The effect of Tibetan herbal mixture (Padma 28) on walking distance in stable intermittent claudication

QUESTION: Evaluation of possible favorable effects of the herbal preparation Padma 28 on the walking distance in patients with stable intermittent claudication. STUDY DESIGN: Randomized, double-blind comparative study of the effective herbal preparation and a placebo treatment. PATIENTS: Eighty-six patients were in the order in which they visited our clinic because of intermittent claudication on an outpatient basis, a screening subject. Forty of these patients met the criteria of the study protocol. These patients had a median age of 67 years, suffered a median of 5 years of intermittent claudication, and at entry into the study their condition was clinically stable. Thirty-six patients completed the protocol corresponding part to the end of the study. INTERVENTION: The group who were randomized assigned to the active treatment received 2 capsules 2 times daily with 340 mg of the dried herbal preparation (Padma 28). The other group received placebo capsules. The treatment was carried out for 4 months. MAIN OUTCOME MEASURE: Main outcome measure was the change in maximum walking distance on a treadmill. The pain-free walking distance was measured as well as the systemic and peripheral systolic blood pressure. The ratio of the systolic blood pressure from the ankle to the upper arm was calculated. Measurements were carried out before treatment and monthly during the treatment. RESULTS: The patients with active treatment achieved compared to the placebo group, a significant prolongation of both pain-free and maximum walking distance. After a month of active treatment, the maximum walking distance was prolonged in the patients of this group significantly from 115 m (72-218 m) to 227 m (73-> 1000 m, p <0.001), this extension study continued to the end. In the placebo group no significant change in maximum walking distance entered. Neither the verum or the placebo treatment, we were able to demonstrate significant changes in the ratio of systolic blood pressure. CONCLUSION: A 4-month treatment with the herbal preparation Padma 28 leads in patients with already long-standing, stable intermittent claudication in a significant increase in walk distance.