|FasTrakIntermittent claudicationPadma(r) 28Peripheral Arterial Occlusive Disease|
|Date: December 15, 2006||HC# 060164-318|
Re: Efficacy of Tibetan Padma(r) 28 for the Treatment of Intermittent Claudication
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Melzer J, Brignoli R, Diehm C, Reichling J, Do D, Saller R. Treating intermittent claudication with Tibetan medicine Padma 28: does it work?. Atherosclerosis. 2006 November;189(1):39-46.Intermittent claudication is a condition caused by ischemia of the muscles and characterized by attacks of lameness and pain, brought on by walking, chiefly in the calf muscles. It is the most common symptom of peripheral arterial occlusive disease (PAOD). The prevalence of intermittent claudication increases with age and affects approximately 2.5% of persons aged <60 years, 8.3% of those aged 60–70 years, and up to 18.8% of those aged 70 years. Padma® 28 (PADMA AG, Switzerland), a medicinal product of Tibetan origin, includes a fixed combination of 20 herbal drugs, a mineral, and camphor and has been used historically to treat circulatory problems and as an anti-inflammatory agent. (The product is marketed in the US as PADMA Basic® [Econugenics®; Santa Rosa, CA]; however, it does not contain aconite or heart-leaf sida [Sida cordifolia]) The objective of this study was to evaluate the current evidence regarding the safety and efficacy of Padma 28 in the treatment of the symptoms associated with PAOD.
A systematic literature review to obtain studies of Padma 28 was conducted through June 2004 by searching for the terms Padma 28, herbal, peripheral arterial disease, Tibetan medicine, and phytotherapy in the following databases: TOXLINE, MEDLINE, HealthSTAR, The Cochrane Collaborative Library, PubMed, AMED, Embase, AIDSLINE, and CANCERLIT. To be eligible for analysis, the studies had to have been randomized and placebo-controlled, had to have had a sample size of greater than/equal to 30, had to have lasted greater than/equal to 12 weeks, and had to have included patients with PAOD who were pain free. Nineteen studies of Padma 28 were identified, 7 of which met the eligibility criteria. Data from a total of 444 patients were used for the review and from 272 patients were used in a meta-analysis. The dosage of Padma 28 ranged from 309 to 382 mg per capsule, 2 of which were taken 2 to 3 times per day. In 6 of the 7 studies, maximum treadmill walking distance was the primary endpoint.
A pooled analysis of the safety and efficacy of Padma 28 in 5 of the trials showed this treatment to be associated with prolongation of maximum treadmill walking distance by >100 m in 18.2% of the patients with intermittent claudication due to PAOD. One in six patients had a “clinically relevant improvement,” which appeared to be independent of demographic, clinical, and disease-related factors. The safety evaluation included a review of the 19 studies originally identified in the literature search. The most common adverse effect was dyspepsia, which had an incidence of 2.4%. The few serious adverse effects observed (myocardial infarction and toe amputation) were related to the underlying pathology. No systemic changes in routine hematologic or biochemical variables were observed in either the verum or placebo groups.
The results indicate that Padma 28 was “very well tolerated” and provided “significant relief from PAOD-related symptoms (i.e. walking distance), probably of the same order of magnitude as other employed medications.” However, the evidence as a whole may not be sufficient to meet the criteria for new drugs for this condition; therefore, larger trials conducted according to international guidelines are needed.
—Brenda Milot, ELS