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Cognitive Efficacy of Pharmacologic Treatments in Multiple Sclerosis: A Systematic Review.

ABSTRACT: INTRODUCTION:Cognitive impairment is prevalent and debilitating among persons with multiple sclerosis (MS). While many pharmacologic treatments have shown good efficacy in reducing clinical relapses, brain lesions, and improving certain physical symptoms, their efficacy for improving cognitive function is not well understood. OBJECTIVES:The current systematic review aimed to evaluate the efficacy of pharmacologic treatments for improving cognitive function among persons with MS. METHODS:A literature search was conducted through the PubMed and PsycINFO databases. Two independent reviewers assessed each paper, and a third reviewer weighed in if the two reviewers could not reach a consensus. Classification of evidence was determined using the 2017 American Academy of Neurology (AAN) criteria for therapeutic trials. Standardized effect sizes (Cohen's d) were calculated to compare across studies. RESULTS:Eighty-seven journal articles published between 1990 and January 2020 were included in the current review. Overall, there is insufficient evidence to support the use of pharmacologic treatments to improve cognitive function in persons with MS. There were many contradictory findings observed in this review, which may be due to possible unidentified moderating treatment response variables and/or lack of standardization in assessment procedures. There was also an overreliance on statistical significance (most papers did not provide sizes of treatment effects), which may not be clinically meaningful. CONCLUSIONS:Higher-quality randomized controlled trials are needed to establish the cognitive efficacy of pharmacologic treatments for MS-related cognitive dysfunction, with cognition as the primary endpoint. Researchers are urged to use standardized criteria (such as the AAN criteria) to guide their research designs. Clinicians should consider effect sizes of studies before deciding whether to prescribe certain medications to ameliorate cognitive symptoms.

SUBMITTER: Chen MH

PROVIDER: S-EPMC7275014 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Cognitive Efficacy of Pharmacologic Treatments in Multiple Sclerosis: A Systematic Review.

Chen Michelle H MH Goverover Yael Y Genova Helen M HM DeLuca John J

CNS drugs 20200601 6

<h4>Introduction</h4>Cognitive impairment is prevalent and debilitating among persons with multiple sclerosis (MS). While many pharmacologic treatments have shown good efficacy in reducing clinical relapses, brain lesions, and improving certain physical symptoms, their efficacy for improving cognitive function is not well understood.<h4>Objectives</h4>The current systematic review aimed to evaluate the efficacy of pharmacologic treatments for improving cognitive function among persons with MS.<h ...[more]

PMID: 32361940

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Project description:ImportanceMigraine is one of the most common neurologic disorders in children and adolescents. However, a quantitative comparison of multiple preventive pharmacologic treatments in the pediatric population is lacking.ObjectiveTo examine whether prophylactic pharmacologic treatments are more effective than placebo and whether there are differences between drugs regarding efficacy, safety, and acceptability.Data sourcesSystematic review and network meta-analysis of studies in MEDLINE, Cochrane, Embase, and PsycINFO published through July 2, 2018.Study selectionRandomized clinical trials of prophylactic pharmacologic treatments in children and adolescents diagnosed as having episodic migraine were included. Abstract, title, and full-text screening were conducted independently by 4 reviewers.Data extraction and synthesisData extraction was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analysis network meta-analysis guidelines. Quality was assessed with the Cochrane Risk of Bias tool. Effect sizes, calculated as standardized mean differences for primary outcomes and risk ratios for discontinuation rates, were assessed in a random-effects model.Main outcomes and measuresPrimary outcomes were efficacy (ie, migraine frequency, number of migraine days, number of headache days, headache frequency, or headache index), safety (ie, treatment discontinuation owing to adverse events), and acceptability (ie, treatment discontinuation for any reason).ResultsTwenty-three studies (2217 patients) were eligible for inclusion. Prophylactic pharmacologic treatments included antiepileptics, antidepressants, calcium channel blockers, antihypertensive agents, and food supplements. In the short term (<5 months), propranolol (standard mean difference, 0.60; 95% CI, 0.03-1.17) and topiramate (standard mean difference, 0.59; 95% CI, 0.03-1.15) were significantly more effective than placebo. However, the 95% prediction intervals for these medications contained the null effect. No significant long-term effects for migraine prophylaxis relative to placebo were found for any intervention.Conclusions and relevanceProphylactic pharmacologic treatments have little evidence supporting efficacy in pediatric migraine. Future research could (1) identify factors associated with individual responses to pharmacologic prophylaxis, (2) analyze fluctuations of migraine attack frequency over time and determine the most clinically relevant length of probable prophylactic treatment, and (3) identify nonpharmacologic targets for migraine prophylaxis.

Project description:ObjectiveIn this study, we aimed to investigate the effects of non-invasive brain stimulation (NIBS) on cognitive and motor functions in patients with multiple sclerosis (pwMS).MethodsA literature search was performed in the Cochrane Library, Embase, PubMed, Web of Science, Medline, CNKI, and Wan fang. The time interval used for database construction was up to December 2022, and the language was not limited. The collected trials were subsequently screened, the data were extracted, the quality was evaluated, and the effect sizes were computed using STATA/MP Version 13 for outcome analysis. Standard mean difference (SMD) and 95% confidence interval (CI) were calculated for domain of interest.ResultsIn total, 17 articles that examined 364 patients with multiple sclerosis were included in this analysis. Non-invasive brain stimulation did not improve the overall cognitive function [SMD = 0.18, 95% CI (-0.32, 0.69), P = 0.475] but helped improve motor function in patients [SMD = 0.52, 95% CI (0.19, 0.85), P = 0.002]. Moreover, this study specifically indicated that non-invasive brain stimulation improved alerting [SMD = 0.68, 95% CI (0.09, 1.26), P = 0.02], whereas non-invasive brain stimulation intervention improved motor function in patients aged <45 years [SMD = 0.67, 95% CI (0.23, 1.10), P = 0.003] and in patients with expanded disability status scale scores (EDSS) <3.5 [SMD = 0.82, 95% CI (0.22, 1.42), P = 0.007]. In particular, NIBS contributed to the improvement of spasticity in pwMS [SMD = 0.68, 95% CI (0.13, 1.23), P = 0.015].ConclusionThese results of this present study provide evidence that non-invasive brain stimulation could improve alertness in pwMS. Furthermore, NIBS may help pwMS with motor function and those who are under 45 years of age or with EDSS < 3.5 improve their motor function. For the therapeutic use of NIBS, we recommend applying transcranial magnetic stimulation as an intervention and located on the motor cortex M1 according to the subgroup analysis of motor function. These findings warrant verification.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier CRD42022301012.

Project description:BackgroundBlinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments.Methods and findingsWe undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1) established blinding of patients or health care providers, (2) maintained the blinding of patients or health care providers, and (3) obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58%) describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage), or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or photography), or adjudication of clinical events.ConclusionsThis review classifies blinding methods and provides a detailed description of methods that could help trialists overcome some barriers to blinding in clinical trials and readers interpret the quality of pharmacologic trials.

Project description:Background: Over the past two decades, various novel disease-modifying drugs for multiple sclerosis (MS) have been approved. However, there is high variability in the patient response to the available medications, which is hypothesized to be partly attributed to genetics. Objectives: To conduct a systematic review of the current literature on the pharmacogenomics of MS therapy. Methods: A systematic literature search was conducted using PubMed/MEDLINE database searching for articles investigating a role of genetic variation in response to disease-modifying MS treatments, published in the English language up to October 9th, 2018. PRISMA guidelines for systematic reviews were applied. Studies were included if they investigated response or nonresponse to MS treatment defined as relapse rate, by expanded disability status scale score or based on magnetic resonance imaging. The following data were extracted: first author's last name, year of publication, PMID number, sample size, ethnicity of patients, method, genes, and polymorphisms tested, outcome, significant associations with corresponding P-values and confidence intervals, response criteria, and duration of the follow-up period. Results: Overall, 48 articles published up to October 2018, evaluating response to interferon-beta, glatiramer acetate, mitoxantrone, and natalizumab, met our inclusion criteria and were included in this review. Among those, we identified 42 (87.5%) candidate gene studies and 6 (12.5%) genome-wide association studies. Existing pharmacogenomic evidence is mainly based on the results of individual studies, or on results of multiple studies, which often lack consistency. In recent years, hypothesis-free approaches identified novel candidate genes that remain to be validated. Various study designs, including the definition of clinical response, duration of the follow-up period, and methodology as well as moderate sample sizes, likely contributed to discordances between studies. However, some of the significant associations were identified in the same genes, or in the genes involved in the same biological pathways. Conclusions: At the moment, there is no available clinically actionable pharmacogenomic biomarker that would enable more personalized treatment of MS. More large-scale studies with uniform design are needed to identify novel and validate existing pharmacogenomics findings. Furthermore, studies investigating associations between rare variants and treatment response in MS patients, using next-generation sequencing technologies are warranted.

Project description:Background: Non-pharmacologic auxiliary treatments have been considered crucial therapies for treating chronic idiopathic constipation (CIC) during the past decades worldwide. Several treatment patterns are available, but their relative efficacy is obscure because there are no head-to-head randomized controlled trials, especially in children. We conducted this network meta-analysis to evalute the effectiveness of these therapies in improving defecation function based on their direct comparisons with standard medical care. Methods: Medline, Embase, and Cochrane Central were searched for randomized controlled trials (RCTs) published in English from inception to October 2020, assessing the efficacy of auxiliary therapies (behavior therapy, physiotherapy, biofeedback, or anorectal manometry) in children with CIC. We extracted data for endpoints, risk of bias, and evidence quality. Eligible studies in the meta-analysis reported the data of a dichotomous assessment of overall response to treatment (response or not) or defecation frequency per week after treatment. The hierarchical Bayesian network meta-analysis was used in the study. We chose a conservative methodology, random effects model, to pool data which could handle the heterogeneity well. The relative risk (RR) with 95% confidence intervals (CIs) was calculated for dichotomous outcomes. For continuous results, weighted mean difference (WMD) with related CIs was calculated. The included treatments were ranked to define the probability of being the best treatment. Results: Seven RCTs (838 patients) met inclusion and endpoint criteria. Based on an endpoint of the absence of constipation (Rome criteria) with laxatives allowed, physiotherapy plus standard medical care (SMC) had the highest probability (84%) to bethe most effective therapy. When the treatment response was defined as an absence of constipation with not laxatives allowed, biofeedback plus SMC ranked first (probability 52%). Physiotherapy plus SMC ranked first when the endpoint was based on defecation frequency per week with laxatives allowed (probability 86%). Conclusion: Almost all auxiliary therapies are effective complementary therapies for treating CIC, but they needed to be used simultaneously with SMC. Nevertheless, because of the small number of eligible studies and their small sample sizes, the differences in treatment duration and the endpoints, large sample RCTs with long-term follow-up are required for further investigation.

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Cognitive Efficacy of Pharmacologic Treatments in Multiple Sclerosis: A Systematic Review.

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Cognitive Efficacy of Pharmacologic Treatments in Multiple Sclerosis: A Systematic Review.

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