Meta-Analysis: Evidence of Efficacy Lacking for Pediatric Headache Prophylaxis

Only 2 medications in common use to reduce the incidence of headache in children and adolescents (<18 years of age) were found to be effective, based on results of a meta-analysis of 21 placebo-controlled and comparator trials. Twenty trials focused on episodic migraines and 1 on chronic daily headache. The analysis was published in JAMA: Pediatrics.
 
Topiramate and trazadone were shown to have only limited efficacy. Placebo was also found to be effective. For flunarizine(Drug information on flunarizine), pizotifen(Drug information on pizotifen), propranolol(Drug information on propranolol), and valproate(Drug information on valproate), no evidence was found to support their use to treat headache in the pediatric population.

An accompanying editorial points out that “no evidence of efficacy does not mean the evidence of no efficacy.” When contemplating if the medications themselves are effective, or if clinicians are observing the placebo effect, editorial writer Marco A. Arruda, MD, PhD, questioned if it mattered, saying: “Although placebo is the enemy of great clinical trials, it is likely the best friend of good clinicians.”

The primary focus of the study was to assess trial design issues when testing preventive treatment for migraine headache. The authors state that “firm conclusions are impossible” based on the currently available data.

The abstract is available here. An excerpt of the editorial is available here (full access available only with a subscription).