Trial 1 (Diener et al, 2004): 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.
Trial 2 (Lipton et al, 2004): this was a double-blind, randomized and placebo-controlled multicenter trial in the USA and Germany with 245 migraine patients with and without aura. The patients were treated for 4 months twice daily with either placebo or 50 mg or 75 mg special butterbur. Maximum response was achieved after 3 months resulting in an attack reduction of 58% with the 2x75 mg dosing. This was statistically significant compared to the placebo response of 28%. The number of therapy responders was 71% after treatment with butterbur.
Trial 3 (Pothmann et al, 2005): 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.