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From the Departments of Neurology and Epidemiology and Population Health (Dr. Lipton), Albert Einstein College of Medicine, Bronx, and New York Headache Center (Dr. Mauskop), New York, NY, and Innovative Medical Research, a Division of Advance PCS, Baltimore, MD; and Pain Clinic and Christian Albrechts University Kiel (Dr. Göbel) and Charite (Dr. Einhäupl), Department of Neurology, Humboldt University Berlin, Germany.
Address correspondence and reprint requests to Dr. R.B. Lipton, Albert Einstein College of Medicine, 1165 Morris Park Ave., Rousso Bldg., Rm. 332, Bronx, NY 10461; e-mail: rlipton{at}aecom.yu.edu
Objective: To evaluate the clinical efficacy of a standardized special root extract from the plant Petasites hybridus as a preventive therapy for migraine.
Methods: This is a three-arm, parallel-group, randomized trial comparing Petasites extract 75 mg bid, Petasites extract 50 mg bid, or placebo bid in 245 patients with migraine. Eligible patients met International Headache Society criteria for migraine, were ages 18 to 65, and had at least two to six attacks per month over the preceding 3 months. The main outcome measure was the decrease in migraine attack frequency per month calculated as percentage change from baseline over a 4-month treatment period.
Results: Over 4 months of treatment, in the per-protocol analysis, migraine attack frequency was reduced by 48% for Petasites extract 75 mg bid (p = 0.0012 vs placebo), 36% for Petasites extract 50 mg bid (p = 0.127 vs placebo), and 26% for the placebo group. The proportion of patients with a 
50% reduction in attack frequency after 4 months was 68% for patients in the Petasites extract 75-mg arm and 49% for the placebo arm (p < 0.05). Results were also significant in favor of Petasites 75 mg at 1, 2, and 3 months based on this endpoint. The most frequently reported adverse reactions considered possibly related to treatment were mild gastrointestinal events, predominantly burping.
Conclusions: Petasites extract 75 mg bid is more effective than placebo and is well tolerated as a preventive therapy for migraine. Petasites 50 mg PO bid was not significantly more effective than placebo on the primary study endpoints.
Received December 4, 2003. Accepted in final form August 2, 2004.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the December 28 issue to find the title link for this article.
Drs. Lipton and Göbel are consultants for Weber & Weber GmbH & Co. KG, Biologische Arzneimittel, Germany, and have received honoraria under $10,000.
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