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. 2024 Apr;134(4):1874-1881.
doi: 10.1002/lary.31092. Epub 2023 Sep 30.

Balloon Eustachian Tuboplasty-A Feasible Double-Blinded Sham Surgery Randomized Clinical Trial Protocol to Study Efficacy

Juha T Laakso  1 , Heidi Oehlandt  2 , Ilkka Kivekäs  3 , Teemu Harju  3 , Jussi Jero  2 , Saku T Sinkkonen  1
Affiliations

Balloon Eustachian Tuboplasty-A Feasible Double-Blinded Sham Surgery Randomized Clinical Trial Protocol to Study Efficacy

Juha T Laakso et al. Laryngoscope. 2024 Apr.

Abstract

Introduction: Balloon Eustachian tuboplasty (BET) is used to treat obstructive Eustachian tube dysfunction (OETD) and recurrent otitis media with effusion (OME). However, there are no indisputable evidence of its efficacy. Here, we present a multicenter, double-blinded, randomized, placebo-controlled trial (MDRCT) design to evaluate the efficacy of BET, and the results of a pilot trial with 3- and 12-months' follow-up.

Material and methods: This was a prospective MDRCT. For a pilot study, OETD (n = 10) and OME (n = 5) patients were recruited and followed. Detailed inclusion and exclusion criteria were used. Participants were randomized at beginning of the operation to active or sham surgery. All procedures were performed under local anesthesia. Controls were performed in double-blinded manner (both patient and physician), at 3 and 12 months after the procedure.

Results: Altogether, 20 ears were treated and followed for 12 months, including 14 active BETs and 6 sham surgeries. Both the active and sham surgery were performed under local anesthesia without problems or deviations from the protocol. There were no differences in the preoperative symptoms (ETDQ-7) or objective measures (tympanometry, Valsalva and Toynbee maneuvers, tubomanometry, Eustachian tube score) between active and sham surgery arms. During follow-up, we noticed largely similar reduction in subjective symptoms and improvement in Eustachian tube score both in active and sham surgery arms.

Conclusions: The pilot study demonstrates that our MDRCT protocol is feasible, and that blinded RCTs are dearly needed to objectively measure the efficacy of BET.

Level of evidence: 2 Laryngoscope, 134:1874-1881, 2024.

Keywords: Eustachian tube dysfunction; balloon Eustachian tuboplasty; placebo-controlled trial; sham surgery.

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References

BIBLIOGRAPHY

    1. Teklu M, Kulich M, Micco AG, et al. Measuring the health utility of chronic eustachian tube dysfunction. Laryngoscope. 2020;130(2):E39-e44. https://doi.org/10.1002/lary.27934.
    1. Schilder AG, Bhutta MF, Butler CC, et al. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol. 2015;40(5):407-411. https://doi.org/10.1111/coa.12475.
    1. Tucci DL, McCoul ED, Rosenfeld RM, et al. Clinical consensus statement: balloon dilation of the eustachian tube. Otolaryngol Head Neck Surg. 2019;161(1):6-17. https://doi.org/10.1177/0194599819848423.
    1. Finkelstein Y, Ophir D, Talmi YP, Shabtai A, Strauss M, Zohar Y. Adult-onset otitis media with effusion. Arch Otolaryngol Head Neck Surg. 1994;120(5):517-527. https://doi.org/10.1001/archotol.1994.01880290029006.
    1. Llewellyn A, Norman G, Harden M, et al. Interventions for adult eustachian tube dysfunction: a systematic review. Health Technol Assess. 2014;18(46):1-180, v-vi. https://doi.org/10.3310/hta18460.

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