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
[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.]