Rotigotine For Restless Legs Syndrome: A Systematic Review

Objective To assess the efficacy and safety of rotigotine for restless legs syndrome (RLS).Methods A search for randomized, double, blind and placebo -controlled clinical trials of rotigotine in treating moderate to severe RLS using Cochrane library, PubMed, Embase and China hownet database was carried out. A meta-analysis of included clinical trials was performed with RevMan 5.2 software. The 2 outcomes that the Standardized mean difference (SMD)of change from baseline in International RLS Study Group rating scale(IRLS) score and the Odds ratio (OR)of response based on The clinical efficacy of the total evaluation (CGI-I) scale score were calculated for efficacy. Safety was assessed with the Relative Rist (RR) of the adverse event.Results A total of 6 clinical trials were included in this meta-analysis, of which 2569 patients were randomly assigned. The records of patients were pooled. Overall SMD were -0.52 [95%CI (-0.60,-0.03), P<0.000001] for the change from baseline in IRLS score, and OR of response based on CGI-1 were 2.19 [95%CI(1.86,2.58), P<0.00001]. The overall RR of rotigotine versus placebo for Drug related adverse reactions and Serious adverse events were 1.49 [95%CI (1.25,1.78), P<0.0001] and 1.34 [95%CI (0.69.11,2.61), P=0.39]Conclusion To treat RLS, rotigotine is an effective and safe drug.