A systematic review and network meta-analysis of existing pharmacologic therapies in patients with idiopathic sudden sensorineural hearing loss


Autoři: Nadera Ahmadzai aff001;  Shaun Kilty aff001;  Wei Cheng aff001;  Leila Esmaeilisaraji aff001;  Dianna Wolfe aff001;  James P Bonaparte aff002;  David Schramm aff001;  Elizabeth Fitzpatrick;  Vincent Lin aff004;  Becky Skidmore aff001;  David Moher aff001;  Brian Hutton aff001
Působiště autorů: Ottawa Hospital Research Institute, Ottawa, Canada aff001;  Department of ENT, the Ottawa Hospital, Ottawa, Canada aff002;  Dr. S. Kilty Medicine Prof. Corp, Ottawa, Canada aff003;  Faculty of Health Sciences, University of Ottawa, Ottawa, Canada aff004;  Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada aff005;  Department of Otolaryngology – Head & Neck Surgery, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, Toronto, Canada aff006;  Faculty of Medicine, University of Toronto, Toronto, Canada aff007;  University of Ottawa School of Epidemiology, Public Health and Preventive Medicine, Ottawa, Canada aff008
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0221713

Souhrn

Background

Hearing loss is one of the leading causes of disability worldwide. Patients with hearing loss experience impaired quality of life, as well as emotional and financial consequences that affect both themselves and their families. Idiopathic sudden sensorineural hearing loss (ISSNHL) is a common but difficult to treat condition that has a sudden onset of ≤ 72 hour associated with various etiologies, with the majority of cases being idiopathic. There exists a wide range of therapeutic options, however, the uncertainty surrounding their comparative efficacy and safety makes selection of treatment difficult. This systematic review and network meta-analysis (NMA) assessed the relative effects of competing treatments for management of ISSNHL.

Methods

A protocol for this review was registered with PROSPERO (CRD42017073756). A detailed search of MEDLINE, Embase and the Cochrane Library from inception to February 8th, 2018 was carried out by an experienced information specialist. Grey literature was also searched. Screening full-text records, and risk of bias assessment were carried out independently by two reviewers, and disagreements were resolved through consensus or third party adjudication, while data was collected by one reviewer and verified by a second reviewer. Bayesian network meta-analyses (NMA) were performed to inform comparisons between interventions for a priori specified outcomes that included pure tone average (PTA) improvement and hearing recovery.

Results

The search identified a total of 1,138 citations, of which 613 remained for review after removal of duplicates. Of these, 23 publications describing 19 unique studies (total sample size of 1,527) met our a priori eligibility criteria, that were assessed to be at unclear or high risk of bias on several domains. We identified data on several interventions for ISSNHL therapy and were able to construct treatment networks consisting of six intervention groups that included placebo; intratympanic (IT) steroid; IT plus systemic steroid; per oral (PO) steroid; intravenous (IV) steroid; and IV plus PO steroid for our NMAs. IT plus systemic steroids demonstrated the largest difference in PTA improvement compared to placebo (25.85 dB, 95% CrI 7.18–40.58), followed by IV plus PO steroids (22.06 dB, 95% CrI 1.24–39.17), IT steroids (18.24 dB, 95% CrI 3.00–29.81). We observed that the difference of PTA improvement between each intervention and placebo diminished over time, attributed to spontaneous recovery. The binary outcomes of hearing recovery demonstrated similar relative ordering of interventions but were less sensitive than PTA improvement to capture the significant differences between interventions and placebo.

Conclusion

Unclear to high risk of bias trials rated IT plus systemic steroid treatment as the best among the six interventions compared, and all active treatments were better than placebo in improving PTA. However, it should be noted that certain comparisons were based on indirect evidence only or few studies of small sample size, and analyses were unable to control for steroid type and dosage. Given these limitations, further data originating from methodologically sound and rigorous trials with adequate reporting are needed to confirm our findings.

Klíčová slova:

Physical sciences – Chemistry – Chemical compounds – Organic compounds – Steroids – Organic chemistry – Mathematics – Statistics – Medicine and health sciences – Pharmaceutics – Drug therapy – Steroid therapy – Otorhinolaryngology – Otology – Hearing disorders – Deafness – Vertigo – Computer and information sciences – Network analysis – Research and analysis methods – Mathematical and statistical techniques – Statistical methods – Metaanalysis – Research assessment – Systematic reviews


Zdroje

1. Mathers C, Stein C, Ma Fat D, Rao C, Inoue M, Tomijima N, et al. Global burden of disease in the year 2000. [Internet]. http://www.who.int/healthinfo/paper50.pdf. 2002.

2. Canadian Hearing Society. Facts and Figures: Prevalence of hearing loss. [Internet]. https://www.chs.ca/facts-and-figures. 2017.

3. Harkonen K, Kivekas I, Rautiainen M, Kotti V, Sivonen V, Vasama JP. Single-Sided Deafness: The Effect of Cochlear Implantation on Quality of Life, Quality of Hearing, and Working Performance. ORLJ Otorhinolaryngol Relat Spec. 2015;77(0301–1569 (Linking)):339–45.

4. Hultcrantz E, Nosrati-Zarenoe R. Corticosteroid treatment of idiopathic sudden sensorineural hearing loss: analysis of an RCT and material drawn from the Swedish national database. Eur Arch Oto-Rhino-Laryngol Off J Eur Fed Oto-Rhino-Laryngol Soc EUFOS Affil Ger Soc Oto-Rhino-Laryngol—Head Neck Surg. 2015 Nov;272(11):3169–75.

5. Anderson JP, Harris JP. Impact of Meniere’s disease on quality of life. Otol Neurotol. 2001 Nov;22(1531–7129 (Linking)):888–94. 11698814

6. Raine C, Atkinson H, Strachan DR, Martin JM. Access to cochlear implants: Time to reflect. CochlearImplantsInt. 2016 Apr;17 Suppl 1(1467–0100 (Linking)):42–6.

7. Alexander TH, Harris JP. Incidence of sudden sensorineural hearing loss. Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2013 Dec;34(9):1586–9.

8. Stachler RJ, Chandrasekhar SS, Archer SM, Rosenfeld RM, Schwartz SR, Barrs DM, et al. Clinical practice guideline: sudden hearing loss. Otolaryngol—Head Neck Surg Off J Am Acad Otolaryngol-Head Neck Surg. 2012 Mar;146(3 Suppl):S1–35.

9. Lawrence R, Thevasagayam R. Controversies in the management of sudden sensorineural hearing loss: an evidence-based review. Clin Otolaryngol Off J ENT-UK Off J Neth Soc Oto-Rhino-Laryngol Cervico-Facial Surg. 2015 Jun;40(3):176–82.

10. Kuhn M, Heman-Ackah SE, Shaikh JA, Roehm PC. Sudden sensorineural hearing loss: a review of diagnosis, treatment, and prognosis. Trends Amplif. 2011 Sep;15(3):91–105. doi: 10.1177/1084713811408349 21606048

11. Chung S-D, Hung S-H, Lin H-C, Sheu J-J. Association between sudden sensorineural hearing loss and anxiety disorder: a population-based study. Eur Arch Oto-Rhino-Laryngol Off J Eur Fed Oto-Rhino-Laryngol Soc EUFOS Affil Ger Soc Oto-Rhino-Laryngol—Head Neck Surg. 2015 Oct;272(10):2673–8.

12. Lim H.J., Kim Y.T., Choi S.J., Lee J.B., Park H.Y., Park K., et al. Efficacy of 3 different steroid treatments for sudden sensorineural hearing loss: a prospective, randomized trial. Otolaryngol Head Neck Surg Off J Am Acad Otolaryngol Head Neck Surg. 2013;148(1):121.

13. Westerlaken B.O., Stokroos R.J., Dhooge I.J., Wit H.P., Albers F.W.. Treatment of idiopathic sudden sensorineural hearing loss with antiviral therapy: a prospective, randomized, double-blind clinical trial. Ann Otol Rhinol Laryngol. 2003;112(11):993. doi: 10.1177/000348940311201113 14653370

14. Dispenza F., Amodio E., Stefano A., Gallina S., Marchese D., Mathur N., et al. Treatment of sudden sensorineural hearing loss with transtympanic injection of steroids as single therapy: a randomized clinical study. Eur Arch Oto Rhino Laryngol. 2011;268(9):1273.

15. Chen J, Liang J, Ou J, Cai W. Mental health in adults with sudden sensorineural hearing loss: an assessment of depressive symptoms and its correlates. J Psychosom Res. 2013 Jul;75(1):72–4. doi: 10.1016/j.jpsychores.2013.03.006 23751242

16. Sano H, Okamoto M, Ohhashi K, Iwasaki S, Ogawa K. Quality of life reported by patients with idiopathic sudden sensorineural hearing loss. Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2013 Jan;34(1):36–40.

17. Carlsson P-I, Hall M, Lind K-J, Danermark B. Quality of life, psychosocial consequences, and audiological rehabilitation after sudden sensorineural hearing loss. Int J Audiol. 2011 Feb;50(2):139–44. doi: 10.3109/14992027.2010.533705 21265640

18. Conlin AE, Parnes LS. Treatment of sudden sensorineural hearing loss: I. A systematic review. Arch Otolaryngol Head Neck Surg. 2007 Jun;133(6):573–81. doi: 10.1001/archotol.133.6.573 17576908

19. Plaza G, Durio E, Herráiz C, Rivera T, García-Berrocal JR, Asociación Madrileña de ORL. [Consensus on diagnosis and treatment of sudden hearing loss. Asociación Madrileña de ORL]. Acta Otorrinolaringol Esp. 2011 Apr;62(2):144–57. doi: 10.1016/j.otorri.2010.09.001 21112580

20. Labus J, Breil J, Stützer H, Michel O. Meta-analysis for the effect of medical therapy vs. placebo on recovery of idiopathic sudden hearing loss. The Laryngoscope. 2010 Sep;120(9):1863–71. doi: 10.1002/lary.21011 20803741

21. Wei BPC, Stathopoulos D, O’Leary S. Steroids for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev. 2013;(7):CD003998. doi: 10.1002/14651858.CD003998.pub3 23818120

22. Arslan N, Oğuz H, Demirci M, Şafak MA, İslam A, Kaytez SK, et al. Combined intratympanic and systemic use of steroids for idiopathic sudden sensorineural hearing loss. Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2011 Apr;32(3):393–7.

23. Caldwell DM, Ades AE, Higgins JPT. Simultaneous comparison of multiple treatments: combining direct and indirect evidence. BMJ. 2005 Oct 15;331(7521):897–900. doi: 10.1136/bmj.331.7521.897 16223826

24. Catala-Lopez F, Tobias A, Cameron C, Moher D, Hutton B. Network meta-analysis for comparing treatment effects of multiple interventions: an introduction. Rheumatol Int. 2014 Nov;34(0172–8172 (Linking)):1489–96. doi: 10.1007/s00296-014-2994-2 24691560

25. Lu G, Ades AE. Combination of direct and indirect evidence in mixed treatment comparisons. Stat Med. 2004 Oct 30;23(20):3105–24. doi: 10.1002/sim.1875 15449338

26. Ahmadzai N, Kilty S, Wolfe D, Bonaparte J, Schramm D, Fitzpatrick E, et al. A protocol for a network meta-analysis of interventions to treat patients with sudden sensorineural hearing loss. Syst Rev. 2018 May 16;7(1):74. doi: 10.1186/s13643-018-0736-3 29769117

27. Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. [Internet] http://handbook.cochrane.org/. 2011.

28. Hutton B, Salanti G, Caldwell DM, Chaimani A, Schmid CH, Cameron C, et al. The PRISMA extension statement for reporting of systematic reviews incorporating network meta-analyses of health care interventions: checklist and explanations. Ann Intern Med. 2015 Jun 2;162(0003–4819 (Linking)):777–84. doi: 10.7326/M14-2385 26030634

29. National Institute for Health Research. PROSPERO: International prospective register of systematic reviews. [Internet]. https://www.crd.york.ac.uk/prospero/. 2017.

30. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol. 2009 Oct;62(1878–5921 (Electronic)):1006–12. doi: 10.1016/j.jclinepi.2009.06.005 19631508

31. Khangura S, Konnyu K, Cushman R, Grimshaw J, Moher D. Evidence summaries: the evolution of a rapid review approach. Syst Rev. 2012 Feb 10;1(2046–4053 (Linking)):10. doi: 10.1186/2046-4053-1-10 22587960

32. Donegan S, Williamson P, D’Alessandro U, Tudur Smith C. Assessing key assumptions of network meta-analysis: a review of methods. Res Synth Methods. 2013 Dec;4(4):291–323. doi: 10.1002/jrsm.1085 26053945

33. Ermutlu G, Suslu N, Yilmaz T, Sarac S. Sudden hearing loss: an effectivity comparison of intratympanic and systemic steroid treatments. 2017;274(10):3585–91.

34. Evidence Synthesis TSD series—NICE Decision Support Unit,TSD 2. A general linear modelling framework for pair-wise and network meta-analysis of randomised controlled trials (last updated Sept 2016).[[Internet]. [Internet]. [cited 2018 Nov 1]. http://nicedsu.org.uk/technical-support-documents/evidence-synthesis-tsd-series/

35. Salanti G, Ades AE, Ioannidis JPA. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol. 2011 Feb;64(2):163–71. doi: 10.1016/j.jclinepi.2010.03.016 20688472

36. Spiegelhalter D, Thomas A, Best N, Dave L. Manuals—OpenBUGS [Internet]. OpenBUGS User Manual: Version 3.2.3 March 2014. [cited 2018 Jul 19]. http://www.openbugs.net/w/Manuals

37. Sturtz S, Ligges U, Gelman A. R2WinBUGS: A Package for Running WinBUGS from R. Stat Softw. 12(3):1–16.

38. Filipo R., Attanasio G., Russo F.Y., Viccaro M., Mancini P., Covelli E.. Intratympanic steroid therapy in moderate sudden hearing loss: a randomized, triple-blind, placebo-controlled trial. The Laryngoscope. 2013;123(3):774. doi: 10.1002/lary.23678 23378346

39. Yang C.H., Ko M.T., Peng J.P., Hwang C.F.. Zinc in the treatment of idiopathic sudden sensorineural hearing loss. The Laryngoscope. 2011;121(3):617. doi: 10.1002/lary.21291 20928835

40. Hong S.M., Park C.H., Lee J.H.. Hearing outcomes of daily intratympanic dexamethasone alone as a primary treatment modality for ISSHL. Otolaryngol Head Neck Surg. 2009;141(5):579. doi: 10.1016/j.otohns.2009.08.009 19861194

41. Gundogan O., Pinar E., Imre A., Ozturkcan S., Cokmez O., Yigiter A.C.. Therapeutic efficacy of the combination of intratympanic methylprednisolone and oral steroid for idiopathic sudden deafness. Otolaryngol Head Neck Surg Off J Am Acad Otolaryngol Head Neck Surg. 2013;149(5):753.

42. Eftekharian A., Amizadeh M.. Pulse steroid therapy in idiopathic sudden sensorineural hearing loss: A randomized controlled clinical trial. The Laryngoscope. 2016;126(1):150. doi: 10.1002/lary.25244 25782020

43. Kosyakov S., Atanesyan A., Gunenkov A., Ashkhatunyan E., Kurlova A.. Intratympanic Steroids for Sudden Sensorineural Hearing Loss. J Int Adv Otol. 2011;7(3):323.

44. Tsounis M, Psillas G, Tsalighopoulos M, Vital V, Maroudias N, Markou K. Systemic, intratympanic and combined administration of steroids for sudden hearing loss. A prospective randomized multicenter trial. Eur Arch Otorhinolaryngol. 2018;275(1):103–10. doi: 10.1007/s00405-017-4803-5 29168028

45. Swachia K., Sharma D., Singh J.. Efficacy of oral vs. intratympanic corticosteroids in sudden sensorineural hearing loss. J Basic Clin Physiol Pharmacol. 2016;27(4):371. doi: 10.1515/jbcpp-2015-0112 26812786

46. Hunchaisri N., Chantapant S., Sirirattanapan J.. Effectiveness of oral zinc supplementation in the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL). J Med Assoc Thail Chotmaihet Thangphaet. 2015;98(4):400.

47. Wang M.M., Han Y.C., Fan Z.M., Zhang D.G., Wang H.B.. Therapeutic Effect on Idiopathic Sudden Sensorineural Hearing Loss with Duration of Onset More Than 3 Months. Indian J Otolaryngol Head Neck Surg. 2013;65(1):61. doi: 10.1007/s12070-012-0604-8 24381923

48. Gordin A., Goldenberg D., Golz A., Netzer A., Joachims H.Z.. Magnesium: a new therapy for idiopathic sudden sensorineural hearing loss. Otol Neurotol. 2002;23(4):447. 12170143

49. Koo J.W., Chang M.Y., Yun S.C., Kim T.S., Kong S.K., Chung J.W., 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 Oto Rhino Laryngol. 2016;273(9):2433.

50. Park M.K., Lee C.K., Park K.H., Lee J.D., Lee C.G., Lee B.D.. Simultaneous versus subsequent intratympanic dexamethasone for idiopathic sudden sensorineural hearing loss. Otolaryngol Head Neck Surg. 2011;145(6):1016. doi: 10.1177/0194599811418169 21817157

51. Bianchin G., Russi G., Romano N., Fioravanti P.. Treatment with HELP-apheresis in patients suffering from sudden sensorineural hearing loss: a prospective, randomized, controlled study. The Laryngoscope. 2010;120(4):800. doi: 10.1002/lary.20835 20213795

52. R. Nosrati-Zarenoe. Idiopathic sudden sensorineural hearing loss. Corticosteroid treatment, the diagnostic protocol and outcome. Link [Internet]. 2011;(1229). https://www.diva-portal.org/smash/get/diva2:411787/FULLTEXT01.pdf

53. Lim H.J., Kim Y.T., Choi S.J.. Erratum: Efficacy of 3 different steroid treatments for sudden sensorineural hearing loss: A prospective, randomized trial (Otolaryngology—Head and Neck Surgery (United States) (2013) 148 (121–127) doi: 10.1177/0194599812464475). Otolaryngol Head Neck Surg. 2013;148(6):1064.

54. Stokroos RJ, Albers FW, Tenvergert EM. Antiviral treatment of idiopathic sudden sensorineural hearing loss: a prospective, randomized, double-blind clinical trial. Acta Otolaryngol. 1998;118(4):488–95. doi: 10.1080/00016489850154603 9726671

55. Nosrati-Zarenoe R., Hultcrantz E.. Corticosteroid treatment of idiopathic sudden sensorineural hearing loss: randomized triple-blind placebo-controlled trial. Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2012;33(4):523.

56. Ji J, Fang X-L. [Clinical observation on warming-removing obstruction needling method for treatment of sudden tinnitus and deafness]. Zhongguo Zhen Jiu Chin Acupunct Moxibustion. 2008 May;28(5):353–5.

57. Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143–8. doi: 10.1001/archotol.1996.01890140029007 8630207

58. Han X, Yin X, Du X, Sun C. Combined Intratympanic and Systemic Use of Steroids as a First-Line Treatment for Sudden Sensorineural Hearing Loss: A Meta-Analysis of Randomized, Controlled Trials. Otol Neurotol Off Publ Am Otol Soc Am Neurotol Soc Eur Acad Otol Neurotol. 2017;38(4):487–95.

59. Qiang Q, Wu X, Yang T, Yang C, Sun H. A comparison between systemic and intratympanic steroid therapies as initial therapy for idiopathic sudden sensorineural hearing loss: a meta-analysis. Acta Otolaryngol (Stockh). 2017 Jun;137(6):598–605.

60. Lai D, Zhao F, Jalal N, Zheng Y. Intratympanic glucocorticosteroid therapy for idiopathic sudden hearing loss: Meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Dec;96(50):e8955.

61. El Sabbagh NG, Sewitch MJ, Bezdjian A, Daniel SJ. Intratympanic dexamethasone in sudden sensorineural hearing loss: A systematic review and meta-analysis. The Laryngoscope. 2017;127(8):1897–908. doi: 10.1002/lary.26394 27861924


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