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. DESIGN: Randomized, placebo-controlled, double-blind prospective clinical trial. SETTING: Tertiary referral clinic. PATIENTS: Adults (≥18 years) and children (6-17 years) presenting with otitis media with effusion, negative middle ear pressure, or both. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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). CONCLUSION: 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.
RCT Entities:
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. DESIGN: Randomized, placebo-controlled, double-blind prospective clinical trial. SETTING: Tertiary referral clinic. PATIENTS: Adults (≥18 years) and children (6-17 years) presenting with otitis media with effusion, negative middle ear pressure, or both. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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). CONCLUSION: 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: Carsten V Dalchow; M Loewenthal; N Kappo; F Jenckel; B B Loerincz; R Knecht Journal: Eur Arch Otorhinolaryngol Date: 2015-03-19 Impact factor: 2.503