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- Title
Placebo adverse events in headache trials: headache as an adverse event of placebo.
- Authors
Reuter, U.; del Rio, M. Sanchez; Carpay, J.A.; Boes, C.J.; Silberstein, S.D.; Sanchez del Rio, M; GSK Headache Masters Program
- 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.
- Subjects
HEADACHE treatment; MIGRAINE; PLACEBOS; REUTER, Uwe; NONSTEROIDAL anti-inflammatory agents; SEROTONIN agonists; ERGOT alkaloids; INTRANASAL medication; CLINICAL trials; COMPARATIVE studies; HEADACHE; RESEARCH methodology; MEDICAL cooperation; RESEARCH; SYSTEMATIC reviews; EVALUATION research; PREVENTION; THERAPEUTICS
- Publication
Cephalalgia, 2003, Vol 23, Issue 7, p496
- ISSN
0333-1024
- Publication type
journal article
- DOI
10.1046/j.1468-2982.2003.00530.x