Cho I, Lee HM, Choi SW, Kong SK, Lee IW, Goh EK, Oh SJ, et al.
Audiology & neuro-otology. Date of publication 2018 Jan 1;volume 23(4):199-207.
1. Audiol Neurootol. 2018;23(4):199-207. doi: 10.1159/000493558. Epub 2018 Oct 31.
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.
Cho I(1), Lee HM(2), Choi SW(1), Kong SK(1), Lee IW(2), Goh EK(1), Oh SJ(3).
Author information:
(1)Department of Otorhinolaryngology and Biomedical Research Institute, Pusan
National University Hospital, Busan, Republic of Korea.
(2)Department of Otorhinolaryngology and Biomedical Research Institute, Yangsan
Pusan National University Hospital, Yangsan, Republic of Korea.
(3)Department of Otorhinolaryngology and Biomedical Research Institute, Pusan
National University Hospital, Busan, Republic of Koreaentmania@pusan.ac.kr.
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSION: 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.
© 2018 S. Karger AG, Basel.
DOI: 10.1159/000493558
PMID: 30380530
