Petasites hybridus root (butterbur) is an effective preventive treatment for migraine.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 15623680 · doi:10.1212/01.wnl.0000147290.68260.11
What was done
A three-arm, parallel-group randomized trial evaluated the efficacy of standardized Petasites hybridus (butterbur) root extract for migraine prevention in 245 patients aged 18 to 65 with two to six attacks per month. Participants were randomized to receive Petasites extract 75 mg twice daily, Petasites extract 50 mg twice daily, or placebo twice daily for 4 months. The primary outcome was the percentage change from baseline in migraine attack frequency per month.
What was found
In the per-protocol analysis over 4 months, migraine attack frequency was reduced by 48% with Petasites 75 mg bid (p = 0.0012 vs placebo), 36% with Petasites 50 mg bid (p = 0.127 vs placebo), and 26% with placebo. A 50% or greater reduction in attack frequency occurred in 68% of the 75 mg arm compared to 49% of the placebo arm (p < 0.05). Petasites 50 mg bid did not significantly differ from placebo on primary endpoints. The most frequent treatment-related adverse reactions were mild gastrointestinal events, predominantly burping.
Why it matters
This trial provides randomized evidence that standardized butterbur root extract at 75 mg twice daily is an effective non-pharmaceutical preventive option for reducing migraine attack frequency.
Limits
The reported primary outcomes are from a per-protocol analysis rather than intention-to-treat, which can introduce attrition bias. The trial followed patients for only 4 months, and the lower dose (50 mg bid) failed to achieve statistically significant separation from placebo.
Cited by
- supports Butterbur herb is supported by solid research as an effective remedy for migraine headaches.
- supports Pyrrolizidine alkaloid-free butterbur herb provides significant relief for migraines.