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Butterbur Clinical Studies

Neurology. 2004 Dec 28;63(12):2240-4.  

Petasites hybridus root (butterbur) is an effective preventive treatment for migraine.

Lipton RB, Gobel H, Einhaupl KM, Wilks K, Mauskop A.

Department of Neurology, Albert Einstein College of Medicine

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 > or =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.

Eur Neurol. 2004;51(2):89-97. Epub 2004 Jan 28.

The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: reanalysis of efficacy criteria.

Diener HC, Rahlfs VW, Danesch U

Department of Neurology, University of Essen, Hufelandstrasse 55, DE-45122 Essen, Germany.

In this first randomised, double-blind and placebo-controlled monocenter trial 60 migraineurs between 18 and 60 years of age were treated twice daily with placebo or 50 mg of the special butterbur extract for a total of 12 weeks. Migraine attacks could maximally be reduced by 52%. After two months 66% of all patients experienced an attack reduction of at least 50% (therapy responders). Additionally, the number of patients, requiring acute pain medication was reduced by more than half in the butterbur group.

Headache. 2005 Mar;45(3):196-203. 

Migraine prevention in children and adolescents: results of an open study with a special butterbur root extract.

Pothmann R, Danesch U

Klinikum Heidberg, Zentrum fur Kinderschmerztherapie, Hamburg, Germany.

29 children, 6 to 9 years old, and 79 adolescents, 10 to 17 years old with severe migraine were treated with butterbur for four months in a multicenter setting. The dosing depended on the age of the patients and ranged from 25 mg to 150 mg of the special butterbur extract. The treatment resulted in a decrease of attack frequency from 9,4 attacks (6-9 years) and 9,7 attacks (10-17 years) at the beginning of the study to 4,0 attacks (6-9 years) and 5,8 attacks (10-17 years) after treatment. Altogether, 85,7% of the children and 74,1% of the adolescents had reduced their migraine attacks by at least 50%. 10% of adolescents have periodic migraines - often misdiagnosed. No triptan has FDA approval for treatment of children or adolescents.  Each clinical trial demonstrates that the special butterbur extract could significantly reduce migraine attacks. Also, more than two thirds of all patients experienced a reduction of migraine attacks of 50% or greater.