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 20.58 ± 8.94, propranolol 33.03 ± 6.11 to 20.35 ± 8.89; P < 0.0001 for all). No significant differences were observed between the two groups for any primary outcomes (P > 0.05), indicating comparable efficacy. Secondary outcomes, including subgroup analyses by age and sex, also showed no significant differences between groups. Conclusions: Both vitamin B6 and propranolol demonstrated a significant positive influence in reducing pediatric migraine symptoms.