Effectiveness of high-dose riboflavin in migraine prophylaxis. A randomized controlled trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 9484373 · doi:10.1212/wnl.50.2.466
What was done
In a 3-month randomized controlled trial, 55 patients with migraine received either high-dose riboflavin (400 mg daily) or placebo. Efficacy was evaluated via intention-to-treat analysis for changes in attack frequency, headache days, 50% responder rates, and adverse events.
What was found
Riboflavin was superior to placebo in reducing attack frequency (p = 0.005) and headache days (p = 0.012). The proportion of patients achieving at least a 50% reduction in headache days was 59% with riboflavin compared to 15% with placebo (p = 0.002), corresponding to a number-needed-to-treat of 2.3. Minor adverse events were reported in three patients (diarrhea and polyuria with riboflavin; abdominal cramps with placebo), with no serious adverse events.
Why it matters
High-dose riboflavin provides a low-cost, well-tolerated, and effective non-pharmacologic option for migraine prophylaxis.
Limits
The study had a small sample size (n = 55) and a short follow-up duration of 3 months. It lacked an active comparator arm using an established prophylactic medication, and baseline migraine characteristics or long-term outcomes beyond 3 months were not reported.
Cited by
- supports High doses of vitamin B2 (riboflavin) can successfully treat or manage migraines.
- supports Clinical research shows that taking 400 milligrams of vitamin B2 (riboflavin) daily is beneficial for migraine sufferers.