A randomized trial of propranolol versus sodium valproate for the prophylaxis of migraine in pediatric patients.

BACKGROUND: Migraine is the most common of the paroxysmal disorders to affect the brain in the pediatric population. Both propranolol and sodium valproate (valproic acid) have been advocated as prophylactic agents for childhood migraine.
OBJECTIVE: To compare the efficacy and tolerability of propranolol and sodium valproate in the prevention of migraine in the pediatric population.
METHODS: Sixty-three children (aged 5-15 years) with migraine without aura, as defined by the 2004 International Headache Society (IHS) criteria, were included in this prospective, double-blind clinical trial and were randomly assigned to two groups. Group A (n = 32 patients) received propranolol 3 mg/kg/day and group B (n = 31 patients) received sodium valproate 30 mg/kg/day, with at least 6 months of follow up. The propranolol dosage was adjusted to 2 mg/kg/day and the sodium valproate dosage to 15 mg/kg/day, after the first follow-up visit. Participants were evaluated by using a detailed questionnaire that asked about the features of headaches and general health characteristics. The study endpoints were successful treatment for a 4- to 6-month period; 3 months of a persistent unsuccessful or incomplete response to treatment; intolerable side effects; and/or patient non-adherence. All data were analyzed longitudinally by comparing baseline data with data from each follow-up.
RESULTS: A total of 60 patients completed the full headache prophylaxis period. The baseline headache frequency was reduced by more than 50% in 83% of propranolol recipients and in 63% of sodium valproate recipients (statistically not significant); the overall reduction of baseline headache frequency per month was better in group A (p = 0.044). The mean headache frequency per month was reduced from 13.86 +/- 2.11 to 4.23 +/- 3.24 in group A, and from 13.23 +/- 2.43 to 5.83 +/- 4.04 in group B; the difference between the two groups was statistically significant (p < 0.01). The mean headache duration per week was decreased from 9.9 +/- 7.4 hours to 3.2 +/- 5.9 hours in group A, and from 9.1 +/- 6.9 hours to 3.7 +/- 5.0 hours in group B; although there was no statistically significant difference between propranolol and sodium valproate, headache duration was markedly improved with each drug (p < 0.002). Reduction of headache severity by at least one grade was seen in 64% of patients in group A and in 56% in group B, and complete cessation of headache attacks occurred in 14% of patients in group A and 10% in group B (not significant). Minor side effects appeared to be fairly well tolerated by patients in both groups, with no significant difference in side effects between the two groups.
CONCLUSION: This prospective study supports the efficacy of propranolol and sodium valproate as prophylaxis for pediatric migraine without aura, based on IHS criteria. There were no significant differences between these two drugs in all evaluated parameters except for the mean headache frequency per month, which was lower with propranolol than with sodium valproate.

RCT Entities:   Population Interventions Outcomes