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

U Reuter, M Sanchez del Rio, J A Carpay, C J Boes, S D Silberstein, GSK Headache Masters Program

Department of Neurology, Charité, Humboldt University of Berlin, Berlin, Germany. uwe.reuter@charite.de

Cephalalgia : an international journal of headache 2003 Sep

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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.

Citation

U Reuter, M Sanchez del Rio, J A Carpay, C J Boes, S D Silberstein, GSK Headache Masters Program. Placebo adverse events in headache trials: headache as an adverse event of placebo. Cephalalgia : an international journal of headache. 2003 Sep;23(7):496-503