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Abstract

Background

Systemic glucocorticoids are commonly used for primary therapy of idiopathic sudden sensorineural hearing loss (ISSNHL). However, the comparative effectiveness and risk profiles of high-dose over lower-dose regimens remain unknown.

Methods

We randomly assigned patients with sudden hearing loss of greater than or equal to 50 dB within 7 days from onset to receive either 5 days of high-dose intravenous prednisolone at 250 mg/d (HD-Pred), 5 days of high-dose oral dexamethasone at 40 mg/d (HD-Dex), or, as a control, 5 days of oral prednisolone (Pred-Control) at 60 mg/d followed by 5 days of tapering doses. The primary outcome was the change in hearing threshold (pure tone average) in the three most affected contiguous frequencies from baseline to day 30. Secondary outcomes included speech understanding, tinnitus, communication competence, quality of life, hypertension, and insulin resistance.

Results

A total of 325 patients were randomly assigned. Mean change in 3PTAmost affected hearing threshold from baseline to 30 days was 34.2 dB (95% CI, 28.4 to 40.0) in the HD-Pred group, 41.4 dB (95% CI, 35.6 to 47.2) in the HD-Dex group, and 41.0 dB (95% CI, 35.2 to 46.8) in the Pred-Control group (P=0.09 for analysis of variance). There were more adverse events related to trial medication in the HD-Pred (n=73) and HD-Dex (n=76) groups than in the Pred-Control group (n=46).

Conclusions

Systemic high-dose glucocorticoid therapy was not superior to a lower-dose regimen in patients with ISSNHL, and it was associated with a higher risk of side effects. (Funded by the Federal Ministry of Education and Research [BMBF]; EudraCT number, 2015‐002602‐36.)

Notes

A data sharing statement provided by the authors is available with the full text of this article at evidence.nejm.org.
Disclosure forms provided by the authors are available with the full text of this article.

Supplementary Material

Protocol (evidoa2300172_protocol.pdf)
Supplementary Appendix (evidoa2300172_appendix.pdf)
Disclosure Forms (evidoa2300172_disclosures.pdf)
Data Sharing Statement (evidoa2300172_data-sharing.pdf)

Information & Authors

Information

Published In

History

Published online: December 26, 2023
Published in issue: January 1, 2024

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Authors

Affiliations

Stefan K. Plontke, M.D. [email protected]
Department of Otorhinolaryngology, Head & Neck Surgery, University Medicine Halle, Halle (Saale), Germany
Matthias Girndt, M.D.
Department of Internal Medicine, University Medicine Halle, Halle (Saale), Germany
Christoph Meisner, Ph.D.
Robert Bosch Society for Medical Research, Robert Bosch Hospital, Stuttgart, Germany
Imma Fischer, Ph.D.
Institute for Clinical Epidemiology and Applied Biometry, University of Tübingen, Tübingen, Germany
Iris Böselt, Ph.D.
Coordination Centre for Clinical Trials, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany
Jan Löhler, M.D.
Scientific Institute for Applied Oto-Rhino-Laryngology of the German Professional Association of ENT Surgeons, Bad Bramstedt, Germany
Beatrice Ludwig-Kraus, M.D.
Department of Laboratory Medicine, Central Laboratory, University Hospital Halle, Halle (Saale), Germany
Michael Richter, Ph.D.
Coordination Centre for Clinical Trials, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany
Jörg Steighardt, Ph.D.
Coordination Centre for Clinical Trials, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany
Bernd Reuter, M.D.
Department of Otorhinolaryngology/Plastic Surgery, SRH Zentralklinikum Suhl, Suhl, Germany
Christoph Böttcher, M.D.
Department of Otorhinolaryngology/Plastic Surgery, SRH Zentralklinikum Suhl, Suhl, Germany
ENT Practice, Bad Neustadt, Germany
Jörg Langer, M.D.
ENT Department, AMEOS Clinic Halberstadt, Halberstadt, Germany
Wolfram Pethe, M.D.
ENT Department, AMEOS Clinic Halberstadt, Halberstadt, Germany
Ingmar Seiwerth, M.D.
Department of Otorhinolaryngology, Head & Neck Surgery, University Medicine Halle, Halle (Saale), Germany
Nebojsa Jovanovic, M.D.
Department of Otorhinolaryngology, Head and Neck Surgery, Plastic Surgery, University Hospital of Giessen and Marburg, Giessen, Germany
Wilma Großmann, M.D.
Department of Otorhinolaryngology, Head and Neck Surgery “Otto Körner,” Rostock University Medical Center, Rostock, Germany
Andrea Kienle-Gogolok, M.D., M.Sc.
ENT Practice, Bad Schönborn, Germany
Andreas Boehm, M.D.
ENT Department, Hospital St. Georg gGmbH, Leipzig, Germany
Marcus Neudert, M.D.
Department of Otorhinolaryngology, Head and Neck Surgery, Technical University Dresden, Faculty of Medicine and University Hospital Carl Gustav Carus, Dresden, Germany
Marc Diensthuber, M.D.
Department of Otorhinolaryngology, Goethe University Frankfurt, University Hospital, Frankfurt, Germany
Andreas Müller, M.D.
Department Otorhinolaryngology/Plastic Surgery, SRH Wald-Klinikum Gera gGmbH, Gera, Germany
Stefan Dazert, M.D.
Department of Otorhinolaryngology, Head and Neck Surgery, St. Elisabeth Hospital, Ruhr University Bochum, Bochum, Germany
Orlando Guntinas-Lichius, M.D.
Department of Otorhinolaryngology, Jena University Hospital, Jena, Germany
Joachim Hornung, M.D.
Department of Otorhinolaryngology and Head and Neck Surgery, University of Erlangen-Nuremberg, Erlangen, Germany
Veronika Vielsmeier, M.D.
Department of Otorhinolaryngology, University of Regensburg, Regensburg, Germany
Joachim Stadler, M.D.
Department of Otorhinolaryngology, Head and Neck Surgery, Heinrich-Braun-Klinikum gGmbH, Zwickau, Germany
Torsten Rahne, Ph.D.
Department of Otorhinolaryngology, Head & Neck Surgery, University Medicine Halle, Halle (Saale), Germany
HODOKORT Trial Investigators*

Notes

Dr. Plontke can be contacted at [email protected] or at the Department of Otorhinolaryngology, Head & Neck Surgery, Martin Luther University Halle-Wittenberg, Ernst Grube Str. 40, 06120 Halle (Saale), Germany.
*
A complete list of the investigators in the HODOKORT trial (Studie zur Wirksamkeit und Sicherheit der HOchDOsis-GlukoKORTikoid-Therapie beim akuten, idiopathischen, sensorineuralen Hörverlust [Efficacy and safety of high dose glucocorticoid therapy for idopathic sudden sensorineural hearing loss]) is provided in the Supplementary Appendix, available at evidence.nejm.org.

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  1. High-Dose Glucocorticoids for Treating Sudden Hearing Loss: Cart before the Horse?, NEJM Evidence, 3, 1, (2023)./doi/full/10.1056/EVIDe2300296
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