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2620059 
Journal Article 
Efficacy of non-modified allergen products for subcutaneous specific immunotherapy - evaluation of evidence in clinical trials 
Bachert, C; Devuyst, L 
2010 
Yes 
Allergologie
ISSN: 0344-5062 
33 
9 
379-394 
WOS:000282397200002 
Background: Allergen products for specific immunotherapy (SIT) differ in terms of qualitative and quantitative composition, standardization, application and dosage. Systematic reviews demonstrate significant heterogeneity in primary outcome of SIT studies. To ensure that patients are treated based on scientific evidence, clinical efficacy of each allergen product should be demonstrated by adequate clinical trials. Objective: To evaluate the clinical efficacy of non-modified allergen products for subcutaneous specific immunotherapy obtainable in Germany by using the recommendations for clinical trials of the World Allergy Organization (WAO). Methods: A systematic literature search was performed to identify randomized clinical trials including outcome measurement of symptom- and medication scores. Results: A total of 65 publications were identified for further analysis. 15 doubleblind, placebo-controlled (DBPC) studies fulfilled the inclusion criteria and were analyzed in detail. Clinical efficacy was documented for grass pollen allergic adults and children in 7 studies with 3 products and for tree pollen allergic adults in 4 studies with 3 products. In 4 studies, clinical efficacy was demonstrated in mite-allergic patients with one product. One product also showed long-term efficacy in grass allergic patients and demonstrated clinical efficacy in adults as well as in children, both, suffering from rhinoconjunctivitis and/or asthma bronchiale. In addition, secondary preventive aspects have been shown for one product in randomized trials. Conclusions: Evidence of clinical efficacy, analyzed according to the WAO recommendations for clinical SIT trials, has been demonstrated for 3 non-modified products with 3 homologous allergen groups in 15 clinical studies. 
SCIT; non-modified allergens; grass; mites; trees; evidence