Placebo as good as most drugs for kids’ migraines
Bickel said there is the least research on the one percent of kids who are most severely affected by migraines - those with chronic daily headaches. For those youth, “we don’t have any evidence to suggest that the medications are enough,” she added.
POWER OF PLACEBO?
In the new analysis, published Monday in JAMA Pediatrics, placebo pills alone led to a drop in kids’ headache frequency from between five and six headaches per month to three per month.
That may have to do with the effect of seeing a doctor and being reassured the pain isn’t due to anything serious, Bickel said.
According to a report from the U.S. Food and Drug Administration published in the same journal issue, two drugs - almotriptan malate (Axert) and rizatriptan benzoate (Maxalt) - are approved to treat (but not prevent) headaches in kids and teens.
In a review of evidence provided to the FDA, Dr. William Rodriguez and his colleagues also found kids tended to get better after treatment with a placebo more often than adults - possibly related to their headaches lasting less time anyway.
For kids who get headaches once a week or less, Bickel said the pain can be treated with over the counter painkillers, or even just waited out in a quiet place.
SOURCE: JAMA Pediatrics, online January 28, 2013
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Pharmacologic Treatment of Pediatric Headaches
El-Chammas and colleagues assessed the effectiveness of prophylactic headache treatment in children and adolescents. See also the editorial by Arruda.
Conclusions Topiramate and trazodone have limited evidence supporting efficacy for episodic migraines. Placebo was effective in reducing headaches. Other commonly used drugs have no evidence supporting their use in children and adolescents. More research is needed.
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Khalil El-Chammas, MD; Jill Keyes, MD; Nathan Thompson, MD; Jayanthi Vijayakumar, MBBS; Dorothy Becher, MPH; Jeffrey L. Jackson, MD, MPH
JAMA Pediatr. 2013;():1-11. doi:10.1001/jamapediatrics.2013.508
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Migraine Therapeutics in Adolescents
Conclusions High placebo response rates are consistent across all trials and may represent the principal challenge in pediatric trials of drugs for abortive treatment of migraine. Enrichment with selection of subjects with long-lasting migraine attacks is not sufficient to overcome high placebo response rates. Another enrichment strategy, the nonrandomization of patients with an early placebo response, successfully reduces the high placebo response rate for rizatriptan and is a trial design that should be considered for future pediatric trials of abortive migraine therapeutics.
Sun et al investigate potential reasons or factors that may contribute to the failure or success of pediatric trials of abortive drugs for treatment of migraine submitted in response to a US Food and Drug Administration–issued Written Request. See also an editorial by Arruda