1. In this study, no significant intergroup differences between amitriptyline, topiramate and placebo for reduction in total number of headache days was observed.
2. Amitriptyline and topiramate were associated with significantly higher rates of adverse side effects compared to placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Pediatric migraine poses a substantial economic burden and reduction in quality of life for those affected. Yet practice guidelines for management of pediatric migraine are consensus based, rather than evidence based. In the Childhood and Adolescent Migraine Prevention (CHAMP) trial, researchers assessed the effects of a 24-week course of amitriptyline compared to topiramate or placebo in pediatric and adolescent migraine patients’ ages 8-17 years with regards to reduction in the overall number of headache days compared to pre-trial baseline. Neither amitriptyline nor topiramate was found to be more effective than placebo with regards to reducing overall headache days compared to pre-trial baseline. Additionally, there were no inter-group differences in secondary outcomes, including headache-related disability, total headache days. The trial was subsequently concluded early for futility after interim analysis. Patients in the amitriptyline and topiramate group did experience significantly higher rates of adverse effects compared to placebo.
Click to read the study, published today in NEJM
Relevant Reading: Quality of life in childhood migraines: clinical impact and comparison to other chronic illnesses.
In-Depth [randomized controlled trial]: In this randomized, double-blind, placebo-controlled study, 328 participants were included in the primary analysis, with 132, 130 and 66 participants randomized to receive amitriptyline, topiramate and placebo, respectively. The primary outcome was the relative reduction of ≥50% in the number of headache days relative to a 28-day pre-trial baseline. The primary analysis occurred in 52%, 55% and 61% of participants in the amitriptyline, topiramate and placebo groups respectively. With regards to intergroup comparisons, the adjusted odds ratio for amitriptyline compared to placebo was 0.71 (98%CI 0.31-1.48; p = 0.26) and for topiramate vs. placebo, it was 0.81 (98.3%CI 0.39-1.68; p = 0.48). There were no significant between-group differences in headache-related disability. Adverse effects in the amitriptyline and topiramate group were significantly higher compared to placebo. Notably, the amitriptyline group, when compared to the placebo group, had significantly higher rates of fatigue (30% vs.14%; p = 0.01) and dry mouth (25% vs. 12%; p = 0.03). The topiramate compared to placebo group had significantly higher rates of paresthesia (31% vs. 8%; p < 0.001) and weight loss (8% vs 0%; p = 0.02).
Image: PD
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