Comparing the Efficacy of Propranolol+ Cinarizine and Propranolol+Placebo in Controlling Pediatric Migraine Headaches: A Randomized Controlled Trial

Background and purpose: Numerous drugs have been suggested to control pediatric migraine headaches, but there are limited numbers of randomized controlled trials to prove their efficacy. The aim of this study was to compare the efficacy of Propranolol + Cinnarizine and Propranolol + placebo in controlling migraine headaches in Children. Materials and methods: A double-blind, placebo-controlled randomized clinical trial was performed in 90 eligible children aged 6-14 years of age attending Shiraz Imam Reza clinic, 2018. They were randomly assigned into either an intervention group (n=45) or a control group (n=45). Intervention group received Propranolol + Cinnarizine and control group received Propranolol + placebo. The frequency, duration, and severity of headaches were recorded for two months.  Data analysis was carried out applying paired samples t-test and independent samples t-test. Results: The mean age of children was 10 ± 2.6 years old.  A positive family history of migraine was found in more than 70% of the participants. There was about 73% decrease in monthly mean frequency of headaches in both groups compared to baeline (reduction from 15 times to 4 times in intervention group and from 11 times to 3 times in control group). Also, mean duration and intensity of headaches decreased by 60% and 50%, respectively, in both groups compared to the baseline (P<0.001). There were no significant differences in mean frequency, duration, and severity of headaches within the first or second month between the two groups (P>0.12). Conclusion: Combination of Propranolol and Cinnarizine showed no additional effect on controlling pediatric migraine headaches compared to Propranolol alone.   (Clinical Trials Registry Number: IRCT20180724040576N1)