Buflomedil in arterial occlusive disease: results of a controlled multicenter study. Double-blind placebo-controlled trial of buflomedil in the treatment of Raynaud's phenomenon: six-month follow-up.
In a double-blind, randomised multicentre study buflomedil, a vasoactive substance, was compared with placebo in the treatment of 93 patients with chronic arterial occlusive disease. After a run-in period of four weeks the patients received either buflomedil (600 mg daily) or placebo over 12 weeks. The pain-free and the total walking distances improved significantly in both groups. However, the differences in the improvement between the two groups were highly significant and in favour of buflomedil: for the pain-free walking distance p less than 0.001 and for the total walking distance p less than 0.01. The results indicate that buflomedil has a beneficial effect on the symptoms and lengthens the walking distance in patients with arterial occlusive disease. The efficacy of buflomedil in reducing the mean daily frequency and severity of winter ischemic attacks has been shown in a randomized, double-blind, placebo-controlled trial including 31 patients (16 in the buflomedil group, 15 in the placebo group) suffering from idiopathic Raynaud's phenomenon and followed up for six months. The efficacy was confirmed by nail fold capillaroscopy, which showed a significant alleviation of hemodymanic disturbances and background pallor in comparison with the placebo. Results in terms of clinical and laboratory safety parameters assessed over a six-month period were satisfactory, thus demonstrating the possibility of a long-term treatment.
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showed moderately positive results; these are undermined by publication bias since we know of at least another four unpublished, irretrievable, and inconclusive studies.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.