Placebo adverse events in headache trials: headache as an adverse event of placebo

Cephalalgia. 2003 Sep;23(7):496-503. doi: 10.1046/j.1468-2982.2003.00530.x.

Abstract

We analysed the adverse events of placebo in acute and preventive randomized, double-blind, placebo-controlled studies for migraine treatment. Fifty-seven trials (oral triptans, non-steroidal anti-inflammatory drugs, nasal ergot alkaloids and preventive agents) were included. From 10 to 30% of subjects reported adverse events after placebo. Most common were features associated with a migraine attack, such as nausea, phono- and photophobia. Other frequent complaints resembled those of the active drug (e.g. chest pressure in triptan trials). A third group of adverse events appeared to be coincidental (e.g. sleep disturbance). Adverse events following placebo are probably related to the drug under study and the symptomatology of migraine; some have no obvious explanation.

Publication types

  • Meta-Analysis

MeSH terms

  • Administration, Intranasal
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Dihydroergocornine / therapeutic use
  • Headache / chemically induced*
  • Headache / drug therapy*
  • Headache / prevention & control
  • Humans
  • Placebos / adverse effects*
  • Randomized Controlled Trials as Topic*
  • Serotonin Receptor Agonists / therapeutic use

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Placebos
  • Serotonin Receptor Agonists
  • Dihydroergocornine