A Cochrane review [Abstract]1 included 35 RCTs with 7365 participants with restless legs syndrome (RLS). Patients were recruited from outpatient clinic settings and private practices. Diagnosis of moderate to very severe RLS was made according to the criteria defined by the International Restless Legs Study Group. The dopamin agonists used in trials were cabergoline (n=3), lisuride (n=2), pergolide (n=5), pramipexole (n=10), ropinirole (n=12), rotigotine (n=5) and sumanirole (one trial, not licensed). Treatment durations varied from one to 30 weeks with durations of 12 weeks in many studies, only 4 studies investigated treatment efficacy up to 7 months. The mean reduction on the International RLS Severity Rating Scale (IRLS) was −5.7 points lower in dopamine agonist treatment compared to placebo (95% CI −6.7 to −4.7; 30 trials, n=6380). Periodic limb movements in sleep per hour of sleep (PLMS-Index) were −22.4/h lower than in placebo (95% CI −27.8 to −16.9; 15 trials, n=1141). Self rated quality of sleep and disease specific quality of life were improved (SMD 0.40, 95% CI 0.33 to 0.47; 22 trials, n=4592) and 0.34 (95% CI 0.23 to 0.44; 17 trials, n=4312), respectively. Patients were more likely to drop out (OR 1.82, 95% CI 1.35 to 2.45; 34 trials, n=7054) and experienced more adverse events under dopamine agonist treatment than with placebo (OR 1.82, 95% CI 1.59 to 2.08; 33 trials, n=7049). Active controlled trials investigated effects of cabergoline, pergolide, and pramipexole in a number of outcomes. The IRLS score was lower with cabergoline and pramipexole compared to levodopa (MD −5.3, 95% CI −8.4 to −2.1; 2 trals, n=422). The most severe side effect, augmentation, was not assessed reliably.
Comment: The quality of evidence is downgraded by indirectness (short follow-up time) and upgraded by large magnitude of effect.
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