Placebo-Controlled Study Shown Viable in Evaluating Efficacy of Balloon Eustachian Tuboplasty

by Linda Kossoff •

CLINICAL QUESTION

Given a lack of indisputable evidence, can a multicenter, double-blind, randomized, placebo-controlled trial (MDRCT) objectively evaluate the efficacy of balloon Eustachian tuboplasty (BET)?

BOTTOM LINE

The MDRCT protocol was shown to be feasible and demonstrated the need for blinded RCTs to objectively measure the efficacy of BET.

BACKGROUND: The most common form of Eustachian tube dysfunction (ETD) is obstructive ETD (OETD), which can result in recurrent otitis media with effusion (OME). Medications or tympanostomy tube placement usually only bring short-term or insufficient relief. Although BET is meant to render long-term benefit, there is no indisputable evidence of its efficacy.

STUDY DESIGN: Prospective study.

SETTING: Department of Otorhinolar-yngology–Head and Neck Surgery, Head and Neck Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

SYNOPSIS: In a pilot study, researchers recruited and followed 15 adult patients (53% female) with OETD (n = 10) or OME (n = 5). All randomly received either active BET (n = 11; seven with OETD/four with OME) or sham surgery (n = 4; three with OETD/one with OME). Procedures were performed under local anesthesia with no adverse events. There were no differences between active and sham surgery arms in preoperative symptoms, tympanometry, Valsalva or Toynbee maneuver perfor-mance, tubomanometry score, or Eustachian tube score. Altogether, 20 ears (14 active BETs and six sham surgeries) were treated and followed over 12 months. At the 12-month mark, symptom scores were reduced in both arms, with similar trends in reduction of points in OETD and OME conditions. There was a statistically significant increase in Eustachian tube score only in the sham surgery arm at 12 months. Authors noted that although the study population was small, the MDRCT protocol used proved feasible and the preliminary results demonstrate clear need for placebo-controlled studies in the future.

CITATION: Laakso JT, Oehlandt H, Kivekäs I, et al. Balloon Eustachian tuboplasty—a feasible double-blinded sham surgery ran-domized clinical trial protocol to study efficacy. Laryngoscope. 2024;134:1874–1881.