Randomized Prospective Trial of Hyperbaric Oxygen
Therapy and Intratympanic Steroid Injection as Salvage
Treatment of Sudden Sensorineural Hearing Loss
*†Ljiljana Cvorovic, *†Milan B. Jovanovic, *†Zoran Milutinovic,
*‡Nenad Arsovic, and *‡Dragoslava Djeric
*Faculty of Medicine, University of Belgrade; ÞDepartment of Otorhinolaryngology and Maxillofacial Surgery,
Clinical-Hospital Centre ‘‘Zemun’’; and þInstitute for Otorhinolaryngology and Maxillofacial Surgery,
Clinical Centre of Serbia, Belgrade, Serbia
Objective: To compare the effects of hyperbaric oxygen (HBO)
and intratympanic (IT) steroid injection on hearing after the
failure of primary treatment in patients with idiopathic sudden
sensorineural hearing loss (ISSHL).
Study Design: A prospective randomized trial.
Setting: Tertiary referral center.
Patients: Fifty patients with failure of primary therapy for ISSHL.
Intervention(s): After primary treatment with systemic steroids
and failure of therapy, defined as less than 10-dB hearing gain,
50 patients were enrolled in the study and received either hy-
perbaric oxygen or intratympanic steroid treatment. The patients
were not matched and not similar.
Main Outcome Measure(s): Hearing gain at 0.25, 0.5, 1, 2, and
4 kHz after treatment.
Results: There were significant differences between hearing
thresholds at all frequencies before and after the HBO treatment.
Similarly, there were significant differences between hearing
thresholds at most frequencies (except 2 kHz) before and after
the treatment in the IT group. The subgroups of patients with
pure tone average less than 81 dB and were younger than
60 years had better response to HBO treatment than those with
profound deafness and in the elderly.
Conclusion: HBO and IT steroid therapy could be successfully
used as salvage therapies in patients with sudden deafness.
Further study is needed to demonstrate superiority of one of the
treatments. Key Words: Hyperbaric oxygen therapyV
Intratympanic steroidVSecondary treatmentVSudden deafness.
Otol Neurotol 34:1021Y1026, 2013.
Idiopathic sudden sensorineural hearing loss (ISSHL),
or sudden deafness, is a rapid loss of hearing over a period
of up to 3 days and at least 30 dB in 3 consecutive fre-
quencies. ISSHL affects 5 to 20 per 100,000 individuals
annually (1). The spontaneous recovery rate, defined as a
hearing gain of at least 30 dB, typically develops within
2 weeks in 73% of patients (2). Long-term morbidity
affects patients with milder symptoms and faster initial
recovery, who are less likely to seek medical attention.
Significant predictors of hearing improvement are the
severity of hearing loss, presence of vertigo, time of ini-
tiation of therapy, hearing level in the contralateral ear,
and shape of audiometric curve (3).
According to Clinical Practice Guideline for Sudden
Hearing Loss (4), corticosteroids are offered as initial
therapy to patients with ISSNHL. This recommendation
is based on evidence from systematic reviews of ran-
domized controlled trials. Hyperbaric oxygen (HBO)
therapy and intratympanic (IT) steroid perfusion are also
offered in cases of incomplete recovery, but these thera-
pies have not been adequately studied or compared in a
randomized controlled fashion. It is, thus, unclear which
rescue therapy should be offered to patients with ISSNHL
and failure of primary therapy.
The goal of this study is to compare the effects of
HBO and IT steroid treatment on hearing after the failure
of the initial treatment in patients with ISSHL.
PATIENTS AND METHODS
A prospective, randomized clinical trial was conducted in a
tertiary referral center. The study enrolled 155 patients with
ISSHL from January 2005 to December 2011 and was approved
by the ethics committee of the Clinical Hospital Centre, Zemun.
Address correspondence and reprint requests to Ljiljana Cvorovic,
Ph.D., Department of Otorhinolaryngology and Maxillofacial Surgery,
Clinical-Hospital Centre ‘‘Zemun, Vukova 9, 11080 Belgrade, Serbia;
E-mail: cvorcica@yahoo.com
The authors disclose no conflicts of interest.
Otology & Neurotology
34:1021Y1026 Ó 2013, Otology & Neurotology, Inc.
1021
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