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Editorial |

No Evidence of Efficacy or Evidence of No Efficacy

Marco A. Arruda, MD, PhD
JAMA Pediatr. 2013;167(3):300-302. doi:10.1001/jamapediatrics.2013.1105.
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Headache is an almost universal complaint. In any given month, nearly 49% of children will report headaches, with 4.2% of those having headaches on 10 or more days per month.1 Affecting nearly 8% of children and adolescents, migraine is the most important cause of pediatric consultations due to headaches.2

The clinical presentation of migraine varies as a function of age,3 and this has diagnostic and therapeutic importance.4 Indeed, the diagnosis and treatment of migraine in children and adolescents resembles a kaleidoscope with many facets of striking peculiarities—in young children, the attacks may be very short and sometimes headaches are not present, such as in the associated periodic syndromes (eg, cyclical vomiting and abdominal migraine). More frequently than adults, children seem to respond to treatment with simple analgesics, and this may probably reflect their exacerbated placebo response. When measured in the context of clinical trials, nearly 55% of children receiving placebo prophylaxis achieve the primary end point and the rate approaches 70% with acute therapy. In adults, rates are close to 35% and 45%, respectively.5 Factors that explain the high placebo rate in children include regression to the mean (short duration of attacks), inadequate study designs, and beliefs and perceptions that are inherent to the age group.6

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