate to severe atopic dermatitis experience over 90% improvement in their disease over a 12-week treatment period and up to 70% of patients have over 50% improvement. A 1-year treatment leads to more than 90% improvement in 75% of patients. The most pronounced side effect is a burning sensation occurring in up to 60% of patients. Atopic dermatitis is a chronic skin disease leading to a demand for long-term treatment control. Such treatment options have not previously been available--except for emollients which are not efficacious for controlling skin inflammation. Tacrolimus and pimecrolimus are new treatment options, free from the potential side effects of topical steroids, which are known for their efficacy in short-term treatment. The new treatment modalities prevent the eczema from relapsing and at the same time they control active eczema. The future will see a shift towards the long-term use of tacrolimus which is able to control the skin inflammation and, hopefully, shorten the course of the eczema.

Efficacy of Punch Elevation Combined with Fractional Carbon Dioxide Laser Resurfacing in Facial Atrophic Acne Scarring: A Randomized Split-face Clinical Study

PubMed Central

Faghihi, Gita; Nouraei, Saeid; Asilian, Ali; Keyvan, Shima; Abtahi-Naeini, Bahareh; Rakhshanpour, Mehrdad; Nilforoushzadeh, Mohammad Ali; Hosseini, Sayed Mohsen

2015-01-01

Background: A number of treatments for reducing the appearance of acne scars are available, but general guidelines for optimizing acne scar treatment do not exist. The aim of this study was to compare the clinical effectiveness and side effects of fractional carbon dioxide (CO2) laser resurfacing combined with punch elevation with fractional CO2 laser resurfacing alone in the treatment of atrophic acne scars. Materials and Methods: Forty-two Iranian subjects (age range 18–55) with Fitzpatrick skin types III to IV and moderate to severe atrophic acne scars on both cheeks received randomized split-face treatments: One side received fractional CO2 laser treatment and the other received one session of punch elevation combined with two sessions of laser fractional CO2 laser treatment, separated by an interval of 1 month. Two dermatologists independently evaluated improvement in acne scars 4 and 16 weeks after the last treatment. Side effects were also recorded after each treatment. Results: The mean ± SD age of patients was 23.4 ± 2.6 years. Clinical improvement of facial acne scarring was assessed by two dermatologists blinded to treatment conditions. No significant difference in evaluation was observed 1 month after treatment (P = 0.56). Their evaluation found that fractional CO2 laser treatment combined with punch elevation had greater efficacy than that with fractional CO2 laser treatment alone, assessed 4 months after treatment (P = 0.02). Among all side effects, coagulated crust formation and pruritus at day 3 after fractional CO2 laser treatment was significant on both treatment sides (P < 0.05). Conclusion: Concurrent use of fractional laser skin resurfacing with punch elevation offers a safe and effective approach for the treatment of acne scarring. PMID:26538695

Ketamine for pain

PubMed Central

Jonkman, Kelly; Dahan, Albert; van de Donk, Tine; Aarts, Leon; Niesters, Marieke; van Velzen, Monique

2017-01-01

The efficacy of the N-methyl-D-aspartate receptor antagonist ketamine as an analgesic agent is still under debate, especially for indications such as chronic pain. To understand the efficacy of ketamine for relief of pain, we performed a literature search for relevant narrative and systematic reviews and meta-analyses. We retrieved 189 unique articles, of which 29 were deemed appropriate for use in this review. Ketamine treatment is most effective for relief of postoperative pain, causing reduced opioid consumption. In contrast, for most other indications (that is, acute pain in the emergency department, prevention of persistent postoperative pain, cancer pain, and chronic non-cancer pain), the efficacy of ketamine is limited. Ketamine’s lack of analgesic effect was associated with an increase in side effects, including schizotypical effects. PMID:28979762

Effects of COMT, DRD2, BDNF, and APOE Genotypic Variation on Treatment Efficacy and Cognitive Side Effects of Electroconvulsive Therapy.

PubMed

Bousman, Chad A; Katalinic, Natalie; Martin, Donel M; Smith, Deidre J; Ingram, Anna; Dowling, Nathan; Ng, Chee; Loo, Colleen K

2015-06-01

The aim of this study was to explore the main and interaction effects of the COMT Val158Met, DRD2 C957T, BDNF Val66Met, and APOE polymorphisms on treatment efficacy and cognitive side effects of electroconvulsive therapy (ECT). A total of 117 adult inpatients with a diagnosis of major depressive disorder recruited from 3 hospitals were administered the Montgomery-Äsberg Depression Rating Scale and a cognitive battery assessing global cognition, anterograde memory, executive function, speed and concentration, as well as retrograde memory at baseline and after ECT treatment. DRD2 C957T heterozygotes had 3.7 (95% confidence interval, 1.13-12.25; P = 0.032) greater odds of remission compared with CC homozygotes. Among the men, COMT Val/Val carriers had greater depressive symptom reduction compared with Met/Met carriers (Montgomery-Äsberg Depression Rating Scale percentage of reduction, 76% vs 35%; P = 0.020) but not among the women (P = 0.903) after ECT. For cognitive outcomes, an interaction effect on anterograde memory was observed between the DRD2 and BDNF polymorphisms (P = 0.016), in which carriers of the DRD2 TT and BDNF Val/Val genotypes had significantly less decline in anterograde performance than those that carried the TC and Met-allele (P = 0.001) or CC and Met-allele (P = 0.003) genotypes. However, no results withstood correction for multiple comparisons. These observations provide preliminary evidence supporting an association between common functional genotypic variation and ECT efficacy as well as anterograde memory side effects after ECT. Validation of these findings is required before firm conclusions can be made and clinical utility can be assessed.

The Cannabis Dilemma: A Review of Its Associated Risks and Clinical Efficacy.

PubMed

Zhang, Melvyn Weibin; Ho, Roger C M

2015-01-01

Cannabis, also known as marijuana, has 9-tetrahydrocannabinol as the main constituent. There has been strict legislation governing the utilization of cannabis locally and worldwide. However, there has been an increasing push to make cannabis legalized, in view of its potential medical and therapeutic effects, for various medical disorders ranging from development disorders to cancer treatment, and being an adjunctive medication for various neurological conditions. It is the aim of this review paper to explore the evidence base for its proposed therapeutic efficacy and to compare the evidence base supporting its proposed therapeutic efficacy with its known and well-researched medical and psychiatric side effects.

Does contraceptive treatment in wildlife result in side effects? A review of quantitative and anecdotal evidence.

PubMed

Gray, Meeghan E; Cameron, Elissa Z

2010-01-01

The efficacy of contraceptive treatments has been extensively tested, and several formulations are effective at reducing fertility in a range of species. However, these formulations should minimally impact the behavior of individuals and populations before a contraceptive is used for population manipulation, but these effects have received less attention. Potential side effects have been identified theoretically and we reviewed published studies that have investigated side effects on behavior and physiology of individuals or population-level effects, which provided mixed results. Physiological side effects were most prevalent. Most studies reported a lack of secondary effects, but were usually based on qualitative data or anecdotes. A meta-analysis on quantitative studies of side effects showed that secondary effects consistently occur across all categories and all contraceptive types. This contrasts with the qualitative studies, suggesting that anecdotal reports are insufficient to investigate secondary impacts of contraceptive treatment. We conclude that more research is needed to address fundamental questions about secondary effects of contraceptive treatment and experiments are fundamental to conclusions. In addition, researchers are missing a vital opportunity to use contraceptives as an experimental tool to test the influence of reproduction, sex and fertility on the behavior of wildlife species.

The effect of Bobath approach on the excitability of the spinal alpha motor neurones in stroke patients with muscle spasticity.

PubMed

Ansari, N N; Naghdi, S

2007-01-01

A clinical study was performed to evaluate the efficacy of the Bobath approach on the excitability of the spinal alpha motor neurones in patients with poststroke spasticity. Ten subjects ranging in age from 37 through 76 years (average 60 years) with ankle plantarflexor spasticity secondary to a stroke were recruited and completed the trial. They had physiotherapy according to Bobath concept for ten treatment sessions, three days per week. Two repeated measures, one before and another after treatment, were taken to quantify clinical efficacy. The effect of this type of therapy on the excitability of alpha motor neurones (aMN) was assessed by measuring the latency of the Hoffmann reflex (H-reflex) and the Hmax/Mmax ratio. The original Ashworth scale and ankle range of motion were also measured. The mean HmaxlMmax ratio on the affected side at baseline was high in the study patients. However, there were no statistically significant differences in the HmaxlMmax ratio or in the H-reflex latency between the baseline values and those recorded after therapy intervention. Before treatment, the HmaxlMmax ratio was significantly higher in the affected side than in the unaffected side. However, it was similar at both sides after treatment. Following treatment, the significant reduction in spasticity was clinically detected as measured with the original Ashworth scale. The ankle joint active and passive range of motion was significantly increased. In conclusion, Bobath therapy had a statistically significant effect on the excitability of the aMN in the affected side compared to the unaffected side in stroke patients with muscle spasticity.

COMPARED EFFICACY OF INTRA-ARTICULAR INJECTION OF METHYLPREDNISOLONE AND TRIAMCINOLONE.

PubMed

Buyuk, Abdul Fettah; Kilinc, Eray; Camurcu, Ismet Yalkin; Camur, Savas; Ucpunar, Hanifi; Kara, Adnan

2017-01-01

To compare the effect of two different corticosteroid types in bilateral and symmetrical knee osteoarthritis (OA). One hundred and twenty-six patients received injections of methylprednisolone acetate (MP) in one knee and triamcinolone hexacetonide (TH) in the contralateral knee. Patients were evaluated before injection and 2, 4, 8, 12, and 24 weeks after. Mean patient age was 68.5±9 years. Mean BMI was 26.3±2.6 kg/m 2 . At first admission, mean VAS score was 7.7±1.3 for the right side and 7.5±1.5 for the left side, and mean WOMAC score was 67.6±14.4. After bilateral intra-articular injection, VAS scores for both knees and WOMAC scores decreased significantly when initial scores were compared with 2, 4, 8, 12, and 24 weeks after injection (p<0.05). A statistically significant change was seen over time when VAS and WOMAC scores for 2, 4, 8, 12, and 24 weeks post-injection were compared to each other (p<0.05). No significant difference was seen between knee sides (p>0.05). MP and TH have similar efficacy in relieving pain and improving function. The efficacy of intra-articular corticosteroid injection peaks 2 weeks after injection and the effect continues until the 24 th week. Level of Evidence II, Comparative Prospective Study.

COMPARED EFFICACY OF INTRA-ARTICULAR INJECTION OF METHYLPREDNISOLONE AND TRIAMCINOLONE

PubMed Central

BUYUK, ABDUL FETTAH; KILINC, ERAY; CAMURCU, ISMET YALKIN; CAMUR, SAVAS; UCPUNAR, HANIFI; KARA, ADNAN

2017-01-01

ABSTRACT Objective: To compare the effect of two different corticosteroid types in bilateral and symmetrical knee osteoarthritis (OA). Methods: One hundred and twenty-six patients received injections of methylprednisolone acetate (MP) in one knee and triamcinolone hexacetonide (TH) in the contralateral knee. Patients were evaluated before injection and 2, 4, 8, 12, and 24 weeks after. Results: Mean patient age was 68.5±9 years. Mean BMI was 26.3±2.6 kg/m2. At first admission, mean VAS score was 7.7±1.3 for the right side and 7.5±1.5 for the left side, and mean WOMAC score was 67.6±14.4. After bilateral intra-articular injection, VAS scores for both knees and WOMAC scores decreased significantly when initial scores were compared with 2, 4, 8, 12, and 24 weeks after injection (p<0.05). A statistically significant change was seen over time when VAS and WOMAC scores for 2, 4, 8, 12, and 24 weeks post-injection were compared to each other (p<0.05). No significant difference was seen between knee sides (p>0.05). Conclusion: MP and TH have similar efficacy in relieving pain and improving function. The efficacy of intra-articular corticosteroid injection peaks 2 weeks after injection and the effect continues until the 24th week. Level of Evidence II, Comparative Prospective Study. PMID:29081706

Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects.

PubMed

Sanacora, G; Smith, M A; Pathak, S; Su, H-L; Boeijinga, P H; McCarthy, D J; Quirk, M C

2014-09-01

Ketamine, an N-methyl-D-aspartate receptor (NMDAR) channel blocker, has been found to induce rapid and robust antidepressant-like effects in rodent models and in treatment-refractory depressed patients. However, the marked acute psychological side effects of ketamine complicate the interpretation of both preclinical and clinical data. Moreover, the lack of controlled data demonstrating the ability of ketamine to sustain the antidepressant response with repeated administration leaves the potential clinical utility of this class of drugs in question. Using quantitative electroencephalography (qEEG) to objectively align doses of a low-trapping NMDA channel blocker, AZD6765 (lanicemine), to that of ketamine, we demonstrate the potential for NMDA channel blockers to produce antidepressant efficacy without psychotomimetic and dissociative side effects. Furthermore, using placebo-controlled data, we show that the antidepressant response to NMDA channel blockers can be maintained with repeated and intermittent drug administration. Together, these data provide a path for the development of novel glutamatergic-based therapeutics for treatment-refractory mood disorders.

Sub-efficacious doses of phosphodiesterase 4 and 5 inhibitors improve memory in a mouse model of Alzheimer's disease.

PubMed

Gulisano, Walter; Tropea, Maria Rosaria; Arancio, Ottavio; Palmeri, Agostino; Puzzo, Daniela

2018-06-06

Cyclic nucleotides cAMP and cGMP cooperate to ensure memory acquisition and consolidation. Increasing their levels by phosphodiesterase inhibitors (PDE-Is) enhanced cognitive functions and rescued memory loss in different models of aging and Alzheimer's disease (AD). However, side effects due to the high doses used limited their application in humans. Based on previous studies suggesting that combinations of sub-efficacious doses of cAMP- and cGMP-specific PDE-Is improved synaptic plasticity and memory in physiological conditions, here we aimed to study whether this treatment was effective to counteract the AD phenotype in APPswe mice. We found that a 3-week chronic treatment with a combination of sub-efficacious doses of the cAMP-specific PDE4-I roflumilast (0.01 mg/kg) and the cGMP-specific PDE5-I vardenafil (0.1 mg/kg) improved recognition, spatial and contextual fear memory. Importantly, the cognitive enhancement persisted for 2 months beyond administration. This long-lasting action, and the possibility to minimize side effects due to the low doses used, might open feasible therapeutic strategies against AD. Copyright © 2018 Elsevier Ltd. All rights reserved.

St. John's Wort seed and feverfew flower extracts relieve painful diabetic neuropathy in a rat model of diabetes.

PubMed

Galeotti, Nicoletta; Maidecchi, Anna; Mattoli, Luisa; Burico, Michela; Ghelardini, Carla

2014-01-01

Painful diabetic peripheral neuropathy (DPN) is a common complication of diabetes and the few approved therapies for the management of pain have limited efficacy and side effects. With the aim to explore and develop new pharmacological treatments, we investigated the antihyperalgesic properties of St. John's Wort (SJW) and feverfew in streptozotocin (STZ)-diabetic rats. Acute administration of a SJW seed extract reversed mechanical hyperalgesia with a prolonged effect. A SJW extract obtained from the aerial portion of the plant and a feverfew flower extract partially relieved neuropathic pain whereas a feverfew leaf extract was ineffective. The antihyperalgesic efficacy of these herbal drugs was comparable to that of clinically used antihyperalgesic drugs (carbamazepine, lamotrigine, l-acetyl-levocarnitine). Further examinations of SJW and feverfew composition revealed that hyperforin and hypericin might be responsible for the antihyperalgesic properties of SJW whereas the efficacy of feverfew seems to be related to the presence of parthenolide. Rats undergoing treatment with SJW and feverfew did not show any behavioral side effect or sign of altered locomotor activity. Our results suggest that SJW and feverfew extracts may become new therapeutic perspectives for painful DPN. © 2013.

Efficacy of 694-nm fractional Q-switched ruby laser (QSRL) combined with sonophoresis on levorotatory vitamin C for treatment of melasma in Chinese patients.

PubMed

Zhou, H L; Hu, B; Zhang, C

2016-07-01

Melasma is a common acquired and distressing pigmentary disorder presenting to dermatology clinics. It is notably difficult to cure and has a tendency to relapse. The efficacy of classical Q-switched laser in treatment of melasma remains controversial. This study aims to investigate the efficacy and safety of 694-nm fractional QSRL combined with sonophoresis on levorotatory vitamin C for the treatment of melasma patients. Twenty-six patients with melasma were enrolled. Each patient received four to six fractional QSRL treatments at pulse energies of 2.5 to 4 J/cm(2) combined with sonophoresis on levorotatory vitamin C at 2-week intervals. The severity and the area of melasma were assessed by two investigators using the melasma area and severity index (MASI). Side effects were documented. Mean MASI score decreased from 15.51 ± 3.00 before treatment to 10.02 ± 4.39 3 months after the final treatment (P < 0.01). Side effects were few and transient. High-density coverage fractional QSRL combined with sonophoresis on levorotatory vitamin C is safe and effective for the treatment of melasma in Chinese patients.

[Clinical observation of icotinib hydrochloride for patients with advanced non-small cell lung cancer].

PubMed

Li, Xi; Yang, Xin-jie; Sun, Yi-fen; Qin, Na; Lü, Jia-lin; Wu, Yu-hua; Zhang, Hui; Zhang, Quan; Zhang, Shu-cai

2012-08-01

To explore the efficacy and side effects of icotinib hydrochloride in the treatment of patients with advanced non-small cell lung cancer (NSCLC). The efficacy and side effects of icotinib hydrochloride in treatment of 59 cases with stage IV NSCIC and followed-up from March 2009 to January 2012 were retrospectively analyzed. Twenty seven patients (45.8%) showed partial response (PR), 17 patients (28.8%) achieved SD, and 15 (25.4%) had progressive disease. The objective response rate (ORR) was 45.8% (27/59), and disease control rate (DCR) was 74.6% (44/59). Among the 23 patients with EGFR mutation, ORR was 73.9% (17/23), and DCR was 95.7% (22/23). Thirty six patients (61.0%) achieved remission of symptoms to varying degrees. The main symptoms relieved were cough, asthmatic suffocating, pain and hoarseness. The major adverse events were mild skin rash (35.6%) and diarrhea (15.3%). Others were dry skin, nausea and stomach problems. The efficacy of icotinib hydrochloride were related to the ECOG performance status, smoking history, EGFR mutation and rash significantly (P < 0.05). Monotherapy with icotinib hydrochloride is effective and tolerable for patients with advanced NSCLC, especially with EGFR mutation.

Technical feasibility and revision efficacy of the sequential deployment of endoscopic bilateral side-by-side metal stents for malignant hilar biliary strictures: a multicenter prospective study.

PubMed

Lee, Tae Hoon; Park, Do Hyun; Lee, Sang Soo; Choi, Hyun Jong; Lee, Jun Kyu; Kim, Tae Hyeon; Kim, Jong Hyeok; Jeong, Seok; Park, Sang-Heum; Moon, Jong Ho

2013-02-01

Theoretically, the side-by-side bilateral placement of metal stents may be technically easier than stent-in-stent bilateral placement in stent revision. However, side-by-side placement can be technically challenging, as the deployment of the first stent can preclude the passage of the second stent. We explored the technical feasibility and revision efficacy of endoscopic bilateral side-by-side stent placement for malignant hilar biliary strictures. Forty-four patients with Bismuth type II or higher malignant hilar biliary strictures were enrolled in seven academic tertiary referral centers. Endoscopic placement of side-by-side bilateral metal stents with 7F thin delivery shaft was performed. The outcome measurements were the technical and functional success, adverse events, endoscopic revision success rate, and stent patency. Overall, the technical and functional success rates were 91 % (40/44), and 98 % (39/40), respectively. Two of the failed patients were converted successfully with subsequent contralateral stent-in-stent placement, and the other patients underwent percutaneous intervention. Early stent-related adverse events occurred in 10 %. The endoscopic revision rate due to stent malfunction during follow-up (median: 180 days) was 45 % (18/40; tumor ingrowth in 4 and in-stent sludge impaction/stone formation in 14 patients). The endoscopic revision success rate was 92 % (12/13). Five patients with comorbidity underwent initial percutaneous intervention. The median survival and stent patency periods were 180 and 157 days, respectively. The sequential placement of a metal stent with a 7F thin delivery shaft in bilateral side-by-side procedures may be feasible and effective for malignant hilar biliary strictures and for endoscopic stent revision.

Efficacy of various side-to-side toothbrushes and impact of brushing parameters on noncontact biofilm removal in an interdental space model.

PubMed

Schmidt, Julia C; Astasov-Frauenhoffer, Monika; Waltimo, Tuomas; Weiger, Roland; Walter, Clemens

2017-06-01

The objective of this study was to evaluate the efficacy of four different side-to-side toothbrushes and the impact of various brushing parameters on noncontact biofilm removal in an adjustable interdental space model. A three-species biofilm, consisting of Porphyromonas gingivalis, Fusobacterium nucleatum, and Streptococcus sanguinis, was formed in vitro on protein-coated titanium disks using a flow chamber combined with a static biofilm growth model. Subsequently, the biofilm-coated disks were exposed to four different powered toothbrushes (A, B, C, D). The parameters distance (0 and 1 mm), brushing time (2, 4, and 6 s), interdental space width (1, 2, and 3 mm), and toothbrush angulation (45° and 90°) were tested. The biofilm volumes were determined using volumetric analyses with confocal laser scanning microscope (Zeiss LSM700) images and Imaris version 7.7.2 software. The median percentages of simulated interdental biofilm reduction by the tested toothbrushes ranged from 7 to 64 %. The abilities of the analyzed toothbrushes to reduce the in vitro biofilm differed significantly (p < 0.05). Three of the tested toothbrushes (A, B, C) were able to significantly reduce a simulated interdental biofilm by noncontact brushing (p ≤ 0.005). The brushing parameters and their combinations tested in the experiments revealed only minor effects on in vitro interdental biofilm reduction (p > 0.05). A three-species in vitro biofilm could be altered by noncontact brushing with toothbrushes A, B, and C in an artificial interdental space model. Certain side-to-side toothbrushes demonstrate in vitro a high efficacy in interdental biofilm removal without bristle-to-biofilm contact.

Nanoassemblies from homostructured polypeptides as efficient nanoplatforms for oral drug delivery.

PubMed

Jia, Yi; Tang, Yuan; He, Hongmei; Li, Shuhui; Che, Ling; Zhou, Xing; Dou, Yin; Zhang, Jianxiang; Li, Xiaohui

2013-04-01

The assembly of homostructured polypeptides bearing various side groups into well-defined nanostructures was presented, with their size and topology mainly dominated by the chemical structure and molecular weight of peptides. Pharmacokinetic and pharmacodynamic studies based on rat models suggested these newly constructed nanoassemblies with low cytotoxicity may function as novel nanoplatforms to efficiently and safely deliver therapeutics to achieve better efficacy but lower side effects. Other applications in biomedical fields, such as biotechnology, medical imaging, and tissue engineering, may also be expected. This research team investigated the assembly of homostructured polypeptides bearing various side groups into well-defined nanostructures, and demonstrated low cytotoxicity in rat disease models, suggesting that these novel nanoplatforms may safely and efficiently deliver therapeutics with low side effects. Copyright © 2013 Elsevier Inc. All rights reserved.

A prospective, split-face, randomized study of the efficacy and safety of a novel fractionated intense pulsed light treatment for melasma in Asians.

PubMed

Yun, Woo Jin; Lee, Sang Min; Han, Ji Su; Lee, Sang Hyung; Chang, Seo Youn; Haw, Sik; Lee, Jung Bok; Won, Chong Hyun; Lee, Mi Woo; Choi, Jee Ho; Chang, Sung Eun

2015-01-01

Intense pulsed light (IPL) has been reported to effectively treat melasma in previous studies, but an aggravation of pigmentation was noted. Fractionated IPL is a novel technique in which microsecond-domain fractionated pulses are delivered to the target area. To compare the safety and efficacy of low-fluency, frequently scheduled fractionated IPL and conventional IPL for melasma treatment. This was a 14-week, split-face study in which 30 Asian women were treated with weekly fractionated IPL on one side of the face and biweekly conventional IPL on the other side. The non-inferiority of a weekly fractionated IPL regimen to a biweekly conventional IPL regimen was verified by a lower margin of the 95% confidence interval for the difference in the Melasma Area and Severity Index (MASI) change from baseline of 2.61 for each side. This value was greater than the previously determined non-inferiority margin of -2.68 (P < 0.025). On the fractionated IPL side, the modified MASI score decreased continuously, but in the conventional IPL group, the MASI score rebounded during the treatment course. Fractionated IPL shows moderate efficacy as a melasma treatment and is therefore a good alternative to conventional IPL as there is no indication of melasma exacerbation. Fractionated IPL can also be used as a maintenance treatment for melasma.

Complementary and alternative medicine for psoriasis: what the dermatologist needs to know.

PubMed

Talbott, Whitney; Duffy, Nana

2015-06-01

Complementary and alternative medicine (CAM) use is common among patients with psoriasis. CAM modalities include traditional Chinese medicine (TCM), herbal therapies, dietary supplements, climatotherapy, and mind/body interventions. In this review, evidence from clinical trials investigating the efficacy of CAM for psoriasis is reviewed. There is a large amount of evidence from controlled trials that have shown that the combination of TCM with traditional therapies for psoriasis is more efficacious than traditional therapies alone. Herbal therapies that have the most evidence for efficacy are Mahonia aquifolium and indigo naturalis, while there is a smaller amount of evidence for aloe vera, neem, and extracts of sweet whey. Dietary supplementation in patients with psoriasis demonstrates consistent evidence supporting the efficacy of fish oil supplements. Zinc supplementation has not been shown to be effective; however, some evidence is available (albeit conflicting) for vitamin D, vitamin B12, and selenium supplementation. Overwhelming evidence supports the effectiveness of Dead Sea climatotherapy. Finally, mindfulness-based stress reduction can be helpful as adjuvant treatment of psoriasis. There are potential benefits to these modalities, but also potential side issues. Concerns with CAM include, but are not limited to, contamination of TCM products with heavy metals or corticosteroids, systemic toxicity or contact dermatitis from herbal supplements, and ultraviolet light-induced carcinomas from climatotherapy. Dermatologists should be aware of these benefits and side effects to allow for informed discussions with their patients.

Clinical efficacy of a novel topical formulation for vitiligo: compared evaluation of different treatment modalities in 149 patients.

PubMed

Buggiani, Gionata; Tsampau, Dionigi; Hercogovà, Jana; Rossi, Riccardo; Brazzini, Benedetta; Lotti, Torello

2012-01-01

Current vitiligo treatments are not always satisfactory for both patients and dermatologists. Recently, combination therapies have been introduced in order to obtain better results and reduce risks in the management of the disease. Novel efficacious products are needed to improve the therapeutic possibilities of dermatologists in the respect of safety for the patients. The objective of the present study was to evaluate the effects of a novel topical in a gel formulation containing phenylalanine, cucumis melo extract, and acetyl cysteine in vitiligo. The present study used an open observational study to evaluate the efficacy and safety of the investigated product, given alone or in combination with 311-nm narrow band microphototherapy. Results were compared with those obtained treating a matched patient population with microphototherapy alone and with clobetasol propionate 0.05% ointment alone. One hundred forty-nine patients suffering from symmetrical vitiligo affecting less than 10% of the skin surface were evaluated. Patients affected by acral vitiligo only were excluded from the analysis. Treatment duration was scheduled for 12 weeks. Excellent repigmentation (>75%) was achieved by 38-73% of patients, depending on the treatment regimen. Mild to moderate side effects were observed only in patients treated with clobetasol 0.05% ointment. The tested gel formulation showed a good efficacy in improving vitiligo repigmentation. No side effects were observed. © 2012 Wiley Periodicals, Inc.

Side Effects to Antidepressant Treatment in Patients With Depression and Comorbid Panic Disorder.

PubMed

Shankman, Stewart A; Gorka, Stephanie M; Katz, Andrea C; Klein, Daniel N; Markowitz, John C; Arnow, Bruce A; Manber, Rachel; Rothbaum, Barbara O; Thase, Michael E; Schatzberg, Alan F; Keller, Martin B; Trivedi, Madhukar H; Kocsis, James H

2017-04-01

Side effects to antidepressant medication can affect the efficacy of treatment, but few predictors foretell who experiences side effects and which side effects they experience. This secondary data analysis examined whether depressed patients with comorbid panic disorder were more likely to experience side effects than those without panic disorder. The study also examined whether greater burden of side effects predicted a poorer treatment course for patients with panic disorder than those without panic disorder. To examine the specificity of these effects, analyses also examined 2 other anxiety disorders-social phobia and generalized anxiety disorder (GAD). Between 2002 and 2006, a large sample (N = 808) of chronically depressed individuals (assessed using the Structured Clinical Interview for DSM-IV-TR Axis I Disorders [SCID-IV]) received antidepressants according to a predetermined algorithm for 12 weeks. Every 2 weeks, depressive symptoms (per the Hamilton Depression Rating Scale) and side effects (specific side effects as well as several indicators of side effect burden) were assessed. Lifetime diagnosis of panic disorder (assessed using the SCID-IV) at baseline was associated with higher likelihood of gastrointestinal (OR = 1.6 [95% CI, 1.0-2.6]), cardiac (OR = 1.8 [95% CI, 1.1-3.1]), neurologic (OR = 2.6 [95% CI, 1.6-4.2]), and genitourinary side effects (OR = 3.0 [95% CI, 1.7-5.3]) during treatment. Increases in side effect frequency, intensity, and impairment over time were more strongly associated with increases in depressive symptoms for patients with panic disorder compared to those without panic disorder. Neither social phobia nor GAD was associated with these effects. Potentially due to heighte​ned interoceptive awareness of changes in their body, chronically depressed individuals with panic disorder may be at greater risk than those without panic disorder for antidepressant side effects and to experience a worsening of depressive symptoms as a result of these side effects over time. ClinicalTrials.gov identifier: NCT00057551​. © Copyright 2017 Physicians Postgraduate Press, Inc.

A randomized comparison of the efficacy, side effects and patient convenience between vaginal and rectal administration of Cyclogest(®) when used for luteal phase support in ICSI treatment.

PubMed

Aghsa, Malek-Mansour; Rahmanpour, Haleh; Bagheri, Maryam; Davari-Tanha, Fatemeh; Nasr, Reza

2012-10-01

This study compares the efficacy, side effects and patient convenience of vaginal and rectal routes of administration of progesterone suppositories (Cyclogest) when used for luteal phase support during in vitro fertilization cycles, through the use of antagonist protocols. 147 patients who underwent intra-cytoplasmic sperm injection cycle were randomized on the day of the embryo transfer (ET) by a computer-generated randomization program to receive 400 mg of Cyclogest either vaginally or rectally twice daily for up to 8 weeks. A pregnancy test was conducted 2 weeks after embryo transfer. If the pregnancy test was negative, the application was discontinued. On day 14th after embryo transfer, patient's acceptability and side effects were assessed using a questionnaire which was given to the patients on the day of ET prior to performing the pregnancy test. The clinical pregnancy rate at the 8th week of gestation and the level of luteal progesterone were evaluated. There were no substantial differences in the demographics or other characteristics between the two groups. There were no significant differences in serum P concentration 6 days after ET, the clinical pregnancy and abortion rates. The difficulty of administration route, the discomforts experienced following administration, and the proportion leaking out on the 14th day were similar between the two groups. Significantly more patients administering the medication per vagina had perineal irritation (21.3 vs. 2.2 %). The prevalence of tenesmus (35.1 vs. 21.1 %) and rectal itching (26.7 vs. 2.8 %) were significantly more in rectal route. This study demonstrates that the efficacy of Cyclogest is similar when administered via both the vaginal and rectal routes. Although their side effects differ, the ease of administration for patients and their preference are similar.

National survey of adherence, efficacy, and side effects of methylphenidate in children with attention-deficit/hyperactivity disorder in Taiwan.

PubMed

Gau, Susan Shur-Fen; Chen, Shin-Jaw; Chou, Wen-Jiun; Cheng, Helen; Tang, Ching-Shu; Chang, Hsueh-Ling; Tzang, Ruu-Fen; Wu, Yu-Yu; Huang, Ya-Fen; Chou, Miao-Chun; Liang, Hsin-Yi; Hsu, Ya-Chen; Lu, Hui-Hua; Huang, Yu-Shu

2008-01-01

To identify the determinants of adherence to immediate-release (IR) methylphenidate in children and adolescents with attention-deficit/hyperactivity disorder (ADHD); to examine the impact of adherence on ADHD-related symptoms; and to compare the efficacy, adherence, and side effects of IR methylphenidate and osmotic release oral system (OROS) methylphenidate. This national survey, involving 12 hospitals, consisted of 2 phases of assessment. Treatment adherence in 240 (39.5%) of the 607 children aged 5 to 16 years with a clinical diagnosis of DSM-IV ADHD enrolled in the study was poor (defined as missing >or= 1 dose of ADHD medication a day and on 2 days or more during school days). Children with poor adherence at phase 1 were able to switch to OROS methylphenidate, while adherents remained on the IR variant. We reassessed 124 poor adherents who switched to OROS methylphenidate. The global ADHD severity, parent-child interaction, classroom behavior, academic performance, and side effects of the child subjects were evaluated by investigators. Parents completed the rating scales about the ADHD-related symptoms. The study began in April 2005 and was completed in February 2006. Determinants for poor adherence included older age, later onset of ADHD, family history of ADHD, higher paternal education level, and multi-dose administration. Mental retardation and treatment at medical centers were inversely related to poor adherence. Overall, poor adherence was associated with more severe ADHD-related symptoms by comparison to good adherence. Similar side effect profile, superior adherence, and improved efficacy were demonstrated in intra-individual comparison of the OROS and IR methylphenidate forms. Given that poor adherence to medication may be an important reason for suboptimal outcome in ADHD treatment, physicians should ensure adherence with therapy before adjusting dosage or switching medication. clinicaltrials.gov Identifier NCT00460720.

Promethazine and its use as a treatment for space motion sickness

NASA Technical Reports Server (NTRS)

Bagian, James P.; Beck, Bradley G.

1993-01-01

Until Mar. 1989, no effective treatment--either prophylactic or symptomatic--for space motion sickness (SMS) had been discovered. Since Mar. 1989, intramuscular (IM) promethazine (PMZ) has been used in the treatment of SMS with extremely favorably results reported by the crew. A retrospective study was undertaken to quantify the efficacy of IM PMZ since its institution and the incidence of its major anticipated side-effect drowsiness and sedation. The results from a standardized crew medical debriefing conducted immediately after landing and follow-up interviews with the crews were used in establishing the efficacy and incidence of side effects from treatment. Only crews from the first 44 Shuttle flights on their first mission were considered. For a total of 132 crewmembers, 96 exhibited symptoms of SMS; and, of these, 20 were treated with IM PMZ. Ninety percent of those receiving IM PMZ 25-50mg received nearly immediate (less than 2 hours) relief of symptoms and 75 percent required no further treatment through the first 2 days of spaceflight. Those not receiving this treatment did not have any near-term resolution of their symptoms, and 50 percent were still ill through the second day of flight. This represents a significant difference at the p = 0.46 level. In stark contrast to the 60 percent to 73 percent incidence of sedation or drowsiness reported in individuals treated with PMZ in terrestrial environment at the doses used here, less than 5 percent reported these symptoms during spaceflight. IM PMZ is an effective therapy for SMS and is associated with minimal incidence of sedation or drowsiness. This combination of efficacy that is absent of significant side effects represents a substantial improvement in the operational situation of crewmembers afflicted with SMS. Studies to understand the mechanisms underlying these observations will be undertaken in the future.

[Comparative Study on Bowel Preparation Efficacy of Ascorbic Acid Containing Polyethylene Glycol by Adding Either Simethicone or 1 L of Water in Health Medical Examination Patients: A Prospective Randomized Controlled Study].

PubMed

Yeo, Se Hwan; Kwak, Jae Hoon; Kim, Yeo Un; Kwon, Tae Ho; Park, Jeong Bae; Park, Jun Hyung; Lee, Yong Kook; Lim, Yun Jeong; Yang, Chang Heon

2016-04-25

There are no studies that looked into the bubble eliminating efficacy of polyethylene glycol with ascorbic acid (PEGA), which has been one of the shortcomings of polyethylene glycol (PEG). In this study, we compared newly introduced PEGA regimen by adding either simethicone or 1 L of water. A prospective randomized controlled study was carried out at Dongguk Universtiy Gyeongju Hospital from July 2014 to September 2014. A total of 90 patients were randomly assigned to 3 groups; PEGA group (n=30) which served as control, simethicone addition group (n=30) to which simethicone 400 mg was additionally prescribed, and water addition group (n=30) to whom additional 1 L of water was given. Cleansing effectiveness, gas elimination efficacy, side effects, and patient satisfaction were compared between the groups. PEGA group demonstrated the highest cleansing effectiveness, but there was no statistically significant difference among the groups. Simethicone addition group showed significantly lesser amount of bubbles than the other groups (2.57±2.05 vs. 1.10±1.83 vs. 2.60±2.84, p=0.017). The rates of side effects in each group were 20.00% vs. 16.77% vs. 53.33%. Water addition group had significantly more side effects than the PEGA group and the simethicone addition group (p=0.003). The patient satisfaction score of each group was 3.37±0.85 vs. 3.73±0.74 vs. 3.20±0.66 with simethicone addition group showing significantly higher satisfaction than water addition group (p=0.020). PEGA bowel preparation agent showed satisfactory bowel cleansing despite the decrease in dosage, and addition of simethicone resulted in better bubble elimination.

Pharmacokinetic and pharmacodynamic profile of dronedarone , a new antiarrhythmic agent for the treatment of atrial fibrillation.

PubMed

Rosa, Gian Marco; Bianco, Daniele; Parodi, Antonello; Valbusa, Alberto; Zawaideh, Camilla; Bizzarri, Nicolò; Ferrero, Simone; Brunelli, Claudio

2014-12-01

Atrial fibrillation (AF) is the most common arrhythmia and is associated with increased morbidity and mortality. Dronedarone is a recent antiarrhythmic drug that has been developed for treatment of AF, with electrophysiological properties similar to amiodarone but with a lower incidence of side effects. This review evaluates the efficacy, safety, tolerability and side effects of dronedarone in the treatment of AF. In particular, the review includes studies comparing: dronedarone and placebo (ANDROMEDA, ATHENA, DAFNE, ERATO, EURIDIS/ADONIS, HESTIA, PALLAS trials), dronedarone and amiodarone (DIONYSOS trial), ranolazine and dronedarone given alone and in combination (HARMONY trial). Dronedarone is an interesting antiarrhythmic agent in well-selected groups of patients. It also has several other pleiotropic effects that may potentially be beneficial in clinical practice, such as the reduction of the risk of stroke and acute coronary syndromes. In addition, combination therapies such as those with dronedarone and ranolazine, currently being investigated in the HARMONY trial, may provide another interesting approach to increase the antiarrhythmic efficacy and further reduce the incidence of side effects. A better understanding of the mechanisms underlying dronedarone's pleiotropic actions is expected to facilitate the selection of patients benefiting from dronedarone, as well as the development of novel antiarrhythmic drugs for AF.

A Meta-analysis of the Effectiveness of Albendazole Compared with Metronidazole as Treatments for Infections with Giardia duodenalis

PubMed Central

Solaymani-Mohammadi, Shahram; Genkinger, Jeanine M.; Loffredo, Christopher A.; Singer, Steven M.

2010-01-01

Background Metronidazole is the most commonly used drug for the treatment of giardiasis in humans. In spite of its therapeutic efficacy for giardiasis, low patient compliance, especially in children, side effects, and the emergence of metronidazole-resistant strains may restrict its use. Albendazole has been used to treat Giardia duodenalis infections in recent years. However, efficacy studies in vivo and in vitro have produced diverse results as to its effectiveness. A moderately benign side effect profile, combined with established efficacy against many helminths, renders it promising for treatment of giardiasis in humans. Methodology and Principal Findings We performed a search in the PubMed, Scopus, EMBASE, the ISI Web of Science, LILIACS, and Cochrane Controlled Trials Register for trials published before February 2010 as well as in references of relevant research and review articles. Eight randomized clinical trials (including 900 patients) comparing the effectiveness of albendazole with that of metronidazole were included in meta-analysis. After extracting and validating the data, the pooled risk ratio (RR) was calculated using an inverse-variance random-effects model. Albendazole was found to be equally as effective as metronidazole in the treatment of giardiasis in humans (RR 0.97; 95% CI, 0.93, 1.01). In addition, safety analysis suggested that patients treated with albendazole had a lower risk of adverse effects compared with those who received metronidazole (RR 0.36; 95% CI, 0.10, 1.34), but limitations of the sample size precluded a definite conclusion. Conclusions/Significance The effectiveness of albendazole, when given as a single dose of 400 mg/day for 5 days, was comparable to that of metronidazole. Patients treated with albendazole tended to have fewer side effects compared with those who took metronidazole. Given the safety, effectiveness, and low costs of albendazole, this drug could be potentially used as an alternative and/or a replacement for the existing metronidazole therapy protocols in the treatment of giardiasis in humans. PMID:20485492

Drug delivery system and breast cancer cells

NASA Astrophysics Data System (ADS)

Colone, Marisa; Kaliappan, Subramanian; Calcabrini, Annarica; Tortora, Mariarosaria; Cavalieri, Francesca; Stringaro, Annarita

2016-06-01

Recently, nanomedicine has received increasing attention for its ability to improve the efficacy of cancer therapeutics. Nanosized polymer therapeutic agents offer the advantage of prolonged circulation in the blood stream, targeting to specific sites, improved efficacy and reduced side effects. In this way, local, controlled delivery of the drug will be achieved with the advantage of a high concentration of drug release at the target site while keeping the systemic concentration of the drug low, thus reducing side effects due to bioaccumulation. Various drug delivery systems such as nanoparticles, liposomes, microparticles and implants have been demonstrated to significantly enhance the preventive/therapeutic efficacy of many drugs by increasing their bioavailability and targetability. As these carriers significantly increase the therapeutic effect of drugs, their administration would become less cost effective in the near future. The purpose of our research work is to develop a delivery system for breast cancer cells using a microvector of drugs. These results highlight the potential uses of these responsive platforms suited for biomedical and pharmaceutical applications. At the request of all authors of the paper an updated version was published on 12 July 2016. The manuscript was prepared and submitted without Dr. Francesca Cavalieri's contribution and her name was added without her consent. Her name has been removed in the updated and re-published article.

Adverse Effects of Nonsystemic Steroids (Inhaled, Intranasal, and Cutaneous): a Review of the Literature and Suggested Monitoring Tool.

PubMed

Gupta, Ratika; Fonacier, Luz S

2016-06-01

Inhaled, intranasal, and cutaneous steroids are prescribed by physicians for a plethora of disease processes including asthma and rhinitis. While the high efficacy of this class of medication is well known, the wide range of adverse effects, both local and systemic, is not well elucidated. It is imperative to monitor total steroid burden in its varied forms as well as tracking for possible side effects that may be caused by a high cumulative dose of steroids. This review article highlights the adverse effects of different steroid modalities as well as suggests a monitoring tool to determine steroid totality and side effects.

Current Perspectives in NSAID-Induced Gastropathy

PubMed Central

Sinha, Mau; Gautam, Lovely; Shukla, Prakash Kumar; Kaur, Punit; Sharma, Sujata; Singh, Tej P.

2013-01-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most highly prescribed drugs in the world. Their analgesic, anti-inflammatory, and antipyretic actions may be beneficial; however, they are associated with severe side effects including gastrointestinal injury and peptic ulceration. Though several approaches for limiting these side effects have been adopted, like the use of COX-2 specific drugs, comedication of acid suppressants like proton pump inhibitors and prostaglandin analogs, these alternatives have limitations in terms of efficacy and side effects. In this paper, the mechanism of action of NSAIDs and their critical gastrointestinal complications have been reviewed. This paper also provides the information on different preventive measures prescribed to minimize such adverse effects and analyses the new suggested strategies for development of novel drugs to maintain the anti-inflammatory functions of NSAIDs along with effective gastrointestinal protection. PMID:23576851

Do I need a flu shot?

PubMed

Denton, A P

1997-08-01

Home care nurses soon will be confronted with questions about influenza prevention. Studies show that high-risk patients who should take the vaccine are more likely to do so if they understand its efficacy and absence of side effects.

Metastatic pancreatic adenocarcinoma and renal cell carcinoma treated with gemcitabine and sunitinib malate. A case report.

PubMed

Bharthuar, Anubha; Pearce, Lori; Litwin, Alan; LeVea, Charles; Kuvshinoff, Boris; Iyer, Renuka

2009-09-04

Pancreatic adenocarcinoma and renal cell carcinoma are relatively frequent cancers that have been rarely reported as synchronous primary malignancies. When present simultaneously, they pose a therapeutic challenge given the many available targeted agents with reported efficacy in renal cell cancer and limited options for metastatic pancreatic cancer. We report the case of a 43-year-old Caucasian gentleman diagnosed simultaneously with metastatic pancreatic adenocarcinoma and localized renal cell carcinoma treated with combination chemotherapy, consisting of gemcitabine and sunitinib. Patient had a radiographic response and prolonged progression free survival of twenty six weeks; side effects were manageable and included grade 3 neutropenia and grade 2 hypertension. This encouraging response, safety profile and progression free survival response suggest that we should further examine this and other such regimens to improve clinical outcomes for maximum efficacy with minimal side-effects.

Identification and characterization of carprofen as a multitarget fatty acid amide hydrolase/cyclooxygenase inhibitor.

PubMed

Favia, Angelo D; Habrant, Damien; Scarpelli, Rita; Migliore, Marco; Albani, Clara; Bertozzi, Sine Mandrup; Dionisi, Mauro; Tarozzo, Glauco; Piomelli, Daniele; Cavalli, Andrea; De Vivo, Marco

2012-10-25

Pain and inflammation are major therapeutic areas for drug discovery. Current drugs for these pathologies have limited efficacy, however, and often cause a number of unwanted side effects. In the present study, we identify the nonsteroidal anti-inflammatory drug carprofen as a multitarget-directed ligand that simultaneously inhibits cyclooxygenase-1 (COX-1), COX-2, and fatty acid amide hydrolase (FAAH). Additionally, we synthesized and tested several derivatives of carprofen, sharing this multitarget activity. This may result in improved analgesic efficacy and reduced side effects (Naidu et al. J. Pharmacol. Exp. Ther.2009, 329, 48-56; Fowler, C. J.; et al. J. Enzyme Inhib. Med. Chem.2012, in press; Sasso et al. Pharmacol. Res.2012, 65, 553). The new compounds are among the most potent multitarget FAAH/COX inhibitors reported so far in the literature and thus may represent promising starting points for the discovery of new analgesic and anti-inflammatory drugs.

Oral medications regarding their safety and efficacy in the management of patent ductus arteriosus

PubMed Central

Oncel, Mehmet Yekta; Erdeve, Omer

2016-01-01

Patent ductus arteriosus (PDA) is a common clinical condition in preterm infants which is inversely related to birth weight and gestational age. Cyclooxygenase inhibitors such as indomethacin and ibuprofen which block the prostaglandin conversion from arachidonic acid are the most commonly used drugs for ductal closure. This review focuses on the safety and efficacy oral medications in the management of PDA in preterm infants. Ibuprofen seems to be the first choice due to its higher safety profile, as it is associated with fewer gastrointestinal and renal side effects when compared to indomethacin. PDA closure rates are better with oral than with intravenous ibuprofen probably due to the pharmacokinetic of the drug. However, these medications were reported to be associated with several adverse including transient renal failure, gastrointestinal bleeding and perforation, hyperbilirubinemia and platelet dysfunction. Paracetamol seems be an alternative to PDA therapy with lower adverse events and side effects. PMID:26862505

Effects of acetylic salicylic acid and pentoxifylline on the efficacy of intravesical BCG therapy in orthotopic murine bladder cancer (MB49).

PubMed

Günther, J H; Frambach, M; Deinert, I; Brandau, S; Jocham, D; Böhle, A

1999-05-01

Intravesical immunotherapy with bacillus Calmette-Guerin (BCG), which has become the gold standard in the adjuvant treatment of superficial bladder cancer, is hampered by local side effects. Anti-inflammatory drugs may be helpful, but as an undesired side effect, therapeutic efficacy of BCG might be impaired. Therefore, we investigated the effects of anti-inflammatory drugs on the efficacy of intravesical BCG in an animal model. Syngenic tumor cells were implanted into the bladders of 75 mice according to our modification of the method. Mice were randomized to 5 groups with 15 animals each and treated with phosphate buffered saline (PBS), group 1; BCG, group 2; BCG + acetylic salicylic acid (ASA), group 3; BCG + pentoxifylline (POF), group 4; autoclaved BCG (aBCG), group 5. Intravesical instillation of 1.35 mg. BCG was initiated one day after tumor inoculation and repeated in weekly intervals for 4 instillations altogether. ASA and POF in doses of 200 mg./kg. and 150 mg./kg., respectively, were given continuously with the drinking water starting at the first instillation. Autoclaved BCG served as control for the importance of viability and was given at the same dose as viable BCG. Mice were monitored for survival, gross hematuria and body weight and after 28 days evaluated for bladder weight and tumor occurrence. Autoclaved BCG and PBS had no effect on tumor growth, whereas animals treated with viable BCG alone and in combination with POF and ASA, respectively, showed a significant reduction in bladder weight: PBS, 248 mg.; BCG, 140 mg. (p = 0.0009); BCG + ASA, 123 mg. (p = 0.0001); BCG + POF, 145 mg. (p = 0.0004); autoclaved BCG, 283 mg. (p = 0.21). Mice treated with BCG, BCG + ASA and BCG + POF showed a significantly higher proportion of survival until day 28 as compared to PBS alone. Autoclaved BCG had no therapeutic efficacy (Kaplan-Meier method/log rank test: BCG, p = 0.0053; BCG + ASA, p = 0.0044; BCG + POF, p = 0.0027; aBCG, p = 0.33). No significant differences among the 3 groups treated with viable BCG, with or without anti-inflammatory drugs, regarding bladder weight and survival were detectable. The efficacy of BCG therapy in murine orthotopic bladder cancer is dependent on BCG viability and is not compromised by ASA or POF. Clinical trials to evaluate the efficacy of routine ASA or POF to reduce BCG side effects in patients, using self-assessment criteria, should be initiated.

Emerging Treatment Mechanisms for Depression: Focus on Glutamate and Synaptic Plasticity

PubMed Central

Gerhard, Danielle M.; Wohleb, Eric S.; Duman, Ronald S.

2016-01-01

Major depression is a chronic and debilitating illness that effects approximately 1 in 5 people, but currently available treatments are limited by low rates of efficacy, therapeutic time lag, and undesirable side effects. Recent efforts have been directed towards investigating rapid-acting agents that reverse the behavioral and neuronal deficits of chronic stress and depression, notably the glutamate NMDA receptor antagonist ketamine. The cellular mechanisms underlying the rapid antidepressant actions of ketamine and related agents are discussed, as well as novel, selective glutamatergic receptor targets that are safer and have fewer side effects. PMID:26854424

Treatment of acne scars and wrinkles in asian patients using carbon-dioxide fractional laser resurfacing: its effects on skin biophysical profiles.

PubMed

Hwang, Young Ji; Lee, Yu Na; Lee, Yang Won; Choe, Yong Beom; Ahn, Kyu Joong

2013-11-01

Although ablative fractional resurfacing is known to be effective against photoaging and acne scars, studies on its efficacy, safety and changes in the skin characteristics of Asians are limited. The aim of this study is to assess the efficacy and safety of carbon dioxide fractional laser (CO2FL) in Koreans treated for wrinkles and acne scars, and to define the changes in skin characteristics during recovery period. We administered one session of CO2FL on 10 acne scar patients and 14 wrinkles patients with skin types IV and V. The surveillance of efficacy and side effects along with the measurement of biophysical properties was carried out before 1 day, 1 week, 1 month and 3 months after treatment. Using a non-invasive method, skin barrier damage, erythema and bronzing of skin during the recovery period were assessed, and all of the items eventually returned to the pre-treatment level. Skin elasticity was measured in the wrinkle group, and the statistically significant effect was sustained throughout the next three months. The outcome of treatment was found to be better than 'moderate improvement' in both the acne scar and wrinkle groups. Further, there were no serious side effects three months post-procedure. CO2 FL is thought to be an effective and safe method for treating moderate to severe acne scars and wrinkles in Asians.

Infliximab treatment in a patient with rheumatoid arthritis on hemodialysis.

PubMed

Singh, Ranju; Cuchacovich, Raquel; Huang, Wenqun; Espinoza, Luis R

2002-03-01

We describe a 60-year-old woman with active rheumatoid arthritis (RA) and endstage renal disease secondary to hypertensive nephrosclerosis undergoing hemodialysis. She had tried multiple antirheumatic medications; however, their usefulness was limited due to toxic side effects or lack of efficacy. She was then treated with chimeric antitumor necrosis factor monoclonal antibody (infliximab), which resulted in immediate improvement in clinical and laboratory measures. After about 2 years of therapy, no side effects have been observed. This report expands the spectrum of infliximab to include RA patients with renal insufficiency.

Analysis of inflammation-induced depression of home cage wheel running in rats reveals the difference between opioid antinociception and restoration of function.

PubMed

Kandasamy, Ram; Calsbeek, Jonas J; Morgan, Michael M

2017-01-15

Opioids are effective at inhibiting responses to noxious stimuli in rodents, but have limited efficacy and many side effects in chronic pain patients. One reason for this disconnect is that nociception is typically assessed using withdrawal from noxious stimuli in animals, whereas chronic pain patients suffer from abnormal pain that disrupts normal activity. We hypothesized that assessment of home cage wheel running in rats would provide a much more clinically relevant method to assess opioid efficacy to restore normal behavior. Intraplantar injection of Complete Freund's Adjuvant (CFA) into the right hindpaw depressed wheel running and caused mechanical allodynia measured with the von Frey test in both male and female rats. Administration of an ED 50 dose of morphine (3.2mg/kg) reversed mechanical allodynia, but did not reverse CFA-induced depression of wheel running. In contrast, administration of a low dose of morphine (1.0mg/kg) restored running for one hour in both sexes, but had no effect on mechanical allodynia. Administration of the atypical opioid buprenorphine had no effect on inflammation-induced depression of wheel running in male or female rats, but attenuated mechanical allodynia in male rats. Administration of buprenorphine and higher doses of morphine depressed wheel running in non-inflamed rats, suggesting that the side effects of opioids interfere with restoration of function. These data indicate that restoration of pain-depressed function requires antinociception in the absence of disruptive side effects. The disruptive side effects of opioids are consistent with the major limitation of opioid use in human pain patients. Copyright © 2016 Elsevier B.V. All rights reserved.

Analysis of inflammation-induced depression of home cage wheel running in rats reveals the difference between opioid antinociception and restoration of function

PubMed Central

Kandasamy, Ram; Calsbeek, Jonas J.; Morgan, Michael M.

2016-01-01

Opioids are effective at inhibiting responses to noxious stimuli in rodents, but have limited efficacy and many side effects in chronic pain patients. One reason for this disconnect is that nociception is typically assessed using withdrawal from noxious stimuli in animals, whereas chronic pain patients suffer from abnormal pain that disrupts normal activity. We hypothesized that assessment of home cage wheel running in rats would provide a much more clinically relevant method to assess opioid efficacy to restore normal behavior. Intraplantar injection of Complete Freund’s Adjuvant (CFA) into the right hindpaw depressed wheel running and caused mechanical allodynia measured with the von Frey test in both male and female rats. Administration of an ED50 dose of morphine (3.2 mg/kg) reversed mechanical allodynia, but did not reverse CFA-induced depression of wheel running. In contrast, administration of a low dose of morphine (1.0 mg/kg) restored running for one hour in both sexes, but had no effect on mechanical allodynia. Administration of the atypical opioid buprenorphine had no effect on inflammation-induced depression of wheel running in male or female rats, but attenuated mechanical allodynia in male rats. Administration of buprenorphine and higher doses of morphine depressed wheel running in non-inflamed rats, suggesting that the side effects of opioids interfere with restoration of function. These data indicate that restoration of pain-depressed function requires antinociception in the absence of disruptive side effects. The disruptive side effects of opioids are consistent with the major limitation of opioid use in human pain patients. PMID:27746208

Comparative Effects of Stimulant Drugs in Hyperkinetic Children.

ERIC Educational Resources Information Center

Conners, C. Keith

The study compared the efficacy, side effects, and safety of magnesium pemoline (Cylert) and destroamphetamine (Dexedrine) as compared with placebo. Subjects were 81 children, ages 6-12 years, who evidenced one or more signs of minimal brain dysfunction, and were referred with major complaints of hyperactivity, short attention span,…

Combination of platelet rich plasma in fractional carbon dioxide laser treatment increased clinical efficacy of for acne scar by enhancement of collagen production and modulation of laser-induced inflammation.

PubMed

Min, Seonguk; Yoon, Ji Young; Park, Seon Yong; Moon, Jungyoon; Kwon, Hyuck Hoon; Suh, Dae Hun

2018-04-01

Platelet-rich plasma (PRP) which contains large amounts of growth factors has been tried to enhance therapeutic efficacy of laser treatment for acne scar with unknown underlying mechanism. The present study was conducted to investigate the molecular mechanism of increased clinical efficacy of PRP when combined with fractional laser treatment for treating acne scars. Subjects with mild to moderate acne scars were treated with two sessions of fractional CO 2 laser therapy given with and without co-administration of PRP. Skin biopsy specimens were obtained at baseline, 1, 3, 7, and 28 days for investigation of molecular profiles associated with skin changes produced by laser plus PRP treatment. The PRP treatment increased clinical efficacy with decreased severity of adverse effects such as erythema, swelling and oozing. Productions of TGFβ1 and TGFβ3 proteins were more highly elevated on the PRP-treated side of the face compared to the control side at day 28. Furthermore, PRP-treated side showed significant increase of c-myc, TIMP, and HGF expression. Experimental fibroblast culture model was also used. PRP administration after laser irradiation increased expressions of p-Akt, TGFβ1, TGFβ3, β-catenin, collagen 1, and collagen 3 in both dose-dependent and time dependent manners in fibroblast. Moreover, we acquired clinical and histological data through randomized control clinical trial. Taken together with human study results combined with the data from cell experiments we suggest that PRP treatment increased fibrogenetic molecules induced by fractional CO 2 laser, which have association with clinical effect. Lasers Surg. Med. 50:302-310, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

[Herbal preparations have both effects and side effects. Widespread usage dictates knowledge among physicians].

PubMed

Mattsson, Karin; Nilsson, Inger

2002-12-12

The article gives a clinically oriented overview of the efficacy and safety of Ginkgo biloba, St. John's wort, ginseng, Echinacea, saw palmetto and kava based on American experiences. Clinical data support the efficacy for some of these drugs. None of them is free of adverse effects. Generally speaking, trials of herbal medicinal products have been too few, too small and too short. The lack of long-term studies is especially unfortunate since many of the drugs are used for a long time. The difference between American and Swedish legislation on herbal medicine products is described.

Luteal Phase Support in assisted reproductive technology treatment: focus on Endometrin® (progesterone) vaginal insert

PubMed Central

Check, Jerome H

2009-01-01

Supplementation of progesterone in the luteal phase and continuance of progesterone therapy during the first trimester has been found in several studies to have benefits in promoting fertility, preventing miscarriages and even preventing pre-term labor. Though it can be administered orally, intramuscularly or even sublingually, a very effective route with fewer side effects can be achieved by an intravaginal route. The first vaginal preparations were not made commercially but were compounded by pharmacies. This had the disadvantage of lack of control by the Food and Drug Administration (FDA) ensuring efficacy of the preparations. Furthermore there was a lack of precise dosing leading to batch to batch variation. The first commercially approved vaginal progesterone preparation in the United States was a vaginal gel which has proven very effective. The main side effect was accumulation of a buildup of the vaginal gel sometimes leading to irritation. Natural micronized progesterone for vaginal administration with the brand name of Utrogestan A® had been approved even before the gel in certain European countries. Endometrin® vaginal tablets are the newest natural progesterone approved by the FDA. Comparisons to the vaginal gel and to intramuscular progesterone have shown similar efficacy especially in studies following controlled ovarian hyperstimulation and oocyte egg retrieval and embryo transfer. Larger studies are needed to compare side effects. PMID:19753133

Depot naltrexone in lieu of incarceration: a behavioral analysis of coerced treatment for addicted offenders.

PubMed

Marlowe, Douglas B

2006-09-01

This article is part of a series of articles examining a proposal to offer depot naltrexone to certain nonviolent opiate-addicted criminal offenders in exchange for release from incarceration or diversion from prosecution. This "negative-reinforcement" behavioral paradigm could have a better chance of success than what has heretofore been attempted with drug-abusing offenders. Traditional correctional efforts have been largely unsuccessful due to the complexities of implementation and the side effects of punishment. Although positive reinforcement can be more efficacious, it has often been strenuously resisted on the ground that it is inequitable to reward antisocial individuals for doing what is minimally expected of most citizens. Negative reinforcement steers between these hurdles by avoiding the iatrogenic effects of punishment, while also being palatable to stakeholders. More research is needed to identify the effects, costs, and side effects of negative-reinforcement arrangements for drug offenders. The current proposal provides an excellent platform for conducting this research because the target intervention (depot naltrexone) is demonstrably efficacious, nonpsychoactive, and has few, if any, side effects. Therefore, use of this medication would be unlikely to invoke the same types of legal and ethical objections that have traditionally been levied against the use of psychoactive medications with vulnerable populations of institutionalized offenders. Specific recommendations are offered for questions that must be addressed in future research studies.

The use of monoamine pharmacological agents in the treatment of sexual dysfunction: evidence in the literature.

PubMed

Moll, Jennifer L; Brown, Candace S

2011-04-01

The monoamine neurotransmitters serotonin, dopamine, and norepinephrine play an important role in many medical and psychological conditions, including sexual responsiveness and behavior. Pharmacological agents that modulate monoamines may help alleviate sexual dysfunction. To provide an overview of pharmacological agents that modulate monoamines and their use in the treatment of sexual dysfunction. EMBASE and PubMed search for articles published between 1950 and 2010 using key words "sexual dysfunction,"monoamines,"monoaminergic receptors," and "generic names for pharmacological agents." To assess the literature evaluating the efficacy of monoamine pharmacologic agents used in the treatment of sexual dysfunction. The literature primarily cites the use of monoaminergic agents to treat sexual side effects from serotonergic reuptake inhibitors (SSRIs), with bupropion, buspirone and ropinirole providing the most convincing evidence. Controlled trials have shown that bupropion improves overall sexual dysfunction, but not frequency of sexual activity in depressed and nondepressed patients. Nefazodone and apomorphine have been used to treat sexual dysfunction, but their use is limited by significant side effect and safety profiles. New research on pharmacologic agents with subtype selectivity at dopaminergic and serotonergic receptors and those that possess dual mechanisms of action are being investigated. There has been tremendous progress over the past 50 years in understanding the role of monoamines in sexual function and the effect of pharmacologic agents which stimulate or antagonize monoaminergic receptors on sexual dysfunction. Nevertheless, large, double-blind, placebo-controlled studies evaluating the efficacy of currently available agents in populations without comorbid disorders are limited, preventing adequate interpretation of data. Continued research on sexual function and specific receptor subtypes will result in the development of more selective pharmacologic agents with the goal of increasing efficacy without the dose-limiting side effects of nonselective agents. © 2011 International Society for Sexual Medicine.

The topical treatment of psoriasis.

PubMed

van de Kerkhof, P C M; Vissers, W H P M

2003-01-01

According to the patients, improvement of efficacy, long-term safety and improvement of compliance are needed. The topical treatment has been innovated during the last decade. Most important are the introduction of two new classes of treatments: topical vitamin D(3) analogues and the retinoid tazarotene. To what extent, however, have we achieved developments which are in line with the needs as expressed by the patients? Improved efficacy has been realized by successful combinations of topical treatments. In particular, the combinations of dithranol, vitamin D(3) and tazarotene with a topical corticosteroid proved to be very effective with a reduced profile of side-effects. The efficacy of vitamin D(3) analogues and tazarotene is such that the efficacy of a potent corticosteroid (betamethasone-17-valerate) is approached; calcipotriol even showed an efficacy which is at least as good as this corticosteroid. The long-term safety of new compounds has been evaluated for at least 12 months in large studies. Remarkably for corticosteroids such information is available for only 12 weeks. However, intermittent applications of a topical corticosteroid in combination with another topical treatment provide an effective and safe long-term control of psoriasis. Compliance is a conditio sine qua non for an effective topical treatment. Important progress has been made to increase compliance. Short-contact dithranol has been popularized as an ambulatory treatment which is a highly effective approach as a care instruction programme. Formulations which are better from a cosmetical point of view have been developed for various topical treatments. Reduction of the frequency of applications proved to be possible for most treatments. Once daily applications for corticosteroids, vitamin D(3) analogues and retinoids have been developed, and intermittent applications, a few times per week, are possible for corticosteroids, which proved to be very effective with a reduced profile of side-effects, and are also developed for dithranol. Copyright 2003 S. Karger AG, Basel

Treatment hurts: Lay theories of graded exposure in the treatment of four anxiety disorders

PubMed Central

Furnham, Adrian; Wilson, Emma; Chapman, Amy; Persuad, Raj

2013-01-01

Objective This paper concerned the perceived suffering/side effects caused by various well-known treatments for personal problems. It looked at whether people understood whether potentially painful treatments that confront negative aversive affect were effective or not. Method In total, 106 participants completed a long questionnaire assessing the ‘psychological pain’ ratings of 30 psychotherapy treatments, varying in fear exposure, for four relatively common anxiety disorders: social phobia, agoraphobia, post-traumatic stress disorder, and obsessive compulsive disorder. Results Factor analytic results revealed four clear factors underlying lay efficacy beliefs of psychotherapy interventions, varying in fear exposure: talking therapies, fear confrontation, fear avoidance, and alternative therapies. Talking therapies were rated the most effective across all disorders, but also the most painful. Fear avoidance therapies were rated the least effective and, along with alternative medicine, the least painful. Treatments involving fear exposure were rated the most painful. Regression analysis revealed talking therapies to be rated more efficacious by younger subjects than older subjects. Conclusion Most people seem able to differentiate between the efficacies of interventions for different anxiety disorders and hold consensually held optimistic conceptions about the usefulness of psychotherapy treatments and counseling that involve fear exposure, despite knowledge of the psychophysical side effects that these therapies often entail. They favored talking cures over others, but that may have been due to misleading items in the questionnaire. PMID:26405431

Conversations between community-based neurologists and patients with epilepsy: results of an observational linguistic study.

PubMed

Gilliam, Frank; Penovich, Patricia E; Eagan, Corey A; Stern, John M; Labiner, David M; Onofrey, Meaghan; Holmes, Gregory L; Mathis, Eileen; Cramer, Joyce

2009-10-01

An in-office linguistic study was conducted to assess neurologist-patient discussions of epilepsy. Naturally occurring interactions among 20 neurologists and 60 of their patients with epilepsy were recorded. Participants were interviewed separately postvisit. Transcripts were analyzed using sociolinguistic techniques. Of 59 patients taking antiepileptic drugs previsit, 44 (75%) discussed side effects with their neurologist. Side effect discussions were most often neurologist initiated. Postvisit, patients and neurologists often disagreed about which side effects were experienced. The presence of a caregiver (e.g., spouse) usually resulted in lengthier, more detailed discussions of side effects, without drastically increasing overall visit length. Discussions of mood- and behavior-related comorbidities occurred infrequently (14 of 60 visits); postvisit, neurologists stated that they felt that management of these conditions was outside their area of expertise. Communication gaps observed in discussions of epilepsy and its treatment warrant further exploration. Additional research is currently underway to assess the efficacy of a previsit assessment tool.

Low doses of haloperidol combined with ondansetron are not effective for prophylaxis of postoperative nausea and vomiting in susceptible patients.

PubMed

Veiga-Gil, Leonor; López-Olaondo, Luis; Pueyo, Javier; Callejas, Raquel; Duque, Paula; Carrascosa, Francisco

2015-02-01

In this observational study we reviewed the efficacy and side effects of different antiemetic combinations used in our hospital for postoperative nausea and vomiting (PONV) prophylaxis in high-risk women undergoing highly emetogenic surgery. After reviewing retrospectively the medical records of patients undergoing highly emetogenic elective surgeries under general anaesthesia, we selected 368 women whose Apfel risk score was ≥ 3 and receiving a combination of 2 antiemetics for PONV prophylaxis. We analysed the incidence of PONV at 2, 6, 12 and 24h after surgery, antiemetic rescue requirements, pattern of occurrence of PONV, side effects and level of sedation were also assessed. The main goal was complete response defined as no PONV within 24h after surgery. Ondansetron 4mg i.v. plus dexamethasone 8mg i.v. (O&Dex), haloperidol 1mg i.v. (O&Hal1), haloperidol 2mg i.v. (O&Hal2) or droperidol 1.25mg i.v. (O&Dro) were the combinations most frequently used. The complete response was better in groups O&Dex: 68.5% (CI: 58-78), O&Hal2: 64.1% (CI: 53-74) and O&Dro 63% (CI: 52-73) than in group O&Hal1: 41.3% (CI: 31-52) (p<0,01). Peak incidence of PONV occurred within the 2-6h period. The incidence of side effects was higher in group O&Hal2. In high risk patients for PONV who underwent highly emetogenic surgeries, the efficacy of low-dose haloperidol (1mg) in combination is limited. Higher doses (2mg) are more effective but its use is associated with a high incidence of side effects. Copyright © 2013 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Efficacy and side effects of dacarbazine in comparison with temozolomide in the treatment of malignant melanoma: a meta-analysis consisting of 1314 patients.

PubMed

Teimouri, Fatemeh; Nikfar, Shekoufeh; Abdollahi, Mohammad

2013-10-01

The widespread prevalence of melanoma, one of the most malignant forms of skin cancer, is increasing rapidly. Two chemotherapeutic regimens are commonly used for the palliative treatment of malignant melanoma: intravenous administration of single-agent dacarbazine or oral administration of temozolomide. The aim of this study was to compare the effectiveness and side effects of dacarbazine with those of temozolomide through a meta-analysis. A thorough literature bibliography search was conducted up to 2012 to gather and review all randomized clinical trials comparing the use of dacarbazine with that of temozolomide in the treatment of malignant melanoma. Three head-to-head randomized clinical trials comprising 1314 patients met the criteria and were included. Comparison of temozolomide with dacarbazine yielded a nonsignificant relative risk (RR) of 0.83 [95% confidence interval (CI) = 0.26-2.64, P = 0.76] for complete response, a nonsignificant RR of 1.05 (95% CI = 0.85-1.3, P = 0.65) for stable disease, and a nonsignificant RR of 2.64 (95% CI = 0.97-1.36, P = 0.11) for disease control rate. The RR for nonhematologic side effects and hematologic side effects, such as anemia, neutropenia, and thrombocytopenia, of temozolomide compared with dacarbazine in patients with malignant melanoma was nonsignificant in all cases, but the RR for lymphopenia of temozolomide compared with dacarbazine was 3.79 (95% CI = 1.38-10.39, P = 0.01), which was significant. Although it is easier to administer oral medication, according to the results, there is no significant difference in the efficacy and side effects of these two drugs. Owing to the higher cost of treatment with temozolomide and the increased prevalence of lymphopenia on using temozolomide, use of dacarbazine as the first choice treatment for malignant melanoma is suggested.

Haloperidol, risperidone, olanzapine and aripiprazole in the management of delirium: A comparison of efficacy, safety, and side effects.

PubMed

Boettger, Soenke; Jenewein, Josef; Breitbart, William

2015-08-01

The aim of this study was to compare the efficacy and side-effect profile of the typical antipsychotic haloperidol with that of the atypical antipsychotics risperidone, olanzapine, and aripiprazole in the management of delirium. The Memorial Delirium Assessment Scale (MDAS), the Karnofsky Performance Status (KPS) scale, and a side-effect rating were recorded at baseline (T1), after 2-3 days (T2), and after 4-7 days (T3). Some 21 cases were case-matched by age, preexisting dementia, and baseline MDAS scores, and subsequently analyzed. The baseline characteristics of the medication groups were not different: The mean age of the patients ranged from 64.0 to 69.6 years, dementia was present in between 23.8 and 28.6%, and baseline MDAS scores were 19.9 (haloperidol), 18.6 (risperidone), 19.4 (olanzapine), and 18.0 (aripiprazole). The doses of medication at T3 were 5.5 mg haloperidol, 1.3 mg risperidone, 7.1 mg olanzapine, and 18.3 mg aripiprazole. Over one week, the decline in MDAS scores between medications was equal, and no differences between individual MDAS scores existed at T2 or T3. After one week, the MDAS scores were 6.8 (haloperidol), 7.1 (risperidone), 11.7 (olanzapine), and 8.3 (aripiprazole). At T2, delirium resolution occurred in 42.9-52.4% of cases and at T3 in 61.9-85.7%; no differences in assessments between medications existed. Recorded side effects were extrapyramidal symptoms (EPSs) in haloperidol- and risperidone-managed patients (19 and 4.8%, respectively) and sedation with olanzapine (28.6%). Haloperidol, risperidone, aripiprazole, and olanzapine were equally effective in the management of delirium; however, they differed in terms of their side-effect profile. Extrapyramidal symptoms were most frequently recorded with haloperidol, and sedation occurred most frequently with olanzapine.

Clinical trial: oral colon-release parnaparin sodium tablets (CB-01-05 MMX) for active left-sided ulcerative colitis.

PubMed

Celasco, G; Papa, A; Jones, R; Moro, L; Bozzella, R; Surace, M M; Naccari, G C; Gasbarrini, G

2010-02-01

The administration of parnaparin sodium as oral colon-release tablets (CB-01-05 MMX) has been proposed as a novel approach for the treatment of ulcerative colitis (UC). To assess the efficacy and the tolerability of 8 weeks' oral daily administration of 210 mg of parnaparin sodium compared with placebo in subjects treated with stable-doses of oral aminosalicylates. This multicenter, randomized, double-blind proof of concept trial compared the efficacy of CB-01-05 MMX 210 mg tablets to placebo in 141 subjects with mild to moderately active left-sided UC treated with stable-doses of aminosalicylates. The efficacy was assessed by clinical activity index (CAI), endoscopic index (EI) and histological score (HS). A total of 121 subjects (61 in test group and 60 in control group) formed the per protocol (PP) population. After 8 weeks of treatment, clinical remission was achieved in 83.6% of the CB-01-05 MMX group, and in 63.3% in the comparator group (P = 0.011). This effect was also significantly evident in the test group at week 4 (P = 0.028). A significant difference was also detected in rectal bleeding, (disappeared respectively in 75.4% and 55.0%; P = 0.018), and in mucosal friability (recovered respectively in 80.3% and in 56.7%; P = 0.005). CB-01-05 MMX was safe and significantly effective in treating subjects with mild-to-moderate left-sided UC treated with stable-doses of aminosalicylates.

The role of exercise in migraine treatment.

PubMed

Koseoglu, E; Yetkin, M F; Ugur, F; Bilgen, M

2015-09-01

This review aims to provide a comprehensive overview of the literature on the use of exercise for migraine treatment with regard to its efficacy, mechanism of action and role in practice. Many randomized studies have reported the efficacy of prophylactic treatment of migrane with medications such as beta blockers or antiepileptic drugs. Studies on alternative approaches, like aerobic exercise and biofeedback, are however limited but also considered to be effective. Scientific databases were searched with keywords "exercise" and "migraine". The resulting publications were gathered, examined and discussed throughly. Past studies had limitations and were few in number, but more recent randomized controlled studies have concretely provided level of evidence about the effectiveness of exercise in prophylactic treatment of migraine. Core properties of exercise like intensity, duration, frequency, type and warming up period are required to be monitored while treating migraine to increase the beneficial effects and, also to prevent injuries and side effects which may include exertional headache. Isometric neck exercise is helpful when the migraine is accompanied by neck pain. Patient population with low beta endorphin level in blood, high physical fitness and high motivation receives significant benefits from the exercise treatment. The action of exercise on migraine is in general related to neurochemical factors, psychological states and increase in cardivascular and cerebrovascular fitness. Considering its effectiveness and minimal side effects, migraine patients should often be encouraged to practice physical exercise with intensity, frequency and duration that should be carefully instituted to achieve the most beneficial outcome while preventing potential injuries and side effects.

Efficacy and cognitive side effects after brief pulse and ultrabrief pulse right unilateral electroconvulsive therapy for major depression: a randomized, double-blind, controlled study.

PubMed

Spaans, Harm-Pieter; Verwijk, Esmée; Comijs, Hannie C; Kok, Rob M; Sienaert, Pascal; Bouckaert, Filip; Fannes, Katrien; Vandepoel, Koen; Scherder, Erik J A; Stek, Max L; Kho, King H

2013-11-01

To compare the efficacy and cognitive side effects of high-dose unilateral brief pulse electroconvulsive therapy (ECT) with those of high-dose unilateral ultrabrief pulse ECT in the treatment of major depression. From April 2007 until March 2011, we conducted a prospective, double-blind, randomized multicenter trial in 3 tertiary psychiatric hospitals. All patients with a depressive disorder according to DSM-IV criteria were eligible. Depression severity was assessed with the Montgomery-Asberg Depression Rating Scale; primary efficacy outcomes were response, defined as a score decrease ≥ 60% from baseline, and remission, defined as a score < 10 at 2 consecutive weekly assessments. Total scores on the Autobiographical Memory Interview and Amsterdam Media Questionnaire were the primary outcome measures for retrograde amnesia. Other cognitive domains included category fluency (semantic memory) and letter fluency (lexical memory). Patients received twice-weekly unilateral brief pulse (1.0 millisecond) or ultrabrief pulse (0.3-0.4 millisecond) ECT 8 times seizure threshold until remission, for a maximum of 6 weeks. Of the 116 patients, 75% (n = 87) completed the study. Among completers, 68.4% (26/58) of those in the brief pulse group achieved remission versus 49.0% (24/49) of those in the ultrabrief pulse group (P = .019), and the brief pulse group needed fewer treatment sessions to achieve remission: mean (SD) of 7.1 (2.6) versus 9.2 (2.3) sessions (P = .008). No significant group differences were found in the evaluation of the cognitive assessments. The efficacy and speed of remission seen with high-dose brief pulse right unilateral ECT twice weekly were superior to those seen with high-dose ultrabrief pulse right unilateral ECT, with equal cognitive side effects as defined by retrograde amnesia, semantic memory, and lexical memory. Netherlands National Trial Register number: NTR1304. © Copyright 2013 Physicians Postgraduate Press, Inc.

A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris.

PubMed

Parish, Lawrence Charles; Parish, Jennifer L; Routh, Hirak B; Avakian, Edward; Olayinka, Babajide; Pappert, Eric J; Plaum, Stefan; Fleischer, Alan B; Hardas, Bhushan

2011-10-01

Naftifine HCl 2% cream (NAFT-2%) is a topical allylamine antifungal preparation under development in the U.S. The objective of this randomized, double-blind, vehicle-controlled study was to evaluate the efficacy and safety of a two-week course of once-daily NAFT-2% vs. vehicle in the treatment of Tinea cruris ("jock itch"). A total of 334 subjects with T. cruris were enrolled and randomly assigned to NAFT-2% (n=166) or vehicle (n=168), which was applied once daily for 14 days. Efficacy and safety were evaluated at week 2 (end of treatment) and week 4. Efficacy measures included complete cure, treatment effectiveness, mycological cure, clinical cure, and clinical success and were analyzed only in subjects with a positive potassium hydroxide (KOH) and dermatophyte culture at baseline (n=75, naftifine; n=71, vehicle). Safety was assessed by adverse events and changes from baseline in clinical status and laboratory studies. At week 4, 25 percent of naftifine-treated subjects achieved complete cure vs. three percent of vehicle subjects and 72 percent achieved mycological cure vs. 16 percent of vehicle treated subjects (one-sided, P<0.001). Treatment effectiveness was achieved in 60 percent of NAFT-2% subjects vs. 10 percent of vehicle subjects (one-sided, P<0.001). Clinical cure rate and clinical success rate were 33 percent and 84 percent in NAFT-2% subjects, respectively vs. 10 percent and 46 percent in vehicle subjects (both P is less than 0.001, 2-sided). Week 2 efficacy response rates in NAFT-2% subjects were all lower than at week 4 but were significantly higher than week 2 vehicle-treated counterparts (P<0.025). Treatment-related AE occurred in 11 subjects (7 NAFT-2%, 4 vehicle) during the study. The most common AE in both groups were contact dermatitis (2 NAFT-2%), pruritus (2 vehicle), and application site reaction (1 per group). NAFT-2% applied once daily for two weeks (one-half the treatment duration for naftifine 1% cream) is efficacious and safe for the treatment of T. cruris.

Efficacy and cognitive side effects of tiagabine and topiramate in patients with epilepsy.

PubMed

Fritz, N; Glogau, S; Hoffmann, J; Rademacher, M; Elger, C E; Helmstaedter, C

2005-05-01

Whereas the efficacy of the newer antiepileptic drugs (AEDs) is well established, there remain questions regarding their cognitive side effects. Therefore, we performed a comparative open randomized trial with TPM and TGB as add-on therapy, with particular consideration of cognition, mood, and health-related quality of life (HRQOL). Forty-one patients with refractory epilepsy were randomly assigned to one of the two treatment groups (TPM vs TGB) and received neuropsychological testing at baseline (T1), after titration (3 months, T2), and during the maintenance phase (another 3 months, T3). Tests included measures of intelligence, attention, working memory, episodic memory, language, and self-report questionnaires regarding mood and HRQOL. Twenty patients (8 TPM, 12 TGB) discontinued the trial for different reasons (no group difference). Seizure outcome (intention-to-treat analysis) was comparably good in both groups (8.1% seizure free, 29.7% seizure reduction>50%). From baseline to after the titration paired sample t tests revealed significant deterioration in verbal fluency, language comprehension, working memory, and visual block tapping under TPM and a deterioration in verbal memory (delayed free recall) in the TGB group. These functions remained stable in the maintenance phase. Self-report measures initially indicated concerns about AED side effects in both groups and concerns about worse cognitive functioning and depression under TPM. In the maintenance phase the TGB group reported feeling a lack of energy, whereas patients on TPM demonstrated improvement on all QOLIE scales on a descriptive level. This study demonstrates the comparable efficacy of TPM and TGB. Consistent with previous reports, TPM but not TGB appears to be associated with persistent negative cognitive side effects on frontal lobe-associated functions, the degree of which may be estimated by the fact that this effect was observed with a very small sample size. In contrast, in patients taking TPM, initially negatively affected HRQOL returns to baseline in the long run on a descriptive level. The latter finding may be interpreted in accordance with the observation that objective performance and subjective self-report under TPM can be dissociated.

Photo-thermal nanosystems for diseased cell treatment

NASA Astrophysics Data System (ADS)

Raeesi, Vahid

The prevalence of cancer and infectious disease demands for development of more effective treatment technologies. Current standard chemo- and radiotherapy for cancer offer only relative therapeutic efficacy at the cost of significant side-effects. On the other hand, resistance of microbes to current antibiotics has raised serious concern in public health sectors such as hospitals. Thermal therapy is an alternative technique that employs high temperatures to treat diseased cells via direct and indirect heat effects. Owing to its nature, this technique can offer enhanced therapeutic efficacy in local diseased regions via either mono- or combinatorial platforms and very minimal side-effects. However, existing bulk heating systems are limited in providing selective and controlled temperature rise in the desired region at tissue/cellular scales. This compromises the therapeutic efficacy of the treatment and increases the risk of off-target heating in healthy tissues. In this thesis, we propose the use of heat-generating nanoparticles to precisely target heat into small regions and study how they can be applied in cancer and bacteria treatment. Our model nanoparticle system generates heat by light stimulation. Different nanosystems based on this particle are developed and their thermal effects on therapeutic distribution are explored at tumor tissue and cellular scales. In addition, the thermal effect of these nanoparticles is utilized to overcome microbial resistance. By mechanistic understanding of nanoparticle thermal effects at different length scales, this research helps to rationalize proper design and development of heat- generating nanomedicine for cancer and microbial treatments.

The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol.

PubMed

van den Bos, W; de Bruin, D M; Muller, B G; Varkarakis, I M; Karagiannis, A A; Zondervan, P J; Laguna Pes, M P; Veelo, D P; Savci Heijink, C D; Engelbrecht, M R W; Wijkstra, H; de Reijke, T M; de la Rosette, J J M C H

2014-10-29

Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective in destroying tumour cells and harbours the advantage of sparing surrounding tissue and vital structures. The aim of the study is to evaluate the safety and efficacy and to acquire data on patient experience of minimally invasive, transperineally image-guided IRE for the focal ablation of prostate cancer. In this multicentre pilot study, 16 patients with prostate cancer who are scheduled for a radical prostatectomy will undergo an IRE procedure, approximately 30 days prior to the radical prostatectomy. Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy. Prior to the IRE procedure and the radical prostatectomy, all patients will undergo a multiparametric MRI and contrast-enhanced ultrasound of the prostate. The efficacy of ablation will be determined by whole mount histopathological examination, which will be correlated with the imaging of the ablation zone. The protocol is approved by the ethics committee at the coordinating centre (Academic Medical Center (AMC) Amsterdam) and by the local Institutional Review Board at the participating centres. Data will be presented at international conferences and published in peer-reviewed journals. This pilot study will determine the safety and efficacy of IRE in the prostate. It will show the radiological and histopathological effects of IRE ablations and it will provide data to construct an accurate treatment planning tool for IRE in prostate tissue. Clinicaltrials.gov database: NCT01790451. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

The safety of tocolytics used for the inhibition of preterm labour.

PubMed

Lamont, Callum D; Jørgensen, Jan Stener; Lamont, Ronald F

2016-09-01

Preterm birth is the major cause of neonatal mortality and morbidity worldwide and a huge cost burden on healthcare. Between 22 and 26 completed weeks of gestation, for every day that delivery is delayed, survival increases by 3%. Following a systematic review of the literature, we have provided an overview of the use of tocolytics for the prevention of preterm birth and have examined the fetal and maternal adverse effects of the various tocolytic agents currently in use. No tocolytic currently in use was developed specifically to treat preterm labour so most have multi-organ side effects. β2-agonists are relatively safe for the fetus but have rare and potentially serious maternal adverse effects. In contrast, prostaglandin synthetase inhibitors have potentially serious side effects for the fetus and neonate but have mild maternal gastrointestinal side effects. In Europe, the choice of first line therapy is either atosiban or nifedipine. The evidence base for atosiban is much more robust than for nifedipine. While their efficacy is similar, atosiban has placebo level side effects and is safer than nifedipine but is much more expensive.

Evidence-based clinical update: Which local anesthetic drug for pediatric caudal block provides optimal efficacy with the fewest side effects?

PubMed

Dobereiner, Elisabeth F A; Cox, Robin G; Ewen, Alastair; Lardner, David R

2010-12-01

The purpose of this evidence-based clinical update is to identify the best evidence when selecting a long-acting local anesthetic agent for single-shot pediatric caudal anesthesia in children. A structured literature search was conducted using PubMed and Medline (OVID) using the terms "caudal" and combinations of at least two of "bupivacaine", "ropivacaine", and "levobupivacaine". The search limits included "randomized controlled trials" (RCTs), "meta-analysis", "evidence-based reviews" or "reviews", "human", and "all child: 0-18 yr". Seventeen RCTs were identified that concerned single-shot pediatric caudal anesthesia with at least two of the three drugs in question. Data were extracted for the areas of clinical efficacy and side effects. Study findings were assigned levels of evidence, and grades of recommendation were made according to Centre for Evidence-Based Medicine criteria. The three drugs investigated were found to be equivalent in terms of efficacy. Evidence showed bupivacaine with the highest incidence of motor block and ropivacaine with the lowest. Adverse effects were rare and unrelated to the choice of drug. There were no serious adverse events. None of the three agents was shown to be superior in terms of efficacy. Bupivacaine is preferred if motor block is desired, ropivacaine is preferred if motor block is to be minimized. Adverse effects in human studies are rare, mild, and unrelated to the choice of drug. Despite encountering the absence of serious adverse events in each of the studies reviewed, it is noted that animal studies suggest a safer profile with ropivacaine or levobupivacaine than with bupivacaine.

Laser treatment of primary axillary hyperhidrosis: a review of the literature.

PubMed

Cervantes, Jessica; Perper, Marina; Eber, Ariel E; Fertig, Raymond M; Tsatalis, John P; Nouri, Keyvan

2018-04-01

Hyperhidrosis o`ccurs when the body produces sweat beyond what is essential to maintain thermal homeostasis. The condition tends to occur in areas marked by high-eccrine density such as the axillae, palms, and soles and less commonly in the craniofacial area. The current standard of care is topical aluminum chloride hexahydrate antiperspirant (10-20%), but other treatments such as anticholinergics, clonidine, propranolol, antiadrenergics, injections with attenuated botulinum toxin, microwave technology, and surgery have been therapeutically implicated as well. Yet, many of these treatments have limited efficacy, systemic side effects, and may be linked with significant surgical morbidity, creating need for the development of new and effective therapies for controlling excessive sweating. In this literature review, we examined the use of lasers, particularly the Neodynium:Yttrium-Aluminum-Garnet (Nd:YAG) and diode lasers, in treating hyperhidrosis. Due to its demonstrated effectiveness and limited side effect profile, our review suggests that Nd:YAG laser may be a promising treatment modality for hyperhidrosis. Nevertheless, additional large, randomized controlled trials are necessary to confirm the safety and efficacy of this treatment option.

Pimecrolimus 1% cream for anogenital lichen sclerosus in childhood

PubMed Central

Boms, Stefanie; Gambichler, Thilo; Freitag, Marcus; Altmeyer, Peter; Kreuter, Alexander

2004-01-01

Background Lichen sclerosus is a chronic inflammatory disease with a predilection of the anogenital region. Because of the potential side effects of repeated local application of potent glucocorticosteroids, equally-effective, safer therapeutic options are required, especially in the treatment of children. Case presentations We report on the efficacy of twice-daily application of pimecrolimus 1% cream in four prepubertal girls (range of age: 4 to 9 years) who suffered from anogenital lichen sclerosus. After three to four-month treatment, all patients had almost complete clinical remission including relief from itch, pain and inflammation. Only minor improvement was observed for the white sclerotic lesions. No significant side effects have been observed. Conclusions Topical pimecrolimus appears to be an effective and safe treatment for children with anogenital lichen sclerosus. The clinical benefits observed in the four patient presented particularly include relief of pruritus, pain and inflammation. Vehicle-controlled studies on a larger number of patients are now warranted to substantiate our promising findings, and to investigate long-term efficacy and safety of topical pimecrolimus in anogenital lichen sclerosus. PMID:15485581

The Clinical Efficacy of Autologous Platelet-Rich Plasma Combined with Ultra-Pulsed Fractional CO2 Laser Therapy for Facial Rejuvenation

PubMed Central

Hui, Qiang; Chang, Peng; Guo, Bingyu; Zhang, Yu

2017-01-01

Abstract Ultra-pulsed fractional CO2 laser is an efficient, precise, and safe therapeutic intervention for skin refreshing, although accompanied with prolonged edema and erythema. In recent years, autologous platelet-rich plasma (PRP) has been proven to promote wound and soft tissue healing and collagen regeneration. To investigate whether the combination of PRP and ultra-pulsed fractional CO2 laser had a synergistic effect on therapy for facial rejuvenation. Totally, 13 facial aging females were treated with ultra-pulsed fractional CO2 laser. One side of the face was randomly selected as experimental group and injected with PRP, the other side acted as the control group and was injected with physiological saline at the same dose. Comprehensive assessment of clinical efficacy was performed by satisfaction scores, dermatologists' double-blind evaluation and the VISIA skin analysis system. After treatment for 3 months, subjective scores of facial wrinkles, skin texture, and skin elasticity were higher than that in the control group. Similarly, improvement of skin wrinkles, texture, and tightness in the experimental group was better compared with the control group. Additionally, the total duration of erythema, edema, and crusting was decreased, in the experimental group compared with the control group. PRP combined with ultra-pulsed fractional CO2 laser had a synergistic effect on facial rejuvenation, shortening duration of side effects, and promoting better therapeutic effect. PMID:27222038

Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial.

PubMed

Harada, Tasuku; Momoeda, Mikio

2016-12-01

To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea. Placebo-controlled, double-blind, randomized trial. Clinical trial sites. Two hundred fifteen subjects with dysmenorrhea. Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles. Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics. The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred. The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea. NCT01129102. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Postinflammatory hyperpigmentation in patients with skin of color.

PubMed

Shokeen, Divya

2016-01-01

Postinflammatory hyperpigmentation (PIH) has posed a substantial challenge for patients with higher Fitzpatrick skin types, specifically types III to VI. Treatment modalities pose a number of limitations due to the number of treatments required, potential side effects, and overall efficacy. Fortunately, multiple therapies have been delineated that can be moderately to highly efficacious in treating PIH in patients with skin of color. This article will review some of these modalities and procedures for this common patient concern.

Novel 755-nm diode laser vs. conventional 755-nm scanned alexandrite laser: Side-by-side comparison pilot study for thorax and axillary hair removal.

PubMed

Paasch, Uwe; Wagner, Justinus A; Paasch, Hartmut W

2015-01-01

Alexandrite (755 nm) and diode lasers (800-810 nm) are commonly used for hair removal. The alexandrite laser technology is somewhat cumbersome whereas new diode lasers are more robust. Recently, alexandrite-like 755 nm wavelength diodes became available. To compare the efficacy, tolerability, and subject satisfaction of a 755 nm diode laser operated in conventional (HR) and non-conventional in-motion (SHR) modes with a conventional scanned alexandrite 755 nm laser for chest and axillary hair removal. A prospective, single-center, proof of principle study was designed to evaluate the safety, efficacy and handling of a 755 nm diode laser system in comparison to a standard alexandrite 755 nm scanning hair removal laser. The new 755 nm diode is suitable to be used in SHR and HR mode and has been tested for its safety, efficacy and handling in a volunteer with success. Overall, both systems showed a high efficacy in hair reduction (88.8% 755 nm diode laser vs. 77.7% 755 nm alexandrite laser). Also, during the study period, no severe adverse effects were reported. The new 755 nm diode laser is as effective and safe as the traditional 755 nm alexandrite laser. Additionally, treatment with the 755 nm diode laser with HR and SHR modes was found to be less painful.

Double-blind study of mirtazapine and placebo in hospitalized patients with major depression.

PubMed

Vartiainen, H; Leinonen, E

1994-06-01

The purpose of the present 6-week multicenter dose finding study was to compare the efficacy and tolerability of mirtazapine (preferentially presynaptic alpha 2-adrenergic receptor blocker) to placebo in hospitalized patients with major depression. The clinical efficacy was evaluated with the Hamilton Depression Scale (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Beck Self-Rating Depression Scale, Global Assessment Scale (GAS), and Brief Psychiatric Rating Scale (BPRS). The side effects were recorded on a checklist of emergent symptoms (ROSE) and physical examinations, ECG, clinical chemistry, and hematology tests were carried out. The dosages of mirtazapine were gradually raised from 15 mg to 50 mg. One hundred and fourteen patients were included. Twenty-two patients (37%) in mirtazapine group and 24 (44%) in the placebo group were prematurely withdrawn from the study mainly due to inadequate efficacy. The decrease in HAM-D and MADRS was generally more pronounced in the mirtazapine group than in the placebo group. Minor side effects were reported in less than 15% of the patients in both groups. Only fatigue and faintness were slightly more pronounced in the mirtazapine group than in the placebo group. No significant changes were found in laboratory parameters. Because of methodological flaws like combining a dose finding study with a placebo controlled study, further conclusions should not be made on the efficacy of mirtazapine when treating depressive patients.

Non-pharmacological biological treatment approaches to difficult-to-treat depression.

PubMed

Fitzgerald, Paul B

2013-09-16

There has been substantial recent interest in novel brain stimulation treatments for difficult-to-treat depression. Electroconvulsive therapy (ECT) is a well established, effective treatment for severe depression. ECT's problematic side-effect profile and questions regarding optimal administration methods continue to be investigated. Magnetic seizure therapy, although very early in development, shows promise, with potentially similar efficacy to ECT but fewer side effects. Vagus nerve stimulation (VNS) and repetitive transcranial magnetic stimulation (rTMS) are clinically available in some countries. Limited research suggests VNS has potentially long-lasting antidepressant effects in a small group of patients. Considerable research supports the efficacy of rTMS. Both techniques require further study of optimal treatment parameters. Transcranial direct current stimulation may provide a low-cost antidepressant option if its efficacy is substantiated in larger samples. Deep brain stimulation is likely to remain reserved for patients with the most severe and difficult-to-treat depression, requiring further exploration of administration methods and its role in depression therapy. New and innovative forms of brain stimulation, including low-intensity ultrasound, low-field magnetic stimulation and epidural stimulation of the cortical surface, are in early stages of exploration and are yet to move into the clinical domain. Ongoing work is required to define which brain stimulation treatments are likely to be most useful, and in which patient groups. Clinical service development of brain stimulation treatments will likely be inconsistent and variable.

Modafinil as a potential motion sickness countermeasure.

PubMed

Hoyt, Robert E; Lawson, Benton D; McGee, Heather A; Strompolis, Melissa L; McClellan, Molly A

2009-08-01

Motion sickness adversely affects military air and sea operations. Medications help prevent motion sickness but are frequently associated with side effects. Better medications or combinations of medications are needed. Dextroamphetamine has documented anti-motion sickness effects but also has a potential for abuse. Modafinil is a relatively new central nervous system stimulant that has none of the drawbacks of dextroamphetamine, but has not been evaluated for the treatment of motion sickness. This double-blind, placebo-controlled study evaluated the anti-motion sickness efficacy of modafinil, alone or in combination with oral scopolamine. Moderate nausea was induced via a Coriolis cross-coupling stimulus. There were 60 participants who were assigned randomly to 1 of 3 conditions: 1) 2 placebo pills (DP); 2) modafinil plus placebo (MP); or 3) modafinil plus oral scopolamine (MS). The primary measure of drug efficacy was the number of head tilts tolerated upon reaching moderate nausea for 1 min without abatement. The combination of modafinil and scopolamine (MS) allowed subjects to tolerate significantly more head tilts than placebo, but modafinil alone (MP) failed to differ significantly from placebo (DP). No significant cognitive performance decrements were observed among the three experimental conditions. Modafinil was not found to be more effective than placebo. Further testing is recommended to determine whether the potentially promising combination of modafinil and scopolamine provides better efficacy or fewer side effects than scopolamine administered alone.

Therapeutic Outcome of Intralesional Immunotherapy in Cutaneous Warts Using the Mumps, Measles, and Rubella Vaccine

PubMed Central

Awal, Guneet

2018-01-01

Background: Various treatment modalities have been described in the literature for treating warts, but none thus far have demonstrated optimal results. Recently, the mumps, measles, and rubella (MMR) antigen has gained popularity because of its proven efficacy in the treatment of warts. Aim: The goal was to evaluate the efficacy and safety of intralesional MMR antigen in the treatment of cutaneous warts. Methods: Patients were divided into an MMR (study) group and a normal saline (control) group. Injections were administered into the single largest wart on each patient every two weeks. Follow-up was done at six weeks and 16 weeks after the last injection for any side effects and/or recurrence. Results: Out of 150 patients, 72 received the MMR injection and 50 received normal saline injections. Twenty-eight patients did not complete the study. A statistically significant (p<0.00001) difference in results was found between the two groups: 68 percent of patients in the MMR group showed complete response compared to 10 percent in the control group. Pain during injection was the most common side effect and was seen in both groups. Conclusion: MMR injection has shown significant results with almost negligible adverse effects. The MMR antigen vaccine has therapeutic potential as a treatment for warts with its demonstrated efficacy, safety profile, and cost-effectiveness. PMID:29785233

Clinical efficacy of melittin in the treatment of cats infected with the feline immunodeficiency virus.

PubMed

Hartmann, Anja D; Wilhelm, Natalie; Erfle, Volker; Hartmann, Katrin

2016-12-05

The bee venom melittin shows an antiviral efficacy against the human immunodeficiency virus in cell culture. It was shown to be non-toxic for cats. Aim of this pilot study was to investigate the clinical efficacy and side-effects of melittin in cats naturally infected with feline immunodeficiency virus (FIV). The study was performed as a prospective, placebo-controlled double-blinded trial. Twenty cats were included, of which 10 cats each were treated with either melittin (500 µg/kg body weight) or phosphate-buffered saline (placebo) subcutaneously twice per week. During the treatment period of 6 weeks, the cats' general health status, determined by the Karnofsky's score, and the severity of clinical signs (conjunctivitis and stomatitis) using a clinical scoring system were evaluated. Haematology, biochemistry profiles, lymphocyte subpopulations, CD4/CD8 ratio, and pterines (biopterine, 7-xanthopterine) as surrogate parameters were also compared. The general health status and the clinical scores for conjunctivitis and stomatitis improved in cats treated with melittin. A statistically significant improvement however could only be detected for conjunctivitis in cats treated with melittin compared to cats treated with placebo which was likely due to different scores between both groups at the beginning. No influence on the lymphocyte subpopulations, CD4/CD8 ratio, and pterine concentrations was observed. No side effects occurred in this study. In the protocol used in the present study, no significant efficacy of melittin could be detected. However, efficacy of melittin, especially if applied in a higher dosage as in the present study or for a longer period, could be evaluated in further studies. Synergistic effects if used in combination with classic antiretroviral drugs could be an interesting future approach.

Endovenous ablation of refluxing saphenous and perforating veins.

PubMed

Proebstle, Thomas; van den Bos, Renate

2017-05-01

Since the end of the nineties endovenous thermal ablation and more recently non-thermal, non-tumescent techniques have been developed and improved. Until now, because of their favourable side effect profile in conjunction to sustained efficacy, in many countries they already replaced high ligation and stripping in the treatment of refluxing saphenous veins as well as for treatment of perforators and selected tributaries. Now, studies and comparative trials are available with long-term follow-ups for most of the techniques, providing valid data on occlusion and reflux rates, side effect profiles, and health related quality of life.

Treatment of Acne Scars and Wrinkles in Asian Patients Using Carbon-Dioxide Fractional Laser Resurfacing: Its Effects on Skin Biophysical Profiles

PubMed Central

Hwang, Young Ji; Lee, Yu Na; Choe, Yong Beom; Ahn, Kyu Joong

2013-01-01

Background Although ablative fractional resurfacing is known to be effective against photoaging and acne scars, studies on its efficacy, safety and changes in the skin characteristics of Asians are limited. Objective The aim of this study is to assess the efficacy and safety of carbon dioxide fractional laser (CO2FL) in Koreans treated for wrinkles and acne scars, and to define the changes in skin characteristics during recovery period. Methods We administered one session of CO2FL on 10 acne scar patients and 14 wrinkles patients with skin types IV and V. The surveillance of efficacy and side effects along with the measurement of biophysical properties was carried out before 1 day, 1 week, 1 month and 3 months after treatment. Results Using a non-invasive method, skin barrier damage, erythema and bronzing of skin during the recovery period were assessed, and all of the items eventually returned to the pre-treatment level. Skin elasticity was measured in the wrinkle group, and the statistically significant effect was sustained throughout the next three months. The outcome of treatment was found to be better than 'moderate improvement' in both the acne scar and wrinkle groups. Further, there were no serious side effects three months post-procedure. Conclusion CO2 FL is thought to be an effective and safe method for treating moderate to severe acne scars and wrinkles in Asians. PMID:24371392

Hyperhidrosis plantaris - a randomized, half-side trial for efficacy and safety of an antiperspirant containing different concentrations of aluminium chloride.

PubMed

Streker, Meike; Reuther, Tilmann; Hagen, Linda; Kerscher, Martina

2012-02-01

Primary focal hyperhidrosis plantaris can cause impairment in social, physical, leisure and occupational activities. Topical treatment with aluminium chloride is the first-line treatment. The aim of this trial was to evaluate efficacy and safety of two different concentrations of aluminium chloride hexa-hydrate (12.5%, 30%) for 6 weeks. 20 volunteers with hyperhidrosis plantaris were included. Efficacy was evaluated using a clinical rating scale of the hyperhidrosis level and qualitative assessments including Minor's (iodine-starch) test and a standardized sniff test. Furthermore a patient questionnaire and measurements of skin surface pH were done to evaluate the subjective assessments and side effects. The hyperhidrosis level significantly decreased in both concentrations. There were no differences in tolerability regarding the skin surface pH and the patient questionnaires. In addition the hidrotic areas decreased after application of both products and the sniff test improved. Topical application of an antiperspirant containing aluminium chloride reduced sweat production in plantar hyperhidrosis significantly. As both 12.5% and 30% were efficacious and safe, we would recommend 12.5% for outpatient treatment. © The Author • Journal compilation © Blackwell Verlag GmbH, Berlin.

Efficacy of functional microarray of microneedles combined with topical tranexamic acid for melasma

PubMed Central

Xu, Yang; Ma, Renyan; Juliandri, Juliandri; Wang, Xiaoyan; Xu, Bai; Wang, Daguang; Lu, Yan; Zhou, Bingrong; Luo, Dan

2017-01-01

Abstract To evaluate the efficacy of a functional microarray of microneedles (MNs) plus topical tranexamic acid (TA) for melasma in middle-aged women in China. Thirty female subjects with melasma were enrolled in this study. The left or right side of the face was chosen randomly to be pretreated with a functional microarray of MNs, followed by topical 0.5% TA solution once per week for 12 weeks. The other half-face was the control, treated with a sham device plus topical 0.5% TA solution. At baseline and at weeks 4, 8, and 12 of treatment, clinical (photographic) evaluations and parameters determined by Visia were recorded. At baseline and week 12, patient satisfaction scores and the biophysical parameters measured by Mexameter were also recorded. Side effects were evaluated at baseline and at the end of the 12 weeks. In total, 28 women (93.3%) completed the study. The brown spots’ scores measured by Visia were significantly lower on the combined therapy side than on the control side at 12 weeks after starting treatment; there was no significant difference between sides at 4 or 8 weeks. After 12 weeks, melanin index (MI) decreased significantly in both 2 groups, and the MI was significantly less on the combined side at week 12. Transepidermal water loss, roughness, skin hydration, skin elasticity, and erythema index showed no significant differences between 2 sides at baseline, 4, 8, and 12 weeks after treatment. Physicians’ evaluations of photographs showed better results at week 12 with combined therapy: >25% improvement was observed in the MNs plus TA side in 25 patients, and in the TA side in only 10 patients. Subjective satisfaction scores on both sides increased significantly. The participants were more satisfied with the results of the combined therapy side than the control side. No obvious adverse reactions were observed throughout the study. Combined therapy with a functional microarray of MNs and topical TA solution is a promising treatment for melasma. PMID:28489798

Irinotecan-loaded double-reversible thermogel with improved antitumor efficacy without initial burst effect and toxicity for intramuscular administration.

PubMed

Din, Fakhar Ud; Kim, Dong Wuk; Choi, Ju Yeon; Thapa, Raj Kumar; Mustapha, Omer; Kim, Dong Shik; Oh, Yu-Kyoung; Ku, Sae Kwang; Youn, Yu Seok; Oh, Kyung Taek; Yong, Chul Soon; Kim, Jong Oh; Choi, Han-Gon

2017-05-01

Intramuscularly administered, anti-tumour drugs induce severe side effects due to their direct contact with body tissues and initial burst effect. In this study, to solve this problem, a novel double-reversible thermogel system (DRTG) for the intramuscular administration of irinotecan was developed. This irinotecan-loaded DRTG was prepared by dispersing the irinotecan-loaded thermoreversible solid lipid nanoparticles (SLNs) in the thermoreversible hydrogel. In DRTG, the former was solid at 25°C but converted to liquid at 36.5°C; in contrast, the latter existed in a liquid form but transformed to gel state in the body. The DRTG was easily administered intramuscularly. Its particle size and drug content were not noticeably changeable, resulting that it was stable at 40°C for at least 6months. Compared to the irinotecan-loaded solution and conventional hydrogel, the DRTG significantly delayed drug release, leading to a reduced burst effect. Moreover, it showed decreased C max and maintained the sustained plasma concentrations at a relatively low level for the long period of 60h in rats, resulting in ameliorated side effects of the anti-tumour drug. Furthermore, it gave significantly improved anti-tumour efficacy in tumour-bearing mice compared to the hydrogel but, unlike the conventional hydrogel, induced no body weight loss and local damage to the muscle. Thus, this DRTG with improved antitumor efficacy without initial burst effect and toxicity could provide a potential pharmaceutical system for the intramuscular administration of irinotecan. Intramuscularly administered, anti-tumour drugs induce severe side effects due to their direct contact with body tissues and initial burst effect. To solve this problem, we developed a novel double-reversible thermogel system (DRTG) for the intramuscular administration of irinotecan. Unlike the conventional hydrogel, the DRTG is a dispersion of the irinotecan-loaded thermoreversible solid lipid nanoparticles in the thermoreversible hydrogel. In DRTG, the former was solid at 25°C but converted to liquid at 36.5°C; in contrast, the latter existed in a liquid form but transformed to gel state in the body. This DRTG gave significantly improved anti-tumour efficacy in tumour-bearing mice compared to the hydrogel but, unlike the conventional hydrogel, induced no body weight loss and local damage to the muscle. Copyright © 2017 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Polyglycerol-opioid conjugate produces analgesia devoid of side effects.

PubMed

González-Rodríguez, Sara; Quadir, Mohiuddin A; Gupta, Shilpi; Walker, Karolina A; Zhang, Xuejiao; Spahn, Viola; Labuz, Dominika; Rodriguez-Gaztelumendi, Antonio; Schmelz, Martin; Joseph, Jan; Parr, Maria K; Machelska, Halina; Haag, Rainer; Stein, Christoph

2017-07-04

Novel painkillers are urgently needed. The activation of opioid receptors in peripheral inflamed tissue can reduce pain without central adverse effects such as sedation, apnoea, or addiction. Here, we use an unprecedented strategy and report the synthesis and analgesic efficacy of the standard opioid morphine covalently attached to hyperbranched polyglycerol (PG-M) by a cleavable linker. With its high-molecular weight and hydrophilicity, this conjugate is designed to selectively release morphine in injured tissue and to prevent blood-brain barrier permeation. In contrast to conventional morphine, intravenous PG-M exclusively activated peripheral opioid receptors to produce analgesia in inflamed rat paws without major side effects such as sedation or constipation. Concentrations of morphine in the brain, blood, paw tissue, and in vitro confirmed the selective release of morphine in the inflamed milieu. Thus, PG-M may serve as prototype of a peripherally restricted opioid formulation designed to forego central and intestinal side effects.

Type and frequency of side effects during PC6 acupuncture: observations from therapists and patients participating in clinical efficacy trials of acupuncture.

PubMed

Enblom, Anna; Johnsson, Anna

2017-12-01

Many therapists practise PC6 acupuncture for emesis (nausea and vomiting) during pregnancy, different cancer therapies, palliative care, after surgery, or to induce relaxing effects in general. Knowledge of side effects is central to shared decision-making. To describe the type and frequency of side effects and the level of needle-induced pain during PC6 acupuncture. We included 1298 PC6 acupuncture treatments, delivered to 221 participants (77% women, mean age 52.5, range 18-91 years). The subjects had received genuine PC6 acupuncture, in one of two previous randomised controlled trials, aimed at inducing antiemetic (n=100, with 100 providing data on side effects and 94 on needle-induced pain, respectively) or relaxing (n=121, with 120 providing data) effects. Side effects during and after the acupuncture treatments were registered in structured treatment protocols and study diaries. No serious complications occurred. Side effects during the acupuncture sessions included minor bleeding in 5.0%, tiredness in 4.9%, numbness in 4.5% and dizziness in 1.4% of the 1298 treatments. After treatment, the mean proportions of participants reporting side effects each week were: tiredness 25.8%; feeling cold 17.8%; dizziness 9.7%; sweating 9.3%; haematoma 8.8%; and soreness at the needling sites 4.3%. Participants perceived the needling to be not painful (47.4% of participants), or mildly (39.1%), moderately (11.6%) or very painful (1.4%). Few side effects occurred and those that did were mild. Nearly 90% found PC6 acupuncture to be not painful or only mildly painful. Healthcare professionals may consider the observed levels of side effects when informing patients about side effects of PC6 acupuncture. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effects of Message Framing on Influenza Vaccination: Understanding the Role of Risk Disclosure, Perceived Vaccine Efficacy, and Felt Ambivalence.

PubMed

Kim, Sungsu; Pjesivac, Ivanka; Jin, Yan

2017-10-20

The current study examined the effects of framing in promotional health messages on intention to vaccinate against seasonal influenza virus. The findings of an experimental study (N = 86) indicated that exposure to both benefits and side effects of vaccination (gain-framed with risk disclosure message) led to lower intention to receive the flu vaccine. This relationship was mediated by both perceived vaccine efficacy and felt ambivalence in a serial order, revealing the underlying psychological mechanisms important for understanding health-related behaviors. Theoretical implications of constructing sub-framed messages are discussed and the concept of second-order framing is introduced.

Mebendazole paste as an anthelmintic in random source research cats.

PubMed

Bradley, R E; Peters, L J

1982-10-01

Mebendazole paste, administered per os daily for 3 days, at dose levels of 22 mg/kg and 33 mg/kg was highly effective in removing Ancylostoma tubaeforme from naturally infected cats. The 22 mg/kg dose gave the highest efficacy (95.5% critical and 98% controlled). The same product at 11 mg/kg, 22 mg/kg, or 33 mg/kg was 100% effective in removing Toxocara cati from naturally infected cats. Both 11 mg/kg and 22 mg/kg dose levels were highly efficacious against the common tapeworm, Dipylidium caninum. No toxic side effects or clinical illness were observed in any of the cats used in this study.

Efficacy and side-effects profile of the ethinylestradiol and etonogestrel contraceptive vaginal ring: a systematic review and meta-analysis.

PubMed

López-Picado, Amanda; Lapuente, Oihane; Lete, Iñaki

2017-04-01

To assess the efficacy and tolerability (side-effects profile), and compliance of the combined contraceptive vaginal ring (CCVR) compared with combined oral hormonal contraceptives (COC). The PubMed, Embase, POPLINE, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, ClinicalTrials.gov, Clinical Trials Registry Platform (ICTRP) and CINAHL databases were searched. Electronic databases were searched for randomised clinical trials comparing the CCVR with COC with a duration of at least 3 months between 01 December and 15 December 2015. The primary outcome was efficacy. The secondary outcomes were compliance, absence of withdrawal bleeding, breakthrough bleeding, nausea and headache. Heterogeneity was assessed using I 2 statistic and Cochran's Q statistic. Results were expressed as odds ratios (OR) with 95% confidence intervals (CIs) using random-effects models or fixed-effects models depending on the heterogeneity. 4368 records were identified, 2844 of which were removed after duplicates and 1524 records were screened. Of these, 1503 were excluded and 21 full text articles were assessed for eligibility. After removing another 7 articles, 14 records were finally included in the qualitative and quantitative analysis. The results show a trend to higher efficacy for the CCVR in preventing pregnancy (Peto OR: 0.52 [95% CI: 0.26-1.04]) and a significantly lower presence of nausea (Peto OR: 0.66 [95% CI: 0.46-0.93]). More cycles were compliant in the CCVR group (Peto OR: 1.22 [95% CI: 1.12-1.32]) and fewer women reported breakthrough bleeding (Peto OR: 0.68 [95% CI: 0.51-0.91]). Our findings demonstrate that the CCVR is as effective and tolerable as the COC but with a better bleeding profile.

Comparison of efficacy of once daily multimatrix mesalazine 2.4 g/day and 4.8 g/day with other 5-aminosalicylic acid preparation in active ulcerative colitis: a randomized, double-blind study.

PubMed

Ogata, Haruhiko; Yokoyama, Tadashi; Mizushima, Seiichi; Hagino, Atsushi; Hibi, Toshifumi

2018-04-01

This study compared the efficacy of multimatrix mesalazine 2.4 g/day and 4.8 g/day with controlled-release mesalazine 2.25 g/day. In this multicenter, randomized, double-blind study, 251 patients with mildly to moderately active ulcerative colitis received multimatrix mesalazine 2.4 g/day once daily (Multimatrix-2.4), 4.8 g/day once daily (Multimatrix-4.8), or controlled-release (time-dependent) mesalazine 2.25 g/day 3 times daily (Time-2.25) for 8 weeks. The primary efficacy endpoint was the change in the ulcerative colitis-disease activity index (UC-DAI) score. The mean change in the UC-DAI score and standard deviation in the per protocol set was -1.9±2.5 for Multimatrix-2.4 and -2.4±2.8 for Time-2.25. The difference between Multimatrix-2.4 and Time-2.25 was 0.3 (two-sided 95% confidence interval [CI], -0.5 to 1.1), thus non-inferiority was not demonstrated based on the pre-defined non-inferiority margin (1.0). In the full analysis set, the difference between Multimatrix-4.8 and Time-2.25 was -1.2 (two-sided 95% CI, -2.0 to -0.5), and the mean change in UC-DAI score in the FAS was -3.3 (two-sided 95% CI, -3.9 to -2.8) for Multimatrix-4.8 and -1.9 (two-sided 95% CI, -2.5 to -1.3) for Multimatrix-2.4, indicating that Multimatrix-4.8 was more effective than Time-2.25 and Multimatrix-2.4. There was no difference among the treatment groups in terms of safety. This study showed that the efficacy of multimatrix mesalazine 2.4 g/day was comparable to controlled release mesalazine 2.25 g/day, although non-inferiority was not demonstrated. Importantly, this was the first study to indicate that multimatrix mesalazine 4.8 g/day was more effective than 2.4g/day with no associated safety concerns.

Assessment of the use of sialogogues in the clinical management of patients with xerostomia.

PubMed

Chainani-Wu, Nita; Gorsky, Meir; Mayer, Priscilla; Bostrom, Alan; Epstein, Joel B; Silverman, Sol

2006-01-01

This study was conducted to assess the clinical efficacy and adverse effects of pilocarpine, bethanechol and cevimeline in patients with xerostomia. In this open-label crossover assessment in 20 patients with xerostomia, a one- to two-week course of each medication with a one-week washout period was prescribed. Side effects, symptoms, whole stimulated and unstimulated saliva were measured. Each sialogogue was found to increase saliva and decrease symptoms. A mixed-effects analysis showed a greater increase in stimulated saliva on bethanechol compared to pilocarpine (0.106, p = 0.0272). Increased sweating was the most common side effect, experienced more frequently with pilocarpine as compared to bethanechol (p = 0.0588) or cevimeline (p = 0.0143). A carryover effect beyond the washout period was seen. Effects on saliva and side effects vary between sialogogues, suggesting a benefit of trials with different sialogogues to determine individual patient preference. The observed carryover effect suggests that intermittent treatment may be an alternative to continuous treatment with sialogogues.

Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates.

PubMed

El-Mashad, Abd El-Rahman; El-Mahdy, Heba; El Amrousy, Doaa; Elgendy, Marwa

2017-02-01

In this prospective study, we compared the efficacy and side effects of indomethacin, ibuprofen, and paracetamol in patent ductus arteriosus (PDA) closure in preterm neonates. Three hundred preterm neonates with hemodynamically significant PDA (hs-PDA) admitted at our neonatal intensive care unit were enrolled in the study. They were randomized into three groups. Group I (paracetamol group) received 15 mg/kg/6 h IV paracetamol infusion for 3 days. Group II (ibuprofen group) received 10 mg/kg IV ibuprofen infusion followed by 5 mg/kg/day for 2 days. Group III (indomethacin group) received 0.2 mg/kg/12 h indomethacin IV infusion for three doses. Laboratory investigations such as renal function test, liver function test, complete blood count, and blood gases were conducted in addition to echocardiographic examinations. All investigations were done before and 3 days after treatment. There was no significant difference between all groups regarding efficacy of PDA closure (P = 0.868). There was a significant increase in serum creatinine levels and serum blood urea nitrogen (BUN) in the ibuprofen and indomethacin groups (P < 0.001). There was a significant reduction in platelet count and urine output (UOP) in both ibuprofen and indomethacin groups (P < 0.001). There was a significant increase in bilirubin levels in only the ibuprofen group (P = 0.003). No significant difference of hemoglobin (HB) level or liver enzymes in all groups (P > 0.05). Ventilatory settings improved significantly in patients with successful closure of PDA than those with failed PDA closure (P < 0.001). Paracetamol is as effective as indomethacin and ibuprofen in closure of PDA in preterm neonates and has less side effects mainly on renal function, platelet count, and GIT bleeding. What is Known: • Hemodynamically significant patent ductus arteriosus has many complications for preterm and low birth weight neonates and better to be closed. Many drugs were used for medical closure of PDA e.g. indomethacin, ibuprofen and recently paracetamol. Many studies compare safety and efficacy of paracetamol with either indomethacin or ibuprofen. What is New: • It is the first large study that compares the efficacy and side effects of the three drugs in one study.

Combining doxorubicin-nanobubbles and shockwaves for anaplastic thyroid cancer treatment: preclinical study in a xenograft mouse model.

PubMed

Marano, Francesca; Frairia, Roberto; Rinella, Letizia; Argenziano, Monica; Bussolati, Benedetta; Grange, Cristina; Mastrocola, Raffaella; Castellano, Isabella; Berta, Laura; Cavalli, Roberta; Catalano, Maria Graziella

2017-06-01

Anaplastic thyroid cancer is one of the most lethal diseases, and a curative therapy does not exist. Doxorubicin, the only drug approved for anaplastic thyroid cancer treatment, has a very low response rate and causes numerous side effects among which cardiotoxicity is the most prominent. Thus, doxorubicin delivery to the tumor site could be an import goal aimed to improve the drug efficacy and to reduce its systemic side effects. We recently reported that, in human anaplastic thyroid cancer cell lines, combining doxorubicin-loaded nanobubbles with extracorporeal shock waves, acoustic waves used in lithotripsy and orthopedics without side effects, increased the intracellular drug content and in vitro cytotoxicity. In the present study, we tested the efficacy of this treatment on a human anaplastic thyroid cancer xenograft mouse model. After 21 days, the combined treatment determined the greatest drug accumulation in tumors with consequent reduction of tumor volume and weight, and an extension of the tumor doubling time. Mechanistically, the treatment induced tumor apoptosis and decreased cell proliferation. Finally, although doxorubicin caused the increase of fibrosis markers and oxidative stress in animal hearts, loading doxorubicin into nanobubbles avoided these effects preventing heart damage. The improvement of doxorubicin anti-tumor effects together with the prevention of heart damage suggests that the combination of doxorubicin-loaded nanobubbles with extracorporeal shock waves might be a promising drug delivery system for anaplastic thyroid cancer treatment. © 2017 Society for Endocrinology.

Comparing Efficacy and Side Effects of Memantine vs. Risperidone in the Treatment of Autistic Disorder.

PubMed

Nikvarz, Nikvarz; Alaghband-Rad, Javad; Tehrani-Doost, Mehdi; Alimadadi, Abbas; Ghaeli, Padideh

2017-01-01

Introduction: This study was aimed to compare the efficacy and side effects of memantine, an antagonist of the NMDA receptor of glutamate, with risperidone given the fact that glutamate has been noted for its possible effects in the pathogenesis of autism. Risperidone, an atypical antipsychotic, has been approved by FDA for the management of irritability associated with autism. Methods: 30 children, aged 4-17 years, entered an 8-week, randomized trial. Patients were randomly assigned to receive either risperidone or memantine. Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), Clinical Global Impressions - Improvement (CGI-I) and Clinical Global Impression-Severity (CGI-S) scales were used to assess behavioral symptoms of the patients. Results: Both risperidone and memantine reduced the scores of 4 subscales of ABC as well as the 10-item and the total score of CARS significantly. However, differences between the 2 drugs in the scores of each evaluating scale were not found to be significant. Relatively, larger number of patients on risperidone showed "very much improvement" when assessed by CGI-I scale when compared with those on memantine. Discussion and conclusion: The present study suggests that memantine may have beneficial effects in the treatment of many core symptoms of autism. Therefore, memantine may be considered as a potential medication in the treatment of those autistic children who do not respond or cannot tolerate side effects of risperidone. © Georg Thieme Verlag KG Stuttgart · New York.

Sodium channel slow inactivation as a therapeutic target for myotonia congenita

PubMed Central

Novak, Kevin R; Norman, Jennifer; Mitchell, Jacob R; Pinter, Martin J; Rich, Mark M

2014-01-01

Objective Patients with myotonia congenita have muscle hyperexcitability due to loss-of-function mutations in the chloride channel in skeletal muscle, which causes spontaneous firing of muscle action potentials (myotonia), producing muscle stiffness. In patients, muscle stiffness lessens with exercise, a change known as the warm-up phenomenon. Our goal was to identify the mechanism underlying warm up and to use this information to guide development of novel therapy. Methods To determine the mechanism underlying warm-up, we used a recently discovered drug to eliminate muscle contraction, thus allowing prolonged intracellular recording from individual muscle fibers during induction of warm-up in a mouse model of myotonia congenita. Results Changes in action potentials suggested slow inactivation of sodium channels as an important contributor to warm-up. These data suggested enhancing slow inactivation of sodium channels might offer effective therapy for myotonia. Lacosamide and ranolazine enhance slow inactivation of sodium channels and are FDA-approved for other uses in patients. We compared the efficacy of both drugs to mexiletine, a sodium channel blocker currently used to treat myotonia. In vitro studies suggested both lacosamide and ranolazine were superior to mexiletine. However, in vivo studies in a mouse model of myotonia congenita suggested side effects could limit the efficacy of lacosamide. Ranolazine produced fewer side effects and was as effective as mexiletine at a dose that produced none of mexiletine’s hypoexcitability side effects. Interpretation We conclude ranolazine has excellent therapeutic potential for treatment of patients with myotonia congenita. PMID:25515836

Effects of wet-cupping on blood pressure in hypertensive patients: a randomized controlled trial.

PubMed

Aleyeidi, Nouran A; Aseri, Khaled S; Matbouli, Shadia M; Sulaiamani, Albaraa A; Kobeisy, Sumayyah A

2015-11-01

Although cupping remains a popular treatment modality worldwide, its efficacy for most diseases, including hypertension, has not been scientifically evaluated. We aimed to determine the efficacy of wet-cupping for high blood pressure, and the incidence of the procedure's side effects in the intervention group. This is a randomized controlled trial conducted in the General Practice Department at King Abdulaziz University Hospital, Jeddah, Saudi Arabia, between May 2013 and February 2014. There were two groups (40 participants each): intervention group undergoing wet-cupping (hijama) in addition to conventional hypertension treatment, and a control group undergoing only conventional hypertension treatment. Three wet-cupping sessions were performed every other day. The mean systolic and diastolic blood pressures were measured using a validated automatic sphygmomanometer. The follow-up period was 8 weeks. Wet-cupping provided an immediate reduction of systolic blood pressure. After 4 weeks of follow-up, the mean systolic blood pressure in the intervention group was 8.4 mmHg less than in the control group (P=0.046). After 8 weeks, there were no significant differences in blood pressures between the intervention and control groups. In this study, wet-cupping did not result in any serious side effects. Wet-cupping therapy is effective for reducing systolic blood pressure in hypertensive patients for up to 4 weeks, without serious side effects. Wet-cupping should be considered as a complementary hypertension treatment, and further studies are needed. ClinicalTrials.gov Identifier NCT01987583.

Antidepressant effects, of magnetic seizure therapy and electroconvulsive therapy, in treatment-resistant depression.

PubMed

Kayser, Sarah; Bewernick, Bettina H; Grubert, Christiane; Hadrysiewicz, Barbara L; Axmacher, Nikolai; Schlaepfer, Thomas E

2011-05-01

Major depression is a common mental health problem and associated with significant morbidity and mortality, including impaired social and physical functioning and increased risk for suicide. Electroconvulsive therapy (ECT) is highly efficacious in treatment-resistant depressive disorders, but cognitive side effects are frequently associated with the treatment. Magnetic seizure therapy (MST) is a form of convulsive therapy, using magnetic fields in order to induce therapeutic seizures. First studies suggested that cognitive side effects of MST, including postictal recovery time, are more benign than those resulting from ECT treatment. In this open-label study we tested the hypothesis that MST is associated with clinically significant antidepressant effects in treatment-resistant depression (TRD) as an add-on therapy to a controlled pharmacotherapy. Twenty patients suffering from TRD were randomly assigned to receive either MST or ECT starting from July 2006 until November 2008. Primary outcome measure was antidepressant response assessed by Montgomery Åsberg Depression Scale. Secondary outcome measures included Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Beck Depression Inventory and 90-Item Symptom Checklist. Antidepressant response (improvement of 50% in MADRS ratings) was statistically significant and of similar size in both treatment groups. Cognitive side effects were observed in neither group. Characteristics in MST- and ECT-induced seizures were comparable, especially regarding ictal activity and postictal suppression. Thus, MST may be a potential alternative to ECT if efficacy and safety are validated in larger clinical trials. Copyright © 2010 Elsevier Ltd. All rights reserved.

Aripiprazole, A Drug that Displays Partial Agonism and Functional Selectivity.

PubMed

Tuplin, Erin W; Holahan, Matthew R

2017-11-14

The treatment of schizophrenia is challenging due to the wide range of symptoms (positive, negative, cognitive) associated with the disease. Typical antipsychotics that antagonize D2 receptors are effective in treating positive symptoms, but extrapyramidal side-effects (EPS) are a common occurrence. Atypical antipsychotics targeting 5-HT2A and D2 receptors are more effective at treating cognitive and negative symptoms compared to typical antipsychotics, but these drugs also result in side-effects such as metabolic syndromes. To identify evidence in the literature that elucidates the pharmacological profile of aripiprazole.s. We searched PubMed for peer reviewed articles on aripiprazole and its clinical efficacy, side-effects, pharmacology, and effects in animal models of schizophrenia symptoms. Aripiprazole is a newer atypical antipsychotic that displays a unique pharmacological profile, including partial D2 agonism and functionally selective properties. Aripiprazole is effective at treating the positive symptoms of schizophrenia and has the potential to treat negative and cognitive symptoms at least as well as other atypical antipsychotics. The drug has a favorable side-effect profile and has a low propensity to result in EPS or metabolic syndromes. Animal models of schizophrenia have been used to determine the efficacy of aripiprazole in symptom management. In these instances, aripiprazole resulted in the reversal of deficits in extinction, pre-pulse inhibition, and social withdrawal. Because aripiprazole requires a greater than 90% occupancy rate at D2 receptors to be clinically active and does not produce EPS, this suggests a functionally selective effect on intracellular signaling pathways. A combination of factors such as dopamine system stabilization via partial agonism, functional selectivity at D2 receptors, and serotonin-dopamine system interaction may contribute to the ability of aripiprazole to successfully manage schizophrenia symptoms. This review examines these mechanisms of action to further clarify the pharmacological actions of aripiprazole. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Safety and efficacy of venom immunotherapy: a real life study

PubMed Central

Kołaczek, Agnieszka; Skorupa, Dawid; Antczak-Marczak, Monika; Kuna, Piotr

2017-01-01

Introduction Venom immunotherapy (VIT) is recommended as the first-line treatment for patients allergic to Hymenoptera venom. Aim To analyze the safety and efficacy of VIT in a real life setting. Material and methods One hundred and eighty patients undergoing VIT were studied to evaluate the safety, efficacy, incidence and nature of symptoms after field stings and adverse reactions to VIT. Results Significantly more patients were allergic to wasp than bee venom (146 vs. 34, p < 0.0001). Early and late side effects were more common during the maintenance (48 patients, 26.7%) than during the induction of VIT (32 patients, 17.8%), were more frequent in patients allergic to bees, and were not associated with angiotensin convertase inhibitors (ACEi) or β-adrenergic antagonists use. Systemic reactions were observed in 4 individuals on wasp VIT (2.7%) and in 6 patients allergic to bees (17.65%). The VIT was efficacious as most patients reported no reactions (50%) or reported only mild local reactions (43.75%) to field stings. The decrease in sIgE at completion of VIT correlated with the dose of vaccine received (r = 0.53, p = 0.004). Beekeeping (RR = 29.54, p < 0.0001) and female sex (RR = 1.27, p = 0.033) were associated with a higher risk of venom allergy. Conclusions Venom immunotherapy is highly efficacious and safe as most of the adverse events during the induction and maintenance phase are mild and local. Side effects of VIT are more common in subjects on bee VIT. Beekeeping and female sex are associated with a higher risk of allergy to Hymenoptera venom. PMID:28507496

Safety and efficacy of venom immunotherapy: a real life study.

PubMed

Kołaczek, Agnieszka; Skorupa, Dawid; Antczak-Marczak, Monika; Kuna, Piotr; Kupczyk, Maciej

2017-04-01

Venom immunotherapy (VIT) is recommended as the first-line treatment for patients allergic to Hymenoptera venom. To analyze the safety and efficacy of VIT in a real life setting. One hundred and eighty patients undergoing VIT were studied to evaluate the safety, efficacy, incidence and nature of symptoms after field stings and adverse reactions to VIT. Significantly more patients were allergic to wasp than bee venom (146 vs. 34, p < 0.0001). Early and late side effects were more common during the maintenance (48 patients, 26.7%) than during the induction of VIT (32 patients, 17.8%), were more frequent in patients allergic to bees, and were not associated with angiotensin convertase inhibitors (ACEi) or β-adrenergic antagonists use. Systemic reactions were observed in 4 individuals on wasp VIT (2.7%) and in 6 patients allergic to bees (17.65%). The VIT was efficacious as most patients reported no reactions (50%) or reported only mild local reactions (43.75%) to field stings. The decrease in sIgE at completion of VIT correlated with the dose of vaccine received ( r = 0.53, p = 0.004). Beekeeping (RR = 29.54, p < 0.0001) and female sex (RR = 1.27, p = 0.033) were associated with a higher risk of venom allergy. Venom immunotherapy is highly efficacious and safe as most of the adverse events during the induction and maintenance phase are mild and local. Side effects of VIT are more common in subjects on bee VIT. Beekeeping and female sex are associated with a higher risk of allergy to Hymenoptera venom.

Alzheimer's Therapeutics: Translation of Preclinical Science to Clinical Drug Development

PubMed Central

Savonenko, Alena V; Melnikova, Tatiana; Hiatt, Andrew; Li, Tong; Worley, Paul F; Troncoso, Juan C; Wong, Phil C; Price, Don L

2012-01-01

Over the past three decades, significant progress has been made in understanding the neurobiology of Alzheimer's disease. In recent years, the first attempts to implement novel mechanism-based treatments brought rather disappointing results, with low, if any, drug efficacy and significant side effects. A discrepancy between our expectations based on preclinical models and the results of clinical trials calls for a revision of our theoretical views and questions every stage of translation—from how we model the disease to how we run clinical trials. In the following sections, we will use some specific examples of the therapeutics from acetylcholinesterase inhibitors to recent anti-Aβ immunization and γ-secretase inhibition to discuss whether preclinical studies could predict the limitations in efficacy and side effects that we were so disappointed to observe in recent clinical trials. We discuss ways to improve both the predictive validity of mouse models and the translation of knowledge between preclinical and clinical stages of drug development. PMID:21937983

Efficacy of cevimeline vs. pilocarpine in the secretion of saliva: a pilot study.

PubMed

Brimhall, Jae; Jhaveri, Malhar A; Yepes, Juan F

2013-01-01

To determine the efficacy and compare the side-effects of cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia. A randomized, cross-over, double blind study was designed. Fifteen patients with diagnosis of xerostomia were assigned to take either 5 mg of pilocarpine or 30 mg of cevimeline three times a day for four weeks. Salivary flow rates were measured during the initial baseline, first and second month appointments. Statistical analysis was carried out with ANOVA and post hoc t-tests. Twelve patients completed both medication treatments. Although both medications proved to increase salivary secretion, there was no significant difference between pilocarpine and cevimeline. Also, the perceived side-effects between the two medications were similar. Both medications increased the secretion of saliva at the end of four weeks. However, there was a slightly higher increment in saliva with pilocarpine. However, the difference was not statistically significant. ©2013 Special Care Dentistry Association and Wiley Periodicals, Inc.

Significant partial response of metastatic intra-abdominal and pelvic round cell liposarcoma to a small-molecule VEGFR-2 tyrosine kinase inhibitor apatinib: A case report.

PubMed

Dong, Min; Bi, Jingwang; Liu, Xiaohong; Wang, Baocheng; Wang, Jun

2016-08-01

Myxoid/round cell liposarcoma is the second most common subtype of liposarcoma. Chemotherapy and radiotherapy have a limited efficacy for treating advanced myxoid/round cell liposarcoma, with relatively serious side effects. We herein present a 68-year-old Chinese woman initially diagnosed with advanced multiple intra-abdominal and pelvic round cell liposarcoma.She refused to receive cytotoxic chemotherapy and received apatinib as the first-line therapy, a novel tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2 that has been used in the treatment of patients with metastatic gastric cancer who progressed with 2 or more chemotherapy regimens. This patient was partially responsive to apatinib with a dose of 500 mg daily. No serious drug-related side effects were observed. Our findings indicate that some cases of liposarcoma may be responsive to antiangiogenic agent apatinib. Randomized clinical studies are needed to further confirm the efficacy and safety of apatinib in the clinical treatment of liposarcoma.

Identification and characterization of carprofen as a multi-target FAAH/COX inhibitor

PubMed Central

Favia, Angelo D.; Habrant, Damien; Scarpelli, Rita; Migliore, Marco; Albani, Clara; Bertozzi, Sine Mandrup; Dionisi, Mauro; Tarozzo, Glauco; Piomelli, Daniele; Cavalli, Andrea; De Vivo, Marco

2013-01-01

Pain and inflammation are major therapeutic areas for drug discovery. Current drugs for these pathologies have limited efficacy, however, and often cause a number of unwanted side effects. In the present study, we identify the non-steroid anti-inflammatory drug, carprofen, as a multi-target-directed ligand that simultaneously inhibits cyclooxygenase-1 (COX-1), COX-2 and fatty acid amide hydrolase (FAAH). Additionally, we synthesized and tested several racemic derivatives of carprofen, sharing this multi-target activity. This may result in improved analgesic efficacy and reduced side effects (Naidu, et al (2009) J Pharmacol Exp Ther 329, 48-56; Fowler, C.J. et al. (2012) J Enzym Inhib Med Chem Jan 6; Sasso, et al (2012) Pharmacol Res 65, 553). The new compounds are among the most potent multi-target FAAH/COXs inhibitors reported so far in the literature, and thus may represent promising starting points for the discovery of new analgesic and anti-inflammatory drugs. PMID:23043222

Efficacy and tolerability of oral lacosamide as adjunctive therapy in pediatric patients with pharmacoresistant focal epilepsy.

PubMed

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.

The impact of cardiovascular drugs on the efficacy of local anesthesia in dentistry.

PubMed

Milosavljevic, Мarko J; Jankovic, Slobodan M

2016-12-01

Drugs used chronically by patients with diseases of the cardiovascular system (group C of the ATC classification) may act on adrenergic receptors and/or certain ion channels, which gives them the potential to interact with the action of local dental anesthetics. The aim of the study was to investigate the effect of systemically administered chronic cardiovascular medication (oral route) on the efficacy of intraoral local anesthesia in patients with diseases of the cardiovascular system. This was a prospective cohort study which analyzed the efficacy of local terminal anesthesia (onset of anesthesia, duration anesthetized area) in the upper jaw of 70 patients: 40 patients on medication for cardiovascular system disorders and 30 patients who were not using these drugs (the control group). The following cardiovascular drugs were used: beta blockers, angiotensin converting enzyme inhibitors, calcium channel blockers, vasodilatators, diuretics, angiotensin receptor blockers, antiarrhythmics, statins and alfa blockers. The onset of anesthesia on the vestibular side was faster in those taking cardiovascular drugs (40.50±19.87 s) than the control patients (58.93±31.07 s; P = 0.004) and duration of anesthesia on this side was shorter. Although the difference was not significant, it was evident that on vestibular and palatal side the anesthetized area was more rapidly reduced in the patients taking cardiovascular drugs. The duration of cardiovascular therapy also had a significant impact on the anesthetized area. Drugs acting on cardiovascular system may influence the effect of local anesthetics used in dentistry, possibly through interaction with autonomic receptors and ion channels.

Nanotechnology in the management of cervical cancer.

PubMed

Chen, Jiezhong; Gu, Wenyi; Yang, Lei; Chen, Chen; Shao, Renfu; Xu, Kewei; Xu, Zhi Ping

2015-03-01

Cervical cancer is a major disease with high mortality. All cervical cancers are caused by infection with human papillomaviruses (HPV). Although preventive vaccines for cervical cancer are successful, treatment of cervical cancer is far less satisfactory because of multidrug resistance and side effects. In this review, we summarize the recent application of nanotechnology to the diagnosis and treatment of cervical cancer as well as the development of HPV vaccines. Early detection of cervical cancer enables tumours to be efficiently removed by surgical procedures, leading to increased survival rate. The current method of detecting cervical cancer by Pap smear can only achieve 50% sensitivity, whereas nanotechnology has been used to detect HPVs with greatly improved sensitivity. In cervical cancer treatment, nanotechnology has been used for the delivery of anticancer drugs to increase treatment efficacy and decrease side effects. Nanodelivery of HPV preventive and therapeutic vaccines has also been investigated to increase vaccine efficacy. Overall, these developments suggest that nanoparticle-based vaccine may become the most effective way to prevent and treat cervical cancer, assisted or combined with some other nanotechnology-based therapy. Copyright © 2015 John Wiley & Sons, Ltd.

The efficacy of Iranian herbal medicines in alleviating hot flashes: A systematic review

PubMed Central

Ghazanfarpour, Masumeh; Sadeghi, Ramin; Abdolahian, Somayeh; Latifnejad Roudsari, Robab

2016-01-01

Background: Hot flashes are the most common symptoms experienced by women around the time of menopause. Many women are interested in herbal medicines because of fear of side effects of hormone therapy. Objective: The aim of this systematic review was to assess the effectiveness of Iranian herbal medicines in alleviating hot flashes. Materials and Methods: MEDLINE (1966 to January 2015), Scopus (1996 to January 2015), and Cochrane Central Register of Controlled Trials (The Cochrane Library, issue 1, 2015) were searched along with, SID, Iran Medex, Magiran, Medlib and Irandoc. Nineteen randomized controlled trials met the inclusion criteria. Results: Overall, studies showed that Anise (Pimpinella anisum), licorice (Glycyrrhizaglabra), Soy, Black cohosh, Red clover, Evening primrose, Flaxseed, Salvia officinalis, Passiflora، itex Agnus Castus, Piascledine (Avacado plus soybean oil), St. John's wort (Hypericum perforatum), and valerian can alleviate the side effects of hot flashes. Conclusion: This research demonstrated the efficacy of herbal medicines in alleviating hot flashes, which are embraced both with people and health providers of Iran Therefore, herbal medicine can be seen as an alternative treatment for women experiencing hot flashes. PMID:27294213

St. John's wort: a new alternative for depression?

PubMed

Josey, E S; Tackett, R L

1999-03-01

The primary purpose of this article is to review the existing literature concerning the therapeutic uses, adverse effects, and possible drug interactions of St. John's wort (Hypericum perforatum) as compared to other antidepressant medications. Reference material was obtained through database searches with time restrictions of 1985 to the present. Studies selected were those written in the English language which compared the role of St. John's wort, tricyclic antidepressants, monoamine oxidase inhibitors, and serotonin-selective reuptake inhibitors in the treatment of depression. Other studies were selected based on their evaluation of the safety and efficacy of St. John's wort as an antidepressant for a minimum of four weeks. A review of existing literature recognized nine clinical trials that reported the efficacy of St. John's wort as compared to placebo and to other antidepressant medications. Of these nine, four controlled studies were chosen based upon their large patient populations and their consistency in brand and dosage of St. John's wort used. These four studies demonstrated that St. John's wort was as effective as other antidepressant medications and more effective than placebo, as the clinical symptoms of depression greatly decreased upon administration of H. perforatum. The side-effect profile of H. perforatum at this time appears to be superior to any current U.S.-approved antidepressant medication. From the existing literature, St. John's wort appears to be a safe and effective alternative in the treatment of depression. Tricylic antidepressants and monoamine oxidase inhibitors can produce serious cardiac side-effects, such as tachycardia and postural hypotension, and many unwanted anticholinergic side-effects, including dry mouth and constipation. St. John's wort has proven to be free of any cardiac, as well as anticholinergic, side-effects normally seen with antidepressant medications. Based upon limited studies, St. John's wort appears to be an acceptable alternative to traditional antidepressant therapy, although trials on a larger scale are warranted in this area. Hypericum is available to the lay public as an over-the-counter preparation and may be misused if not fully understood.

Adenovirus vector covalently conjugated to polyethylene glycol with a cancer-specific promoter suppresses the tumor growth through systemic administration.

PubMed

Yao, Xinglei; Yoshioka, Yasuo; Morishige, Tomohiro; Eto, Yusuke; Narimatsu, Shogo; Mizuguchi, Hiroyuki; Mukai, Yohei; Okada, Naoki; Nakagawa, Shinsaku

2010-01-01

Cancer gene therapy with adenovirus vectors (Adv) is limited to local administration because systemic administration of Adv produces a weak therapeutic effect and severe side effects. Previously, we generated a dual cancer-specific Adv system by using Adv covalently conjugated to polyethylene glycol (PEG) for transductional targeting and the telomere reverse transcriptase (TERT) promoter as a cancer-specific promoter for transcriptional targeting (PEG-Ad-TERT). We demonstrated that systemic administration of PEG-Ad-TERT showed superior antitumor effects against lung metastatic cancer with negligible side effects. Here, we investigated the therapeutic efficacy of systemic administration of PEG-Ad-TERT for the treatment of primary tumors. We first evaluated the transgene expression of PEG-Ad-TERT containing the luciferase gene (PEG-Ad-TERT/Luc) in primary tumors. Systemic administration of PEG-Ad-TERT/Luc resulted high transgene expression, similar to that observed in tumors for the conventional cytomegalovirus (CMV) promoter-driven Adv containing the luciferase gene (Ad-CMV/Luc). By comparison, transgene expression was 2500-fold lower than that of Ad-CMV/Luc in liver. We then examined the therapeutic effect of systemic administration of PEG-Ad-TERT containing the herpes simplex virus thymidine kinase (HSVtk) gene (PEG-Ad-TERT/HSVtk) for the treatment of primary tumors. We showed that PEG-Ad-TERT/HSVtk produced a notable antitumor effect against primary tumors with negligible side effects. These results demonstrated that PEG-Ad-TERT can be regarded as a prototype Adv with suitable efficacy and safety for systemic cancer gene therapy against both metastatic and primary tumors.

Computational models of Bitemporal, Bifrontal and Right Unilateral ECT predict differential stimulation of brain regions associated with efficacy and cognitive side effects.

PubMed

Bai, S; Gálvez, V; Dokos, S; Martin, D; Bikson, M; Loo, C

2017-03-01

Extensive clinical research has shown that the efficacy and cognitive outcomes of electroconvulsive therapy (ECT) are determined, in part, by the type of electrode placement used. Bitemporal ECT (BT, stimulating electrodes placed bilaterally in the frontotemporal region) is the form of ECT with relatively potent clinical and cognitive side effects. However, the reasons for this are poorly understood. This study used computational modelling to examine regional differences in brain excitation between BT, Bifrontal (BF) and Right Unilateral (RUL) ECT, currently the most clinically-used ECT placements. Specifically, by comparing similarities and differences in current distribution patterns between BT ECT and the other two placements, the study aimed to create an explanatory model of critical brain sites that mediate antidepressant efficacy and sites associated with cognitive, particularly memory, adverse effects. High resolution finite element human head models were generated from MRI scans of three subjects. The models were used to compare differences in activation between the three ECT placements, using subtraction maps. In this exploratory study on three realistic head models, Bitemporal ECT resulted in greater direct stimulation of deep midline structures and also left temporal and inferior frontal regions. Interpreted in light of existing knowledge on depressive pathophysiology and cognitive neuroanatomy, it is suggested that the former sites are related to efficacy and the latter to cognitive deficits. We hereby propose an approach using binarised subtraction models that can be used to optimise, and even individualise, ECT therapies. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Efficacy of Specific Plant Products on Microorganisms Causing Dental Caries.

PubMed

Kanth, M Rajini; Prakash, A Ravi; Sreenath, G; Reddy, Vikram Simha; Huldah, S

2016-12-01

Dental caries and periodontal diseases are the most common oral diseases seen globally, both in developed and developing countries. Oral microorganisms that is gram positive and gram negative bacteria are known to be involved in causation of these diseases. Nowadays commercially available dentrifices and mouth rinses are known to contain ingredients that can alter the oral microbial flora and have undesirable side effects such as vomiting, diarrhoea, disarrangement of oral, intestinal flora and tooth staining. Naturally available plant products are known to be less harmful with fewer side effects and also economical for the patient. The aim of this study was to determine the antimicrobial properties of 10 naturally available plant products against oral microorganisms causing caries and to check the efficacy of these products in-vitro and to use these in mouth washes and dentrifices. Sample of caries material was scrapped out from the extracted teeth and transferred to liquid broth, streaked over the agar media to allow for the growth of microorganisms. Plant products like clove oil, neem, ginger-garlic paste, tea tree oil, ginger, garlic, cinnamon oil, green tea, eucalyptus oil and turmeric were used. Antimicrobial efficacy of these products, was estimated by measuring zones of inhibition in the nutrient agar media. Clove oil was the most effective of all products against microorganisms causing caries with zone of inhibition - 30mm followed by ginger-garlic paste - 25mm, Neem - 15mm, tea tree oil - 15mm. Based on the above results, it can be inferred that these natural products have the maximum efficacy against microorganisms and can be recommended in dentifrices, mouth rinses, topical gels, etc.

New findings in pharmacogenetics of schizophrenia.

PubMed

Zai, Clement C; Tiwari, Arun K; Zai, Gwyneth C; Maes, Miriam S; Kennedy, James L

2018-05-01

This review highlights recent advances in the investigation of genetic factors for antipsychotic response and side effects. Antipsychotics prescribed to treat psychotic symptoms are variable in efficacy and propensity for causing side effects. The major side effects include tardive dyskinesia, antipsychotic-induced weight gain (AIWG), and clozapine-induced agranulocytosis (CIA). Several promising associations of polymorphisms in genes including HSPG2, CNR1, and DPP6 with tardive dyskinesia have been reported. In particular, a functional genetic polymorphism in SLC18A2, which is a target of recently approved tardive dyskinesia medication valbenazine, was associated with tardive dyskinesia. Similarly, several consistent findings primarily from genes modulating energy homeostasis have also been reported (e.g. MC4R, HTR2C). CIA has been consistently associated with polymorphisms in the HLA genes (HLA-DQB1 and HLA-B). The association findings between glutamate system genes and antipsychotic response require additional replications. The findings to date are promising and provide us a better understanding of the development of side effects and response to antipsychotics. However, more comprehensive investigations in large, well characterized samples will bring us closer to clinically actionable findings.

Stem cells as anticancer drug carrier to reduce the chemotherapy side effect

NASA Astrophysics Data System (ADS)

Salehi, Hamideh; Al-Arag, Siham; Middendorp, Elodie; Gergley, Csilla; Cuisinier, Frederic

2017-02-01

Chemotherapy used for cancer treatment, due to the lack of specificity of drugs, is associated to various damaging side effects that have severe impact on patients' quality of life. Over the past 30 years, increasing efforts have been placed on optimizing chemotherapy dosing with the main goal of increasing antitumor efficacy while reducing drug-associated toxicity. A novel research shows that stem cells may act as a reservoir for the anticancer agent, which will subsequently release some of the drug's metabolites, or even the drug in its original form, in vicinity of the cancer cells. These cells may play a dual role in controlling drug toxicity depending on their capacity to uptake and release the chemotherapeutic drug. In our study, we show that Dental Pulp Stem Cells DPSCs are able to rapidly uptake Paclitaxel PTX, and to release it in the culture medium in a time-dependent manner. This resulting conditioned culture medium is to be transferred to breast cancer cells, the MCF-7. By applying Confocal Raman Microscopy, the anticancer drug uptake by the MCF-7 was measured. Surprisingly, the cancer cells -without any direct contact with PTX- showed a drug uptake. This proves that the stem cells carried and delivered the anticancer drug without its modification. It could be a revolution in chemotherapy to avoid the drug's side effects and increase its efficacy.

Impact of an early education multimedia intervention in managing nutrition-related chemotherapy side effects: a pilot study.

PubMed

Thompson, Julie; Silliman, Kathryn; Clifford, Dawn E

2013-12-01

The purpose of the educational intervention was to measure changes in knowledge, perceived benefit of nutrition, and perceived self efficacy in handling side effects of chemotherapy before and after viewing a 15 minute DVD among patients with cancer. A convenience sample of 14 (4 male, 10 female, 61 ± 9 years) patients with cancer, early to chemotherapy, participated in the study. Participants completed a survey with demographic, knowledge items, and perceived health belief and self efficacy statements; viewed the DVD; and were then sent home with a one page handout. Two weeks after the nutrition education intervention, a second survey was completed including an item about tips used. Change was measured using paired t-test and wilcoxon signed rank tests. The mean score on the four knowledge items significantly increased (p < 0.05). No significant differences were noted in statements intended to evaluate changes in perceived health beliefs. However, perceived knowledge and skills related to managing side effects increased (p < 0.05). All participants responded that the DVD was informative and most (n = 11, 79%) responded that it was useful. The majority reported (n = 10, 71%) a tip they used from the DVD. This short multimedia nutrition education intervention was found primarily to increase knowledge and could form a useful component of counseling services for patients undergoing chemotherapy.

Long-term follow-up for efficacy and safety of treatment of retinitis pigmentosa with valproic acid.

PubMed

Bhalla, Sheena; Joshi, Deval; Bhullar, Shaminder; Kasuga, Daniel; Park, Yeonhee; Kay, Christine N

2013-07-01

The purpose of this study was to determine the long-term efficacy and safety of valproic acid (VPA) treatment in patients with pigmentary retinal dystrophies. A retrospective chart review was conducted on 31 patients with a diagnosis of pigmentary retinal dystrophy prescribed VPA at a single centre. Visual field (VF), visual acuity (VA), length of treatment, liver enzymes and side effects were analysed. VF areas were defined using Goldmann VF (GVF) tracings recorded before, during and after VPA treatment using the V4e isopter for each eye. Using custom software, planimetric areas of VF were calculated. Five of the patients (10 eyes) had two Goldmann VF tracings, allowing comparison between baseline and follow-up VF. After 9.8 months of VPA, VF decreased by 0.145 cm(2) (26.478%) (p=0.432). For 22 of the patients (41 eyes), VA data was available, and logarithm of the minimum angle of resolution (logMAR) score changed by 0.056 log units (representing a decline in VA) after 14.9 months on VPA (p=0.002). Twelve patients (38.7%) reported negative side effects related to VPA use. VPA plays a complex role in patients with pigmentary retinal dystrophies and may be associated with VA and field decline as well as adverse side effects. Physicians should use caution with using VPA for pigmentary retinal dystrophies.

Dietary naringenin supplementation attenuates experimental autoimmune encephalomyelitis by modulating autoimmune inflammatory responses in mice

USDA-ARS?s Scientific Manuscript database

Autoimmune disease is prevalent in humans. Since conventional therapies have limited efficacy and often come with significant side effects, nutrition may provide an alternative and complementary approach to improving the autoimmune disorders. Naringenin, a flavonoid found in citrus fruits, has been ...

Efficacy and safety of second-generation antipsychotics in children and adolescents with psychotic and bipolar spectrum disorders: comprehensive review of prospective head-to-head and placebo-controlled comparisons.

PubMed

Fraguas, David; Correll, Christoph U; Merchán-Naranjo, Jessica; Rapado-Castro, Marta; Parellada, Mara; Moreno, Carmen; Arango, Celso

2011-08-01

To review data on efficacy and safety of second-generation antipsychotics (SGAs) in children and adolescents with psychotic and bipolar spectrum disorders. Medline/PubMed/Google Scholar search for studies comparing efficacy and/or tolerability: (i) between two or more SGAs; (ii) between SGAs and placebo; and (iii) between at least one SGA and one first-generation antipsychotic (FGA). The review focused on three major side-effect clusters: 1. body weight, body mass index, and cardiometabolic parameters, 2. prolactin levels, and 3. neuromotor side effects. In total, 34 studies with 2719 children and adolescents were included. Studies lasted between 3 weeks and 12 months, with most studies (79.4%) lasting 3 months or less. Nine studies (n=788) were conducted in patients with schizophrenia, 6 (n=719) in subjects with bipolar disorder, and 19 (n=1212) in a mixed population. Data on efficacy showed that, except for clozapine being superior for refractory schizophrenia, there were no significant differences between SGAs. By contrast, safety assessments showed relevant differences between SGAs. Mean weight gain ranged from 3.8 kg to 16.2 kg in patients treated with olanzapine (n=353), from 0.9 kg to 9.5 kg in subjects receiving clozapine (n=97), from 1.9 kg to 7.2 kg in those on risperidone (n=571), from 2.3 kg to 6.1 kg among patients taking quetiapine (n=133), and from 0 kg to 4.4 kg in those treated with aripiprazole (n=451). Prolactin levels increased the most in subjects on risperidone (mean change ranging from 8.3 ng/mL to 49.6 ng/mL), followed by olanzapine (-1.5 ng/mL to +13.7 ng/mL). Treatment with aripiprazole was associated with decreased prolactin levels, while clozapine and quetiapine were found to be mostly neutral. With respect to neuromotor side effects, SGAs were associated with less parkinsonism and akathisia than FGAs. Most of the studies comparing neuromotor side effects between SGAs found no significant differences. SGAs do not behave as a homogeneous group in children and adolescents with psychotic and mood disorders. Except for clozapine, the heterogeneity within the SGA group is mainly due to differences in the rates and severity of adverse events, especially regarding weight gain as a proxy for the risk of cardiometabolic disturbances. Published by Elsevier B.V.

Anti-interleukin-6 receptor antibody (tocilizumab) treatment of multicentric Castleman's disease.

PubMed

Matsuyama, Masashi; Suzuki, Takeshi; Tsuboi, Hiroto; Ito, Satoshi; Mamura, Mizuko; Goto, Daisuke; Matsumoto, Isao; Tsutsumi, Akito; Sumida, Takayuki

2007-01-01

We report three cases of multicentric Castleman's disease (MCD) successfully treated with anti-interleukin-6 receptor antibody (tocilizumab). Tocilizumab was administered intravenously at a dose of 8 mg/kg every 2 weeks. In each case, tocilizumab alleviated symptoms, including generalized fatigue, pyrexia, and alleviated biochemical abnormalities, including anemia, hypoalbuminemia, hypergammaglobulinemia, and increased C-reactive protein (CRP). Side effects included hypercholesterolemia, acute pyelonephritis, mild inflammation of the parotid glands, and upper respiratory system inflammation. Other severe side effects were not observed. These results indicate that tocilizumab is effective for the treatment of MCD. This is the first report on tocilizumab efficacy for Castleman's disease after approval for use for Castleman's disease.

Pharmacogenetics and outcome with antipsychotic drugs.

PubMed

Pouget, Jennie G; Shams, Tahireh A; Tiwari, Arun K; Müller, Daniel J

2014-12-01

Antipsychotic medications are the gold-standard treatment for schizophrenia, and are often prescribed for other mental conditions. However, the efficacy and side-effect profiles of these drugs are heterogeneous, with large interindividual variability. As a result, treatment selection remains a largely trial-and-error process, with many failed treatment regimens endured before finding a tolerable balance between symptom management and side effects. Much of the interindividual variability in response and side effects is due to genetic factors (heritability, h(2)~ 0.60-0.80). Pharmacogenetics is an emerging field that holds the potential to facilitate the selection of the best medication for a particular patient, based on his or her genetic information. In this review we discuss the most promising genetic markers of antipsychotic treatment outcomes, and present current translational research efforts that aim to bring these pharmacogenetic findings to the clinic in the near future.

[Pharmacogenetics in primary health care: implementation and future expectations].

PubMed

Houwink, Elisa J F; Rigter, Tessel; Swen, Jesse J; Cornel, Martina C; Kienhuis, Anne; Rodenburg, Wendy; Weda, Marjolein

2015-01-01

Personalised medicine is a targeted approach to the prevention, diagnosis and treatment of disorders on the basis of the specific genetic profile of the patient. Pharmacogenetics research shows that differences in the genetic profile of patients explain the interindividual differences in efficacy and side effects of medicines. Although there are high expectations of personalised medicine and pharmacogenetics in healthcare, both are only used to a limited extent to date. Pharmacogenetics seems particularly important in diseases with a poor prognosis and treatments with potentially serious side effects. Pharmacogenetics testing is reimbursed in the case of serious side effects or unexpected ineffectiveness. 95% of patients in the Netherlands have at least one abnormality in the panel of genes for which guidance is available. The KNMP (Royal Dutch Pharmacists' Association) provides dosing advice based on genotype for 80 medicines, 27 of which are regularly prescribed in primary health care.

Pharmacogenetics and outcome with antipsychotic drugs

PubMed Central

Pouget, Jennie G.; Shams, Tahireh A.; Tiwari, Arun K.; Müller, Daniel J.

2014-01-01

Antipsychotic medications are the gold-standard treatment for schizophrenia, and are often prescribed for other mental conditions. However, the efficacy and side-effect profiles of these drugs are heterogeneous, with large interindividual variability. As a result, treatment selection remains a largely trial-and-error process, with many failed treatment regimens endured before finding a tolerable balance between symptom management and side effects. Much of the interindividual variability in response and side effects is due to genetic factors (heritability, h2~ 0.60-0.80). Pharmacogenetics is an emerging field that holds the potential to facilitate the selection of the best medication for a particular patient, based on his or her genetic information. In this review we discuss the most promising genetic markers of antipsychotic treatment outcomes, and present current translational research efforts that aim to bring these pharmacogenetic findings to the clinic in the near future. PMID:25733959

Treatment of mild to moderate acne with a fixed combination of hydroxypinacolone retinoate, retinol glycospheres and papain glycospheres.

PubMed

Veraldi, S; Barbareschi, M; Guanziroli, E; Bettoli, V; Minghetti, S; Capitanio, B; Sinagra, J L; Sedona, P; Schianchi, R

2015-04-01

A fixed combination of 0.1% hydroxypinacolone retinoate (synthetic esther of 9-cis-retinoic acid), 1% retinol in glycospheres and 2% papain in glycospheres in aqueous gel has been recently introduced into the Italian market in order to reduce the incidence and severity of irritant contact dermatitis caused by topical retinoids, without compromising their efficacy. Primary objectives of this sponsor-free, pilot, open, multicenter study were to evaluate the efficacy and tolerability of this gel in patients with comedonal-papular, mild to moderate acne of the face. Ninety-eight Caucasian patients (28 males and 70 females), with an age ranging from 15 to 40 years, were treated with the gel once daily for 12 weeks. Acne severity and treatment efficacy were evaluated by means of the Global Acne Grading System (GAGS) and lesions count. Ninety-four patients were considered evaluable. A 41% mean reduction in the GAGS score was observed; a 40.8% mean reduction of total lesions was recorded; 15.3% of patients experienced mild to moderate local side effects (dryness, peeling, erythema, burning). No patients stopped the treatment because of these side effects. This study, based on a high number of evaluable patients, demonstrates that this fixed combination is an effective and safe option for the treatment of comedonal-papular, mild to moderate acne of the face. A controlled clinical study is necessary to confirm these data.

Laser treatment of solar lentigines on dorsum of hands: QS Ruby laser versus ablative CO2 fractional laser - a randomized controlled trial.

PubMed

Schoenewolf, Nicola L; Hafner, Jürg; Dummer, Reinhard; Bogdan Allemann, Inja

2015-04-01

Lentigines solares (LS) on the dorsum of hands are often esthetically disturbing. Q-switched ruby laser treatment is highly effective in the treatment of these lesions. Ablative fractional photothermolysis may be a suitable alternative. We compared the Q-switched ruby laser with ablative CO2 fractional photothermolysis for the treatment of solar lentigines. To evaluate the efficacy and side-effects of 694nm Q-switched ruby laser (Sinon) with the ablative 10,600nm CO2 fractional laser (Quantel Excel O2) in an intra-individual side-to-side comparison in the treatment of LS on the dorsum of hands. Eleven patients were included in the study. The hands of each patient were randomized for treatment with the two laser systems. Three treatment sessions were scheduled at weeks 0, 4 and 8. Evaluations by patients, treating physician and blinded experts were scheduled at weeks 0, 4, 8, 16 and 24. The Q-switched ruby laser was significantly more efficacious than the ablative CO2 fractional laser for removing LS on the dorsum of hands (p = 0.01). In this first study on this topic, the Q-switched ruby laser was superior to the ablative CO2 fractional laser in the treatment of lentigines solares on the dorsum of hands.

Intravitreal injection therapy in the treatment of noninfectious uveitis.

PubMed

Modorati, Giulio; Miserocchi, Elisabetta

2012-01-01

Uveitis is responsible for 5-20% of legal blindness in the United States and in Europe. In noninfectious uveitis, the most frequent uveitic complication that endangers sight is cystoid macular edema. Clinical characteristics, inflammation grading and visual acuity determine the choice of the correct therapy for each patient. We can utilize drugs either alone or in combination using different dosages and routes of administration. Intravitreal injection directly into the vitreous cavity leads to rapid therapeutic drug concentration in the retinal tissue and reduces systemic side effects. Intravitreally injected triamcinolone acetonide is the most powerful drug for the treatment of cystoid macular edema related to intraocular inflammation, but it also causes the most frequent and serious side effects. Due to the numerous side effects associated with the use of corticosteroids, there is a need to identify other anti-inflammatory agents with a better safety profile. Recent studies have demonstrated that intravitreal immunosuppressant injections of methotrexate or anti-VEGF agents may lead to fewer intraocular side effects, but also have a lower therapeutic activity for the reduction of macular edema. At present, intraocular anti-TNF-α drugs do not show promising results. As regards nonsteroidal anti-inflammatory drugs, further data are necessary to fully understand their efficacy and potential side effects. Copyright © 2012 S. Karger AG, Basel.

Comparison the effectiveness of pyruvic acid 50% and salicylic acid 30% in the treatment of acne.

PubMed

Jaffary, Fariba; Faghihi, Gita; Saraeian, Sara; Hosseini, Sayed Mohsen

2016-01-01

Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles and one of the most common skin diseases. The peeling method has been recently found to be effective for acne treatment. This study aimed to compare the efficacy of pyruvic acid 50% and salicylic acid 30% peeling in the treatment of mild to moderate acne. In a prospective single-blinded clinical trial, 86 patients with acne were randomly assigned into two groups. In both groups, the routine treatment of acne (topical solution of erythromycin 4%, triclorocarban soap, and sunscreen) were used twice a day for 8 weeks. In addition, salicylic acid 30% for the control group and pyruvic acid 50% for the case group were used. In both groups, acne severity index (ASI) was calculated before and at week 2, 4, 6, and 8 of the treatment. Patient satisfaction was assessed at the end of the treatment. Side effects were recorded using a checklist. In both groups, the reduction in the number of comedones, papules, and ASI were statistically significant ( P < 0.001) in the course of treatment. However, it was not significant regarding the number of pustules ( P = 0.09). None of the number of comedone, papules, pustules, and ASI was statistically different between study groups. Both treatment groups had similar side effects except for scaling in the fifth session, which was significantly lower in salicylic acid - treated patients ( P = 0.015). Both pyruvic acid 50% and salicylic acid 30% are effective in the improvement of mild to moderate acne with no significant difference in efficacy and side effects.

Safety and clinical efficacy of tenvermectin, a novel antiparasitic 16-membered macrocyclic lactone antibiotics.

PubMed

Fei, Chenzhong; She, Rufeng; Li, Guiyu; Zhang, Lifang; Fan, Wushun; Xia, Suhan; Xue, Feiqun

2018-05-30

Tenvermectin (TVM) is a novel 16-membered macrocyclic lactone antibiotics, which contains component TVM A and TVM B. However there is not any report on safety and clinical efficacy of TVM for developing as a potential drug. In order to understand the part of safety and clinical efficacy of TVM, we conducted the acute toxicity test, the standard bacterial reverse mutation (Ames) test and the clinical deworming test. In the acute toxicity studies, TVM, TVM A and ivermectin (IVM) were administrated once by oral gavage to mice and rats. Results showed that the oral LD 50 values of TVM, TVM A and IVM in mice were 74.41, 106.95 and 53.06 mg/kg respectively. The oral LD 50 values of TVM and TVM A in rats were determined to be 164.22 and 749.34 mg/kg respectively. TVM and IVM are moderately toxic substances, meanwhile the TVM A belongs to low toxic compounds, implying that the acute toxicity is highly related to the length of side chain of TVM at position C25. In the Ames test, results showed that TVM did not induce mutagenicity in Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 with and without metabolic activation system, speculating that the mutagenicity is probably not related to the side chain at position C25 of 16-membered macrocyclic lactone antibiotics. In the efficacy trail of TVM against swine nematodes, growing pigs natural infection of Ascaris suum and Trichuris suis were treated with a single subcutaneous injection 0.3 mg/kg b.w.. Results showed that TVM and IVM had excellent effect in expelling Ascaris suum, and TVM had potential efficacy against Trichuris suis, however IVM had no effect on Trichuris suis. This study suggests that the side chain of TVM at position C25 may have important biological functions, which is one of the key sites of the studies on structure-activity relationship of 16-membered macrocyclic lactone compounds. TVM is a new compound exhibited some advantages worthy of developing. Copyright © 2018 Elsevier B.V. All rights reserved.

Efficacy of rivastigmine tartrate, transdermal system, in Alzheimer's disease.

PubMed

Nieto, Rachel A; Deardorff, William James; Grossberg, George T

2016-01-01

As the most common major neurocognitive disorder, Alzheimer's disease (AD) will play an increasingly important role both socially and financially as the population ages. Approved treatments for AD are symptomatic in nature and show modest improvements in cognition and global functioning among patients with AD. This article focuses on the pharmacokinetics, pharmacodynamics, efficacy, and safety of the transdermal patch form of the cholinesterase inhibitor rivastigmine. The rivastigmine transdermal system is approved for the treatment of patients with mild, moderate, and severe AD. Three randomized trials have shown the rivastigmine patch to be efficacious and tolerable across all stages of AD. The rivastigmine patch offers several advantages over the capsule form, including decreased peak to trough plasma fluctuations, reduced rates of nausea and vomiting, better treatment adherence, higher probability of reaching the target dose, ease of administration, and greater satisfaction among caregivers. These factors may be especially important in patients with severe AD, in which patients are more vulnerable to adverse side effects from higher doses. While the patch is more expensive than generic therapies, patient populations that may benefit from the patch include those that are particularly sensitive to GI side effects, have chronic gastrointestinal problems, have difficulty swallowing medications, or have failed to respond with high doses of other generic options.

Efficacy and acceptability of oxcarbazepine vs. carbamazepine with betahistine mesilate tablets in treating vestibular paroxysmia: a retrospective review.

PubMed

Yi, Chong; Wenping, Xiang; Hui, Xue; Xin, He; Xiue, Li; Jun, Zhang; Shangyong, Geng

2016-06-01

Vestibular paroxysmia (VP) is a rare episodic peripheral vestibular disorder that can cause acute short attacks of vertigo. This study aimed to compare the efficacy and acceptability of carbamazepine (CBZ), CBZ plus betahistine mesilate tablets (BMT) and oxcarbazepine (OXC) plus BMT in treating VP within 12 weeks. A retrospective analysis of data from 196 VP patients treated in our hospital was conducted. There were 73 patients receiving CBZ, 65 patients receiving CBZ+BMT and 58 patients receiving OXC+BMT. The frequency of vertigo, vertigo duration, vertigo score, response rate (RR) and side effects were compared between groups to assess efficacy and acceptability at the end of 12(th) week. After 12 weeks' treatment, the CBZ+BMT group had a greater reduction in the frequency of vertigo, vertigo duration and vertigo score than the other two groups. The RR was highest in the CBZ+BMT group, second in the OXC+BMT group and lowest in the CBZ group. The incidence of side-effects was highest in the CBZ group, second in the CBZ+BMT group and lowest in the OXC+BMT group. Two patients in the CBZ group were withdrawn. These results indicated that using BMT as an augmentation for CBZ or OXC might be a good choice in treating VP.

Quantitative comparison of topical aluminum salt solution efficacy for management of sweating: a randomized, controlled trial.

PubMed

Swary, Jillian H; West, Dennis P; Kakar, Rohit; Ortiz, Sara; Schaeffer, Matthew R; Veledar, Emir; Alam, Murad

2015-12-01

There is a lack of studies objectively comparing the efficacy of topical antiperspirants in reducing sweat. To objectively and quantitatively compare the efficacy of two aluminum salt solutions for the reduction of induced sweating. A subject, rater, and statistician-blinded, randomized, controlled trial. Nineteen subjects were exposed to a standardized heat challenge for 3 h. Topical agent A (20% aluminum chloride hexahydrate) was randomized to either axilla, and topical agent B (1% aluminum acetate) assigned to the contralateral side. A sauna suit induced sweating during three 30-min heat intervals: (1) with no study agents (pre); (2) with both study agents, one on each side; and (3) after the agents were washed off (post). Sweat levels were measured by securing Whatman(®) filter paper to each axilla and measuring the paper weight after each heat interval. The difference in paper weight following each heat interval between Study Agent A and Study Agent B was measured by a gravimetric scale. Topical agent A had a significantly greater effect at reducing axillary sweating than B (P = 0.0002). In a sweating simulation, 20% aluminum chloride hexahydrate quantitatively and objectively appeared to reduce sweat more effectively than 1% aluminum acetate. © 2015 Wiley Periodicals, Inc.

A double-blind vehicle-controlled study of a preparation containing undecylenoyl phenylalanine 2% in the treatment of melasma in females.

PubMed

Katoulis, Alexander; Alevizou, Antigoni; Soura, Efthymia; Mantas, Nikolaos; Bozi, Evangelia; Gregoriou, Stamatis; Makris, Michalis; Rigopoulos, Dimitris

2014-06-01

Undecylenoyl phenylalanine is a novel skin-lightening agent, probably acting as α-melanocyte-stimulating hormone (α-MSH) and beta-adrenergic receptor (β-ADR) antagonist. The objective of this double-blind randomized comparative study was to evaluate the efficacy and safety of a preparation containing undecylenoyl phenylalanine 2% in the topical treatment of melasma in females. Forty female patients with melasma were randomly assigned to apply either the active preparation or the vehicle alone, twice daily for 12 weeks. Patients were evaluated monthly for efficacy and safety. In all, 37 patients completed the study. Of the 20 patients on active treatment, no one responded completely, but 17 (85%) had partial response. Of them, 11 had moderate improvement and six had marked improvement. Lightening of the lesions was evident from the first follow-up visit at 4 weeks. A statistically significant difference (P < 0.001) in efficacy between the active preparation and the vehicle was documented. Using patient assessment ratings, 80% were extremely satisfied or satisfied with the result. The reported side effects were minor and included erythema and itching or burning at the site of application. Undecylenoyl phenylalanine 2% achieved a significant lightening of melasma lesions with minimal side effects. © 2014 Wiley Periodicals, Inc.

Efficacy of Acupuncture versus Combined Oral Contraceptive Pill in Treatment of Moderate-to-Severe Dysmenorrhea: A Randomized Controlled Trial

PubMed Central

Sriprasert, Intira; Suerungruang, Suparerk; Athilarp, Porntip; Matanasarawoot, Anuchart

2015-01-01

This open-label randomized controlled trial was designed to compare the efficacy of acupuncture and combined oral contraceptive (COC) pill in treating moderate-to-severe primary dysmenorrhea. Fifty-two participants were randomly assigned to receive either acupuncture (n = 27) or COC (n = 25) for three menstrual cycles. Mefenamic acid was prescribed as a recue analgesic drug with both groups. The statistical approach used for efficacy and safety assessments was intention-to-treat analysis. By the end of the study, both treatments had resulted in significant improvement over baselines in all outcomes, that is, maximal dysmenorrhea pain scores, days suffering from dysmenorrhea, amount of rescue analgesic used, and quality of life assessed by SF-36 questionnaire. Over the three treatment cycles, COC caused greater reduction in maximal pain scores than acupuncture, while improvements in the remaining outcomes were comparable. Responders were defined as participants whose maximal dysmenorrhea pain scores decreased at least 33% below their baseline. Response rates following both interventions at the end of the study were not statistically different. Acupuncture commonly caused minimal local side effects but did not cause any hormone-related side effects as did COC. In conclusion, acupuncture is an alternative option for relieving dysmenorrhea, especially when COC is not a favorable choice. PMID:26346199

Comparison of cefuroxime axetil, cefaclor, and amoxicillin-clavulanate potassium suspensions in acute otitis media in infants and children.

PubMed

Pichichero, M; Aronovitz, G H; Gooch, W M; McLinn, S E; Maddern, B; Johnson, C; Darden, P M

1990-10-01

In this randomized, blinded, multicenter comparison study, 377 infants and children with acute otitis media (AOM) received a 10-day course of an oral suspension of one of the following: cefuroxime axetil (CAE), 30 mg/kg/day; cefaclor (CEC), 40 mg/kg/day; or amoxicillin-clavulanate potassium (AMX-CL), 40 mg/kg/day. Clinical efficacy was determined by pneumatic otoscopy and tympanometric testing 3 to 5, 11 to 14, and 22 to 26 days after the initiation of therapy. There was a statistically significant difference among the three treatment groups with respect to clinical outcome; more patients in the CAE group (62%) than in the CEC group (46%) or the AMX-CL group (52%) had complete resolution of signs and symptoms of AOM (including effusion). Paired comparisons revealed a significant difference in efficacy between CAE and CEC and a nearly significant difference between AMX-CL and CEC. Taste acceptability was highest for CEC and lowest for this formulation of CAE. Significantly more patients in the AMX-CL group than in the CAE or CEC group had a side effect, primarily diarrhea, vomiting, or diaper rash. We conclude that CAE suspension has greater clinical efficacy than CEC and fewer side effects than AMX-CL.

Levetiracetam in adult patients with and without learning disability: focus on behavioral adverse effects.

PubMed

Brodtkorb, Eylert; Klees, Theresa M; Nakken, Karl O; Lossius, Rasmus; Johannessen, Svein I

2004-04-01

Optimal antiepileptic drug treatment in patients with learning disability (LD) represents a particular challenge. These patients are often unable to report toxicity, and side effects may manifest as behavioral problems. The aim of this open study was to compare efficacy and tolerability of levetiracetam (LEV) in patients with LD and those without LD. One hundred eighty-four consecutive adult patients who received LEV were followed for an average of 8.1 months. Fifty-six patients (30%) had LD. Thirty-nine percent of patients with refractory epilepsy (37% with and 40% without LD) had > 50% seizure reduction. Significantly more behavioral side effects (23% vs 10%) and a tendency toward less reported somatic central nervous side effects were found in the LD group. We conclude that LEV is equally effective and well tolerated in both patients with LD and patients without LD. However, behavioral problems are more frequent in patients with LD, whereas the tendency toward seizure increase is not enhanced.

Hair loss at injection sites of mesotherapy for alopecia.

PubMed

El-Komy, Mohamed; Hassan, Akmal; Tawdy, Amira; Solimon, Mohamed; Hady, Mohamed Abdel

2017-12-01

The side effects of mesotherapy for treatment of various forms of alopecia are often underreported, while scientific data for its efficacy are severely lacking. To demonstrate the late onset side effects of mesotherapy for alopecia. Three patients with androgenetic alopecia showed hair loss after previously uneventful mesotherapy sessions up to 1 year. Clinical, dermoscopic, and histopathological findings suggested an inflammatory scaring process at sites of mesotherapy injections. Mesotherapy for androgenetic alopecia may paradoxically induce hair loss and scarring. Proper regulation and monitoring of the use of mesotherapy products for treating hair loss in women, needs to be addressed. © 2017 Wiley Periodicals, Inc.

[Prevention and management of locoregional complications of botulinum A toxin injections in cosmetic treatment].

PubMed

Gassia, V

2009-05-01

Botulinum toxin serotype A injections used in treating dynamic wrinkles is one of the least invasive cosmetic procedures. High patient satisfaction and low onset of always moderate side effects contribute to the growing popularity of botulinum toxin injections in cosmetic treatment over the past few years. Years of experience and use, in therapeutics [1,2] and esthetics (20 years) have proven the efficacy and the safety of this wrinkle treatment. Today, no severe or long-term side effects have been reported in esthetics. This article discusses only the most frequent locoregional effects. They are rare, moderate, transitory, and totally reversible. Properly informing and selecting patients will contribute to successfully preventing and managing these effects.

A prospective, split-face, double-blinded, randomized study of the efficacy and safety of a fractional 1064-nm Q-switched Nd:YAG laser for photoaging-associated mottled pigmentation in Asian skin.

PubMed

Won, Kwang Hee; Lee, Sang Hyung; Lee, Mi Hye; Rhee, Do-Young; Yeo, Un-Cheol; Chang, Sung Eun

2016-11-01

Laser toning using low-fluence 1064-nm Q-switched neodymium-doped yttrium aluminum laser (QSNY) has gained popularity in the treatment of photoaging-associated mottled pigmentation (PMP). However, hypopigmentation or lack of efficacy has been reported depending on the fluences used. To compare a novel fractional 1064-nm QSNY with conventional 1064-nm QSNY for the treatment of photoaging-associated mottled pigmentary lesions except epidermal lesions of lentigines and freckles through a randomized, split-face, double-blind study. Thirteen Asian women were treated every week for 6 weeks with fractional 1064-nm QSNY on one side of the face and conventional 1064-nm QSNY on the other side. We evaluated the pigmentation area and severity index (PSI), melanin index, erythema index, and the patient's global assessment of improvement. At three months post-treatment, the PSI score improved compared with baseline, by 14.48% on the conventional 1064-nm QSNY side and 21.81% on the fractional 1064-nm QSNY side. Both groups showed improvements in the melanin index. Both fractional 1064-nm QSNY and strictly low-fluence conventional 1064-nm QSNY are moderately effective against PMP and other photoaging signs. Fractional laser toning shows better subjective outcomes than conventional toning.

Immunological Effects of Conventional Chemotherapy and Targeted Anticancer Agents.

PubMed

Galluzzi, Lorenzo; Buqué, Aitziber; Kepp, Oliver; Zitvogel, Laurence; Kroemer, Guido

2015-12-14

The tremendous clinical success of checkpoint blockers illustrates the potential of reestablishing latent immunosurveillance for cancer therapy. Although largely neglected in the clinical practice, accumulating evidence indicates that the efficacy of conventional and targeted anticancer agents does not only involve direct cytostatic/cytotoxic effects, but also relies on the (re)activation of tumor-targeting immune responses. Chemotherapy can promote such responses by increasing the immunogenicity of malignant cells, or by inhibiting immunosuppressive circuitries that are established by developing neoplasms. These immunological "side" effects of chemotherapy are desirable, and their in-depth comprehension will facilitate the design of novel combinatorial regimens with improved clinical efficacy. Copyright © 2015 Elsevier Inc. All rights reserved.

The Prodrug 4-Chlorokynurenine Causes Ketamine-Like Antidepressant Effects, but Not Side Effects, by NMDA/GlycineB-Site Inhibition

PubMed Central

Zanos, Panos; Piantadosi, Sean C.; Wu, Hui-Qiu; Pribut, Heather J.; Dell, Matthew J.; Can, Adem; Snodgrass, H. Ralph; Zarate, Carlos A.; Schwarcz, Robert

2015-01-01

Currently approved antidepressant drug treatment typically takes several weeks to be effective. The noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist ketamine has shown efficacy as a rapid-acting treatment of depression, but its use is associated with significant side effects. We assessed effects following blockade of the glycineB co-agonist site of the NMDA receptor, located on the GluN1 subunit, by the selective full antagonist 7-chloro-kynurenic acid (7-Cl-KYNA), delivered by systemic administration of its brain-penetrant prodrug 4-chlorokynurenine (4-Cl-KYN) in mice. Following administration of 4-Cl-KYN, 7-Cl-KYNA was promptly recovered extracellularly in hippocampal microdialysate of freely moving animals. The behavioral responses of the animals were assessed using measures of ketamine-sensitive antidepressant efficacy (including the 24-hour forced swim test, learned helplessness test, and novelty-suppressed feeding test). In these tests, distinct from fluoxetine, and similar to ketamine, 4-Cl-KYN administration resulted in rapid, dose-dependent and persistent antidepressant-like effects following a single treatment. The antidepressant effects of 4-Cl-KYN were prevented by pretreatment with glycine or the α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist 2,3-dihydroxy-6-nitro-7-sulfamoyl-benzo[f]quinoxaline-2,3-dione (NBQX). 4-Cl-KYN administration was not associated with the rewarding and psychotomimetic effects of ketamine, and did not induce locomotor sensitization or stereotypic behaviors. Our results provide further support for antagonism of the glycineB site for the rapid treatment of treatment-resistant depression without the negative side effects seen with ketamine or other channel-blocking NMDA receptor antagonists. PMID:26265321

The Prodrug 4-Chlorokynurenine Causes Ketamine-Like Antidepressant Effects, but Not Side Effects, by NMDA/GlycineB-Site Inhibition.

PubMed

Zanos, Panos; Piantadosi, Sean C; Wu, Hui-Qiu; Pribut, Heather J; Dell, Matthew J; Can, Adem; Snodgrass, H Ralph; Zarate, Carlos A; Schwarcz, Robert; Gould, Todd D

2015-10-01

Currently approved antidepressant drug treatment typically takes several weeks to be effective. The noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist ketamine has shown efficacy as a rapid-acting treatment of depression, but its use is associated with significant side effects. We assessed effects following blockade of the glycineB co-agonist site of the NMDA receptor, located on the GluN1 subunit, by the selective full antagonist 7-chloro-kynurenic acid (7-Cl-KYNA), delivered by systemic administration of its brain-penetrant prodrug 4-chlorokynurenine (4-Cl-KYN) in mice. Following administration of 4-Cl-KYN, 7-Cl-KYNA was promptly recovered extracellularly in hippocampal microdialysate of freely moving animals. The behavioral responses of the animals were assessed using measures of ketamine-sensitive antidepressant efficacy (including the 24-hour forced swim test, learned helplessness test, and novelty-suppressed feeding test). In these tests, distinct from fluoxetine, and similar to ketamine, 4-Cl-KYN administration resulted in rapid, dose-dependent and persistent antidepressant-like effects following a single treatment. The antidepressant effects of 4-Cl-KYN were prevented by pretreatment with glycine or the α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor antagonist 2,3-dihydroxy-6-nitro-7-sulfamoyl-benzo[f]quinoxaline-2,3-dione (NBQX). 4-Cl-KYN administration was not associated with the rewarding and psychotomimetic effects of ketamine, and did not induce locomotor sensitization or stereotypic behaviors. Our results provide further support for antagonism of the glycineB site for the rapid treatment of treatment-resistant depression without the negative side effects seen with ketamine or other channel-blocking NMDA receptor antagonists. Copyright © 2015 by The American Society for Pharmacology and Experimental Therapeutics.

'Bright side' and 'dark side' hypomania are associated with differences in psychological functioning, sleep and physical activity in a non-clinical sample of young adults.

PubMed

Brand, Serge; Gerber, Markus; Pühse, Uwe; Holsboer-Trachsler, Edith

2011-06-01

No research has yet focused on hypomanic states in non-clinical early adult populations. The aim of the present study was therefore to assess hypomania in a large non-clinical sample of young adults. A total of 862 participants (639 females and 223 males; mean age: M=24.67; SD=5.91) took part in the study. They completed a series of validated self-report questionnaires assessing hypomania (HCL-32) and other aspects of psychological functioning, sleep, stress, quality of life, cognitive-emotional elaboration of pain, self-efficacy, and physical activity. Based on the HCL-32, 19% of the participants (n=169) were categorized as currently being in a hypomanic state. Of those, 57.6% were classified as "active/elated" ('bright side'), whereas 42.4% were classified as "irritable/risk-taking" ('dark side'). Compared to non-hypomanic participants and the 'bright side' group, 'dark side' hypomanic participants reported more depressive symptoms, sleep disturbances, somatic complaints, perceived stress, negative coping strategies, and lower self-efficacy. By contrast, 'bright side' hypomanic participants had lower stress scores, more positive self-instructions, and higher levels of exploration, self-efficacy, and physical activity. A cross-sectional design was adopted, assessing university students, who may not be representative of the stage of early adulthood. The present results underscore the notion of a continuity between a mood state and both favorable ('bright side') and unfavorable ('dark side') hypomanic states. In early adulthood, 'bright' and 'dark side' hypomania differs with respect to physical activity, psychological functioning and sleep. Copyright © 2010 Elsevier B.V. All rights reserved.

Glycolic acid peels versus salicylic-mandelic acid peels in active acne vulgaris and post-acne scarring and hyperpigmentation: a comparative study.

PubMed

Garg, Vijay Kumar; Sinha, Surabhi; Sarkar, Rashmi

2009-01-01

Many clinicians have used glycolic acid (GA) peels for facial acne, scarring, and hyperpigmentation, mainly in lighter skin types. Salicylic-mandelic acid combination peels (SMPs) are a newer modality, and there have been no well-controlled studies comparing them with other conventional agents. To compare the therapeutic efficacy and tolerability of 35% GA peels and 20% salicylic-10% mandelic acid peels in active acne and post-acne scarring and hyperpigmentation. Forty-four patients with facial acne and post-acne scarring and hyperpigmentation were divided into two groups, with one receiving GA peels and the other SMPs at fortnightly intervals for six sessions. The treating physician performed objective evaluation of treatment outcomes. The patients, the treating physician, and an independent observer made subjective assessments. Side effects of both agents were also noted. Both the agents were effective, but SMPs had a higher efficacy for most active acne lesions (p<.001) and hyperpigmentation (p<.001). Side effects were also lesser with SMPs. Both the agents were effective and safe in Indian patients, with SMPs being better for active acne and post-acne hyperpigmentation.

A Teacher's Guide to Using Extinction in School Settings

ERIC Educational Resources Information Center

Burt, Jonathan L.; Pennington, Robert C.

2017-01-01

The use of extinction procedures or the discontinuation of reinforcement following a behavior targeted for reduction is often used to enhance the efficacy of behavioral interventions. Unfortunately, the application of extinction procedures is associated with several side effects that can produce potentially harmful and counterproductive outcomes.…

Saw palmetto for prostate disorders.

PubMed

Gordon, Andrea E; Shaughnessy, Allen F

2003-03-15

Saw palmetto is an herbal product used in the treatment of symptoms related to benign prostatic hyperplasia. The active component is found in the fruit of the American dwarf palm tree. Studies have demonstrated the effectiveness of saw palmetto in reducing symptoms associated with benign prostatic hyperplasia. Saw palmetto appears to have efficacy similar to that of medications like finasteride, but it is better tolerated and less expensive. There are no known drug interactions with saw palmetto, and reported side effects are minor and rare. No data on its long-term usage are available. The herbal product also has been used to treat chronic prostatitis, but currently there is no evidence of its efficacy.

[A comparative evaluation of the efficacy of magneto- and laser therapy in patients with osteoarthrosis deformans].

PubMed

Selivonenko, V G; Syvolap, V D; Porada, L V; Medvedeva, V N; Boev, S S; Morozov, A I; Slin'ko, V G; Berest, S M; Garbuz, L N; Sholokh, S G

1997-01-01

A comparative evaluation of efficacy of magneto- and laser therapy was carried out in 82 patients with osteoarthrosis deformans. The magnetic field and laser irradiation dispelled the pain syndrome and synovitis manifestations. It is recommendable that the multiple-modality therapy of patients with osteoarthrosis deformans should involve magneto- and laser therapy (15 to 20 procedures per one course) that improve results of the treatment being received and allow the time of hospitalization to be reduced at an average by 5 bed-days. Laser appeared to be a very effective mode of treatment. No unfavourable side effects were recordable.

Motives of Dutch men who have sex with men for daily and intermittent HIV pre-exposure prophylaxis usage and preferences for implementation: A qualitative study.

PubMed

Bil, Janneke P; van der Veldt, Wendy M; Prins, Maria; Stolte, Ineke G; Davidovich, Udi

2016-09-01

Although PrEP is not yet registered in Europe, including the Netherlands, its approval and implementation are expected in the near future. To inform future pre-exposure prophylaxis (PrEP) implementation, this study aimed to gain insight into motives and preferences for daily or intermittent PrEP use among Dutch HIV-negative men having sex with men (MSM).Between February and December 2013, semistructured interviews were conducted until data saturation was reached (N = 20). Interviews were analyzed using the Grounded Theory approach.Motives for (not) using daily PrEP were based on beliefs about PrEP efficacy and side effects, preferences for other prevention strategies, self-perceived HIV risk, self-perceived efficacy of PrEP adherence, beliefs about possible benefits (e.g., anxiety reduction, sex life improvement), and barriers of PrEP use (e.g., costs, monitoring procedures). The perceived benefits of intermittent versus daily PrEP use were the lower costs and side effects and the lower threshold to decision to start using intermittent PrEP. Barriers of intermittent PrEP versus daily PrEP use were the perceived need to plan their sex life and adhere to multiple prevention strategies. Although some perceived PrEP as a condom substitute, others were likely to combine PrEP and condoms for sexually transmitted infections (STI) prevention and increased HIV protection. Participants preferred PrEP service locations to have specialized knowledge of HIV, antiretroviral therapy, sexual behavior, STIs, patients' medical background, be easily approachable, be able to perform PrEP follow-up monitoring, and provide support.To maximize the public health impact of PrEP, ensuring high uptake among MSM at highest risk is important. Therefore, targeted information about PrEP efficacy and side effects need to be developed, barriers for accessing PrEP services should be minimized, and perceived self-efficacy to use PrEP should be addressed and improved. To prevent increases in STIs, condom use should be monitored and PrEP should be integrated into routine STI screening and counseling.

Motives of Dutch men who have sex with men for daily and intermittent HIV pre-exposure prophylaxis usage and preferences for implementation

PubMed Central

Bil, Janneke P.; van der Veldt, Wendy M.; Prins, Maria; Stolte, Ineke G.; Davidovich, Udi

2016-01-01

Abstract Although PrEP is not yet registered in Europe, including the Netherlands, its approval and implementation are expected in the near future. To inform future pre-exposure prophylaxis (PrEP) implementation, this study aimed to gain insight into motives and preferences for daily or intermittent PrEP use among Dutch HIV-negative men having sex with men (MSM). Between February and December 2013, semistructured interviews were conducted until data saturation was reached (N = 20). Interviews were analyzed using the Grounded Theory approach. Motives for (not) using daily PrEP were based on beliefs about PrEP efficacy and side effects, preferences for other prevention strategies, self-perceived HIV risk, self-perceived efficacy of PrEP adherence, beliefs about possible benefits (e.g., anxiety reduction, sex life improvement), and barriers of PrEP use (e.g., costs, monitoring procedures). The perceived benefits of intermittent versus daily PrEP use were the lower costs and side effects and the lower threshold to decision to start using intermittent PrEP. Barriers of intermittent PrEP versus daily PrEP use were the perceived need to plan their sex life and adhere to multiple prevention strategies. Although some perceived PrEP as a condom substitute, others were likely to combine PrEP and condoms for sexually transmitted infections (STI) prevention and increased HIV protection. Participants preferred PrEP service locations to have specialized knowledge of HIV, antiretroviral therapy, sexual behavior, STIs, patients’ medical background, be easily approachable, be able to perform PrEP follow-up monitoring, and provide support. To maximize the public health impact of PrEP, ensuring high uptake among MSM at highest risk is important. Therefore, targeted information about PrEP efficacy and side effects need to be developed, barriers for accessing PrEP services should be minimized, and perceived self-efficacy to use PrEP should be addressed and improved. To prevent increases in STIs, condom use should be monitored and PrEP should be integrated into routine STI screening and counseling. PMID:27684827

Challenges of the pharmacological management of benzodiazepine withdrawal, dependence, and discontinuation

PubMed Central

Revadigar, Neelambika; Manobianco, Brittany E.

2018-01-01

Background: Benzodiazepines (BZDs) are among the most prescribed sedative hypnotics and among the most misused and abused medications by patients, in parallel with opioids. It is estimated that more than 100 million Benzodiazepine (BZD) prescriptions were written in the United States in 2009. While medically useful, BZDs are potentially dangerous. The co-occurring abuse of opioids and BZD, as well as increases in BZD abuse, tolerance, dependence, and short- and long-term side effects, have prompted a worldwide discussion about the challenging aspects of medically managing the discontinuation of BZDs. Abrupt cessation can cause death. This paper addresses the challenges of medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse and associated medical complications. The focus of this review is on the challenges of several medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse, and associated medical complications. Methods: An electronic search was performed of Medline, Worldwide Science, Directory of Open Access Journals, Embase, Cochrane Library, Google Scholar, PubMed Central, and PubMed from 1990 to 2017. The review includes double-blind, placebo-controlled studies for the most part, open-label pilot studies, and animal studies, in addition to observational research. We expand the search to review articles, naturalistic studies, and to a lesser extent, letters to the editor/case reports. We exclude abstract and poster presentations, books, and book chapters. Results: The efficacy of these medications is not robust. While some of these medicines are relatively safe to use, some of them have a narrow therapeutic index, with severe, life-threatening side effects. Randomized studies have been limited. There is a paucity of comparative research. The review has several limitations. The quality of the documents varies according to whether they are randomized studies, nonrandomized studies, naturalistic studies, pilot studies, letters to the editors, or case reports. Conclusions: The use of medications for the discontinuation of BZDs seems appropriate. It is a challenge that requires further investigation through randomized clinical trials to maximize efficacy and to minimize additional risks and side effects. PMID:29713452

Challenges of the pharmacological management of benzodiazepine withdrawal, dependence, and discontinuation.

PubMed

Fluyau, Dimy; Revadigar, Neelambika; Manobianco, Brittany E

2018-05-01

Benzodiazepines (BZDs) are among the most prescribed sedative hypnotics and among the most misused and abused medications by patients, in parallel with opioids. It is estimated that more than 100 million Benzodiazepine (BZD) prescriptions were written in the United States in 2009. While medically useful, BZDs are potentially dangerous. The co-occurring abuse of opioids and BZD, as well as increases in BZD abuse, tolerance, dependence, and short- and long-term side effects, have prompted a worldwide discussion about the challenging aspects of medically managing the discontinuation of BZDs. Abrupt cessation can cause death. This paper addresses the challenges of medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse and associated medical complications. The focus of this review is on the challenges of several medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse, and associated medical complications. An electronic search was performed of Medline, Worldwide Science, Directory of Open Access Journals, Embase, Cochrane Library, Google Scholar, PubMed Central, and PubMed from 1990 to 2017. The review includes double-blind, placebo-controlled studies for the most part, open-label pilot studies, and animal studies, in addition to observational research. We expand the search to review articles, naturalistic studies, and to a lesser extent, letters to the editor/case reports. We exclude abstract and poster presentations, books, and book chapters. The efficacy of these medications is not robust. While some of these medicines are relatively safe to use, some of them have a narrow therapeutic index, with severe, life-threatening side effects. Randomized studies have been limited. There is a paucity of comparative research. The review has several limitations. The quality of the documents varies according to whether they are randomized studies, nonrandomized studies, naturalistic studies, pilot studies, letters to the editors, or case reports. The use of medications for the discontinuation of BZDs seems appropriate. It is a challenge that requires further investigation through randomized clinical trials to maximize efficacy and to minimize additional risks and side effects.

Pharmacokinetics of Intranasal Scopolamine Gel Formulation (Inscop)

NASA Technical Reports Server (NTRS)

Boyd, Jason L.; Du, Brian; Daniels, Vernie; Simmons, Rita; Buckey, Jay; Putcha, Lakshmi

2009-01-01

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during early flight days of space missions. Orally administered scopolamine is commonly used by astronauts to prevent SMS. Bioavailability of oral (PO) SMS medications is often low and highly variable. Intranasal (IN) administration of medications achieves higher and more reliable bioavailability than from an equivalent PO dose. Methods: To test the safety and reliability of INSCOP, two clinical studies were performed, a dose escalation study and a comparison study administering INSCOP during normal ambulation and head down tilt bedrest. Efficacy was evaluated by testing INSCOP with two, different motion sickness inducing paradigms. Results: Preliminary results indicate that INSCOP demonstrates linear pharmacokinetics and a low side effect profile. In head down tilt bedrest, relative bioavailability of INSCOP was increased for females at both doses (0.2 and 0.4 mg) and for males at the higher dose (0.4 mg) but is reduced at the lower dose (0.2 mg) compared to normal ambulation. INSCOP displays gender specific differences during ABR. One of the treatment efficacy trials conducted at Dartmouth Hitchcock Medical Center demonstrated that INSCOP is efficacious at both doses (0.2 and 0.4 mg) in suppressing motion sickness symptoms as indicated by longer chair ride times with INSCOP administration than with placebo, and efficacy increases with dose. Similar results were seen using another motion sickness simulator, the motion simulator dome, at the Naval Aerospace Medical Research Laboratory, with significantly increased time in the dome in motion-susceptible subjects when using INSCOP compared to untreated controls. Conclusion: Higher bioavailability, linear pharmacokinetics, a low incidence of side effects, and a favorable efficacy profile make INSCOP a desirable formulation for prophylactic and rescue treatment of astronauts in space and military personnel on duty.

Updates on the role of adrenal steroidogenesis inhibitors in Cushing's syndrome: a focus on novel therapies.

PubMed

Fleseriu, Maria; Castinetti, Frederic

2016-12-01

Endogenous Cushing's syndrome (CS) is a rare disease that results from exposure to high levels of cortisol; Cushing's disease (CD) is the most frequent form of CS. Patients with CS suffer from a variety of comorbidities that increase the risk of mortality. Surgical resection of the disease-causing lesion is generally the first-line treatment of CS. However, some patients may not be eligible for surgery due to comorbidities, and approximately 25 % of patients, especially those with CD, have recurrent disease. For these patients, adrenal steroidogenesis inhibitors may control cortisol elevation and subsequent symptomatology. CS is rare overall, and clinical studies of adrenal steroidogenesis inhibitors are often small and, in many cases, data are limited regarding the efficacy and safety of these treatments. Our aim was to better characterize the profiles of efficacy and safety of currently available adrenal steroidogenesis inhibitors, including drugs currently in development. We performed a systematic review of the literature regarding adrenal steroidogenesis inhibitors, focusing on novel drugs. Currently available adrenal steroidogenesis inhibitors, including ketoconazole, metyrapone, etomidate, and mitotane, have variable efficacy and significant side effects, and none are approved by the US Food and Drug Administration for CS. Therefore, there is a clear need for novel, prospectively studied agents that have greater efficacy and a low rate of adverse side effects. Efficacy and safety data of current and emerging adrenal steroidogenesis inhibitors, including osilodrostat (LCI699) and levoketoconazole (COR-003), show promising results that will have to be confirmed in larger-scale phase 3 studies (currently ongoing). The management of CS, and particularly CD, remains challenging. Adrenal steroidogenesis inhibitors can be of major interest to control the hypercortisolism at any time point, either before or after surgery, as discussed in this review.

Calcium channel blockers: spectrum of side effects and drug interactions.

PubMed

Hedner, T

1986-01-01

Calcium antagonists are a chemically heterogenous group of agents with potent cardiovascular effects which are beneficial in the treatment of angina pectoris, arterial hypertension and cardiac arrhythmias. The main side effects for the group are dose-dependent and the result of the main action or actions of the calcium antagonists, i.e. vasodilatation, negative inotropic effects and antiarrhythmic effects. Pronounced hypotension is reported for the main calcium antagonist drugs; verapamil, diltiazem and nifedipine. While conduction disturbances and bradycardia are seen more often after verapamil and diltiazem, tachycardia, headache and flush are more frequent after nifedipine. Constipation is relatively frequent after verapamil while nifedipine is reported to induce diarrhea in som patients. Idiosyncratic side effects are rare but have been reported from the skin, mouth, musculoskeletal system, the liver and the central nervous system. These side effects include urticarial rashes, gingival hyperplasia, arthralgia, hepathotoxicity and transistory mental confusion or akathisia. Verapamil, diltiazem and possibly also nifedipine have been reported to increase serum digoxin concentrations but the clinical relevance of these drug interactions are not clear. Furthermore, verapamil and diltiazem may potentiate the effects of beta-adrenergic blocking drugs and verapamil may also potentiate the effects of neuromuscular blocking drugs. It is concluded that side effects after calcium antagonist drugs are mostly trivial and transient although they may sometimes be relatively common. Clinically relevant drug interactions are few. Judged from the point of efficacy and safety, calcium antagonists will have a major place in the future pharmacotherapy of several cardiovascular disorders.

Efficacy of functional microarray of microneedles combined with topical tranexamic acid for melasma: A randomized, self-controlled, split-face study.

PubMed

Xu, Yang; Ma, Renyan; Juliandri, Juliandri; Wang, Xiaoyan; Xu, Bai; Wang, Daguang; Lu, Yan; Zhou, Bingrong; Luo, Dan

2017-05-01

To evaluate the efficacy of a functional microarray of microneedles (MNs) plus topical tranexamic acid (TA) for melasma in middle-aged women in China.Thirty female subjects with melasma were enrolled in this study. The left or right side of the face was chosen randomly to be pretreated with a functional microarray of MNs, followed by topical 0.5% TA solution once per week for 12 weeks. The other half-face was the control, treated with a sham device plus topical 0.5% TA solution. At baseline and at weeks 4, 8, and 12 of treatment, clinical (photographic) evaluations and parameters determined by Visia were recorded. At baseline and week 12, patient satisfaction scores and the biophysical parameters measured by Mexameter were also recorded. Side effects were evaluated at baseline and at the end of the 12 weeks.In total, 28 women (93.3%) completed the study. The brown spots' scores measured by Visia were significantly lower on the combined therapy side than on the control side at 12 weeks after starting treatment; there was no significant difference between sides at 4 or 8 weeks. After 12 weeks, melanin index (MI) decreased significantly in both 2 groups, and the MI was significantly less on the combined side at week 12. Transepidermal water loss, roughness, skin hydration, skin elasticity, and erythema index showed no significant differences between 2 sides at baseline, 4, 8, and 12 weeks after treatment. Physicians' evaluations of photographs showed better results at week 12 with combined therapy: >25% improvement was observed in the MNs plus TA side in 25 patients, and in the TA side in only 10 patients. Subjective satisfaction scores on both sides increased significantly. The participants were more satisfied with the results of the combined therapy side than the control side. No obvious adverse reactions were observed throughout the study.Combined therapy with a functional microarray of MNs and topical TA solution is a promising treatment for melasma.

Clinically insubstantial cognitive side effects of bitemporal electroconvulsive therapy at 0.5 msec pulse width.

PubMed

Warnell, Ronald L; Swartz, Conrad M; Thomson, Alice

2011-11-01

We measured cognitive side effects from bitemporal electroconvulsive therapy (ECT) using stimuli of 0.5 msec pulse width 900 milliamperes (mA). Mini-Mental State Exam (MMSE) and 21-item Hamilton Rating Scale for Depression (HRSD-21) were rated within 36 hours before and 36 hours after a series of 6 bitemporal ECT sessions on 15 patients age ≥45. MMSE remained high after ECT (pre-ECT mean 29, standard deviation [SD] 1.60, post-ECT mean 28.53, SD 1.36) with no significant change. The mean HRSD-21 fell from 27.5 to 16.3. Post-ECT MMSE was significantly and markedly higher than in previous studies of bitemporal ECT; all had used ECT stimuli of pulse width at least 1 msec. With stimuli of 0.5 msec pulse width and 900 mA, 6 bitemporal ECTs did not decrease MMSE score. This result leaves no opportunity for further decrease in basic cognitive side effects, and complements published reports of stronger physiological effects with stimuli of 0.5 msec pulse width and 900 mA. ECT stimuli of 0.5 msec pulse width and 900 mA are more desirable than wider pulse widths. Six bitemporal ECT sessions using these stimuli generally will not have more cognitive side effects than treatments with other placements, allowing maintenance of full efficacy with clinically insubstantial side effects.

Propranolol in Treatment of Huge and Complicated Infantile Hemangiomas in Egyptian Children

PubMed Central

Hassan, Basheir A.; Shreef, Khalid S.

2014-01-01

Background. Infantile hemangiomas (IHs) are the most common benign tumours of infancy. Propranolol has recently been reported to be a highly effective treatment for IHs. This study aimed to evaluate the efficacy and side effects of propranolol for treatment of complicated cases of IHs. Patients and Methods. This prospective clinical study included 30 children with huge or complicated IHs; their ages ranged from 2 months to 1 year. They were treated by oral propranolol. Treatment outcomes were clinically evaluated. Results. Superficial cutaneous hemangiomas began to respond to propranolol therapy within one to two weeks after the onset of treatment. The mean treatment period that was needed for the occurrence of complete resolution was 9.4 months. Treatment with propranolol was well tolerated and had few side effects. No rebound growth of the tumors was noted when propranolol dosing stopped except in one case. Conclusion. Propranolol is a promising treatment for IHs without obvious side effects. However, further studies with longer follow-up periods are needed. PMID:24899888

Propranolol in treatment of huge and complicated infantile hemangiomas in egyptian children.

PubMed

Hassan, Basheir A; Shreef, Khalid S

2014-01-01

Background. Infantile hemangiomas (IHs) are the most common benign tumours of infancy. Propranolol has recently been reported to be a highly effective treatment for IHs. This study aimed to evaluate the efficacy and side effects of propranolol for treatment of complicated cases of IHs. Patients and Methods. This prospective clinical study included 30 children with huge or complicated IHs; their ages ranged from 2 months to 1 year. They were treated by oral propranolol. Treatment outcomes were clinically evaluated. Results. Superficial cutaneous hemangiomas began to respond to propranolol therapy within one to two weeks after the onset of treatment. The mean treatment period that was needed for the occurrence of complete resolution was 9.4 months. Treatment with propranolol was well tolerated and had few side effects. No rebound growth of the tumors was noted when propranolol dosing stopped except in one case. Conclusion. Propranolol is a promising treatment for IHs without obvious side effects. However, further studies with longer follow-up periods are needed.

Airway compromise secondary to vagus nerve stimulator: case report and implications for otolaryngologists.

PubMed

Bhatt, Y M; Hans, P S; Belloso, A

2010-05-01

Vagus nerve stimulators are devices used in the management of patients with drug-refractory epilepsy unsuitable for resective or disconnective surgery. Implanted usually by neurosurgeons, these devices are infrequently encountered by otolaryngologists. Despite significant anti-seizure efficacy, side effects related to laryngopharyngeal stimulation are not uncommon. A 28-year-old man with a history of effective vagus nerve stimulator use presented with a cluster of seizures and respiratory distress associated with intermittent stridor. The duration of stridor corresponded to the period of vagus nerve stimulation. Endoscopy revealed forced adduction of the left vocal fold against a medialised right vocal fold. The device was switched off and the stridor immediately resolved. Airway compromise is an under-recognised side effect of vagus nerve stimulation. We describe the first known case of stridor and contralateral vocal fold palsy in a vagus nerve stimulator user. We highlight the need for better understanding amongst otolaryngologists of the laryngopharyngeal side effects of this technology.

Advances in the management of insomnia

PubMed Central

Bishop, Todd M.; Marcus, Jonathan A.

2014-01-01

Insomnia is highly prevalent and associated with considerable morbidity. Several very efficacious treatments, both pharmacologic and non-pharmacologic, exist for the management of insomnia. New modes of delivery and new formulations of existing sedative-hypnotic medications have been introduced. Novel agents are still being developed and tested to arrive at a hypnotic that has limited side effects while still being efficacious. Innovations with respect to behavioral interventions, which are drastically under-utilized, have focused mainly on making these interventions more widely available through dissemination efforts, briefer formats and more accessible platforms. PMID:24991425

Rush immunotherapy for wasp venom allergy seems safe and effective in patients with mastocytosis.

PubMed

Verburg, M; Oldhoff, J M; Klemans, R J B; Lahey-de Boer, A; de Bruin-Weller, M S; Röckmann, H; Sanders, C; Bruijnzeel-Koomen, C A F M; Pasmans, S G M A; Knulst, A C

2015-11-01

Patients with mastocytosis and wasp venom allergy (WA) may benefit from venom immunotherapy (VIT). However, fatal insect sting reactions have been described in mastocytosis patients despite previous immunotherapy. We investigated the safety and efficacy of (rush) VIT in patients with mastocytosis and WA. To investigate the safety and efficacy of (rush) VIT in patients with mastocytosis and WA. We describe nine patients with cutaneous mastocytosis and WA who received VIT. Cutaneous mastocytosis was confirmed by histopathology and systemic mastocytosis was diagnosed according to World Health Organization criteria. VIT was given according to a rush protocol. Given the difference in safety and efficacy of VIT in patients with WA and honeybee venom allergy, we reviewed the literature for VIT with the focus on WA patients with mastocytosis and addressed the difference between patients with cutaneous versus systemic mastocytosis. Nine patients had WA and mastocytosis, of whom six had cutaneous mastocytosis, two combined cutaneous and systemic mastocytosis and one systemic mastocytosis. All patients received rush IT with wasp venom. Most patients had only mild local side effects, with no systemic side effects during the course of VIT. One patient had a systemic reaction upon injection on one occasion, during the updosing phase, with dyspnoea and hypotension, but responded well to treatment. Immunotherapy was continued after temporary dose adjustment without problems. Two patients with a previous anaphylactic reaction were re-stung, without any systemic effects. VIT is safe in cutaneous mastocytosis patients with WA, while caution has to be made in case of systemic mastocytosis. VIT was effective in the patients who were re-stung.

A phase III, randomized, double-blind, matched-pairs, active-controlled clinical trial and preclinical animal study to compare the durability, efficacy and safety between polynucleotide filler and hyaluronic acid filler in the correction of crow's feet: a new concept of regenerative filler.

PubMed

Pak, Chang Sik; Lee, Jongho; Lee, Hobin; Jeong, Jaehoon; Kim, Eun-Hee; Jeong, Jinwook; Choi, Hyeyeon; Kim, Byunghwi; Oh, Sujin; Kim, Iksoo; Heo, Chan Yeong

2014-11-01

The Rejuran® is a new filler product made from purified polynucleotides. Here we present data from an animal study and a clinical trial to examine the durability, efficacy and safety of the Rejuran® on crow's feet. For the animal study, 25 mice were divided into three groups: Group 1 received phosphate buffered saline (PBS); Group 2 were treated with Yvoire®; and Group 3 were treated with Rejuran®. The durability and efficacy of each treatment were assessed by microscopy and staining. In the clinical trial, 72 patients were randomized to receive Rejuran® treatment for crow's feet on one side and Yvoire-Hydro® on the contralateral side, at a ratio of 1:1. Repeated treatments were performed every two weeks for a total of three times, over a total of 12 weeks' observation. All injections and observations of efficacy and safety were performed by the same two investigators. In the animal study, the Rejuran® group showed similar durability and inflammatory response to the Yvoire® group. Upon efficacy assessment, the Rejuran® group showed the greatest elasticity and collagen composition, and a significant difference in skin surface roughness and wrinkle depth. In the clinical trial, the primary and secondary objective efficacy outcome measure showed no statistical significance between the two groups, and in safety outcomes there were no unexpected adverse effects. Our data suggest that the Rejuran®, as a new regenerative filler, can be useful to reduce wrinkles, by showing evidence for its efficacy and safety.

Agomelatine versus Sertraline: An Observational, Open-labeled and 12 Weeks Follow-up Study on Efficacy and Tolerability

PubMed Central

Akpınar, Esma; Cerit, Cem; Talas, Anıl; Tural, Ümit

2016-01-01

Objective In this open-labeled, 12 weeks follow-up study, we aimed to compare the efficacy and tolerability of agomelatine with sertraline Methods The outpatients of adult psychiatry clinic who have a new onset of depression and diagnosed as ‘major depressive episode’ by clinician according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition and prescribed agomelatine (25 mg/day) or sertraline (50 mg/day) were included in the study. Results The decline of mean Montgomery-Asberg Depression Rating Scale (MADRS) scores of agomelatine group was significantly higher than the sertraline group at the end of 2nd week; however, the difference was not significant at the end of 3 months. Mean Clinical Global Impression-Improvement scale (CGI-I) scores of agomelatine group was lower than sertraline group at first week. Mean CGI-Severity scale and CGI-I scores were favour to sertraline group at the end of the study. Remission rates were 46.7% for sertraline group and 33.3% for agomelatine group while response rates were 76.7% for both groups. Any patient from agomelatine group dropped-out due to adverse effects. The amount of side effects was also less with agomelatine. Conclusion Agomelatine has a rapid onset efficacy on depressive symptoms and this can be beneficial for some critical cases. Considering MADRS scores, agomelatine seems to have similar efficacy with sertraline but we also point the need for long term studies since CGI scores were favour to sertraline group at the end of the study. Agomelatine has a favourable tolerability profile both in terms of discontinuation and the amount of side effects compared to sertraline. PMID:27776387

Ablative skin resurfacing.

PubMed

Agrawal, Nidhi; Smith, Greg; Heffelfinger, Ryan

2014-02-01

Ablative laser resurfacing has evolved as a safe and effective treatment for skin rejuvenation. Although traditional lasers were associated with significant thermal damage and lengthy recovery, advances in laser technology have improved safety profiles and reduced social downtime. CO2 lasers remain the gold standard of treatment, and fractional ablative devices capable of achieving remarkable clinical improvement with fewer side effects and shorter recovery times have made it a more practical option for patients. Although ablative resurfacing has become safer, careful patient selection and choice of suitable laser parameters are essential to minimize complications and optimize outcomes. This article describes the current modalities used in ablative laser skin resurfacing and examines their efficacy, indications, and possible side effects. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Comparison of efficacy of once daily multimatrix mesalazine 2.4 g/day and 4.8 g/day with other 5-aminosalicylic acid preparation in active ulcerative colitis: a randomized, double-blind study

PubMed Central

Yokoyama, Tadashi; Mizushima, Seiichi; Hagino, Atsushi; Hibi, Toshifumi

2018-01-01

Background/Aims This study compared the efficacy of multimatrix mesalazine 2.4 g/day and 4.8 g/day with controlled-release mesalazine 2.25 g/day. Methods In this multicenter, randomized, double-blind study, 251 patients with mildly to moderately active ulcerative colitis received multimatrix mesalazine 2.4 g/day once daily (Multimatrix-2.4), 4.8 g/day once daily (Multimatrix-4.8), or controlled-release (time-dependent) mesalazine 2.25 g/day 3 times daily (Time-2.25) for 8 weeks. The primary efficacy endpoint was the change in the ulcerative colitis-disease activity index (UC-DAI) score. Results The mean change in the UC-DAI score and standard deviation in the per protocol set was −1.9±2.5 for Multimatrix-2.4 and −2.4±2.8 for Time-2.25. The difference between Multimatrix-2.4 and Time-2.25 was 0.3 (two-sided 95% confidence interval [CI], −0.5 to 1.1), thus non-inferiority was not demonstrated based on the pre-defined non-inferiority margin (1.0). In the full analysis set, the difference between Multimatrix-4.8 and Time-2.25 was −1.2 (two-sided 95% CI, −2.0 to −0.5), and the mean change in UC-DAI score in the FAS was −3.3 (two-sided 95% CI, −3.9 to −2.8) for Multimatrix-4.8 and −1.9 (two-sided 95% CI, −2.5 to −1.3) for Multimatrix-2.4, indicating that Multimatrix-4.8 was more effective than Time-2.25 and Multimatrix-2.4. There was no difference among the treatment groups in terms of safety. Conclusions This study showed that the efficacy of multimatrix mesalazine 2.4 g/day was comparable to controlled release mesalazine 2.25 g/day, although non-inferiority was not demonstrated. Importantly, this was the first study to indicate that multimatrix mesalazine 4.8 g/day was more effective than 2.4g/day with no associated safety concerns. PMID:29743838

Acute Pain Service and multimodal therapy for postsurgical pain control: evaluation of protocol efficacy.

PubMed

Moizo, E; Berti, M; Marchetti, C; Deni, F; Albertin, A; Muzzolon, F; Antonino, A

2004-11-01

The institution of a postoperative Acute Pain Control Service is mandatory to improve the control of pain induced by surgical injury. Treatment of postoperative pain may be achieved using a combination of analgesic agents and techniques, reducing the incidence of side effects owing to the lower doses of the individual drugs. In 1997 we established an Acute Pain Service (APS) at the San Raffaele Hospital in Milan. The aim of this study was to assess the efficacy and safety of our APS both in terms of treatment protocols and organisational issues. In this prospective observational study we included 592 patients undergoing abdominal, gynecological, or orthopedic surgery with severe expected pain. According to general guidelines on pain treatment, the patients were assigned to different treatment protocols based on the kind of operation. All protocols were based on the multimodal therapy, with the association of nonsteroidal anti-inflammatory drugs (NSAIDS), opioids and regional anesthesia techniques. During the first 48 h of the postoperative period we recorded vital signs, level of pain and occurrence of any side effect. Our analgesic protocols proved to be effective and safe (low incidence of side effects) for every surgery. The incidence of postoperative nausea and vomiting was higher in patients receiving patient-controlled morphine than that with continuous epidural or nerve block. After lower abdominal surgery, pain at movement at 24 h was significantly lower in the epidural group than in the Patient Control Analgesia group. Nausea and vomiting, numbness and paresthesias at the lower limbs were higher in gynecological patients. A larger percentage of orthopedic patients in the epidural group reported numbness and paresthesias at the lower limbs in comparison with patients receiving continuous peripheral nerve block. In agreement with previous literature, this study confirmed that a multimodal approach to pain treatment provides an adequate control of postoperative pain, minimizing side effects.

Caspofungin in the treatment of invasive fungal infections.

PubMed

Keady, Simon; Thacker, Meera

2006-02-01

Caspofungin is a member of a new class of antifungals called Echinocandins and is the first to have marketing authorisation in the United Kingdom. This article reviews the clinical efficacy, side effect profile, dosing and administration schedule of caspofungin. The article also discusses the warnings and precautions associated with the use of this drug. Caspofungin is an effective treatment option in the management of fungal infections.

Selective blockade of TRPA1 channel attenuates pathological pain without altering noxious cold sensation or body temperature regulation.

PubMed

Chen, Jun; Joshi, Shailen K; DiDomenico, Stanley; Perner, Richard J; Mikusa, Joe P; Gauvin, Donna M; Segreti, Jason A; Han, Ping; Zhang, Xu-Feng; Niforatos, Wende; Bianchi, Bruce R; Baker, Scott J; Zhong, Chengmin; Simler, Gricelda H; McDonald, Heath A; Schmidt, Robert G; McGaraughty, Steve P; Chu, Katharine L; Faltynek, Connie R; Kort, Michael E; Reilly, Regina M; Kym, Philip R

2011-05-01

Despite the increasing interest in TRPA1 channel as a pain target, its role in cold sensation and body temperature regulation is not clear; the efficacy and particularly side effects resulting from channel blockade remain poorly understood. Here we use a potent, selective, and bioavailable antagonist to address these issues. A-967079 potently blocks human (IC(50): 51 nmol/L, electrophysiology, 67 nmol/L, Ca(2+) assay) and rat TRPA1 (IC(50): 101 nmol/L, electrophysiology, 289 nmol/L, Ca(2+) assay). It is >1000-fold selective over other TRP channels, and is >150-fold selective over 75 other ion channels, enzymes, and G-protein-coupled receptors. Oral dosing of A-967079 produces robust drug exposure in rodents, and exhibits analgesic efficacy in allyl isothiocyanate-induced nocifensive response and osteoarthritic pain in rats (ED(50): 23.2 mg/kg, p.o.). A-967079 attenuates cold allodynia produced by nerve injury but does not alter noxious cold sensation in naive animals, suggesting distinct roles of TRPA1 in physiological and pathological states. Unlike TRPV1 antagonists, A-967079 does not alter body temperature. It also does not produce locomotor or cardiovascular side effects. Collectively, these data provide novel insights into TRPA1 function and suggest that the selective TRPA1 blockade may present a viable strategy for alleviating pain without untoward side effects. Copyright © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Five Alzheimer's disease cases with refractory behavioural psychological symptoms of dementia treated with blonanserin.

PubMed

Hamuro, Atsushi; Saito, Satona

2010-12-01

The aim of the present study was to determine the efficacy, side-effects and tolerability of blonanserin for treating refractory behavioural psychological symptoms of dementia (BPSD). The present study was a 12-week, prospective, structured clinical trial of blonanserin for the treatment of BPSD. The degree of cognitive function, activities of daily living score, and the degree of BPSD were determined using the Mini-Mental State Examination (MMSE), Disability Assessment for Dementia (DAD), Neuropsychiatric Inventory (NPI) and the Rating Scale for Aggressive Behaviour in the Elderly (RAGE). The severity of extrapyramidal symptoms was assessed using the Drug-Induced Extrapyramidal Symptoms scale (DIEEPS). Five patients were enrolled. These patients met the NINCDS-ADRDA criteria. The patients were prescribed more than two kinds of existing antipsychotic drugs and were considered refractory cases; the drugs were discontinued because they were ineffectual and side-effects appeared. Each drug was prescribed independently for at least 2 weeks. The mean changes (at baseline and at the last week, respectively) in the MMSE (12.25, 9.25), in the DAD (6.5, 6.75), in the RAGE (5.5, 5.3) and in the DIEEPS (0.5, 1.5) were minimal. The mean changes in the NPI were two or fewer points. Some side-effects (one gait abnormality and one pneumonia) were observed. The results of this preliminary study show that blonanserin does not have adequate efficacy for the treatment of refractory BPSD. © 2010 The Authors. Psychogeriatrics © 2010 Japanese Psychogeriatric Society.

Amifostine reduces side effects and improves complete response rate during radiotherapy: Results of a meta-analysis

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

Sasse, Andre Deeke; Gontijo de Oliveira Clark, Luciana; Sasse, Emma Chen

Purpose: To evaluate the efficacy of amifostine in diminishing radiotherapy side effects and whether or not it protects the tumor. Methods and Materials: We performed a systematic review and meta-analysis of 14 included randomized controlled trials, comprising 1451 patients, comparing the use of radiotherapy vs. radiotherapy plus amifostine for cancer treatment. Results: The use of amifostine significantly reduced the risk of developing mucositis (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.29-0.48; p < 0.00001), esophagitis (OR, 0.38; CI, 0.26-0.54; p < 0.00001), acute xerostomia (OR, 0.24; CI, 0.15-0.36; p < 0.00001), late xerostomia (OR, 0.33; CI, 0.21-0.51; p

Safety, tolerability, and efficacy of metformin extended-release oral antidiabetic therapy in patients with type 2 diabetes: An observational trial in Asia

PubMed Central

Kim, Chul-Hee; Han, Kyung-Ah; Oh, Han-Jin; Tan, Kevin Eng-Kiat; Sothiratnam, Radhakrishna; Tjokroprawiro, Askandar; Klein, Marcus

2012-01-01

Background The aim of the present prospective observational study was to assess the tolerability and antihyperglycemic efficacy of metformin extended-release (MXR) in the routine treatment of patients with type 2 diabetes mellitus (T2DM) from six Asian countries. Methods Data from 3556 patients treated with once-daily MXR for 12 weeks, or until discontinuation, were analyzed. Results Treatment with MXR was well tolerated, with 97.4% of patients completing 12 weeks of treatment. Only 3.3% of patients experienced one or more gastrointestinal (GI) side-effects and only 0.7% of patients discontinued for this reason (primary endpoint). The incidence of GI side-effects and related discontinuations appeared to be considerably lower during short-term MXR therapy than during previous treatment (mean 2.71 years’ duration), most commonly with immediate-release metformin. A 12-week course of MXR therapy also reduced HbA1c and fasting glucose levels from baseline. Conclusions The present study provides new insights into the incidence of GI side-effects with MXR in Asian patients with T2DM and on the tolerability of MXR in non-Caucasian populations. Specifically, these data indicate that once-daily MXR not only improves measures of glycemic control in Asian patients with T2DM, but also has a favorable GI tolerability profile that may help promote enhanced adherence to oral antidiabetic therapy. PMID:22742083

Effectiveness, safety, and effect on quality of life of topical salicylic acid peels for treatment of postinflammatory hyperpigmentation in dark skin.

PubMed

Joshi, Smita S; Boone, Susan L; Alam, Murad; Yoo, Simon; White, Lucile; Rademaker, Alfred; Helenowski, Irene; West, Dennis P; Kundu, Roopal V

2009-04-01

There are no randomized split-face model studies investigating treatments for postinflammatory hyperpigmentation (PIH) in dark skin. To assess the efficacy, safety, and effect on quality of life of salicylic acid peels for PIH in dark skin. Ten subjects with Fitzpatrick skin phototypes IV to VI were randomized to receive two 20% salicylic acid peels followed by three 30% salicylic acid peels to half of the face. The contralateral half remained untreated. Response was evaluated by photography reviewed by three blinded dermatologists. The Visual Analog Scale, Dermatology Life Quality Index (DLQI), and treatment quality questionnaire were administered. Improvement of PIH on the treatment side according to each rater (p=.81, p=.81, p=.42) and according to the raters combined (p=.11) approached but did not reach statistical significance. Subjects' Visual Analog Scale scores indicated significantly greater improvement of PIH on the treatment side than in the control (p=.004). Quality of life measured according to the DLQI improved after treatment but not statistically significantly so (p=.13). Treatment had no significant adverse effects. Salicylic acid peels are safe in this population. Although patients rated them as clinically effective, blinded raters found a brief series of peels to have less efficacy. Measured quality of life improved nominally.

Combining Pharmacological Countermeasures to Attenuate the Acute Radiation Syndrome-A Concise Review.

PubMed

Hofer, Michal; Hoferová, Zuzana; Depeš, Daniel; Falk, Martin

2017-05-19

The goal of combined pharmacological approaches in the treatment of the acute radiation syndrome (ARS) is to obtain an effective therapy producing a minimum of undesirable side effects. This review summarizes important data from studies evaluating the efficacy of combining radioprotective agents developed for administration prior to irradiation and therapeutic agents administered in a post-irradiation treatment regimen. Many of the evaluated results show additivity, or even synergism, of the combined treatments in comparison with the effects of the individual component administrations. It can be deduced from these findings that the research in which combined treatments with radioprotectors/radiomitigators are explored, tested, and evaluated is well-founded. The requirement for studies highly emphasizing the need to minimize undesirable side effects of the radioprotective/radiomitigating therapies is stressed.

Special Educators' Knowledge regarding Psychotropic Interventions for Students with Emotional and Behavioral Disorders

ERIC Educational Resources Information Center

Ryan, Joseph B.; Reid, Robert; Ellis, Cynthia

2008-01-01

The use of psychotropic interventions to manage the inappropriate behaviors displayed by students with emotional and behavior disorders has become more common over the past several decades. The efficacious use of these medications requires monitoring students for desired behavioral outcomes as well as potential side effects. Educators are in an…

Enhanced Patient Expectant and Antiemetic Drug Efficacy

DTIC Science & Technology

1999-07-01

Breast Cancer Nausea and Vomiting Expectancy Patient Information Antiemetic Side Effect 15. NUMBER OF PAGES 15 16. PRICE CODE 17. SECURITY ...CLASSIFICATION OF REPORT Unclassified 18. SECURITY CLASSIFICATION OF THIS PAGE Unclassified 19. SECURITY CLASSIFICATION OF ABSTRACT...5-HT3 receptor antagonist class of antiemetics (ondansetron, granisetron , tropisitron) have greatly reduced chemotherapy-related vomiting, this has

Review of the Role of Two Antilibidinal Drugs in the Treatment of Sex Offenders with Mental Retardation.

ERIC Educational Resources Information Center

Cooper, A. J.

1995-01-01

This paper reviews the efficacy, cautions, side effects, and modes of action of two antiandrogens (medroxyprogesterone acetate and cyproterone acetate) in treating individuals with mental retardation who have engaged in offensive sexual behavior. Ethical and medico-legal issues are also discussed. (Author/JDD)

The Influence of Staff Training on Challenging Behaviour in Individuals with Intellectual Disability: A Review

ERIC Educational Resources Information Center

Cox, Alison D.; Dube, Charmayne; Temple, Beverley

2015-01-01

Many individuals with intellectual disability engage in challenging behaviour. This can significantly limit quality of life and also negatively impact caregivers (e.g., direct care staff, family caregivers and teachers). Fortunately, efficacious staff training may alleviate some negative side effects of client challenging behaviour. Currently, a…

Topical Oxybutynin 10% Gel for the Treatment of Primary Focal Hyperhidrosis: A Randomized Double-blind Placebo-controlled Split Area Study.

PubMed

Artzi, Ofir; Loizides, Christophoros; Zur, Eyal; Sprecher, Eli

2017-10-02

Limited efficacy, costs, side-effects and complications are issues of concern for most current therapeutic modalities for focal hyperhidrosis. This study evaluated the efficacy of topical oxybutynin 10% gel in treating 61 patients with primary focal hyperhidrosis. The gel was applied to the right or left axilla, palms or soles vs. a placebo compound to the contralateral side for 30 days. A blinded visual grading of the change in starch-iodine tests was performed by 2 non-involved physicians. The Hyperhidrosis Disease Severity Scale (HDSS) and Dermatology Life Quality Index (DLQI) questionnaires were administered before and after treatment. The patients rated their satisfaction with treatment. Fifty-three patients completed the 4-week treatment. Sweat reduction in the drug-treated sweating areas was higher than in the control-treated areas. There was a significant mean improvement in pre- and post-treatment HDSS and DQLI (p = 0.001 for both). Thirty-nine subjects (74%) reported moderate-to-high satisfaction. Twice-daily topical application of oxybutynin 10% gel appears to be an effective, safe and well-tolerated treatment for focal primary hyperhidrosis.

Formulation of tretinoin-loaded topical proniosomes for treatment of acne: in-vitro characterization, skin irritation test and comparative clinical study.

PubMed

Rahman, Salwa Abdel; Abdelmalak, Nevine Shawky; Badawi, Alia; Elbayoumy, Tahany; Sabry, Nermeen; El Ramly, Amany

2015-01-01

Tretinoin (TRT) is a widely used retinoid for the topical treatment of acne, photo-aged skin, psoriasis and skin cancer which makes it a good candidate for topical formulation. Yet side effects, like redness, swelling, peeling, blistering and, erythema, in addition to its high lipophilicity make this challenging. Therefore, the aim of this study was the development of TRT-loaded proniosomes to improve the drug efficacy and to increase user acceptability and compliance by reducing its side effects. Nine formulae were prepared according to 3(2) factorial design and were evaluated for their morphology, vesicle size, entrapment efficiency (EE %), and% of drug released after 5 h. Hydrogel of the candidate formula, N8G (proniosomes prepared with 0.025% TRT, and Span60: cholesterol molar ratio of 3:1 and incorporated in 1% carbopol gel) was developed and evaluated for skin irritation test and clinical study in acne patients compared to marketed product. Candidate formula showed higher efficacy and very low irritation potential when compared to marketed product in human volunteers.

Lubiprostone for chronic idiopathic constipation and irritable bowel syndrome with constipation.

PubMed

Saad, Richard; Chey, William D

2008-08-01

Lubiprostone, a locally acting highly selective type-2 chloride channel activator, has been US FDA approved since January 2006 for the treatment of adults with chronic idiopathic constipation and FDA approved since April 2008 for the treatment of woman aged 18 years or older suffering from irritable bowel syndrome (IBS) with constipation. Through activation of the type-2 chloride channels located on the luminal side of intestinal epithelial cells, it promotes fluid secretion, increasing the liquid content of stool and accelerating small bowel as well as colonic transit. Lubiprostone has demonstrated efficacy with respect to increasing weekly spontaneous bowel movements and improving stool consistency, straining and constipation severity, both in short- and long-term studies. It has also demonstrated efficacy in the treatment of IBS with constipation, with beneficial effects on global symptoms, abdominal pain, constipation-related symptoms and overall quality of life. There is no evidence of a rebound in constipation or IBS symptoms following cessation of lubiprostone. In general, lubiprostone is well tolerated, with the most common side effects including nausea, headache and diarrhea.

Significant partial response of metastatic intra-abdominal and pelvic round cell liposarcoma to a small-molecule VEGFR-2 tyrosine kinase inhibitor apatinib

PubMed Central

Dong, Min; Bi, Jingwang; Liu, Xiaohong; Wang, Baocheng; Wang, Jun

2016-01-01

Abstract Introduction: Myxoid/round cell liposarcoma is the second most common subtype of liposarcoma. Chemotherapy and radiotherapy have a limited efficacy for treating advanced myxoid/round cell liposarcoma, with relatively serious side effects. Case presentation: We herein present a 68-year-old Chinese woman initially diagnosed with advanced multiple intra-abdominal and pelvic round cell liposarcoma. She refused to receive cytotoxic chemotherapy and received apatinib as the first-line therapy, a novel tyrosine kinase inhibitor of vascular endothelial growth factor receptor-2 that has been used in the treatment of patients with metastatic gastric cancer who progressed with 2 or more chemotherapy regimens. This patient was partially responsive to apatinib with a dose of 500 mg daily. No serious drug-related side effects were observed. Conclusion: Our findings indicate that some cases of liposarcoma may be responsive to antiangiogenic agent apatinib. Randomized clinical studies are needed to further confirm the efficacy and safety of apatinib in the clinical treatment of liposarcoma. PMID:27495042

[Comparisons of efficacy and safety of levetiracetam versus phenytoin for seizure prophylaxis in patients with brain injury: a meta analysis].

PubMed

Li, J N; Chen, Y M

2016-10-25

Objective: To systematically review the efficacy, side effects and case-fatality rate of levetiracetam (LEV) versus phenytoin (PHT) for seizure prophylaxis of brain injured patients. Methods: Randomized controlled trials of high quality about LEV versus PHT in seizure prophylaxis of brain injured patients from 2000 to 2016 were collected according to the key word PHT, LEV, brain injury in PubMed, Medline, Ovid, Springer, CNKI, Wanfang data and so on. Valid data were extracted to conduct meta-analysis by RevMan 5.3 software according to inclusion and exclusion criteria. Results: A total of 13 English articles were finally included with 2 529 patients in total.Meta-analysis showed that no significant differences were observed in LEV versus PHT at preventing the occurrence of seizures ( RR =0.88, 95% CI : 0.61-1.27). No superiority of either drug at preventing early seizures ( RR =0.74, 95% CI : 0.42-1.27). As to the occurrence of late seizures, the differences of the two drugs were not statistically significant ( RR =0.71, 95% CI : 0.43-1.20). Number of patients with side effect was not statistically significantly different between the two groups ( RR =0.73, 95% CI : 0.48-1.11). But significant difference was found between LEV and PHT in discontinuation because of side effect ( RR =0.11, 95% CI : 0.06-0.23); no significant differences were noted in the case-fatality rate of patients received pretreatment between the two drugs ( RR =1.57, 95% CI : 0.92-2.67). There were no significant differences between the two groups in the length of stay ( WMD =-1.03, 95% CI : -4.97-2.91). Conclusions: LEV and PHT demonstrate equal efficacy in seizure prevention after brain injury. The differences are insignificant in the side effect, the case-fatality rate and the length of stay between LEV and PH treatment, but adverse drug reactions requiring change in therapy occur more in PHT. Phenytoin remains the first choice for seizure prevention after brain injury based on the existing evidence, while levetiracetam seems to be a favorable choice where there is risk of drug-drug interactions and drug toxicity. However, very few randomized controlled trials on this topic were found, and larger prospective trials are warranted.

Anesthetic efficacy of Oraqix® versus Hurricaine® and placebo for pain control during non-surgical periodontal treatment

PubMed Central

Mayor-Subirana, Gemma; Yagüe-García, José; Arnabat-Domínguez, Josep; Berini-Aytés, Leonardo; Gay-Escoda, Cosme

2014-01-01

Objectives: To evaluate the efficacy of Oraqix® during scaling and root planing (SRP) in comparison with 20% benzocaine and placebo. Study Design: 15 patients requiring 4 sessions of SRP were enrolled. For each patient, Oraqix®, Hurricaine®, vaseline or no anesthetic product were randomly assigned each to a quadrant. Treatment pain was evaluated on a 100 mm Visual Analog Scale (VAS) and on a Verbal Rating Scale (VRS). The amount of product administered, the need to re-anesthetise, patient and operator satisfaction and the onset of side-effects were also recorded. Results: Oraqix® was significantly better than nothing, with a reduction of VAS score to 13.3 units, but without significant differences with Vaseline or Hurricaine®. Oraqix® was better in VRS reduction than not using any anesthetic (p=0.001) or using vaseline (p=0.024), but similar to Hurricaine® (p=0.232). Conclusions: Oraqix® effectively controls pain in SRP procedures, with few side-effects and a good acceptance on the part of patients and clinicians. Key words:Controlled clinical trial, topical anesthetic, scaling and root planing. PMID:24316699

Effectiveness and Safety of Newer Antidiabetic Medications for Ramadan Fasting Diabetic Patients

PubMed Central

2016-01-01

Hypoglycemia is the most common side effects for most glucose-lowering therapies. It constitutes a serious risk that faces diabetic patients who fast during Ramadan (the 9th month in the Islamic calendar). New glucose-lowering classes like dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonist (GLP-1 RA), and sodium-glucose cotransporter-2 (SGLT-2) inhibitors are efficacious in controlling blood glucose level with less tendency to induce hypoglycemia and thus may constitute a good choice for diabetic patients during Ramadan. This study reviews the safety and efficacy of newer glucose-lowering therapies during Ramadan. This study was accomplished through a careful literature search about studies that assess the benefit and side effects of these new glucose-lowering therapies during Ramadan during September 2015. Vildagliptin, sitagliptin, liraglutide, exenatide, and dapagliflozin were the only studied glucose-lowering therapies. All of the studied newer glucose-lowering therapies except dapagliflozin were associated with reduced risk to induce hypoglycemia. Gastrointestinal upset was common with the usage of liraglutide while increased thirst sensation was common with dapagliflozin. In conclusion DPP-4 inhibitors such as vildagliptin and sitagliptin may form a suitable glucose-lowering therapy option for Ramadan fasting patients. PMID:27642611

A New Type of ECT Stimuli: Burst Stimulus ECT.

PubMed

Aksay, S S; Bumb, J M; Janke, C; Kranaster, L; Sartorius, A

2015-11-01

Pulse width in electroconvulsive therapy has significant influence on effectiveness and side effects. While shorter pulses are beneficial for cognitive performance, there is still a debate about a negative impact on ECT efficacy at least for ultra-brief pulse durations. We report a first patient treated with burst stimulus ECT, i. e., with 4 consecutive 250-µs pulses, separated by another 250 µs. Within the same patient we compared 6 classical vs. 6 burst stimulus ECT sessions. In all cases a typical tonic-clonic seizure was observed. Seizure parameters like concordance, coherence and mid-ictal amplitude increased numerically, but not significantly with burst ECT. The time needed to show a reorientation was significantly shortened with burst stimuli (30 min vs. 14 min, p=0.007). In conclusion we present the first case of ECT in a single patient comparing "classical" single stimulus pulses vs. burst stimulus ECT. The new burst stimulus was better tolerated regarding reorientation time after the treatment, while parameters of seizure quality remained basically unchanged. Whether burst stimulus ECT has the potential to improve ECT quality by reducing side effects without losing efficacy has to be investigated in clinical trials. © Georg Thieme Verlag KG Stuttgart · New York.

Cryolipolysis for Targeted Fat Reduction and Improved Appearance of the Enlarged Male Breast.

PubMed

Munavalli, Girish S; Panchaprateep, Ratchathorn

2015-09-01

Pseudogynecomastia refers to benign male breast enlargement due to excess subareolar fat. Standard treatment is surgical excision under general anesthesia, liposuction, or a combination of both. The safety and efficacy of cryolipolysis was investigated for nonsurgical treatment of pseudogynecomastia. Enrollment consisted of 21 males with pseudogynecomastia. Subjects received a first treatment consisting of a 60-minute cryolipolysis cycle, followed by a two-minute massage, and a second 60-minute cycle with 50% treatment area overlap. At 60 days of follow-up, subjects received a second 60-minute treatment. Safety was evaluated by monitoring side effects and adverse events. Efficacy was assessed by ultrasound, clinical photographs, and subject surveys. Surveys revealed that 95% of subjects reported improved visual appearance and 89% reported reduced embarrassment associated with pseudogynecomastia. Ultrasound showed mean fat layer reduction of 1.6 ± 1.2 mm. Blinded reviewers correctly identified 82% of baseline photographs. Side effects included mild discomfort during treatment and transient paresthesia and tenderness. One case of paradoxical hyperplasia (PH) occurred but likelihood of PH in the male breast is not believed to be greater than in any other treatment area. This study demonstrated feasibility of cryolipolysis for safe, effective, and well-tolerated nonsurgical treatment of pseudogynecomastia.

Paracetamol in Patent Ductus Arteriosus Treatment: Efficacious and Safe?

PubMed Central

Bardanzellu, Flaminia; Neroni, Paola; Fanos, Vassilios

2017-01-01

In preterm infants, failure or delay in spontaneous closure of Ductus Arteriosus (DA), resulting in the condition of Patent Ductus Arteriosus (PDA), represents a significant issue. A prolonged situation of PDA can be associated with several short- and long-term complications. Despite years of researches and clinical experience on PDA management, unresolved questions about the treatment and heterogeneity of clinical practices in different centers still remain, in particular regarding timing and modality of intervention. Nowadays, the most reasonable strategy seems to be reserving the treatment only to hemodynamically significant PDA. The first-line therapy is medical, and ibuprofen, related to several side effects especially in terms of nephrotoxicity, is the drug of choice. Administration of oral or intravenous paracetamol (acetaminophen) recently gained attention, appearing effective as traditional nonsteroidal anti-inflammatory drugs (NSAIDs) in PDA closure, with lower toxicity. The results of the studies analyzed in this review mostly support paracetamol efficacy in ductal closure, with inconstant low and transient elevation of liver enzymes as reported side effect. However, more studies are needed to confirm if this therapy shows a real safety profile and to evaluate its long-term outcomes, before considering paracetamol as first-choice drug in PDA treatment. PMID:28828381

The combined oral contraceptive pill containing drospirenone and ethinyl estradiol plus levomefolate calcium.

PubMed

Rapkin, Rachel B; Creinin, Mitchell D

2011-10-01

Neural tube defects are the second most common congenital anomaly in the United States, although their incidence may be decreased by periconception folic acid supplementation. A new oral contraceptive containing drospirenone and ethinyl estradiol plus levomefolate calcium was formulated to decrease the risk of neural tube defects in pregnancies conceived while taking or shortly after discontinuing this pill. Because of its novelty, very few studies have been performed to evaluate the efficacy, side effects and safety related to contraception, premenstrual dysphoric disorder and acne; therefore, literature evaluating similar contraceptives without levomefolate is reviewed. Additionally, we review studies evaluating the addition of levomefolate calcium to oral contraceptives containing 3 mg drospirenone and either 20 or 30 μg ethinyl estradiol. To date, no study has been performed to evaluate the effect this new oral contraceptive has on reducing the incidence of neural tube defects. This new pill has similar contraceptive efficacy, side effect, safety and benefits profile to other drospirenone-containing contraceptives. While also approved to prevent neural tube defects, no studies validate this claim and physician time is better spent counseling women, regardless of contraceptive choice, on the importance of folic acid supplementation during the child-bearing years.

Comparison the effectiveness of pyruvic acid 50% and salicylic acid 30% in the treatment of acne

PubMed Central

Jaffary, Fariba; Faghihi, Gita; Saraeian, Sara; Hosseini, Sayed Mohsen

2016-01-01

Background: Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles and one of the most common skin diseases. The peeling method has been recently found to be effective for acne treatment. This study aimed to compare the efficacy of pyruvic acid 50% and salicylic acid 30% peeling in the treatment of mild to moderate acne. Materials and Methods: In a prospective single-blinded clinical trial, 86 patients with acne were randomly assigned into two groups. In both groups, the routine treatment of acne (topical solution of erythromycin 4%, triclorocarban soap, and sunscreen) were used twice a day for 8 weeks. In addition, salicylic acid 30% for the control group and pyruvic acid 50% for the case group were used. In both groups, acne severity index (ASI) was calculated before and at week 2, 4, 6, and 8 of the treatment. Patient satisfaction was assessed at the end of the treatment. Side effects were recorded using a checklist. Results: In both groups, the reduction in the number of comedones, papules, and ASI were statistically significant (P < 0.001) in the course of treatment. However, it was not significant regarding the number of pustules (P = 0.09). None of the number of comedone, papules, pustules, and ASI was statistically different between study groups. Both treatment groups had similar side effects except for scaling in the fifth session, which was significantly lower in salicylic acid – treated patients (P = 0.015). Conclusion: Both pyruvic acid 50% and salicylic acid 30% are effective in the improvement of mild to moderate acne with no significant difference in efficacy and side effects. PMID:27904577

Combined therapy using bevacizumab and turmeric ethanolic extract (with absorbable curcumin) exhibited beneficial efficacy in colon cancer mice.

PubMed

Yue, Grace Gar-Lee; Kwok, Hin-Fai; Lee, Julia Kin-Ming; Jiang, Lei; Wong, Eric Chun-Wai; Gao, Si; Wong, Hing-Lok; Li, Lin; Chan, Kar-Man; Leung, Ping-Chung; Fung, Kwok-Pui; Zuo, Zhong; Lau, Clara Bik-San

2016-09-01

Turmeric is commonly used as a medicinal herb and dietary supplement. Its active ingredient, curcumin, has been shown to possess antitumor effects in colorectal cancer patients. However, poor absorption of curcumin in intestine impedes its wide clinical application. Our previous findings showed that the presence of turmerones increased the accumulation of curcumin inside colonic cells. Hence, we hypothesized that curcumin with turmerones or present in turmeric ethanolic extract would augment its anti-tumor activities in tumor-bearing mice. The pharmacokinetics of curcumin in different preparations (containing same amount of curcumin) were studied in mice. The anti-tumor efficacies of curcumin or turmeric extract (with absorbable curcumin) in combination with bevacizumab were further investigated in HT29 colon tumor-bearing mice. Pharmacokinetic results showed that the plasma curcumin level of turmeric extract-fed mice was the highest, suggesting turmeric extract had the best bioavailability of curcumin. Besides, combined turmeric extract plus bevacizumab treatment significantly inhibited the tumor growth. Such inhibitory effects were stronger than those of curcumin plus bevacizumab or bevacizumab alone and were comparable with those of 5-fluorouracil+leucovorin+oxaliplatin (FOLFOX) plus bevacizumab. Notably, there was no observable side effect induced by turmeric extract treatment while significant side effects were found in FOLFOX-treated mice. In conclusion, combination of turmeric extract with bevacizumab possessed potent anti-tumor effects without observable side effects, strongly suggesting the adjuvant use of turmeric extract in colorectal cancer therapy. Our current findings warrant the confirmation regarding the benefits arising from the combined use of bevacizumab and turmeric in colorectal cancer patients in the near future. Copyright © 2016 Elsevier Ltd. All rights reserved.

Efficacy of chloral hydrate-hydroxyzine and chloral hydrate-midazolam in pediatric magnetic resonance imaging sedation.

PubMed

Fallah, Razieh; Fadavi, Nafiseh; Behdad, Shekofah; Fallah Tafti, Mahmoud

2014-01-01

Magnetic resonance imaging (MRI) is a useful diagnostic tool for the evaluation of congenital or acquired brain lesions. But, in all of less than 8-year-old children, pharmacological agents and procedural sedation should be used to induce motionless conditions for imaging studies. The purpose of this study was to compare the efficacy and safety of combination of chloral hydrate-hydroxyzine (CH+H) and chloral hydrate-midazolam (CH+M) in pediatric MRI sedation. In a parallel single-blinded randomized clinical trial, sixty 1-7-year-old children who underwent brain MRI, were randomly assigned to receive chloral hydrate in a minimum dosage of 40 mg/kg in combination with either 2 mg/kg of hydroxyzine or 0.5 mg/kg of midazolam. The primary outcomes were efficacy of adequate sedation (Ramsay sedation score of five) and completion of MRI examination. The secondary outcome was clinical side-effects. Twenty-eight girls (46.7%) and 32 boys (53.3%) with the mean age of 2.72±1.58 years were studied. Adequate sedation and completion of MRI were achieved in 76.7% of CH+H group. Mild and transient clinical side-effects, such as vomiting of one child in each group and agitation in 2 (6.6 %) children of CH+M group, were also seen. The adverse events were more frequent in CH+M group. Combinations of chloral hydrate-hydroxyzine and chloral hydrate-midazolam were effective in pediatric MRI sedation; however, chloral hydrate-hydroxyzine was safer.

A systematic review of effectiveness and safety of different regimens of levonorgestrel oral tablets for emergency contraception.

PubMed

Shohel, Mohammad; Rahman, Mohammad Mahfuzur; Zaman, Asif; Uddin, Mir Muhammad Nasir; Al-Amin, Md Mamun; Reza, Hasan Mahmud

2014-04-04

Unintended pregnancy is a complex phenomenon which raise to take an emergency decision. Low contraceptive prevalence and high user failure rates are the leading causes of this unexpected situation. High user failure rates suggest the vital role of emergency contraception to prevent unplanned pregnancy. Levonorgestrel - a commonly used progestin for emergency contraception. However, little is known about its pharmacokinetics and optimal dose for use. Hence, there is a need to conduct a systematic review of the available evidences. Randomized, double-blind trials were sought, evaluating healthy women with regular menstrual cycles, who requested emergency contraception within 72 h of unprotected coitus, to one of three regimens: 1.5 mg single dose levonorgestrel, two doses of 0.75 mg levonorgestrel given 12 h apart or two doses of 0.75 mg levonorgestrel given 24 h apart. The primary outcome was unintended pregnancy; other outcomes were side-effects and timing of next menstruation. Every trial under consideration successfully established the contraceptive effectiveness of levonorgestrel for preventing unintended pregnancy. Moreover, a single dose of levonorgestrel 1.5 mg for emergency contraception supports its safety and efficacy profile. If two doses of levonorgestrel 0.75 mg are intended for administration, the second dose can positively be taken 12-24 h after the first dose without compromising its contraceptive efficacy. The main side effect was frequent menstrual irregularities. No serious adverse events were reported. The review shows that, emergency contraceptive regimen of single-dose levonorgestrel is not inferior in efficacy to the two-dose regimen. All the regimens studied were very efficacious for emergency contraception and prevented a high proportion of pregnancies if taken within 72 h of unprotected coitus. Single levonorgestrel dose (1.5 mg) can substitute two 0.75 mg doses 12 or 24 h apart. With either regimen, the earlier the treatment is given, the more effective it seems to be.

A systematic review of effectiveness and safety of different regimens of levonorgestrel oral tablets for emergency contraception

PubMed Central

2014-01-01

Background Unintended pregnancy is a complex phenomenon which raise to take an emergency decision. Low contraceptive prevalence and high user failure rates are the leading causes of this unexpected situation. High user failure rates suggest the vital role of emergency contraception to prevent unplanned pregnancy. Levonorgestrel - a commonly used progestin for emergency contraception. However, little is known about its pharmacokinetics and optimal dose for use. Hence, there is a need to conduct a systematic review of the available evidences. Methods Randomized, double-blind trials were sought, evaluating healthy women with regular menstrual cycles, who requested emergency contraception within 72 h of unprotected coitus, to one of three regimens: 1.5 mg single dose levonorgestrel, two doses of 0.75 mg levonorgestrel given 12 h apart or two doses of 0.75 mg levonorgestrel given 24 h apart. The primary outcome was unintended pregnancy; other outcomes were side-effects and timing of next menstruation. Results Every trial under consideration successfully established the contraceptive effectiveness of levonorgestrel for preventing unintended pregnancy. Moreover, a single dose of levonorgestrel 1.5 mg for emergency contraception supports its safety and efficacy profile. If two doses of levonorgestrel 0.75 mg are intended for administration, the second dose can positively be taken 12–24 h after the first dose without compromising its contraceptive efficacy. The main side effect was frequent menstrual irregularities. No serious adverse events were reported. Conclusions The review shows that, emergency contraceptive regimen of single-dose levonorgestrel is not inferior in efficacy to the two-dose regimen. All the regimens studied were very efficacious for emergency contraception and prevented a high proportion of pregnancies if taken within 72 h of unprotected coitus. Single levonorgestrel dose (1.5 mg) can substitute two 0.75 mg doses 12 or 24 h apart. With either regimen, the earlier the treatment is given, the more effective it seems to be. PMID:24708837

Studies of the Effects of Perfluorocarbon Emulsions on Platelet Number and Function in Models of Critical Battlefield Injury

DTIC Science & Technology

2016-09-01

to treat traumatic injuries by enhanced delivery of oxygen . A concerned side effect of PFC may cause thrombocytopenia (TCYP). FDA requests...Morris, A., Zhu, J., Spiess, B.D., Parsons, J.T. The Effect of Perfluorocarbon Oxygen Therapeutics in a Sheep Survival Model of Severe Hemorrhagic...of effectively oxygenating sensitive tissue in the absence of adequate hemoglobin and/or blood flow. PFC emulsion volumes required for efficacy can

Suitability of the adenosine antagonist istradefylline for the treatment of Parkinson's disease: pharmacokinetic and clinical considerations.

PubMed

Müller, Thomas

2013-08-01

Recent experimental and clinical research has shown that A2A adenosine receptor antagonism can bring about an improvement in the motor behavior of patients with Parkinson's disease. Istradefylline , a xanthine derivative, has the longest half-life of all the currently available A2A adenosine receptor antagonists; it can successfully permeate through the blood-brain barrier and has a high human A2A adenosine receptor affinity. In this article, the author discusses the potential role of A2A adenosine receptor antagonists in the treatment of Parkinson's disease through the evaluation of istradefylline. Specifically, the article reviews the clinical and pharmacokinetic information available to elucidate its therapeutic potential. A2A adenosine receptor antagonists are efficacious in combination with l-dopa. l-dopa has a complex pharmacokinetic behavior and causes long-term behavioral and metabolic side effects. Future research on A2A adenosine receptor antagonism should consider compounds like istradefylline as l-dopa and/or dopamine agonist-sparing treatment alternatives, since their clinical handling, safety and side-effect profile are superior to l-dopa and/or dopamine agonists. The current focus to demonstrate a specific dyskinesia-ameliorating efficacy of A2A adenosine receptor antagonism in clinical trials is risky, since the presentation of dyskinesia varies on a day-to-day basis and is considerably influenced by peripheral l-dopa metabolism. The demonstration of an antidyskinetic effect may convince authorities, but this is far less relevant in clinical practice as patients generally better tolerate dyskinesia than other phenomena and dopaminergic side effects.

Treatment of good-prognosis polyarteritis nodosa and Churg-Strauss syndrome: comparison of steroids and oral or pulse cyclophosphamide in 25 patients. French Cooperative Study Group for Vasculitides.

PubMed

Gayraud, M; Guillevin, L; Cohen, P; Lhote, F; Cacoub, P; Deblois, P; Godeau, B; Ruel, M; Vidal, E; Piontud, M; Ducroix, J P; Lassoued, S; Christoforov, B; Babinet, P

1997-12-01

Twenty-five patients with good-prognosis polyarteritis nodosa or Churg-Strauss syndrome entered a prospective, randomized, multicentre study comparing two treatments: either oral corticosteroids and oral cyclophosphamide (CY; 2 mg/kg/day) for 1 yr (group A), or oral corticosteroids and monthly i.v. CY pulses (0.6 g/m2) (group B) for 1 yr. The objective was to determine the optimal CY regimen. Judgement criteria were the efficacy of the treatment in controlling the disease and the development of side-effects. Among the 25 patients who could be analysed, complete recovery was achieved with the experimental treatment in 9/12 patients in group A and 10/13 patients in group B. Two patients in each group relapsed after the end of therapy and were well controlled by corticosteroids or other drugs. One failure occurred in each group. The mean follow-up was 60.8 +/- 14.5 months after the beginning of the treatment. Side-effects associated with the administration of CY and steroids were noted 27 times in group A vs 14 times in group B (not significant). The oldest patient in these series (group B) died of pneumonia. No superiority in terms of efficacy could be established between the two regimens; however, the number of patients included was too small to conclude definitively. Toxic side-effects were significantly more frequent in women (P < 0.02). The high number of adverse effects leads us to recommend pulse over oral CY and an overall lowering of the doses of immunosuppression.

"Sisters, Mothers, Daughters and Aunties": HIV vaccine acceptability among African, Caribbean and other Black women in Toronto.

PubMed

Weaver, James; Newman, Peter A; Williams, Charmaine C; Massaquoi, Notisha; Brown, Marsha

2013-08-20

Black women in Canada are at disproportionately high risk for HIV. We assessed HIV vaccine acceptability and correlates of acceptability among Black women from African and Caribbean communities in Toronto. "Sisters, Daughters, Mothers, and Aunties" was a community-based research project. Black women of African and Caribbean descent were recruited using venue-based sampling across diverse community organizations in Toronto. We used a structured questionnaire to collect data on socio-demographic characteristics and acceptability of 8 future HIV vaccines, each defined by a set of 7 dichotomous attributes. Conjoint analysis was used to quantify the relative impact of vaccine attributes on acceptability, with multiple regression to adjust for socio-demographic characteristics associated with overall acceptability. Mean vaccine acceptability was 58.8 (SD=17.2) on the 100-point scale. Efficacy had the greatest impact on acceptability, followed by side effects, cost, duration of protection, and number of doses. Acceptability of a high (99%) efficacy vaccine (70.1/100) was significantly greater than for a 50% efficacy vaccine (47.6/100). Vaccine acceptability was significantly higher among women of Caribbean versus African descent, ever married versus single women, and women with full-time versus part-time employment. Black women in Toronto indicated a modest level of acceptability for future HIV vaccines. Educational interventions that address the benefits of partially efficacious vaccines and clearly explain potential side effects, as well as vaccine cost subsidies may promote HIV vaccine uptake. Differences in acceptability within Black communities suggest that tailored multi-level interventions may mitigate barriers to uptake.

Tissue Engineering of the Urethra: A Systematic Review and Meta-analysis of Preclinical and Clinical Studies.

PubMed

Versteegden, Luuk R M; de Jonge, Paul K J D; IntHout, Joanna; van Kuppevelt, Toin H; Oosterwijk, Egbert; Feitz, Wout F J; de Vries, Rob B M; Daamen, Willeke F

2017-10-01

Urethra repair by tissue engineering has been extensively studied in laboratory animals and patients, but is not routinely used in clinical practice. To systematically investigate preclinical and clinical evidence of the efficacy of tissue engineering for urethra repair in order to stimulate translation of preclinical studies to the clinic. A systematic search strategy was applied in PubMed and EMBASE. Studies were independently screened for relevance by two reviewers, resulting in 80 preclinical and 23 clinical studies of which 63 and 13 were selected for meta-analysis to assess side effects, functionality, and study completion. Analyses for preclinical and clinical studies were performed separately. Full circumferential and inlay procedures were assessed independently. Evaluated parameters included seeding of cells and type of biomaterial. Meta-analysis revealed that cell seeding significantly reduced the probability of encountering side effects in preclinical studies. Remarkably though, cells were only sparsely used in the clinic (4/23 studies) and showed no significant reduction of side effects. ln 21 out of 23 clinical studies, decellularized templates were used, while in preclinical studies other biomaterials showed promising outcomes as well. No direct comparison to current clinical practice could be made due to the limited number of randomized controlled studies. Due to a lack of controlled (pre)clinical studies, the efficacy of tissue engineering for urethra repair could not be determined. Meta-analysis outcome measures were similar to current treatment options described in literature. Surprisingly, it appeared that favorable preclinical results, that is inclusion of cells, were not translated to the clinic. Improved (pre)clinical study designs may enhance clinical translation. We reviewed all available literature on urethral tissue engineering to assess the efficacy in preclinical and clinical studies. We show that improvements to (pre)clinical study design is required to improve clinical translation of tissue engineering technologies. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

What do women with breast cancer expect from their treatment? Correlates of negative treatment expectations about endocrine therapy.

PubMed

Heisig, Sarah R; Shedden-Mora, Meike C; von Blanckenburg, Pia; Rief, Winfried; Witzel, Isabell; Albert, Ute-Susann; Nestoriuc, Yvonne

2016-12-01

Patients' negative treatment expectations can lead to nocebo-related side effects and non-initiation of treatment. This study aims to identify correlates of treatment expectations in patients with breast cancer before the start of endocrine therapy. Expectations were assessed in a cross-sectional sample of 166 patients with breast cancer after receiving treatment information. Side effect expectations (one item) and treatment necessity-concern balance (Beliefs about Medicines Questionnaire) were assessed. Correlates were analyzed using regression analyses. The structure of treatment expectations was investigated using a network analysis. About 25% of patients expressed negative expectations. Higher side effect expectations were associated with lower treatment efficacy expectations (ß = -0.20, p = 0.01), higher medication overuse beliefs (ß = 0.17, p = 0.01), and a negative treatment appraisal before study treatment information (ß = -0.17, p = 0.02). A negative necessity-concern balance was associated with lower treatment efficacy expectations (ß = 0.36, p < 0.001), lower adherence intention (ß = 0.21, p < 0.001), and no knowledge of tumor's receptor status (ß = 0.21, p < 0.001); furthermore, it was associated with higher medication harmfulness beliefs (ß = -0.16, p = 0.02), negative treatment pre-appraisal (ß = 0.15, p = 0.01), higher somatosensory amplification (ß = -0.14, p = 0.02), and higher education (ß = -0.12, p = 0.02). The most important network node was the concern that endocrine therapy disrupts life. Negative treatment expectations before treatment start are mainly associated with psychological variables. These results are relevant for patient education in clinical settings. To improve expectations, clinicians might emphasize treatment efficacy and discuss general and specific medication concerns. Improving treatment knowledge could also be beneficial. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Efficacy of topical azathioprine and betamethasone versus betamethasone-only emollient cream in 2-18 years old patients with moderate-to-severe atopic dermatitis: A randomized controlled trial

PubMed Central

Iraji, Fariba; Farhadi, Sadaf; Faghihi, Gita; Mokhtari, Fatemeh; Basiri, Akram; Jafari-Koshki, Tohid; Nilforoushzadeh, Mohammad Ali

2015-01-01

Background: Atopic dermatitis is a chronic skin disease with increasing prevalence worldwide and a considerable burden especially among children. To circumvent the problems related to oral azathioprine (AZT) we aimed to evaluate its topical variant and assess its efficacy in patients aged 2–18. Materials and Methods: In a single-blind trial, we randomized the patients into two groups, one treated with topical emollient containing AZT and betamethasone (BM), and the other treated solely with topical emollient of BM. The treatments were administered twice a day for 8 weeks in both groups. The efficacy, recurrence, and the presence of side effects were evaluated using SPSS 20. Results: The amount of reduction in severity scoring for atopic dermatitis (SCORAD) score was significantly greater in the group treated with the topical AZT (P = 0.024). Incidentally, there were no difference between two treatments in difference in proportions of recurrence and adverse effects as well as SCORAD reduction in subgroups of sex and age (all P > 0.05). Conclusions: Our results showed the superiority of topical AZT over BM with a low recurrence and adverse effects. No expectation of severe side effects, like those of oral AZT, is the major advantage of topical AZT. The sample size was an issue in uncovering the value of AZT in the subgroups. Conducting prolonged studies of quality-of-life and comparing the topical AZT potency relative to the common alternatives are recommended areas of future work. PMID:26623403

Photodynamic therapy using chlorophyll-a in the treatment of acne vulgaris: a randomized, single-blind, split-face study.

PubMed

Song, Byong Han; Lee, Dong Hun; Kim, Byung Chul; Ku, Sang Hyeon; Park, Eun Joo; Kwon, In Ho; Kim, Kwang Ho; Kim, Kwang Joong

2014-10-01

Chlorophyll-a is a novel photosensitizer recently tested for the treatment of acne vulgaris. We sought to evaluate the clinical efficacy and safety of chlorophyll-a photodynamic therapy used for acne treatment. Subjects with acne on both sides of the face were included. Eight treatment sessions were performed over a 4-week duration. Half of the face was irradiated using a blue and red light-emitting diode after topical application of chlorophyll-lipoid complex. The other half underwent only light-emitting diode phototherapy. The lesion counts and acne severity were assessed by a blinded examiner. Sebum secretion, safety, and histologic changes were also evaluated. In total, 24 subjects completed the study. Facial acne improved on both treated sides. On the chlorophyll-a photodynamic therapy-treated side, there were significant reductions in acne lesion counts, acne severity grades, and sebum levels compared with the side treated with light-emitting diode phototherapy alone. The side effects were tolerable in all the cases. All the subjects were of Asian descent with darker skin types, which may limit the generalizability of the study. A chlorophyll-a arm alone is absent, as is a no-treatment arm. We suggest that chlorophyll-a photodynamic therapy for the treatment of acne vulgaris can be effective and safe with minimal side effects. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Efficacy of 10% whole Azadirachta indica (neem) chip as an adjunct to scaling and root planning in chronic periodontitis: A clinical and microbiological study.

PubMed

Vennila, K; Elanchezhiyan, S; Ilavarasu, Sugumari

2016-01-01

Anti-microbial therapy is essential along with conventional therapy in the management of periodontal disease. Instead of systemic chemical agents, herbal products could be used as antimicrobial agents. Herbal local drug delivery systems are effective alternative for systemic therapy in managing the chronic periodontal disease. In this study, 10% neem oil chip was used as a local drug delivery system to evaluate the efficacy in the periodontal disease management. Twenty otherwise healthy patients with the bilateral periodontal probing depth of 5-6 mm were included in the study. After scaling and root planning (SRP), 10% nonabsorbable neem chip was placed in the pocket in one side of the arch. Other side was done with SRP only. Clinical parameters were recorded on the baseline, 7th day, and 21st day. Plaque samples were obtained for a microbiological study on the baseline and 21st day. Porphyromonas gingivalis strains were seen using quantitative and qualitative polymerase chain reaction assay. All results were statistically evaluated. Clinical parameters showed statistically improved on the neem chip sites and presence of P. gingivalis strains were significantly reduced on the neem chip sites. Hence, 10% neem oil local delivery system delivers desired effects on P. gingivalis. Further research is needed to evaluate the neem oil efficacy on other periodontal pathogens.

Levetiracetam monotherapy for treatment of structural epilepsy in dogs: 19 cases (2010-2015).

PubMed

Kelly, Darren; Raimondi, Francesca; Shihab, Nadia

2017-10-14

To evaluate the efficacy and tolerability of levetiracetam monotherapy in dogs with structural epilepsy. Retrospective case series. Nineteen client-owned dogs with structural epilepsy. Seizure frequencies after initiation of treatment were used to evaluate the efficacy of levetiracetam monotherapy. Seizure control was considered good if no seizures occurred within three months of starting treatment or poor if seizures returned within one month of starting treatment. Tolerability was evaluated by considering the occurrence and severity of any reported side effects. Ten of the 19 dogs were considered to have a good response to treatment with 7 achieving complete seizure freedom. Nine dogs were considered to have poor response to treatment. There was a statistically significant reduction in the percentage of patients experiencing cluster seizures from 68.4% to 15.8% (p=0.002). Side effects were noted in 8 of the 19 dogs but were considered mild in all cases. Follow-up times ranged from 12 days to 426 days. When used in conjunction with other appropriate therapies, levetiracetam may be an efficacious option for monotherapy in dogs with structural epilepsy. Its tolerability makes it a suitable option for use in a wide variety of patients. © British Veterinary Association (unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Adherence issues related to sublingual immunotherapy as perceived by allergists

PubMed Central

Scurati, Silvia; Frati, Franco; Passalacqua, Gianni; Puccinelli, Paola; Hilaire, Cecile; Incorvaia, Cristoforo

2010-01-01

Objectives: Sublingual immunotherapy (SLIT) is a viable alternative to subcutaneous immunotherapy to treat allergic rhinitis and asthma, and is widely used in clinical practice in many European countries. The clinical efficacy of SLIT has been established in a number of clinical trials and meta-analyses. However, because SLIT is self-administered by patients without medical supervision, the degree of patient adherence with treatment is still a concern. The objective of this study was to evaluate the perception by allergists of issues related to SLIT adherence. Methods: We performed a questionnaire-based survey of 296 Italian allergists, based on the adherence issues known from previous studies. The perception of importance of each item was assessed by a VAS scale ranging from 0 to 10. Results: Patient perception of clinical efficacy was considered the most important factor (ranked 1 by 54% of allergists), followed by the possibility of reimbursement (ranked 1 by 34%), and by the absence of side effects (ranked 1 by 21%). Patient education, regular follow-up, and ease of use of SLIT were ranked first by less than 20% of allergists. Conclusion: These findings indicate that clinical efficacy, cost, and side effects are perceived as the major issues influencing patient adherence to SLIT, and that further improvement of adherence is likely to be achieved by improving the patient information provided by prescribers. PMID:20622914

Urothelial effects of oral agents for overactive bladder.

PubMed

Andersson, Karl-Erik; Fullhase, Claudius; Soler, Roberto

2008-11-01

The cholinergic system of the bladder includes muscarinic receptors distributed to detrusor myocytes and structures within mucosa including bladder afferent (sensory) nerves. The receptors have been shown to be involved in afferent signaling from the bladder, but it has not been established to what extent effects on this mucosal signaling pathway contribute to the therapeutic efficacy of the clinically used antimuscarinics. Mucosa can be influenced by antimuscarinics via the bloodstream. However, some antimuscarinics and their active metabolites are excreted in urine in amounts that may affect the mucosal muscarinic receptors from the luminal side. This has not yet been demonstrated to imply superior clinical efficacy. Nevertheless, mucosal afferent signaling pathways are therapeutically interesting targets that should be further explored.

Black and white teas as potential agents to combine with amphotericin B and protect red blood cells from amphotericin B-mediated toxicity.

PubMed

Oliveira, V M; Khalil, N M; Carraro, E

2018-02-01

Amphotericin B is a fungicidal substance that is treatment of choice for most systemic fungal infections affecting immunocompromised patients. However, severe side effects have limited the utility of this drug. The aim of this study was to evaluate the antifungal effect of the combination of amphotericin B with black tea or white tea and protective of citotoxic effect. The present study shows that white and black teas have additive effects with amphotericin B against some species Candida. In addition, the combination of white and black tea with amphotericin B may reduce the toxicity of amphotericin B to red blood cells. Our results suggest that white and black tea is a potential agent to combine with amphotericin for antifungal efficacy and to reduce the amphotericin dose to lessen side effects.

Botulinum toxin type A in simple motor tics: short-term and long-term treatment-effects.

PubMed

Rath, Judith J G; Tavy, Dénes L J; Wertenbroek, Agnes A A C M; van Woerkom, Theodoor C A M; de Bruijn, Sebastiaan F T M

2010-08-01

To determine the short-term and long-term treatment-effects of botulinum toxin type A in simple motor tics, we analyzed 15 consecutive patients (18 tics) with simple motor tics that were treated every 3 months with injections of BTX-A. Efficacy (rated on a 4-level scale) and duration of effect of the first 2 and last 2 (if treated 5 times or more) treatments were recorded, as well as latency of response, changes of premonitory urges (PMUs) and possible side effects. Total number of treatments for each tic varied from 2 to 50 (mean 11, median 6). In 16 of 18 tics (89%) short-term efficacy was reported successful (good or moderate). Long-term efficacy was reported in 12 tics of which 11 showed similar or even increased beneficial effects. Premonitory urge (PMU) was reported in 8 patients (53%). PMU, if present, lessened or disappeared after treatment with BTX-A. A permanent remission of the treated tic was seen in 3 patients with a maximum follow-up of 10 years. BTX-A appears a safe and effective treatment for simple motor tics and retains its efficacy after long-term treatment. BTX may also induce permanent remission of the treated tics and effects of BTX are not restricted to merely motor behaviour.

Fluvoxamine versus other anti-depressive agents for depression

PubMed Central

Omori, Ichiro M; Watanabe, Norio; Nakagawa, Atsuo; Cipriani, Andrea; Barbui, Corrado; McGuire, Hugh; Churchill, Rachel; Furukawa, Toshi A

2014-01-01

Background Fluvoxamine, one of the oldest selective serotonin reuptake inhibitors (SSRIs), is prescribed to patients with major depression in many countries. Several studies have previously reviewed the efficacy and tolerability of fluvoxamine for the treatment of major depression. However, these reviews are now outdated. Objectives Our objective is to evaluate the effectiveness, tolerability and side effect profile of fluvoxamine for major depression in comparison with other anti-depressive agents, including tricyclics (TCAs), heterocyclics, other SSRIs, SNRIs, other newer agents and other conventional psychotropic drugs. Search methods We searched the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register. Trial databases and ongoing trial registers in North America, Europe, Japan and Australia, were handsearched for randomised controlled trials. We checked reference lists of the articles included in the review, previous systematic reviews and major textbooks of affective disorder for published reports and citations of unpublished research. The date of last search was 31 August 2008. Selection criteria We included all randomised controlled trials, published in any language, that compared fluvoxamine with any other active antidepressants in the acute phase treatment of major depression. Data collection and analysis Two independent review authors inspected citations and abstracts, obtained papers, extracted data and assessed the risk of bias of included studies. We analysed dichotomous data using odds ratios (ORs) and continuous data using the standardised mean difference (SMD). A random effects model was used to combine studies. Main results A total of 54 randomised controlled trials (n = 5122) were included. No strong evidence was found to indicate that fluvoxamine was either superior or inferior to other antidepressants regarding response, remission and tolerability. However, differing side effect profiles were evident, especially with regard to gastrointestinal side effects of fluvoxamine when compared to other antidepressants. For example, fluvoxamine was generally associated with a higher incidence of vomiting/nausea (versus imipramine, OR 2.23, CI 1.59 to 3.14; versus clomipramine, OR 2.13, CI 1.06 to 4.27; versus amitriptyline, OR 2.86, CI 1.31 to 2.63). Authors’ conclusions We found no strong evidence that fluvoxamine was either superior or inferior to any other antidepressants in terms of efficacy and tolerability in the acute phase treatment of depression. However, differing side effect profiles were evident. Based on these findings, we conclude that clinicians should focus on practical or clinically relevant considerations, including these differences in side effect profiles. PMID:20238342

Structure-based discovery of opioid analgesics with reduced side effects.

PubMed

Manglik, Aashish; Lin, Henry; Aryal, Dipendra K; McCorvy, John D; Dengler, Daniela; Corder, Gregory; Levit, Anat; Kling, Ralf C; Bernat, Viachaslau; Hübner, Harald; Huang, Xi-Ping; Sassano, Maria F; Giguère, Patrick M; Löber, Stefan; Da Duan; Scherrer, Grégory; Kobilka, Brian K; Gmeiner, Peter; Roth, Bryan L; Shoichet, Brian K

2016-09-08

Morphine is an alkaloid from the opium poppy used to treat pain. The potentially lethal side effects of morphine and related opioids-which include fatal respiratory depression-are thought to be mediated by μ-opioid-receptor (μOR) signalling through the β-arrestin pathway or by actions at other receptors. Conversely, G-protein μOR signalling is thought to confer analgesia. Here we computationally dock over 3 million molecules against the μOR structure and identify new scaffolds unrelated to known opioids. Structure-based optimization yields PZM21-a potent G i activator with exceptional selectivity for μOR and minimal β-arrestin-2 recruitment. Unlike morphine, PZM21 is more efficacious for the affective component of analgesia versus the reflexive component and is devoid of both respiratory depression and morphine-like reinforcing activity in mice at equi-analgesic doses. PZM21 thus serves as both a probe to disentangle μOR signalling and a therapeutic lead that is devoid of many of the side effects of current opioids.

Use of Hematopoietic Growth Factor in the Management of Hematological Side Effects Associated to Antiviral Treatment for Hcv Hepatitis

PubMed Central

Mancino, Paola; Falasca, Katia; Ucciferri, Claudio; Pizzigallo, Eligio; Vecchiet, Jacopo

2010-01-01

Haematological abnormalities are common during combination antiviral therapy for chronic hepatitis C. Although dose reduction or discontinuation can easily treat these side effects, they can adversely affect the efficacy of combination antiviral therapy reducing the likelihood of a sustained viral response (SVR). To avoid potentially diminishing a patient’s chance of response, many physicians have begun using growth factors off-label to manage anaemia and neutropenia in hepatitis C. Haematopoietic growth factors are generally well tolerated and they may be useful for managing haematological side effects of anti-HCV therapy improving patients’ quality of life. To date, the role and benefit of these agents during anti-HCV therapy and their positive impact on SVR have not conclusively determined in the published studies. However, the possibility of a benefit to individual outpatients remains, and an individualized approach is recommended. This review explores the incidence, clinical significance, and management of anaemia, neutropenia and thrombocytopenia associated with combination therapy for HCV infection. PMID:21415945

Structure–based discovery of opioid analgesics with reduced side effects

PubMed Central

Manglik, Aashish; Lin, Henry; Aryal, Dipendra K.; McCorvy, John D.; Dengler, Daniela; Corder, Gregory; Levit, Anat; Kling, Ralf C.; Bernat, Viachaslau; Hübner, Harald; Huang, Xi-Ping; Sassano, Maria F.; Giguère, Patrick M.; Löber, Stefan; Duan, Da; Scherrer, Grégory; Kobilka, Brian K.; Gmeiner, Peter; Roth, Bryan L.; Shoichet, Brian K.

2016-01-01

Morphine is an alkaloid from the opium poppy used to treat pain. The potentially lethal side effects of morphine and related opioids—which include fatal respiratory depression—are thought to be mediated by μ-opioid-receptor (μOR) signalling through the β-arrestin pathway or by actions at other receptors. Conversely, G-protein μOR signalling is thought to confer analgesia. Here we computationally dock over 3 million molecules against the μOR structure and identify new scaffolds unrelated to known opioids. Structure-based optimization yields PZM21—a potent Gi activator with exceptional selectivity for μOR and minimal β-arrestin-2 recruitment. Unlike morphine, PZM21 is more efficacious for the affective component of analgesia versus the reflexive component and is devoid of both respiratory depression and morphine-like reinforcing activity in mice at equi-analgesic doses. PZM21 thus serves as both a probe to disentangle μOR signalling and a therapeutic lead that is devoid of many of the side effects of current opioids. PMID:27533032

Lysine clonixinate vs naproxen sodium for the acute treatment of migraine: a double-blind, randomized, crossover study.

PubMed

Krymchantowski, Abouch Valenty; Peixoto, Patricia; Higashi, Rafael; Silva, Ariovaldo; Schutz, Vivian

2005-12-14

The process of inflammation is crucial in migraine, and several nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in the treatment of migraine attacks. Despite their efficacy, the routine use of NSAIDs is limited by side effects as well as incomplete efficacy in some patients. Among the available options, lysine clonixinate (LC) and naproxen sodium (NS) have proved effective in migraine. The aim of this study was to compare the efficacy and tolerability of oral formulations of LC and NS in the treatment of moderate or severe migraine attacks, with a double-blind, crossover design. Seventy subjects (62 women, 8 men) between ages 18 and 71 years (mean age, 41) with migraine according to the criteria of the International Headache Society were prospectively enrolled. The patients were randomized into 2 groups and each participant treated 2 migraine attacks. Group 1 treated the first attack with LC and the second attack with NS. Group 2 treated 2 attacks in a counterbalanced order. Doses were 250 mg of LC or 550 mg of NS, which were encapsulated for equal appearance. Headache intensity, nausea, photophobia, and side effects were evaluated at baseline, 1 hour, and 2 hours after drug administration. Rescue drugs were allowed after 2 hours for those who didn't respond, and this was also compared between groups. Sixty patients (54 women, 6 men) completed the study. At 1 hour, 13.6% patients who used LC were pain-free compared with 11.9% who used NS (P = .78). At 2 hours, 35.6% patients who took LC and 32.2% who took NS were pain-free (P = .69). At baseline, 52.5% of the patients randomized to group 1 reported nausea, compared with 33.9% in group 2, and both drugs eliminated nausea: At both 1 hour and 2 hours, nausea diminished significantly for those taking LC, but only after 2 hours for those who took NS (P < .0001). Both drugs eliminated photophobia at 1 hour and 2 hours; however, LC was superior to NS in reducing photophobia at 2 hours (P = .027). Ten patients who took LC and 8 who took NS required rescue drugs after 2 hours. Twelve patients who used LC and 16 who took NS reported side effects. Although this study did not include a placebo arm, which impairs any definitive efficacy claims, we found LC and NS to be similarly effective and well tolerated in patients presenting moderate or severe attacks of migraine.

Valsartan plus hydrochlorothiazide: a review of its use since its introduction.

PubMed

Bains, Jujhar; Smith, William B

2011-08-01

This review focuses on the role of the fixed-dose combination (FDC) drug valsartan/hydrochlorothiazide (HCTZ) in the treatment of hypertension. Effective blood pressure control often is not achieved with monotherapy and, instead, requires combinations of drugs with different mechanisms of action to produce additive or synergistic effects. FDC valsartan/HCTZ enhances not only efficacy for blood pressure control but also provides beneficial effects on target organs beyond that expected from arterial pressure reduction alone. Data describe key clinical trial experiences with the FDC, with particular attention to efficacy and tolerability. Literature searches of these various topics were conducted in January 2011. There is evidence of potential benefits with this combination associated with left ventricular hypertrophy, left ventricular dysfunction and renal disease. The FDC is an effective treatment for patients with hypertension and is superior to monotherapy than either drug alone. In addition to the benefits of each drug, valsartan/HCTZ's metabolic interactions reduce some of the negative effects of both compounds. With its increased simplicity, minimal side-effect profile and efficacy without a significant cost penalty, valsartan/HCTZ represents an excellent choice for antihypertensive therapy.

Efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin cream in chinese patients with melasma: a randomized, double-blind, placebo-controlled, multicenter, parallel-group study.

PubMed

Gong, Zijian; Lai, Wei; Zhao, Guang; Wang, Xuemin; Zheng, Min; Li, Li; Yang, Qingqi; Dang, Yuping; Liu, Lunfei; Zou, Ying

2015-06-01

This study aimed to determine the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin (FAHT) cream for the treatment of moderate and severe facial melasma. The primary objective was assessment of clinical efficacy, instrumental measured efficacy, and integral therapeutic efficacy at the end of weeks 4 and 8. A total of 233 subjects were randomly allocated (1:1 ratio) to receive topically administered FAHT cream (n = 117) or placebo (n = 116) once nightly for 8 weeks. Observed side effects were documented throughout. In the per protocol set (PPS; those subjects who met all requirements of the protocol), the integral therapeutic efficacy rate of FAHT cream on moderate and severe melasma was 68.57% (vs. placebo, 0.94%), the clinical effective rate of FAHT cream was 74.29 % (vs. placebo, 0.94%), and the instrumental measure efficacy of FAHT cream was 71.43% (vs. placebo, 6.60%). The difference in efficacy between the two groups was statistically significant (p < 0.001). In the full analysis set (FAS; the PPS and those subjects who were lost to follow-up but received at least one study treatment), the integral therapeutic efficacy rate of FAHT cream was 64.60% (vs. placebo, 0.88%), the clinical effective rate of FAHT cream was 69.91% (vs. placebo, 0.88%), and the instrumental measure efficacy of FAHT cream was 69.03 % (vs. placebo, 7.08%). The difference in efficacy between the two groups was statistically significant (p < 0.001). Of 113 subjects in the FAHT group, 34 (30.1%) reported adverse effects. Most of the pathological adverse effects were mild and resolved with either continuous treatment or discontinuation. Of 113 subjects in the placebo group, three (2.6%) reported mild adverse effects. No severe adverse effects or other abnormal clinical results were associated with the study treatment. FAHT cream is efficacious, well tolerated, and has a high margin of safety for the treatment of moderate and severe melasma in the Chinese population.

Efficacy of steroidal vs non-steroidal agents in oral lichen planus: a randomised, open-label study.

PubMed

Singh, A R; Rai, A; Aftab, M; Jain, S; Singh, M

2017-01-01

This study compared the therapeutic efficacy of steroidal and non-steroidal agents for treating oral lichen planus. Forty patients with clinical and/or histologically proven oral lichen planus were randomly placed into four groups and treated with topical triamcinolone, oral dapsone, topical tacrolimus or topical retinoid for three months. Pre- and post-treatment symptoms and signs were scored for each patient. Patients in all treatment groups showed significant clinical improvement after three months (p 0.05) and for topical retinoid vs topical tacrolimus (p > 0.05). Non-steroidal drugs such as dapsone, tacrolimus and retinoid are as efficacious as steroidal drugs for treating oral lichen planus, and avoid the side effects associated with steroids.

[Light, laser and PDT therapy for acne].

PubMed

Borelli, C; Merk, K; Plewig, G; Degitz, K

2005-11-01

In recent years, a number of studies have evaluated the treatment of acne using electromagnetic waves, such as lasers, photodynamic therapy, visible light or radio waves. While the efficacy of laser treatment is still uncertain, photodynamic therapy shows promising results, but with marked side-effects, as destruction of sebaceous glands. Treatment with blue light (405-420 nm wavelength) also appears effective and can be regarded as an treatment option for inflammatory acne.

Gemcitabine-loaded albumin nanospheres (GEM-ANPs) inhibit PANC-1 cells in vitro and in vivo

NASA Astrophysics Data System (ADS)

Li, Ji; Di, Yang; Jin, Chen; Fu, Deliang; Yang, Feng; Jiang, Yongjian; Yao, Lie; Hao, Sijie; Wang, Xiaoyi; Subedi, Sabin; Ni, Quanxing

2013-04-01

With the development of nanotechnology, special attention has been given to the nanomaterial application in tumor treatment. Here, a modified desolvation-cross-linking method was successfully applied to fabricate gemcitabine-loaded albumin nanospheres (GEM-ANPs), with 110 and 406 nm of mean diameter, respectively. The aim of this study was to assess the drug distribution, side effects, and antitumor activity of GEM-ANPs in vivo. The metabolic viability and flow cytometry analysis revealed that both GEM-ANPs, especially 406-nm GEM-ANPs, could effectively inhibit the metabolism and proliferation and promote the apoptosis of human pancreatic carcinoma (PANC-1) in vitro. Intravenous injection of 406-nm GEM-ANPs exhibited a significant increase of gemcitabine in the pancreas, liver, and spleen of Sprague-Dawley rats ( p < 0.05). Moreover, no signs of toxic side effects analyzed by blood parameter changes were observed after 3 weeks of administration although a high dose (200 mg/kg) of GEM-ANPs were used. Additionally, in PANC-1-induced tumor mice, intravenous injection of 406-nm GEM-ANPs also could effectively reduce the tumor volume by comparison with free gemcitabine. With these findings, albumin nanosphere-loading approach might be efficacious to improve the antitumor activity of gemcitabine, and the efficacy is associated with the size of GEM-ANPs.

[Axillary hyperhidrosis--efficacy and tolerability of an aluminium chloride antiperspirant. Prospective evaluation on 20 patients with idiopathic axillary hyperhidrosis].

PubMed

Streker, M; Reuther, T; Verst, S; Kerscher, M

2010-02-01

The purpose of this study was to evaluate the efficacy and tolerability of aluminium chloride gel for treatment of axillary hyperhidrosis. A total of 20 patients aged 22-38 (mean age: 26.9+/-4.3) with idiopathic axillary hyperhidrosis were included and treated with an antiperspirant (Sweat-off, Sweat-off GmbH, Hügelsheim). Study duration was 42 days. Treatment efficacy was evaluated clinically, as well as by starch-iodine test, gravimetric analysis and evaluation of the skin surface pH. After treatment there was a significant clinical improvement accompanied by significant qualitative and quantitative reduction of sweat as well as a significant reduction of skin surface pH. Except for slight skin irritation in 6 patients, there were no other side effects. Patient satisfaction improved markedly during the study. Treatment of axillary hyperhidrosis with aluminium chloride is an effective, safe and inexpensive treatment modality.

[Advances in studies on toxicity of aconite].

PubMed

Chen, Rong-Chang; Sun, Gui-Bo; Zhang, Qiang; Ye, Zu-Guang; Sun, Xiao-Bo

2013-04-01

Aconite has the efficacy of reviving yang for resuscitation, dispelling cold and relieving pain, which is widely used in clinic, and shows unique efficacy in treating severe diseases. However, aconite has great toxicity, with obvious cardio-toxicity and neurotoxicity. Its toxicological mechanism main shows in the effect on voltage-dependent sodium channels, release of neurotransmitters and changes in receptors, promotion of lipid peroxidation and cell apoptosis in heart, liver and other tissues. Aconite works to reduce toxicity mainly through compatibility and processing. Besides traditional processing methods, many new modern processing techniques could also help achieve the objectives of detoxification and efficacy enhancement. In order to further develop the medicinal value of aconite and reduce its side effect in clinical application, this article gives comprehensive comments on aconite's toxicity characteristics, mechanism and detoxification methods on the basis of relevant reports for aconite's toxicity and the author's experimental studies.

Continuous Lidocaine Infusions to Manage Opioid-Refractory Pain in a Series of Cancer Patients in a Pediatric Hospital.

PubMed

Gibbons, Kathleen; DeMonbrun, Andrea; Beckman, Elizabeth J; Keefer, Patricia; Wagner, Deb; Stewart, Margaret; Saul, D'Anna; Hakel, Stephanie; Liu, My; Niedner, Matthew

2016-07-01

Research on the safety and efficacy of continuous lidocaine infusions (CLIs) for the treatment of pain in the pediatric setting is limited. This article describes a series of pediatric oncology patients who received lidocaine infusions for refractory, longstanding, cancer-related pain. This is a retrospective review of patients who underwent lidocaine infusions to manage severe, opioid-refractory, cancer-related pain. Four patients ranging in age from 8 to 18 years were admitted to a pediatric hospital for their medical conditions and/or pain management. Structured chart review established demographic and diagnosis information, infusion rates, side effects, and efficacy of infusions in providing pain relief. Lidocaine bolus doses, infusion rates, serum concentrations, and subjective pain scores were analyzed. Median pain scores prior to lidocaine infusions were 8/10, falling to 2/10 at the infusion termination (P < 0.003), and rising to 3/10 in the first 24 hr after lidocaine (P < 0.029 compared to preinfusion pain). The infusions were generally well tolerated, with few side effects noted. In most cases, the improvement in pain scores persisted beyond termination of the infusion. CLIs were a helpful adjuvant in the four cases presented and may be an effective therapy for a more diverse array of refractory cancer pain. The majority of patients experienced pain relief well beyond the metabolic elimination of the lidocaine, corroborating a modulation effect on pain windup. Additional research regarding infusion rates, serum concentrations, side effects, and outpatient follow-up in a larger group of patients will provide additional insight into the role and safety of this therapy in children. © 2016 Wiley Periodicals, Inc.

An observational study of Venlafaxine and CYP2D6 in clinical practice.

PubMed

Rolla, R; Gramaglia, Carla; Dalò, Valentina; Ressico, Francesca; Prosperini, Pierluigi; Vidali, Matteo; Meola, Silvia; Pollarolo, Paola; Bellomo, Giorgio; Torre, Eugenio; Zeppegno, Patrizia

2014-01-01

Venlafaxine (V) is a serotonin-norepinephrine selective reuptake inhibitor, mainly metabolized by cytochrome P4502D6 (CYP2D6). CYP2D6 polymorphisms result in a variety of phenotypes: poor (PMs), intermediate (IMs), extensive (EMs), and ultrarapid metabolizers (UMs). PMs usually show poor tolerance to drugs metabolized by CYP2D6, while UMs need greater doses. The aim of this study was to evaluate the impact of CYP2D6 genotype on V dosage, therapeutic response, and side effects in a clinical outpatient setting. 47 patients with Major Depressive Disorder, treated with V 75 - 300 mg/day, underwent CYP2D6 genotyping using the INFINITI-CYP2D6 assay. Duration of treatment and clinical outcome (Clinical Global Impression [CGI] effectiveness index) were assessed. CGI assessment was performed after 6 weeks, 6 months, and 1 year of treatment with a V median dose of 150 mg/day. CYP2D6 genotyping resulted in 1 PM, 3 IMs, 42 EMs, and 1 UM. The UM took the greatest V dose (375 mg) without side effects; IMs/PMs took moderate/high doses of V (150 - 300 mg) without adverse effects; EMs displayed high response variability. PM/IM patients responded to V differently than expected according to genotype. However, the UM patient responded to a dosage higher than the usual therapeutic range and without developing side effects, suggesting an association between CYP2D6 gene duplication and the therapeutic efficacy of venlafaxine. The CYP2D6 genotyping may thus provide clinicians with a potential explanation for those patients requiring greater doses of CYP2D6 substrates in order to obtain the same therapeutic efficacy.

Comparison of the effect of lithium plus quetiapine with lithium plus risperidone in children and adolescents with bipolar I disorder: a randomized clinical trial.

PubMed

Habibi, Nastaran; Dodangi, Nasrin; Nazeri, Ali

2017-01-01

Background: In the treatment of bipolar disorder in youths, often more than one medication should be prescribed. In the current study, we compared the efficacy and tolerability of the combination of lithium and quetiapine with lithium and risperidone in the treatment of manic or mixed episodes in children and adolescents. Methods: Thirty patients (aged 10-18 years) who were hospitalized for a manic or mixed episode were recruited from consecutive inpatient admissions to the Child and Adolescent Psychiatric Unit at Razi Psychiatric Hospital (University of Social Welfare and Rehabilitation Sciences, Tehran, Iran) from June 2012 to September. They were randomly treated with lithium (with the usual dose to achieve blood levels 0.8-1) and quetiapine (400-600 mg per day) or risperidone (0.5-6 mg per day). The primary outcome measure with respect to efficacy was the mean decrease in Young Mania Rating Scale (YMRS) score. Side effects were also assessed. The independent t test and two-factor repeated measure analysis of variance (ANOVA) was used for data analysis. P-value of less than 0.05 was considered statistically significant. Results: The reduction in YMRS scores was similar in both groups. The remission rate (YMRS <12) in the group treated with quetiapine was 80% and with risperidone was 66.6%; the difference was not significant. The most common side effect was sedation in both groups. Extrapyramidal side effects were observed only with risperidone. Both drugs caused increased levels of prolactin. Conclusion: Both protocols were effective. Quetiapine in combination with lithium in manic or mixed episodes of bipolar I disorder in children and adolescents was not superior to lithium and risperidone, but was associated with fewer complications.

[Efficacy and side-effects of docetaxel combined with cisplatin on the treatment of local advanced esophageal cancer with concomitant radiation therapy].

PubMed

Zhang, Ting-rong; Zhao, Tao; Xu, Xin; Gu, Xiao-wei; Pan, Yu-kai

2010-10-01

To investigate the therapeutical effect and side-effect of docetaxel combined with cisplatin (DDP) on the treatment of local advanced esophageal cancer with concomitant radiation therapy. Ninety patients with LOCAL advanced esophageal squamous cell carcinoma were divided into two groups: (DDP + 5-Fu) group and (docetaxel + DDP) group. Chemotherapy was carried out every 4 weeks for a total of 4 courses. The radiation dose was 50.4 Gy/28FX. The median survival time of patients in the (DDP + 5-Fu) group was 16 months and that in (docetaxel + DDP) group was 21 months (P = 0.0278). The 3-year survival rate in the (docetaxel + DDP) group was obviously higher than that in the (DDP + 5-Fu) group (23.9% vs. 12.1%). The ORR in (docetaxel + DDP) group (84.5%) was significantly higher than that in the (DDP + 5-Fu) group (71.1%) (P = 0.025). No significant differences were observed in the incidence of side-effects in the two groups. The conventional dose chemotherapy of docetaxel + DDP with concomitant radiation therapy showed a better partial remission rate and long-term survival rate for the treatment of local advanced esophageal cancer than the traditional chemotherapy (DDP + 5-Fu) with concomitant radiation therapy and the side-effects are not increased.

Enhanced Patient Expectation and Antiemetic Drug Efficacy

DTIC Science & Technology

1999-07-01

NUMBER OF PAGES 15 Breast Cancer Expectancy Antiemetic Nausea and Vomiting Patient Information Side Effect 16. PRICE CODE 17. SECURITY CLASSIFICATION 18... SECURITY CLASSIFICATION OF THIS 19. SECURITY CLASSIFICATION 20. LIMITATION OF ABSTRACT OF REPORT PAGE OF ABSTRACT Unclassified Unclassified...by the introduction of the 5-HT 3 receptor antagonist class of antiemetics (ondansetron, granisetron , tropisitron) have greatly reduced chemotherapy

SSRI adverse events: how to monitor and manage.

PubMed

Murphy, Tanya K; Segarra, Ana; Storch, Eric A; Goodman, Wayne K

2008-04-01

Antidepressants are efficacious for pediatric major depressive disorder, obsessive compulsive disorder (OCD), and non-OCD anxiety disorders. Antidepressants should be used in an evidence-based fashion, with frequent monitoring for side effects, especially when initiating treatment and adjusting dosage. With diligence to appropriate prescribing and monitoring, the benefits of therapy outweigh the potential of treatment related risk.

Feasibility and efficacy of intraarticular steroids (IAS) in juvenile idiopathic arthritis (JIA).

PubMed

Verma, Sumit; Gupta, Rajiva; Lodha, Rakesh; Kabra, S K

2009-03-01

Thirteen children with juvenile idiopathic arthritis (JIA) were treated with intraarticular steroid injection of triamcilone acetonide as a day care procedure. More than half (53.4%) the children were free of pain, limp and NSAID's use, with improvement in functional score at 12 weeks. No side effects were reported during the period of the study.

Preschool ADHD: exploring uncertainties in diagnostic validity and utility, and treatment efficacy and safety.

PubMed

Sonuga-Barke, Edmund J S; Daley, David; Thompson, Margaret; Swanson, Jim

2003-07-01

The current scientific and clinical status of preschool attention deficit hyperactivity disorder and its management is reviewed. Recent clinical and neuropsychological research supporting the utility of the construct will be presented along with a critical analysis of diagnostic issues. The published literature on treatment efficacy (both pharmacological and nonpharmacological) will be reviewed with a special focus on the issue of the safety and side effects of psycho-stimulants. The need for early identification and preventative intervention is indicated but caution should be employed in the use of psychostimulants with this age group.

Coagulopathy induced by saw palmetto: a case report.

PubMed

Villanueva, Salvador; González, Jenniffer

2009-01-01

Saw palmetto is the most popular herbal supplement used to treat symptoms of benign prostatic hyperplasia (BPH). The safety and efficacy of saw palmetto has been established in the literature. While the majority of studies document the efficacy and safety of saw palmetto, some studies document the adverse side effects, including increased risk of bleeding. There are no reports in the literature about increased prothombin time (PT), partial thromboplastin time (PTT) or international normalized ratio (INR) while using saw palmetto. We present a case of hematuria and coagulopathy in a patient who was using saw palmetto.

[Advances in studies on bear bile powder].

PubMed

Zhou, Chao-fan; Gao, Guo-jian; Liu, Ying

2015-04-01

In this paper, a detailed analysis was made on relevant literatures about bear bile powder in terms of chemical component, pharmacological effect and clinical efficacy, indicating bear bile powder's significant pharmacological effects and clinical application in treating various diseases. Due to the complex composition, bear bile powder is relatively toxic. Therefore, efforts shall be made to study bear bile powder's pharmacological effects, clinical application, chemical composition and toxic side-effects, with the aim to provide a scientific basis for widespread reasonable clinical application of bear bile powder.

Herbal Medicine in Ischemic Stroke: Challenges and Prospective.

PubMed

Gaire, Bhakta Prasad

2018-04-01

Herbal medicines, mainly of plant source, are invaluable source for the discovery of new therapeutic agents for all sorts of human ailments. The complex pathogenesis of stroke and multifactorial effect of herbal medicine and their active constituents may suggest the promising future of natural medicine for stroke treatment. Anti-oxidant, anti-inflammatory, anti-apoptotic, neuroprotective and vascular protective effect of herbal medicines are believed to be efficacious in stroke treatment. Herbs typically have fewer reported side effects than allopathic medicine, and may be safer to use over longer period of time. Herbal medicines are believed to be more effective for the longstanding health complaints, such as stroke. Several medicinal plants and their active constituents show the promising results in laboratory research. However failure in transformation of laboratory animal research to the clinical trials has created huge challenge for the use of herbal medicine in stroke. Until and unless scientifically comprehensive evidence of the efficacy and safety of herbal medicine in ischemic stroke patients is available, efforts should be made to continue implementing treatment strategies of proven effectiveness. More consideration should be paid to natural compounds that can have extensive therapeutic time windows, perfect pharmacological targets with few side effects. Herbal medicine has excellent prospective for the treatment of ischemic stroke, but a lot of effort should be invested to transform the success of animal research to human use.

[Efficacy, tolerability and safety of cannabinoids for chronic neuropathic pain: A systematic review of randomized controlled studies].

PubMed

Petzke, F; Enax-Krumova, E K; Häuser, W

2016-02-01

Recently published systematic reviews came to different conclusions with respect to the efficacy, tolerability and safety of cannabinoids for treatment of chronic neuropathic pain. A systematic search of the literature was carried out in MEDLINE, the Cochrane central register of controlled trials (CENTRAL) and clinicaltrials.gov up until November 2015. We included double-blind randomized placebo-controlled studies (RCT) of at least 2 weeks duration and with at least 9 patients per treatment arm comparing medicinal cannabis, plant-based or synthetic cannabinoids with placebo or any other active drug treatment in patients with chronic neuropathic pain. Clinical endpoints of the analyses were efficacy (more than 30 % or 50 % reduction of pain, average pain intensity, global improvement and health-related quality of life), tolerability (drop-out rate due to side effects, central nervous system and psychiatric side effects) and safety (severe side effects). Using a random effects model absolute risk differences (RD) were calculated for categorical data and standardized mean differences (SMD) for continuous variables. The methodological quality of RCTs was rated by the Cochrane risk of bias tool. We included 15 RCTs with 1619 participants. Study duration ranged between 2 and 15 weeks. Of the studies 10 used a plant-derived oromucosal spray with tetrahydrocannabinol/cannabidiol, 3 studies used a synthetic cannabinoid (2  with nabilone and 1  with dronabinol) and 2 studies used medicinal cannabis. The 13 studies with parallel or cross-over design yielded the following results with 95 % confidence intervals (CI): cannabinoids were superior to placebo in the reduction of mean pain intensity with SMD - 0.10 (95 % CI - 0.20- - 0.00, p = 0.05, 13 studies with 1565 participants), in the frequency of at least a 30 % reduction in pain with an RD of 0.10 [95 % CI 0.03-0.16, p = 0.004, 9 studies with 1346 participants, number needed to treat for additional benefit (NNTB) 14, 95 % CI 8-45] and in the frequency of a large or very large global improvement with an RD of 0.09 (95 % CI 0.01-0.17, p = 0.009, 7 studies with 1092 participants). There were no statistically significant differences between cannabinoids and placebo in the frequency of at least a 50 % reduction in pain, in improvement of health-related quality of life and in the frequency of serious adverse events. Patients treated with cannabinoids dropped out more frequently due to adverse events with an RD of 0.04 [95 % CI 0.01-0.07, p = 0.009, 11 studies with 1572 participants, number needed to treat for additional harm (NNTH) 19, 95 % CI 13-37], reported central nervous system side effects more frequently with an RD of 0.38 (95 % CI 0.18-0.58, p = 0.0003, 9 studies with 1304 participants, NNTH 3, 95 % CI 2-4) and psychiatric side effects with an RD of 0.11 (95 % CI 0.06-0.16, p < 0.0001, 9 studies with 1304 participants, NNTH 8, 95 % CI 7-12). Cannabinoids were marginally superior to placebo in terms of efficacy and inferior in terms of tolerability. Cannabinoids and placebo did not differ in terms of safety during the study period. Short-term and intermediate-term therapy with cannabinoids can be considered in selected patients with chronic neuropathic pain after failure of first-line and second-line therapies.

Differential effects of left and right neuropathy on opioid gene expression in lumbar spinal cord.

PubMed

Kononenko, Olga; Mityakina, Irina; Galatenko, Vladimir; Watanabe, Hiroyuki; Bazov, Igor; Gerashchenko, Anna; Sarkisyan, Daniil; Iatsyshyna, Anna; Yakovleva, Tatiana; Tonevitsky, Alex; Marklund, Niklas; Ossipov, Michael H; Bakalkin, Georgy

2018-05-28

The endogenous opioid system (EOS) controls the processing of nociceptive stimuli and is a pharmacological target for opioids. Alterations in expression of the EOS genes under neuropathic pain condition may account for low efficacy of opioid drugs. We here examined whether EOS expression patterns are altered in the lumbar spinal cord of the rats with spinal nerve ligation (SNL) as a neuropathic pain model. Effects of the left- and right-side SNL on expression of EOS genes in the ipsi- and contralateral spinal domains were analysed. The SNL-induced changes were complex and different between the genes; between the dorsal and ventral spinal domains; and between the left and right sides of the spinal cord. Prodynorphin (Pdyn) expression was upregulated in the ipsilateral dorsal domains by each the left and right-side SNL, while changes in expression of μ-opioid receptor (Oprm1) and proenkephalin (Penk) genes were dependent on the SNL side. Changes in expression of the Pdyn and κ-opioid receptor (Oprk1) genes were coordinated between the ipsi- and contralateral sides. Withdrawal response thresholds, indicators of mechanical allodynia correlated negatively with Pdyn expression in the right ventral domain after right side SNL. These findings suggest multiple roles of the EOS gene products in spinal sensitization and changes in motor reflexes, which may differ between the left and right sides. Copyright © 2018. Published by Elsevier B.V.

An over-the-counter central sensitization therapy: a chronic back pain registry study of pain relief, medication use and their adverse effects.

PubMed

Staelin, Richard; Koneru, Sree N; Rawe, Ian M

2017-03-01

Back pain, the most prevalent musculoskeletal chronic pain condition, is usually treated with analgesic medications of questionable efficacy and frequent occurrence of adverse side effects. The objective was to determine the effectiveness of the ActiPatch medical devices in reducing chronic back pain, document medication related adverse side effects and establish their impact on quality of life. Upon completing a 7-day trial, subjects were contacted via email with an assessment form using the Constant Contact email program. A total of 1394 responses were collected from subjects who used the device for back pain. Medication adverse effects are common and impact quality of life in the lay population. ActiPatch is an effective intervention for the majority of subjects for treating chronic back pain, although this requires further investigation in randomized clinical trials.

Novel strategies in immunotherapy for allergic diseases.

PubMed

Rajakulendran, Mohana; Tham, Elizabeth Huiwen; Soh, Jian Yi; Van Bever, H P

2018-04-01

Conventional immunotherapy (IT) for optimal control of respiratory and food allergies has been fraught with concerns of efficacy, safety, and tolerability. The development of adjuvants to conventional IT has potentially increased the effectiveness and safety of allergen IT, which may translate into improved clinical outcomes and sustained unresponsiveness even after cessation of therapy. Novel strategies incorporating the successful use of adjuvants such as allergoids, immunostimulatory DNA sequences, monoclonal antibodies, carriers, recombinant proteins, and probiotics have now been described in clinical and murine studies. Future approaches may include fungal compounds, parasitic molecules, vitamin D, and traditional Chinese herbs. More robust comparative clinical trials are needed to evaluate the safety, clinical efficacy, and cost effectiveness of various adjuvants in order to determine ideal candidates in disease-specific and allergen-specific models. Other suggested approaches to further optimize outcomes of IT include early introduction of IT during an optimal window period. Alternative routes of administration of IT to optimize delivery and yet minimize potential side effects require further evaluation for safety and efficacy before they can be recommended.

[Efficacy of chondroitin sulphate in the treatment of elderly patients with gonarthrosis and coxarthrosis].

PubMed

Lazebnik, L B; Drozdov, V N

2005-01-01

To study chondroitin sulphate (CS) efficacy, tolerance and response duration in elderly patients with osteoarthrosis (OA) with consideration of OA duration and stage. A total of 97 patients aged 65-85 years with stage II-IV OA by Kellgren-Lawrence received CS treatment. The treatment efficacy was assessed by functional Lecken's index, pain intensity at walking and rest, general functional condition, need in nonsteroid anti-inflammatory (NSAI) drugs. Standardization was achieved with visual analogue scale (VAS). Positive effects (pain relief, better functional parameters, lower intake of NSAI drugs) were more pronounced and stable in patients with OA stage 1 and 2. In OA of stage 3 and 4, a beneficial effect of a 6-month CS course was unstable. Side effects were at the level of mean statistics. CS (structum) is recommended for treatment of OA stage 1-4 by Kellgren-Lawrence. Duration of the treatment depends on severity of x-ray symptoms of the disease.

Effects of dosage and dosing frequency on the efficacy and safety of high-dose metformin in Japanese patients with type 2 diabetes mellitus.

PubMed

Kanto, Kousei; Ito, Hiroyuki; Noso, Shinsuke; Babaya, Naru; Hiromine, Yoshihisa; Taketomo, Yasunori; Toma, Junko; Niwano, Fumimaru; Yasutake, Sara; Kawabata, Yumiko; Ikegami, Hiroshi

2017-09-30

Differences in the efficacy and safety of antidiabetic drugs among different ethnic groups are well documented. Metformin is widely used in the treatment of type 2 diabetes in Western countries, but high doses of metformin have been approved only recently for clinical use in Japan. The aim of the present study was to investigate the effects of dosage and dosing frequency on the efficacy and safety of high-dose metformin in Japanese patients. A total of 71 Japanese patients with type 2 diabetes were prospectively studied for the effects of dosage and dosing frequency on the efficacy and safety of metformin during hospitalization. Dose effects were studied in 27 patients treated with 0, 500, 1,000, 1,500 and 2,250 mg/day of metformin. The effect of dosing frequency was compared in 56 patients with 1,500 mg/day of metformin administered either two or three times per day. Significant dose-dependent improvement in daily profiles of blood glucose was observed with metformin dosages up to 1,500 mg/day, with a trend towards further improvement observed at 2,250 mg/day. The efficacy of 1,500 mg of metformin was comparable when the drug was administered either two or three times per day. The most frequently reported side-effects were gastrointestinal symptoms, which were not affected by the dosage or dosing frequency of metformin. These results show that the efficacy of high-dose metformin is dose-dependent in Japanese patients. The efficacy and safety of metformin were similar when the drug was administered either two or three times per day. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Clinical efficacy and safety of sildenafil citrate (Viagra) in a multi-racial population in Singapore: A retrospective study of 1520 patients.

PubMed

Lim, Peter Huat Chye; Li, Man Kay; Ng, Foo Cheong; Chia, Sing Joo; Consigliere, David; Gooren, Louis; Ng, Kok Kit; Munisamy, Malathy; Perianan, Moorthy

2002-06-01

Sildenafil citrate (Viagra), a selective inhibitor of cGMP-specific phosphodiesterase type-5, has been used as an oral therapeutic drug for erectile dysfunction. The present paper is a clinical study of the success rate and side-effects of the use of sildenafil in a multi-racial population in Singapore. From April 1999 to May 2000, 1520 patients were given sildenafil citrate. Of these, 912 patients (mean age, 54.6 years; age range, 22-99 years) were followed up and evaluated for clinical efficacy and safety of the drug. The mean duration of erectile dysfunction (ED) and follow-up periods were 31.5 and 3.0 months, respectively. Satisfactory erections assessed by single global efficacy question (GEQ) occurred in 83% of patients, major side-effects in the form of flushing (3.48%), headache (1.97%), blurred vision (1.25%), giddiness (1.18%), warmth (1.11%) and others (4.92%) were recorded in 127 patients (13.9%). Racially, Chinese men with ED had higher efficacy (85.7%), compared to Indian men (74.2%) and Malay men (72.8%). With respect to comorbid profiles, an efficacy of 77.8% (n = 271), 83.9% (n = 292), 86.4% (n = 44) and 83.3% (n = 199) was recorded in diabetic, hypertensive, ischemic heart disease patients and in benign prostatic hyperplasia patients, respectively. Patients who smoked (n = 135) and drank alcohol (n = 118) showed an efficacy of 80%. Baseline hormonal profiles of luteinizing hormone, follicle stimulating hormone, testosterone and prolactin did not affect the success rates of sildenafil citrate. Many patients had earlier received other forms of treatment (medicated urethral suppository for erection (MUSE; 84.9%); vacuum devices (86.8%), traditional medicines (100%) and other oral medications (89.2%)), but this did not influence the success rate of sildenafil citrate. But patients previously treated with prostaglandin-E intracavernosal injections were less successful on sildenafil citrate (77.3%). In the total cohort, 50 mg sildenafil citrate was an effective dose in 49% of patients and 46.5% patients needed 100 mg sildenafil citrate, while 4.1% of the total cohort needed only 25 mg sildenafil citrate. Oral sildenafil citrate has been shown to be an effective, safe and well tolerated drug in Singaporean men with ED, as in men from other parts of the world.

Glutamatergic dysfunction in catatonia? Successful treatment of three acute akinetic catatonic patients with the NMDA antagonist amantadine.

PubMed Central

Northoff, G; Eckert, J; Fritze, J

1997-01-01

Therapeutic efficiacy of the NMDA antagonist amantadine is reported in three acute neuroleptic free akinetic catatonic patients. Intravenous infusion of amantadine led to the resolution of catatonic symptoms and considerable reductions of scores in various motor scales (Simpson Angus scale for extrapyramidal side effects (SEPS), the abnormal involuntary movement scale (AIMS), Rogers catatonia and schizophrenia scales). The therapeutic effect of amantadine showed a characteristic temporal pattern with most pronounced effects four to six hours after administration and recurrence of catatonic symptoms by 24 hours later, at least partially. Such a temporal pattern of therapeutic efficacy and decreasing efficacy occurred in all three patients on all days. The results suggest the central importance of glutamatergic dysfunction in catatonic syndrome. PMID:9120462

Orthostatic side effects of clomipramine and moclobemide during treatment for depression.

PubMed

Stage, Kurt Bjerregaard Bjerregaard

2005-01-01

From a clinical point of view, orthostatic hypotension is a significant side effect during antidepressant treatment, particularly in the case of tricyclic antidepressants (TCAs). This prospective, randomized clinical trial evaluated the effects of clomipramine and moclobemide on orthostatic blood pressure during treatment for depression. One hundred and fifteen depressed inpatients, age up to 70 years, were randomized to treatment with either moclobemide (400 mg/day) or clomipramine (150 mg/day) after 1 week of placebo treatment. Orthostatic blood pressure was measured weekly over the 6-week study period. Clomipramine, but not moclobemide, caused a statistically significant fall in systolic (F = 9.37, P = 0.0037) and diastolic orthostatic blood pressure (F = 3.74, P = 0.0017). In the clomipramine-treated group of patients, we found no correlation between subjective complaints of orthostatic dizziness and the size of systolic orthostatic blood pressure. In conclusion, this study indicates that moclobemide does not induce orthostatic side effects, which is a significant problem in treatment with TCAs. However, the choice of antidepressants depends on other factors as well, e.g. the therapeutic efficacy.

Adenosine-Associated Delivery Systems

PubMed Central

Kazemzadeh-Narbat, Mehdi; Annabi, Nasim; Tamayol, Ali; Oklu, Rahmi; Ghanem, Amyl; Khademhosseini, Ali

2016-01-01

Adenosine is a naturally occurring purine nucleoside in every cell. Many critical treatments such as modulating irregular heartbeat (arrhythmias), regulation of central nervous system (CNS) activity, and inhibiting seizural episodes can be carried out using adenosine. Despite the significant potential therapeutic impact of adenosine and its derivatives, the severe side effects caused by their systemic administration have significantly limited their clinical use. In addition, due to adenosine’s extremely short half-life in human blood (less than 10 s), there is an unmet need for sustained delivery systems to enhance efficacy and reduce side effects. In this paper, various adenosine delivery techniques, including encapsulation into biodegradable polymers, cell-based delivery, implantable biomaterials, and mechanical-based delivery systems, are critically reviewed and the existing challenges are highlighted. PMID:26453156

Experience with rufinamide in a pediatric population: a single center's experience.

PubMed

Vendrame, Martina; Loddenkemper, Tobias; Gooty, Vasu D; Takeoka, Masanori; Rotenberg, Alexander; Bergin, Ann M; Eksioglu, Yaman Z; Poduri, Annapurna; Duffy, Frank H; Libenson, Mark; Bourgeois, Blaise F; Kothare, Sanjeev V

2010-09-01

Rufinamide is a new antiepileptic drug recently approved as adjunctive treatment for generalized seizures in Lennox-Gastaut syndrome. We undertook a retrospective analysis of 77 patients with refractory epilepsy and receiving rufinamide to evaluate the drug's efficacy, tolerability, safety, and dosing schedules. It appeared efficacious in diverse epilepsy syndromes, with the highest responder rate in focal cryptogenic epilepsies (81.1% of patients with >50% response rate), and in diverse seizure types, with the highest responder rate in tonic/atonic and partial seizures (48.6% and 46.7% of patients with >50% response rate, respectively). Rufinamide was well tolerated: only 13% of patients developed side effects necessitating drug withdrawal. These findings suggest that rufinamide may possess good efficacy and tolerability, and that its efficacy may extend to epilepsy syndromes beyond Lennox-Gastaut, including both partial and generalized epilepsy syndromes. Copyright 2010 Elsevier Inc. All rights reserved.

Local therapeutic efficacy with reduced systemic side effects by rapamycin-loaded subcapsular microspheres.

PubMed

Falke, Lucas L; van Vuuren, Stefan H; Kazazi-Hyseni, Filis; Ramazani, Farshad; Nguyen, Tri Q; Veldhuis, Gert J; Maarseveen, Erik M; Zandstra, Jurjen; Zuidema, Johan; Duque, Luisa F; Steendam, Rob; Popa, Eliane R; Kok, Robbert Jan; Goldschmeding, Roel

2015-02-01

Kidney injury triggers fibrosis, the final common pathway of chronic kidney disease (CKD). The increase of CKD prevalence worldwide urgently calls for new therapies. Available systemic treatment such as rapamycin are associated with serious side effects. To study the potential of local antifibrotic therapy, we administered rapamycin-loaded microspheres under the kidney capsule of ureter-obstructed rats and assessed the local antifibrotic effects and systemic side effects of rapamycin. After 7 days, microsphere depots were easily identifiable under the kidney capsule. Both systemic and local rapamycin treatment reduced intrarenal mTOR activity, myofibroblast accumulation, expression of fibrotic genes, and T-lymphocyte infiltration. Upon local treatment, inhibition of mTOR activity and reduction of myofibroblast accumulation were limited to the immediate vicinity of the subcapsular pocket, while reduction of T-cell infiltration was widespread. In contrast to systemically administered rapamycin, local treatment did not induce off target effects such as weight loss. Thus subcapsular delivery of rapamycin-loaded microspheres successfully inhibited local fibrotic response in UUO with less systemic effects. Therapeutic effect of released rapamycin was most prominent in close vicinity to the implanted microspheres. Copyright © 2014 Elsevier Ltd. All rights reserved.

The efficacy of treatment of patients with severe constipation or recurrent pseudo-obstruction with pyridostigmine.

PubMed

O'Dea, C J; Brookes, J H; Wattchow, D A

2010-06-01

Disorders of colonic motility, such as severe constipation and pseudo-obstruction, remain difficult to treat. The pathophysiology of these conditions is not completely understood, but previous studies suggest a deficiency of cholinergic innervation and an imbalance in autonomic regulation of colonic motor function as contributing factors. Therefore, increasing the availability of acetylcholine in the bowel wall with a cholinesterase inhibitor, such as pyridostigmine, may improve symptoms. We studied thirteen patients with severe constipation (slow transit type) or recurrent pseudo-obstruction. The six patients with slow transit constipation had mechanical obstruction and pelvic floor dysfunction excluded, and normal calibre colon and slow transit confirmed. These patients were offered pyridostigmine in an attempt to avoid surgery. The seven patients with pseudo-obstruction had dilated bowel on imaging, and mechanical obstruction was excluded. These patients received pyridostigmine when symptoms recurred, despite previous treatments. Pyridostigmine was initiated at 10 mg b.i.d. and increased if required. One of the six patients with slow transit constipation reported improvement of symptoms and had concurrently weaned anti-psychotic medications. Pyridostigmine was ceased in the remaining five patients due to lack of efficacy and/or side effects. Four patients proceeded to surgery for refractory symptoms. All seven patients with pseudo-obstruction had some improvement of symptoms with few side effects. Of these, two later had surgery for recurrent symptoms. In patients with slow transit constipation, treatment with pyridostigmine does not improve symptoms. However, it does improve symptoms in patients with recurrent pseudo-obstruction with few side effects, offering an extra treatment option for these patients.

[Nitroglycerin patch for tocolysis--a prospective randomized comparison with fenoterol by infusion].

PubMed

Schleussner, E; Richter, S; Gross, W; Kähler, C; Möller, A; Möller, U; Seewald, H J

2001-01-01

To evaluate tocolytic efficacy of transdermal glyceryl trinitrate (GTN) in comparison to fenoterol per infusionem in a prospective randomized multicenter study. 50 pregnant women between 27 and 35 weeks of gestation with preterm labour were treated with either GTN patches (0.4-0.8 mg/h) or fenoterol per infusionem (60-120 micrograms/h) up to stop of contractions or 35 weeks in maximum. The primary outcomes were the prolongation of gestation by 48 h, 7 days or up to 37 weeks of gestation as well as the neonatal outcome. The progression of cervical ripening and maternal side effects during tocolysis were assessed as secondary outcome criteria. There was no difference in successful tocolysis for 48 h and 7 days in both groups, whereas significantly more women passed 37 weeks after GTN therapy. So mean duration of pregnancy, birth weight and height were greater, whereas transfer into neonatal care unit was significantly rare after GTN. There were no differences in neonatal outcome and progression of cervical ripening during tocolysis. Maternal side effects during GTN were fewer and weaker compared with fenoterol. Circa 70% of GTN treated women had a headache temporary, whereas more than 90% of the patients with fenoterol suffered from tachycardia and tremor. Tocolytic efficacy of transdermal GTN was at least equivalent to the established beta-mimetic therapy with fenoterol. Because of the lower preterm delivery rate transfer into neonatal care for control was significantly rarer after GTN with equally good neonatal outcome in both groups. Beside the headache transdermal GTN therapy had lower maternal side effects in comparison to fenoterol.

Neurotoxicity Associated with Platinum-Based Anti-Cancer Agents: What are the Implications of Copper Transporters?

PubMed

Stojanovska, Vanesa; McQuade, Rachel; Rybalka, Emma; Nurgali, Kulmira

2017-01-01

Platinum-based anti-cancer agents, which include cisplatin, carboplatin and oxaliplatin, are an important class of drugs used in clinical setting to treat a variety of cancers. The cytotoxic efficacy of these drugs is mediated by the formation of inter-strand and intrastrand crosslinks, or platinum adducts on nuclear DNA. There is also evidence demonstrating that mitochondrial DNA is susceptible to platinum-adduct damage in dorsal root ganglia neurons. Although all platinum-based agents form similar DNA adducts, they are quite different in terms of activation, systemic toxicity and tolerance. Platinum-based agents are well known for their neurotoxicity and gastrointestinal side-effects which are major causes for dose limitation and treatment discontinuation compromising the efficacy of anti-cancer treatment. Accumulating evidence in non-neuronal cells shows that the copper transport system is associated with platinum drug sensitivity and resistance. There is minimal research concerning the role of copper transporters within the central and peripheral nervous systems. It is unclear whether neurons are more sensitive to platinum-based drugs, are insufficient in drug clearance, or whether platinum accumulation affects intracellular copper status and coppermediated functions. Understanding these mechanisms is important as neurotoxicity is the predominant side-effect of platinum-based chemotherapy. This review highlights the role of copper transpor ters in drug influx, differences in drug activation and side-effects caused by platinum-based agents, as well as their association with central and peripheral neuropathies and gastrointestinal toxicities. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Complementary and alternative medicine for autism spectrum disorders: rationale, safety and efficacy.

PubMed

Whitehouse, Andrew J O

2013-09-01

Complementary and alternative medicine is widely used for children with autism spectrum disorder, despite uncertainty regarding efficacy. This review describes complementary and alternative practices commonly used among this population, the rationale for the use of each practice, as well as the side-effect profile and evidence for efficacy. The existing evidence base indicates that melatonin can be recommended as a treatment for sleeping disturbances associated with autism spectrum disorder, while secretin can be rejected as an efficacious treatment for broader autistic symptoms. There is insufficient evidence to draw conclusions on the efficacy of modified diets, hyperbaric oxygen therapy, immune therapy, and vitamin and fatty acid supplementation. There is a clear need for methodologically rigorous studies to provide evidence-based guidance to families and clinicians regarding complementary and alternative practices for individuals with autism spectrum disorders. © 2013 The Author. Journal of Paediatrics and Child Health © 2013 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

The dark and bright sides of self-efficacy in predicting learning, innovative and risky performances.

PubMed

Salanova, Marisa; Lorente, Laura; Martínez, Isabel M

2012-11-01

The objective of this study is to analyze the different role that efficacy beliefs play in the prediction of learning, innovative and risky performances. We hypothesize that high levels of efficacy beliefs in learning and innovative performances have positive consequences (i.e., better academic and innovative performance, respectively), whereas in risky performances they have negative consequences (i.e., less safety performance). To achieve this objective, three studies were conducted, 1) a two-wave longitudinal field study among 527 undergraduate students (learning setting), 2) a three-wave longitudinal lab study among 165 participants performing innovative group tasks (innovative setting), and 3) a field study among 228 construction workers (risky setting). As expected, high levels of efficacy beliefs have positive or negative consequences on performance depending on the specific settings. Unexpectedly, however, we found no time x self-efficacy interaction effect over time in learning and innovative settings. Theoretical and practical implications within the social cognitive theory of A. Bandura framework are discussed.

Effect of olive leaf, Satureja khuzestanica, and Allium sativum extracts on Giardia lamblia cysts compared with metronidazole in vitro.

PubMed

Fallahi, Sh; Rostami, A; Delfan, B; Pournia, Y; Rashidipour, M

2016-12-01

Giardia lamblia is one of the common causes of worldwide diarrhea in children. Appropriate medicinal treatment for giardiasis is available but there are some evidences of drug resistance, insufficient efficacy, and unpleasant side effects. In order to reach a more natural drug with suitable efficacy and the lowest side effects, the effects of the hydroalcoholic extracts of olive leaf, Satureja khuzestanica , and Allium sativum on G. lamblia cysts were evaluated in vitro, as well as antigiardial effect of the extracts was compared with metronidazole as the drug of choice. 2 and 5 mg of the plants extracts and powder of metronidazole 250 mg pills were added to 1 ml of G. lamblia cysts suspension (containing 5,000 cyst/ml normal saline), and the percentages of bioavailability of G. lamblia cysts were examined at the 2nd and 4th h after exposure and in 4 and 37 °C temperatures using eosin 0.1 % and a haemocytometer. The data were analyzed by multiway ANOVA test, Tukey's test, and the SPSS software, version 18. The examinations demonstrated that olive leaf extract had the most fatality rate on G. lamblia cysts in vitro (37.90 ± 7.01 %), followed by the extract of S. khuzestanica (32.52 ± 9.07 %). Metronidazole 250 mg pills had relatively effective fatality rate on G. lamblia cysts in vitro (28.75 ± 10.30 %), whereas A. sativum (garlic) had the lowest fatality effect on G. lamblia cysts in vitro (22.65 ± 10.47 %). With respect to higher fatality effect of olive leaf and S. khuzestanica extracts compared with metronidazole in vitro, these plants can be used as suitable candidates to make new antigiardial drugs with low side effects and without drug resistance in the treatment of giardiasis in children.

National Drug Formulary review of statin therapeutic group using the multiattribute scoring tool

PubMed Central

Ramli, Azuana; Aljunid, Syed Mohamed; Sulong, Saperi; Md Yusof, Faridah Aryani

2013-01-01

Purpose HMG-CoA reductase inhibitors (statins) are extensively used in treating hypercholesterolemia. The statins available in Malaysia include atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin, and fluvastatin. Over the years, they have accumulated in the National Drug Formulary; hence, the need for review. Effective selection of the best drugs to remain in the formulary can become complex due to the multiple drug attributes involved, and is made worse by the limited time and resources available. The multiattribute scoring tool (MAST) systematizes the evaluation of the drug attributes to facilitate the drug selection process. In this study, a MAST framework was developed to rank the statins based on their utilities or benefits. Methods Published literature on multicriteria decision analysis (MCDA) were studied and five sessions of expert group discussions were conducted to build the MAST framework and to review the evidence. The attributes identified and selected for analysis were efficacy (clinical efficacy, clinical endpoints), safety (drug interactions, serious side effects and documentation), drug applicability (drug strength/formulation, indications, dose frequency, side effects, food–drug interactions, and dose adjustments), and cost. The average weights assigned by the members for efficacy, safety, drug applicability and cost were 32.6%, 26.2%, 24.1%, and 17.1%, respectively. The utility values of the attributes were scored based on the published evidence or/and agreements during the group discussions. The attribute scores were added up to provide the total utility score. Results Using the MAST, the six statins under review were successfully scored and ranked. Atorvastatin scored the highest total utility score (TUS) of 84.48, followed by simvastatin (83.11). Atorvastatin and simvastatin scored consistently high, even before drug costs were included. The low scores on the side effects for atorvastatin were compensated for by the higher scores on the clinical endpoints resulting in a higher TUS for atorvastatin. Fluvastatin recorded the lowest TUS. Conclusion The multiattribute scoring tool was successfully applied to organize decision variables in reviewing statins for the formulary. Based on the TUS, atorvastatin is recommended to remain in the formulary and be considered as first-line in the treatment of hypercholesterolemia. PMID:24353428

Protocol of a prospective study for the combination treatment of Shu-Gan-jian-Pi decoction and steroid standard therapy in autoimmune hepatitis patients.

PubMed

Chi, Xiao-Ling; Xiao, Huan-Ming; Xie, Yu-Bao; Cai, Gao-Shu; Jiang, Jun-Min; Tian, Guang-Jun; Shi, Mei-Jie; Wu, Shu-Duo; Zhao, Peng-Tao; Chen, Hui-Jun

2016-12-07

Prednisone plus azathioprine is considered the mainstay of therapy in the current recommendations for autoimmune hepatitis (AIH). However, it does not provide good benefits for AIH patients because of its serious side effects. Therefore, more and more AIH patients prefer to seek for traditional Chinese medicine (TCM) to manage their symptoms and reduce the side effects of steroids in China. Shu-Gan-Jian-Pi Decoction is a popular used Chinese herbal formula in Guangdong province of China, which has demonstrated the effect of improving efficacy and reducing side effects of corticosteroids in AIH patients. The aim of this study is to evaluate the effects of Shu-Gan-Jian-Pi Decoction combined with steroid in AIH patients. So, this study aims to explore whether the combination treatment of Shu-Gan-Jian-Pi Decoction and steroid standard therapy could improve the clinical management of AIH. A prospective non-randomized study on AIH will be conducted between October 2015 and June 2017 in Guangdong Provincial hospital of Chinese medicine. Eligible AIH patients will be classified as the case group (n = 66) and the control group (n = 66) based on the interventions. Patients taking Shu-Gan-Jian-Pi Decoction combined with prednisone and azathioprine will be in the case group and those taking prednisone and azathioprine will be in the control group. The whole study will last 48 weeks, including a 24-week observation period and a 24-week follow-up period. The primary outcome was complete response to therapy, defined as complete biochemical remission at the patient's last visit of observation period and the absence of predefined steroid-specific side effects throughout treatment. This trial will evaluate the efficacy and safety of Shu-Gan-Jian-Pi Decoction combined with prednisone and azathioprine on AIH patients. The achievement of this trial will provide evidence-based data for Shu-Gan-Jian-Pi Decoction, which could provide good benefits for AIH patients. Chinese Clinical Trial Registry: ChiCTR-OOC-15006155 . Registration date: 28 March 2015.

A systematic review and meta-analysis for the adverse effects, immunogenicity and efficacy of Lyme disease vaccines: Guiding novel vaccine development.

PubMed

Badawi, Alaa; Shering, Maria; Rahman, Shusmita; Lindsay, L Robbin

2017-04-20

Lyme borreliosis (LB) is the most prevalent arthropod-borne infectious disease in North America. Currently, no vaccine is available to prevent LB in humans, although monovalent and multivalent vaccines have been developed in the past. The aim of the current study is to conduct a systematic review and meta-analysis to evaluate and compare the findings from these two classes of vaccines for their reactogenicity, immunogenicity and efficacy, in the hope this may assist in the development of future vaccines. A search strategy was developed for online databases (PubMed, Ovid MEDLINE, and Embase). Search terms used were "vaccine/vaccination", "Lyme disease/Borreliosis", "clinical trial(s)" and "efficacy". Only seven clinical trials were included to compare the results of the monovalent vaccines to those of the multivalent one. Meta-analyses were conducted to evaluate the reactogenicity and immunogenicity of the two vaccine classes. Odds ratio (OR) for LB (and 95% confidence intervals; 95% CI) were calculated for the efficacy of the monovalent vaccine from three different clinical trials at different dose schedules. Incidence of redness (local adverse effect) and fever (systemic side effect) were, respectively, 6.8- and 2.9-fold significantly lower (p < 0.05) in individuals who received multivalent vaccines compared to those receiving the monovalent one. Incidences of all other local and systemic adverse effects were non-significantly lower in the multivalent vaccine compared to the monovalent vaccines. Seroprotection was comparable among individuals who received the two vaccine classes at the 30 μg dose level. Efficacy in the prevention of LB was only evaluated for the monovalent vaccines. OR of LB ranged from 0.49 (95% CI: 0.14-0.70; p < 0.005, vs. placebo) to 0.31 (95% CI: 0.26-0.63; p < 0.005) for the initial and final doses respectively, with an overall OR of 0.4 (95% CI: 0.26-0.63, p < 0.001). The current study further validates that the monovalent and multivalent LB vaccines result in mild local side effects and self-limiting systemic adverse effects, with the multivalent vaccine slightly more tolerable than the monovalent one. Both vaccine classes were similarly highly immunogenic. A new vaccine with high safety standards, better efficacy, low cost, and public acceptance is yet to be developed. Meanwhile, personal protection limiting exposure to ticks is recommended.

Comparative study of 5 % potassium hydroxide solution versus 0.05% tretinoin cream for Molluscum Contagiosum in children.

PubMed

Rajouria, E A; Amatya, A; Karn, D

2011-01-01

Molluscum contagiosum is one of the commonest cutaneous viral infections in children. All treatment modalities are associated with substantial pain, tissue destruction, and frequent recurrence. To compare the efficacy and side effects of KOH 5% solution with tretinoin 0.05% cream for the treatment of molluscum contagiosum in children. Fifty patients were randomly divided into 2 groups; 25 each for 5% KOH solution and 0.05% tretinoin cream. The given medication was applied at bed time over molluscum lesions. The assessment of response and side effects were performed weekly for 4 weeks. At the end of 4 weeks, the mean lesion count decreased from 9.48 +/- 3.00 SD to 1.67 +/- 0.58 SD and from 8.35 +/- 2.82 SD to 2.00 +/- 1.00 SD in patients treated with 5% KOH solution and 0.05% tretinoin cream respectively. The result of both KOH and tretinoin showed good response, well tolerated by children but between the two, KOH showed fast recovery and most lesions were resolved before 4 week. The side effects could be minimized if applied as stated above. On the other hand, tretinoin showed delayed response and even some of lesion extended beyond 4 week but the side effect were less, and hence can be used in recurrent cases.

A Review of Nanoparticle Photosensitizer Drug Delivery Uptake Systems for Photodynamic Treatment of Lung Cancer.

PubMed

Gift, Mokwena Mpho; Ann, Kruger Cherie; Ivan, Mfouo-Tynga; Heidi, Abrahamse

2018-03-24

Lung cancer is a leading cause of cancer related deaths worldwide and so current research is focused on trying to improve treatment modalities, such as photodynamic therapy (PDT). PDT has 3 fundamental factors, namely a photosensitizer (PS) drug, light and oxygen. When a PS drug is administered to a patient, it can either passively or actively accumulate within a tumour site and once exposed to a specific wavelength of light, it is stimulated to produce reactive oxygen species (ROS), resulting in tumour destruction. However, the efficacy of ROS generation for tumour destruction is highly dependent on the accumulation of the PS in tumour cells. Thus PS selective / targeted uptake and delivery in tumour cells is a crucial factor in PDT cancer drug absorption studies. Generally, within non-targeted drug delivery mechanisms, only small amounts of PS is able to passively accumulates in tumour sites due to the enhanced permeability and retention (EPR) effect and the remainder distributes into healthy tissues, causing side effects. Thus to improve the efficacy of PDT, research is currently focused on the development of specific receptor based photosynthetic nanocarrier drugs, which promotes the active uptake and absorption of PS drugs in tumour sites only, avoiding unwanted side effects. The aim of this review is to focus on current non-targeted passive versus specifically active targeted PS nanoparticle drug delivery systems, that have been investigated for the PDT treatment of lung cancer and so to deduce its efficacy and recent advancements. Copyright © 2018. Published by Elsevier B.V.

Alternative Therapies for Diabetes: A Comparison of Western and Traditional Chinese Medicine (TCM) Approaches.

PubMed

Xiao, Eric; Luo, Luguang

2017-05-18

Across the world, the economic and health costs of diabetes are rising at an alarming rate. Each year in the United States, billions of dollars are spent on T2 Diabetes mellitus (T2DM) treatments, but such treatments are not always effective and can lead to adverse events. Many pharmacological treatments exist to control the primary and secondary symptoms of T2DM, but these medications are not always efficacious, do little to treat secondary T2DM symptoms, and often carry adverse side effects. Traditional Chinese Medicine (TCM) is a form of alternative medicine that is becoming appealing to western healthcare systems because of its comprehensive, holistic approach to managing T2DM patients. Works across TCM printed texts, clinical trial databases, medical association practice guidelines, and the existing literature on TCM and western diabetes treatments (in print and online) are reviewed. Conventional pharmaceutical therapies for T2DM are not efficacious enough to maintain satisfactory blood glucose levels for all patients, and even patients who maintain stable blood glucose levels may still suffer from secondary T2DM symptoms as well as from the side effects of their medications. TCM therapies have demonstrated promising results in T2DM clinical studies without causing the types of side effects associated with standard pharmaceutical treatments. In addition, the economic burden of TCM diabetes treatments on patients and payers is oftentimes less than that of pharmaceutical regimens. TCM approaches can be a viable alternative approach to treatment in the modern U.S. healthcare landscape, but a number of obstacles impede its assimilation into western health systems. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Oxcarbazepine in the treatment of bipolar and schizoaffective disorders.

PubMed

Popova, Ekaterine; Leighton, Caroline; Bernabarre, Antoni; Bernardo, Miquel; Vieta, Eduard

2007-06-01

Oxcarbazepine is an antiepileptic drug that has been approved by the US FDA and is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and children aged over 4 years. The aim of this report is to investigate the results of clinical trials in order to ascertain the efficacy and safety of oxcarbazepine for use in bipolar disorder and schizoaffective disorder. Oxcarbazepine is a keto-congener of carbamazepine with fewer side effects and drug interactions. Orally administrated oxcarbazepine is rapidly and completely absorbed and has a half-life of 9 h. Currently, there is a lack of controlled clinical trials studying the use of oxcarbazepine. In light of controlled and open-label prospective studies, it may be useful for manic symptoms in the treatment of bipolar and schizoaffective patients. Case reports, retrospective and prospective studies suggest that oxcarbazepine might have prophylactic efficacy and long-term benefit for these patients. In addition, owing to its lower propensity for drug interactions and side effects, it may be useful in the treatment of refractory patients with bipolar and schizoaffective disorder. However, most of the trials have relevant methodological shortcomings. The side-effect profile of oxcarbazepine is similar to carbamazepine, but the severity of these effects appears to be slightly less. The symptoms that are most frequently associated with the use of oxcarbazepine are asthenia, headache, dizziness, somnolence, nausea, diplopia and skin rash. Isolated cases of hyponatremic coma have been reported, thus electrolyte abnormalities should be closely monitored. Oxcarbazepine is now a generic drug, but the metabolite licarbazepine and other related compounds, such as eslicarbazepine, are currently being studied under controlled conditions and might become useful therapies for bipolar and schizoaffective disorder in the future.

p-Dodecylaminophenol derived from the synthetic retinoid, fenretinide: antitumor efficacy in vitro and in vivo against human prostate cancer and mechanism of action.

PubMed

Takahashi, Noriko; Watanabe, Yusuke; Maitani, Yoshie; Yamauchi, Takayasu; Higashiyama, Kimio; Ohba, Toshihiro

2008-02-01

Fenretinide, N-(4-hydroxyphenyl)retinamide (4-HPR) is an aminophenol-containing synthetic retinoid derivative of all-trans-retinoic acid, which is a potent chemopreventive and antiproliferative agent against various cancers. Clinical studies of 4-HPR have shown side effects consisting of night blindness and ocular toxicity. To maintain potent anticancer activity without side effects, p-dodecylaminophenol (p-DDAP) was designed based on structure-activity relationships of 4-HPR. In our study, we investigate whether p-DDAP shows anticancer activity against human prostate cancer cell line PC-3 when compared with 4-HPR. p-DDAP inhibited PC-3 cell growth progressively from low to high concentration in a dose-dependent manner. p-DDAP was the most potent antiproliferative agent in vitro among 6 p-alkylaminophenols and 3 4-hydroxyphenyl analogs examined including 4-HPR. Cells treated with p-DDAP were shown to undergo apoptosis, based on condensation nuclei, cytofluorimetric analysis, propidium iodide staining and the expression of bcl-2 and caspase 3. p-DDAP arrested the S phase of the cell cycle, while 4-HPR arrested the G(0)/G(1) phase. In addition, both the i.v. and i.p. administration of p-DDAP suppressed tumor growth in PC-3-implanted mice in vivo. p-DDAP showed no effects on blood retinol concentrations, in contrast to reductions after 4-HPR administration. These results indicate that p-DDAP exhibits excellent anticancer efficacy against hormonal independent prostate cancer in vitro and in vivo, and it may have great potential for clinical use in the treatment of prostate cancer with reduced side effects. (c) 2007 Wiley-Liss, Inc.

Conventional versus novel antipsychotics: changing concepts and clinical implications.

PubMed Central

Remington, G; Chong, S A

1999-01-01

Novel antipsychotics represent a significant advance in the treatment of schizophrenia after many years of few developments. The conventional antipsychotics are potent D2 antagonists, but fail to achieve a response in about 30% of cases. They are also associated with a high rate of extrapyramidal side effects. The greater and broader spectrum of efficacy combined with the reduced short- and long-term side effects of the new drugs such as quetiapine, risperidone, olanzapine and ziprasidone, contribute to a fresh optimism for the pharmacotherapy of schizophrenia. These novel agents are now driving further advances in schizophrenia research through a growing understanding of their pharmacological and clinical profiles. Clozapine, the first novel antipsychotic, has relatively low activity at D2 receptors, a high affinity for D4 receptors and a greater 5-HT2 (serotonin) than D2 antagonism. Hence, clozapine and other novel antipsychotics can be classified as such by this latter characteristic. However, some of these drugs have D2 occupancy greater than 60% (the clinical response threshold), while others have a lower D2 occupancy. The novel antipsychotics according have also been classified according to their activity on different neurotransmitter systems. While more effective, novel antipsychotics are not a panacea; they have limitations and side effects. In clinical practice, the American Psychiatric Association recommends either a conventional or novel antipsychotic for initial treatment of schizophrenia, whereas Canadian guidelines recommend novel agents. These agents should also be considered for treatment of refractory schizophrenia. Patients whose schizophrenia does not respond to one of these agents may respond to another. Future research should involve longer clinical trials, given the long periods needed to establish efficacy, and should address many remaining questions about the novel agents. PMID:10586534

Evaluation of the efficacy and safety of combinations of hydroquinone, glycolic acid, and hyaluronic acid in the treatment of melasma.

PubMed

Ibrahim, Zeinab A; Gheida, Shereen F; El Maghraby, Gamal M; Farag, Zeinab E

2015-06-01

Various treatments are currently available for melasma. However, results are often disappointing. 1 To assess the efficacy and safety of combinations of hydroquinone, glycolic acid, and hyaluronic acid in the treatment of melasma after topical application. 2 To evaluate the dermoscopy as a tool in diagnosis and follow-up of melasma treatment. One hundred patients with mild, moderate-to-severe melasma were divided into five groups. Group I (twenty patients were treated with cream formula containing 4% hydroquinone), group II (twenty patients were treated with cream formula containing 4% hydroquinone + 10% glycolic acid), group III (twenty patients were treated with cream formula containing 4% hydroquinone + 0.01% hyaluronic acid), group IV (twenty patients were treated with cream formula containing 4% hydroquinone + 10% glycolic acid + 0.01% hyaluronic acid), and group V (twenty patients were treated with placebo cream). All patients were subjected to dermoscopic examination and digital photographs before and after treatment. The response and side effects were evaluated. Groups I, III, and IV showed highly significant changes in modified Melasma Area and Severity Index (mMASI) score after using the treatment. Group II showed significant change in mMASI score after using the treatment. The side effects were more reported in group II, followed by group IV, followed by group I, followed by group III. There was highly significant difference between the dermoscopic color findings before and after treatment. Vascularization was another dermoscopic finding. A cream formula containing 4% hydroquinone + 10% glycolic acid + 0.01% hyaluronic acid was very effective in treatment of melasma with tolerable side effects. Dermoscope is a valuable noninvasive tool in the diagnosis and follow-up of melasma treatment. © 2015 Wiley Periodicals, Inc.

Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study.

PubMed

Vanlangenhove, Peter; De Keukeleire, Katrien; Everaert, Karel; Van Maele, Georges; Defreyne, Luc

2012-06-01

This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. A total of 112 insufficient spermatic veins (left-sided, n=84; right-sided, n=28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n=54; Histoacryl, Braun, Germany) or NBCA-MS (n=58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n=54/54, 100% vs. NBCA-MS, n=54/57, 94.7%; P=0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n=45/54, 83.3% vs. NBCA-MS, n=41/58, 70.7%; P=0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n=25/54, 46.3% vs. NBCA-MS, n=29/58, 50%; P=0.71). No glue-related complications were noted. NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

Oxcarbazepine monotherapy in patients with brain tumor-related epilepsy: open-label pilot study for assessing the efficacy, tolerability and impact on quality of life.

PubMed

Maschio, M; Dinapoli, L; Sperati, F; Fabi, A; Pace, A; Vidiri, A; Muti, P

2012-02-01

We conducted a prospective, observational study to verify the efficacy, tolerability and impact on quality of life, mood and global neurocognitive performances of oxcarbazepine monotherapy in patients with brain tumor-related epilepsy (BTRE). Patients were followed for 12 months. We recruited 25 patients (11 females 14 males; mean age 49.7) affected with BTRE (17 de novo patients and 7 in monotherapy with other antiepileptics) and introduced oxcarbazepine monotherapy because of uncontrolled seizures and/or side effects. At first visit, patients underwent neurological examination, Qolie 31P V2, EORTC QLQC30, Zung self-depression rating scale (ZSDRS) and adverse events profile. A seizure diary was given to each patient. Follow-up duration was 1-12 months (mean 7.1 months, 5 patients died and 10 dropped out). Totals of 16 patients underwent both chemotherapy and radiotherapy, 4 chemotherapy only, 1 radiotherapy only, and 4 did not undergo any systemic therapy. Mean dosage of oxcarbazepine was 1,230 mg/day (min 600, max 2,100 mg/day). McNemar's test showed a significant difference in seizure freedom rate (P = 0.002) between baseline and final follow-up in the intent-to-treat population. Six patients (24%) had serious side effects and one patient (4%) mild. Logistic regression revealed that, in our study, chemotherapy and radiotherapy did not affect the efficacy of OXC in seizure outcome (P = 0.658). The test evaluation at final follow-up showed a significant improvement in ZSDRS (P = 0.011) and no change over time. Oxcarbazepine seems to be efficacious in controlling seizures and in improving mood in patients with BTRE, but special caution should be taken when it is administered during radiotherapy.

Treating depression with antidepressants: drug-placebo efficacy debates limit broader considerations.

PubMed

Yapko, Michael D

2013-01-01

The core issue regarding antidepressants for many clinicians is whether they perform significantly better than placebos. However, this article suggests eight additional concerns beyond drug efficacy alone to consider regarding antidepressants including: (1) formulating only a one-dimensional, biological view of depression; (2) defining the client's role as passive in treatment; (3) economic corruption of the research and reporting; (4) false or misleading consumer advertising; (5) conflicting data that confuse practitioners and consumers alike; (6) over- and under-prescription of medications; (7) drug side-effects; and (8) harm to the environment. The enhanced effects of psychotherapy utilizing hypnosis offer a means of avoiding most, if not all, of the problems associated with the use of antidepressants as a primary form of treatment.

Safety of vedolizumab in the treatment of Crohn's disease and ulcerative colitis.

PubMed

Hagan, Matilda; Cross, Raymond K

2015-01-01

Vedolizumab is the latest FDA-approved anti-integrin therapy for treatment of moderate-to-severe inflammatory bowel disease (IBD). The safety and efficacy of vedolizumab have been studied in short-term clinical trials. This paper reviews the safety profile of vedolizumab compared with other biologics. It also highlights the mechanism of action of the medication. We discuss the current position of vedolizumab in our current algorithm for IBD management and comment on future prospects of the drug. Vedolizumab appears to be a safe and effective option in the treatment of moderate-to-severe IBD in the short term. Long-term observational studies and post-marketing safety data are needed to ascertain the long-term efficacy and side effect profile.

Structure-activity relationships of rosiglitazone for peroxisome proliferator-activated receptor gamma transrepression.

PubMed

Toyota, Yosuke; Nomura, Sayaka; Makishima, Makoto; Hashimoto, Yuichi; Ishikawa, Minoru

2017-06-15

Anti-inflammatory effects of peroxisome proliferator-activated receptor gamma (PPRAγ) ligands are thought to be largely due to PPARγ-mediated transrepression. Thus, transrepression-selective PPARγ ligands without agonistic activity or with only partial agonistic activity should exhibit anti-inflammatory properties with reduced side effects. Here, we investigated the structure-activity relationships (SARs) of PPARγ agonist rosiglitazone, focusing on transrepression activity. Alkenic analogs showed slightly more potent transrepression with reduced efficacy of transactivating agonistic activity. Removal of the alkyl group on the nitrogen atom improved selectivity for transrepression over transactivation. Among the synthesized compounds, 3l exhibited stronger transrepressional activity (IC 50 : 14μM) and weaker agonistic efficacy (11%) than rosiglitazone or pioglitazone. Copyright © 2017 Elsevier Ltd. All rights reserved.

Comparison between the efficacy of ginger and sumatriptan in the ablative treatment of the common migraine.

PubMed

Maghbooli, Mehdi; Golipour, Farhad; Moghimi Esfandabadi, Alireza; Yousefi, Mehran

2014-03-01

Frequency and torment caused by migraines direct patients toward a variety of remedies. Few studies to date have proposed ginger derivates for migraine relief. This study aims to evaluate the efficacy of ginger in the ablation of common migraine attack in comparison to sumatriptan therapy. In this double-blinded randomized clinical trial, 100 patients who had acute migraine without aura were randomly allocated to receive either ginger powder or sumatriptan. Time of headache onset, its severity, time interval from headache beginning to taking drug and patient self-estimation about response for five subsequent migraine attacks were recorded by patients. Patients(,) satisfaction from treatment efficacy and their willingness to continue it was also evaluated after 1 month following intervention. Two hours after using either drug, mean headaches severity decreased significantly. Efficacy of ginger powder and sumatriptan was similar. Clinical adverse effects of ginger powder were less than sumatriptan. Patients' satisfaction and willingness to continue did not differ. The effectiveness of ginger powder in the treatment of common migraine attacks is statistically comparable to sumatriptan. Ginger also poses a better side effect profile than sumatriptan. Copyright © 2013 John Wiley & Sons, Ltd.

[Gabapentin in the treatment of chronic intractable pain].

PubMed

Gustorff, B; Nahlik, G; Spacek, A; Kress, H G

2002-02-01

Gabapentin has been shown to reduce pain associated with diabetic neuropathia and postherpetic neuralgia. To date it is not known, whether gabapentin is generally effective in other types of pain. It was therefore the aim to study gabapentin in patients suffering from intractable pain with respect to efficacy, predictive factors and side effects. Retrospective analysis of the data sheet of pretreated patients suffering from intractable pain and treated with gabapentin as a third line drug at a university pain clinic. Pain intensity (visual analogue scale, VAS 0 -10 cm), pain characteristics, diagnosis, pre- and co-treatment, and side effects were assessed. Response to treatment was defined as a 50% reduction in pain or a pain intensity of VAS

Contraceptive effect and potential side-effects of deslorelin acetate implants in rats (Rattus norvegicus): Preliminary observations

PubMed Central

Grosset, Claire; Peters, Stijn; Peron, Franck; Figuéra, Joëlle; Navarro, Christelle

2012-01-01

During the last ten years, numerous species have been treated with deslorelin implants to induce contraception. The aims of the study were 1) to assess contraceptive efficacy of 4.7 mg subcutaneous deslorelin implants in rats, 2) to determine the latency of contraceptive effect, and 3) to determine potential side effects. Three experimental females were implanted and their estrous cycle was studied by vaginal smear. Two weeks after implantation, a male whose fertility was previously assessed with a control female, was introduced into their cage. No female conceived during the 4 mo following implantation. Additionally, 38 pet rats were recruited from clients in practice to test for potential side effects, including 6 males and 32 females with a mean age of 14 mo. Local reaction and transient weight gain during the first 2 wk, as well as behavioral changes were recorded. According to this pilot study, deslorelin implant could be used as a contraceptive method in female rats. The latency period is about 2 wk. Nevertheless, it might be possible to refine the treatment further using hormonal measurements. The duration of contraceptive effect is to be determined in an upcoming study. PMID:23277700

Side effects as influencers of treatment outcome.

PubMed

Sharif, Zafar

2008-01-01

Research relative to the efficacy of a therapeutic agent commands a clinician's greatest interest, but treatment decisions are made based on optimizing efficacy and tolerability/safety considerations. Second-generation atypical antipsychotic drugs are a study in the importance of taking a careful look at the full benefit-risk profile of each drug. The disorders that atypical antipsychotics are approved to treat--schizophrenia, schizoaffective disorder, and bipolar disorder--are associated with an increased rate of certain medical comorbidities compared to the general population. Between-drug differences in efficacy are relatively modest for the atypicals, or between atypicals and conventionals, while differences in safety and tolerability are larger and more clinically relevant. The current article will provide a brief summary of safety-related issues that influence treatment outcome and choice of drug.

A study on the evaluation method and recent clinical efficacy of bevacizumab on the treatment of radiation cerebral necrosis.

PubMed

Zhuang, Hongqing; Yuan, Xiangkun; Zheng, Yi; Li, Xubin; Chang, Joe Y; Wang, Junjie; Wang, Xiaoguang; Yuan, Zhiyong; Wang, Ping

2016-04-12

In order to investigate the efficacy of bevacizumab on the treatment of radiation cerebral necrosis, patients who were diagnosed with radiation cerebral necrosis by imaging after stereotactic radiotherapy were collected. Bevacizumab was applied at a dose of 5 mg/kg once every three weeks at least three times. The changes in cerebral necrosis symptoms before and after treatment, the cerebral edema volume, the cerebral necrosis volume, and the changes in magnetic resonance imaging (MRI) strengthening phase signals of cerebral necrosis were used as the first observation point. The side effects of bevacizumab were used as the second observation point. Total of 14 radiation cerebral necrosis patients were treated with bevacizumab between June 2011 and February 2013 were collected. There were 12 symptomatic patients, of whom 10 patients (83.3%) had reduced symptoms. The edema index grades of nine patients (64.29%) improved. The cerebral necrosis volumes of 13 patients (92.86%) decreased. The T1 phase signal strengths of the intracranial enhanced MRIs of 12 patients (85.71%) significantly decreased. The clinical side effects of bevacizumab were mild. In conclusion, Preliminary results showed that treatment of radiation cerebral necrosis using bevacizumab was safe and effective. This treatment measure is worthy of further study.

A study on the evaluation method and recent clinical efficacy of bevacizumab on the treatment of radiation cerebral necrosis

PubMed Central

Zhuang, Hongqing; Yuan, Xiangkun; Zheng, Yi; Li, Xubin; Chang, Joe Y.; Wang, Junjie; Wang, Xiaoguang; Yuan, Zhiyong; Wang, Ping

2016-01-01

In order to investigate the efficacy of bevacizumab on the treatment of radiation cerebral necrosis, patients who were diagnosed with radiation cerebral necrosis by imaging after stereotactic radiotherapy were collected. Bevacizumab was applied at a dose of 5 mg/kg once every three weeks at least three times. The changes in cerebral necrosis symptoms before and after treatment, the cerebral edema volume, the cerebral necrosis volume, and the changes in magnetic resonance imaging (MRI) strengthening phase signals of cerebral necrosis were used as the first observation point. The side effects of bevacizumab were used as the second observation point. Total of 14 radiation cerebral necrosis patients were treated with bevacizumab between June 2011 and February 2013 were collected. There were 12 symptomatic patients, of whom 10 patients (83.3%) had reduced symptoms. The edema index grades of nine patients (64.29%) improved. The cerebral necrosis volumes of 13 patients (92.86%) decreased. The T1 phase signal strengths of the intracranial enhanced MRIs of 12 patients (85.71%) significantly decreased. The clinical side effects of bevacizumab were mild. In conclusion, Preliminary results showed that treatment of radiation cerebral necrosis using bevacizumab was safe and effective. This treatment measure is worthy of further study. PMID:27067388

Basic pharmacology of NMDA receptors.

PubMed

Gonda, Xenia

2012-01-01

NMDA receptors are ionotropic receptors mediating glutamatergic neurotransmission and play a role in several basic functions in the central nervous system, from regulating neurodevelopment and synaptic plasticity, learning and memory formation, cognitive processes, rhythm generation necessary for locomotor activity and breathing, and excitotoxicity. Due to their complex involvement in the above processes, NMDA receptors have been established to play a role in the etiopathology of several neuropsychiatric disorders such as ischaemia and traumatic brain injury, neurodegenerative disorders, pain syndromes, addiction, affective disorders and such neurodevelopmental disorders as autism or schizophrenia. NMDA receptors contain multiple types of subunits with distinct functional and pharmacological properties making the picture more complex. These receptors also offer multiple binding sites to be targeted with pharmacons, however, early broad-spectrum NMDA receptor antagonists had limited clinical use due to their intolerable adverse effect profile. The discovery of several types of subunit selective NMDA receptor antagonists may offer valuable therapeutic possibilities for several disorders, with improved clinical efficacy and decreased side effects. However, in spite of our increasing knowledge concerning the involvement of NMDA receptors in pathological processes, molecules with a selective action, tolerable side effect profile and good clinical efficacy are still only in clinical development in the majority of cases. Nevertheless, NMDA receptors offer a novel opportunity in the treatment of various neuropsychiatric conditions.

[New oral antidiabetic drugs].

PubMed

Féry, F

2014-09-01

The therapeutic options for type 2 diabetes have grown considerably in recent years with the successive emergence on the market of glitazones, incretin mimetics, gliptins and very soon gliflozins. Meanwhile, physicians have been advised to take into account individual patient characteristics and preferences when setting glycemic targets and choosing the most appropriate molecule. Faced with an abundance of options, clinicians, even those specialized in diabetology, are left confused and are divided in their choices. To guide them in their practice, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) jointly published a position statement in 2012. The guidelines posit that the main criteria to be considered are glucose-lowering efficacy, risk of hypoglycemia, effect on body weight, side effects and costs. Not surprisingly, they propose metformin as first line treatment but do not formulate a precise indication regarding the molecule to be introduced in case of metformin contra-indication, intolerance or monotherapy failure. In addition, there is no mention of gliflozins, which were still under evaluation at the time but are now approved and already marketed in some countries. Here we review the mechanisms of action, efficacy and side effects of the two most recent drug classes, namely incretin-based therapies and gliflozins, and try to position them in the therapeutic algorithm of type 2 diabetes.

The efficacy of prazosin for the treatment of posttraumatic stress disorder nightmares in U.S. military veterans.

PubMed

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.

Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders

PubMed Central

2014-01-01

Background Anxiety and related disorders are among the most common mental disorders, with lifetime prevalence reportedly as high as 31%. Unfortunately, anxiety disorders are under-diagnosed and under-treated. Methods These guidelines were developed by Canadian experts in anxiety and related disorders through a consensus process. Data on the epidemiology, diagnosis, and treatment (psychological and pharmacological) were obtained through MEDLINE, PsycINFO, and manual searches (1980–2012). Treatment strategies were rated on strength of evidence, and a clinical recommendation for each intervention was made, based on global impression of efficacy, effectiveness, and side effects, using a modified version of the periodic health examination guidelines. Results These guidelines are presented in 10 sections, including an introduction, principles of diagnosis and management, six sections (Sections 3 through 8) on the specific anxiety-related disorders (panic disorder, agoraphobia, specific phobia, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, and posttraumatic stress disorder), and two additional sections on special populations (children/adolescents, pregnant/lactating women, and the elderly) and clinical issues in patients with comorbid conditions. Conclusions Anxiety and related disorders are very common in clinical practice, and frequently comorbid with other psychiatric and medical conditions. Optimal management requires a good understanding of the efficacy and side effect profiles of pharmacological and psychological treatments. PMID:25081580

Fractional CO2 laser is as effective as Q-switched ruby laser for the initial treatment of a traumatic tattoo.

PubMed

Seitz, Anna-Theresa; Grunewald, Sonja; Wagner, Justinus A; Simon, Jan C; Paasch, Uwe

2014-12-01

Q-switched laser treatments are considered the standard method for removing both regular and traumatic tattoos. Recently, the removal of tattoo ink using ablative fractional lasers has been reported. Ablative fractional CO2 laser and q-switched ruby laser treatments were used in a split-face mode to compare the safety and efficacy of the two types of laser in removing a traumatic tattoo caused by the explosion of a firework. A male patient suffering from a traumatic tattoo due to explosive deposits in his entire face was subjected to therapy. A series of eleven treatments were performed. The right side of the face was always treated using an ablative fractional CO2 laser, whereas the left side was treated only using a q-switched ruby laser. After a series of eleven treatments, the patient demonstrated a significant lightening on both sides of his traumatic tattoo, with no clinical difference. After the first six treatments, the patient displayed greater lightening on the right side of his face, whereas after another five treatments, the left side of the patient's face appeared lighter. No side effects were reported. In the initial stage of removing the traumatic tattoo, the ablative fractional laser treatment appeared to be as effective as the standard ruby laser therapy. However, from the 6th treatment onward, the ruby laser therapy was more effective. Although ablative fractional CO2 lasers have the potential to remove traumatic tattoos, they remain a second-line treatment option.

TEM8 May Be a Better Anti-Angiogenesis Target | Center for Cancer Research

Cancer.gov

Anti-angiogenesis agents have improved the efficacy of many treatment strategies for solid tumors, but their ability to inhibit tumor vasculature is often incomplete and comes at a price, namely, side effects that can harm normal tissues including blood vessels. As a result, tumor angiogenesis is seldom completely halted, and both angiogenesis and tumor growth inevitably

Scombroid poisoning: prompt resolution of symptoms with cimetidine.

PubMed

Blakesley, M L

1983-02-01

Ingestion of tainted fish of the tuna class may result in the toxic erythema and histamine overload of scombroid poisoning. We report four cases in which prompt resolution of symptoms was achieved by administration of intravenous cimetidine, with minimal side effects. A search of the literature failed to locate previous reports of the efficacy of cimetidine in the treatment of this syndrome.

Efficacy of the Stranger Safety Abduction-Prevention Program and Parent-Conducted in Situ Training

ERIC Educational Resources Information Center

Miltenberger, Raymond G.; Fogel, Victoria A.; Beck, Kimberly V.; Koehler, Shannon; Shayne, Rachel; Noah, Jennifer; McFee, Krystal; Perdomo, Andrea; Chan, Paula; Simmons, Danica; Godish, Danielle

2013-01-01

Using a control group design, we evaluated the effectiveness of the "Stranger Safety" DVD (The Safe Side, 2004) and parent training of abduction-prevention skills with 6- to 8-year-old children. Children in the training or control group who did not demonstrate the safety skills received in situ training from their parents. There was no…

Evaluation of a Commercially Available Program and in Situ Training by Parents to Teach Abduction-Prevention Skills to Children

ERIC Educational Resources Information Center

Beck, Kimberly V.; Miltenberger, Raymond G.

2009-01-01

Child abduction is a serious problem; therefore, it is essential that researchers evaluate the efficacy of commercially available abduction-prevention programs. A multiple baseline design across participants (ages 6 to 8 years) was used to evaluate the effects of a training program, The Safe Side. Experimenters assessed safety responses in situ in…

Carrier-Mediated Antiviral Therapy

DTIC Science & Technology

1988-01-01

methyimethacrylate). (x) Adsorption onto 0.2% aluminium hydroxide. (L) Fluid vaccine. The vaccines with nanoparticles as adjuvants were tested by...such treatment regimens, the doses of the interferons needed to obtain efficacy can result in toxic side effects. For all these reasons, methods of...adjuvants can be used in human vaccines. Besides the classic aluminum adjuvants. particulate polymeric carriers, the so-called nanoparticles , hold promise for

OnabotulinumtoxinA in the treatment of neurogenic bladder

PubMed Central

Gulamhusein, Aziz; Mangera, Altaf

2012-01-01

This review examines the evidence for use of onabotulinumtoxinA in the treatment of neurogenic lower urinary tract dysfunction. Since its first use in 1988 to treat detrusor sphincter dyssynergia, use of botulinum toxin has increased in this group of patients. We discuss the mechanism of action, patient selection, dosing, efficacy, and side effect profile of this now licensed treatment option. PMID:22977301

TEM8 May Be a Better Anti-Angiogenesis Target | Center for Cancer Research

Cancer.gov

Anti-angiogenesis agents have improved the efficacy of many treatment strategies for solid tumors, but their ability to inhibit tumor vasculature is often incomplete and comes at a price, namely, side effects that can harm normal tissues including blood vessels. As a result, tumor angiogenesis is seldom completely halted, and both angiogenesis and tumor growth inevitably progress.

Chemotherapeutic treatment of naturally acquired generalized demodicosis.

PubMed

Folz, S D; Kratzer, D D; Conklin, R D; Nowakowski, L H; Kakuk, T J; Rector, D L

1983-08-01

Fifty-two dogs naturally parasitized with Demodex canis and having the generalized form of the disease were utilized to evaluate the efficacy and safety of single or multiple topical treatments with a liquid concentrate formulation of amitraz. Ten dogs (5 treated, 5 controls) were utilized to evaluate a single treatment. A single topical treatment with the miticide did not significantly reduce the incidence of dogs with mites, however, significant clinical improvement resulted. Side-effects were not observed after treatment. Forty-two dogs (26 treated, 16 controls) were utilized to evaluate multiple topical treatments with the liquid concentrate. A series of 3-6 treatments was applied topically at 14-day intervals. The dogs treated with the miticide received an average of 4.5 topical treatments. All (100%) of the dogs responded clinically, and the mean rate of improvement at four weeks post-treatment was 99.1%. Most dogs (96.2%) were cleared of mites after 3-6 treatments, and Mitaban did not cause any dermatologic, ocular, or other clinical side-effects. Multiple treatments with the liquid concentrate were highly efficacious and safe for treatment of generalized demodicosis. Control dogs did not improve clinically and retained mite populations.

R-ketamine: a rapid-onset and sustained antidepressant without psychotomimetic side effects

PubMed Central

Yang, C; Shirayama, Y; Zhang, J-c; Ren, Q; Yao, W; Ma, M; Dong, C; Hashimoto, K

2015-01-01

Although the efficacy of racemate ketamine, a rapid onset and sustained antidepressant, for patients with treatment-resistant depression was a serendipitous finding, clinical use of ketamine is limited, due to psychotomimetic side effects and abuse liability. Behavioral and side-effect evaluation tests were applied to compare the two stereoisomers of ketamine. To elucidate their potential therapeutic mechanisms, we examined the effects of these stereoisomers on brain-derived neurotrophic factor (BDNF)–TrkB signaling, and synaptogenesis in selected brain regions. In the social defeat stress and learned helplessness models of depression, R-ketamine showed a greater potency and longer-lasting antidepressant effect than S-ketamine (esketamine). Furthermore, R-ketamine induced a more potent beneficial effect on decreased dendritic spine density, BDNF–TrkB signaling and synaptogenesis in the prefrontal cortex (PFC), CA3 and dentate gyrus (DG) of the hippocampus from depressed mice compared with S-ketamine. However, neither stereoisomer affected these alterations in the nucleus accumbens of depressed mice. In behavioral tests for side effects, S-ketamine, but not R-ketamine, precipitated behavioral abnormalities, such as hyperlocomotion, prepulse inhibition deficits and rewarding effects. In addition, a single dose of S-ketamine, but not R-ketamine, caused a loss of parvalbumin (PV)-positive cells in the prelimbic region of the medial PFC and DG. These findings suggest that, unlike S-ketamine, R-ketamine can elicit a sustained antidepressant effect, mediated by increased BDNF–TrkB signaling and synaptogenesis in the PFC, DG and CA3. R-ketamine appears to be a potent, long-lasting and safe antidepressant, relative to S-ketamine, as R-ketamine appears to be free of psychotomimetic side effects and abuse liability. PMID:26327690

Efficacy of a separate informed consent for anesthesia services: A prospective study from the Caribbean.

PubMed

Rampersad, Kavi; Chen, Deryk; Hariharan, Seetharaman

2016-01-01

This study aimed to determine whether a separate written consent form improved the efficacy of the informed consent process for anesthesia in adult patients undergoing elective surgery at a tertiary care teaching hospital. We randomized patients into two groups prospectively. The first group (Group A) signed the hospital's standard Consent for Operation form only while the second group (Group B) signed a separate Consent for Anesthesia form additionally. Patients were interviewed postoperatively with an eight-item questionnaire with responses in a 5-point Likert scale. A composite adequacy of consent index was generated from the responses and analyzed. Two hundred patients (100 in each group) were studied. All patients indicated that the anesthesiologist(s) had their permission to proceed with their anesthesia care. The mean adequacy of consent index score in Group B was higher than that of Group A (30.6 ± 4.6 [standard deviation (SD)] vs. 27.9 ± 5.2 [SD]) (P < 0.001). The separate written consent had a positive impact on the patients' understanding of the nature and purpose of the intended anesthesia procedures (P = 0.04), satisfaction with the adequacy of information provided about common side effects (P < 0.001) and rare but serious complications (P = 0.008). A separate written consent for anesthesia improved the efficacy of the informed consent process with respect to better information about the nature and purpose of anesthesia, common side effects, and rare but serious complications.

Comparison between pathogen directed antibiotic treatment and empirical broad spectrum antibiotic treatment in patients with community acquired pneumonia: a prospective randomised study

PubMed Central

van der Eerden, M M; Vlaspolder, F; de Graaff, C S; Groot, T; Bronsveld, W; Jansen, H; Boersma, W

2005-01-01

Background: There is much controversy about the ideal approach to the management of community acquired pneumonia (CAP). Recommendations differ from a pathogen directed approach to an empirical strategy with broad spectrum antibiotics. Methods: In a prospective randomised open study performed between 1998 and 2000, a pathogen directed treatment (PDT) approach was compared with an empirical broad spectrum antibiotic treatment (EAT) strategy according to the ATS guidelines of 1993 in 262 hospitalised patients with CAP. Clinical efficacy was primarily determined by the length of hospital stay (LOS). Secondary outcome parameters for clinical efficacy were assessment of therapeutic failure on antibiotics, 30 day mortality, duration of antibiotic treatment, resolution of fever, side effects, and quality of life. Results: Three hundred and three patients were enrolled in the study; 41 were excluded, leaving 262 with results available for analysis. No significant differences were found between the two treatment groups in LOS, 30 day mortality, clinical failure, or resolution of fever. Side effects, although they did not have a significant influence on the outcome parameters, occurred more frequently in patients in the EAT group than in those in the PDT group (60% v 17%, 95% CI –0.5 to –0.3; p<0.001). Conclusions: An EAT strategy with broad spectrum antibiotics for the management of hospitalised patients with CAP has comparable clinical efficacy to a PDT approach. PMID:16061709

Dronedarone: current evidence for its safety and efficacy in the management of atrial fibrillation.

PubMed

Schweizer, Patrick A; Becker, Rüdiger; Katus, Hugo A; Thomas, Dierk

2011-01-06

Atrial fibrillation (AF) is the most common sustained arrhythmia. Management of AF includes rate control, rhythm control if necessary, prevention of thromboembolic events, and treatment of the underlying disease. Rate control is usually achieved by pharmacological suppression of calcium currents or by applying β-blockers or digitalis compounds. In contrast, the number of compounds available for rhythm control is still limited. Class Ic agents increase mortality in patients with structural heart disease, and amiodarone harbors an extensive side effect profile despite its efficacy in maintaining sinus rhythm. Furthermore, rhythm control by these compounds has not been shown to reduce patient mortality. Dronedarone is a new anti-arrhythmic drug that has been developed to provide rhythm and rate control in AF patients with fewer side effects compared with amiodarone. This review primarily focuses on clinical trials evaluating efficacy and safety of the novel drug. Conclusions from these studies are critically reviewed, and recommendations for clinical practice are discussed. Dronedarone significantly reduced the incidence of hospitalization due to cardiovascular events or death in high-risk patients with atrial fibrillation (ATHENA trial). However, dronedarone was less efficient than amiodarone in maintaining normal sinus rhythm (DIONYSOS trial) and is contraindicated in severe or deteriorating heart failure (ANDROMEDA trial). In summary, dronedarone represents a valuable addition to the limited spectrum of antiarrhythmic drugs and is currently recommended in patients with paroxysmal and persistent AF to achieve rate and rhythm control, excluding cases of severe or unstable congestive heart failure.

Comparison of salicylic acid 30% peel and pneumatic broadband light in the treatment of mild to moderately severe facial acne vulgaris.

PubMed

Thuangtong, Rattapon; Tangjaturonrusamee, Chinmanat; Rattanaumpawan, Pinyo; Ditre, Chérie M

2017-07-01

Acne patients experience not only a medical disease but also an aesthetic condition, and this latter complication greatly motivates patients to seek out the best treatment regimen to hasten improvement in their appearance. The available clinical procedures for acne treatment include salicylic acid 30% peel and pneumatic broadband light (PBBL). The objective of this study was to compare the efficacy of salicylic acid 30% peel and PBBL treatments in patients with mild to moderately severe facial acne vulgaris. Twelve patients were recruited for a 12-week prospective, single-blind, randomized, split-face study. Patients were treated with a salicylic acid 30% peel on one side of the face and PBBL treatment was administered on the opposite side of the face for 6 consecutive weeks without other acne treatments. At every visit, treatment evaluations were performed using a modified Global Acne Grading Score (mGAGS), acne quality of life (QOL) questionnaire, Wong-Baker FACES Pain Rating Scale (WBPRS) assessments, and clinical photography. Improvement in acne symptoms was observed for both treatment procedures without significant differences and with minimal side effects. Salicylic acid 30% peel and PBBL were well tolerated in our study, and both clinical procedures were efficacious and well-tolerated by the patients.

Imidazenil prevention of alprazolam-induced acquisition deficit in patas monkeys is devoid of tolerance

PubMed Central

Auta, James; Guidotti, Alessandro; Costa, Erminio

2000-01-01

The partial allosteric modulators (PAMs) of γ-aminobutyric acid-gated Cl− current intensities at γ-aminobutyric acid type A receptors have high affinity but low intrinsic efficacy on benzodiazepine recognition sites. Unlike the full allosteric modulators (FAM), like alprazolam, triazolam, and diazepam, PAMs are virtually devoid of unwanted side effects, including tolerance. Imidazenil (IMD) is a PAM that elicits potent anxiolytic and anticonvulsant actions in rodents and nonhuman primates and retains its anticonvulsant and anxiolytic effects, even in rodents that are tolerant to FAMs. IMD antagonizes the side effects of FAMs in rodents and nonhuman primates. Using patas monkeys and a multiple schedule with repeated acquisition and performance of chain responses, we report that IMD administration for 17 days antagonized without showing tolerance ALP-induced disruption of acquisition. PMID:10696114

Strategies to minimize cognitive side effects with ECT: aspects of ECT technique.

PubMed

Prudic, Joan

2008-03-01

The adverse cognitive effects of electroconvulsive therapy are important limitations in the use of this treatment that continues to be a significant therapeutic strategy after 7 decades of use. Among the approaches to mitigation of these side effects are considerations involving the prescription and manipulation of the electrical stimulus itself. The impact of the following electrical factors on the cognitive outcomes of electroconvulsive therapy are surveyed: efficiency of the stimulus as expressed in electrical waveform; targeting of the stimulus, the major concept underlying electrode placement; stimulus dosing; and frequency and number of treatments. The current state of development of knowledge in these areas is summarized, and methods to achieve the best cognitive outcomes without sacrificing clinical efficacy are discussed. Future trends in the further optimization of the electrical stimulus are briefly mentioned.

Advances in the medical treatment of juvenile rheumatoid arthritis.

PubMed

Onel, K B

2000-02-01

Juvenile rheumatoid arthritis (JRA) remains a challenge for clinicians. Nonsteroidal anti-inflammatory drugs and corticosteroids remain the mainstays of therapy, but concerns persist about side effects and the ability of these agents to prevent progression of bony disease. In recent years, novel treatments have been developed and quickly discarded because of unexpected toxicities or lack of efficacy. However, recent studies have shown that methotrexate and sulfasalazine are relatively safe and effective for JRA. Newly developed drugs, such as selective cyclooxygenase-2 inhibitors and soluble tumor necrosis factor receptor, whose development has stemmed from a more basic understanding of pathophysiology, may provide better disease control with fewer side effects. Finally, novel therapies, such as stem cell transplantation, may offer hope for children with JRA, especially systemic-onset JRA, whose disease has been refractory to conventional therapy.

Comparing the effects of low-dose contraceptive pills to control dysfunctional uterine bleeding by oral and vaginal methods.

PubMed

Mehrabian, Ferdous; Abbassi, Fariba

2013-09-01

Background and Objective : Contraceptive pills are generally taken orally and can cause side effects such as nausea, vomiting and hypertension. The vaginal use of these pills can reduce such complications. Our objective was to compare the efficacy and side effects of low dose contraceptive pills by oral and vaginal route in the management of dysfunctional uterine bleeding-(DUB) Methods: This comparative observational study was conducted at Beheshti and Alzahra (SA) teaching hospitals, affiliated to Isfahan University of Medical Sciences in 2010-2011. One hundred women who presented with DUB were randomly assigned into two groups of equal number, receiving the low dose oral contraceptive pills by oral or vaginal route for three month. The amount and duration of bleeding were compared at the beginning and at the end of the study and side effects by these two methods compared. The results of this study showed that both oral and vaginal routes effectively reduced the duration and amount of bleeding due to DUB after three courses of treatment. This effect was better in the vaginal method compared with oral administration (P = 0.03). Regarding the side effects, nausea and vomiting were significantly higher in the oral group than in the vaginal group (P = 0.03). Vulvovaginitis infection was more frequent in the vaginal group than in the oral group (P = 0.03). Low dose contraceptive pills are effective in reducing the amount, time, and duration of bleeding in patients with DUB. In addition, reduction of gastrointestinal side effects by vaginal route helps to use these pills by the patient with proper training of physicians, midwives and patients.

TARGETING POLYMER THERAPEUTICS TO BONE

PubMed Central

Low, Stewart; Kopeček, Jindřich

2012-01-01

An aging population in the developing world has led to an increase in musculoskeletal diseases such as osteoporosis and bone metastases. Left untreated many bone diseases cause debilitating pain and in the case of cancer, death. Many potential drugs are effective in treating diseases but result in side effects preventing their efficacy in the clinic. Bone, however, provides an unique environment of inorganic solids, which can be exploited in order to effectively target drugs to diseased tissue. By integration of bone targeting moieties to drug-carrying water-soluble polymers, the payload to diseased area can be increased while side effects decreased. The realization of clinically relevant bone targeted polymer therapeutics depends on (1) understanding bone targeting moiety interactions, (2) development of controlled drug delivery systems, as well as (3) understanding drug interactions. The latter makes it possible to develop bone targeted synergistic drug delivery systems. PMID:22316530

[Psychic aspects of the premenstrual dysphoric disorders. New therapeutic strategies: our experience with Vitex agnus castus].

PubMed

Ciotta, L; Pagano, I; Stracquadanio, M; Di Leo, S; Andò, A; Formuso, C

2011-06-01

The premenstrual dysphoric disorder (PMDD) is one of the main problems of the premenstrual phase. It consists of symptoms that sometimes invalidate the scope of employment, social and psycho-affective of patients, requiring thus a diagnostic and therapeutic approach as detailed and accurate as possible. The therapeutic strategies available for this disease are many, but recently the emphasis has been on Vitex agnus castus (VAC), considered by many as evidence drug of choice for both PMS and for the PMDD, being with satisfactory therapeutic properties and small side effects. Our study evaluated a group of patients suffering from PMDD and the clinical efficacy of treatment with VAC (and compared the effectiveness of the results of a more homogeneous group of patients treated with fluoxetine). This study confirms the data reported in the literature regarding the effectiveness of VAC therapy with no side effects.

Pituitary-directed medical therapy in Cushing's disease.

PubMed

Petersenn, Stephan; Fleseriu, Maria

2015-04-01

Transsphenoidal surgery remains the first line therapy in Cushing's disease, but a large number of patients will not be cured or disease will recur over time. Repeat pituitary surgery, bilateral adrenalectomy, and radiation have limitations with respect to efficacy and/or side effects. Therefore, there is a clear need for an effective medical treatment. The studies reviewed here suggest a role for pituitary-directed therapies, applying multireceptor ligand somatostatin analogs like pasireotide or second-generation dopamine agonists. Retinoic acid has been also studied in a small prospective study. These compounds target ACTH-secretion at the pituitary level and possibly inhibit corticotrope proliferation. Specific side effects of these compounds need to be considered, especially when used as long-term therapy. These novel approaches could provide options for treatment of patients in whom surgery has failed or is not possible, and while awaiting effects of radiation therapy. Preoperative use to decrease cortisol excess, potentially reducing perioperative complications, needs to be further studied.

Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.

PubMed

Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

2015-01-01

The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1-4) in the tibio-femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce their required doses, and delay potential future surgical intervention.

Investigation of antidepressant-like and anxiolytic-like actions and cognitive and motor side effects of four N-methyl-D-aspartate receptor antagonists in mice.

PubMed

Refsgaard, Louise K; Pickering, Darryl S; Andreasen, Jesper T

2017-02-01

Evidence suggests that N-methyl-D-aspartate receptor (NMDAR) antagonists could be efficacious in treating depression and anxiety, but side effects constitute a challenge. This study evaluated the antidepressant-like and anxiolytic-like actions, and cognitive and motor side effects of four NMDAR antagonists. MK-801, ketamine, S-ketamine, RO 25-6981 and the positive control, citalopram, were tested for antidepressant-like and anxiolytic-like effects in mice using the forced-swim test, the elevated zero maze and the novelty-induced hypophagia test. Side effects were assessed using a locomotor activity test, the modified Y-maze and the rotarod test. All compounds increased swim distance in the forced-swim test. In the elevated zero maze, the GluN2B subtype-selective RO 25-6981 affected none of the measured parameters, whereas all other compounds showed anxiolytic-like effects. In the novelty-induced hypophagia test, citalopram and MK-801 showed anxiogenic-like action. All NMDAR antagonists induced hyperactivity. The high doses of ketamine and MK-801 impaired performance in the modified Y-maze test, whereas S-ketamine and RO 25-6891 showed no effects in this test. Only MK-801 impaired rotarod performance. The study supports that NMDARs could be a possible therapeutic target for treating depression and anxiety. However, selective antagonism of GluN2B subunit-containing NMDARs showed no effect on anxiety-like behaviours in this study.

Psoriasis and Microbiota: A Systematic Review.

PubMed

Benhadou, Farida; Mintoff, Dillon; Schnebert, Benjamin; Thio, Hok Bing

2018-06-02

Recent advances have highlighted the crucial role of microbiota in the pathophysiology of chronic inflammatory diseases as well as its impact on the efficacy of therapeutic agents. Psoriasis is a chronic, multifactorial inflammatory skin disorder, which has a microbiota distinct from healthy, unaffected skin. Through an extensive review of the literature, we aim to discuss the skin and gut microbiota and redefine their role in the pathogenesis of psoriasis. Unfortunately, the direct link between the skin microbiota and the pathogenesis of psoriasis remains to be clearly established. Apart from improving the course of psoriasis, selective modulation of the microbiota may increase the efficacy of medical treatments as well as attenuate their side effects.

Melatonin Treatment in Children with Developmental Disabilities.

PubMed

Schwichtenberg, A J; Malow, Beth A

2015-06-01

Melatonin is commonly recommended to treat sleep problems in children with developmental disabilities. However, few studies document the efficacy and safety of melatonin in these populations. This article reviews recent studies of melatonin efficacy in developmental disabilities. Overall, short treatment trials were associated with a significant decrease in sleep onset latency time for each of the disorders reviewed, with 1 notable exception-tuberous sclerosis. Reported side effects were uncommon and mild. Across disorders, additional research is needed to draw disability-specific conclusions. However, studies to date provide positive support for future trials that include larger groups of children with specific disabilities/syndromes. Copyright © 2015 Elsevier Inc. All rights reserved.

Antifungal Therapy in Birds: Old Drugs in a New Jacket.

PubMed

Antonissen, Gunther; Martel, An

2018-05-01

The use of antifungals in birds is characterized by interspecies and interindividual variability in the pharmacokinetics, affecting drug safety and efficacy. Oral antifungal drug absorption is a complex process affected by drug formulation characteristics, gastrointestinal anatomy, and physiology. New antifungal drug delivery systems can enhance drug stability, reduce off-target side effects, prolong residence time in the blood, and improve efficacy. Topical administration of antifungals through nebulization shows promising results. However, therapeutic output is highly influenced by drug formulation and type of nebulizer, indicating these factors should be taken into account when selecting this medication route. Copyright © 2018 Elsevier Inc. All rights reserved.

Randomized, Double-Blind, Split-Face Study Evaluating Fractional Ablative Erbium:YAG Laser-Mediated Trans-Epidermal Delivery of Cosmetic Actives and a Novel Acoustic Pressure Wave Ultrasound Technology for the Treatment of Skin Aging, Melasma, and Acne Scars.

PubMed

Alexiades, Macrene

2015-11-01

Fractional laser resurfacing enhances trans-epidermal delivery (TED), however laser penetration depths >250- μm fail to substantively increase drug delivery. Evaluate the safety and efficacy of a novel acoustic pressure wave ultrasound device following fractional ablative Er:YAG 2940-nm laser (FELR) and topical agents for rhytids, melasma, and acne scars. Randomized, blinded, parallel group split-face side-by-side, controlled study evaluating FELR and topical anti-aging and anti-pigment agents to entire face succeeded by ultrasound to randomized side. Fifteen subjects were enrolled to three treatment arms:rhytids, melasma, and acne scars. Two monthly treatments were administered with 1, 3, and 6 month follow-up. Efficacy was assessed by Comprehensive Grading Scale of Rhytids, Laxity, and Photoaging by Investigator and two blinded physician evaluators. Subject assessments, digital photographs, and reflectance spectroscopic analyses were obtained. Rhytid severity was reduced from a mean of 3.25 to 2.60 on the 4-point grading scale. Spectrophotometric analysis demonstrated increases in lightness (L*) and reductions in redness (a*) and pigment (b*), with greater improvements on the ultrasound side as compared to FELR and topicals alone. Moderate erythema post-treatment resolved in 7 days and no serious adverse events were observed. In this randomized, paired split-face clinical study, FELR-facilitated TED of topical anti-aging actives with ultrasound treatment is safe and effective with improvement in rhytids, melasma, and acne scars. Statistically significant greater improvement in pigment levels was observed on the ultrasound side as compared to FELR-TED and topical agents alone.

Safety and effectiveness of cantharidin-podophylotoxin-salicylic acid in the treatment of recalcitrant plantar warts.

PubMed

López López, Daniel; Vilar Fernández, Juan Manuel; Losa Iglesias, Marta Elena; Álvarez Castro, Carlos; Romero Morales, Carlos; García Sánchez, María Matilde; Becerro de Bengoa Vallejo, Ricardo

2016-07-01

The aim of our study was to evaluate the efficacy and safety of topical cantharidin-podophylotoxin-salicylic acid (CPS) treatment of recalcitrant plantar warts (RPW). This study was carried out in a health center in the city of A Coruña (Spain) between January and December 2013. A total of 75 patients completed all the stages of the research process. Information related to treatment with CPS and adverse effects was abstracted from medical records. Of 93 potential patients identified, 75 had at least one follow-up visit or telephone call after treatment and were included in this study. Patients experienced an average of 5.4 visits until complete resolution of their plantar wart occurred, although CPS was not applied at every visit. Fifty-four patients required one application to eliminate the wart and 21 patients required two applications/patient. Seventy-seven percent of patients experienced blistering - an expected therapeutic side effect. All patients experienced some form of an adverse event, the most common being pain (81.3%) and significant blistering (15%). Other side effects were rare (18.7%) and included pruritus, possible mild infection, significant irritation, and bleeding. All patients reported treatment, supporting our results that CPS is a safe and efficacious treatment modality for RPW and should be considered when symptomatic infection necessitates treatment. © 2016 Wiley Periodicals, Inc.

The efficacy of cyclosporine A in cats with presumed atopic dermatitis: a double blind, randomised prednisolone-controlled study.

PubMed

Wisselink, Marinus A; Willemse, Ton

2009-04-01

The objective of this study was to compare the efficacy of cyclosporine A (CsA) and prednisolone in feline atopic dermatitis (AD) in a randomised, controlled double blind study. Twenty-nine cats with feline AD were randomly allocated to two groups. Eleven cats were treated orally with prednisolone (1mg/kg SID) and 18 were treated with CsA (5mg/kg/day) for 4 weeks. At day 0 (D0) and D28, skin lesions were graded by means of the canine atopic dermatitis extent and severity index (CADESI). Skin biopsies and intradermal allergy tests were performed at D0 and blood samples for haematology and serum biochemistry were collected at D0 and D28. During the trial the cat owners were asked to evaluate the intensity of the pruritus once weekly on a linear analog scale and to record side effects. Based on the CADESI there was no significant difference between the two groups in the amount of remission (P=0.0562) or in the number of cats that improved by >25% (P=0.0571). The effect of CsA and prednisolone on pruritus as evaluated by the owners was not significantly different (P=0.41) between the two groups. No serious side effects were observed. The conclusion was that CsA is an effective alternative to prednisolone therapy in cats with presumed atopic dermatitis.

The Clinical and Histological Effect of a Low-Fluence Q-Switched 1,064-nm Neodymium: Yttrium-Aluminum-Garnet Laser for the Treatment of Melasma and Solar Lentigenes in Asians: Prospective, Randomized, and Split-Face Comparative Study.

PubMed

Kaminaka, Chikako; Furukawa, Fukumi; Yamamoto, Yuki

2017-09-01

The low-fluence Q-switched 1,064-nm neodymium:yttrium-aluminum-garnet laser (QSNYL) is popular for melasma treatment among Asians. This study was to evaluate the clinical and histological effects of the low-fluence QSNYL for treatment of melasma and solar lentigenes. In this randomized split-face clinical study, 22 patients with melasma or solar lentigo received low-fluence QSNYL weekly for 10 sessions on one cheek. The treatment efficacy was determined by Mexameter skin colorimetry, physician and patient assessment, and by evaluating histological changes. The treated sides had statistically significant reductions in the melanin and erythema indices (EI); 50.0% of melasma and 62.5% of solar lentigo patients had >50% clearance after the final treatment. The increased EI, vascularity, and mast cell activity in patients with melasma and large-sized solar lentigo showed no improvement. The recurrence rates were 16.7% and 12.7% for melasma and solar lentigo, respectively. Postinflammatory hyperpigmentation developed in 1 patient, but no serious side effects were noted. Low-fluence QSNYL is effective in treating melasma and small type solar lentigo in Asians. The authors' study also demonstrated that lesion thickness, vascularity, and mast cell activity can be used to predict the efficacy of the treatment of these lesions.

Anaesthesia for electroconvulsive therapy - new tricks for old drugs: a systematic review.

PubMed

Stripp, Tobias Kvist; Jorgensen, Martin Balslev; Olsen, Niels Vidiendal

2018-04-01

The objective of this review is to investigate existing literature in order to delineate whether the use of anaesthesia and timing of seizure induction in a new and optimised way may improve the efficacy of electroconvulsive therapy (ECT). PubMed/MEDLINE was searched for existing literature, last search on 24 June 2015. Relevant clinical studies on human subjects involving choice of anaesthetic, ventilation and bispectral index (BIS) monitoring in the ECT setting were considered. The references of relevant studies were likewise considered. Propofol yields the shortest seizures, etomidate and ketamine the longest. Etomidate and ketamine+propofol 1 : 1 seems to yield the seizures with best quality. Seizure quality is improved when induction of ECT is delayed until the effect of the anaesthetic has waned - possibly monitored with BIS values. Manual hyperventilation with 100% O2 may increase the pO2/pCO2-ratio, which may be correlated with better seizure quality. Etomidate or a 1 : 1 ketamine and propofol combination may be the best method to achieve general anaesthesia in the ECT setting. There is a need for large randomised prospective studies comparing the effect of methohexital, thiopental, propofol, ketamine, propofol+ketamine 1 : 1 and etomidate in the ECT treatment of major depressed patients. These studies should investigate safety and side effects, and most importantly have antidepressant efficacy and cognitive side effects as outcome measures instead of seizure quality.

COBALT COMPOUNDS AS ANTIDOTES FOR HYDROCYANIC ACID.

PubMed

EVANS, C L

1964-12-01

The antidotal potency of a cobalt salt (acetate), of dicobalt edetate, of hydroxocobalamin and of cobinamide against hydrocyanic acid was examined mainly on mice and rabbits. All the compounds were active antidotes for up to twice the LD50; under some conditions for larger doses. The most successful was cobalt acetate for rabbits (5xLD50), which was effective at a molar cyanide/cobalt (CN/Co) ratio of 5, but had as a side-effect intense purgation. Hydroxocobalamin was irregular in action, but on the whole was most effective for mice (4.5xLD50 at a molar ratio of 1), and had no apparent side effects. Dicobalt edetate, at molar ratios of up to 2, was more effective for rabbits (3xLD50) than for mice (2xLD50), but had fewer side effects than cobalt acetate. The effect of thiosulphate was to augment the efficacy of dicobalt edetate and, in mice, that of hydroxocobalamin; but, apparently, in rabbits, to reduce that of hydroxocobalamin. Cobinamide, at a molar ratio of 1, was slightly more effective than hydroxocobalamin on rabbits and also less irregular in its action. Cobalt acetate by mouth was effective against orally administered hydrocyanic acid. The oxygen uptake of the body, reduced by cyanide, is rapidly reinstated when one of the cobalt antidotes has been successfully administered.

A multicentre study of vigabarin for drug-resistant epilepsy

PubMed Central

Browne, T. R.; Mattson, R. H.; Penry, J. K.; Smith, D. B.; Treiman, D. M.; Wilder, B. J.; Ben-Menachem, E.; Miketta, R. M.; Sherry, K. M.; Szabo, G. K.

1989-01-01

1 Vigabatrin (GVG) was given in a single-blind fashion to 89 patients with complex partial seizures (CPS) refractory to conventional drugs. 2 The median number of CPS per month decreased from 11.0 to 5.0 after addition of GVG, and 51% of patients had a 50% or greater decrease in CPS frequency (P < 0.001). 3 Side effects (principally drowsiness, ataxia, headache) occurred mainly during the initiation of therapy and decreased during therapy. After 12 weeks on GVG side effects significantly interfered with functioning in only 13% of patients, and the efficacy: toxicity ratio warranted continued administration in 74% of patients. 4 Co-administration of GVG resulted in a mean decrease of 20% in phenytoin serum concentration (P < 0.001). 5 Sixty-six patients having a favourable response to GVG during the single-blind study have been followed for 6-54 (median 33) months on GVG. Only 17 patients have dropped out of long-term follow-up due to break through seizures and/or side effects. No serious systemic or neurological toxicity has been detected. PMID:2667606

Oral Versus Topical Diclofenac Sodium in the Treatment of Osteoarthritis.

PubMed

Tieppo Francio, Vinicius; Davani, Saeid; Towery, Chris; Brown, Tony L

2017-06-01

Osteoarthritis (OA) is one of the most common causes of joint pain in the United States and non-steroidal anti-inflammatories (NSAIDs), such as Diclofenac sodium, which is currently available in two main routes of administration; oral and topical distribution have been established as one of the standard treatments for OA. Generally, oral NSAIDs are well tolerated; however our narrative review suggests that the topical solution had a better tolerability property than oral Diclofenac sodium, especially due to side effects of gastrointestinal bleeding with the utilization of the oral format. In addition, the topical route may be considered a reasonable selection by clinicians for management of musculoskeletal pain in those patients with a history of potential risk and adverse side effects. Most studies reviewed comparing oral versus topical solution of Diclofenac sodium revealed comparable efficacy, with minimal side effects utilizing the topical route. The key point of this narrative review is to help clinicians that currently must decide between very inexpensive diclofenac oral presentations and expensive topical presentations especially in the elderly population and the pros and cons of such decision-making process.

Determination of physical parameters associated with self-efficacy in patients with chronic mechanic low back pain.

PubMed

Duray, M; Yagci, N; Ok, N

2018-03-23

Self-efficacy that is associated with various pain-related disabilities such as chronic low back pain (LBP), should be questioned besides physical assessments. To investigate the physical factors associated with self-efficacy in patients with chronic mechanic LBP. One hundred nine patients diagnosed as chronic mechanic LBP (65 females, 44 males) between 20-50 years old were included to this study. The intensity of LBP was assessed by using a 10-cm Visual Analogue Scale. For musculoskeletal fitness measurement; muscle strength, muscle endurance, and flexibility tests were applied. Functional Reach Test for balance evaluation, Self-Efficacy Scale for self-efficacy measurement, Roland-Morris Disability Questionnaire for disability level evaluation were used. We found a moderate negative correlation between self-efficacy and pain intensity (r=-0.506); a negative and strong correlation between self-efficacy and disability level (r=-0.654) (p< 0.05). Self efficacy had a significant association with right (r= 0.265) and left (r= 0.290) lateral side bending flexibility (p< 0.05). According to multiple regression analysis results, it was found that disability level had a significant effect on self-efficacy (β=-2.014; p< 0.01). Poor musculoskeletal fitness and pain intensity may cause decreasing self-efficacy but the major determinant of decreased self-efficacy was low-back related disability scores.

[Topical therapy of ulcerative colitis].

PubMed

Rogler, G; Beglinger, C; Mottet, C; Seibold, F; Gross, V

2011-11-16

The availability of new topical preparations for the treatment of left sided ulcerative colitis ulcerosa offers a therapy optimization for many patients. Rectal application of steroids and 5-aminosalicylic acid (5-ASA) is associated with fewer side effects and has a higher therapeutic efficacy in mild to moderate-active left-sided colitis as compared to a systemic therapy. Often it is argued that the patients' compliance is insufficient with a rectal therapy. However, with sufficient information on the proven advantages this is usually not the case. The rectal application of drugs in distal ulcerative colitis is suitable also for the maintenance of remission. Therefore the new therapy guidelines recommend topical therapy more than in former times. Subsequently, these manuscripts focussed specifically on the topical therapy of distal colitis, to elucidate that clear treatment advantages are present in daily practice.

Efficacy of adhesive strips to reduce postoperative periorbital edema and ecchymosis following rhinoplasty

PubMed

Tatar, Sedat; Bulam, Mehmet Hakan; Özmen, Selahattin

2018-02-23

Background/aim: Periorbital edema and ecchymosis may develop following rhinoplasty. The aim of this study was to assess the efficacy of adhesive strip application on the upper and lower eyelids to reduce postoperative edema and ecchymosis following rhinoplasty. Materials and methods: The eyelids of one side were randomly selected, and an adhesive strip of standard size and number was applied at the end of the operation. The strips were removed at postoperative day 3; photos of the eyes were taken at days 3 and 7. Edema and ecchymosis were graded on a scale from 1 to 4. The ecchymosis areas on the lower and upper eyelids were measured and compared in square centimeters. Results: The mean ecchymosis area of the lower eyelid on the side of the adhesive strip and on the side without the strip was 1.63 cm2 and 3.32 cm2 in the early period, respectively. It was 1.15 cm2 on the upper eyelid on the side of the adhesive strip, and 1.87 cm2 on the side without the strip. It was 0.224 cm2 on the side of the adhesive strip, and 0.498 cm2 on the side without the adhesive strip in the late period. Conclusion: Applying adhesive strips reduces periorbital edema and ecchymosis.

Rapid compensatory changes in GABA receptor efficacy in rat vestibular neurones after unilateral labyrinthectomy

PubMed Central

Yamanaka, Toshiaki; Him, Aydin; Cameron, Susan A; Dutia, Mayank B

2000-01-01

The inhibitory effects of the GABAA agonist muscimol and the GABAB agonist baclofen on tonically active medial vestibular nucleus (MVN) neurones were recorded in slices of the rat dorsal brainstem in vitro, to determine whether any changes occurred in the functional efficacy of GABAergic inhibition in these cells during the initial rapid stage of ‘vestibular compensation’, the behavioural recovery that takes place after unilateral labyrinthectomy (UL). These experiments were carried out in preparations where the midline was cut, severing all commissural connections between the two vestibular nuclei. Slices of the MVN were prepared from normal animals and animals that had been unilaterally labyrinthectomised 4 h earlier. The mean in vitro discharge rate of MVN neurones in the rostral region of the ipsi-lesional nucleus after UL was significantly higher than that in control slices, confirming our earlier reports of an increase in intrinsic excitability of these cells in the early stage of vestibular compensation. The in vitro discharge rates of caudal ipsi-lesional MVN cells, and rostral and caudal contra-lesional MVN cells, were not different from controls. Muscimol and baclofen caused reversible, dose-related inhibition of the tonic discharge rate of MVN cells in control slices. In slices prepared from UL animals, MVN cells in the rostral region of the ipsi-lesional nucleus showed a marked downregulation of their response to both muscimol and baclofen, seen as a rightward shift and a decrease in slope of the dose-response relationships for the two agonists. In the contra-lesional nucleus, there was a small but significant upregulation of the responsiveness of both rostral and caudal MVN cells to baclofen, and a marked upregulation of the responsiveness of caudal MVN cells to muscimol. In slices from animals that had undergone bilateral labyrinthectomy 4 h earlier, the downregulation of the functional efficacy of GABA receptors in the rostral MVN cells did not occur. The changes in GABA receptor efficacy after UL are therefore not due to the vestibular de-afferentation itself, but are instead due to the imbalance in excitability of the vestibular nuclei of the lesioned and intact sides, and the enhanced commissural inhibition of the ipsi-lesional MVN cells that follows UL. The downregulation of GABA receptor efficacy in the ipsi-lesional MVN neurones is functionally compensatory, in that their response to commissural and cerebellar inhibitory drive will be significantly reduced after UL. Their intrinsic membrane conductances, and their remaining excitatory synaptic inputs, will consequently be more effective in causing depolarisation and the restoration of resting activity. Simultaneously the upregulation of GABAergic efficacy in the contra-lesional MVN will tend to reduce the hyperactivity on the contralateral side. These adaptive changes therefore represent a plausible cellular mechanism for the recovery of resting discharge in the ipsi-lesional MVN neurones, and the ‘re-balancing’ of the excitability of the vestibular neurones of the lesioned and intact sides, as occurs after UL in vivo. We propose that the adaptive regulation of the functional efficacy of GABA receptors in the MVN neurones may be an important cellular mechanism for the ‘homeostasis of bilateral excitability’ of the vestibular nuclei of the two sides. PMID:10699085

[Side effects of biologic therapies in psoriasis].

PubMed

Altenburg, A; Augustin, M; Zouboulis, C C

2018-04-01

The introduction of biologics has revolutionized the treatment of moderate to severe plaque psoriasis. Due to the continuous expansion of biological therapies for psoriasis, it is particularly important to acknowledge efficacy and safety of the compounds not only in clinical trials but also in long-term registry-based observational studies. Typical side effects and significant risks of antipsoriatic biologic therapies considering psoriatic control groups are presented. A selective literature search was conducted in PubMed and long-term safety studies of the psoriasis registries PsoBest, PSOLAR and BADBIR were evaluated. To assess the long-term safety of biologics, the evaluation of the course of large patient cohorts in long-term registries is of particular medical importance. Newer biologic drugs seem to exhibit a better safety profile than older ones.

Review: aromatase inhibitors for ovulation induction.

PubMed

Casper, Robert F; Mitwally, Mohamed F M

2006-03-01

For the last 40 yr, the first line of treatment for anovulation in infertile women has been clomiphene citrate (CC). CC is a safe, effective oral agent but is known to have relatively common antiestrogenic endometrial and cervical mucous side effects that could prevent pregnancy in the face of successful ovulation. In addition, there is a significant risk of multiple pregnancy with CC, compared with natural cycles. Because of these problems, we proposed the concept of aromatase inhibition as a new method of ovulation induction that could avoid many of the adverse effects of CC. The objective of this review was to describe the different physiological mechanisms of action for CC and aromatase inhibitors (AIs) and compare studies of efficacy for both agents for ovulation induction. We conducted a systematic review of all the published studies, both controlled and noncontrolled, comparing CC and AI treatment, either alone or in combination with gonadotropins, for ovulation induction or augmentation, identified through the Entrez-PubMed search engine. Because of the recent acceptance of the concept of using AIs for ovulation induction, few controlled studies were identified, and the rest of the studies were pilot or preliminary comparisons. Based on these studies, it appears that AIs are as effective as CC in inducing ovulation, are devoid of any antiestrogenic side effects, result in lower serum estrogen concentrations, and are associated with good pregnancy rates with a lower incidence of multiple pregnancy than CC. When combined with gonadotropins for assisted reproductive technologies, AIs reduce the dose of FSH required for optimal follicle recruitment and improve the response to FSH in poor responders. Preliminary evidence suggests that AIs may replace CC in the future because of similar efficacy with a reduced side effect profile. Although worldwide experience with AIs for ovulation induction is increasing, at present, definitive studies in the form of randomized controlled trials comparing CC with AIs are lacking.

Oral administration of non-absorbable delayed release 6-mercaptopurine is locally active in the gut, exerts a systemic immune effect and alleviates Crohn’s disease with low rate of side effects: results of double blind Phase II clinical trial

PubMed Central

Israeli, E; Goldin, E; Fishman, S; Konikoff, F; Lavy, A; Chowers, Y; Melzer, E; Lahat, A; Mahamid, M; Shirin, H; Nussinson, E; Segol, O; Ya’acov, A Ben; Shabbat, Y; Ilan, Y

2015-01-01

Therapy for Crohn’s disease (CD) with thiopurines is limited by systemic side effects. A novel formulation of fixed-dose, delayed-release 6-mercaptopurine (DR-6MP) was developed, with local effect on the gut immune system and minimal absorption. The aim of this study was to evaluate the safety and efficacy of DR-6MP in patients with moderately severe CD compared to systemically delivered 6-mercaptopurine (Purinethol). Seventy CD patients were enrolled into a 12-week, double-blind controlled trial. The primary end-point was the percentage of subjects with clinical remission [Crohn’s Disease Activity Index (CDAI) < 150] or clinical response (100-point CDAI reduction). Twenty-six (56·5%) and 13 (54·2%) subjects from the DR-6MP and Purinethol cohorts, respectively, completed the study. DR-6MP had similar efficacy to Purinethol following 12 weeks of treatment. However, the time to maximal clinical response was 8 weeks for DR-6MP versus 12 weeks for Purinethol. A higher proportion of patients on DR-6MP showed clinical remission at week 8. A greater improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) score was noted in the DR-6MP group. DR-6MP led to a decrease of CD62+ expression on T cells, implying a reduction of lymphocyte adhesion to site of inflammation. DR-6MP was safer than Purinethol, with significantly fewer adverse events (AEs). There was no evidence of drug-induced leucopenia in the DR-6MP group; the proportion of subjects who developed hepatotoxicity was lower for the DR-6MP. Non-absorbable DR-6MP is safe and biologically active in the gut. It is clinically effective, exerting a systemic immune response with low systemic bioavailability and a low incidence of side effects. PMID:25846055

Oral administration of non-absorbable delayed release 6-mercaptopurine is locally active in the gut, exerts a systemic immune effect and alleviates Crohn's disease with low rate of side effects: results of double blind Phase II clinical trial.

PubMed

Israeli, E; Goldin, E; Fishman, S; Konikoff, F; Lavy, A; Chowers, Y; Melzer, E; Lahat, A; Mahamid, M; Shirin, H; Nussinson, E; Segol, O; Ya'acov, A Ben; Shabbat, Y; Ilan, Y

2015-08-01

Therapy for Crohn's disease (CD) with thiopurines is limited by systemic side effects. A novel formulation of fixed-dose, delayed-release 6-mercaptopurine (DR-6MP) was developed, with local effect on the gut immune system and minimal absorption. The aim of this study was to evaluate the safety and efficacy of DR-6MP in patients with moderately severe CD compared to systemically delivered 6-mercaptopurine (Purinethol). Seventy CD patients were enrolled into a 12-week, double-blind controlled trial. The primary end-point was the percentage of subjects with clinical remission [Crohn's Disease Activity Index (CDAI) < 150] or clinical response (100-point CDAI reduction). Twenty-six (56·5%) and 13 (54·2%) subjects from the DR-6MP and Purinethol cohorts, respectively, completed the study. DR-6MP had similar efficacy to Purinethol following 12 weeks of treatment. However, the time to maximal clinical response was 8 weeks for DR-6MP versus 12 weeks for Purinethol. A higher proportion of patients on DR-6MP showed clinical remission at week 8. A greater improvement in Inflammatory Bowel Disease Questionnaire (IBDQ) score was noted in the DR-6MP group. DR-6MP led to a decrease of CD62(+) expression on T cells, implying a reduction of lymphocyte adhesion to site of inflammation. DR-6MP was safer than Purinethol, with significantly fewer adverse events (AEs). There was no evidence of drug-induced leucopenia in the DR-6MP group; the proportion of subjects who developed hepatotoxicity was lower for the DR-6MP. Non-absorbable DR-6MP is safe and biologically active in the gut. It is clinically effective, exerting a systemic immune response with low systemic bioavailability and a low incidence of side effects. © 2015 British Society for Immunology.

Strategies to increase demand for maternal health services in resource-limited settings: challenges to be addressed.

PubMed

Elmusharaf, Khalifa; Byrne, Elaine; O'Donovan, Diarmuid

2015-09-08

Universal health access will not be achieved unless women are cared for in their own communities and are empowered to take decisions about their own health in a supportive environment. This will only be achieved by community-based demand side interventions for maternal health access. In this review article, we highlight three common strategies to increase demand-side barriers to maternal healthcare access and identify the main challenges that still need to be addressed for these strategies to be effective. Common demand side strategies can be grouped into three categories:(i) Financial incentives/subsidies; (ii) Enhancing patient transfer, and; (iii) Community involvement. The main challenges in assessing the effectiveness or efficacy of these interventions or strategies are the lack of quality evidence on their outcome and impact and interventions not integrated into existing health or community systems. However, what is highlighted in this review and overlooked in most of the published literature on this topic is the lack of knowledge about the context in which these strategies are to be implemented. We suggest three challenges that need to be addressed to create a supportive environment in which these demand-side strategies can effectively improve access to maternal health services. These include: addressing decision-making norms, engaging in intergenerational dialogue, and designing contextually appropriate communication strategies.

Comparison of the discontinuation rates and side-effect profiles of pilocarpine and cevimeline for xerostomia in primary Sjögren's syndrome.

PubMed

Noaiseh, Ghaith; Baker, Joshua F; Vivino, Frederick B

2014-01-01

There are currently no head-to-head comparisons of sialagogues for Primary Sjögren's syndrome (pSS). We compared the tolerability and side effect profile of pilocarpine and cevimeline in patients with pSS and determined clinical, laboratory and pathological variables associated with therapeutic failure. We retrospectively reviewed the use of pilocarpine and cevimeline in 118 patients with pSS who fulfilled the 2002 American European Consensus Group criteria in a University-based setting. Clinical, laboratory and pathological baseline variables were collected. Failure of therapy was defined as the clinician or patient's decision to stop treatment either due to lack of efficacy or side effects. Cevimeline was associated with lower failure rates compared to pilocarpine among first-time users: 27% vs. 47% (p=0.02), and all users: 32% vs. 61% (p<0.001). Severe sweating was the most frequent side effect leading to cessation of therapy and occurred more frequently in pilocarpine (25%) than cevimeline (11%) users (p=0.02). Patients who previously failed one secretagogue were less likely to discontinue treatment with the other agent, 52% of first-time users vs. 27% of second-time users (p=0.004). Only ANA positivity was associated with failure: [59% vs. 38%] (p=0.03). pSS patients were more likely to continue cevimeline than pilocarpine long-term due to fewer reported side effects with cevimeline. Therapeutic failure of one secretagogue did not predict similar results with the other since second time users were more likely to continue long-term treatment.

Comparison of efficacy of ginger with various antimotion sickness drugs

NASA Technical Reports Server (NTRS)

Wood, C. D.; Manno, J. E.; Wood, M. J.; Manno, B. R.; Mims, M. E.

1988-01-01

Ginger and several other medications were compared with scopolamine and d-amphetamine for effectiveness in prevention of motion sickness. Methods: Double-blind techniques were used. The subjects were given the medications two hours before they were rotated in a chair making head movements until a symptom total short of vomiting was reached. Standardized N.A.S.A. techniques were used for speed of rotation and end-point of motion sickness. Results: The three doses of ginger were all at the placebo level of efficacy. Amitriptyline, ethopropazine and trihexyphenidyl increased the tolerated head movements but the increase was not statistically significant. Significant levels of protection were produced by dimenhydrinate, promethazine, scopolamine and d-amphetamine. Protection was further increased by combination of these latter drugs with d-amphetamine. Efficacy was greatest as the dose was increased. Conclusions: The medication of choice in this study was scopolamine 0.6 mg with d-amphetamine 10 mg. This combination provided good protection with acceptable side effects.

Memory and Learning--Using Mouse to Model Neurobiological and Behavioural Aspects of Down Syndrome and Assess Pharmacotherapeutics

ERIC Educational Resources Information Center

Gardiner, Katheleen

2009-01-01

Mouse models are a standard tool in the study of many human diseases, providing insights into the normal functions of a gene, how these are altered in disease and how they contribute to a disease process, as well as information on drug action, efficacy and side effects. Our knowledge of human genes, their genetics, functions, interactions and…

Buspirone versus Methylphenidate in the Treatment of Attention Deficit Hyperactivity Disorder: A Double-Blind and Randomized Trial

ERIC Educational Resources Information Center

Davari-Ashtiani, Rozita; Shahrbabaki, Mahin Eslami; Razjouyan, Katayoon; Amini, Homayoun; Mazhabdar, Homa

2010-01-01

The efficacy and side effects of buspirone compared with methylphenidate (MPH) in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). A total of 34 children with ADHD as defined by DSM-IV-TR were randomized to buspirone or methylphenidate dosed on weight-adjusted basis at buspirone (0.5 mg/kg/day) and methylphenidate…

Radiotherapy and "new" drugs-new side effects?

PubMed Central

2011-01-01

Background and purpose Targeted drugs have augmented the cancer treatment armamentarium. Based on the molecular specificity, it was initially believed that these drugs had significantly less side effects. However, currently it is accepted that all of these agents have their specific side effects. Based on the given multimodal approach, special emphasis has to be placed on putative interactions of conventional cytostatic drugs, targeted agents and other modalities. The interaction of targeted drugs with radiation harbours special risks, since the awareness for interactions and even synergistic toxicities is lacking. At present, only limited is data available regarding combinations of targeted drugs and radiotherapy. This review gives an overview on the current knowledge on such combined treatments. Materials and methods Using the following MESH headings and combinations of these terms pubmed database was searched: Radiotherapy AND cetuximab/trastuzumab/panitumumab/nimotuzumab, bevacizumab, sunitinib/sorafenib/lapatinib/gefitinib/erlotinib/sirolimus, thalidomide/lenalidomide as well as erythropoietin. For citation crosscheck the ISI web of science database was used employing the same search terms. Results Several classes of targeted substances may be distinguished: Small molecules including kinase inhibitors and specific inhibitors, antibodies, and anti-angiogenic agents. Combination of these agents with radiotherapy may lead to specific toxicities or negatively influence the efficacy of RT. Though there is only little information on the interaction of molecular targeted radiation and radiotherapy in clinical settings, several critical incidents are reported. Conclusions The addition of molecular targeted drugs to conventional radiotherapy outside of approved regimens or clinical trials warrants a careful consideration especially when used in conjunction in hypo-fractionated regimens. Clinical trials are urgently needed in order to address the open question in regard to efficacy, early and late toxicity. PMID:22188921

Spirulina and Pentoxyfilline – A Novel Approach for Treatment of Oral Submucous Fibrosis

PubMed Central

Mulk, Bhavana Sujana; Deshpande, Prasannasrinivas; Velpula, Nagalakshmi; Chappidi, Vani; Chintamaneni, Raja Lakshmi; Goyal, Stuti

2013-01-01

Background: Oral submucous fibrosis is a habit associated insidious precancerous condition of the oral cavity commonly found in Asian countries. Many treatment modalities have been attempted in treating the condition apart from steroids which have been the main stay. Hence the present study was designed to assess the efficacy of spirulina and pentoxyfilline and also to compare them in oral submucous fibrosis. Material and Methods: Fourty Patients with clinico-histological diagnosis of oral sub mucous fibrosis were selected and divided into two groups with 20 in each group by simple randomization method. Group I received Pentoxyfilline and Group II Spirulina for period of 3 months. The efficacy was assessed by parameters like mouth opening, burning sensation and tongue protrusion using vernier caliper, visual analog scale and a metric scale respectively along with the side effects. Results: Student’s t-test was applied to obtain the results. Both Pentoxyfilline and Spirulina groups showed statistically significant results (p=0.000) in all the three parameters namely mouth opening, burning sensation and tongue protrusion. On comparing both the drugs statistically insignificant results were obtained for mouth opening (p=0.35) and tongue protrusion (p=0.25) but statistically significant difference was seen in subjective parameter i.e burning sensation (p=0.04). Side effects like bloating of stomach, nausea and gastritis were noted in the pentoxyfilline group in contrast to Spirulina group. Conclusion: Newer drugs Pentoxyfilline and Spirulina showed promising results in treatment of Oral sub mucous fibrosis. Spirulina was used for the first time for treatment of Oral submucous fibrosis (OSMF) and it proved to be superior than pentoxyfilline as no side effects were observed. Also it was superior in reducing burning sensation and hence can be advised in OSMF patients suffering from severe subjective symptoms. PMID:24551724

Virtual Reality Cue Refusal Video Game for Alcohol and Cigarette Recovery Support: Summative Study.

PubMed

Metcalf, Mary; Rossie, Karen; Stokes, Katie; Tallman, Christina; Tanner, Bradley

2018-04-16

New technologies such as virtual reality, augmented reality, and video games hold promise to support and enhance individuals in addiction treatment and recovery. Quitting or decreasing cigarette or alcohol use can lead to significant health improvements for individuals, decreasing heart disease risk and cancer risks (for both nicotine and alcohol use), among others. However, remaining in recovery from use is a significant challenge for most individuals. We developed and assessed the Take Control game, a partially immersive Kinect for Windows platform game that allows users to counter substance cues through active movements (hitting, kicking, etc). Formative analysis during phase I and phase II guided development. We conducted a small wait-list control trial using a quasi-random sampling technique (systematic) with 61 participants in recovery from addiction to alcohol or tobacco. Participants used the game 3 times and reported on substance use, cravings, satisfaction with the game experience, self-efficacy related to recovery, and side effects from exposure to a virtual reality intervention and substance cues. Participants found the game engaging and fun and felt playing the game would support recovery efforts. On average, reported substance use decreased for participants during the intervention period. Participants in recovery for alcohol use saw more benefit than those in recovery for tobacco use, with a statistically significant increase in self-efficacy, attitude, and behavior during the intervention. Side effects from the use of a virtual reality intervention were minor and decreased over time; cravings and side effects also decreased during the study. The preliminary results suggest the intervention holds promise as an adjunct to standard treatment for those in recovery, particularly from alcohol use. ©Mary Metcalf, Karen Rossie, Katie Stokes, Christina Tallman, Bradley Tanner. Originally published in JMIR Serious Games (http://games.jmir.org), 16.04.2018.

[Influence of Saccharomyces boulardii Sachets combined with bismuth quadruple therapy for initial Helicobacter pylori eradication].

PubMed

Zhu, X Y; Du, J; Wu, J; Zhao, L W; Meng, X; Liu, G F

2017-08-08

Objective: To evaluate the efficacy and safety of Saccharomyces boulardii Sachets combined with bismuth quadruple therapy for initial Helicobacter pylori ( H . pylori ) eradication. Methods: From March 2014 to March 2015, 240 participants from the third hospital of Hebei medical university with H . pylori infection were recruited and randomized into three groups: Quadruple therapy group received bismuth potassium citrate 220 mg bid + Rabeprazole 10 mg bid + amoxicillin 1 000 mg bid+ furazolidone 100 mg bid for 10 days. Short-term group and long-term group received the same quadruple therapy for 10 days as above, as well as Saccharomyces boulardii Sachets 500 mg bid for 14 days and 28 days, respectively. H . pylori eradication was confirmed by (13)C/(14)C-UBT at least 4 weeks after completion of therapy. And side effects were investigated during the therapy. Results: The H . pylori eradication rates in quadruple therapy, short-term and long-term group were 80%, 87.5% and 87.5% by ITT analysis ( P =0.321) and 92.8%, 94.6% and 95.9% by PP analysis ( P =0.717), respectively. The overall side effect rate and occurrence of diarrhea and abdominal distension were significantly lower in short-term or long-term group as compared with quadruple therapy group( P =0.007, 0.003, 0.004), but there was no significant difference between the two probiotics groups. Conclusions: Both short and long-term Saccharomyces boulardii Sachets reduced the overall side effect rate and occurrence of diarrhea or abdominal distension when combined with bismuth quadruple therapy for initial H . pylori eradication and no difference was observed in efficacy or safety between the two groups.

A randomized double-blind, placebo-controlled trial of minocycline in children and adolescents with fragile x syndrome.

PubMed

Leigh, Mary Jacena S; Nguyen, Danh V; Mu, Yi; Winarni, Tri I; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M; Hessl, David; Hagerman, Randi J

2013-04-01

Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Previous open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, aged 3.5 years to 16 years (n = 55, mean age 9.2 [SD, 3.6] years). Participants were randomized to minocycline or placebo for 3 months and then switched to the other treatment. Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared with placebo (2.49 ± 0.13 and 2.97 ± 0.13, respectively, p = .0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analog Scale (minocycline: 5.26 cm ± 0.46 cm, placebo: 4.05 cm ± 0.46 cm; p = .0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding, and preliminary efficacy analysis results known to investigators. Minocycline treatment for 3 months in children with FXS resulted in greater global improvement than placebo. Treatment for 3 months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline.

PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial.

PubMed

Voskuijl, W; de Lorijn, F; Verwijs, W; Hogeman, P; Heijmans, J; Mäkel, W; Taminiau, J; Benninga, M

2004-11-01

Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative. To compare PEG 3350 (Transipeg: polyethylene glycol with electrolytes) with lactulose in paediatric constipation and evaluate clinical efficacy/side effects. One hundred patients (aged 6 months-15 years) with paediatric constipation were included in an eight week double blinded, randomised, controlled trial. After faecal disimpaction, patients <6 years of age received PEG 3350 (2.95 g/sachet) or lactulose (6 g/sachet) while children > or =6 years started with 2 sachets/day. Primary outcome measures were: defecation and encopresis frequency/week and successful treatment after eight weeks. Success was defined as a defecation frequency > or =3/week and encopresis < or =1 every two weeks. Secondary outcome measures were side effects after eight weeks of treatment. A total of 91 patients (49 male) completed the study. A significant increase in defecation frequency (PEG 3350: 3 pre v 7 post treatment/week; lactulose: 3 pre v 6 post/week) and a significant decrease in encopresis frequency (PEG 3350: 10 pre v 3 post/week; lactulose: 8 pre v 3 post/week) was found in both groups (NS). However, success was significantly higher in the PEG group (56%) compared with the lactulose group (29%). PEG 3350 patients reported less abdominal pain, straining, and pain at defecation than children using lactulose. However, bad taste was reported significantly more often in the PEG group. PEG 3350 (0.26 (0.11) g/kg), compared with lactulose (0.66 (0.32) g/kg), provided a higher success rate with fewer side effects. PEG 3350 should be the laxative of first choice in childhood constipation.

Virtual Reality Cue Refusal Video Game for Alcohol and Cigarette Recovery Support: Summative Study

PubMed Central

Rossie, Karen; Stokes, Katie; Tallman, Christina; Tanner, Bradley

2018-01-01

Background New technologies such as virtual reality, augmented reality, and video games hold promise to support and enhance individuals in addiction treatment and recovery. Quitting or decreasing cigarette or alcohol use can lead to significant health improvements for individuals, decreasing heart disease risk and cancer risks (for both nicotine and alcohol use), among others. However, remaining in recovery from use is a significant challenge for most individuals. Objective We developed and assessed the Take Control game, a partially immersive Kinect for Windows platform game that allows users to counter substance cues through active movements (hitting, kicking, etc). Methods Formative analysis during phase I and phase II guided development. We conducted a small wait-list control trial using a quasi-random sampling technique (systematic) with 61 participants in recovery from addiction to alcohol or tobacco. Participants used the game 3 times and reported on substance use, cravings, satisfaction with the game experience, self-efficacy related to recovery, and side effects from exposure to a virtual reality intervention and substance cues. Results Participants found the game engaging and fun and felt playing the game would support recovery efforts. On average, reported substance use decreased for participants during the intervention period. Participants in recovery for alcohol use saw more benefit than those in recovery for tobacco use, with a statistically significant increase in self-efficacy, attitude, and behavior during the intervention. Side effects from the use of a virtual reality intervention were minor and decreased over time; cravings and side effects also decreased during the study. Conclusions The preliminary results suggest the intervention holds promise as an adjunct to standard treatment for those in recovery, particularly from alcohol use. PMID:29661748

A Randomized Double-Blind, Placebo-Controlled Trial of Minocycline in Children and Adolescents with Fragile X Syndrome

PubMed Central

Leigh, Mary Jacena S.; Nguyen, Danh V.; Mu, Yi; Winarni, Tri I.; Schneider, Andrea; Chechi, Tasleem; Polussa, Jonathan; Doucet, Paul; Tassone, Flora; Rivera, Susan M.; Hessl, David; Hagerman, Randi J.

2013-01-01

Objective Minocycline rescued synaptic abnormalities and improved behavior in the fragile X mouse model. Prior open-label human studies demonstrated benefits in individuals with fragile X syndrome (FXS); however, its efficacy in patients with FXS has not been assessed in a controlled trial. Method Randomized, double-blind, placebo-controlled, crossover trial in individuals with FXS, ages 3.5-16 years (n=55, mean age 9.2 (SD 3.6 years)). Participants were randomized to minocycline or placebo for three months, then switched to the other treatment. Results Sixty-nine subjects were screened and 66 were randomized. Fifty-five subjects (83.3%) completed at least the first period and 48 (72.7%) completed the full trial. Intention-to-treat analysis demonstrated significantly greater improvements in one primary outcome, Clinical Global Impression Scale-Improvement after minocycline compared to placebo (2.49 ±0.13, 2.97 ±0.13, respectively, p 0.0173) and greater improvement in ad hoc analysis of anxiety and mood-related behaviors on the Visual Analoge Scale (minocycline 5.26 cm ±0.46 cm, placebo 4.05 cm±0.46cm; p 0.0488). Side effects were not significantly different during the minocycline and placebo treatments. No serious adverse events occurred on minocycline. Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding and preliminary efficacy analysis results known to investigators. Conclusion Minocycline treatment for three months in children with FXS resulted in greater global improvement than placebo. Treatment for three months appears safe; however, longer trials are indicated to further assess benefits, side effects, and factors associated with a clinical response to minocycline. PMID:23572165

Effects of omeprazole in improving concurrent chemoradiotherapy efficacy in rectal cancer.

PubMed

Zhang, Jin-Liang; Liu, Min; Yang, Qing; Lin, Shi-Yong; Shan, Hong-Bo; Wang, Hui-Yun; Xu, Guo-Liang

2017-04-14

To explore the effects of omeprazole on chemoradiotherapy efficacy and tumor recurrence in rectal cancer. The medical data of 125 rectal cancer patients who received the same neoadjuvant chemoradiotherapy (CRT) followed by surgery were retrospectively collected. Patients who received omeprazole (OME) orally at a dose of 20 mg at least once daily for six days and/or intravenously at 40 mg a day were recognized as eligible OME users (EOU). Otherwise, patients were regarded as non-eligible OME users (non-EOU). Moreover, a preferred OME dose cut-off of 200 mg on tumor recurrence was obtained by receiver operating characteristic (ROC) curves. Patients were divided into two groups: the effective OME group (EOG, OME ≥ 200 mg) and the non-effective OME group (non-EOG, OME < 200 mg). The good response rate of CRT efficacy (50.8%) in EOU was significantly increased compared with non-EOU (30.6%) ( P = 0.02). The recurrence rate in the EOG was 10.3%, which was significantly lower compared with 31.3% in non-EOG ( P = 0.025). The good response rate of CRT efficacy in EOG was 55.2%, which was obviously higher compared with 36.5% in non-EOG, with a significant difference ( P = 0.072). Multivariate Cox analysis demonstrated that OME (non-EOG and EOG) was an independent and significant impact factor for DFS ( P = 0.048, HR = 0.30, 95%CI: 0.09-0.99). When applied as an adjuvant drug in cancer treatment for relieving common side effects of chemotherapy, omeprazole has a synergetic effect in improving CRT efficacy and decreasing rectal cancer recurrence.

Quantitative differences in the immunomodulatory effects of Rebif and Avonex in IFN-β 1a treated multiple sclerosis patients

PubMed Central

Christophi, George P.; Christophi, Jennifer A.; Gruber, Ross C.; Mihai, Cornelia; Mejico, Luis J.; Massa, Paul T.; Jubelt, Burk

2012-01-01

Interferon-β (IFN-β) is a current effective treatment for multiple sclerosis (MS) and exerts its therapeutic effects by down-modulating the systemic immune response and cytokine signaling. In clinical practice there are several formulations of interferon including a low dose of IFN-β 1a formulation of 30μg IM once weekly (Avonex) and a high dose formulation of 44 μg SC three times weekly (Rebif). Recent studies suggest that Rebif is more efficacious compared to Avonex in preventing relapses and decreasing MRI activity in relapsing remitting MS (RRMS) patients. This study examines whether there are quantitative gene expression changes in interferon-treated RRMS patients that can explain the difference in efficacy and side effects between Rebif and Avonex. Herein, RRMS patients were treated for three months with IFN-β 1a and the levels of plasma cytokines and gene expression in peripheral blood mononuclear cells were examined. Thirty-two normal subjects were compared to thirty-two RRMS patients, of which ten were treated with Rebif and ten with Avonex. Rebif and Avonex both significantly and equally suppressed plasma TNF-α and IL-6 levels. Rebif suppressed IL-13 significantly more than Avonex. Rebif also significantly suppressed the levels of the chemokines CCL17 and RANTES, the protease ADAM8, and COX-2 at a higher degree compared to Avonex. The STAT1-inducible genes IP-10 and caspase 1 were significantly increased with Rebif compared to Avonex. In conclusion, the higher dosed, more frequently administered IFN-β 1a Rebif when compared to IFN β-1a Avonex has more potent immunomodulatory effects. These quantitative results might relate to efficacy and side-effect profile of the two IFN-β 1a formulations and provide prospective practical clinical tools to monitor treatment and adjust dosage. PMID:21658727

Omalizumab for pediatric asthma.

PubMed

Townley, Robert G; Agrawal, Swati; Sapkota, Kiran

2010-11-01

Omalizumab is of proven efficacy in the treatment of severe allergic bronchial asthma and works through inhibiting the activity of IgE and the allergic immune mechanism IgE mediates. It has been demonstrated to be efficacious in children with asthma but is not approved by the FDA for use in children below 12 years of age. Omalizumab is a 95% humanized monoclonal antibody that binds to circulating IgE at the same site on the Fc domain as the high-affinity IgE receptor, FcϵRI. This blocks the interaction between IgE and mast cells and basophils, thereby preventing the release of inflammatory mediators that cause allergic signs and symptoms. From the review of the literatures and statements from the FDA, Genentec and Novartis, the reader will gain a better appreciation of the value of omalizumab in treatment of severe asthma and the current status of its reported side effects. Omalizumab is of proven efficacy in adults and children with severe asthma and allows a markedly reduced dependence on oral and inhaled corticosteroids and decreased hospitalizations. A potential mechanism of omalizumab's effect on thrombus formation and cardiovascular effect is postulated.

Novel strategies in immunotherapy for allergic diseases

PubMed Central

Tham, Elizabeth Huiwen; Soh, Jian Yi; Van Bever, HP

2018-01-01

Conventional immunotherapy (IT) for optimal control of respiratory and food allergies has been fraught with concerns of efficacy, safety, and tolerability. The development of adjuvants to conventional IT has potentially increased the effectiveness and safety of allergen IT, which may translate into improved clinical outcomes and sustained unresponsiveness even after cessation of therapy. Novel strategies incorporating the successful use of adjuvants such as allergoids, immunostimulatory DNA sequences, monoclonal antibodies, carriers, recombinant proteins, and probiotics have now been described in clinical and murine studies. Future approaches may include fungal compounds, parasitic molecules, vitamin D, and traditional Chinese herbs. More robust comparative clinical trials are needed to evaluate the safety, clinical efficacy, and cost effectiveness of various adjuvants in order to determine ideal candidates in disease-specific and allergen-specific models. Other suggested approaches to further optimize outcomes of IT include early introduction of IT during an optimal window period. Alternative routes of administration of IT to optimize delivery and yet minimize potential side effects require further evaluation for safety and efficacy before they can be recommended. PMID:29732290

Bilastine: a new H1 -antihistamine with an optimal profile for updosing in urticaria.

PubMed

Church, M K; Labeaga, L

2017-09-01

This review set out to examine published papers detailing the efficacy of bilastine in skin models and urticaria to assess whether it meets the optimal profile for updosing in urticaria, that is, strong clinical efficacy and freedom from unwanted side effects, particularly sedation. Bilastine is a highly effective H 1 -antihistamine even when used at the basic dose of 20 mg daily. Its facilitated uptake after oral dosage gives it a rapid onset and long duration of action. In both wheal and flare studies and in urticaria updosing fourfold showed increased effectiveness. With respect to somnolence, bilastine is a substrate for P-glycoprotein, a membrane pump which prevents it crossing the blood-brain barrier. Consequently, bilastine is a practically 'non-sedating' H 1 -antihistamine. In conclusion, the excellent profile of bilastine in both efficacy and safety make it the ideal H 1 -antihistamine for updosing the daily dose fourfold in difficult-to-treat urticaria as recommended by the EAACI/GA 2 LEN/EDF/WAO guideline for the management of urticaria. © 2017 European Academy of Dermatology and Venereology.

May selective serotonin reuptake inhibitors (SSRIs) provide some benefit for the treatment of schizophrenia?

PubMed

Buoli, Massimiliano; Serati, Marta; Ciappolino, Valentina; Altamura, A Carlo

2016-07-01

The treatment of some psychopathological dimensions of schizophrenia (e.g. negative and depressive symptoms) is still challenging for the modest efficacy of atypical antipsychotics. Among pharmacological alternatives, augmentative Selective Serotonin Reuptake Inhibitors (SSRIs) to antipsychotics are frequently prescribed in clinical practice to improve negative/depressive symptoms of schizophrenia patients; however, the data about the efficacy of these molecules on negative, depressive and obsessive-compulsive symptoms of schizophrenia are contrasting. Research using the main database sources has been conducted to obtain an overview of the use and efficacy of SSRIs in schizophrenia. Data are too scanty to draw definitive recommendations. In a preliminary way, it can be said that available data do not show effectiveness of SSRIs on depressive symptoms of schizophrenia. Regarding negative symptoms, studies are contrasting, but paroxetine appears to be the most effective compound among SSRIs. Despite limited data, SSRIs appear to be useful for the treatment of obsessive-compulsive symptoms of schizophrenia, particularly fluvoxamine. Close clinical and pharmacological monitoring is needed in case of concomitant administration of antipsychotics and antidepressants for potential serious side effects and influence on plasma drug dosages.

Tranexamic Acid in the Treatment of Melasma: A Review of the Literature.

PubMed

Perper, Marina; Eber, Ariel Eva; Fayne, Rachel; Verne, Sebastian Hugo; Magno, Robert James; Cervantes, Jessica; ALharbi, Mana; ALOmair, Ibrahim; Alfuraih, Abdulkarem; Nouri, Keyvan

2017-06-01

Melasma is a common acquired pigmentary disorder marked by irregular hyperpigmented macules or patches and most commonly occurs in women of darker skin color. It is a chronic often-relapsing condition that causes negative psychosocial effects in those affected. Current treatments such as hydroquinone, kojic acid, and retinoids, among others, demonstrate variable efficacy and side-effect profiles. We conducted a comprehensive literature review examining the use of tranexamic acid (TA), a well-known anti-fibrinolytic agent, in the treatment of melasma. TA delivered orally, topically, and through physical methods works via the inhibition of ultraviolet (UV)-induced plasmin activity in keratinocytes. Predefined search terms were entered into PubMed. Articles were then independently screened by two authors to include only those written in the English language and relating to human subjects with at least mild melasma. The search identified 28 articles, 15 of which met the criteria for full review. The review revealed that TA treatment for melasma is equally effective or more effective than other standard therapies and may induce fewer side effects. Our comprehensive review suggests that TA may be a promising treatment option for melasma because of its demonstrated effectiveness alone and in combination with other modalities as well as its limited side-effect profile.

Clinical efficacy of new aloe vera- and myrrh-based oral mucoadhesive gels in the management of minor recurrent aphthous stomatitis: a randomized, double-blind, vehicle-controlled study.

PubMed

Mansour, Ghada; Ouda, Soliman; Shaker, Ahmed; Abdallah, Hossam M

2014-07-01

To evaluate the clinical efficacy, and safety of newly customized natural oral mucoadhesive gels, containing either aloe vera or myrrh as active ingredients, in the management of minor recurrent aphthous stomatitis (MiRAS). Ninety subjects with MiRAS were recruited from Oral Medicine Clinic, at Faculty of Dentistry, King Abdulaziz University, Saudi Arabia, for this randomized, double-blind, placebo-controlled study. Two new natural gels, containing aloe vera and myrrh, were prepared in a concentration of (0.5% w/w), in addition to a plain mucoadhesive gel used as a placebo. Patients with fresh ulcers (<48-h duration) were instructed to apply either one of the three gels four times a day for a period of 5 days. Clinical efficacy was investigated in the form of changes in ulcer size, pain intensity, erythema, and exudation at days 4 and 6 of study entry. Participants were interviewed for the emergence of any side effects. 76.6% of patients using aloe gel showed complete ulcer healing, 86.7%, and 80% of them revealed subsidence of erythema and exudation, respectively, especially at day 6 visit, whereas 76.7% of myrrh-treated patients revealed almost absence of pain at day 6. No side effects were encountered with the use of any of the three gels. The new formulated aloe- and myrrh-based gels proved to be effective in topical management of MiRAS. Aloe was superior in decreasing ulcer size, erythema, and exudation; whereas myrrh resulted in more pain reduction. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Pilot study on the efficacy and safety of generic mycophenolate mofetil (Mycept) compared with Cellcept among incident low-risk primary kidney transplant recipients.

PubMed

Danguilan, R A; Lamban, A B; Luna, C A C; Bacinillo, M; Momongan, M I C

2014-01-01

The aim of this study was to establish the efficacy and safety of generic mycophenolate mofetil (Mycept) and determine the bioequivalence with Cellcept. This will provide patients an alternative cost-effective option that may improve compliance and long-term outcome. This was a comparative study between 2 nonconcurrent matched groups on Mycept and Cellcept. A total of 56 patients were included based on criteria (20 incidental patients on Mycept, matched to 20 historical patients on Cellcept, and 16 additional incidental patients on Cellcept). Patient and graft survival and safety parameters were reviewed at 6 months. Bioequivalence of Mycept with Cellcept was done by measuring area under the curve (AUC) of mycophenolic acid (MPA), maximum concentration, and time to maximum concentration for 16 patients in each group. Twenty incidental Mycept patients completed 6 months of follow-up. No significant difference was observed in survival (P = 1.0), graft function (P = .2320), and rejection episodes (P = .6250) between groups. The most common side effect of Mycept was hematologic and infectious. The MPA AUC of Mycept (37.38 ng/mL) was within the recommended MPA of 30-60 ng/mL. The maximum concentration (6.06 ng/mL) and time to maximum concentration (1.19 hours) of the 10 Mycept patients were not significantly different from the 10 Cellcept patients. There was no proven statistically significant difference between Mycept and Cellcept in efficacy and graft survival at 6 months after kidney transplantation. Hematologic side effects were noted more frequently among patients on Mycept and monitoring regularly is recommended. Copyright © 2014 Elsevier Inc. All rights reserved.

Improved antimicrobial therapy with cationic tetra- and octa-substituted phthalocyanines

NASA Astrophysics Data System (ADS)

Angelov, I.; Mantareva, V.; Kussovski, V.; Woehrle, D.; Borisova, E.; Avramov, L.

2008-12-01

Photodynamic therapy (PDT) today is an innovative and not yet widespread light-drug initiated treatment that is based on the photoactive compound irradiated with proper light to produce oxygen species that are toxic to the pathogenic biological objects- bacteria, viruses, tumor cells. The obstacles that limited the efficacy of PDT concern to the selectivity and multi-drug resistance prolong time for cellular release and side effects of skin photosensitivity for commercial porphyrin originated photosensitizers (PS). Now there are very intensive investigations for introducing in practice a new, with a least side effects PSs for PDT. The usefulness of the more extended macromolecules structured with proper substituents refers not only to the improved optical properties like far-red and with intensive absorption and emission capacity, but mainly to the ability for selective delivery and adhesion to the target cells, such as bacteria or other pathogens. The present study focuses on the charge effect of photodynamic agent on the uptake capacity toward gram-negative bacteria cells and their further photoinactivation. The multi-drug resistant microorganism Aeromanas hydrophilla, which is causing diseases to fishes and humans, is treated. The new octa-cationic phthalocyanines are designed to compare PDT efficacy to the efficacy of tetra-substituted derivatives with the same functional peripheral substituents. The higher cellular accumulation to the bacteria cells as a result of the high number of positive charges of photosensitizer, leading to the better adhesion to the cellular membranes and improved photoinactivation of bacteria causing superficial and intraorgan infections. These results set a base of a rationale design of covalently octa-substituted phthalocyanines with positive charge for a successful treatment of microorganisms.

Fractionated microneedle radiofrequency for treatment of primary axillary hyperhidrosis: A sham control study.

PubMed

Fatemi Naeini, Farahnaz; Abtahi-Naeini, Bahareh; Pourazizi, Mohsen; Nilforoushzadeh, Mohammad Ali; Mirmohammadkhani, Majid

2015-11-01

Primary axillary hyperhidrosis (PAH) creates social stress in patients. Although there are several options for treating PAH, only surgical modalities have conferred a permanent solution. This study evaluated the clinical effectiveness of fractionated microneedle radiofrequency (FMR) treatment for PAH. This study is based on a single-blind, sham control comparative design. In all, 25 patients with severe PAH underwent three sessions of FMR at 3-week intervals. One side was treated with FMR while the other was sham controlled. Efficacy was evaluated using the hyperhidrosis disease severity scale (HDSS), sweating intensity visual analogue scale (VAS) and patient satisfaction at baseline, 3 weeks after each session and at 3 months after the last. Skin biopsies were obtained from two enrolled patients. The HDSS and VAS demonstrated significant improvement after treatment on the treated side in comparison with the control side. The mean ± SD of the HDSS after 21 weeks were 1.87 ± 0.61 and 3.38 ± 0.49 (P < 0.001) for the treated and the controlled side, respectively. The follow-up evaluation revealed that 79% of the patients showed a 1 or 2-score decrease in HDSS. In total, 80% of patients reported more than 50% satisfaction at the end of the study. Histopathological findings showed a decrease of the number of the sweat glands in the treated side, confirming the above findings. Treatment of PAH with FMR as a non-invasive modality can be a safe option with positive therapeutic effects on HDSS without any long-lasting side effects. © 2014 The Australasian College of Dermatologists.

Monopolar radiofrequency facial tightening: a retrospective analysis of efficacy and safety in over 600 treatments.

PubMed

Weiss, Robert A; Weiss, Margaret A; Munavalli, Girish; Beasley, Karen L

2006-09-01

Monopolar radiofrequency skin heating coupled with cryogen cooling of facial skin for skin tightening has been utilized on over 10,000 patients since 2002. In order to establish the actual rate and degree of side effects in our clinical experience, a retrospective chart review was performed. Charts and clinical images of over 600 consecutive patient treatments between May 2002 and June 2006 using a monopolar radiofrequency device (Thermacool, Thermage, Haywood, CA) for skin tightening at the Maryland Laser, Skin and Vein Institute were retrospectively reviewed. The primary presentation for treatment was skin laxity of the lower face. Treatment was delivered with a 1-cm2 standard tip at fluences of 81 to 124 J/cm2 (level of 12.5 to 15), a 1-cm2 "fast" tip at fluences of 62 to 109 J/cm2 (level of 72.0 to 76.0), a 1.5-cm2 "big fast" tip at fluences of 75 to 130 J/cm2 (level of 61.5 to 65), and a 3-cm2 "bigger" tip at equivalent fluences as each became available. As treatment algorithms evolved over 4 years, the algorithm of multiple passes at lower fluence associated with better clinical outcomes and greater patient acceptance has been adopted. The most common immediate and expected clinical effects were erythema and edema lasting less than 24 hours, although 6 patients reported edema lasting for up to 1 week. There were no permanent side effects. In total, 2.7% of treatments resulted in temporary side effects, the most significant of which was a slight depression on the cheek (n = 1), which completely resolved within 3.5 months. Other side effects included localized areas of acneiform subcutaneous erythematous papules (n = 4) and a linear superficial crust (n = 1) with the original tip, all of which resolved within 1 week. One patient reported small erythematous subcutaneous nodules resolving in 17 days. Tenderness of the neck lasting from 2 weeks (n = 2) to 3 weeks (n = 1) was also reported. Our data, obtained in an office setting without injectable anesthetic or i.v. sedation, indicate that monopolar RF for skin tightening is a very safe procedure. The treatment algorithm and tips have evolved over several years leading to increased safety and efficacy. Side effects are infrequent, self-limited, and minor, comparing favorably to other nonablative devices utilized for facial rejuvenation.

Comparison of Efficacy and Side Effects of Oral Baclofen Versus Tizanidine Therapy with Adjuvant Botulinum Toxin Type A in Children With Cerebral Palsy and Spastic Equinus Foot Deformity.

PubMed

Dai, Alper I; Aksoy, Sefika N; Demiryürek, Abdullah T

2016-02-01

This retrospective study aimed to compare the therapeutic response, including side effects, for oral baclofen versus oral tizanidine therapy with adjuvant botulinum toxin type A in a group of 64 pediatric patients diagnosed with static encephalopathy and spastic equinus foot deformity. Following botulinum toxin A treatment, clinical improvement led to the gradual reduction of baclofen or tizanidine dosing to one-third of the former dose. Gross Motor Functional Measure and Caregiver Health Questionnaire scores were markedly elevated post-botulinum toxin A treatment, with scores for the tizanidine (Gross Motor Functional Measure: 74.45 ± 3.72; Caregiver Health Questionnaire: 72.43 ± 4.29) group significantly higher than for the baclofen group (Gross Motor Functional Measure: 68.23 ± 2.66; Caregiver Health Questionnaire: 67.53 ± 2.67, P < .001). These findings suggest that the combined use of botulinum toxin A and a low dose of tizanidine in treating children with cerebral palsy appears to be more effective and has fewer side effects versus baclofen with adjuvant botulinum toxin A. © The Author(s) 2015.

Issues in hypertension: drug tolerability and special populations.

PubMed

Gavras, H P

2001-07-01

Improvements in the death rate from coronary heart disease and in the control of hypertension have leveled off in recent years, reversing a trend toward steady improvement that began in 1972. Of the roughly 20% of Americans who suffer from hypertension, only 29% achieve adequate control (<140/90 mm Hg) with treatment and nearly half receive no treatment at all. Poor adherence to therapy doubtless plays a key role in this failure. As a major cause of poor adherence, tolerability becomes an extremely important element in any discussion of effective antihypertensive treatment. Despite their efficacy in treating hypertension, diuretics, beta-blockers, and calcium channel blockers have all been associated with numerous side effects, including increased serum lipid levels, insulin resistance, and edema. With the introduction of the angiotensin converting enzyme (ACE) inhibitors, patients were able to achieve blood pressure goals with fewer side effects. These agents, however, cause an irritating cough in up to 19% of patients. A newer class of drugs, the angiotensin receptor blockers (ARB), have similar effects to the ACE inhibitors, but their highly selective nature produces even fewer side effects. Eprosartan is a structurally unique ARB. Like the other ARB, this promising new agent has a side effect profile similar to placebo, and its response rate rivals or exceeds that of enalapril. Although it remains to be seen whether the ARB can significantly reduce morbidity and mortality from cardiovascular disease, preliminary data from the Evaluation of Losartan in the Elderly (ELITE) trial appear to be promising.

Polypeptide-based combination of paclitaxel and cisplatin for enhanced chemotherapy efficacy and reduced side-effects.

PubMed

Song, Wantong; Tang, Zhaohui; Li, Mingqiang; Lv, Shixian; Sun, Hai; Deng, Mingxiao; Liu, Huaiyu; Chen, Xuesi

2014-03-01

A novel methoxy poly(ethylene glycol)-b-poly(l-glutamic acid)-b-poly(l-phenylalanine) (mPEG-b-P(Glu)-b-P(Phe)) triblock copolymer was prepared and explored as a micelle carrier for the co-delivery of paclitaxel (PTX) and cisplatin (cis-diamminedichlo-platinum, CDDP). PTX and CDDP were loaded inside the hydrophobic P(Phe) inner core and chelated to the middle P(Glu) shell, respectively, while mPEG provided the outer corona for prolonged circulation. An in vitro release profile of the PTX+CDDP-loaded micelles showed that the CDDP chelation cross-link prevented an initial burst release of PTX. The PTX+CDDP-loaded micelles exhibited a high synergism effect in the inhibition of A549 human lung cancer cell line proliferation over 72 h incubation. For the in vivo treatment of xenograft human lung tumor, the PTX+CDDP-loaded micelles displayed an obvious tumor inhibiting effect with a 83.1% tumor suppression rate (TSR%), which was significantly higher than that of a free drug combination or micelles with a single drug. In addition, more importantly, the enhanced anti-tumor efficacy of the PTX+CDDP-loaded micelles came with reduced side-effects. No obvious body weight loss occurred during the treatment of A549 tumor-bearing mice with the PTX+CDDP-loaded micelles. Thus, the polypeptide-based combination of PTX and CDDP may provide useful guidance for effective and safe cancer chemotherapy. Copyright © 2013 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

The use of low dose methotrexate in children with chronic anterior and intermediate uveitis.

PubMed

Malik, A R; Pavesio, C

2005-07-01

To assess the efficacy of low dose methotrexate (MTX) therapy for children with chronic anterior and intermediate uveitis. A retrospective case review of 10 children who received MTX for chronic uveitis at a tertiary referral centre was performed. The following data were recorded for each patient: age, sex, race, duration of uveitis, primary diagnosis, anatomical localisation of uveitis, corticosteroid therapy, dose range of MTX, duration of MTX therapy, and side effects of MTX therapy. Several clinical parameters were evaluated to study the effect of MTX. These included visual acuity, anterior chamber inflammation, and topical and oral corticosteroid requirement. After MTX VA of 6/6 or better was present in 100% right eyes and 80% left eyes (p = 0.055 and p = 0.016, respectively). Anterior chamber inflammation decreased in 60% of children after MTX (p = 0.0168). The requirement of topical steroid decreased from a mean of 5.6 times a day before MTX to 1.5 times a day after MTX (p = 0.005). The dose of oral steroid decreased from a mean of 18 mg per day to 2.85 mg per day (p = 0.012). The most common adverse effect was nausea (20%). No patient required discontinuation of MTX because of side effects. MTX is effective and safe for chronic anterior and intermediate uveitis in children. An increase awareness of its efficacy is required among paediatricians and ophthalmologists to prevent sight threatening complication of chronic uveitis and its treatment with long term use of steroids.

Sertraline versus other antidepressive agents for depression.

PubMed

Cipriani, Andrea; La Ferla, Teresa; Furukawa, Toshi A; Signoretti, Alessandra; Nakagawa, Atsuo; Churchill, Rachel; McGuire, Hugh; Barbui, Corrado

2010-04-14

The National Institute for Health and Clinical Excellence clinical practice guideline on the treatment of depressive disorder recommended that selective serotonin reuptake inhibitors should be the first-line option when drug therapy is indicated for a depressive episode. Preliminary evidence suggested that sertraline might be slightly superior in terms of effectiveness. To assess the evidence for the efficacy, acceptability and tolerability of sertraline in comparison with tricyclics (TCAs), heterocyclics, other SSRIs and newer agents in the acute-phase treatment of major depression. MEDLINE (1966 to 2008), EMBASE (1974 to 2008), the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Central Register of Controlled Trials up to July 2008. No language restriction was applied. Reference lists of relevant papers and previous systematic reviews were hand-searched. Pharmaceutical companies and experts in this field were contacted for supplemental data. Randomised controlled trials allocating patients with major depression to sertraline versus any other antidepressive agent. Two review authors independently extracted data. Discrepancies were resolved with another member of the team. A double-entry procedure was employed by two reviewers. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy (the number of patients who responded or remitted), acceptability (the number of patients who failed to complete the study) and tolerability (side-effects). A total of 59 studies, mostly of low quality, were included in the review, involving multiple treatment comparisons between sertraline and other antidepressant agents. Evidence favouring sertraline over some other antidepressants for the acute phase treatment of major depression was found, either in terms of efficacy (fluoxetine) or acceptability/tolerability (amitriptyline, imipramine, paroxetine and mirtazapine). However, some differences favouring newer antidepressants in terms of efficacy (mirtazapine) and acceptability (bupropion) were also found. In terms of individual side effects, sertraline was generally associated with a higher rate of participants experiencing diarrhoea. This systematic review and meta-analysis highlighted a trend in favour of sertraline over other antidepressive agents both in terms of efficacy and acceptability, using 95% confidence intervals and a conservative approach, with a random effects analysis. However, the included studies did not report on all the outcomes that were pre-specified in the protocol of this review. Outcomes of clear relevance to patients and clinicians were not reported in any of the included studies.

Sertraline versus other antidepressive agents for depression.

PubMed

Cipriani, Andrea; La Ferla, Teresa; Furukawa, Toshi A; Signoretti, Alessandra; Nakagawa, Atsuo; Churchill, Rachel; McGuire, Hugh; Barbui, Corrado

2009-04-15

The National Institute for Health and Clinical Excellence clinical practice guideline on the treatment of depressive disorder recommended that selective serotonin reuptake inhibitors should be the first-line option when drug therapy is indicated for a depressive episode. Preliminary evidence suggested that sertraline might be slightly superior in terms of effectiveness. To assess the evidence for the efficacy, acceptability and tolerability of escitalopram in comparison with tricyclics (TCAs), heterocyclics, other SSRIs and newer agents in the acute-phase treatment of major depression. MEDLINE (1966 to 2008), EMBASE (1974 to 2008), the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Central Register of Controlled Trials up to July 2008. No language restriction was applied. Reference lists of relevant papers and previous systematic reviews were hand-searched. Pharmaceutical companies and experts in this field were contacted for supplemental data. Randomised controlled trials allocating patients with major depression to sertraline versus any other antidepressive agent. Two review authors independently extracted data. Discrepancies were resolved with another member of the team. A double-entry procedure was employed by two reviewers. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy (the number of patients who responded or remitted), acceptability (the number of patients who failed to complete the study) and tolerability (side-effects). A total of 59 studies, mostly of low quality, were included in the review, involving multiple treatment comparisons between sertraline and other antidepressant agents. Evidence favouring sertraline over some other antidepressants for the acute phase treatment of major depression was found, either in terms of efficacy (fluoxetine) or acceptability/tolerability (amitriptyline, imipramine, paroxetine and mirtazapine). However, some differences favouring newer antidepressants in terms of efficacy (mirtazapine) and acceptability (bupropion) were also found. In terms of individual side effects, sertraline was generally associated with a higher rate of participants experiencing diarrhoea. This systematic review and meta-analysis highlighted a trend in favour of sertraline over other antidepressive agents both in terms of efficacy and acceptability, using 95% confidence intervals and a conservative approach, with a random effects analysis. However, the included studies did not report on all the outcomes that were pre-specified in the protocol of this review. Outcomes of clear relevance to patients and clinicians were not reported in any of the included studies.

Sertraline versus other antidepressive agents for depression.

PubMed

Cipriani, Andrea; La Ferla, Teresa; Furukawa, Toshi A; Signoretti, Alessandra; Nakagawa, Atsuo; Churchill, Rachel; McGuire, Hugh; Barbui, Corrado

2010-01-20

The National Institute for Health and Clinical Excellence clinical practice guideline on the treatment of depressive disorder recommended that selective serotonin reuptake inhibitors should be the first-line option when drug therapy is indicated for a depressive episode. Preliminary evidence suggested that sertraline might be slightly superior in terms of effectiveness. To assess the evidence for the efficacy, acceptability and tolerability of sertraline in comparison with tricyclics (TCAs), heterocyclics, other SSRIs and newer agents in the acute-phase treatment of major depression. MEDLINE (1966 to 2008), EMBASE (1974 to 2008), the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Central Register of Controlled Trials up to July 2008. No language restriction was applied. Reference lists of relevant papers and previous systematic reviews were hand-searched. Pharmaceutical companies and experts in this field were contacted for supplemental data. Randomised controlled trials allocating patients with major depression to sertraline versus any other antidepressive agent. Two review authors independently extracted data. Discrepancies were resolved with another member of the team. A double-entry procedure was employed by two reviewers. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy (the number of patients who responded or remitted), acceptability (the number of patients who failed to complete the study) and tolerability (side-effects). A total of 59 studies, mostly of low quality, were included in the review, involving multiple treatment comparisons between sertraline and other antidepressant agents. Evidence favouring sertraline over some other antidepressants for the acute phase treatment of major depression was found, either in terms of efficacy (fluoxetine) or acceptability/tolerability (amitriptyline, imipramine, paroxetine and mirtazapine). However, some differences favouring newer antidepressants in terms of efficacy (mirtazapine) and acceptability (bupropion) were also found. In terms of individual side effects, sertraline was generally associated with a higher rate of participants experiencing diarrhoea. This systematic review and meta-analysis highlighted a trend in favour of sertraline over other antidepressive agents both in terms of efficacy and acceptability, using 95% confidence intervals and a conservative approach, with a random effects analysis. However, the included studies did not report on all the outcomes that were pre-specified in the protocol of this review. Outcomes of clear relevance to patients and clinicians were not reported in any of the included studies.

Sertraline versus other antidepressive agents for depression

PubMed Central

Cipriani, Andrea; La Ferla, Teresa; Furukawa, Toshi A; Signoretti, Alessandra; Nakagawa, Atsuo; Churchill, Rachel; McGuire, Hugh; Barbui, Corrado

2014-01-01

Background The National Institute for Health and Clinical Excellence clinical practice guideline on the treatment of depressive disorder recommended that selective serotonin reuptake inhibitors should be the first-line option when drug therapy is indicated for a depressive episode. Preliminary evidence suggested that sertraline might be slightly superior in terms of effectiveness. Objectives To assess the evidence for the efficacy, acceptability and tolerability of sertraline in comparison with tricyclics (TCAs), heterocyclics, other SSRIs and newer agents in the acute-phase treatment of major depression. Search methods MEDLINE (1966 to 2008), EMBASE (1974 to 2008), the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Central Register of Controlled Trials up to July 2008. No language restriction was applied. Reference lists of relevant papers and previous systematic reviews were hand-searched. Pharmaceutical companies and experts in this field were contacted for supplemental data. Selection criteria Randomised controlled trials allocating patients with major depression to sertraline versus any other antidepressive agent. Data collection and analysis Two review authors independently extracted data. Discrepancies were resolved with another member of the team. A double-entry procedure was employed by two reviewers. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy (the number of patients who responded or remitted), acceptability (the number of patients who failed to complete the study) and tolerability (side-effects). Main results A total of 59 studies, mostly of low quality, were included in the review, involving multiple treatment comparisons between sertraline and other antidepressant agents. Evidence favouring sertraline over some other antidepressants for the acute phase treatment of major depression was found, either in terms of efficacy (fluoxetine) or acceptability/tolerability (amitriptyline, imipramine, paroxetine and mirtazapine). However, some differences favouring newer antidepressants in terms of efficacy (mirtazapine) and acceptability (bupropion) were also found. In terms of individual side effects, sertraline was generally associated with a higher rate of participants experiencing diarrhoea. Authors’ conclusions This systematic review and meta-analysis highlighted a trend in favour of sertraline over other antidepressive agents both in terms of efficacy and acceptability, using 95% confidence intervals and a conservative approach, with a random effects analysis. However, the included studies did not report on all the outcomes that were pre-specified in the protocol of this review. Outcomes of clear relevance to patients and clinicians were not reported in any of the included studies. PMID:20393946

Nanoformulated water-soluble paclitaxel to enhance drug efficacy and reduce hemolysis side effect.

PubMed

Gu, Weiting; Chen, Jie; Patra, Prabir; Yang, Xiaoyan; Gu, Quanrong; Wei, Lingxuan; Acker, Jason P; Kong, Beihua

2017-07-01

Surgery, chemotherapy, and radiotherapy are the three top cancer treatment modalities. Paclitaxel (PTX) is one of the most widely used chemotherapy drugs. However, its clinical applications have been significantly limited due to: (i) serious hemolysis effect of currently available commercial paclitaxel formulations and (ii) its water insolubility. An easy way to deliver paclitaxel by a new nanocarrier system using pluronic copolymers of P123/F68 and Sorbitan monopalmitate (Span 40) was reported in our previous research article. The characterization of the formulation and analysis of drug release and cellular uptake were also presented. In this article, we reported discoveries of our follow-up in vivo antitumor and in vitro hemolytic study discoveries. The experimental results showed that the nanoformulated PTX achieved much better tumor suppression performance while reducing hemolysis side effects. This newly formulated drug can significantly improve patient outcomes in cancer chemotherapy.

Continuous subcutaneous infusion of lidocaine for persistent hiccup in advanced cancer.

PubMed

Kaneishi, Keisuke; Kawabata, Masahiro

2013-03-01

Persistent hiccup can cause anorexia, weight loss, disabling sleep deprivation, anxiety, and depression. Therefore, relief of persistent hiccup is important for advanced cancer patients and their family. Most reports on this condition are case series reports advocating the use of baclofen, haloperidol, gabapentin, and midazolam. However, these medications are occasionally ineffective or accompanied by intolerable side effects. The sodium channel blocker lidocaine has been shown to be effective in treating a variety of disorders thought to involve neuropathic mechanisms. Intravenous administration of lidocaine is common but efficacy has also been reported for subcutaneous infusion. In advanced cancer patients, subcutaneous infusion is easy, advantageous, and accompanied by less discomfort. We report a case of severe and sustained hiccup caused by gastric cancer that was successfully treated with a continuous subcutaneous infusion of lidocaine (480 mg (24 ml)/day) without severe side effects.

Nutraceuticals in Acute and Prophylactic Treatment of Migraine.

PubMed

Daniel, Oved; Mauskop, Alexander

2016-04-01

People who suffer from headaches often prefer nutraceutical treatment over traditional pharmacological approaches, due to fear of possible side effects, drug dependence, or addiction. Since treatment with nutraceuticals does not require a doctor's prescription, many patients rely on their own judgment as to when and which one to take, often without consultation or guidance from their physician. Some physicians could provide information about potential efficacy and side effects of various products, but many are not familiar with the nutraceuticals. Widespread skepticism persists among doctors about the effectiveness of these treatments. This is largely due to the lack of rigorous clinical studies. However, even when incontrovertible scientific evidence exists, many physicians remain distrustful of the evidence. The following review summarizes randomized controlled trials of some of the most commonly used non-pharmacological treatments, including magnesium, coenzyme Q10, riboflavin (vitamin B2), petasites, and feverfew (Table 1).

The use of flupirtine in treatment of tinnitus.

PubMed

Salembier, L; De Ridder, D; Van de Heyning, P H

2006-12-01

Flupirtine, a functional NMDA antagonist, does not seem to be efficacious in the treatment of tinnitus. The purpose of this study was to investigate whether flupirtine has any beneficial effect on tinnitus perception. Twenty-four patients were selected (6 female and 18 male patients) with continuous subjective tinnitus. Eight patients suffered left-sided tinnitus, 4 right-sided tinnitus and 12 bilateral tinnitus. We assessed the burden of the tinnitus by loudness visual analogue scale (VAS) and tinnitus questionnaire (TQ) according to Hallam et al., and Hiller and Goebel. All patients were treated with a 2 x 100 mg daily dosage of oral flupirtine for 3 weeks in an open prospective design. There was no statistical effect on VAS and TQ of the treatment with flupirtine. Only one patient (4.2%) experienced a positive effect on the tinnitus but discontinued the treatment because of amnesia and concentration disorders.

Targeting interleukin-6 for noninfectious uveitis

PubMed Central

Lin, Phoebe

2015-01-01

Interleukin-6 (IL-6) is a pleiotropic cytokine implicated in the pathogenesis of many immune-mediated disorders including several types of non-infectious uveitis. These uveitic conditions include Vogt-Koyanagi-Harada syndrome, uveitis associated with Behçet disease, and sarcoidosis. This review summarizes the role of IL-6 in immunity, highlighting its effect on Th17, Th1, and plasmablast differentiation. It reviews the downstream mediators activated in the process of IL-6 binding to its receptor complex. This review also summarizes the biologics targeting either IL-6 or the IL-6 receptor, including tocilizumab, sarilumab, sirukumab, olokizumab, clazakizumab, and siltuximab. The target, dosage, potential side effects, and potential uses of these biologics are summarized in this article based on the existing literature. In summary, anti-IL-6 therapy for non-infectious uveitis shows promise in terms of efficacy and side effect profile. PMID:26392750

Uncovering the Origin of Skin Side Effects from EGFR-Targeted Therapies | Center for Cancer Research

Cancer.gov

The epidermal growth factor receptor (EGFR), a key regulator of cell proliferation, is often mutated or overexpressed in a variety of cancer types. EGFR-targeted therapies, including monoclonal antibodies and small molecule inhibitors, can effectively treat patients whose tumors depend on aberrant EGFR signaling. Within a few weeks of initiating therapy, however, patients develop a characteristic rash with leukocyte infiltration into the skin accompanied by pruritus (itching), scaling of the skin, hair loss, and even changes in skin cell differentiation. The side effects can become so severe that patients take reduced doses, which can limit efficacy, or stop treatment altogether. To understand how EGFR inhibitors cause these skin changes in the hopes of identifying a means of preventing them, Stuart Yuspa, M.D., of CCR’s Laboratory of Cancer Biology and Genetics, and his colleagues examined patient samples and generated a mouse model of EGFR loss in the skin.

Fibrin tissue adhesive and autologous concha cartilage for reconstruction of the posterior-superior canal wall of the chinchilla middle ear.

PubMed

Siedentop, Karl H; O'Grady, Kevin; Bhattacharyya, Tapan K; Shah, Ami

2004-05-01

We conducted this study to prove that fibrin tissue adhesive (FTA) is safe, efficacious, biocompatible, and readily biodegradable with no deleterious side effects for fixation of a cartilage graft to bone along the chinchilla canal wall. A posterior-superior canal defect was created in 12 chinchillas. The canal walls of six chinchillas were closed with autologous concha cartilage alone, whereas the canal wall of the remaining six animals were closed with cartilage in conjunction with fibrin tissue adhesive. Animals were killed 8 weeks postoperatively. Three of six cartilage grafts were displaced in the graft alone group, whereas all six grafts in the cartilage with FTA group healed without displacement. Fibrin tissue adhesive was found to be effective, biocompatible, biodegradable, and without any deleterious side effects for reconstruction of the superior-posterior canal wall of chinchillas.

Evaluation of nicotine and cotinine analogs as potential neuroprotective agents for Alzheimer's disease.

PubMed

Gao, Jie; Adam, Bao-Ling; Terry, Alvin V

2014-03-15

The currently available therapies for Alzheimer's disease (AD) and related forms of dementia are limited by modest efficacy, adverse side effects, and the fact that they do not prevent the relentless progression of the illness. The purpose of the studies described here was to investigate the neuroprotective effects of the nicotine metabolite cotinine as well as a small series of cotinine and nicotine analogs (including stereoisomers) and to compare their effects to the four clinically prescribed AD therapies. Copyright © 2014 Elsevier Ltd. All rights reserved.

Efficacy of imipenem/cilastatin in endocarditis.

PubMed

Dickinson, G; Rodriguez, K; Arcey, S; Alea, A; Greenman, R

1985-06-07

Imipenem, a potent new beta-lactam antibiotic, which is bactericidal against most pathogenic bacteria, and cilastatin, a dehydropeptidase inhibitor combined with imipenem to prevent the metabolism of imipenem in the kidney, were evaluated in the treatment of bacterial endocarditis. Seventeen patients, including 14 who used intravenous drugs, were treated with imipenem/cilastatin in a dose of 500 mg each infused over 30 minutes every six hours. The mean duration of treatment was 29 days with a range of 21 to 56 days. Causative bacteria were Staphylococcus aureus in 10 patients, S. aureus plus group B Streptococcus in one, viridans group Streptococcus in two, Neisseria subflava, Eikenella corrodens, and group G Streptococcus in one patient, and Staphylococcus epidermidis, Hemophilus aphrophilus, and Enterobacter aerogenes in one patient each. The minimal bactericidal concentration of imipenem against 16 of 18 isolates tested was 0.04 micrograms/ml, 1 microgram/ml against H. aphrophilus, and 0.4 micrograms/ml against E. aerogenes. The site of infection was the right side of the heart in 11 patients, the left side in five, and both sides in one. The mean number of days to defervescence was 9.7. All patients were cured, and none required cardiac surgery. Adverse effects were few and interrupted treatment occurred in only one patient who had acute dyspnea during an infusion on Day 26 of therapy. Imipenem/cilastatin appears to be a relatively safe and highly effective treatment of staphylococcal endocarditis in intravenous drug users; too few patients with endocarditis caused by other bacteria were treated to allow a firm statement about efficacy in non-staphylococcal endocarditis.

Buprenorphine: revisiting the efficacy of transdermal delivery system.

PubMed

Kitzmiller, Joseph P; Barnett, Christopher J; Steiner, Nathan S; Stoicea, Nicoleta; Kamar, Nawal; Luzum, Jasmine A; Mikulik, Eduard; Bergese, Sergio D

2015-01-01

Buprenorphine is a lipid-soluble pharmaceutic used in the management of chronic pain. It is a partial agonist at μ-opioid receptors, an antagonist at κ-opioid receptors, an agonist at δ-opioid receptors and a partial agonist at ORL-1 (nociceptin) receptors. An extensive literature search, including Google Scholar and Pubmed database, was conducted. Terms including and associated to 'efficacy of transdermal buprenorphine' were utilized to procure contemporary research articles in order to evaluate and compare the transdermal buprenorphine patch to commonly used traditional pain management medications. Transdermal buprenorphine has demonstrated better efficacy than conventional pain management pharmacotherapies. Side effects were similar to those associated with other opioids and included headache, dizziness, somnolence, constipation, dry mouth, nausea, vomiting, pruritus and erythema. Similar to transdermal delivery systems used with other medication, transdermal buprenorphine was associated with application-site pruritus and application-site reactions. Transdermal buprenorphine has significant potential for managing chronic pain. In addition to increased convenience and efficacy, advantages of transdermal buprenorphine include decreased tolerance and decreased withdrawal.

Efficacy and tolerability of levetiracetam for pediatric refractory epilepsy.

PubMed

Muramatsu, Kazuhiro; Sawaura, Noriko; Ogata, Tomomi; Makioka, Nishiki; Tomita, Keiko; Motojima, Toshino; Ida, Kuniko; Hazama, Kyoko; Arakawa, Hirokazu

2017-03-01

Levetiracetam has a high tolerability and is effective against various seizure types and epilepsy syndromes. However, no study has specifically evaluated the efficacy of levetiracetam in children with refractory epilepsy based on magnetic resonance imaging (MRI) findings and the presence of intellectual disability (ID). We retrospectively evaluated levetiracetam efficacy and safety in 49 pediatric patients who met the following inclusion criteria: (1) diagnosis of refractory epilepsy with first-line antiepileptic (AED) treatment ⩾2years, (2) younger than 20years old, and (3) received oral levetiracetam treatment for ⩾6months. We assessed the relationships of these outcomes with MRI findings and ID status. Eighteen (37%) patients achieved a ⩾50% reduction in seizure frequency, and the majority (78%) had no remarkable side effects. Twenty-two (45%) patients had previously been treated with more than seven antiepileptic drugs prior to levetiracetam. Among 18 patients who achieved a ⩾50% reduction in seizure frequency, 13 and 5 had negative and positive MRI findings, and 9 and 9 had and did not have ID, respectively. Our findings suggest that even for intractable pediatric cases with symptomatic etiology (i.e., MRI lesion and ID), levetiracetam has favorable efficacy for refractory epilepsy with tolerable adverse effects. Copyright © 2016 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

The German fibromyalgia consumer reports - a cross-sectional survey.

PubMed

Häuser, Winfried; Jung, Eva; Erbslöh-Möller, Brigitte; Gesmann, Mechthild; Kühn-Becker, Hedi; Petermann, Franz; Langhorst, Jost; Thoma, Reinhard; Weiss, Thomas; Wolfe, Frederick; Winkelmann, Andreas

2012-05-18

Consumer surveys provide information on effectiveness and side effects of medical interventions in routine clinical care. A report of fibromyalgia syndrome (FMS) consumers has not been carried out in Europe. The study was carried out from November 2010 to April 2011. Participants diagnosed with FMS rated the effectiveness and side effects of pharmacological and non-pharmacological FMS interventions on a 0 to 10 scale, with 10 being most efficacious (harmful). The questionnaire was distributed by the German League for people with Arthritis and Rheumatism and the German Fibromyalgia Association to their members and to all consecutive FMS patients of nine clinical centers of different levels of care. 1661 questionnaires (95% women, mean age 54 years, mean duration since FMS diagnosis 6.8 years) were analysed. The most frequently used therapies were self-management strategies, prescription pain medication and aerobic exercise. The highest average effectiveness was attributed to whole body and local warmth therapies, thermal bathes, FMS education and resting. The highest average side effects were attributed to strong opioids, local cold therapy, gamma-amino-butyric acid analogues (pregabalin and gabapentin), tramadol and opioid transdermal systems. The German fibromyalgia consumer reports highlight the importance of non-pharmcological therapies in the long-term management of FMS, and challenges the strong recommendations for drug therapies given by FMS-guidelines.

Combined immunotherapy and antiangiogenic therapy of cancer with microencapsulated cells.

PubMed

Cirone, Pasquale; Bourgeois, Jacqueline M; Shen, Feng; Chang, Patricia L

2004-10-01

An alternative form of gene therapy involves immunoisolation of a nonautologous cell line engineered to secrete a therapeutic product. Encapsulation of these cells in a biocompatible polymer serves to protect these allogeneic cells from host-versus-graft rejection while recombinant products and nutrients are able to pass by diffusion. This strategy was applied to the treatment of cancer with some success by delivering either interleukin 2 or angiostatin. However, as cancer is a complex, multifactorial disease, a multipronged approach is now being developed to attack tumorigenesis via multiple pathways in order to improve treatment efficacy. A combination of immunotherapy with angiostatic therapy was investigated by treating B16-F0/neu melanoma-bearing mice with intraperitoneally implanted, microencapsulated mouse myoblasts (C2C12) genetically modified to deliver angiostatin and an interleukin 2 fusion protein (sFvIL-2). The combination treatment resulted in improved survival, delayed tumor growth, and increased histological indices of antitumor activity (apoptosis and necrosis). In addition to improved efficacy, the combination treatment also ameliorated some of the undesirable side effects from the individual treatments that have led to the previous failure of the single treatments, for example, inflammatory response to IL-2 or vascular mimicry due to angiostatin. In conclusion, the combination of immuno- and antiangiogenic therapies delivered by immunoisolated cells was superior to individual treatments for antitumorigenesis activity, not only because of their known mechanisms of action but also because of unexpected protection against the adverse side effects of the single treatments. Thus, the concept of a "cocktail" strategy, with microencapsulation delivering multiple antitumor recombinant molecules to improve efficacy, is validated.

Cryolipolysis for fat reduction and body contouring: safety and efficacy of current treatment paradigms.

PubMed

Ingargiola, Michael J; Motakef, Saba; Chung, Michael T; Vasconez, Henry C; Sasaki, Gordon H

2015-06-01

Cryolipolysis is a nonsurgical technique for localized fat reduction. With the increased risk of complications from more invasive methods such as liposuction, cryolipolysis presents a promising method for nonsurgical body contouring. This study presents a systematic review of the available clinical data, with an emphasis on the efficacy, methods, safety, and complications of cryolipolysis. To identify clinical studies that assessed outcomes of cryolipolysis, a systematic review of the MEDLINE and Cochrane databases was performed with the search algorithm cryolipolysis OR cool sculpting OR fat freezing OR lipocryolysis. The primary literature search returned 319 articles. After inclusion criteria were applied and additional articles were idenfied via manual review of article references, 19 studies were selected for review. Average reduction in caliper measurement ranged from 14.67 percent to 28.5 percent. Average reduction by ultrasound ranged from 10.3 percent to 25.5 percent. No significant impact on lipid levels or liver function tests after cryolipolysis treatments was noted in any study. Only mild, short-term side effects, such as erythema, swelling, and pain, were noted. Paradoxical adipose hyperplasia was described in one patient. Cryolipolysis is a promising procedure for nonsurgical fat reduction and body contouring and presents a compelling alternative to liposuction and other, more invasive methods. This procedure appears to be safe in the short term, with a limited side effect profile, and results in significant fat reduction when used for localized adiposities. It remains unclear whether posttreatment manual massage and multiple treatments in the same anatomic area enhance the efficacy of cryolipolysis.

Preparation and in vitro and in vivo evaluation of HupA PLGA microsphere.

PubMed

Ye, Liang; Fu, Fenghua; Liu, Wanhui; Sun, Kaoxiang; Li, Youxin; He, Jie; Yu, Xin; Yu, Pengfei; Tian, Jingwei

2013-03-01

Acetylcholinesterase inhibitors (AChEIs), including Huperzine A (HupA), have been the mainstay of treatment for Alzheimer's disease (AD). However, AChEIs can cause gastrointestinal side effects, which has been related to the high Cmax and short tmax after oral administration. Clinical trials have verified that extended-release formulation with lower Cmax and prolonged tmax, such as rivastigmine patch, could perform a similar efficacy with significantly improved tolerability compared with the oral formulations. In this study, we developed an extended-release microspheres formulation of HupA (called as HAM) with poly(lactide-co-glycolide) (PLGA) as drug carrier. HAM has showed the loading rate as 1.35% (w/w) and yielded 42% with mean particle size at 72.6 μm. In vitro and in vivo pharmacokinetics studies have showed that HAM produced a relatively smooth and continuous drug concentration in 14 days. Furthermore, in vivo pharmacokinetics data have demonstrated that the Cmax was lower and the tmax was considerably later in single intramuscular administration of HAM (1,000 μg/kg) than the counterparts in single intragastric administration of HAT (75 μg/kg/d). Meanwhile, HAM has performed a continuous inhibition to brain AChE activity in normal rats and improvement of memory deficit in Aβ1-40 i.c.v. infused AD rat model for 14 days. The results have suggested that HAM has performed good extended-release properties and good prolonged pharmacological efficacy in vivo in the 2-week period, and could exert a similar efficacy with significantly lowered gastrointestinal side effects as compared with oral formulation.

What RA patients expect of their treatment--discussion over the result of our survey.

PubMed

Funahashi, Keiko; Matsubara, Tsukasa

2012-11-01

We conducted a survey among Japanese rheumatoid arthritis (RA) patients to better understand what they expect from treatment and whether there is a difference between expectations of biologics-treated and disease-modifying antirheumatic drugs (DMARDs)-treated patients. An anonymous survey was conducted with 165 outpatients from our clinic (with informed written consent). On the survey, they wrote their age, gender, medical history, and commented on: (1) expectations for treatment, (2) disappointment with treatment, (3) experience of, and thoughts about switching treatments, (4) information wanted before starting a new treatment, (5) expectations before administration and noticeable differences after treatment, (6) level of satisfaction with current treatment, and (7) expectations of possible treatments. Patients who had never been treated with DMARDs were excluded from the survey. For "treatment goals before administration," 86 % responded with "assured efficacy," while 73 % responded "suppress joint destruction" or "recover from joint destruction." Also, more patients hoped for "long-lasting efficacy" (67 %) over "fast acting" (41 %), which suggests significance of the long-term improvement of QOL. Related to "disappointment with treatment," patients also felt anxiety over switching treatment for possibilities of not responding enough, or side effects. RA patients have high expectations for medication in terms of assured improvement of conditions and long-lasting efficacy of drugs, while the biggest concern was if they would have side effects or not, and if so, what type. The results suggest patients hope to have worries over switching medications dispelled. The results also verified those who have used biologics before have higher treatment goals than those who have not.

Efficacy and Safety of Remifentanil as an Alternative Labor Analgesic

PubMed Central

Devabhakthuni, Sandeep

2013-01-01

The objective of this review was to evaluate the clinical efficacy and safety of remifentanil in the management of labor pain. Although neuraxial analgesia is the best option during labor, alternative analgesic options are needed for patients with contraindications. Using a systematic literature search, clinical outcomes of remifentanil for labor pain have been summarized. Also, comparisons of remifentanil to other options including meperidine, epidural analgesia, fentanyl, and nitrous oxide are provided. Based on the literature review, remifentanil is associated with high overall maternal satisfaction and favorable side-effect profile. However, due to the low reporting of adverse events, large, randomized controlled trials are needed to evaluate maternal and neonatal safety adequately and determine the optimal dosing needed to provide effective analgesia. While remifentanil is a feasible alternative for patients who cannot or do not want to receive epidural analgesia, administration should be monitored closely for potential adverse effects. PMID:24665213

Anticancer polysaccharides from natural resources: a review of recent research.

PubMed

Zong, Aizhen; Cao, Hongzhi; Wang, Fengshan

2012-11-06

Taking into account the rising trend of the incidence of cancers of various organs, effective therapies are urgently needed to control human malignancies. However, almost all of the chemotherapy drugs currently on the market cause serious side effects. Fortunately, several previous studies have shown that some non-toxic biological macromolecules, including polysaccharides and polysaccharide-protein complexes, possess anti-cancer activities or can increase the efficacy of conventional chemotherapy drugs. Based on these encouraging observations, a great deal of effort has been focused on discovering anti-cancer polysaccharides and complexes for the development of effective therapeutics for various human cancers. This review focuses on the advancements in the anti-cancer efficacy of various natural polysaccharides and polysaccharide complexes in the past 5 years. Most polysaccharides were tested using model systems, while several involved clinical trials. Copyright © 2012 Elsevier Ltd. All rights reserved.

Efficacy of probiotics as an adjuvant agent in eradication of Helicobacter pylori infection and associated side effects.

PubMed

Goli, Y Dasteh; Moniri, R

2016-09-01

The intestinal tract is a host to various types of bacteria that are essential to health. Interactions between intestinal bacteria, i.e. the normal microbiota of the host's intestine, have been a subject of intensive research, as they may influence disease cycles. Recent studies of selected probiotic species and their therapeutic benefits have suggested a potential efficacy in treatment of several gastrointestinal illnesses, including Helicobacter pylori infection. The increasing evidence from these clinical studies supports the promising role of probiotics in improving the treatment of H. pylori by increasing eradication rates as well as decreasing the adverse effects of current medication therapy. However, many unsolved questions remain which require high quality trials on specific probiotic strains in the future. The main part of this review will focus on the effects of supplementary probiotic products during standard triple H. pylori therapy.

A Comprehensive Review of Tourette Syndrome and Complementary Alternative Medicine.

PubMed

Kumar, Ashutosh; Duda, L; Mainali, G; Asghar, S; Byler, D

2018-01-01

Tourette syndrome (TS) is a neuropsychiatric condition defined by both motor and phonic tics over a period of at least 1 year with the onset before 18 years of age. The purpose of this article is to review the use of complementary alternative medicine (CAM) in children and adults with Tourette syndrome with emphasis on recent research. Most patients do not tell their physician about the use of CAM unless if specifically asked. Of the studies reviewed, description of the treatment and the frequency of use were most often reported. Few studies examine the role or effectiveness of CAM in the treatment of TS specifically. Practitioners should be aware of current research regarding various CAM modalities used for TS patients, including efficacy, potential adverse effects, and interactions with medications. Robust data about the use of CAM, efficacy, and potential side effects is lacking and requires further research to clarify optimal use.

Efficacy and tolerability of Hairgain in individuals with hair loss: a placebo-controlled, double-blind study.

PubMed

Thom, E

2001-01-01

This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of a new agent for the treatment of hair loss, based on a marine protein, minerals and vitamins. Sixty subjects with hair loss of different aetiologies participated in the 6-month blinded phase of the study. Objective assessments indicated that the treatment was effective and subjective assessments showed a statistically significant positive effect of treatment. Exposure to the active preparation for a further 6 months in an open phase indicated a further improvement in hair growth. Exposure of the patients previously treated with placebo to the active preparation for 12 months gave similar results. Tolerability was good and no side-effects were reported. The product investigated may provide an alternative to pharmacotherapy for the treatment of hair-loss problems in individuals with androgenic alopecia.

Inhibitory efficacy of the quantified prunellae spica extract on H22 tumor bearing mice

NASA Astrophysics Data System (ADS)

Wang, Zhi-ping; Chen, Tong-sheng

2013-02-01

Hepatocarcinoma, a malignant cancer, threaten human life badly. It is a current issue to seek the effective natural remedy from plant to treat cancer due to the resistence of the advanced hepatocarcinoma to chemotherapy. In this report, we assessed the antitumor activity of a prunellae spica aqueous extract (PSE) in vitro and in vivo. PSE was quantified by HPLC and UV. MTT assay showed that PSE did not effectively inhibit the growth of H22 cells. The in vivo anti-tumor activity was assessed by using the mice bearing H22 tumor. In vivo studies showed the higher antitumor efficacy of PSE without significant side effect assessed by the reduced tumor weight, and the extended survival time of the mice bearing H22 solid and ascites tumor. Collectively, PSE is a promising Chinese medicinal herb for treating hepatocarcinoma.

Parasympathomimetic drugs for the treatment of salivary gland dysfunction due to radiotherapy.

PubMed

Davies, Andrew N; Thompson, Jo

2015-10-05

This is an updated version of the original Cochrane review on parasympathomimetic drugs for the treatment of salivary gland dysfunction due to radiotherapy (published in Issue 3, 2007). Salivary gland dysfunction is a predictable side effect of radiotherapy to the head and neck region. Pilocarpine hydrochloride (a choline ester) is licensed in many countries for the treatment of radiation-induced salivary gland dysfunction. Other parasympathomimetics have also been used 'off licence' in the treatment of this condition. To determine the efficacy and tolerability of parasympathomimetic drugs in the treatment of radiation-induced salivary gland dysfunction (specifically radiation-induced xerostomia). For this update, we ran searches of the Cochrane Oral Health Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 6), MEDLINE, EMBASE, and CINAHL in July 2015. We checked the reference lists of retrieved articles for additional studies, contacted experts in the field for unpublished and ongoing trials, and contacted relevant pharmaceutical companies for unpublished and ongoing trials. The selection criteria for the review were: 1) randomised controlled trials; 2) people suffering from radiation-induced salivary gland dysfunction; 3) people treated with parasympathomimetic drugs; and 4) assessable data available on primary outcome measure. The two review authors independently collected data from the full-text version of relevant papers including: 1) citation details; 2) participants; 3) interventions; 4) assessments; 5) outcomes (that is efficacy, tolerability); and 6) quality issues.Due to a lack of appropriate data, we were unable to perform a meta-analysis. In the original review, three studies, including a total of 298 participants, fulfilled the inclusion criteria. All three studies involved the use of pilocarpine hydrochloride. We have included no additional studies in the update of the review; we have excluded eight additional studies.The data suggest that pilocarpine hydrochloride is more effective than placebo and at least as effective as artificial saliva. The response rate was 42% to 51%. The time to response was up to 12 weeks. The overall side effect rate was high, and side effects were the main reason for withdrawal (6% to 15% of participants taking 5 mg three times a day had to withdraw). The side effects were usually the result of generalised parasympathomimetic stimulation (for example sweating, headaches, urinary frequency, vasodilatation). Response rates were not dose dependent, but side effect rates were dose dependent. There is limited evidence to support the use of pilocarpine hydrochloride in the treatment of radiation-induced xerostomia. Currently, there is little evidence to support the use of other parasympathomimetic drugs in the treatment of radiation-induced xerostomia. Available studies suggest that approximately half of patients will respond, but side effects can be problematic. The conclusions of the update are the same as the conclusions of the original review, since no new relevant studies have been published in the interim.

Safety and efficacy of Regadenoson in myocardial perfusion imaging (MPI) stress tests: A review

NASA Astrophysics Data System (ADS)

Ahmed, Ambereen

2018-02-01

Myocardial perfusion imaging (MPI) tests are often used to help diagnose coronary heart disease (CAD). The tests usually involve applying stress, such as hard physical exercise together with administration of vasodilators, to the patients. To date, many of these tests use non-selective A2A adenosine receptor agonists which, however, can be associated with highly undesirable and life-threatening side effects such as chest pain, dyspnea, severe bronchoconstriction and atrioventricular conduction anomalies. Regadenoson is a relatively new, highly selective A2A adenosine receptor agonist, suitable for use in MPI tests which exhibits far fewer adverse side effects and, unlike others testing agents, can be used without the necessity of excessive concomitant exercise. Also, the dose of regadenoson required is not dependent upon patient weight or renal impairment, and it can be rapidly administered by i.v. Injection. Regadenoson use in MPI testing thus has the potential as a simplified, relatively safe, time-saving and cost-effective method for helping diagnose CAD. The present study was designed to review several articles on the safety, efficacy, and suitability of regadenoson in MPI testing for CAD. Overall, the combined studies demonstrated that use of regadenoson in conjunction with low-level exercise in MPI is a highly efficient and relatively safe test for CAD, especially for more severe health-compromised patients.

Treatment of anorexia nervosa with long-term risperidone in an outpatient setting: case study.

PubMed

Kracke, Elsa J; Tosh, Aneesh K

2014-01-01

There are currently few studies focusing on the efficacy of long-term atypical antipsychotics to treat anorexia nervosa in the pediatric population. This case report follows the treatment of a 17 year-old female with anorexia nervosa over her four-year undergraduate career. After two years of multidisciplinary treatment, low-dose risperidone was initiated due to persistence of her disease. She expressed decreased rigidity around meal times, her weight improved and she had resumption of menses. She was compliant with treatment through graduation and maintained her weight gain. Atypical antipsychotics are a treatment option in the management of anorexia nervosa. Risperidone has not been studied as frequently as olanzapine for eating disorders. Risperidone was chosen for its more favorable side effect profile and decreased cost to the patient. Previous studies on anorexia nervosa treatment have occurred during inpatient treatment and have limited follow-up due to patients' refusal to initiate or maintain medication compliance. This case presents 17 months of outpatient data. The efficacy of risperidone therapy was evaluated with frequent weight checks, subjective decrease in rigidity, serial complete metabolic panels, and restoration of menses. In this case report, an adolescent female treated with low-dose risperidone had decreased rigid thinking, weight gain and resolution of secondary amenorrhea without medication side effects. Therefore, the atypical antipsychotic risperidone may be an effective long-term outpatient treatment option for patients with anorexia nervosa.

How phenobarbital revolutionized epilepsy therapy: the story of phenobarbital therapy in epilepsy in the last 100 years.

PubMed

Yasiry, Zeid; Shorvon, Simon D

2012-12-01

Phenobarbital (phenobarbitone) was first used as an antiepileptic drug 100 years ago, in 1912. This article tells the story of the discovery of its antiepileptic action, its early development, and the subsequent course of its clinical use over the 100-year period. The side effects, pharmacokinetics, and misuse of barbiturates are considered, along with the more recent clinical trials and the drug's current clinical utilization. The introduction of controlled drug regulations, the comparative cost of phenobarbital, and its inclusion on the World Health Organization (WHO) essential drug list are discussed. It is one of the few drugs on the formulary in 1912 that is still listed today, and remarkably its efficacy in epilepsy has not been significantly bettered. The current recommendation by the WHO is that phenobarbital should be offered as the first option for therapy for convulsive epilepsy in adults and children if availability can be ensured. This is rated as a strong recommendation because of the proven efficacy and low cost of phenobarbital, and despite its perceived side-effect profile and the practical problems of access. Whether this recommendation puts "a hierarchy on the brain," as has been suggested, is arguable. Much still needs to be learned about the drug's effects, and the issues raised by phenobarbital have lessons for all antiepileptic drug therapy. Wiley Periodicals, Inc. © 2012 International League Against Epilepsy.

Efficacy and safety of a conversion from the original tacrolimus and mycophenolate mofetil to the generics Tacpan® and Mowel® after liver transplantation

PubMed Central

Vollmar, Johanna; Bellmann, Maren Christina; Darstein, Felix; Hoppe-Lotichius, Maria; Mittler, Jens; Heise, Michael; Rüttger, Bernd; Weyer, Veronika; Zimmermann, Anca; Lang, Hauke; Galle, Peter R; Zimmermann, Tim

2015-01-01

Background Expensive pharmaceuticals are a major reason for cost intensive health care systems. Long-term immunosuppressive therapy plays a relevant role after organ transplantation. Patents of original drugs have expired and cheaper products are available. Little data are available regarding efficacy and safety of generic immunosuppressive agents. Methods In this prospective study, 25 patients, who were clinically stable for a minimum of 2 years after liver transplantation, were converted from the original formulations of tacrolimus (TAC) and mycophenolate mofetil to the generics Tacpan® (TAP) and Mowel® (MOW). Patients were followed-up for 6 months. Results were compared retrospectively to 25 age- and sex-matched controls treated with the original brands. Results In the matched-pair analysis of TAC trough level/dose ratio, no significant difference was found between TAP/MOW and TAC/mycophenolate mofetil groups. No acute rejection occurred in either group. In total, 17 patients reported mild side effects in the TAP/MOW group. The most common side effects were gastrointestinal symptoms. Intra-individual analysis of costs revealed a considerable cost reduction in the TAP/MOW group (in median 25.03%; P<0.001). Conclusion In summary, the use of the generics TAP/MOW is effective and seems to be safe and cost-efficient in stable liver-transplantation patients. PMID:26604701

Formulation and evaluation of novel coated floating tablets of bergenin and cetirizine dihydrochloride for gastric delivery.

PubMed

He, Shuang; Li, Feng; Zhou, Dan; Du, Junrong; Huang, Yuan

2012-10-01

A novel coated gastric floating drug-delivery system (GFDDS) of bergenin (BN) and cetirizine dihydrochloride (CET) was developed. First, the pharmacodynamic studies were performed and the results revealed that the new compounds of bergenin/cetirizine dihydrochloride had comparative efficacy as commercial products (bergenin/chlorphenamine maleate) but with fewer side effects on central nervous system (CNS). Subsequently, bergenin was formulated as an extended-release core tablet while cetirizine dihydrochloride was incorporated into the gastric coating film for immediate release. The formulation of GFDDS was optimized by CET content uniformity test, in vitro buoyancy and drug release. Herein, the effects of sodium bicarbonate (effervescent), hydroxypropyl methylcellulose (HPMC, matrix polymer) and coating weight gain were investigated respectively. The optimized GFDDS exhibited good floating properties (buoyancy lag time < 2 min; floating duration > 10 h) and satisfactory drug-release profiles (immediate release of CET in 10 min and sustained release of BN for 12 h). In vivo gamma scintigraphy proved that the optimized GFDDS could retain in the stomach with a prolonged gastric retention time (GRT) of 5 h, and the coating layer showed no side effect for gastric retention. The novel coated gastric floating drug-delivery system offers a new approach to enhance BN's absorption at its absorption site and the efficacy of both CET and BN.