Objective. To determine the efficacy for migraine prophylaxis of a compound containing a combination of riboflavin, magnesium, and feverfew. Background. P revious studies of magnesium and feverfew for migraine prophylaxis have found co nflicting results, and there has been only a single placebocontrolled trial of r iboflavin. Design/Methods. Randomized double blind placebo controlled trial of a compound providing a daily dose of riboflavin 400 mg, magnesium 300 mg, and feverfew 100 mg. The placebo contained 25 mg riboflavin. The study included a 1 month run in phase and 3 month trial. The protocol allowed for 120 patients to be randomized, with a preplanned interim analysis of the data after 48 patien ts had completed the trial. Results. Forty nine patients completed the 3 mon th trial. For the primary outcome measure, a 50%or greater reduction in migrain es, there was no difference between active and “placebo”groups, achieved by 10 (42%) and 11 (44%), respectively (P = .87). Similarly, there was no significa nt difference in secondary outcome measures, for active versus placebo groups, r espectively: 50%or greater reduction in migraine days (33%and 40%, P = .63); or change in mean number of migraines, migraine days, migraine index, or triptan doses. Compared to baseline, however, both groups showed a significant reductio n in number of migraines, migraine days, and migraine index. This effect exceeds that reported for placebo agents in previous migraine trials. Conclusion. Rib oflavin 25 mg showed an effect comparable to a combi nation of riboflavin 400 m g, magnesium 300 mg, and feverfew 100 mg. The placebo response exceeds that repo rted for any other placebo in trials of migraine prophylaxis, and suggests that riboflavin 25 mg may be an active comparator. There is at present conflicting sc ientific evidence with regard to the efficacy of these compounds for migraine pr ophylaxis.
展开▼
