Placebo adverse events in headache trials: headache as an adverse event of placebo.
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.
Reuter
U
U
Department of Neurology, Charité, Humboldt University of Berlin, Berlin, Germany. uwe.reuter@charite.de
Sanchez del Rio
M
M
Carpay
J A
JA
Boes
C J
CJ
Silberstein
S D
SD
D000281:Administration, Intranasal; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D025441:Dihydroergocornine / Q000627:therapeutic use; D006261:Headache / Q000139:chemically induced* / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D010919:Placebos / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use
D000894:Anti-Inflammatory Agents, Non-Steroidal; D010919:Placebos; D017366:Serotonin Receptor Agonists; D025441:Dihydroergocornine