Objective: To compare efficacy and safety of topiramate (TPM) and propranolol for migraine prophylaxis in children.
Methods: In a parallel single-blinded randomized clinical trial, 5-15 y-old referred migraineurs to Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from May through October 2011, were evaluated. Patients were distributed into two groups, 50 of whom were treated with 3 mg/kg/d of topiramate (TPM) and another group of 50, were treated with 1 mg/kg of propranolol for 3 mo. Primary endpoints were efficacy in reduction of monthly frequency, severity, duration and headache related disability. Secondary outcome was clinical side effects.
Results: Fifty two girls and 48 boys with mean age of 10.34 ± 2.31 y were evaluated. Monthly frequency, severity and duration of headache decreased with TPM, from 13.88 ± 8.4 to 4.13 ± 2.26 attacks, from 6.32 ± 1.93 to 2.8 ± 2.12, and from 2.36 ± 1.72 to 0.56 ± 0.5 h, respectively. Monthly frequency, severity and duration of headache also decreased with propranolol from 16.2 ± 6.74 to 8.8 ± 4.55 attacks, from 6.1 ± 1.54 to 4.8 ± 1.6 and from 2.26 ± 1.26 to 1.35 ± 1.08 h, respectively. Pediatric Migraine Disability Assessment score reduced from 31.88 ± 9.72 to 9.26 ± 7.21 with TPM and from 33.08 ± 8.98 to 23.64 ± 9.88 with propranolol. Transient mild side effects were seen in 18 % of TPM and in 10 % of propranolol (P = 0.249) groups.
Conclusions: Topiramate is more effective than propranolol for pediatric migraine prophylaxis.