Research ArticleMigraine

Altered Placebo and Drug Labeling Changes the Outcome of Episodic Migraine Attacks

Science Translational Medicine  08 Jan 2014:
Vol. 6, Issue 218, pp. 218ra5
DOI: 10.1126/scitranslmed.3006175

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Placebo and Medication Effects in Episodic Migraine

Placebo and medication effects are intimately related in clinical practice and drug development. In new work, Kam-Hansen et al. investigated how information—ranging from “negative” to “neutral” to “positive”—provided to patients, who received either active drug or placebo, modified their headache pain as measured by patient-reported pain scores. In a randomized order over six consecutive attacks, 66 patients with episodic migraine received either placebo or Maxalt (10-mg rizatriptan) under three information conditions (told placebo, told Maxalt or placebo, told Maxalt). Each participant also reported on an initial no-treatment attack, yielding a total of 459 documented migraine attacks. Maxalt was superior to placebo for pain relief. Increasing information from negative to neutral to positive progressively enhanced the effects of both placebo and Maxalt. The efficacy of open-label placebo was superior to that of no treatment. Relative to no treatment, the placebo, under each information condition, accounted for more than 50% of the drug effect. The benefits of placebo persisted even when the placebo was honestly described. Whether treatment involves medication or placebo, the information provided to patients and the ritual of pill taking are important components of medical care.