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.

Prevention for Pediatric and Adolescent Migraine

“…Both showed a significant reduction in headache frequency with either drug, and there was no significant difference between propranolol and valproate. An open, randomized comparison of propranolol and cinnarizine showed equal efficacy in reduction of headache frequency, although cinnarizine is not available in the United States or Canada. Although these studies suggest that propranolol is effective in pediatric migraine, none of the above studies had a placebo control, which limits interpretation of the results.…”

“…As noted above, cinnarizine has limited evidence for use in pediatric migraine. However, one open label, randomized trial comparing cinnarizine and propranolol in pediatric migraine showed similar reduction in headache frequency with either medication …”

“…However, one open label, randomized trial comparing cinnarizine and propranolol in pediatric migraine showed similar reduction in headache frequency with either medication. 42 A double-blind, placebo-controlled, crossover study of nimodipine in prevention of pediatric migraine yielded inconclusive results. In the first phase of the study, there was no difference in headache reduction between nimodipine and placebo.…”

Possibilities to Use a Fixed Combination of Piracetam and Cinnarizine in Neurological Practice

“…Широко применяются в клинической практике с превентивной целью и блокаторы кальциевых каналов (флунаризин, циннаризин). В исследованиях при сравнении циннаризина с бета-блокатором (пропрано-лол) и антиконвульсантом (вальпроат) циннаризин про-демонстрировал сходную профилактическую эффектив-ность и переносимость [46,47].…”

Primary Headache in Children and Adolescents: Update on Pharmacotherapy of Migraine and Tension-Type Headache

“…All four demonstrated efficacy and safety parameters in line with previous studies, even in lower doses (0.5 to 1 mg/ kg). 55,56,60,61 Propranolol must not be prescribed to patients with a history of atopic disease, asthma, diabetes, or heart block. Moreover, the authors do not administer propranolol to athletic patients because it may interfere with their physical activity.…”