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Buflomedil for intermittent claudication.

T L De Backer1, R H Vander Stichele, M G Bogaert

  • 1Heymans Institute of Pharmacology - Medical School, University of Gent, De Pintelaan 185, Gent, Belgium, B-9000. Marc.Bogaert@rug.ac.be

The Cochrane Database of Systematic Reviews
|May 2, 2001
PubMed
Summary
This summary is machine-generated.

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Limited evidence suggests buflomedil may offer moderate benefits for intermittent claudication (IC). However, the quality of most trials is poor, and publication bias is a concern, leaving efficacy uncertain.

Area of Science:

  • Vascular Medicine
  • Pharmacology
  • Clinical Trials

Background:

  • Intermittent claudication (IC) is a symptom of peripheral vascular disease causing limb pain during exercise.
  • Buflomedil is a vasoactive agent used for vascular conditions, but its efficacy for IC is not well-established.

Purpose of the Study:

  • To critically evaluate the available evidence on the efficacy of buflomedil for treating intermittent claudication.

Main Methods:

  • A systematic search of multiple databases (Medline, IPA, Cochrane) and direct contact with manufacturers and authors was conducted.
  • Inclusion criteria required double-blinded, randomized controlled trials (RCTs) comparing oral buflomedil to placebo in patients with Fontaine stage II IC, measuring pain-free walking distance (PFWD) and maximum walking distance (MWD).

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Main Results:

  • Two eligible RCTs were identified from a meta-analysis, with data extracted on walking distances.
  • Both RCTs indicated moderate improvements in PFWD with buflomedil, though one was statistically significant and the other (in a diabetic population) was not.
  • Statistically significant gains in MWD were observed in both RCTs, but with wide confidence intervals.

Conclusions:

  • The available evidence for buflomedil's efficacy in intermittent claudication is limited due to the poor quality and exclusion of most trials.
  • While the two included trials showed moderately positive results, potential publication bias from four irretrievable, inconclusive studies undermines these findings.
  • There is insufficient evidence to definitively conclude on the efficacy of buflomedil for intermittent claudication.