Riboflavin may be an effective therapy for the prevention of migraine headaches in some adults, according to a new review published in the Journal of Clinical Pharmacy and Therapeutics.
To better understand the safety and effectiveness of riboflavin, an extensive literature search was conducted for relevant studies that included trials of riboflavin in the prophylactic treatment of migraine headache. Eleven clinical trials were used for the basis of this review which provided mixed results on therapeutic effect.
One study, which included 55 adult patients, compared riboflavin 400mg/day to placebo for 3 months. Results showed a significant difference in attack frequency (P<0.0001) and number of attack days (P<0.0001) between the two groups. The study was deemed ‘Class I’ by the American Academy of Neurology rating system, the only Class I study involving adult subjects in the review.
A Class II study, comparing riboflavin 400mg/day to sodium valproate 500mg/day found that both treatments reduced headache severity, frequency and duration (reduction in number of headaches/month: riboflavin: 9.2±6.2 to 2.4±1.6; sodium valproate: 6.5±3.1 to 2.1±1.0), demonstrating non-inferiority of riboflavin to sodium valproate. In addition, the riboflavin arm experienced less adverse effects (P=0.005).
Other lower Class studies found that riboflavin was associated with a decrease in migraine frequency (Boehnke et al. 2004; Shoenen et al. 1994; Nambiar et al. 2011).
Evidence was weaker in studies that assessed riboflavin in children with migraines. A double-blind, placebo-controlled trial (MacLennon et al. 2008) of 48 migraine patients aged 5 to 15 found that 66.6% of the placebo group, and 44.4% of the riboflavin 200mg/day group, had a reduction of 50% in migraine frequency. Another trial, this time involving 42 children 6–13 years old, found that a reduction in mean frequency was not statistically significant for riboflavin compared to placebo (3.60 migraines/month to 2.05 migraines/month for riboflavin vs. 3.05 migraines/month to 1.4 migraines/month for placebo).
Moreover, there are still questions about what constitutes a therapeutic dose as limited information suggests that only a maximum of 27mg of riboflavin can be absorbed from a single dose. However, in clinical trials, doses ranged from 50–400mg, substantially higher than the amount found in vitamin supplements. More studies are needed to determine whether higher doses actually impart greater benefits.
The authors concluded that for adult prophylaxis, riboflavin “is well tolerated, inexpensive and most controlled clinical trials have shown modest reductions in migraine headache frequency.” In children and adolescents, however, the results are still inconclusive.
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