Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2003; 8: 153
Herbal medicine is considered as completely ‘natural’ by its users and, for this reason, by definition, safe. However, many, even serious, adverse events have been reported (kava and acute hepatitis, just to cite one). In addition, several interactions between herbal remedies and synthetic drugs have been pointed out in recent years (such as hypericum and antiretroviral drugs, oral contraceptives and cyclosporin).
To increase knowledge on adverse events with herbal preparations we set up a pilot study to collect spontaneous reports.
The reporting form is similar to that used for spontaneous reporting of adverse drug events (which is mandatory in Italy). The information about the initiative was spread through journals of alternative and ‘conventional’ medicine, the Web (epidemiological sites) and the main medical associations. The reporting forms can be downloaded from the Web in PDF format (http://www.epicentro.iss.it) and then sent by fax to the National Institute of Health. The reports are analysed by a team of phytotherapists, pharmacologists and epidemiologists in order to establish the imputability of the reactions to the herbal product.
From April to August 2002 we received 22 reports. After a first analysis, this small sample has shown some interesting points: the interaction between Boswellia serrata (which has a specific action on arachidonic metabolites) and anticoagulants; a certain number of reports of allergic reactions to products containing propolis. In particular, the use of spray for children seems to be associated with a high incidence of dangerous and harmful effects.
