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- Title
Comparison of Two Different Treatment Protocols Using Systemic and Intratympanic Steroids with and without Hyperbaric Oxygen Therapy in Patients with Severe to Profound Idiopathic Sudden Sensorineural Hearing Loss: A Randomized Controlled Trial.
- Authors
Cho, Ilyoung; Lee, Hyun-Min; Choi, Sung-Won; Kong, Soo-Keun; Lee, Il-Woo; Goh, Eui-Kyung; Oh, Se-Joon
- Abstract
<bold>Objectives: </bold>This study aimed to investigate the efficacy of simultaneous steroid and hyperbaric oxygen therapy (HBOT) in patients with severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL), which has a poor prognosis.<bold>Methods: </bold>Sixty patients diagnosed with severe to profound ISSNHL (≥70 dB HL) were randomly divided into two groups in a prospective controlled trial: an oral steroid + intratympanic steroid injection (ITSI) group (control group) and an oral steroid + ITSI + HBOT group (study group). Pure-tone audiometry (PTA) results and word discrimination scores (WDS) were compared between the two groups before treatment and 10 days and 1, 2, and 3 months after treatment. Hearing improvement was assessed using the modified American Academy of Otolaryngology-Head and Neck Surgery criteria. Analyses were by both intention to treat and per protocol.<bold>Results: </bold>A total of 58 patients completed the 3-month follow-up, and 2 patients in the study group were excluded due to follow-up loss in the per-protocol analysis. In the intention-to-treat and per-protocol analyses, the study group showed significantly better hearing levels than did the control group at 500 Hz (p < 0.05) 1 month after treatment and at 1 kHz (p < 0.05) 3 months after treatment. However, the average PTA values and PTA at 2, 4, and 8 kHz showed no significant difference. WDS improvement was significantly higher in the study group compared to the control group 3 months after treatment by both per-protocol (66.4 ± 13.3 and 56.7 ± 19.1%, respectively; p = 0.029) and intention-to-treat analyses (65.9 ± 14.1 and 56.7 ± 19.1%, respectively; p = 0.035). The sum of complete and partial hearing recovery for the study group was significantly higher than that for the control group by per-protocol analysis (60.7 vs. 33.3%; p = 0.037) and intention-to-treat analysis (60.0 vs. 33.3%; p = 0.038).<bold>Conclusion: </bold>These results demonstrate that the addition of HBOT to steroid combination therapy does not improve the average PTA values in severe to profound ISSNHL; however, it was associated with a better outcome at 500 Hz 1 month after treatment and, at 1 kHz, WDS 3 months after treatment. The sum of complete and partial hearing recovery was significantly higher for the study group than for the control group.
- Subjects
HYPERBARIC oxygenation; MAGNETIC resonance imaging; ESSENTIAL hypertension; SENSORINEURAL hearing loss
- Publication
Audiology & Neurotology, 2018, Vol 23, Issue 4, p199
- ISSN
1420-3030
- Publication type
journal article
- DOI
10.1159/000493558