title: Efficacy and safety of cinnarizine in the prophylaxis of migraine headaches in children: an open, randomized comparative trial with propranolol.
abstract: 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.
authors.affiliation: Department of Neurology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mansoureh
authors.initials: M
authors.lastname: Togha
authors.forename: Reza Azizi
authors.initials: RA
authors.lastname: Malamiri
authors.forename: Neda
authors.initials: N
authors.lastname: Rashidi-Ranjbar
authors.forename: Solmaz
authors.initials: S
authors.lastname: Asa
authors.forename: Farhad
authors.initials: F
authors.lastname: Mahvelati
authors.forename: Mahmoud Reza
authors.initials: MR
authors.lastname: Ashrafi
mesh_terms: D000293:Adolescent; D000704:Analysis of Variance; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D002648:Child; D002936:Cinnarizine / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy* / Q000517:prevention & control* / Q000523:psychology; D011433:Propranolol / Q000627:therapeutic use*; D011788:Quality of Life; D012189:Retrospective Studies; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use*
chemical_list: D002121:Calcium Channel Blockers; D014665:Vasodilator Agents; D002936:Cinnarizine; D011433:Propranolol