A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial

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A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial

Maizels et al., 2004 | Headache | Rct

Citation

Maizels Morris, Blumenfeld Andrew, Burchette Raoul. A combination of riboflavin, magnesium, and feverfew for migraine prophylaxis: a randomized trial. Headache. 2004-Oct;44(9):885-90

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.

Key Findings

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,

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size 120
Age Range See abstract
Condition See abstract

MeSH Terms

  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Magnesium
  • Male
  • Migraine Disorders
  • Phytotherapy
  • Plant Preparations
  • Riboflavin
  • Tanacetum parthenium
  • Treatment Outcome

Evidence Classification

  • Level: Rct
  • Publication Types: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial
  • Vertical: riboflavin

Provenance

  • PMID: 15447697
  • DOI: (not available)
  • PMCID: Not in PMC
  • Verified: 2026-04-10 via PubMed E-utilities API

Source extracted via PubMed E-utilities API on 2026-04-10