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Safety implications regarding use of phytomedicines.

Cuzzolin L, Zaffani S, Benoni G

Department of Medicine & Public Health - Section of Pharmacology, University of Verona, Policlinico G.B. Rossi, 37134, Verona, Italy, laura.cuzzolin@univr.it.

OBJECTIVE: Since the approach of the general population to phytomedicine is that the therapy therapy is natural and therefore safe, the aim of this study was to investigate the relationship between the use of herbal compounds, alone or in combination with traditional drugs, and the appearance of side-effects among a sample of Italian women. METHODS: Our research was conducted over a 5-month period in the outpatient ambulatories of an urban university general hospital. The sample population consisted of women who were interviewed about phytotherapy use on the basis of a pre-structured questionnaire. RESULTS: Among 1,063 women contacted, 1,044 completed the interview and 491 (47%) reported taking at least one herbal compound in the last year; 272 women (55.4%) consumed only phytomedicines, while 219 (44.6%) also took traditional drugs. Seventy-three different herbal products were used, 32 were consumed in association with traditional drugs. Forty-seven of 491 (9.6%) women reported side-effects, 22 after taking only phytomedicines (8.1%), 25 in combination with traditional drugs (11.4%). The observed adverse manifestations included the following: gastrointestinal after dandelion, propolis or fennel; cardiovascular after liquorice, ginseng, and green tea; dermatological after propolis, thyme, arnica, and passionflower; and neurological after guarana and liquorice. Drugs taken in association and potentially involved in adverse reactions were NSAIDs, antibiotics, benzodiazepines, antihypertensives and oral contraceptives. In some cases (n=5), side-effects were so serious to justify an admission to the hospital. In 29/47 of cases (61.7%), the adverse reaction was not communicated to the doctor. CONCLUSIONS: Our data confirm that herbal products are largely taken on a self-treatment basis, and users have the convinction that these therapies are natural and therefore safe.

Published 17 January 2006 in Eur J Clin Pharmacol, 62(1): 37-42.
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