title: Efficacy of Pramipexole for the Treatment of Primary Restless Leg Syndrome: A Systematic Review and Meta-analysis of Randomized Clinical Trials.
abstract: OBJECTIVE
  The objective of this meta-analysis was to systematically evaluate the efficacy of pramipexole for the treatment of primary moderate-to-severe restless leg syndrome (RLS).
  
  
  METHODS
  Databases of PubMed, OVID, ScienceDirect, SpringerLink, Thomson Reuters Web of Science, the Cochrane Library, the Wiley Online Library, ArticleFirst, CALIS, Study, CNKI, and WanFang were searched to identify randomized controlled trials (RCTs) investigating pramipexole for the treatment of primary moderate-to-severe RLS. A meta-analysis was then conducted to pool results.
  
  
  RESULTS
  Twelve RCTs involving 3286 participants were included in this study. The mean (SD) treatment duration was 11.12 (5.72) weeks/person. The meta-analysis found that the post-treatment change in the International Restless Leg Syndrome Study Group Rating Scale (IRLS) score of the pramipexole group was significantly superior to that of the placebo group (weighted mean difference [WMD] = -4.64; 95% CI, -5.95 to -3.33; n = 8). More patients in the pramipexole group reported at least a 50% reduction in the IRLS score after treatment (risk ratio [RR] = 1.57; 95% CI, 1.43 to 1.73; n = 8). In terms of the scores for the Clinical Global Impression of Improvement scale (RR = 1.48; 95% CI, 1.31 to 1.66; n = 11) and the Patient Global Impression scale (RR = 1.54; 95% CI, 1.31 to 1.81; n = 9), treatment outcomes of the pramipexole group were significantly superior to those of the placebo group. In terms of the change in quality of life (WMD = 5.39; 95% CI, 2.28 to 8.50; n = 4), the change in daytime tiredness (WMD = -0.61; 95% CI, -1.21 to -0.01; n = 4), the change in the number of periodic limb movements per hour of sleep (WMD = -35.95; 95% CI, -56.42 to -15.48; n = 3), and the change in the quality of sleep (WMD = 3.60; 95% CI, 1.69 to 5.50; n = 6), the treatment outcomes of the pramipexole group were significantly superior to those of the placebo group.
  
  
  CONCLUSIONS
  This meta-analysis study indicated that pramipexole could effectively improve the symptoms of patients with primary moderate-to-severe RLS, although the quality of evidence was relatively low. Future clinical trials focusing on the medium-term and long-term treatment outcomes and using mainly objective indicators for evaluation are warranted. It is also necessary to pay close attention to augmentation during medication.
authors.affiliation: Department of Neurology, Taihe Hospital Affiliated to Hubei University of Medicine, Shiyan City, China.
authors.forename: Guang Jian
authors.initials: GJ
authors.lastname: Liu
authors.affiliation: Center for Clinical and Translational Science, Mayo Clinic, Rochester Minnesota.
authors.forename: Lang
authors.initials: L
authors.lastname: Wu
authors.affiliation: Department of Neurology, Taihe Hospital Affiliated to Hubei University of Medicine, Shiyan City, China.
authors.forename: Song
authors.initials: S
authors.lastname: Lin Wang
authors.affiliation: Department of Neurology, Taihe Hospital Affiliated to Hubei University of Medicine, Shiyan City, China.
authors.forename: Li Li
authors.initials: LL
authors.lastname: Xu
authors.affiliation: Department of Neurology, Xiangyang Center Hospital Affiliated to Hubei University of Arts and Science, Xiangyang City, China. Electronic address: liying_changxf@163.com.
authors.forename: Li
authors.initials: L
authors.lastname: Ying Chang
authors.affiliation: Department of Neurology, Taihe Hospital Affiliated to Hubei University of Medicine, Shiyan City, China. Electronic address: wyfymc@sina.com.
authors.forename: Yun
authors.initials: Y
authors.lastname: Fu Wang
mesh_terms: D052160:Benzothiazoles / Q000627:therapeutic use*; D018491:Dopamine Agonists / Q000627:therapeutic use*; D005221:Fatigue / Q000209:etiology; D006801:Humans; D000077487:Pramipexole; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012148:Restless Legs Syndrome / Q000150:complications / Q000188:drug therapy*; D012720:Severity of Illness Index; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D052160:Benzothiazoles; D018491:Dopamine Agonists; D000077487:Pramipexole
keywords: clinical trials; efficacy; pramipexole; restless leg syndrome (RLS)