There is limited evidence supporting the efficacy of trazodone and topiramate in the prevention of pediatric episodic migraine headaches, show results from a meta-analysis.
The research found no evidence for efficacy with other drugs in the management of headaches in children and adolescents, whereas placebo showed significant efficacy, highlighting the importance of including a placebo control in future studies.
Khalil El-Chammas (Medical College of Wisconsin, Milwaukee, USA) and colleagues searched literature databases to identify randomized trials of pharmacologic treatments for the prevention of headache among patients aged under 18 years.
Twenty-one trials met the inclusion criteria, of which 13 were placebo-controlled and 10 had active comparators. All but one trial focused on episodic migraine headaches (defined as less than 15 headaches per month) while one examined chronic daily headaches.
The mean age of participants was 11.4 years, mean percentage of females was 46%, mean study duration was 12 weeks, and mean sample size was 70 participants.
Just two drugs were significantly more effective than placebo, report El-Chammas et al in JAMA Pediatrics. Topiramate reduced the frequency of headaches by 0.71 episodes per month versus placebo, while with trazodone the mean monthly reduction was 0.60 episodes.
Meanwhile, drugs that were no more effective than placebo included clonidine, flunarizine, pizotifen, propranolol, valproate, and fluoxetine.
Notably, patients given placebo experienced a significant decline in the average frequency of headaches, from 5.6 to 2.9 per month.
Among the active comparator trials, the only significant result was that flunarizine was significantly more effective than piracetam, being associated with 2.2 fewer headaches per month, on average.
Flunarizine was not found to be superior to aspirin, dihydroergotamine, or propranolol, however.
Finally, the drugs were generally well tolerated, note the researchers. Topiramate and valproate carried the highest burden of side effects, although this did not translate into a higher rate of drug discontinuations.
"More studies of pediatric headaches need to be conducted," El-Chammas and co-authors conclude. "Because there was a significant placebo response, future trials need to include placebo controls."
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