A randomized trial of propranolol versus sodium valproate for the prophylaxis of
migraine in pediatric patients.
Author(s): Bidabadi E, Mashouf M.
Affiliation(s): Guilan University of Medical Sciences, No. 15-135 Ave., Golsar, Rasht, Iran.
Publication date & source: 2010, Paediatr Drugs. , 12(4):269-75
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
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.