A Cochrane review [Abstract]1included 9 RCTs with 521 participants with restless legs syndrome. Treatment durations varried between one to 8 weeks. Symptom severity (11 point rating scale) was more reduced with levodopa than placebo (MD -1.34, 95% CI -2.18 to -0.5; 2 studies, n=48). Periodic limb movements in sleep per hour of sleep improved by -26.28/h compared to placebo (95% CI -30.53 to -22.02; 5 trials, n=300).The CGI-I changed more with levodopa than placebo (MD -1.25, 95% CI -1.89 to -0.62; 2 studies, n=236). Sleep quality (sleep questionnaire, visual analogue scale) showed a large effect (SMD 0.92, 95% CI 0.52 to 1.33; 2 studies, n=60) whereas quality of life (50 mm Visual Analogue Scales) improved by 3.23 compared to placebo (95% CI 1.64 to 4.82; 2 studies, n=60). Few patients dropped out of treatment (3/218) but more levodopa than placebo treated patients experienced adverse events (OR 2.61, 95% CI 1.35 to 5.04). Two dopamine agonist-controlled studies (n=67) showed smaller effects with levodopa than cabergoline and pramipexole on the IRLS (MD 5.25, 95% CI 2.10 to 8.40), CGI-I (MD 0.62, 95% CI 0.37 to 0.87), and quality of life (MD 5.54, 95% CI 2.65 to 8.43).
Comment: The quality of evidence is downgraded by limitations in study quality (unclear allocation concealment, short follow-up).
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