How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement
Year: 2011
Type: review
Abstract: To cite this article: Bousquet J, Schünemann HJ, Bousquet PJ, Bachert C, Canonica GW, Casale TB, Demoly P, Durham S, Carlsen K-H, Malling H-J, Passalacqua G, Simons FER, Anto J, Baena-Cagnani CE, Bergmann K-C, Bieber T, Briggs AH, Brozek J, Calderon MA, Dahl R, Devillier P, Gerth van Wijk R, Howarth P, Larenas D, Papadopoulos NG, Schmid-Grendelmeier P, Zuberbier T. How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA2LEN statement. Allergy 2011; 66: 765–774. Abstract Specific immunotherapy (SIT) is one of the treatments for allergic rhinitis. However, for allergists, nonspecialists, regulators, payers, and patients, there remain gaps in understanding the evaluation of randomized controlled trials (RCTs). Although treating the same diseases, RCTs in SIT and pharmacotherapy should be considered separately for several reasons, as developed in this study. These include the severity and persistence of allergic rhinitis in the patients enrolled in the study, the problem of the placebo, allergen exposure (in particular pollen and mite), the analysis and reporting of the study, the level of symptoms of placebo-treated patients, the clinical relevance of the efficacy of SIT, the need for a validated combined symptom–medication score, the differences between children and adults and pharmacoeconomic analyses. This statement reviews issues raised by the interpretation of RCTs in sublingual immunotherapy. It is not possible to directly extrapolate the rules or parameters used in medication RCTs to SIT. It also provides some suggestions for the research that will be needed. Interestingly, some of the research questions can be approached with the available data obtained from large RCTs.
Source: Allergy
Authors: J. Bousquet, H. J. Schünemann, P. J. Bousquet, C. Bachert, G. W. Canonica, T. B. Casale, P. Demoly, S. Durham, K.-H. Carlsen, H.-J. Malling, G. Passalacqua, F. E. R. Simons, J. Anto, C. E. Baena-Cagnani, K.-C. Bergmann, T. Bieber, A. H. Briggs, J. Brozek, M. A. Calderon, R. Dahl, P. Devillier, R. Gerth van Wijk, P. Howarth, D. Larenas, N. G. Papadopoulos, P. Schmid-Grendelmeier, T. Zuberbier
Institutions: Inserm, Centre de recherche en Epidémiologie et Santé des Populations, Hôpital Arnaud de Villeneuve, McMaster University, Ghent University Hospital, University of Genoa, Creighton University, Imperial College London, Oslo University Hospital, University of Oslo, University of Manitoba, Universitat Pompeu Fabra, Center for Research in Environmental Epidemiology, Municipal Institute for Medical Research, Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública, Hospital del Mar Research Institute, Universidad Católica de Córdoba, Charité – Universitätsmedizin Berlin, University Hospital Bonn, University of Glasgow, Royal Brompton Hospital, Aarhus University Hospital, Université de Versailles Saint-Quentin-en-Yvelines, Hôpital Foch, Erasmus MC, University of Southampton, Hospital Médica Sur, National and Kapodistrian University of Athens, University Hospital Zurich
Language: English
Subfield: Immunology and Allergy
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W1599242518