Outcomes research analysis of continuous intratympanic glucocorticoid delivery in patients with acute severe to profound hearing loss: basis for planning randomized controlled trials.
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).
Plontke
Stefan
S
Department of Otorhinolaryngology--Head and Neck Surgery and Tübingen Hearing Research Center, University of Tübingen, Tübingen, Germany. Stefan.Plontke@uni-tuebingen.de
Löwenheim
Hubert
H
Preyer
Serena
S
Leins
Patrick
P
Dietz
Klaus
K
Koitschev
Assen
A
Zimmermann
Rainer
R
Zenner
Hans-Peter
HP
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
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids