EFFECTIVENESS OF HIGH-DOSE RIBOFLAVIN IN MIGRAINE PROPHYLAXIS - A RANDOMIZED CONTROLLED TRIAL

A deficit of mitochondrial energy metabolism may play a role in migrai ne pathogenesis. We found in a previous open study that high-dose ribo flavin was effective in migraine prophylaxis. We now compared riboflav in (400 mg) and placebo in 55 patients with migraine in a randomized t rial of 3 months duration. Using an intention-to-treat analysis, ribof lavin was superior to placebo in reducing attack frequency (p = 0.005) and headache days (p = 0.012). Regarding the latter, the proportion o f 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-t o-treat for effectiveness was 2.3. Three minor adverse events occurred , two in the riboflavin group (diarrhea and polyuria) and one in the p lacebo group (abdominal cramps). None was serious. Because of its high efficacy, excellent tolerability, and low cost, riboflavin is an inte resting option for migraine prophylaxis and a candidate for a comparat ive trial with an established prophylactic drug.