Comparative effectiveness and safety of topiramate versus amitriptyline for the prophylactic management of chronic migraine: a prospective comparative study.

Abstract

Background: Chronic migraine is a chronic disabling neurological disease and has a significant impact on quality of life. Topiramate and amitriptyline are commonly used for migraine prevention, but treatment decisions should consider their effectiveness and safety profiles. This study aimed to compare the effectiveness and safety of topiramate and amitriptyline in chronic migraine.

Methods: We conducted a quasi-experimental study at a specialised healthcare facility in Lahore, Pakistan, over a one-year period from March 2023 to March 2024. A total of 330 patients meeting the ICHD-3 criteria for chronic migraine were enrolled, including group (a) 165 patients treated with topiramate and group (b) 165 treated with amitriptyline. We used monthly headache frequency and the Headache Impact Test-6 (HIT-6) score to measure headache frequency and headache-related disability at baseline and at Weeks 4, 8, and 12. Adverse events were noted during the study period. We analysed the data using independent-samples t-tests, paired-samples t-tests, and the Chi-Square test, respectively.

Results: The mean age of both groups (a) and (b) was 32.37 ± 8.48 years and 34.49 ± 9.02 years, respectively. Both treatments effectively decreased headache frequency and HIT-6 scores during the 12-week follow-up. Mean headache frequency was significantly reduced in group (a) vs. group (b) at week 12 (0.85 ± 0.63 vs. 1.22 ± 0.81 headache days per month, respectively, p < 0.001). Similarly, at Week 12, the mean HIT-6 score was significantly lower in the topiramate group than in the amitriptyline group (49.58 ± 6.16 vs. 51.64 ± 5.94, respectively; p = 0.002). Overall headache frequency decreased from 20.39 ± 4.23 episodes/month at baseline to 1.03 ± 0.75 episodes/month at week 12 (p < 0.001), while HIT-6 scores decreased from 68.14 ± 4.44 to 50.61 ± 6.13 (p < 0.001). Adverse events were reported in 25.5% of the patients taking topiramate and 35.8% of the patients taking amitriptyline (p = 0.042).

Conclusion: Topiramate and amitriptyline both were effective in decreasing headache frequency and headache-related disability among chronic migraine patients. Topiramate was slightly more effective and better tolerated than amitriptyline.