Migraine headaches are common in children. Early diagnosis and appropriate interventions are mandatory to prevent decades of suffering and diminished quality of life. There is need for data regarding the efficacy and safety of prophylactic agents in children with
migraine; therefore, we designed a randomized clinical trial to compare the efficacy and safety of
cinnarizine with that of a well-known prophylactic agent (
propranolol) in the prophylaxis of pediatric
migraine headache. A total of 120 patients aged between 6 and 17 years were recruited and 113 patients succeeded in completing all phases of the trial. Of them, 57 patients were given
cinnarizine, and
propranolol was administered in 56 patients. Reduction in
headache frequency was the main response to treatment.
Cinnarizine reduced the baseline
headache frequency by more than 50% in 74.6% of patients and the mean
headache frequency per month was reduced from 11.851 ± 0.739 (mean ± SEM) to 3.358 ± 0.739 (mean ± SEM) attacks per month (P < 0.001). In the
propranolol group, more than 50% reduction of the baseline
headache frequency was seen in 72.5% of patients and the mean
headache frequency per month was reduced from 10.264 ± 0.830 (mean ± SEM) to 2.774 ± 0.830 (mean ± SEM) attacks per month (P < 0.001). No significant difference was seen in 50% reduction of the baseline
headache frequency between treatment groups (P = 0.358). No significant adverse effects were reported. In this open study,
cinnarizine appeared thus as effective as
propranolol and safe for the prophylaxis of
migraine in children, but this remains to be confirmed in a double-blind placebo-controlled trial.