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Tibetan formula effective in peripheral artery disease

A controlled, double-blind pilot trial adds to the growing body of evidence that Padma 28 is a safe and effective treatment for peripheral arterial occlusive disease (Sallon et al, 1998). Padma 28 is a complex herbal preparation based on a traditional Tibetan formula consisting of 20 herbs. According to the authors of the study, Padma 28 has been used in traditional Tibetan medicine to treat conditions caused by over-consumption of meat, fat, and alcohol. Earlier clinical studies have shown that Padma 28 is effective in increasing pain-free walking distance in people with peripheral arterial occlusive disease (PAOD), and results of laboratory studies indicate that the formula has antioxidant activity. The present study was designed to further investigate the efficacy, safety, and tolerability of the formula in the treatment of PAOD.

PAOD, also known as intermittent claudication, is a circulation disorder caused by hardening and narrowing of the arteries in the lower limbs. The condition results in impaired blood flow to the muscles and subsequent pain and cramping with walking. PAOD affects an estimated 12 percent of older adults and is expected to increase in frequency as the population ages.

The study involved a total of 72 patients, 37 of whom were randomized to treatment with Padma 28 (two 403 mg capsules twice daily) and 35 to placebo. After six months of treatment, results were assessed with hemodynamic tests, including measurement of ankle pressure after exercise on a treadmill (an indicator of how blood flow changes to meet the increased demand placed on the limbs by exercise.) According to these objective measurements, those taking Padma 28 had a significant 12 percent improvement in post-exercise ankle pressure drop (the rate at which ankle pressure returned to pre-exercise levels). More than 48 percent had improvement greater than 15 percent, compared to 22 percent of placebo patients.

Patients also completed subjective self-assessment questionnaires. These showed that 58 percent of participants taking Padma 28 perceived improvement in pain-free walking distance, compared with 39 percent of those on placebo. In addition, 40 percent of patients taking Padma 28 reported an overall improvement in well-being, including increased energy and better mood and concentration, compared to only 15.4 percent of control patients.

A total of thirteen patients (six in the Padma 28 group and seven on placebo) dropped out before the study ended. Three patients in the Padma group and one in the placebo group dropped out because of gastrointestinal disturbances; the other dropouts were unrelated to treatment side effects. Of the remaining 59 participants, five in the Padma 28 group and three taking placebo reported side effects of either gastrointestinal upset or tiredness.

The investigators speculated that the effectiveness of Padma 28 in treating POAD may be due to its antioxidant activity. They concluded, "While the precise mode of action requires clarification, results suggest that Padma 28 may be an effective treatment for intermittent claudication." The Padma 28 capsules used in the study were supplied by Padma AG of Zollikon, Switzerland. - Evelyn Leigh

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[Sallon S, Beer G, Rosenfeld J, Anner H, Volcoff D, Ginsberg G, Paltiel O, Berlatzky Y. The efficacy of Padma 28, a herbal preparation, in the treatment of intermittent claudication: a controlled double-blind pilot study with objective assessment of chronic occlusive arterial disease patients. Journal of Vascular Investigation 1998; 4(3): 129-136.]

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