title: Buflomedil for intermittent claudication.
abstract: BACKGROUND
  Intermittent claudication (IC) is pain caused by chronic occlusive arterial disease, that develops in a limb during exercise and is relieved with rest. Buflomedil is a vasoactive agent used to treat peripheral vascular disease. However, its clinical efficacy for IC has not yet been critically examined. This is an update of a Cochrane review first published in 2000, and previously updated in 2007 and 2008.
  
  
  OBJECTIVE
  To evaluate the available evidence on the efficacy of buflomedil for IC.
  
  
  METHODS
  For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched January 2013) and CENTRAL (2012, Issue 12).
  
  
  METHODS
  Double-blinded, randomized controlled trials (RCTs) in patients with IC (Fontaine stage II) receiving oral buflomedil compared with placebo. Pain-free walking distance (PFWD) and maximum walking distance (MWD) were analysed by standardized exercise test.
  
  
  METHODS
  Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information.
  
  
  RESULTS
  We included two RCTs with 127 participants. Both RCTs showed moderate improvements in PFWD for patients on buflomedil. This improvement was statistically significant for both trials (WMD 75.1 m, 95% confidence interval (CI) 20.6 to 129.6; WMD 80.6 m, 95% CI 3.0 to 158.2), the latter being a wholly diabetic population. For both RCTs, MWD gains were statistically significant with wide confidence intervals (WMD 80.7 m, 95% CI 9.4 to 152; WMD 171.4 m, 95% CI 51.3 to 291.5), respectively.
  
  
  CONCLUSIONS
  There is little evidence available to evaluate the efficacy of buflomedil for IC. Most trials were excluded due to poor quality. The two included trials showed moderately positive results; these are undermined by publication bias since we know of at least another four unpublished, irretrievable, and inconclusive studies.Buflomedil's benefit is small in relation to safety issues and its narrow therapeutic range.
authors.affiliation: Heart Center, Ghent University Hospital, Ghent, Belgium. tine.debacker@ugent.be
authors.forename: Tine L M
authors.initials: TL
authors.lastname: de Backer
authors.forename: Robert
authors.initials: R
authors.lastname: Vander Stichele
mesh_terms: D000284:Administration, Oral; D004311:Double-Blind Method; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy*; D017594:Publication Bias; D011759:Pyrrolidines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*
chemical_list: D011759:Pyrrolidines; D014665:Vasodilator Agents; C010651:buflomedil
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