Placebo response in pediatric migraine

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The placebo response is something that is often talked about but not well understood. It may be more important for some disease processes than others. When there is a remitting and relapsing course and a substantial psychosocial component, the placebo response may be particularly important. Treatment of pediatric migraine is an area where the placebo effect can pose important challenges to study design and to planning studies of appropriate size. It has rarely been studied in pediatric patients in a systematic manner. In this issue of The Journal, Fernandes et al report on the results of a systematic review of the placebo response in clinical trials of pediatric migraine. They found that the pooled placebo effect for pain relief and being pain-free at 2 hours was 46% and 21%, respectively, and there was substantial variability from study-to-study. Factors that were found to influence the placebo response were studies performed in North America and the use of a 4-point pain scale for outcome. The fact that the placebo response is large and variable suggests that it remains important to include placebo groups in treatment trials for migraine in pediatric patients. It also suggests that we need to learn more about the mechanisms that underly the placebo response in pediatric patients.