Treating intermittent claudication with Tibetan medicine Padma 28: does it work?

Herbal drugs are being increasingly used in medical practice, often without appropriate scrutiny of their safety and efficacy. The medicinal product Padma 28 is a fixed combination with Tibetan origin, used in Europe since the 1960s for the symptomatic treatment of circulatory disorders, including those of peripheral arterial occlusive disease (PAOD). We have conducted an analysis of all available data on this herbal drug from published literature as well as from original data we obtained from contacting the authors of published papers, reports and the manufacturer. A total of 19 trials have reported on 2084 patients to date, 444 of whom were in six controlled clinical studies on PAOD. A meta-analysis of five trials showed Padma 28 to increase walking distance by >100m in 18.2% of the patients with verum, versus 2.1% with placebo (P<0.001; odds ratio: 10 [95% CI 3.03, 33.33]; RR: 0.12; number needed to treat=6.2). The safety profile appears to be favourable. Available evidence shows that Padma 28 provides significant relief from PAOD-related symptoms (i.e. walking distance), probably of the same order of magnitude as other employed medications. However, larger confirmatory RCTs are desirable.