The quality of evidence is downgraded by study quality (unclear allocation concealment) and by potential publication bias.
Buflomedil is not recommended for intermittent claudication.The balance between benefit and risk for buflomedil in the symptomatic treatment of intermittent claudication is unfavourable.
A Cochrane review included 2 studies with a total of 127 subjects. Both studies showed moderate improvements in pain-free walking distance for patients on buflomedil. This improvement was statistically significant for both trials (WMD 75.1 m, 95% 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 studies, maximum walking distance 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. Recent safety concerns have been raised about buflomedil because of lethal and non-lethal neurologic and cardiovascular adverse events in cases of accidental and voluntary overdoses . The authors conclude that buflomedil's benefit is small in relation to safety issues and its narrow therapeutic range.
European Medicines Agency recommended suspension of all buflomedil-containing medicines in November 2011 (see ).