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A Comparative Study on Prophylactic Efficacy of Cinnarizine and Amitriptyline in Childhood Migraine: A Randomized Double-Blind Clinical Trial Publisher Pubmed



Olfat M1 ; Hosseinpour S2 ; Masoumi S3 ; Gogia Rastogi R4 ; Vance Hastriter E4 ; Lewis KS4 ; Little R4 ; T Karnik K4 ; Hickman C4 ; Heidari M2 ; Shervin Badv R2 ; Mohammadi M2 ; Zamani GR2 ; Mohammadpour M1 Show All Authors
Authors
  1. Olfat M1
  2. Hosseinpour S2
  3. Masoumi S3
  4. Gogia Rastogi R4
  5. Vance Hastriter E4
  6. Lewis KS4
  7. Little R4
  8. T Karnik K4
  9. Hickman C4
  10. Heidari M2
  11. Shervin Badv R2
  12. Mohammadi M2
  13. Zamani GR2
  14. Mohammadpour M1
  15. Ashrafi MR2
  16. Tavasoli AR2, 4
Show Affiliations
Authors Affiliations
  1. 1. Division of Pediatric Intensive Care, Children’s Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Neurology, Children’s Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Velenjak, Iran
  4. 4. Department of Neurology, Barrow Neurological Institute at Phoenix Children’s Hospital, Phoenix, AZ, United States

Source: Cephalalgia Published:2024


Abstract

Background: Pediatric migraine prophylaxis is indicated when headaches are frequent and/or disabling. We aimed to conduct a study to compare the efficacy of cinnarizine and amitriptyline in pediatric migraine prophylaxis. Methods: In a randomized, double-blind trial, patients aged 4–17 years with migraine who were eligible for prophylaxis enrolled. The primary outcome was a reduction response rate of ≥50% with p < 0.005 with respect to headache characteristics. The secondary outcome was migraine disability assessment. We evaluated patients every four weeks for three months: T1: week 4, T2: week 8 and T3: week 12. The safety profile was also assessed. Results: Thirty patients were randomly assigned to each group. However, 43 patients completed the trial. Headache frequency decreased in amitriptyline group more effectively in T1 (p = 0.004). Amitriptyline was more successful in reducing the headache duration in all three periods (p < 0.005). There was no significant difference in severity improvement and reducing disability score between the two groups (p > 0.005). No serious adverse events were observed. Conclusions: Both medications are effective in ameliorating migraine headaches and related disabilities. However, amitriptyline appears be a preferable option over cinnarizine, given its faster onset of action, efficacy in reducing headache duration and longer-lasting effects. Trial Registration: The study was registered with the Iranian Registry of Clinical Trials (IRCT) under the code IRCT-20191112045413N1. © International Headache Society 2024.
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1. Cinnarizine As an Alternative Recommendation for Migraine Prophylaxis: A Narrative Review, Expert Review of Neurotherapeutics (2020)
2. Cinnarizine and Sodium Valproate As the Preventive Agents of Pediatric Migraine: A Randomized Double-Blind Placebo-Controlled Trial, Cephalalgia (2020)
3. The Effect of Melatonin on Reducing the Frequency and Severity of Migraine Attacks: A Double-Blind, Randomized Clinical Trial, Iranian Journal of Medical Sciences (2024)
4. Association Between the Dietary Inflammatory Index and Chronic Daily Headache: Findings From Dena Persian Cohort, Nutrition and Food Science (2023)
5. Migraine, Headache and Migraine in Practice (2022)
6. Tension-Type Headache, Nature Reviews Disease Primers (2021)
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