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Rheopheresis for idiopathic sudden hearing loss: results from a large prospective, multicenter, randomized, controlled clinical trial

  • Otology
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European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Idiopathic sudden hearing loss (ISHL) has been suggested to precipitate as final common pathway of microcirculatory impairment of the inner ear associated with a variety of etiologies and characterized by a local hyperviscosity syndrome in cochlear vessels. Therefore, we investigated the effect of Rheopheresis, a method of therapeutic apheresis reducing plasma viscosity and improving microcirculation on hearing recovery. Patients were randomly assigned to receive two Rheopheresis treatments, or treatment according to current German guidelines consisting either of i.v. corticosteroids (methylprednisolon 250 mg for 3 days and subsequent oral dosing with tapering to zero) or i.v. hemodilution (500 mL 6% hydroxyethyl starch plus 600 mg pentoxifylline per day), each applied for 10 days. The primary outcome parameter was absolute recovery of hearing as measured by pure tone audiometry 10 days after the start of treatment. Secondary outcomes were recovery of hearing at day 42, the improvement of speech audiometry, tinnitus and feeling of pressure and the frequency of adverse events. In total, 240 patients with sudden hearing loss were enrolled from otorhinolaryngological departments at hospitals as well as out-patient clinics in Germany. Analysis was performed for the intention-to-treat as well as per protocol population. Mean absolute recovery of hearing on day 10 within the intention-to-treat population (ITT, n = 193) was 23.95 dB (SD 15.05) in the Rheopheresis group and 24.29 dB (SD 15.48) in the control group. Equal efficacy of Rheopheresis and tested standard treatments was demonstrated (P = 0.00056). Single Rheopheresis led to a higher recovery of hearing after 48 h in patients with high plasma viscosity (>1.8 mPas s; P = 0.029) or high total protein (>74 g/dL; P = 0.02). However, an overall good recovery of ISHL was observed with none of the tested therapies being superior regarding the primary outcome parameter. Improvement of health-related quality of life as documented by the SF36 was higher in the Rheopheresis group, exhibiting a significant difference for the physical summary scale at the final follow-up at day 42 (P = 0.006). In conclusion, Rheopheresis proved to be an effective treatment option within the ENT armamentarium for ISHL. Two Rheopheresis treatments within 3 days lasting for about 2 h each could be used to replace a 10-day infusion regimen, especially in patients who desire fast recovery from acute hearing loss. Also, this may be a second line treatment option for patients refractory to i.v. corticosteroids or hemodilution.

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Acknowledgments

This study was supported financially by the Hans and Marlies Stock Foundation for Science and Research, Art and Culture, Cologne within the Stifterverband für die Deutsche Wissenschaft and Asahi Kasei Kuraray Medical Co., Ltd, Tokyo, Japan.

Study group

J. Floege, A. Nachtsheim, N. Pasch, M. Sondermann, Aachen; P. Tolsdorff, Bad Honneff; H. Scherer, W. Zidek, Berlin; K.A. Brensing, H. Wischerath, Bonn; A. Schadel, Darmstadt; J. Spaeth, B. Wölbert, Düren; J. Schlee, Eschweiler; W. Grotz, J. Lamprecht, Essen; T. Tsobanelis, W. von Heimburg, Frankfurt; P. Breitenberger, Germering; R. Budde, Haltern; R. Königsberger, Herrsching; H. Köhler, Homburg/Saar; P. Brendt, M. Lenzenhuber, W. Schütz, Jülich; H. Christ, B. Göhlen, A. Heibges, W. Lehmacher, U. Parpart, C·F. Peerenboom-Fey, T. Shahab, P. Schmalz, Cologne; S. Zymolka, Ludwigsfelde; U. Schirmböck, Ludwigshafen; H. Davids, H. Kingreen, H. Scholz, Lüdenscheid; K. Hörmann, A. Schwarzbeck, Mannheim; K. Frey, M. Schmidt, Marl; A. Goldmann, H. Seidler, Neunkirchen; K·H. Götz, I. Großmann, H. Künne, C. Mai, Neuruppin; K·H. Ahrens, V. Gläser, Plauen; G. Hartmann, Potsdam; T. Risler, H·P. Zenner, Tübingen; F·C. Burkart, Radolfzell; G. Schindlbeck, Viernheim.

Conflict of interest statement

Ralph Mösges has served as scientific advisor to Apheresis Research Institute and has received honoraria for lecturing. Reinhard Klingel received research funds from Diamed Medizintechnik GmbH, Cologne, Germany and Asahi Kasei Kuraray Medical Co., Ltd., Tokyo, Japan.

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Authors and Affiliations

  1. Institute of Medical Statistics, Informatics und Epidemiology, University of Cologne, Lindenburger Allee 42, 50931, Cologne, Germany

    Ralph Mösges, Juliane Köberlein & Walter Lehmacher

  2. Apheresis Research Institute, Cologne, Germany

    Andreas Heibges & Reinhard Klingel

  3. Rheopheresis Center, Cologne, Germany

    Bernard Erdtracht

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  1. Ralph Mösges
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  2. Juliane Köberlein
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for the RHEO-ISHL Study Group

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Correspondence to Ralph Mösges.

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Mösges, R., Köberlein, J., Heibges, A. et al. Rheopheresis for idiopathic sudden hearing loss: results from a large prospective, multicenter, randomized, controlled clinical trial. Eur Arch Otorhinolaryngol 266, 943–953 (2009). https://doi.org/10.1007/s00405-008-0823-5

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