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High-Dose Ribof lavin for Migraine Prophylaxis in Children: A Double-Blind, Randomized, Placebo-Controlled Trial

Neurology Department, Women's and Children's Hospital, North Adelaide, South Australia, and TY Nelson Department of Neurology and Neurosurgery, The Children's Hospital at Westmead, Westmead, New South Wales, Australia, suzanna.thompson{at}cywhs.sa.gov.au

Fiona M. Wade, RN

TY Nelson Department of Neurology and Neurosurgery, The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Katharine M. L. Forrest, MRCPCH

TY Nelson Department of Neurology and Neurosurgery, The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Pyara D. Ratanayake, MD

TY Nelson Department of Neurology and Neurosurgery, The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Elizabeth Fagan, MBBS

TY Nelson Department of Neurology and Neurosurgery, The Children's Hospital at Westmead, Westmead, New South Wales, Australia

Jayne Antony, PhD

TY Nelson Department of Neurology and Neurosurgery, The Children's Hospital at Westmead, Westmead, New South Wales, Australia

This 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.

Key Words: randomized controlled trial • migraine

Journal of Child Neurology, Vol. 23, No. 11, 1300-1304 (2008)
DOI: 10.1177/0883073808318053


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