Efficacy of Pregabalin versus Cinnarizine in Preventive Treatment of Children with Migraine Headache: A Randomized Double-Blind Clinical Trial Study
7 affiliations
- 1Pediatric Child Neurology Department, Pediatric Growth and Development Research Center, Institute of Endocrinology and Metabolism, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran
- 2Pediatrician, Aliasghar Children's Hospital, School of Medicine, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
- 3Pediatric Neurology, Pediatric Growth and Development Research Center, Faculty of Medicine, Teran University of Medical Sciences, Tehran, Iran
- 4School of Dentistry, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
- 5Pars Advanced and Minimally Invasive Medical Manners Research Center, Pars Hospital, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.
- 6Department of Pediatrics, Tehran Medical Sciences, Azad University, Tehran Iran
- 7Infectious diseases research Center, Kashan University of Medical Sciences, Kashan, Iran
Abstract
Objectives:: Different drugs have been proposed to control migraine headaches in children, which have different effectiveness. This study aims to compare the effectiveness of Pregabalin and Cinnarizine in the preventive treatment of children with migraine headaches.
Materials & Methods:: In this randomized, double-blind clinical trial, 74 children aged 6 to 17 years with migraine headaches were included. Patients were randomly assigned to Pregabalin (n = 37) and Cinnarizine (n = 37) groups. In the Pregabalin group, one oral capsule (50 or 75 mg) was prescribed at bedtime, and in the Cinnarizine group, patients received oral tablets (25 or 50 mg) at bedtime. The frequency of migraine headaches, the severity of migraine headaches, and the severity of migraine disability were measured and recorded at the beginning of the study, 4, 8, and 12 weeks after initiation of intervention, through the patient’s notes, pain scale (VAS), and PEDMIDAS, respectively. The data were analyzed using SPSS version 25, and the significance level for all statistical tests was set at < 0.05.
Results:: Three out of 74 patients did not continue follow-up for unknown reasons, and later it was found that all three were in the pregabalin group. Of 71 subjects, 38 (53.5%) were boys: 17 (50%) in the Pregabalin group and 21 (56.8%) in the Cinnarizine group. No significant difference was observed between the two groups regarding gender (P-value = 0.0569). The mean and standard deviation of the patients’ ages were 10.24 and 2.51, respectively, and their age range was 6 to 17 years. Headache frequency decreased by 72% in the Cinnarizine group and 58% in the Pregabalin group. Headache intensity decreased by 63% and 35% in the Cinnarizine and Pregabalin groups, respectively. Furthermore, the reduction rate of disability caused by migraine attacks was 89% in the Cinnarizine group and 73% in the Pregabalin group.
Conclusion:: The findings revealed that both drugs reduced migraine headaches, but Cinnarizine was more effective than Pregabalin in controlling children’s migraine headaches, with this improvement sustained through the third month.
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BibTeX
@article{vafaeeshahi2026efficacy,
title = {{Efficacy of Pregabalin versus Cinnarizine in Preventive Treatment of Children with Migraine Headache: A Randomized Double-Blind Clinical Trial Study}},
author = {Mohammad Vafaee-Shahi and Helen Vaferi and Mahmoudreza Ashrafi and Aina Riahi and Azar Mohammadzadeh and Navid Hadavi and Davood Kheirkhah},
journal = {Iranian Journal of Child Neurology},
year = {2026},
month = sep,
doi = {10.22037/ijcn.v20i4.52664},
url = {https://doi.org/10.22037/ijcn.v20i4.52664},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Efficacy of Pregabalin versus Cinnarizine in Preventive Treatment of Children with Migraine Headache: A Randomized Double-Blind Clinical Trial Study
AU - Mohammad Vafaee-Shahi
AU - Helen Vaferi
AU - Mahmoudreza Ashrafi
AU - Aina Riahi
AU - Azar Mohammadzadeh
AU - Navid Hadavi
AU - Davood Kheirkhah
PY - 2026
DA - 2026/09/01
JO - Iranian Journal of Child Neurology
DO - 10.22037/ijcn.v20i4.52664
UR - https://doi.org/10.22037/ijcn.v20i4.52664
AB - Objectives:: Different drugs have been proposed to control migraine headaches in children, which have different effectiveness. This study aims to compare the effectiveness of Pregabalin and Cinnarizine in the preventive treatment of children with migraine headaches. Materials & Methods:: In this randomized, double-blind clinical trial, 74 children aged 6 to 17 years with migraine headaches were included. Patients were randomly assigned to Pregabalin (n = 37) and Cinnarizine (n = 37) groups. In the Pregabalin group, one oral capsule (50 or 75 mg) was prescribed at bedtime, and in the Cinnarizine group, patients received oral tablets (25 or 50 mg) at bedtime. The frequency of migraine headaches, the severity of migraine headaches, and the severity of migraine disability were measured and recorded at the beginning of the study, 4, 8, and 12 weeks after initiation of intervention, through the patient’s notes, pain scale (VAS), and PEDMIDAS, respectively. The data were analyzed using SPSS version 25, and the significance level for all statistical tests was set at < 0.05. Results:: Three out of 74 patients did not continue follow-up for unknown reasons, and later it was found that all three were in the pregabalin group. Of 71 subjects, 38 (53.5%) were boys: 17 (50%) in the Pregabalin group and 21 (56.8%) in the Cinnarizine group. No significant difference was observed between the two groups regarding gender (P-value = 0.0569). The mean and standard deviation of the patients’ ages were 10.24 and 2.51, respectively, and their age range was 6 to 17 years. Headache frequency decreased by 72% in the Cinnarizine group and 58% in the Pregabalin group. Headache intensity decreased by 63% and 35% in the Cinnarizine and Pregabalin groups, respectively. Furthermore, the reduction rate of disability caused by migraine attacks was 89% in the Cinnarizine group and 73% in the Pregabalin group. Conclusion:: The findings revealed that both drugs reduced migraine headaches, but Cinnarizine was more effective than Pregabalin in controlling children’s migraine headaches, with this improvement sustained through the third month.
SN - 1735-4668
SN - 2008-0700
ER -