title: Sublingual immunotherapy for large local reactions caused by honeybee sting: a double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Sublingual immunotherapy (SLIT) proved effective and safe in respiratory allergy, and thus its use in hymenoptera allergy can be hypothesized.
  
  
  OBJECTIVE
  We sought to assess, in a proof-of-concept study, whether SLIT might potentially be beneficial in hymenoptera allergy. The sting challenge in large local reactions (LLRs) was used to test this hypothesis.
  
  
  METHODS
  We performed a randomized, double-blind, placebo-controlled study involving patients with LLRs who were monosensitized to honeybee. After the baseline sting challenge, they were randomized to either SLIT or placebo for 6 months. The treatment (Anallergo, Florence, Italy) involved a 6-week build-up period, followed by maintenance with 525 microg of venom monthly. The sting challenge was repeated after 6 months.
  
  
  RESULTS
  Thirty patients (18 male patients; mean age, 44.5 years) were enrolled, and 26 completed the study, with 1 dropout in the active group and 3 dropouts in the placebo group. In the active group the median of the peak maximal diameter of the LLRs decreased from 20.5 to 8.5 cm (P = .014), whereas no change was seen in the placebo group (23.0 vs 20.5 cm, P = not significant). The diameter was reduced more than 50% in 57% of patients. One case of generalized urticaria occurred in a placebo-treated patient at sting challenge. No adverse event caused by SLIT was reported.
  
  
  CONCLUSIONS
  Honeybee SLIT significantly reduced the extent of LLRs, and its safety profile was good. Although LLRs are not an indication for immunotherapy, this proof-of-concept study suggests that SLIT in hymenoptera allergy deserves further investigation. Trials involving systemic reactions and dose-ranging studies are needed.
authors.affiliation: Allergy Clinic, Nuovo Ospedale San Giovanni di Dio, Florence, Italy.
authors.forename: Maurizio G
authors.initials: MG
authors.lastname: Severino
authors.forename: Gabriele
authors.initials: G
authors.lastname: Cortellini
authors.forename: Patrizia
authors.initials: P
authors.lastname: Bonadonna
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Francescato
authors.forename: Ilaria
authors.initials: I
authors.lastname: Panzini
authors.forename: Donatella
authors.initials: D
authors.lastname: Macchia
authors.forename: Paolo
authors.initials: P
authors.lastname: Campi
authors.forename: Igino
authors.initials: I
authors.lastname: Spadolini
authors.forename: Walter G
authors.initials: WG
authors.lastname: Canonica
authors.forename: Giovanni
authors.initials: G
authors.lastname: Passalacqua
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D000818:Animals; D001514:Bee Venoms / Q000008:administration & dosage / Q000276:immunology*; D001516:Bees; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000276:immunology / Q000628:therapy*; D007299:Insect Bites and Stings / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D010919:Placebos
chemical_list: D001514:Bee Venoms; D010919:Placebos