|Rates of the primary outcome — a 50% or greater relative reduction in the number of headache days — were similar in the amitriptyline, topiramate, and placebo groups (52%, 55%, and 61%). The groups also did not differ significantly in the change in headache-related disability, change in number of headache days, or incidence of serious adverse events. However, some adverse events were significantly more frequent with active treatment than with placebo, including paresthesia and weight loss with topiramate, and fatigue and dry mouth with amitriptyline.Neither amitriptyline nor topiramate is better than placebo at preventing headaches in children aged 8 to 17 years with migraine, according to aNew England Journal of Medicine study.
Researchers randomized 361 children to amitriptyline (1 mg/kg per day), topiramate (2 mg/kg per day), or placebo for 24 weeks. The trial was stopped early for futility.
In NEJM Journal Watch Pediatrics and Adolescent Medicine, Dr. Louis Bell comments: “Primary care pediatricians are left with stressing the nonmedication fundamentals for prevention of migraine. Discussing migraine prevention with pediatric neurologists in light of these findings will be important. In the meantime, I would consider holding off on giving prophylactic therapy because the adverse effects appear to outweigh the benefits.”