Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2004; 9: 30–1
To assess the efficacy and safety of the Tibetan herbal medicinal product Padma 28 in patients with peripheral arterial disease (PAD).
Data sources for a meta-analysis were electronic databases from inception to June 2003, reference lists from published trials, experts in the field and the manufacturer. Eligible studies were controlled or randomised placebo-controlled trials on patients with PAD. The manufacturer provided the raw data of these studies, which were reanalysed and then pooled for meta-analysis.
The review identified Padma 28 as a descriptor in 22 clinical trials. Seven papers dealt with PAD (n = 444) and six papers met the inclusion criteria. After 4 months patients in the treatment group (n = 201) showed an increase of the maximum treadmill walking distance by 100 m or more compared to placebo (n = 192) [23.5% verum (mean 92.7 ± 118.5 m) vs. 2.1% placebo (mean 21.2 ± 85.9m); P < 0.001, OR 14.3, 95% CI 5.1–40.6]. None of the four serious adverse events could be related to verum. Adverse events were not significantly different between verum and placebo.
The meta-analysis indicated that Padma 28 significantly increases walking distance in patients with stable PAD Fontaine stage IIb. The mechanisms of action have not been elucidated but clinical and pharmacological data suggest, for example, an inhibition of reactive oxygen species and anti-inflammatory activity as the most likely mechanisms.
This study was in part supported by a grant from PADMA AG, Schwerzenbach, Switzerland.
