title: Management of eustachian tube dysfunction with nasal steroid spray: a prospective, randomized, placebo-controlled trial.
abstract: OBJECTIVE
  To determine the efficacy of intranasal aqueous triamcinolone acetonide in treating the tympanometric signs and symptoms of eustachian tube dysfunction, such as otitis media with effusion and negative middle ear pressure.
  
  
  METHODS
  Randomized, placebo-controlled, double-blind prospective clinical trial.
  
  
  METHODS
  Tertiary referral clinic.
  
  
  METHODS
  Adults (≥18 years) and children (6-17 years) presenting with otitis media with effusion, negative middle ear pressure, or both.
  
  
  METHODS
  The 2 treatment arms consisted of aqueous triamcinolone or matching placebo administered once daily intranasally for 6 weeks. All subjects underwent tympanometry, otologic examination, and completion of a symptom questionnaire before and after treatment.
  
  
  METHODS
  Resolution of abnormal tympanometry and change in symptom scores (severity and frequency).
  
  
  RESULTS
  Ninety-one patients presenting from September 1, 2005, through December 31, 2008, with otitis media with effusion or with negative middle ear pressure were enrolled and randomly assigned to treatment or placebo in a double-blind manner. No statistically significant difference in normalization of abnormal tympanometric signs was demonstrated with the active treatment arm compared with placebo on either a per-patient basis (19% vs 32%; P = .18) or a per-ear basis (22% vs 35%; P = .15). There was also no significant difference in the overall poststudy symptom score between the 2 treatment arms, after adjusting for the prestudy overall symptom score in an analysis of covariance model (P = .27).
  
  
  CONCLUSIONS
  These findings do not support the use of intranasal steroid sprays to treat the manifestations of eustachian tube dysfunction. Trial Registration clinicaltrials.gov Identifier: NCT00279916.
authors.affiliation: Department of Otorhinolaryngology, Mayo Clinic, Rochester, MN 55905, USA. orvidas.laura@mayo.edu
authors.forename: Michael B
authors.initials: MB
authors.lastname: Gluth
authors.forename: Darren R
authors.initials: DR
authors.lastname: McDonald
authors.forename: Amy L
authors.initials: AL
authors.lastname: Weaver
authors.forename: Christopher D
authors.initials: CD
authors.lastname: Bauch
authors.forename: Charles W
authors.initials: CW
authors.lastname: Beatty
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Orvidas
mesh_terms: D000293:Adolescent; D000328:Adult; D016009:Chi-Square Distribution; D002648:Child; D004311:Double-Blind Method; D005064:Eustachian Tube / Q000187:drug effects* / Q000503:physiopathology*; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D016015:Logistic Models; D008297:Male; D059085:Nasal Sprays; D010034:Otitis Media with Effusion / Q000188:drug therapy* / Q000503:physiopathology; D010919:Placebos; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014222:Triamcinolone Acetonide / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D005938:Glucocorticoids; D059085:Nasal Sprays; D010919:Placebos; D014222:Triamcinolone Acetonide