The First Placebo-Controlled Trial of a Special Butterbur Root Extract for the Prevention of Migraine: Reanalysis of Efficacy CriteriaDiener H.C.a · Rahlfs V.W.b · Danesch U.c
aDepartment of Neurology, University of Essen, Essen, bidv Data Analysis and Study Planning, Gauting, and cWeber & Weber GmbH, Inning, Germany
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This is an independent reanalysis of a randomised, placebo-controlled parallel-group study on the efficacy and tolerability of a special butterbur root extract (Petadolex®) for the prophylaxis of migraine. The original protocol and analysis had a number of major shortcomings. In order to follow regulatory requirements, an independent reanalysis of the original data was performed. Following a 4-week baseline phase, 33 patients were randomised to treatment with two capsules 25 mg butterbur twice a day and 27 to placebo. The mean attack frequency per month decreased from 3.4 at baseline to 1.8 after 3 months (p = 0.0024) in the verum group and from 2.9 to 2.6 in the placebo group (n.s.). The responder rate (improvement of migraine frequency ≧50%) was 45% in the verum group and 15% in the placebo group. Butterbur was well tolerated. This small trial indicates that butterbur may be effective in the prophylaxis of migraine.
© 2004 S. Karger AG, Basel
- Grossmann M, Schmidramsl H: An extract of Petasites hybridus is effective in the prophylaxis of migraine. Int J Clin Pharmacol Ther 2000;38:430–435.
Headache Classification Committee of the International Headache Society: Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Cephalalgia 1988;8(suppl 7):1–93.
- Tfelt-Hansen P, Block G, Dahlof C, Diener HC, Ferrari MD, Goadsby PJ, Guidetti V, Jones B, Lipton RB, Massiou H, Meinert C, Sandrini G, Steiner T, Winter PB, for the International Headache Society Clinical Trials Subcommittee: Guidelines for controlled trials of drugs in migraine: Second edition. Cephalalgia 2000;20:765–786.
Wei LJ, Lachin JM: Two-sample asymptotically distribution-free tests for incomplete multivariate observations. J Am Stat Assoc 1984;79:653–661.
Thall PF, Lachin JM: Analysis of recurrent events: Nonparametric methods for random interval count data. J Am Assoc 1988;83:339–347.
- Lachin JM: Some large-sample distribution-free estimators and tests for multivariate partially incomplete data from two populations. Stat Med 1992;11:1151–1170.
- Colditz GA, Miller JN, Mosteller F: Measuring gain in the evaluation of medical technology: The probability of a better outcome. Int J Technol Assess Health Care 1988;4:637–642.
- Ziolo G, Samochewiec L: Study on clinical properties and mechanism of action of Petasites in bronchial asthma and chronic obstructive bronchitis. Pharm Acta Helv 1998;72:359–380.
Aebi A, Buechi J, Waaler T, Eichenberger E, Schmutz J: Inhaltsstoffe von Petasites hybridus (L) Fl Wett I. Pharm Acta Helv 1955;29:277–279.
Bucher K: Über ein antispastisches Prinzip in Petasites officinalis Moench. Arch Exp Pathol Pharmakol 1951;213:69–71.
- Ko W, Lei C, Lin Y, Chen C: Relaxant effects of petasins in isolated guinea pig trachea and their structure-activity relationships. Planta Med 2000;66:650–652.
- Thomet OA, Wiesmann UN, Blaser K, Simon HU: Differential inhibition of inflammatory effector functions by petasin, isopetasin and neopetasin in human eosinophils. Clin Exp Allergy 2001;31:1310–1320.
- Brune K, Bickel D, Peskar BA: Gastro-protective effects by extracts of Petasites hybridus: The role of inhibition of peptido-leukotriene synthesis. Planta Med 1993;59:494–496.
- Scheidegger C, Dahinden C, Wiesmann U: Effects of extracts of individual components from Petasites on prostaglandin synthesis in cultured skin fibroblasts and on leucotriene synthesis in isolated human peripheral leucocytes. Pharm Acta Helv 1998;72:359–380.
- Thomet OA, Wiesmann UN, Schapowal A, Bizer C, Simon H: Role of petasin in the potential anti-inflammatory activity of a plant extract of Petasites hybridus. Biochem Pharmacol 2001;61:1041–1047.
- Ko W, Lei C, Lin Y, Chen C: Mechanisms of relaxant action of S-petasine and S-isopetasin, sesquiterpenes of Petasites formosanus, in isolated guinea pig trachea. Planta Med 2001:67:224–229.
- Wang G-J, Shum AY-C, Lin Y-L, Liao J-F, Wu X-C, Ren J, et al: Calcium channel blockade in vascular smooth muscle cells: Major hypotensive mechanism of S-petasine, a hypotensive sesquiterpene from Petasites formosanus. J Pharm Exp Ther 2001;297:240–246.
Lipton RB, Göbel H, Wilks K, Mauskop A: Efficacy of petasites (an extract from Petasites rhizoma) 50 and 75 mg for prophylaxis of migraine: Results of a randomized, double-blind, placebo-controlled study. Neurology 2002;58(suppl 3):A472.
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