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Carpay, J. A.

Mayo Clinic

Afd Neurologie, Ziekenhuis Gooi Noord, Laren, the Netherlands

Citations 1

Placebo Adverse Events in Headache Trials: Headache as an Adverse Event of Placebo
Reuter, Uwe , Río, Margarita Sánchez del , Carpay, J. A., Boes, CJ, Silberstein, SD, Program, for the GSK Headache Masters, Program, for the GSK Headache Masters, Reuter, Uwe

Cephalalgia | September 2, 2003 | Volume: 23 | Issue: 7 | Pages: 496-503

10.1046/j.1468-2982.2003.00530.x Get It

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.