Year: 2020
Type: article
Abstract: The placebo (Latin "I will please") effect commonly occurs in clinical trials. The psychological and physiological factors associated with patients' expectations about a treatment's positive and negative effects have yet to be well characterized, although a functional prefrontal cortex and intense bidirectional communication between the central nervous system and the immune system appear to be prerequisites for a placebo effect. The use of placebo raises certain ethical issues, especially if patients in a placebo group are denied an effective treatment for a long period of time. The placebo effect appears to be relatively large (up to 77%, relative to pretreatment scores) in controlled clinical trials of allergen immunotherapy (AIT), such as the pivotal, double-blind, placebo-controlled (DBPC) randomized clinical trials currently required by regulatory authorities worldwide. The European Academy of Allergy and Clinical Immunology (EAACI) therefore initiated a Task Force, in order to better understand the placebo effect in AIT and its specific role in comorbidities, blinding issues, adherence, measurement time points, variability and the natural course of the disease. In this Position Paper, the EAACI Task Force highlights several important topics regarding the placebo effect in AIT such as a) regulatory aspects, b) neuroimmunological and psychological mechanisms, c) placebo effect sizes in AIT trials, d) methodological limitations in AIT trial design and e) potential solutions in future AIT trial design. In conclusion, this Position Paper aims to examine the methodological problem of placebo in AIT from different aspects and also to highlight unmet needs and possible solutions for future trials.
Source: Allergy
DOI: 10.1111/all.14331
Authors: Oliver Pfaar, Ioana Agache, Karl‐Christian Bergmann, Carsten Bindslev‐Jensen, Jean Bousquet, Peter S. Creticos, Philippe Devillier, Stephen R. Durham, Peter Hellings, Susanne Kaul, Jörg Kleine‐Tebbe, Ludger Klimek, Lars Jacobsen, Marek Jutel, Antonella Muraro, Nikolaos G. Papadopoulos, Winfried Rief, Glenis K. Scadding, Manfred Schedlowski, Mohamed H. Shamji, Gunter Sturm, Ronald van Ree, Carmen Vidal, Stefan Vieths, Bettina Wedi, Roy Gerth van Wijk, Anthony J. Frew
Institutions: Philipps University of Marburg, Transilvania University of Brașov, Humboldt-Universität zu Berlin, Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Charité – Universitätsmedizin Berlin, Odense University Hospital, Centre Hospitalier Universitaire de Montpellier, Johns Hopkins University, Johns Hopkins Medicine, Université Paris-Saclay, Hôpital Foch, Imperial College London, Universitair Ziekenhuis Leuven, Amsterdam UMC Location University of Amsterdam, Ghent University, University of Amsterdam, KU Leuven, Paul Ehrlich Institut, Zentrum für Rhinologie und Allergologie, University of Wrocław, Wroclaw Medical University, All-Med, Azienda Ospedale - Università Padova, National and Kapodistrian University of Athens, University of Manchester, University College London, Stiftung Universitätsmedizin Essen, NIHR Imperial Biomedical Research Centre, University of Graz, Medical University of Graz, Amsterdam University Medical Centers, Universidade de Santiago de Compostela, Medizinische Hochschule Hannover, Erasmus MC, University of Sussex, Royal Sussex County Hospital, University of Brighton
Language: English
Subfield: Cognitive Neuroscience
Field: Neuroscience
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $4,150
OpenAlex ID: W3019310658