Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
John Cavenagh, PhD, PA-C
Objective: The objective of this selective EBM review is to determine whether or not riboflavin is effective as prophylaxis for reducing the frequency of migraine headaches in the pediatric population.
Study Design: Systematic review of the three English language primary studies, published between 2008-2010.
Data Sources: Two randomized controlled trials and one retrospective study published after 1996 comparing migraine frequency before and after administration of riboflavin were obtained using PubMed and EBSCO databases.
Outcomes Measured: Reduction in migraine frequency, determined by child-parent collaborated headache diary while using prophylactic intervention, was the primary outcome measured. This outcome was compared with a baseline period frequency of migraines, as reported by the subjects.
Results: Bruijn et al illustrated no significant reduction in the mean frequency of migraine attacks between riboflavin and placebo. MacLennan et al determined that prophylactic riboflavin had no positive effect, as evidenced by a NNT of -4. Condo et al showed that migraine frequency decreased significantly during the prophylactic periods compared with baseline, with a P-value of < 0. 0 1 for each phase of the retrospective study. The documented adverse events were typical of riboflavin side effects; they included nausea, vomiting, diarrhea and temporary urine discoloration. The events were mild to moderate in nature and resolved without sequelae. Exceptions included one participant dropped out of the study due to vomiting and another child who developed tension headaches during treatment.
Conclusions: The results of these three studies are inconclusive, as the two randomized controlled trials do not demonstrate that riboflavin is effective as prophylaxis; however, the retrospective study demonstrates the opposite is true, with a significant p-value. The size and difference in the characteristics of the sample populations used for each study as well as riboflavin dosage variations could contribute to the lack of continuity across the three studies. Therefore, further trials in this topic are warranted to clarify the generalizability of the evidence to the entire pediatric population that experiences migraines.
Haines, Megan, "Is Riboflavin Effective as Prophylaxis for Reducing the Frequency of Migraine Headaches in the Pediatric Population?" (2014). PCOM Physician Assistant Studies Student Scholarship. 165.