@article{3004243,
    title = "How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: An ARIA-GA2LEN statement",
    author = "Bousquet, J. and Schünemann, H.J. and Bousquet, P.J. and Bachert, C. and Canonica, G.W. and Casale, T.B. and Demoly, P. and Durham, S. and Carlsen, K.-H. and Malling, H.-J. and Passalacqua, G. and Simons, F.E.R. and Anto, J. and Baena-Cagnani, C.E. and Bergmann, K.-C. and Bieber, T. and Briggs, A.H. and Brozek, J. and Calderon, M.A. and Dahl, R. and Devillier, P. and Gerth Van Wijk, R. and Howarth, P. and Larenas, D. and Papadopoulos, N.G. and Schmid-Grendelmeier, P. and Zuberbier, T.",
    journal = "Allergy: European Journal of Allergy and Clinical Immunology",
    year = "2011",
    volume = "66",
    number = "6",
    pages = "765-774",
    publisher = "Wiley-Blackwell Publishing Ltd",
    doi = "10.1111/j.1398-9995.2011.02590.x",
    keywords = "antiallergic agent;  antihistaminic agent;  house dust allergen;  omalizumab;  placebo;  pollen extract, allergic rhinitis;  asthma;  conjunctivitis;  cost effectiveness analysis;  desensitization;  disease severity;  evaluation;  house dust allergy;  human;  immunotherapy;  nonhuman;  pharmacoeconomics;  pollen;  practice guideline;  priority journal;  ragweed;  randomized controlled trial (topic);  research;  review;  statistical analysis;  study design;  sublingual drug administration",
    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. © 2011 John Wiley & Sons A/S."
}