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Updated: May 12, 2026
Computerized Dynamic Posturography for Postural Control Assessment in Patients with Intermittent Claudication
Published on: December 11, 2013
Buflomedil for intermittent claudication
Tine L M de Backer1, Robert Vander Stichele
1Heart Center, Ghent University Hospital, Ghent, Belgium. tine.debacker@ugent.be
Insights
Buflomedil offers moderate improvements in walking distance for intermittent claudication (IC) patients, but evidence is limited. Safety concerns and publication bias temper its potential benefits for peripheral vascular disease.
Area of Science:
- Vascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Intermittent claudication (IC) is characterized by exercise-induced limb pain due to chronic occlusive arterial disease.
- Buflomedil is a vasoactive agent used for peripheral vascular disease, but its efficacy for IC requires critical evaluation.
- This review updates previous Cochrane analyses from 2000, 2007, and 2008.
Purpose of the Study:
- To critically assess the available scientific evidence regarding the effectiveness of buflomedil in treating intermittent claudication.
- To synthesize findings from randomized controlled trials (RCTs) evaluating buflomedil's impact on walking distances in IC patients.
Main Methods:
- Searched specialized databases (Cochrane Peripheral Vascular Diseases Group) up to January 2013.
- Included double-blinded RCTs comparing oral buflomedil to placebo in patients with IC (Fontaine stage II).
- Analyzed pain-free walking distance (PFWD) and maximum walking distance (MWD) using standardized exercise tests; assessed trial quality and extracted data.
Main Results:
- Two RCTs involving 127 participants were included.
- Buflomedil demonstrated statistically significant, moderate improvements in both PFWD and MWD compared to placebo.
- Improvements in PFWD were observed in general and diabetic populations, with significant gains in MWD.
Conclusions:
- Limited high-quality evidence exists for buflomedil's efficacy in intermittent claudication.
- Positive results from included trials are potentially biased by the exclusion of at least four unpublished studies.
- Buflomedil's modest benefits must be weighed against safety concerns and its narrow therapeutic index.
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.
Objectives:
To evaluate the available evidence on the efficacy of buflomedil for IC.
Search 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).
Selection Criteria:
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.
Data Collection And Analysis:
Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information.
Main 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.
Authors' 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.
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