Purpose
The objective of this meta-analysis was to systematically evaluate the efficacy of pramipexole for the treatment of primary moderate to severe RLS.
Methods
Databases of PubMed, OVID, ScienceDirect, SpringerLink, Thomson Reuters Web of Science, the Cochrane Library, the Wiley Online Library, ArticleFirst, CALIS, Study, CNKI, and WanFang were searched to identify randomized controlled trials (RCTs) investigating pramipexole for the treatment of primary moderate to severe RLS. A meta-analysis was then conducted to pool results.
Findings
Twelve RCTs involving 3286 participants were included in this study. The average treatment duration was 11.12 (±5.72) weeks/person. The meta-analysis demonstrated that the post-treatment change in the International Restless Leg Syndrome Study Group Rating Scale (IRLS) score of pramipexole group was significantly superior to that of placebo group (weighted mean difference (WMD)=-4.64, 95% confidence intervals (CI) −5.95 to −3.33, n=8). More patients in pramipexole group showed at least a 50% reduction in the IRLS score after treatment (risk ratio [RR]) =1.57, 95% CI 1.43 to 1.73, n=8). In terms of the scores for the Clinical Global Impression of Improvement scale (CGI-I; RR=1.48, 95% CI 1.31 to 1.66, n=11) and the Patient Global Impression scale (PGI; RR=1.54, 95% CI 1.31 to 1.81, n=9), pramipexole group’s treatment outcomes were significantly superior to those of placebo group. In terms of the change in quality of life (WMD=5.39, 95% CI 2.28 to 8.50, n=4), change in daytime tiredness (WMD=-0.61, 95% CI −1.21 to −0.01, n=4), change in the number of periodic limb movements per hour of sleep (WMD=-35.95, 95% CI −56.42 to −15.48, n=3) and change in the quality of sleep (WMD=3.60, 95% CI 1.69 to 5.50, n=6), the treatment outcomes of pramipexole group were significantly superior to those of placebo group.
Implications
This meta-analysis study indicated that pramipexole could effectively improve the symptoms of primary moderate to severe RLS patients, although the quality of evidence was relatively low. Future clinical trials focusing on the medium-term and long-term treatment outcomes and using mainly objective indicators for evaluation are warranted. It is also necessary to pay close attention to augmentation during medication.
