학술논문
A comparative study on prophylactic efficacy of cinnarizine and amitriptyline in childhood migraine: a randomized double-blind clinical trial.
Document Type
Article
Author
Olfat, Mehrnaz; Hosseinpour, Sareh; Masoumi, Safdar; Gogia Rastogi, Reena; Vance Hastriter, Eric; Lewis, Kara Stuart; Little, Robert; T Karnik, Kavitha; Hickman, Carolyn; Heidari, Morteza; Shervin Badv, Reza; Mohammadi, Mahmoud; Zamani, Gholam Reza; Mohammadpour, Masoud; Ashrafi, Mahmoud Reza; Tavasoli, Ali Reza
Source
Subject
*CLINICAL trials
*AMITRIPTYLINE
*MIGRAINE
*CINNARIZINE
*COMPARATIVE studies
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Language
ISSN
0333-1024
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. [ABSTRACT FROM AUTHOR]