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Efficacy and safety of cinnarizine in the prophylaxis of migraine headaches in children: an open, randomized comparative trial with propranolol

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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.

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Acknowledgments

We are extremely indebted to the authorities of the Research Deputy of Tehran University of Medical Sciences for their financial and logistic support. We offer our special thanks to patients and their parents for their cooperation.

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Authors and Affiliations

  1. Department of Neurology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran

    Mansoureh Togha

  2. Department of Paediatric Neurology, Paediatrics Centre of Excellence, Children’s Medical Centre, Tehran University of Medical Sciences, #62, Gharib Street, P.O. Box 1419733151, Tehran, Iran

    Reza Azizi Malamiri, Neda Rashidi-Ranjbar, Solmaz Asa & Mahmoud Reza Ashrafi

  3. Department of Paediatric Neurology, Golestan Medical, Educational, and Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran

    Reza Azizi Malamiri

  4. Department of Paediatric Neurology, Mofid Children Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Farhad Mahvelati

Authors
  1. Mansoureh Togha
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  2. Reza Azizi Malamiri
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  3. Neda Rashidi-Ranjbar
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  4. Solmaz Asa
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  5. Farhad Mahvelati
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  6. Mahmoud Reza Ashrafi
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Correspondence to Mahmoud Reza Ashrafi.

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Togha, M., Malamiri, R.A., Rashidi-Ranjbar, N. et al. Efficacy and safety of cinnarizine in the prophylaxis of migraine headaches in children: an open, randomized comparative trial with propranolol. Acta Neurol Belg 112, 51–55 (2012). https://doi.org/10.1007/s13760-012-0011-7

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  • DOI: https://doi.org/10.1007/s13760-012-0011-7

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