AlexanderMauskop, Director, New York Headache Centerdrmauskop@nyheadache.com
New York, NY
Submitted July 25, 2012
The guidelines for the prophylactic treatment of episodic migraines consider Petasites (butterbur) to have "established efficacy". [1] The first of two studies of butterbur involved 60 patients and 100 mg of butterbur. [2] Review of that study's data concluded that "The original protocol and analysis had a number of major shortcomings." [3] The second study, in which this author participated, involved 245 patients and showed a daily dose of 100 mg of butterbur extract to be ineffective, while 150 mg was effective.[4] However, the main concern is not efficacy, but safety. The butterbur extract used in these clinical trials has since been reformulated and is no longer available in Germany, where it is manufactured. Unlike the US, Germany regulates herbal products and requires them to undergo teratogenicity and carcinogenicity studies. The original butterbur extract did pass those tests, but the manufacturer did not repeat them for the new formulation. Butterbur contains pyrrolizidine alkaloids, which are hepatotoxic and carcinogenic. In view of the lack of regulation of herbal products in the US and because of the potential for serious toxicity, none of the butterbur extracts, including the one manufactured in Germany, can be safely recommended to our migraine patients.
1. Holland S, Silberstein SD, Freitag F, Dodick DW,Argoff C, Ashman
E. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults.
Neurology2012;78:1346-1353.
2. Grossman W, Schmidramsl H. An extract of Petasites hybridus is
effective in the prophylaxis of migraine. Altern Med Rev 2001;6:303-310.
3. Diener, H.C., Rahlfs, V.W., Danesch, U. The first placebo-controlled
trial of a special butterbur root extract for the prevention of migraine:
reanalysis of efficacy criteria. Eur. Neurol. 2004;51:89-97.
4. Lipton RB, Gobel H, Einhaupl KM, Wilks K, Mauskop A.Petasites hybridus
root (butterbur) is an effective preventive treatment for migraine.
Neurology 2004; 63: 2240- 2244.
For disclosures contact the editorial office at journal
@neurology.org.
The guidelines for the prophylactic treatment of episodic migraines consider Petasites (butterbur) to have "established efficacy". [1] The first of two studies of butterbur involved 60 patients and 100 mg of butterbur. [2] Review of that study's data concluded that "The original protocol and analysis had a number of major shortcomings." [3] The second study, in which this author participated, involved 245 patients and showed a daily dose of 100 mg of butterbur extract to be ineffective, while 150 mg was effective.[4] However, the main concern is not efficacy, but safety. The butterbur extract used in these clinical trials has since been reformulated and is no longer available in Germany, where it is manufactured. Unlike the US, Germany regulates herbal products and requires them to undergo teratogenicity and carcinogenicity studies. The original butterbur extract did pass those tests, but the manufacturer did not repeat them for the new formulation. Butterbur contains pyrrolizidine alkaloids, which are hepatotoxic and carcinogenic. In view of the lack of regulation of herbal products in the US and because of the potential for serious toxicity, none of the butterbur extracts, including the one manufactured in Germany, can be safely recommended to our migraine patients.
1. Holland S, Silberstein SD, Freitag F, Dodick DW,Argoff C, Ashman E. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults. Neurology2012;78:1346-1353.
2. Grossman W, Schmidramsl H. An extract of Petasites hybridus is effective in the prophylaxis of migraine. Altern Med Rev 2001;6:303-310.
3. Diener, H.C., Rahlfs, V.W., Danesch, U. The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: reanalysis of efficacy criteria. Eur. Neurol. 2004;51:89-97.
4. Lipton RB, Gobel H, Einhaupl KM, Wilks K, Mauskop A.Petasites hybridus root (butterbur) is an effective preventive treatment for migraine. Neurology 2004; 63: 2240- 2244.
For disclosures contact the editorial office at journal @neurology.org.