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A comparative study on prophylactic efficacy of cinnarizine and amitriptyline in childhood migraine: a randomized
Mehrnaz Olfat1, Sareh Hosseinpour2, Safdar Masoumi3
1Division of Pediatric Intensive Care, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran.
Insights
Amitriptyline demonstrated faster onset and longer-lasting effects in reducing pediatric migraine duration and frequency compared to cinnarizine. Both drugs were effective for migraine prophylaxis, with no serious adverse events reported.
Area of Science:
- Neurology
- Pediatric Neurology
- Clinical Pharmacology
Background:
- Pediatric migraine prophylaxis is crucial for frequent or disabling headaches.
- Cinnarizine and amitriptyline are commonly used for migraine prophylaxis in children.
- A comparative study was needed to evaluate their efficacy.
Purpose of the Study:
- To compare the efficacy of cinnarizine and amitriptyline in pediatric migraine prophylaxis.
- To assess the impact on headache characteristics, frequency, duration, severity, and disability.
- To evaluate the safety profiles of both medications.
Main Methods:
- A randomized, double-blind trial involving pediatric patients (4-17 years) with migraine.
- Primary outcome: ≥50% reduction in headache characteristics (p<0.005).
- Secondary outcome: Migraine Disability Assessment Scale; safety assessment over 12 weeks.
Main Results:
- Amitriptyline showed a more effective decrease in headache frequency at week 4 (p=0.004).
- Amitriptyline significantly reduced headache duration across all assessment periods (p<0.005).
- No significant differences were observed in severity or disability scores; no serious adverse events.
Conclusions:
- Both cinnarizine and amitriptyline effectively ameliorate pediatric migraine headaches and related disabilities.
- Amitriptyline is a preferable option due to its faster onset and sustained efficacy in reducing headache duration.
- Further research may explore long-term effects and optimal dosing for pediatric migraine prophylaxis.
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.
