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Randomized Controlled Trial Clinical Trial
High-dose riboflavin for migraine prophylaxis in children: a double-blind, randomized, placebo-controlled trial.
- Suzanna C MacLennan, Fiona M Wade, Katharine M L Forrest, Pyara D Ratanayake, Elizabeth Fagan, and Jayne Antony.
- Neurology Department, Women's and Children's Hospital, North Adelaide, South Australia, Australia. suzanna.thompson@cywhs.sa.gov.au
- J. Child Neurol. 2008 Nov 1; 23 (11): 1300-4.
AbstractThis is the first study to evaluate the efficacy of riboflavin for migraine prophylaxis in children. This was a randomized, double-blind study of riboflavin (200 mg daily) versus placebo in 48 children. The primary efficacy measure was the number of patients achieving a 50% or greater reduction in the number of migraine attacks per 4 weeks. Other outcome measures were the mean severity of migraine per day, mean duration of migraine, days with nausea or vomiting, analgesic use, and adverse effects. A 50% or greater reduction in headaches was seen in 14/21 patients in the placebo group and 12/27 patients in the riboflavin group (not significant P = .125). There were no differences between riboflavin and placebo for primary or secondary outcome variables. These results suggest that riboflavin is not an effective therapy for preventing migraine in children. A high placebo responder rate was seen, with implications for other studies of migraine in children.
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