title: Efficacy and safety of 6.25 mg t.i.d. feverfew CO2-extract (MIG-99) in migraine prevention--a randomized, double-blind, multicentre, placebo-controlled study.
abstract: The efficacy and tolerability of a CO(2)-extract of feverfew (MIG-99, 6.25 mg t.i.d.) for migraine prevention were investigated in a randomized, double-blind, placebo-controlled, multicentre, parallel-group study. Patients (N = 170 intention-to-treat; MIG-99, N = 89; placebo, N = 81) suffering from migraine according to International Headache Society criteria were treated for 16 weeks after a 4-week baseline period. The primary endpoint was the average number of migraine attacks per 28 days during the treatment months 2 and 3 compared with baseline. Safety parameters included adverse events, laboratory parameters, vital signs and physical examination. The migraine frequency decreased from 4.76 by 1.9 attacks per month in the MIG-99 group and by 1.3 attacks in the placebo group (P = 0.0456). Logistic regression of responder rates showed an odds ratio of 3.4 in favour of MIG-99 (P = 0.0049). Adverse events possibly related to study medication were 9/107 (8.4%) with MIG-99 and 11/108 (10.2%) with placebo (P = 0.654). MIG-99 is effective and shows a favourable benefit-risk ratio.
authors.affiliation: Neurologische Universitätsklinik, Essen, Germany. h.diener@uni-essen.de
authors.forename: H C
authors.initials: HC
authors.lastname: Diener
authors.forename: V
authors.initials: V
authors.lastname: Pfaffenrath
authors.forename: J
authors.initials: J
authors.lastname: Schnitker
authors.forename: M
authors.initials: M
authors.lastname: Friede
authors.forename: H-H
authors.initials: HH
authors.lastname: Henneicke-von Zepelin
mesh_terms: D000293:Adolescent; D000328:Adult; D002245:Carbon Dioxide; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D008517:Phytotherapy / Q000009:adverse effects*; D010936:Plant Extracts / Q000009:adverse effects; D020903:Tanacetum parthenium / Q000009:adverse effects*
chemical_list: D010936:Plant Extracts; D002245:Carbon Dioxide