Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2006; 11: 12
In Europe, preparations from Harpagophyum procumbens have been used for more than 50 years in the treatment of osteoarthritic and low back pain. The Harpagophytum mechanism of action is broader than that of synthetic anti-inflammatory drugs involving inhibition of cyclo-oxygenase-2, lipoxygenase, cytokine release and elastase as well as anti-oxidative and chondroprotective effects (Phytomedicine 2004; 11: 691–5). The aim of the study was to review the safety of treatment with Harpagophyum preparations.
Ovid (Medline), Pubmed, Cochrane Collaboration Library (ab 1985) and manual search were used to identify any clinical trials investigating Harpagophyum products and preclinical toxicity. The authors extracted the data on safety independently and discussed disagreements.
Twenty-four clinical trials were identified. A total of 6778 patients have received various Harpagophyum products for up to 1 year in double-blind (n = 615) or observational trials that were mostly post-marketing surveillances (n = 6163). Minor adverse events (AE) were described in 19 studies (n = 4160) in a total of 125 patients. This corresponds to an overall adverse event rate of at least 3%. Few of the AEs (e.g. gastrointestinal complaints and allergies) were probably related to Harpagophytum. The three studies on pre-clinical toxicity indicated very low acute toxicity. Data on chronic toxicity, mutagenicity and carcinogenicity were not found.
Although it seems likely that the incidence of AEs during treatment with Harpagophyum products is very low and that serious AEs do not occur, the whole range of safety data is needed to assure the safety of Harpagophytum use since long-term treatments are recommended.
