W-L-104 SLEEP IMPROVEMENTWITH ROTIGOTINE TRANSDERMAL SYSTEM IN PATIENTS WITH MODERATE-TO-SEVERE IDIOPATHIC RESTLESS LEGS SYNDROME (RLS): RESULTS FROM TWO 6-MONTH PLACEBO-CONTROLLED TRIALS

2011 ◽  
Vol 12 ◽  
pp. S121
Author(s):  
Art Walters ◽  
Richard Bogan ◽  
William Ondo ◽  
Richard Allen ◽  
Markku Partinen ◽  
...  
2017 ◽  
Vol 32 ◽  
pp. 48-55 ◽  
Author(s):  
Jan-Peer Elshoff ◽  
John Hudson ◽  
Daniel L. Picchietti ◽  
Keith Ridel ◽  
Arthur S. Walters ◽  
...  

Neurology ◽  
2017 ◽  
Vol 88 (23) ◽  
pp. 2216-2224 ◽  
Author(s):  
Maria A. Silva ◽  
Gonçalo S. Duarte ◽  
Raquel Camara ◽  
Filipe B. Rodrigues ◽  
Ricardo M. Fernandes ◽  
...  

Objective:To estimate the placebo and nocebo responses in restless legs syndrome (RLS) and explore their determinants.Methods:Databases were searched up to October 2015. Randomized, double-blind, placebo-controlled trials of patients with RLS were included if quantitative data were extractable in the placebo arm. Placebo response was defined as the within-group change from baseline, using any scale measuring RLS severity or disability. Nocebo response was defined as the proportion of patients experiencing adverse events in the placebo arm. Random-effects meta-analysis was used to pool data. Statistical heterogeneity was assessed with I2 statistic. Several predetermined subgroup and sensitivity analysis were performed. PROSPERO registration number is CRD42015027992.Results:We included 85 randomized controlled trials (5,046 participants). Pooled placebo response effect size was −1.41 (95% confidence interval [CI] −1.56 to −1.25, 64 trials, I2 = 88.1%), corresponding to −6.58 points in the International RLS Study Group Scale (IRLS). Pooled nocebo response was 45.36% (95% CI 40.47%–50.29%, 72 trials; I2 = 89.8%). The placebo and nocebo responses were greater in trials with longer duration, evaluating pharmacologic interventions and idiopathic RLS, and in industry-funded and unpublished studies. The placebo response was considerably smaller in objective as compared to subjective outcomes. In addition, the nocebo response increases proportionally with the placebo response, and has the same predictors.Conclusions:The magnitude of the placebo response in RLS is above the threshold of minimal clinical important difference, and the frequency of adverse events is also considerable. These results are relevant to inform the design and interpretation of future clinical trials.


2008 ◽  
Vol 9 (3) ◽  
pp. 228-239 ◽  
Author(s):  
Wolfgang H. Oertel ◽  
Heike Benes ◽  
Diego Garcia-Borreguero ◽  
Peter Geisler ◽  
Birgit Högl ◽  
...  

2020 ◽  
Vol 65 ◽  
pp. 13-17 ◽  
Author(s):  
Gonçalo S. Duarte ◽  
Mariana Alves ◽  
Maria A. Silva ◽  
Raquel Camara ◽  
Daniel Caldeira ◽  
...  

Healthcare ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1538
Author(s):  
Yu-Chi Su ◽  
Yao-Hong Guo ◽  
Chung-Lun Liao ◽  
Yu-Ching Lin

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.


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