A randomized, double-blind placebo-controlled trial of iron in restless legs syndrome

Background: Previous open-label trials have shown iron to be efficacious in the treatment of restless legs syndrome. We performed a randomized, double -blind, placebo-controlled trial of iron sulfate. Methods: Twenty eight pat ients were randomized to receive either ferrous sulfate 325 mg b.i.d. or pl acebo for 12 weeks. The primary outcome measure was the dichotomous variabl e of improvement or no improvement in average quality of sleep as recorded by a visual analog scale nightly over a 2-week period, comparing a pretreat ment 2-week baseline to weeks 13-14, Secondary outcome measures included a comparison of the qualify of sleep as measured by a visual analog scale, ef fect of restless legs syndrome on life as a whole as measured by a differen t visual analog scale, and the percentage of nights patients were symptomat ic. Results: No significant differences were noted between iron and placebo groups for both primary and secondary outcome measures. Responders taking iron did have a significant increase in their iron saturation compared to n onresponders taking iron. Conclusions: Iron sulfate does not appear to be a n effective empiric treatment for restless legs syndrome. Copyright (C) 200 0 S. Karger AG, Basel.