Butterbur (Petasites hybridus) in prevention of migraine

The MHRA advised against the use of butterbur, and unlicensed butterbur products were withdrawn from the UK market in 2012 after reports of severe liver injury. Long-term use of butterbur may lead to reversible cholestatic hepatitis. (1)

There had previously been some evidence regarding the effectiveness of Petasites hybridus root (butterbur) as a prophylactic treatment for migraine:(2)

• 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
• 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
• main outcome measure was the decrease in migraine attack frequency per month calculated as percentage change from baseline over a 4-month treatment period
  • 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
  • most frequently reported adverse reactions considered possibly related to treatment were mild gastrointestinal events, predominantly burping
• the study authors concluded that 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

Reference:

1. D'Andrea G, Cevoli S, Cologno D. Herbal therapy in migraine. Neurol Sci. 2014 May;35 Suppl 1:135-40.
2. Lipton RB et al. Petasites hybridus root (butterbur) is an effective preventive treatment for migraine. Neurology 2004;63:2240-4