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Treatment for Restless Legs Syndrome [Internet]

Treatment for Restless Legs Syndrome [Internet]

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US)

Version: November 2012

Results

Results of the literature search and screening process are shown in Figure 2. We identified 671 unique publications. Title and abstract screening resulted in 138 potentially relevant publications. Full-text screening resulted in 53 studies that fulfilled eligibility criteria and were included: of these 33 were randomized controlled trials (RCTs) (31 placebo or usual care controlled) and 18 were observational studies (including open-label extensions of included RCTs) that reported long-term treatment withdrawals, reasons for withdrawals, or percentage of patients developing augmentation. All RCTs that examined pharmacologic treatments were industry sponsored.

Executive Summary

Restless legs syndrome (RLS) is a neurological disorder characterized by unpleasant sensations in the legs and a distressing, irresistible urge to move them. RLS can result in reduced quality of life and interrupt sleep, leading to daytime fatigue. However, effective treatment options are not well established and there is little guidance on diagnosis and treatment. A comprehensive review of the effectiveness and harms of treatments for RLS could lead to improved care for individuals with the syndrome.

Discussion

The primary intent of this report was to conduct a comparative effectiveness review on treatments for restless legs syndrome. However, we identified only two randomized controlled trials that directly compared treatment options. Included studies did not permit reliable indirect comparisons from which to draw robust conclusions about comparative benefits and harms. Results from small, placebo-controlled randomized trials of generally short duration demonstrated that dopamine agonists (ropinirole, pramipexole, and rotigotine) and anticonvulsant alpha-2-delta ligands (gabapentin enacarbil, gabapentin, and pregabalin) increase the percentage individuals responding to treatment (as defined by a 50 percent reduction in the International Restless Legs Syndrome (IRLS) Study Group symptom scale score or reporting “improved or much improved” on the clinician-assessed global impressions scale score (CGI) or patient-assessed global impressions scales score (PGI), reduce restless legs syndrome (RLS) symptoms, and improve disease-specific quality of life and patient-reported sleep outcomes. However, adverse effects of pharmacologic therapies and long-term treatment withdrawals due to adverse effects or lack of efficacy are common.

Introduction

Restless legs syndrome (RLS), or Willis-Ekbom disease, is a neurological disorder that characterized by unpleasant or painful sensations in the legs and a distressing, irresistible urge to move them. RLS symptoms worsen during inactivity and at night. Partial or complete relief may result from movement such as walking, stretching, or bending of the legs. Yet, the relief is often temporary and symptoms return when movement ceases. If the disease progresses, symptoms may occur earlier in the day and intensify even further at night and/or extend beyond the legs to the arms and/or trunk. The clinical course of RLS varies, and periods of remission are common. Severe restless legs syndrome, however, may require long-term treatment.

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