Evidence map›Paper›PMID 24841917›Full record

ArticleOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology2014

Controlled release dexamethasone implants in the round window niche for salvage treatment of idiopathic sudden sensorineural hearing loss.

Stefan K Plontke, Alexander Glien, Torsten Rahne, Karsten Mäder, Alec N Salt

Open access · greenAbstract read
In one paragraph

Article in Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
1.8field-weighted citation impact, top 15% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Hearing Changes After Intratympanic Steroids for Secondary (Salvage) Therapy of Sudden Hearing Loss: A Meta-Analysis Using Mathematical Simulations of Drug Delivery Protocols.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2018
    Pooled it
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Intratympanic steroid use for idiopathic sudden sensorineural hearing loss: current otolaryngology practice in Germany and Austria.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 · 2018
    Article
  19. Article
  20. Diagnostics and therapy of sudden hearing loss.GMS current topics in otorhinolaryngology, head and neck surgery · 2017
    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

5 authors at 3 institutions in 2 countries.

Stefan K Plontke*Department of Otorhinolaryngology-Head and Neck Surgery, University of Halle-Wittenberg, Halle (Saale); †Institute of Pharmacy, Pharmaceutics and Biopharmaceutics, Pharmaceutical Technology Group, University of Halle-Wittenberg, Halle (Saale), Germany; and ‡Department of Otolaryngology, Washington University School of Medicine, St. Louis, Missouri, U.S.A.
Alexander Glien
Torsten Rahne
Karsten Mäder
Alec N Salt
Wittenberg University · USMartin Luther University Halle-Wittenberg · DEWashington University in St. Louis · US

Funding

INNER EAR FLUID INTERACTIONSR01DC001368 · NIDCD · WASHINGTON UNIVERSITY · PI SALT, ALEC N · 1992 to 2019
$6.9M
NIDCD NIH HHS R01 DC001368NIDCD NIH HHS R01DC01368
6 · The paper itself

Abstract

objectiveTo evaluate the feasibility and hearing outcome of a biocompatible degradable dexamethasone releasing implant for continuous drug delivery to the round window membrane in patients with idiopathic sudden sensorineural hearing loss (ISSHL) and insufficient recovery after systemic high dose glucocorticoid therapy. PATIENTS: Five patients with profound or moderate-to-severe hearing loss after systemic high-dose prednisolone for ISSHL received local salvage therapy with a controlled release dexamethasone implant in the middle ear.

interventionPieces of a sterile rod shaped poly(D,L-lactide-co-glycolide) PLGA polymer matrix containing a total of 0.7 mg dexamethasone, which is approved for intravitreal use were implanted into the round window niche. MAIN OUTCOME MEASURE(S): Intraoperative handling and feasibility and hearing recovery as measured by change in pure tone threshold, final word recognition score, and categories of improvement were evaluated.

resultsThe implants were surgically placed without major difficulties. The mean hearing threshold significantly improved at follow up by 31 ± 31 dB HL (from 94 ± 27 to 63 ± 36 dB HL; p < 0.05). Two of five patients recovered completely. One patient showed partial hearing recovery with serviceable hearing.

conclusionAlthough no drugs are currently approved for local therapy of inner ear disorders, there is increasing evidence that intratympanic glucocorticoids are effective as salvage therapy in ISSHL. The present study has shown encouraging results with a biodegradable polymer delivery system, demonstrating the translation of preclinical studies with controlled drug delivery into clinical practice.

Indexed as

AgedAudiometry, Pure-ToneDelayed-Action PreparationsDexamethasoneDrug Delivery SystemsFemaleGlucocorticoidsHearing Loss, SensorineuralHearing Loss, SuddenHearing TestsHumansMaleMiddle AgedRound Window, EarTreatment OutcomeTympanic MembraneDelayed-Action PreparationsDexamethasoneGlucocorticoids

Identifiers

PMID24841917
PMCPMC4134359
OpenAlexW2325892523

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.