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High-dose riboflavin for migraine prophylaxis in children: a double-blind, randomized, placebo-controlled trial
Suzanna C MacLennan1, Fiona M Wade, Katharine M L Forrest
1Neurology Department, Women's and Children's Hospital, North Adelaide, South Australia, Australia. suzanna.thompson@cywhs.sa.gov.au
Insights
Riboflavin (200 mg daily) did not effectively prevent migraines in children compared to placebo. This study found no significant difference in migraine reduction, highlighting a high placebo response rate in pediatric migraine research.
Area of Science:
- Neurology
- Pediatrics
- Clinical Pharmacology
Background:
- Migraine is a common neurological disorder in children.
- Preventive treatments for pediatric migraine are limited.
- Riboflavin (vitamin B2) has shown potential for migraine prophylaxis in adults.
Purpose of the Study:
- To evaluate the efficacy of daily riboflavin supplementation for migraine prevention in children.
- To compare riboflavin's effectiveness against a placebo in a pediatric population.
- To assess secondary outcomes including migraine severity, duration, and associated symptoms.
Main Methods:
- A randomized, double-blind, placebo-controlled study.
- Involved 48 children diagnosed with migraine.
- Participants received either 200 mg of riboflavin daily or a placebo for the study duration.
Main Results:
- No statistically significant difference was observed in the primary outcome (≥50% reduction in migraine attacks per 4 weeks) between the riboflavin and placebo groups (P = .125).
- Secondary outcome measures, including migraine severity, duration, nausea/vomiting, and analgesic use, also showed no significant differences.
- A high placebo response rate was noted, suggesting a significant psychological component or other factors influencing outcomes in pediatric migraine studies.
Conclusions:
- Riboflavin supplementation at 200 mg daily is not an effective therapy for preventing migraine in children.
- The high placebo response rate observed has important implications for the design and interpretation of future clinical trials for pediatric migraine.
- Further research may be needed to explore alternative preventive strategies or identify specific subgroups of children who might benefit from riboflavin.
Abstract:
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.
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