The placebo effect in healthy volunteers : influence of experimental conditions on the adverse events profile during phase I studies.
In contrast to the plethora of publications on placebo effects in patients, very little is known about placebo effects in healthy volunteers during clinical pharmacology studies.
We therefore reviewed the adverse events spontaneously reported during placebo administration in 109 double-blind, placebo-controlled studies involving 1228 volunteers.
The overall incidence of adverse events in the healthy volunteers during placebo administration was 19%. The expected, complets were more frequent after repeated dosing (28%) and in elderly subjects (26%). Overall, the most frequent adverse events were headache (7%), drowsiness (5%), and asthenia (4%), with some variation depending on study design and population.
Mots-clés Pascal : Placebo, Essai clinique phase I, Epidémiologie, Homme, Normal, Effet secondaire, Rétrospective
Mots-clés Pascal anglais : Placebo, Phase I trial, Epidemiology, Human, Normal, Secondary effect, Retrospective
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 94-0127362
Code Inist : 002B02A06. Création : 199406.