Purpose: We performed a meta-analysis of randomized placebo-controlled trials of nonergot dopamine agonists (NEDAs) for the treatment of restless legs syndrome.
Methods: A systematic literature search was conducted through July 2007. The primary outcome measures assessed were the percentage of responders to medication as determined by the Clinical Global Impression-Improvement (CGI-I) scale and the adjusted mean change in the International Restless Legs Syndrome Study Group Scale (IRLS) score from baseline compared with placebo. Meta-regression analysis was performed to evaluate the impact of study duration on the primary outcomes. Safety endpoints were also evaluated.
Results: A total of 14 trials (n = 3,197 subjects) were included in the meta-analysis. NEDA use resulted in greater response as measured by the CGI-I scale (relative risk [RR] 1.36; 95% CI, 1.24 to 1.49; P <.001), and greater reductions in IRLS scores (weighted mean difference [WMD] -4.93; 95% CI, -6.42 to -3.43; P <.001) from baseline vs placebo. Meta-regression analysis showed an inverse relationship between study duration and reduction in IRLS score. NEDAs were associated with a significant risk of adverse events (including nausea, dizziness, somnolence, and fatigue.)
Conclusions: Use of NEDAs in patients with moderate-to-severe restless legs syndrome results in significant reductions in symptom severity, but a significant portion of patients will discontinue their use as a result of adverse events.