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Permanent URL to this publication: http://dx.doi.org/10.5167/uzh-48926

Bousquet, J; Schünemann, H J; Bousquet, P J; Bachert, C; Canonica, G W; Casale, T B; Demoly, P; Durham, S; Carlsen, K H; Malling, H J; Passalacqua, G; Simons, F E R; Anto, J; Baena-Cagnani, C E; Bergmann, K C; Bieber, T; Briggs, A H; Brozek, J; Calderon, M A; Dahl, R; Devillier, P; Gerth van Wijk, R; Howarth, P; Larenas, D; Papadopoulos, N G; Schmid-Grendelmeier, P; Zuberbier, T (2011). How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA(2) LEN statement. Allergy, 66(6):765-774.

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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.


38 citations in Web of Science®
48 citations in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Dermatology Clinic
Dewey Decimal Classification:610 Medicine & health
Deposited On:04 Aug 2011 11:22
Last Modified:05 Apr 2016 14:58
Publisher DOI:10.1111/j.1398-9995.2011.02590.x
PubMed ID:21496059

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