Abstract
Objective To evaluate the efficacy and safety of pramipexole in treating restless legs syndrome (RLS). Methods A search for randomized, double-blind, and placebo-controlled clinical trials of pramipexole in treating moderate to severe RLS using CNKI, PubMed, Embase and Cochrane Library database was carried out. A meta-analysis of included clinical trials was performed with RevMan 5.0 software. The 2 outcomes that the weighted mean difference(WMD) of change from baseline in International RLS Study Group rating scale(IRLS) score and the relative risk (RR) of response based on the Clinical Global Impression-Improvement (CGI-I) scale score were calculated for efficacy. Safety was assessed with RR of the adverse event (AE). Results A total of 5 clinical trials were included in this meta-analysis, of which 1776 patients were randomly assigned (945 on pramipexole, 831 on placebo). The records of patients were pooled. Overall WMD were -6.34 (Z=12.76, P<0.01) for the change from baseline in IRLS score, and RR of response based on CGI-I were 1.65 (Z=10.39, P<0.01) .The overall RR of pramipexole versus placebo were 1.14 (Z=1.87, P=0.06) for AE. Conclusion To treat RLS, pramipexole is an effective and safe drug. Key words: Restless legs syndrome; Benzothiazoles; Meta-analysis
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