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Update on the efficacy and safety of Petadolex®, a butterbur extract for migraine prophylaxis

Authors Prieto JM

Received 4 September 2013

Accepted for publication 25 November 2013

Published 10 March 2014 Volume 2014:4 Pages 1—9

DOI https://doi.org/10.2147/BTAT.S54023

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3


Jose M Prieto

Department of Pharmaceutical and Biological Chemistry, UCL School of Pharmacy, London, UK

Abstract: Migraine has a heavy socioeconomic impact in terms of lost productivity and burden on the health care system. The efficacy of current drug regimens in migraine prophylaxis is limited, and therapeutic alternatives are needed. These include a range of herbal medicines based on butterbur, feverfew, St John's wort, and Ginkgo. Of these, Petadolex®, an extract of the butterbur root, is the most promising. Petadolex® has been investigated in four studies, including one good quality clinical trial involving 202 patients, two randomized controlled trials with smaller cohorts including adults and children, and a large observational, open-label study. However, post-marketing surveillance only supports its safety at lower doses and over treatment durations shorter than those used in the clinical trials. Moreover, the long-term safety of the product has been called into question, leading to withdrawal in some European countries. This review draws an overall picture of this complex set of data. The safety and efficacy of Petadolex® remains a matter of debate by a number of clinical, regulatory, and professional bodies.

Keywords: Petasites hybridus, migraine, herbal medicine, clinical evidence, safety

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