Objective: To compare the effects of 800 mg of valerian with a placebo on sleep quality and symptom severity in people with restless legs syndrome (RLS).
Methods: A prospective, triple-blinded, randomized, placebo-controlled, parallel design was used to compare the efficacy of valerian with placebo on sleep quality and symptom severity in patients with RLS. Thirty-seven participants were randomly assigned to receive 800 mg of valerian or placebo for 8 weeks. The primary outcome of sleep was sleep quality with secondary outcomes including sleepiness and RLS symptom severity.
Results: Data were collected at baseline and 8 weeks comparing use of valerian and placebo on sleep disturbances (Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale) and severity of RLS symptoms (International RLS Symptom Severity Scale) from 37 participants aged 36 to 65 years. Both groups reported improvement in RLS symptom severity and sleep. In a nested analysis comparing sleepy vs nonsleepy participants who received 800 mg ofvalerian (n=17), significant differences before and after treatment were found in sleepiness (P=.01) and RLS symptoms (P=.02). A strong positive association between changes in sleepiness and RLS symptom severity was found (P=.006).
Conclusions: The results of this study suggest that the use of 800 mg of valerian for 8 weeks improves symptoms of RLS and decreases daytime sleepiness in patients that report an Epworth Sleepiness Scale (ESS) score of 10 or greater. Valerian may be an alternative treatment for the symptom management ofRLS with positive health outcomes and improved quality of life.