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Erschienen in: European Archives of Oto-Rhino-Laryngology 7/2009

01.07.2009 | Otology

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

verfasst von: Ralph Mösges, Juliane Köberlein, Andreas Heibges, Bernard Erdtracht, Reinhard Klingel, Walter Lehmacher, for the RHEO-ISHL Study Group

Erschienen in: European Archives of Oto-Rhino-Laryngology | Ausgabe 7/2009

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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.
Literatur
6.
Zurück zum Zitat Burschka MA, Hassan HA, Reineke T, van Bebber L, Caird DM, Mösges R (2001) Effect of treatment with Ginkgo biloba extract EGb 761 (oral) on unilateral idiopathic sudden hearing loss in a prospective randomized double-blind study of 106 outpatients. Eur Arch Otorhinolaryngol 258(5):213–219. doi: 10.​1007/​s004050100343 PubMedCrossRef Burschka MA, Hassan HA, Reineke T, van Bebber L, Caird DM, Mösges R (2001) Effect of treatment with Ginkgo biloba extract EGb 761 (oral) on unilateral idiopathic sudden hearing loss in a prospective randomized double-blind study of 106 outpatients. Eur Arch Otorhinolaryngol 258(5):213–219. doi: 10.​1007/​s004050100343 PubMedCrossRef
8.
Zurück zum Zitat Cadoni G, Scipione S, Rocca B, Agostino S, La Greca C, Bonvissuto D, Paludetti G (2006) Lack of association between inherited thrombophilic risk factors and idiopathic sudden sensorineural hearing loss in Italian patients. Ann Otol Rhinol Laryngol 115(3):195–200 PubMed Cadoni G, Scipione S, Rocca B, Agostino S, La Greca C, Bonvissuto D, Paludetti G (2006) Lack of association between inherited thrombophilic risk factors and idiopathic sudden sensorineural hearing loss in Italian patients. Ann Otol Rhinol Laryngol 115(3):195–200 PubMed
11.
Zurück zum Zitat Selmani Z, Pyykko I, Ishizaki H, Marttila TI (2001) Cochlear blood flow measurement in patients with Meniere’s disease and other inner ear disorders. Acta Otolaryngol Suppl 545:10–13 PubMed Selmani Z, Pyykko I, Ishizaki H, Marttila TI (2001) Cochlear blood flow measurement in patients with Meniere’s disease and other inner ear disorders. Acta Otolaryngol Suppl 545:10–13 PubMed
12.
Zurück zum Zitat Hirano K, Ikeda K, Kawase T, Oshima T, Kekehata S, Takahashi S, Sato T, Kobayashi T, Takasaka T (1999) Prognosis of sudden deafness with special reference to risk factors of microvascular pathology. Auris Nasus Larynx 26(2):111–115. doi: 10.​1016/​S0385-8146(98)00072-8 PubMedCrossRef Hirano K, Ikeda K, Kawase T, Oshima T, Kekehata S, Takahashi S, Sato T, Kobayashi T, Takasaka T (1999) Prognosis of sudden deafness with special reference to risk factors of microvascular pathology. Auris Nasus Larynx 26(2):111–115. doi: 10.​1016/​S0385-8146(98)00072-8 PubMedCrossRef
14.
15.
Zurück zum Zitat Klemm E, Altmann E, Lange O (1983) Rheologische Probleme der Mikrozirkulation und Konsequenzen medikamentöser Hörsturztherapie. Laryngol Rhinol Otol (Stuttg) 62(2):62–64 CrossRef Klemm E, Altmann E, Lange O (1983) Rheologische Probleme der Mikrozirkulation und Konsequenzen medikamentöser Hörsturztherapie. Laryngol Rhinol Otol (Stuttg) 62(2):62–64 CrossRef
16.
Zurück zum Zitat Fowler EP Jr (1982) Intra-venule phenomena. Acta Otolaryngol 1961(53):107–115 Fowler EP Jr (1982) Intra-venule phenomena. Acta Otolaryngol 1961(53):107–115
17.
Zurück zum Zitat Maass B (1982) Innenohrdurchblutung-Anatomisch-funktionelle Betrachtungen. HNO 30(10):355–364 Blood supply of the internal ear—anatomico-functional considerations PubMed Maass B (1982) Innenohrdurchblutung-Anatomisch-funktionelle Betrachtungen. HNO 30(10):355–364 Blood supply of the internal ear—anatomico-functional considerations PubMed
18.
Zurück zum Zitat Lazarini PR, Camargo AC (2006) Idiopathic sensorineural hearing loss: etiopathogenic aspects. Rev Bras Otorrinolaringol (Engl Ed) 72(4):554–561 Lazarini PR, Camargo AC (2006) Idiopathic sensorineural hearing loss: etiopathogenic aspects. Rev Bras Otorrinolaringol (Engl Ed) 72(4):554–561
20.
Zurück zum Zitat Suckfüll M, Thiery J, Wimmer C, Mees K, Schorn K (1997) Hypercholesterinämie und Hyperfibrinogenämie beim Hörsturz. Laryngorhinootologie 76(8):453–457 Hypercholesteremia and hyperfibrinogenemia in sudden deafness PubMedCrossRef Suckfüll M, Thiery J, Wimmer C, Mees K, Schorn K (1997) Hypercholesterinämie und Hyperfibrinogenämie beim Hörsturz. Laryngorhinootologie 76(8):453–457 Hypercholesteremia and hyperfibrinogenemia in sudden deafness PubMedCrossRef
23.
Zurück zum Zitat Klingel R, Fassbender C, Fassbender T, Göhlen B (2003) Clinical studies to implement Rheopheresis for age-related macular degeneration guided by evidence-based-medicine. Transfus Apheresis Sci 29(1):71–84. doi: 10.​1016/​S1473-0502(03)00101-0 CrossRef Klingel R, Fassbender C, Fassbender T, Göhlen B (2003) Clinical studies to implement Rheopheresis for age-related macular degeneration guided by evidence-based-medicine. Transfus Apheresis Sci 29(1):71–84. doi: 10.​1016/​S1473-0502(03)00101-0 CrossRef
24.
25.
Zurück zum Zitat Suzuki H, Furukawa M, Kumagai M, Takahasi E, Matsuura K, Katori Y, Shimomura A, Kobayashi T (2003) Defibrinogenation therapy for idiopathic sensorineural hearing loss in comparison with high-dose steroid therapy. Acta Otolaryngol 123(1):46–50. doi: 10.​1080/​0036554021000028​082 PubMedCrossRef Suzuki H, Furukawa M, Kumagai M, Takahasi E, Matsuura K, Katori Y, Shimomura A, Kobayashi T (2003) Defibrinogenation therapy for idiopathic sensorineural hearing loss in comparison with high-dose steroid therapy. Acta Otolaryngol 123(1):46–50. doi: 10.​1080/​0036554021000028​082 PubMedCrossRef
27.
Zurück zum Zitat Alexiou C, Arnold W, Fauser C, Schratzenstaller B, Gloddek B, Fuhrmann S, Lamm K (2001) Sudden sensorineural hearing loss: does application of glucocorticoids make sense? Arch Otolaryngol Head Neck Surg 127(3):253–258 PubMed Alexiou C, Arnold W, Fauser C, Schratzenstaller B, Gloddek B, Fuhrmann S, Lamm K (2001) Sudden sensorineural hearing loss: does application of glucocorticoids make sense? Arch Otolaryngol Head Neck Surg 127(3):253–258 PubMed
28.
Zurück zum Zitat DIN 45621-1, Freiburger Sprachtest, Sprache für Gehörprüfung-Teil 1: Ein-und mehrsilbige Wörter (1995) DIN 45621-2, Sprache für Gehörprüfung-Teil 2: Sätze, (1980) DIN 45621-1, Freiburger Sprachtest, Sprache für Gehörprüfung-Teil 1: Ein-und mehrsilbige Wörter (1995) DIN 45621-2, Sprache für Gehörprüfung-Teil 2: Sätze, (1980)
29.
Zurück zum Zitat Guideline for ISHL of the German Society for Otorhinolaryngology Head and Neck Surgery (Dt. Ges. f. HNO-Heilkunde KuH-C). (2004) AWMF guidelines No. 017/010. http://​www.​awmf.​org Guideline for ISHL of the German Society for Otorhinolaryngology Head and Neck Surgery (Dt. Ges. f. HNO-Heilkunde KuH-C). (2004) AWMF guidelines No. 017/010. http://​www.​awmf.​org
31.
Zurück zum Zitat Kubo T, Matsunaga T, Asai H, Kawamoto K, Kusakari J, Nomura Y, Oda M, Yanagita N, Niwa H, Uemura T (1988) Efficacy of defribinogenation and steroid therapies on sudden deafness. Arch Otolaryngol Head Neck Surg 114(6):649–652 PubMed Kubo T, Matsunaga T, Asai H, Kawamoto K, Kusakari J, Nomura Y, Oda M, Yanagita N, Niwa H, Uemura T (1988) Efficacy of defribinogenation and steroid therapies on sudden deafness. Arch Otolaryngol Head Neck Surg 114(6):649–652 PubMed
32.
Zurück zum Zitat Probst R, Tschopp K, Ludin E, Kellerhals B, Podvinec M, Pfaltz CR (1992) A randomized, double-blind, placebo-controlled study of dextran/pentoxifylline medication in acute acoustic trauma and sudden hearing loss. Acta Otolaryngol 112:435–443. doi: 10.​3109/​0001648920913742​4 PubMedCrossRef Probst R, Tschopp K, Ludin E, Kellerhals B, Podvinec M, Pfaltz CR (1992) A randomized, double-blind, placebo-controlled study of dextran/pentoxifylline medication in acute acoustic trauma and sudden hearing loss. Acta Otolaryngol 112:435–443. doi: 10.​3109/​0001648920913742​4 PubMedCrossRef
33.
Zurück zum Zitat Klemm E, Bepperling F, Burschka MA, Mösges R, Study Group (2007) Hemodilution therapy with hydroxyethyl starch solution (130/0.4) in unilateral idiopathic sudden sensorineural hearing loss: a dose-finding, double-blind, placebo-controlled, international multicenter trial with 210 patients. Otol Neurotol 28(2):157–170. doi: 10.​1097/​01.​mao.​0000231502.​54157.​ad Klemm E, Bepperling F, Burschka MA, Mösges R, Study Group (2007) Hemodilution therapy with hydroxyethyl starch solution (130/0.4) in unilateral idiopathic sudden sensorineural hearing loss: a dose-finding, double-blind, placebo-controlled, international multicenter trial with 210 patients. Otol Neurotol 28(2):157–170. doi: 10.​1097/​01.​mao.​0000231502.​54157.​ad
37.
Zurück zum Zitat Rajagopalan L, Greeson JN, Xia A, Liu H, Sturm A, Raphael RM, Davidson AL, Oghalai JS, Pereira FA, Brownell WE (2007) Tuning of the outer hair cell motor by membrane cholesterol. J Biol Chem 282(5):36659–36670. doi: 10.​1074/​jbc.​M705078200 PubMedCrossRef Rajagopalan L, Greeson JN, Xia A, Liu H, Sturm A, Raphael RM, Davidson AL, Oghalai JS, Pereira FA, Brownell WE (2007) Tuning of the outer hair cell motor by membrane cholesterol. J Biol Chem 282(5):36659–36670. doi: 10.​1074/​jbc.​M705078200 PubMedCrossRef
39.
Zurück zum Zitat Canis M, Heigl F, Hettich R, Osterkorn D, Osterkorn K, Suckfuell M (2008) H.E.L.P.-Apherese bei der Behandlung des Hörsturzes—Eine Anwendungsbeobachtung an 152 Patienten. HNO 9:961–966. doi: 10.​1007/​s00106-008-1818-7 CrossRef Canis M, Heigl F, Hettich R, Osterkorn D, Osterkorn K, Suckfuell M (2008) H.E.L.P.-Apherese bei der Behandlung des Hörsturzes—Eine Anwendungsbeobachtung an 152 Patienten. HNO 9:961–966. doi: 10.​1007/​s00106-008-1818-7 CrossRef
Metadaten
Titel
Rheopheresis for idiopathic sudden hearing loss: results from a large prospective, multicenter, randomized, controlled clinical trial
verfasst von
Ralph Mösges
Juliane Köberlein
Andreas Heibges
Bernard Erdtracht
Reinhard Klingel
Walter Lehmacher
for the RHEO-ISHL Study Group
Publikationsdatum
01.07.2009
Verlag
Springer-Verlag
Erschienen in
European Archives of Oto-Rhino-Laryngology / Ausgabe 7/2009
Print ISSN: 0937-4477
Elektronische ISSN: 1434-4726
DOI
https://doi.org/10.1007/s00405-008-0823-5