Skip to main content

Advertisement

SpringerLink
Log in

The efficacy and safety of systemic injection of Ginkgo biloba extract, EGb761, in idiopathic sudden sensorineural hearing loss: a randomized placebo-controlled clinical trial

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

Abstract

Steroids are currently the most frequently accepted agents for idiopathic sudden sensorineural hearing loss (ISSNHL). However, the therapeutic effect of steroids is not always satisfactory. In this pilot study, we evaluated whether systemic treatment with Ginkgo biloba extract (EGb761) has an additive therapeutic effect in patients receiving a systemic steroid due to ISSNHL. A multicenter, randomized, double-blind clinical trial was performed. Fifty-six patients with ISSNHL were allocated to either EGb761 or placebo. In both groups, methylprednisolone was administered for 14 days. EGb761 was infused intravenously for 5 days in the EGb761 group, while the same amount of normal saline was infused in the placebo group. For the efficacy evaluation, pure-tone audiometry, speech audiometry, tinnitus handicap inventory (THI) and short form-36 health (SF-36) survey outcomes were obtained before administration and on days 3, 5, 14 and 28 of administration. Twenty-four patients in each group completed the study protocol. There was no difference in hearing loss between the two groups before treatment. At day 28, air conduction threshold values in the placebo and EGb761 groups were 34.63 ± 28.90 and 23.84 ± 25.42 dB, respectively (p = 0.082). Speech discrimination scores in the placebo and EGb761 groups were 69.17 ± 40.89 and 87.48 ± 28.65 %, respectively (p = 0.050). THI and SF-36 scores in the placebo and EGb761 groups were similar. Although a combination of steroid and EGb761 for initial treatment did not show better pure tone threshold, compared with steroid alone, speech discrimination was significantly improved in combination therapy. Further studies will be needed to know if addition of EGb761 actually improves the outcome of ISSNHL treatment.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Stachler RJ, Chandrasekhar SS, Archer SM, Rosenfeld RM, Schwartz SR, Barrs DM, Brown SR, Fife TD, Ford P, Ganiats TG, Hollingsworth DB, Lewandowski CA, Montano JJ, Saunders JE, Tucci DL, Valente M, Warren BE, Yaremchuk KL, Robertson PJ (2012) Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg 146:S1–S35

    Article  PubMed  Google Scholar 

  2. Byl FM (1977) Seventy-six cases of presumed sudden hearing loss occurring in 1973: prognosis and incidence. Laryngoscope 87:817–825

    Article  CAS  PubMed  Google Scholar 

  3. Byl FM Jr (1984) Sudden hearing loss: 8 years’ experience and suggested prognostic table. Laryngoscope 94:647–661

    Article  PubMed  Google Scholar 

  4. Klemm E, Deutscher A, Mosges R (2009) A present investigation of the epidemiology in idiopathic sudden sensorineural hearing loss. Laryngorhinootologie 88:524–527

    Article  CAS  PubMed  Google Scholar 

  5. Lazarini PR, Camargo AC (2006) Idiopathic sudden sensorineural hearing loss: etiopathogenic aspects. Braz J Otorhinolaryngol 72:554–561

    Article  PubMed  Google Scholar 

  6. Mattox DE, Simmons FB (1977) Natural history of sudden sensorineural hearing loss. Ann Otol Rhinol Laryngol 86:463–480

    Article  CAS  PubMed  Google Scholar 

  7. Shin SO (2007) Clinical Characteristics of Sudden Deafness and Therapeutic Approach Otorhinolaryngology Seoul Symposium. pp 108–117

  8. Carlsson PI, Hall M, Lind KJ, Danermark B (2011) Quality of life, psychosocial consequences, and audiological rehabilitation after sudden sensorineural hearing loss. Int J Audiol 50:139–144

    Article  PubMed  Google Scholar 

  9. Chiossoine-Kerdel JA, Baguley DM, Stoddart RL, Moffat DA (2000) An investigation of the audiologic handicap associated with unilateral sudden sensorineural hearing loss. Am J Otol 21:645–651

    CAS  PubMed  Google Scholar 

  10. Mosges R, Koberlein J, Erdtracht B, Klingel R (2008) Quality of life in patients with idiopathic sudden hearing loss: comparison of different therapies using the Medical Outcome Short Form (36) Health Survey questionnaire. Otol Neurotol 29:769–775

    Article  PubMed  Google Scholar 

  11. Wilson WR, Byl FM, Laird N (1980) The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Arch Otolaryngol 106:772–776

    Article  CAS  PubMed  Google Scholar 

  12. Conlin AE, Parnes LS (2007) Treatment of sudden sensorineural hearing loss: I. A systematic review. Arch Otolaryngol Head Neck Surg 133:573–581

    Article  PubMed  Google Scholar 

  13. Conlin AE, Parnes LS (2007) Treatment of sudden sensorineural hearing loss: II. A Meta-analysis. Arch Otolaryngol Head Neck Surg 133:582–586

    Article  PubMed  Google Scholar 

  14. Nosrati-Zarenoe R, Hultcrantz E (2012) Corticosteroid treatment of idiopathic sudden sensorineural hearing loss: randomized triple-blind placebo-controlled trial. Otol Neurotol 33:523–531

    Article  PubMed  Google Scholar 

  15. Wei BP, Mubiru S, O’Leary S (2006) Steroids for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev 1:Cd003998

  16. Wei BP, Stathopoulos D, O’Leary S (2013) Steroids for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev 7:Cd003998

    PubMed  Google Scholar 

  17. Xenellis J, Papadimitriou N, Nikolopoulos T, Maragoudakis P, Segas J, Tzagaroulakis A, Ferekidis E (2006) Intratympanic steroid treatment in idiopathic sudden sensorineural hearing loss: a control study. Otolaryngol Head Neck Surg 134:940–945

    Article  PubMed  Google Scholar 

  18. Kellerhals B, Hippert F, Pfaltz CR (1971) Treatment of acute acoustic trauma with low molecular weight dextran. Pract Otorhinolaryngol (Basel) 33:260–264

    CAS  Google Scholar 

  19. Singleton GT (1971) Cervical sympathetic chain block in sudden deafness. Laryngoscope 81:734–736

    Article  CAS  PubMed  Google Scholar 

  20. McCabe BF (2007) Autoimmune sensorineural hearing loss. Ann Otol Rhinol Laryngol 116:875–879

    PubMed  Google Scholar 

  21. Fowler EP (1950) Sudden deafness. Ann Otol Rhinol Laryngol 59:980–987

    Article  CAS  PubMed  Google Scholar 

  22. Hallberg OE (1956) Sudden deafness of obscure origin. Laryngoscope 66:1237–1267

    Article  CAS  PubMed  Google Scholar 

  23. Haberkamp TJ, Tanyeri HM (1999) Management of idiopathic sudden sensorineural hearing loss. Am J Otol 20:587–592 (discussion 593–595)

    CAS  PubMed  Google Scholar 

  24. Hoffmann F, Beck C, Schutz A, Offermann P (1994) Ginkgo extract EGb 761 (tenobin)/HAES versus naftidrofuryl (Dusodril)/HAES. A randomized study of therapy of sudden deafness. Laryngorhinootologie 73:149–152

    Article  CAS  PubMed  Google Scholar 

  25. Reisser CH, Weidauer H (2001) Ginkgo biloba extract EGb 761 or pentoxifylline for the treatment of sudden deafness: a randomized, reference-controlled, double-blind study. Acta Otolaryngol 121:579–584

    Article  CAS  PubMed  Google Scholar 

  26. Byun JY, Cho Y, Chu H, Park S, Han GC, Cheon BC, Shin JE, Chung JW, Chai SW, Choi JY (2011) Standardization for a Korean Version of Chronic Ear Survey: translation and verification of validity and reliability. Korean J Otorhinolaryngol Head Neck Surg 54:755–760

    Article  Google Scholar 

  27. Cinamon U, Bendet E, Kronenberg J (2001) Steroids, carbogen or placebo for sudden hearing loss: a prospective double-blind study. Eur Arch Otorhinolaryngol 258:477–480

    Article  CAS  PubMed  Google Scholar 

  28. Labus J, Breil J, Stutzer H, Michel O (2010) Meta-analysis for the effect of medical therapy vs. placebo on recovery of idiopathic sudden hearing loss. Laryngoscope 120:1863–1871

    Article  PubMed  Google Scholar 

  29. Cole RR, Jahrsdoerfer RA (1988) Sudden hearing loss: an update. Am J Otol 9:211–215

    CAS  PubMed  Google Scholar 

  30. Shikowitz MJ (1991) Sudden sensorineural hearing loss. Med Clin North Am 75:1239–1250

    Article  CAS  PubMed  Google Scholar 

  31. Thurmond M, Amedee RG (1998) Sudden sensorineural hearing loss: etiologies and treatments. J La State Med Soc 150:200–203

    CAS  PubMed  Google Scholar 

  32. Fisch U, Nagahara K, Pollak A (1984) Sudden hearing loss: circulatory. Am J Otol 5:488–491

    CAS  PubMed  Google Scholar 

  33. Miller JM, Dengerink H (1988) Control of inner ear blood flow. Am J Otolaryngol 9:302–316

    Article  CAS  PubMed  Google Scholar 

  34. Suckfull M (2002) Fibrinogen and LDL apheresis in treatment of sudden hearing loss: a randomised multicentre trial. Lancet 360:1811–1817

    Article  CAS  PubMed  Google Scholar 

  35. Agarwal L, Pothier DD (2009) Vasodilators and vasoactive substances for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev 4:Cd003422

  36. Choi SJ, Kim SW, Lee JB, Lim HJ, Kim YJ, Tian C, So HS, Park R, Choung YH (2013) Gingko biloba extracts protect auditory hair cells from cisplatin-induced ototoxicity by inhibiting perturbation of gap junctional intercellular communication. Neuroscience 244:49–61

    Article  CAS  PubMed  Google Scholar 

  37. Huang X, Whitworth CA, Rybak LP (2007) Ginkgo biloba extract (EGb 761) protects against cisplatin-induced ototoxicity in rats. Otol Neurotol 28:828–833

    Article  PubMed  Google Scholar 

  38. Tian CJ, Kim YJ, Kim SW, Lim HJ, Kim YS, Choung YH (2013) A combination of cilostazol and Ginkgo biloba extract protects against cisplatin-induced Cochleo-vestibular dysfunction by inhibiting the mitochondrial apoptotic and ERK pathways. Cell Death Dis 4:e509

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  39. Nevado J, Sanz R, Sanchez-Rodriguez C, Garcia-Berrocal JR, Martin-Sanz E, Gonzalez-Garcia JA, Esteban-Sanchez J, Ramirez-Camacho R (2010) Ginkgo biloba extract (EGb761) protects against aging-related caspase-mediated apoptosis in rat cochlea. Acta Otolaryngol 130:1101–1112

    Article  PubMed  Google Scholar 

  40. Tziridis K, Korn S, Ahlf S (2014) Protective effects of Ginkgo biloba extract EGb 761 against noise trauma-induced hearing loss and tinnitus development. Neural Plast 2014:427298

    PubMed  PubMed Central  Google Scholar 

  41. Lamm K, Arnold W (2000) The effect of blood flow promoting drugs on cochlear blood flow, perilymphatic pO(2) and auditory function in the normal and noise-damaged hypoxic and ischemic guinea pig inner ear. Hear Res 141:199–219

    Article  CAS  PubMed  Google Scholar 

  42. Jang CH, Cho YB, Kim JS, Cho SW, Yang HC, Jung KH, Kim JY, Choi CH, Lim Y, Park H, Kang SI (2011) Effect of Ginkgo biloba extract on endotoxin-induced labyrinthitis. Int J Pediatr Otorhinolaryngol 75:905–909

    Article  PubMed  Google Scholar 

  43. Dubreuil C (1986) Therapeutic trial in acute cochlear deafness. A comparative study of Ginkgo biloba extract and nicergoline. Presse Med 15:1559–1561

    CAS  PubMed  Google Scholar 

Download references

Acknowledgments

This study was funded by YuYu Pharma, Inc., Seoul, Korea.

Author information

Author notes

    Authors and Affiliations

    1. Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea

      Ja-Won Koo & Mun Young Chang

    2. Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

      Sung-Cheol Yun

    3. Department of Otolaryngology, School of Medicine, Kangwon National University, Chuncheon, Republic of Korea

      Tae Su Kim

    4. Department of Otorhinolaryngology-Head and Neck Surgery, Pusan National University Hospital, Pusan National University School of Medicine and Biomedical Research Institute, Busan, Republic of Korea

      Soo-Keun Kong & Eui-Kyung Goh

    5. Department of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

      Jong Woo Chung

    Authors
    1. Ja-Won Koo
      View author publications

      You can also search for this author in PubMed Google Scholar

    2. Mun Young Chang
      View author publications

      You can also search for this author in PubMed Google Scholar

    3. Sung-Cheol Yun
      View author publications

      You can also search for this author in PubMed Google Scholar

    4. Tae Su Kim
      View author publications

      You can also search for this author in PubMed Google Scholar

    5. Soo-Keun Kong
      View author publications

      You can also search for this author in PubMed Google Scholar

    6. Jong Woo Chung
      View author publications

      You can also search for this author in PubMed Google Scholar

    7. Eui-Kyung Goh
      View author publications

      You can also search for this author in PubMed Google Scholar

    Corresponding authors

    Correspondence to Jong Woo Chung or Eui-Kyung Goh.

    Ethics declarations

    Conflict of interest

    No potential conflict of interest relevant to this article was reported.

    Additional information

    J.-W. Koo and M. Y. Chang contributed equally to this work as first authors.

    J. W. Chung and E.-K. Goh contributed equally as corresponding authors to the completion of this study.

    Electronic supplementary material

    Rights and permissions

    Reprints and permissions

    About this article

    Check for updates. Verify currency and authenticity via CrossMark

    Cite this article

    Koo, JW., Chang, M.Y., Yun, SC. et al. The efficacy and safety of systemic injection of Ginkgo biloba extract, EGb761, in idiopathic sudden sensorineural hearing loss: a randomized placebo-controlled clinical trial. Eur Arch Otorhinolaryngol 273, 2433–2441 (2016). https://doi.org/10.1007/s00405-015-3821-4

    Download citation

    • Received:

    • Accepted:

    • Published:

    • Issue Date:

    • DOI: https://doi.org/10.1007/s00405-015-3821-4

    Keywords

    Search

    Navigation