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Original Article |
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Evaluation of the nocebo effect during oral challenge in
patients with adverse drug reactions |
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G. Liccardia,
G. Sennab,
M. Russoa,
P. Bonadonnab,
M. Crivellaro, A. Damab,
M. D’Amatoa,
G. D’Amatoa,
G. W. Canonicac,
G. Passalacquac |
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a) Dept of Chest Diseases, Division of
Pneumology and Allergology “A. Cardarelli” Hospital,
Naples
b) Allergy Service, Verona General Hospital, Verona
c) Allergy & Respiratory Diseases, DIMI, University of
Genoa |
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J Invest Allergol Clin Immunol
2004; Vol. 14(2): 104-107 |
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Abstract |
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Summary: The
nocebo effect is the
onset of untoward
reactions following
the administration
of an indifferent
substance. The oral
challenge with
alternative drugs
plays a central role
in the management of
drug allergy and the
use of inert
substances is part
of this procedure.
We evaluated the
occurrence and
clinical
characteristics of
nocebo effect in
patients with
adverse drug
reactions. Six
hundred patients,
seen in three
different centres (Genoa,
Naples and Verona)
with a history of
reactions to drugs,
underwent a blind
oral challenge with
the administration
of an indifferent
substance and active
drugs. The
administration of an
inert substance
provoked untoward
reactions in 54
patients (27%) in
Verona, 60 (30%) in
Naples and 48 (24%)
in Genoa. The
overall occurrence
of nocebo effect
was 27%. The
majority of
reactions were
subjective symptoms
(itching, malaise,
headache etc),
perceived as
troublesome by all
subjects. The
occurrence was
significantly higher
in women than in men.
Our data, collected
in a large
population, confirm
that the nocebo
effect occurs
frequently in
clinical practice.
In managing adverse
drug reactions
through oral
challenge the nocebo
effect is mandatory
to recognize false
positive responses .
Key words:
Placebo effect,
nocebo effect,
adverse drug
reaction, drug
challenge |
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