title: Sublingual immunotherapy in tree pollen allergy. Double-blind, placebo-controlled study with a biologically standardised extract of three pollens (alder, birch and hazel) administered by a rush schedule.
abstract: BACKGROUND
  sublingual immunotherapy has been recognised as safe and effective but it is still poorly documented in tree pollen allergy. Allergy to alder, birch and hazel is important in Northern European countries but its clinical relevance is increasing in Southern Europe.
  
  
  METHODS
  thirty patients, selected and observed for one pollen season, were randomised to receive placebo (15 patients) or active treatment (15 patients). Twenty-seven patients completed the first year and 24 of them were treated with active therapy during the second year of the study in comparison to a parallel group of ten patients treated only with drugs. Symptom and drug scores during each pollen season, birch-specific IgE, changes in skin test reactivity, changes in specific Nasal Provocation Test and the daily average pollen count for the relevant trees were considered for the assessment of the efficacy of the treatment.
  
  
  RESULTS
  both active and placebo group showed a statistically significant improvement in scores in comparison to the previous year, under a lower allergenic pressure. The improvement was higher in the active group (76.04 % reduction of drugs) but not significantly different from that registered in the placebo group (37.05 % reduction). In the open phase of the study, treated patients showed significantly better scores in comparison to the control group. No significant changes in skin reactivity, specific IgE and Nasal Provocation Test were registered. SLIT tolerance was very good.
  
  
  CONCLUSIONS
  our data show a better but not statistically significant clinical outcome for patients actively treated with SLIT, but the placebo effect and the year-by-year variability of the environmental allergenic load in our small-size pilot study do not allow for a conclusive statement about the efficacy of this form of therapy.
authors.affiliation: Allergy Service, San Martino Hospital, Genoa, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Voltolini
authors.forename: P
authors.initials: P
authors.lastname: Modena
authors.forename: P
authors.initials: P
authors.lastname: Minale
authors.forename: D
authors.initials: D
authors.lastname: Bignardi
authors.forename: C
authors.initials: C
authors.lastname: Troise
authors.forename: P
authors.initials: P
authors.lastname: Puccinelli
authors.forename: S
authors.initials: S
authors.lastname: Parmiani
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000388:Air / Q000032:analysis; D029661:Alnus; D029662:Betula; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007558:Italy; D008297:Male; D008875:Middle Aged; D009299:Nasal Provocation Tests; D011058:Pollen / Q000276:immunology*; D011852:Radioallergosorbent Test; D012621:Seasons; D012882:Skin Tests; D016896:Treatment Outcome; D014197:Trees
chemical_list: D007073:Immunoglobulin E