Padma 28 for intermittent claudication.

BACKGROUND: Intermittent claudication is pain caused by chronic occlusive arterial disease that develops in a limb during exercise and is relieved with rest. Most drug treatments of intermittent claudication have a limited effect in improving walking distance. Padma 28, a Tibetan herbal preparation, has been used to treat intermittent claudication, but there is debate as to whether Padma 28 produces a clinical benefit beyond the placebo effect.

OBJECTIVES: To determine whether Padma 28 is effective, compared with placebo or other medications, in increasing pain-free and maximum walking distance for patients with intermittent claudication.

SEARCH METHODS: The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched April 2013), CENTRAL (2013, Issue 3) and clinical trials databases. In addition, a pharmaceutical company was contacted.

SELECTION CRITERIA: Randomised controlled trials of Padma 28 compared with placebo or other pharmacological treatments in people suffering from intermittent claudication.

DATA COLLECTION AND ANALYSIS: All review authors independently assessed the selected studies and extracted the data. Risk of bias was evaluated independently by two review authors. Depending on the data provided in the individual trials, we extracted mean or median walking distance at the end of the trial, or change in walking distance over the course of the trial, or both. Where not provided, and whenever possible, the statistical significance of differences in these parameters between treatment and placebo groups in individual trials was calculated. Where possible, data were combined by meta-analysis.

MAIN RESULTS: Five trials involving 365 participants were identified. All trials compared Padma 28 with placebo for at least 16 weeks of follow-up. Pain-free and maximum walking distances both increased significantly in the groups treated with Padma 28, with no significant change in the placebo group. In general, the studies presented results comparing the treatment arms before and after treatment but made no comparisons between the Padma 28 and placebo groups. Pooled data of maximum walking distance after treatment with Padma 28 and placebo from two studies indicated a statistically significant difference in maximum walking distance (mean difference (MD) 95.97 m, 95% confidence interval (CI) 79.07 m to 112.88 m, P < 0.00001). The clinical importance of these observed changes in walking distance is unclear as no quality of life data were reported. There was no effect on ankle brachial index. Mild side effects, especially gastrointestinal discomfort, tiredness and skin eruption, were reported but this outcome was not statistically significantly different between the groups (odds ratio (OR) 1.09, 95% CI 0.42 to 2.83, P = 0.86).

AUTHORS' CONCLUSIONS: Some evidence exists from individual trials to suggest that Padma 28 may be effective in increasing walking distances, at least in the short term (four months), in people with intermittent claudication. Side effects do not appear to be a problem. However, the longer term effects of treatment are unknown and the clinical significance of the improvements in walking distance are questionable. Moreover, the quality of the evidence is limited by the small sample size of the available trials, lack of detail on key elements required to assess sources of bias, such as around randomisation and blinding, limited reporting of statistical analyses that compared treatment groups, and relatively high withdrawal rates that were linked to the outcome that is patients were withdrawn if they failed to improve walking distance. There was also evidence of publication bias. We therefore feel there is currently insufficient evidence to support the use of Padma 28 in the routine management of intermittent claudication. Further well-designed research would be required to determine the true effects of this herbal preparation.