ABSTRACT
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.
Subject(s)
Effect Modifier, Epidemiologic , Personality/physiology , Adult , Female , Humans , Male , Placebo Effect , Type A PersonalityABSTRACT
A review of the available literature concerning sudden withdrawal of drugs shows that withdrawal syndrome have occurred with centrally antihypertensive drugs, beta-blockers on anginal patients, antiparkinsonian drugs and glucocorticoids. Because of a lack of controlled trials led among a large number of individuals, the correct frequency of this withdrawal syndrome is unknown. In most patients, it's hard to distinguish a return to a previous state from an overshoot phenomenon. In that way, gradual and supervised withdrawal of these agents should prevent the complication of sudden cessation of these therapy.
