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A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial.
Headache 2004; 44(9):885-90H

Abstract

OBJECTIVE

To determine the efficacy for migraine prophylaxis of a compound containing a combination of riboflavin, magnesium, and feverfew.

BACKGROUND

Previous studies of magnesium and feverfew for migraine prophylaxis have found conflicting results, and there has been only a single placebo-controlled trial of riboflavin.

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 patients had completed the trial.

RESULTS

Forty-nine patients completed the 3-month trial. For the primary outcome measure, a 50% or greater reduction in migraines, there was no difference between active and "placebo" groups, achieved by 10 (42%) and 11 (44%), respectively (P=.87). Similarly, there was no significant difference in secondary outcome measures, for active versus placebo groups, respectively: 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 reduction in number of migraines, migraine days, and migraine index. This effect exceeds that reported for placebo agents in previous migraine trials.

CONCLUSION

Riboflavin 25 mg showed an effect comparable to a combination of riboflavin 400 mg, magnesium 300 mg, and feverfew 100 mg. The placebo response exceeds that reported 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 scientific evidence with regard to the efficacy of these compounds for migraine prophylaxis.

Authors+Show Affiliations

Kaiser Permanente, Family Practice, Woodland Hills, CA, USA.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15447697

Citation

Maizels, Morris, et al. "A Combination of Riboflavin, Magnesium, and Feverfew for Migraine Prophylaxis: a Randomized Trial." Headache, vol. 44, no. 9, 2004, pp. 885-90.
Maizels M, Blumenfeld A, Burchette R. A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial. Headache. 2004;44(9):885-90.
Maizels, M., Blumenfeld, A., & Burchette, R. (2004). A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial. Headache, 44(9), pp. 885-90.
Maizels M, Blumenfeld A, Burchette R. A Combination of Riboflavin, Magnesium, and Feverfew for Migraine Prophylaxis: a Randomized Trial. Headache. 2004;44(9):885-90. PubMed PMID: 15447697.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial. AU - Maizels,Morris, AU - Blumenfeld,Andrew, AU - Burchette,Raoul, PY - 2004/9/28/pubmed PY - 2005/1/28/medline PY - 2004/9/28/entrez SP - 885 EP - 90 JF - Headache JO - Headache VL - 44 IS - 9 N2 - OBJECTIVE: To determine the efficacy for migraine prophylaxis of a compound containing a combination of riboflavin, magnesium, and feverfew. BACKGROUND: Previous studies of magnesium and feverfew for migraine prophylaxis have found conflicting results, and there has been only a single placebo-controlled trial of riboflavin. 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 patients had completed the trial. RESULTS: Forty-nine patients completed the 3-month trial. For the primary outcome measure, a 50% or greater reduction in migraines, there was no difference between active and "placebo" groups, achieved by 10 (42%) and 11 (44%), respectively (P=.87). Similarly, there was no significant difference in secondary outcome measures, for active versus placebo groups, respectively: 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 reduction in number of migraines, migraine days, and migraine index. This effect exceeds that reported for placebo agents in previous migraine trials. CONCLUSION: Riboflavin 25 mg showed an effect comparable to a combination of riboflavin 400 mg, magnesium 300 mg, and feverfew 100 mg. The placebo response exceeds that reported 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 scientific evidence with regard to the efficacy of these compounds for migraine prophylaxis. SN - 0017-8748 UR - https://www.unboundmedicine.com/medline/citation/15447697/A_combination_of_riboflavin_magnesium_and_feverfew_for_migraine_prophylaxis:_a_randomized_trial_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0017-8748&date=2004&volume=44&issue=9&spage=885 DB - PRIME DP - Unbound Medicine ER -