Evidence map›Paper›PMID 29912819›Full record

Trial reportOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology2018

A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up.

Ted A Meyer, Ellen M O'Malley, Rodney J Schlosser, Zachary M Soler, Jason Cai, Mark J Hoy, Patrick W Slater, Jeffrey L Cutler, Roger J Simpson, Michael J Clark and 4 more

3 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 35 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 4 pooled it
7.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02391584 nacompletednot on this map

XprESS Eustachian Tube Dilation Study

TypeinterventionalSponsorEntellus Medical, Inc.Ran2015 to 2017Enrolled60ConditionsEustachian Tube DysfunctionArmsXprESS, Control
NCT03886740 nawithdrawnnot on this mapstarted 2019, after this paper: background citation

Tympanostomy Tubes Versus Eustachian Tube Dilation

TypeinterventionalSponsorColumbia UniversityRan2019 to 2021Enrolled0ConditionsEustachian Tube Dysfunction, Eustachian Tube Dysfunction of Left Ear, Eustachian Tube Dysfunction of Right Ear (Diagnosis), Eustachian Tube Dysfunction of Both Ears (Diagnosis)ArmsReducing symptoms of Eustachian tube dysfunction
NCT05600595 unknown statusnot on this mapstarted 2022, after this paper: background citation

The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring in Children

TypeobservationalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2022 to 2024Enrolled450ConditionsAdenoidectomy, Tonsillectomy, Eustachian Tube DysfunctionArmsOperation for snoring in children
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 4 syntheses or guidelines pooled it, 99 citations in OpenAlex.

  1. Pooled it
  2. Effect of balloon dilatation among adult population with eustachian tube dysfunction: a systematic review.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Pooled it
  3. [Balloon Eustachian tuboplasty for treatment of Eustachian tube dysfunction: A systematic review and Meta-analysis].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2020
    Pooled it
  4. Balloon Dilation for Chronic Eustachian Tube Dysfunction Under Local and General Anesthesia: A Systematic Review and Meta-Analysis.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Balloon dilation improves both the hearing level and the quality of life in patients suffering from obstructive Eustachian tube dysfunction.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Article
  15. Balloon dilation improves both the hearing level and the quality of life in patients suffering from obstructive Eustachian tube dysfunction.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 4 institutions in 2 countries.

Ted A MeyerDepartment of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.
Ellen M O'MalleyEntellus Medical, Inc., Plymouth, Minnesota.
Rodney J SchlosserDepartment of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.
Zachary M SolerDepartment of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.
Jason CaiNorth American Science Associates (NAMSA), Shanghai, China.
Mark J HoyDepartment of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.
Patrick W SlaterAustin Ear Clinic, Austin, Texas.
Jeffrey L CutlerColorado Sinus Institute, Denver, Colorado.
Roger J SimpsonEar Nose Throat and Sinus Clinic, LLC, North Platte, Nebraska.
Michael J ClarkDonald Guthrie Foundation, Sayre, Pennsylvania.
Habib G RizkDepartment of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.
Theodore R McRackanDepartment of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.
Christopher F D'EspositoDepartment of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.
Shaun A NguyenDepartment of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina.
Medical University of South Carolina · USGuthrie Foundation · USNAMSA (France) · FROhio Sinus Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveCompare Eustachian tube balloon dilation versus continued medical therapy (control) for treating persistent Eustachian tube dysfunction (ETD). STUDY

designProspective, multicenter, randomized controlled trial.

settingTertiary care academic center and private practice. PATIENTS: Diagnosed with medically refractory persistent ETD.

interventions1:1 Randomization to balloon dilation or control. After 6 weeks, control participants had the option to undergo balloon dilation if symptoms persisted.

main outcome measuresPrimary efficacy endpoint was the comparison between treatment arms in the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Primary safety endpoint was complication rate.

resultsSixty participants were randomized (31 balloon dilation, 29 control). Mean (SD) change in overall ETDQ-7 score at 6 weeks was -2.9 (1.4) for balloon dilation compared with -0.6 (1.0) for control: balloon dilation was superior to control (p < 0.0001). No complications were reported in either study arm. Among participants with abnormal baseline assessments, improvements in tympanogram type (p < 0.006) and tympanic membrane position (p < 0.001) were significantly better for balloon dilation than control. Technical success was 100% (91 successful dilations/91 attempts) and most procedures (72%) were completed in the office under local anesthesia. Improvements in the ETDQ-7 scores were maintained through 12 months after balloon dilation.

conclusionsBalloon dilation is a safe and effective treatment for persistent ETD. Based on improved ETDQ-7 scores, balloon dilation is superior to continued medical management for persistent ETD. Symptom improvement is durable through a minimum of 12 months. Procedures are well tolerated in the office setting under local anesthesia.

Indexed as

Eustachian TubeAdultAgedDilatationEar DiseasesFemaleFollow-Up StudiesHearing TestsHumansMaleMiddle AgedPatient SatisfactionProspective StudiesTreatment Outcome

Identifiers

PMID29912819
PMCPMC6075883
OpenAlexW2808159977

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.