Influence of the behaviour pattern on the nocebo response of healthy volunteers.
The occurrence of a nocebo effect after placebo administration to healthy volunteers in a Phase I trial was analysed according to their type of personality (Bortner Rating Scale). More subjects with a behaviour pattern A (competitive and aggressive) (50%) described subjective side effects of the placebo than type B subjects (17%, P = 0.03). The volunteers who had nocebo effect had a higher Bortner score (BS) than did placebo non-responsive subjects (P = 0.05). The BS was 205 for paramedical staff, 189 for medical and dentistry students, 173 for non-science students and 161 for science students (P < 0.04). The nocebo response was not statistically correlated with professional status. These results suggest that volunteer's type of personality might influence the reporting of subjective symptoms after placebo, and therefore impair the evaluation of new drugs in Phase I clinical trials.
Drici
M D
MD
Clinical Pharmacology Center, University of Nice-Sophia Antipolis, France.
Raybaud
F
F
De Lunardo
C
C
Iacono
P
P
Gustovic
P
P
D000328:Adult; D015987:Effect Modifier, Epidemiologic; D005260:Female; D006801:Humans; D008297:Male; D010551:Personality / Q000502:physiology*; D015990:Placebo Effect; D014434:Type A Personality