High-dose riboflavin for migraine prophylaxis in children: a double-blind, randomized, placebo-controlled trial.
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.
MacLennan
Suzanna C
SC
Neurology Department, Women's and Children's Hospital, North Adelaide, South Australia, Australia. suzanna.thompson@cywhs.sa.gov.au
Wade
Fiona M
FM
Forrest
Katharine M L
KM
Ratanayake
Pyara D
PD
Fagan
Elizabeth
E
Antony
Jayne
J
D000293:Adolescent; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000517:prevention & control*; D011446:Prospective Studies; D012189:Retrospective Studies; D012256:Riboflavin / Q000627:therapeutic use*; D014803:Vitamin B Complex / Q000627:therapeutic use*
D014803:Vitamin B Complex; D012256:Riboflavin