Randomised controlled trials (RCTs) that evaluated the impact of ropinirole on sleep in patients with restless legs syndrome compared to placebo were eligible for inclusion. Included studies had to use the Medical Outcomes Study (MOS) sleep scale over at least 12 weeks or the Clinical Global Impression-Improvement (CGI-I) scale to assess sleep outcomes. Studies designed to assess maintenance treatment or long-term safety were excluded. Studies where ropinirole was an adjunct treatment were excluded.
Included studies were restricted to those of moderate to very severe primary restless leg syndrome requiring treatment only at night. Mean age of participants was approximately 54 years. The proportion of males was 37%. Most participants reported risk factors for sleep disturbance (alcohol use, caffeine use, comorbid conditions and concomitant drugs). Most participants were recruited in USA and UK.
The authors did not state how many reviewers performed the study selection.