Efficacy and safety of dopamine agonists in restless legs syndrome.
Author(s): Hornyak M, Trenkwalder C, Kohnen R, Scholz H.
Affiliation(s): Interdisciplinary Pain Centre, University Medical Centre, Breisacher Strasse 64,
79106 Freiburg, Germany. magdolna.hornyak@uniklinik-freiburg.de
Publication date & source: 2012, Sleep Med. , 13(3):228-36
OBJECTIVE: Restless legs syndrome (RLS) is a common neurological disorder causing
considerable impairment to daily living. This article is an overview of a
comprehensive Cochrane meta-analysis on the efficacy and safety of dopamine
agonists (DAs), the first-line treatment of RLS.
METHODS: CENTRAL, MEDLINE, EMBASE, PsycINFO, and CINAHL databases were searched
for double-blind randomized controlled trials (RCTs) of DAs vs placebo.
RESULTS: Thirty-five placebo-controlled RCTs (total number of patients=6954) were
eligible. The likelihood of bias was considered to be low. The mean treatment
duration of the RCTs was 10.3 (standard deviation 7.3) weeks, with treatment
durations up to seven months. Overall, DAs showed a moderate improvement in the
International RLS Severity Scale score (mean difference -5.7 points [95%
confidence interval, CI, -6.7 to -4.7; P<0.00001]) and the Clinical Global
Impression-Improvement response (risk ratio 1.44 [95% CI 1.34-1.54; P<0.00001])
compared with placebo. Periodic limb movements decreased by -22.38/h (95% CI
-27.8 to -16.9; P<0.00001) for DAs compared with placebo. Sleep quality and
disease-specific quality of life increased slightly to moderately. Safety data
confirmed the established safety characteristics of DAs. Augmentation, a specific
side-effect of dopaminergic treatment of RLS, was not assessed adequately.
CONCLUSIONS: This meta-analysis showed that DAs have moderate efficacy in the
treatment of RLS. Actively controlled and long-term studies are still lacking.
Large-scale comparative studies are needed to identify the most efficient
treatments for this chronic disorder.
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