Review of Clinical Trials Finds Pharmacologic Therapy Associated with Relief for Patients with Restless Legs Syndrome

A review of 29 randomized controlled trials (RCTs) by Timothy J. Wilt, M.D., M.P.H., of the Minneapolis VA Health Care System, Minnesota, and colleagues suggests that pharmacologic therapy was associated with improved symptoms and better sleep in patients with restless legs syndrome (RLS). (Online First)

Researchers report they found high-strength evidence that the proportion of patients who had a clinically important response, defined as a 50 percent or greater reduction from baseline in average International Restless Legs Syndrome (IRLS) symptom scale scores, was greater with dopamine agonist therapy compared with placebo (61 percent vs. 41 percent). Dopamine agonists also were associated with improved patient-reported sleep scale scores and quality-of-life measures. High-strength evidence also showed that use of calcium channel alpha-2-delta ligands was associated with an increased proportion of IRLS responders compared with placebo (61 percent vs. 37 percent), according to study results.

“On the basis of short-term RCTs that enrolled highly selected populations with long-term high-moderate to very severe symptoms, dopamine agonists and calcium channel alpha-2-delta ligands reduced RLS symptoms and improved sleep outcomes and disease-specific quality of life. Adverse effects and treatment withdrawals due to adverse effects were common,” the study concludes.

(JAMA Intern Med. Published online March 4, 2013. doi:10.1001/.jamainternmed.2013.3733.