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FACT
Focus on Alternative and Complementary Therapies

Adverse events from herbal preparations

Firenzuoli F1, Menniti-Ippolito F2, Mazzanti G3, Bianchi A4, Raschetti R2
1Centre for Natural Medicine, S. Giuseppe Hospital, Empoli, Italy
2National Institute of Health (Istituto Superiore di Sanita), Rome, Italy
3Department of Pharmacology of Natural Substances and General Physiology, University ‘La Sapienza’, Rome, Italy
4COE, Barzio, Italy

Objective

In Italy phytotherapy is used by 4.8% of the adult population and 2.5% of children (data from a year 2000 survey). Adverse reactions to herbal medicine and possible interactions between herbal preparations and synthetic drugs have been pointed out in recent years. To improve knowledge on these events, we set up a pilot study in order to collect spontaneous reports.

Methods

The reporting form is similar to that in use for spontaneous reporting of adverse drug events. The reporting form can be downloaded from the website (http://www.epicentro.iss.it) in PDF format and completed forms sent to the National Institute of Health in Italy. The reports are analysed by a team of experts.

Results

From April 2002 to June 2003 the coordinating centre received 84 reports. Thirty-one percent of reported events were dermatological, 19% neurological, 19% gastrointestinal, 15% cardio-vascular. Ninety-seven products were involved: 25% herbal preparations, 13% integrators and 6% galenic preparations. Forty-eight per cent of reports were sent by hospital physicians, 23% from general practitioners and 14% from pharmacists. Many interesting findings were pointed out, among others: two reports of rhabdomyolysis, one probably due to a high dose intake of liquorice and one to guggul (Commiphora mukul), a natural lipid-lowering agent; six reports of allergic reactions of different kinds and severity to products containing propolis.

Conclusion

Products containing herbs are often used in Italy for therapeutic purposes as self-medication, with the wrong belief that ‘natural’ means ‘safe’. It is important to provide correct information to patients on safety of herbal preparations.

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