Balloon Eustachian Tuboplasty Combined With Tympanocentesis Is not Superior to Balloon Eustachian Tuboplasty in Chronic Otitis Media With Effusion-A Randomized Clinical Trial
Abstract
Objective: Balloon Eustachian tuboplasty (BET) appears to be a promising therapeutic option for Eustachian tube dysfunction. However, data are lacking on its effect in adults with chronic otitis media with effusion (COME) and whether it should be combined with tympanocentesis.
The aim of our study was to determine if there is a beneficial effect of BET combined with tympanocentesis compared with BET only and provide data on the effect of BET in adults with COME. Study Design: Randomized clinical trial.
Setting: Tertiary referral hospital. Participants: Adults with COME lasting more than 6 months after tympanostomy tube exclusion.
Among 40 eligible ears, 30 were randomized to treatment. Intervention: BET (group 1) versus BET with concurrent tympanocentesis (group 2).
Main Outcome Measures: Tympanometry, Valsalva or Toynbee maneuver with tympanometry verification, Eustachian Tube Dysfunction Questionnaire, and pure-tone audiometry. Results: A total of 25 patients (14 ears in group 1 and 15 ears in group 2) were included in the analysis.
No significant difference in the effect of treatment was found between the groups. When patients were evaluated as one group, after 2, 6, and 12 months, improvement was found in tympanometry in 55, 48, and 48%; in the ability to perform maneuvers in 55, 41, and 41%; in audiometry in 69, 62, and 59%; and in questionnaire scores in 76, 72, and 69%, respectively.
Conclusions: There was no beneficial outcome of tympanocentesis performed concurrently with BET and therefore it should not be routinely recommended. The success of therapy appears to be reduced compared with other pathologies caused by Eustachian tube dysfunction.