The Effect of Gabapentin Enacarbil on Pain Associated with Moderate-to-Severe Primary Restless Legs Syndrome in Adults: Pooled Analyses from Three Randomized Controlled Trials

CNS Drugs ◽  
2016 ◽  
Vol 30 (5) ◽  
pp. 443-454 ◽  
Author(s):  
Neal Hermanowicz ◽  
Aaron Ellenbogen ◽  
Gordon Irving ◽  
Mark Buchfuhrer ◽  
Mark J. Jaros ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Restless Legs Syndrome ◽  
Controlled Trials ◽  
Gabapentin Enacarbil ◽  
Restless Legs ◽  
Randomized Controlled

Cardiovascular events reported in randomized controlled trials in restless legs syndrome

2020 ◽  
Vol 65 ◽  
pp. 13-17 ◽  
Author(s):  
Gonçalo S. Duarte ◽  
Mariana Alves ◽  
Maria A. Silva ◽  
Raquel Camara ◽  
Daniel Caldeira ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Restless Legs Syndrome ◽  
Cardiovascular Events ◽  
Controlled Trials ◽  
Restless Legs ◽  
Randomized Controlled

scholarly journals Effectiveness and Safety of Botulinum Toxin Type A in Treatment of Restless Legs Syndrome: A Systematic Review and Meta-Analysis

Healthcare ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1538
Author(s):  
Yu-Chi Su ◽  
Yao-Hong Guo ◽  
Chung-Lun Liao ◽  
Yu-Ching Lin
Keyword(s):  
Botulinum Toxin ◽  
Randomized Controlled Trials ◽  
Restless Legs Syndrome ◽  
Rating Scale ◽  
Botulinum Toxin Type A ◽  
Type A ◽  
Botulinum Toxin Type ◽  
Controlled Trials ◽  
Restless Legs ◽  
Randomized Controlled

Our study aimed to investigate the effectiveness and safety of botulinum toxin type A in patients with restless legs syndrome. We searched electronic databases, including PubMed, Cochrane Library, and Web of Science, up to 12 June 2021, for published articles. We enrolled randomized controlled clinical trials and non-randomized controlled studies involving patients with restless legs syndrome who were treated with botulinum toxin. Quality assessment was performed using the Cochrane risk of bias tool and Joanna Briggs Institute Critical Appraisal Checklist for Quasi-Experimental Studies. As for the results, we included four articles comprising 62 participants, two studies were randomized controlled trials. Improvement in International Restless Legs Syndrome Study Group (IRLSSG) rating scale was observed in three studies. Adverse events were temporary and self-limited. Meta-analyses were performed, including the two randomized controlled trials with 27 participants. Compared with placebo, botulinum toxin injection significantly reduced scores of IRLSSG rating scale (SMD, −0.819, 95% confidence interval [CI], −1.377 to −0.262). A total of 11.8% (95% CI, 0.7–72.4%) of patients reported at least one adverse event. In conclusion, botulinum toxin injection may relieve restless legs syndrome related symptoms. However, decisive conclusions cannot be drawn because of the small number of patients included in our meta-analysis. Large-scale, randomized controlled trials are warranted to discover the optimal dose, safety, and long-term effect of intervention with botulinum toxin type A for patients with restless legs syndrome.

Effect of Aerobic Exercise on Dialysis-Related Symptoms in Individuals Undergoing Maintenance Hemodialysis

2021 ◽  
Vol 16 (4) ◽  
pp. 560-574
Author(s):  
Nicholas Hargrove ◽  
Nada El Tobgy ◽  
Olivia Zhou ◽  
Mark Pinder ◽  
Brittany Plant ◽  
...  
Keyword(s):  
Aerobic Exercise ◽  
Randomized Controlled Trials ◽  
Beck Depression Inventory ◽  
Restless Legs Syndrome ◽  
Meta Analysis ◽  
Maintenance Hemodialysis ◽  
Controlled Trials ◽  
Exercise Interventions ◽  
Restless Legs ◽  
Randomized Controlled

BackgroundHemodialysis is associated with a high symptom burden that impairs health-related quality of life and functional status. Effective symptom management is a priority for individuals receiving hemodialysis. Aerobic exercise may be an effective, nonpharmacologic treatment for specific hemodialysis-related symptoms. This systematic review investigated the effect of aerobic exercise on hemodialysis-related symptoms in adults with kidney failure undergoing maintenance hemodialysis.Design, setting, participants, & measurementsWe searched MEDLINE, PubMed, Cochrane CENTRAL, CINAHL, PsycINFO, SPORTDiscus, EMBASE, PEDro, and Scopus databases from 1960 or inception until April 15, 2020 for randomized controlled trials investigating the effect of aerobic exercise on hemodialysis-related symptoms, identified as prespecified primary or secondary outcomes, as compared with controls in adults on maintenance hemodialysis. We identified restless legs syndrome as the primary outcome.ResultsOf 3048 studies identified, 15 randomized controlled trials met the eligibility criteria. These studies investigated the effect of aerobic exercise on restless legs syndrome (two studies), sleep disturbance (four studies), anxiety (four studies), depression (nine studies), muscle cramping (one study), and fatigue (one study). Exercise interventions were intradialytic in ten studies and outside of hemodialysis in five studies. Heterogenous interventions and outcomes and moderate to high risk of bias precluded meta-analysis for most symptoms. Aerobic exercise demonstrated improvement in symptoms of restless legs syndrome, muscle cramping, and fatigue, as compared with nonexercise controls. Meta-analysis of depressive symptoms in studies using the Beck Depression Inventory demonstrated a greater reduction in Beck Depression Inventory score with exercise as compared with control (mean difference −7.57; 95% confidence interval, −8.25 to −6.89).ConclusionsOur review suggests that in adults on maintenance hemodialysis, aerobic exercise improves several hemodialysis-related symptoms, including restless legs syndrome, symptoms of depression, muscle cramping, and fatigue. However, the use of validated outcome measures with demonstrated reliability and responsiveness in more diverse hemodialysis populations is required to fully characterize the effect of this intervention.Clinical Trial registry name and registration number:PROSPERO #CRD42017056658

scholarly journals Long-term Maintenance Treatment of Restless Legs Syndrome With Gabapentin Enacarbil: A Randomized Controlled Study

2010 ◽  
Vol 85 (6) ◽  
pp. 512-521 ◽  
Author(s):  
Richard K. Bogan ◽  
Michel A. Cramer Bornemann ◽  
Clete A. Kushida ◽  
Pierre V. Trân ◽  
Ronald W. Barrett
Keyword(s):  
Restless Legs Syndrome ◽  
Maintenance Treatment ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Gabapentin Enacarbil ◽  
Restless Legs ◽  
Randomized Controlled ◽  
Term Maintenance

The Effect of Partly Missing Covariates on Statistical Power in Randomized Controlled Trials With Discrete-Time Survival Endpoints

Methodology ◽  
2017 ◽  
Vol 13 (2) ◽  
pp. 41-60
Author(s):  
Shahab Jolani ◽  
Maryam Safarkhani
Keyword(s):  
Randomized Controlled Trials ◽  
Discrete Time ◽  
Treatment Effect ◽  
Survival Data ◽  
Controlled Trials ◽  
Missing Covariates ◽  
Indicator Method ◽  
Imputation Methods ◽  
Randomized Controlled ◽  
Baseline Covariates

Abstract. In randomized controlled trials (RCTs), a common strategy to increase power to detect a treatment effect is adjustment for baseline covariates. However, adjustment with partly missing covariates, where complete cases are only used, is inefficient. We consider different alternatives in trials with discrete-time survival data, where subjects are measured in discrete-time intervals while they may experience an event at any point in time. The results of a Monte Carlo simulation study, as well as a case study of randomized trials in smokers with attention deficit hyperactivity disorder (ADHD), indicated that single and multiple imputation methods outperform the other methods and increase precision in estimating the treatment effect. Missing indicator method, which uses a dummy variable in the statistical model to indicate whether the value for that variable is missing and sets the same value to all missing values, is comparable to imputation methods. Nevertheless, the power level to detect the treatment effect based on missing indicator method is marginally lower than the imputation methods, particularly when the missingness depends on the outcome. In conclusion, it appears that imputation of partly missing (baseline) covariates should be preferred in the analysis of discrete-time survival data.

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