Efficacy and Safety of Pyridoxine Versus Propranolol for Pediatric Migraine Prophylaxis: A Randomized Controlled Trial
Abstract
Background: Migraine is a highly disabling disorder, particularly in children. However, studies focusing on the prophylaxis of primary headaches in pediatric populations remain rare. Objectives: The present study aimed to compare the efficacy of pyridoxine (vitamin B6) and propranolol in the prophylaxis of pediatric migraine. Methods: In this prospective, randomized, double-blind clinical trial, 62 children aged 7 - 17 years with migraine were randomly assigned to receive either propranolol (10 mg three times daily, n = 31) or pyridoxine (40 mg once daily, n = 31). Randomization was performed using a computer-generated sequence, and both patients and outcome assessors were blinded. Primary outcomes included headache frequency, headache duration, and pediatric migraine disability assessment (Ped-MIDAS) scores, assessed at baseline and after three months. Secondary outcomes included subgroup analyses by age and sex, and the occurrence of adverse events. Analysis of covariance (ANCOVA) was used to adjust for baseline values, age, and sex. Results: The study included 62 participants (31 per group) with a mean age of 9.8 ± 2.47 years in total. Gender distribution was similar between groups, with 59.7% males and 40.3% females. In primary outcomes, headache duration and Ped-MIDAS scores significantly improved in both treatment groups (headache duration: Pyridoxine 6.10 ± 0.91 to 3.00 ± 1.55 hours, propranolol 6.03 ± 0.95 to 3.03 ± 1.44 hours; Ped-MIDAS: Pyridoxine 33.26 ± 5.83 to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 62 participants or records.
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