title: An evidence-based analysis of house dust mite allergen immunotherapy: a call for more rigorous clinical studies.
abstract: BACKGROUND
  According to meta-analyses and reviews, subcutaneous allergen immunotherapy (SCIT) and sublingual allergen immunotherapy (SLIT) are beneficial in patients with allergic rhinitis (AR) and allergic asthma (AA) induced by house dust mites (HDMs). However, the reported effect sizes have varied greatly from one study to another.
  
  
  OBJECTIVE
  We sought to perform an evidence-based medicine assessment of commercially available SCIT and SLIT formulations in patients with HDM-induced AA and HDM-induced AR.
  
  
  METHODS
  We searched for double-blind, placebo-controlled randomized clinical trials and analyzed study designs, doses, regimens, patient-reported outcomes, safety reporting, and compliance.
  
  
  RESULTS
  Forty-four studies met our inclusion criteria. Some studies tested both SLIT and SCIT or scored both AA and AR outcomes; therefore we reviewed 35 treatment arms in patients with AA (20 for SCIT and 15 for SLIT) and 23 treatment arms in patients with AR (7 for SCIT and 16 for SLIT). The treatment duration ranged from 6 weeks to 3 years. For SCIT, the dose of Der p 1 major allergen (when reported) ranged from 7 to 30 μg for maintenance doses and 60 to 420 μg for cumulative doses. For SLIT, the doses of Der p 1 (when reported) were 0.8 to 70 μg for maintenance doses and 60 to 23,695 μg for cumulative doses. Safety data were often absent or poorly reported. A statistically significant active versus placebo symptom score was observed more frequently for SCIT than for SLIT.
  
  
  CONCLUSIONS
  There is no consensus on basic treatment parameters (eg, dose and duration) in HDM SCIT and SLIT. There is an urgent need for rigorous, long-term, double-blind, placebo-controlled randomized clinical trials with an efficacy criterion that reflects the particular features of HDM-induced allergic disease.
authors.affiliation: Section of Allergy and Clinical Immunology, Imperial College London, National Heart and Lung Institute, Royal Brompton Hospital, London, United Kingdom.
authors.forename: Moises A
authors.initials: MA
authors.lastname: Calderon
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Casale
authors.forename: Harold S
authors.initials: HS
authors.lastname: Nelson
authors.forename: Pascal
authors.initials: P
authors.lastname: Demoly
mesh_terms: D000818:Animals; D039741:Antigens, Dermatophagoides / Q000276:immunology / Q000627:therapeutic use*; D003888:Desensitization, Immunologic / Q000379:methods*; D019317:Evidence-Based Medicine; D006801:Humans; D006967:Hypersensitivity / Q000276:immunology / Q000628:therapy*; D039981:Pyroglyphidae / Q000276:immunology; D016032:Randomized Controlled Trials as Topic; D063729:Sublingual Immunotherapy
chemical_list: D039741:Antigens, Dermatophagoides
keywords: AA; AE; AIT; AR; Adverse event; Allergen immunotherapy; Allergic asthma; Allergic rhinitis; DBPC; Double-blind, placebo-controlled; EBM; Evidence-based medicine; HDM; House dust mite; QoL; Quality of life; RCT; Randomized clinical trial; SCIT; SLIT; SPT; Skin prick test; Subcutaneous allergen immunotherapy; Sublingual allergen immunotherapy; TEAE; Treatment-emergent adverse event; VAS; Visual analog scale; allergen immunotherapy; allergic asthma; allergic rhinitis; house dust mite; respiratory allergy; subcutaneous; sublingual