title: Outcomes research analysis of continuous intratympanic glucocorticoid delivery in patients with acute severe to profound hearing loss: basis for planning randomized controlled trials.
abstract: CONCLUSIONS
  The data presented herein form the basis for conducting randomized placebo-controlled clinical trials evaluating the safety and efficacy of salvage treatment in patients with idiopathic sudden severe sensorineural hearing loss (but not anacusis) refractory to initial systemic therapy. Comparison of different application protocols and drug delivery systems will allow assessment of the value of continuous versus intermittent intratympanic glucocorticoid drug delivery.
  
  
  OBJECTIVE
  To describe and critically evaluate the results of continuous intratympanic glucocorticoid delivery in patients with acute unilateral severe and profound sensorineural hearing loss refractory to initial systemic therapy and to compare the outcome with a historical control group.
  
  
  METHODS
  In a retrospective chart review, treatment results were analyzed in 23 patients with acute severe and profound hearing loss and failure of systemic standard therapy who received a continuous intratympanic delivery of glucocorticoids as a salvage treatment. Audiological results were compared within the local therapy group and with the results of an historical control group who did not receive salvage treatment. The study and control groups were matched with respect to hearing loss after initial systemic treatment failure.
  
  
  RESULTS
  The average pure-tone threshold after intratympanic salvage treatment showed a statistically significant improvement of 15 dB (95% CI 7-24 dB; p<0.001). After exclusion of patients with complete anacusis, i.e. a non-measurable hearing threshold, the local therapy group showed a significantly better improvement (mean 19 dB; 95% CI 6-32 dB) than the historical control group (mean 5 dB; 95% CI -2-11 dB; p<0.05).
authors.affiliation: Department of Otorhinolaryngology--Head and Neck Surgery and Tübingen Hearing Research Center, University of Tübingen, Tübingen, Germany. Stefan.Plontke@uni-tuebingen.de
authors.forename: Stefan
authors.initials: S
authors.lastname: Plontke
authors.forename: Hubert
authors.initials: H
authors.lastname: Löwenheim
authors.forename: Serena
authors.initials: S
authors.lastname: Preyer
authors.forename: Patrick
authors.initials: P
authors.lastname: Leins
authors.forename: Klaus
authors.initials: K
authors.lastname: Dietz
authors.forename: Assen
authors.initials: A
authors.lastname: Koitschev
authors.forename: Rainer
authors.initials: R
authors.lastname: Zimmermann
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Zenner
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001301:Audiometry, Pure-Tone; D001309:Auditory Threshold / Q000187:drug effects; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006319:Hearing Loss, Sensorineural / Q000188:drug therapy*; D003639:Hearing Loss, Sudden / Q000188:drug therapy*; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods / Q000592:standards; D012189:Retrospective Studies; D016896:Treatment Outcome; D014432:Tympanic Membrane
chemical_list: D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids