title: Prognostic impact of salvage treatment on hearing recovery in patients with sudden sensorineural hearing loss refractory to systemic corticosteroids: A retrospective observational study.
abstract: OBJECTIVE
  To determine the prognostic factors for hearing recovery in patients with sudden sensorineural hearing loss (SSHL) refractory to systemic corticosteroids following salvage treatment.
  
  
  METHODS
  This is a retrospective observational study at nine tertiary referral hospitals. A total of 120 patients with sudden deafness refractory to systemic corticosteroids were enrolled. The patients were randomly assigned to receive topical application of recombinant human IGF-1 or intratympanic injection of dexamethasone as salvage treatment. Multiple regression analysis was performed to identify determinants of hearing recovery using pure tone audiometry results at 8 weeks after treatment. Clinical predictors that were evaluated included age, sex, pretreatment hearing level, presence of vertiginous symptoms, days to study entry from symptom onset and salvage treatment assignment (IGF-1 vs. dexamethasone).
  
  
  RESULTS
  The linear regression model identified age (P=0.001), pretreatment hearing level (P<0.001), days to study entry from symptom onset (P=0.011) and treatment assignment (P=0.033) at 8 weeks after treatment as significant variables influencing the recovery of pure tone audiometry average thresholds. Younger age (<60 years), early initiation of salvage treatment and treatment with topical IGF-1 therapy had significant effects on hearing recovery.
  
  
  CONCLUSIONS
  The results indicate that early initiation and choice of treatment modalities for salvage treatment may be important for the prognosis of patients with refractory SSHL. The positive effect of topical IGF-1 therapy on hearing recovery indicates its utility as salvage treatment.
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto 606-8507, Japan. Electronic address: tnakagawa@ent.kuhp.kyoto-u.ac.jp.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Nakagawa
authors.affiliation: Department of Data Science, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto 606-8507, Japan.
authors.forename: Michio
authors.initials: M
authors.lastname: Yamamoto
authors.affiliation: Department of Otolaryngology, Okinaka Memorial Institute for Medical Research, Toranomon Hospital, Tokyo 105-8470, Japan.
authors.forename: Kozo
authors.initials: K
authors.lastname: Kumakawa
authors.affiliation: Department of Otorhinolaryngology, Shinshu University School of Medicine, Matsumoto 390-8621, Japan.
authors.forename: Shin-Ichi
authors.initials: S
authors.lastname: Usami
authors.affiliation: Department of Otolaryngology, Ehime University Graduate School of Medicine, Ehime 791-0295, Japan.
authors.forename: Naohito
authors.initials: N
authors.lastname: Hato
authors.affiliation: Department of Otolaryngology, Graduate School of Comprehensive Human Science, University of Tsukuba, 305-8575 Tsukuba, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Tabuchi
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Nagoya City University Graduate School of Medical Sciences and Medical School, Nagoya 467-8601, Japan.
authors.forename: Mariko
authors.initials: M
authors.lastname: Takahashi
authors.affiliation: Department of Otolaryngology, Kobe City Medical Center General Hospital, Kobe 650-0047, Japan.
authors.forename: Keizo
authors.initials: K
authors.lastname: Fujiwara
authors.affiliation: Department of Otorhinolaryngology, Hirosaki University Graduate School of Medicine, Hirosaki 036-8562, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Sasaki
authors.affiliation: Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka 812-8582, Japan.
authors.forename: Shizuo
authors.initials: S
authors.lastname: Komune
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto 606-8507, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Yamamoto
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto 606-8507, Japan.
authors.forename: Harukazu
authors.initials: H
authors.lastname: Hiraumi
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto 606-8507, Japan.
authors.forename: Tatsunori
authors.initials: T
authors.lastname: Sakamoto
authors.affiliation: Department of Experimental Therapeutics, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto 606-8507, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Shimizu
authors.affiliation: Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto 606-8507, Japan.
authors.forename: Juichi
authors.initials: J
authors.lastname: Ito
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000367:Age Factors; D001301:Audiometry, Pure-Tone; D003907:Dexamethasone / Q000627:therapeutic use*; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D003639:Hearing Loss, Sudden / Q000188:drug therapy*; D006801:Humans; D000069555:Injection, Intratympanic; D007334:Insulin-Like Growth Factor I / Q000627:therapeutic use*; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins; D020127:Recovery of Function; D012189:Retrospective Studies; D016879:Salvage Therapy; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D011994:Recombinant Proteins; D007334:Insulin-Like Growth Factor I; C000604197:mecasermin; D003907:Dexamethasone
keywords: Drug delivery system; Insulin-like growth factor 1; Local application; Multiple regression analysis; Sudden sensorineural hearing loss