Higher-level evidence demonstrates lack of efficacy
This RCT provides new, higher-level evidence that demonstrates the lack of efficacy of amitriptyline and topiramate in the prevention of pediatric migraines. It also highlights the risk of increased adverse events with topiramate and amitriptyline.
Two of the 3 topiramate trials used in the older meta-analysis by El-Chammas and colleagues5 and this new RCT1 were included in an updated meta-analysis by Le and colleagues (total participants 465) published in 2017.2 This newer meta-analysis found no statistical benefit associated with the use of topiramate over placebo. It demonstrated a nonsignificant decrease in the number of patients with at least a 50% relative reduction in headache frequency (risk ratio = 1.26; 95% CI, 0.94-1.67) and in the overall number of headache days (mean difference = -0.77; 95% CI, -2.31 to 0.76) in patients younger than 18 years of age.2 Both meta-analyses, however, showed an increase in the rate of adverse events in patients using topiramate vs placebo.2,5
Is there a gender predominance?
El-Chammas and colleagues5 describe male pediatric patients as being the predominant pediatric gender with migraines. However, they do not quote an incidence rate or cite the reference for this statement. No other reference to gender predominance was noted in the literature. The current study,1 in addition to the total population of the meta-analysis by Le and colleagues,2 included women as the predominant patient population. Hopefully, future studies will help to delineate if there is a gender predominance and, if so, whether the current treatment data apply to both genders.
CHALLENGES TO IMPLEMENTATION
None to speak of
There are no barriers to implementing this recommendation immediately in all primary care settings.
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.