Evaluation of Acupuncture in the Treatment of Restless Legs Syndrome: A Randomized Controlled Trial.

The aim of this study was to examine the additive effect of medical acupuncture on controlling the symptoms of restless legs syndrome (RLS). A total of 46 randomly allocated patients diagnosed with RLS were assigned to receive either 10 sessions of acupuncture plus gabapentin (300 mg/d), or gabapentin (300 mg/d) alone (23 patients in each group) over 4 weeks in a single-blind study. The symptoms of patients were assessed by the Visual Analogue Scale (VAS), the International Restless Legs Syndrome Rating Scale (IRLSRS), and the Pittsburgh Sleep Quality Index (PSQI) at baseline, just after the therapeutic course and 8 weeks later. For all outcome measures, there was a significant time-group interaction, showing that the behavior of groups differed regarding changes in VAS, IRLSRS, and PSQI in favor of the experimental group. After therapeutic course termination and in 8 weeks follow up, VAS and IRLSRS had a significant improvement in both the experimental group and the control group, but PSQI improved significantly just in the experimental group. Based on the findings of the present study, acupuncture plus a low dose of gabapentin (300 mg/d) is clinically useful in the treatment of RLS during 8 weeks follow up, and also has an additive therapeutic effect over gabapentin alone in patients with RLS.