Effectiveness of high-dose riboflavin in migraine prophylaxis. A randomized controlled trial

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#adolescent #adult #dose-response-relationship-drug #female #humans

Effectiveness of high-dose riboflavin in migraine prophylaxis. A randomized controlled trial

Schoenen et al., 1998 | Neurology | Rct

Citation

Schoenen J, Jacquy J, Lenaerts M. Effectiveness of high-dose riboflavin in migraine prophylaxis. A randomized controlled trial. Neurology. 1998-Feb;50(2):466-70

Abstract

A deficit of mitochondrial energy metabolism may play a role in migraine pathogenesis. We found in a previous open study that high-dose riboflavin was effective in migraine prophylaxis. We now compared riboflavin (400 mg) and placebo in 55 patients with migraine in a randomized trial of 3 months duration. Using an intention-to-treat analysis, riboflavin was superior to placebo in reducing attack frequency (p = 0.005) and headache days (p = 0.012). Regarding the latter, the proportion of patients who improved by at least 50%, i.e. "responders," was 15% for placebo and 59% for riboflavin (p = 0.002) and the number-needed-to-treat for effectiveness was 2.3. Three minor adverse events occurred, two in the riboflavin group (diarrhea and polyuria) and one in the placebo group (abdominal cramps). None was serious. Because of its high efficacy, excellent tolerability, and low cost, riboflavin is an interesting option for migraine prophylaxis and a candidate for a comparative trial with an established prophylactic drug.

Key Findings

Because of its high efficacy, excellent tolerability, and low cost, riboflavin is an interesting option for migraine prophylaxis and a candidate for a comparative trial with an established prophylactic drug.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population migraine in a randomized
Sample Size 55
Age Range See abstract
Condition See abstract

MeSH Terms

  • Adolescent
  • Adult
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Middle Aged
  • Migraine Disorders
  • Placebos
  • Riboflavin
  • Severity of Illness Index
  • Time Factors

Evidence Classification

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

Provenance

  • PMID: 9484373
  • 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