Hyun-Jin Lee1, Min-Beom Kim2, Shin-Young Yoo3, Shi Nae Park4, Eui-Cheol Nam5, In Seok Moon6, Ho-Ki Lee7. 1. Department of Otorhinolaryngology, Gyeongsang National University Changwon Hospital, Changwon, Korea. 2. Department of Otorhinolaryngology-Head and Neck Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. 3. Ear and Hearing, Myung Dong Clinic, Seoul, Korea. 4. Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, The Catholic University of Korea, Seoul, Korea. 5. Department of Otolaryngology, Kangwon National University, School of Medicine, Chuncheon, Korea. 6. Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea. 7. Soree Ear Clinic, Seoul, Korea.
Abstract
OBJECTIVE: The purpose of this study was to investigate the effectiveness of intratympanic dexamethasone injection (ITDI) in acute tinnitus of presumed cochlear origin. STUDY DESIGN: A prospective, randomized, placebo-controlled, double-blinded, multicenter study. METHODS:Between August 2013 and December 2015, 54 patients with unilateral tinnitus were enrolled at four different centers. Patients were assigned either to an ITDI (n = 27) or an intratympanic normal saline injection (ITNI; n = 27) group through block randomization. Intratympanic injections were administered four times over 2 weeks. At 4 weeks after initial injection, we analyzed the improvement rates of tinnitus using the tinnitus handicap Inventory (THI) and visual analogue scale (VAS) for loudness, awareness, and annoyance. We defined improvement as the reduction of more than 7 points or of more than 20% in the final THI score compared to the initial THI score. RESULTS: The initial mean hearing thresholds and VAS and THI scores of the two groups did not differ significantly. At 4 weeks after initial injection, the mean VAS and THI scores of both groups had significantly reduced. However, the improvement rate did not differ significantly between the groups (ITDI, 51.9%; ITNI, 59.3%). CONCLUSION: The results indicate that ITDI might not be more effective than ITNI for the treatment of acute unilateral tinnitus. Therefore, ITDI should not be considered as the main treatment for patients presenting with acute tinnitus as the primary symptom. LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:184-188, 2018.
RCT Entities:
OBJECTIVE: The purpose of this study was to investigate the effectiveness of intratympanic dexamethasone injection (ITDI) in acute tinnitus of presumed cochlear origin. STUDY DESIGN: A prospective, randomized, placebo-controlled, double-blinded, multicenter study. METHODS: Between August 2013 and December 2015, 54 patients with unilateral tinnitus were enrolled at four different centers. Patients were assigned either to an ITDI (n = 27) or an intratympanic normal saline injection (ITNI; n = 27) group through block randomization. Intratympanic injections were administered four times over 2 weeks. At 4 weeks after initial injection, we analyzed the improvement rates of tinnitus using the tinnitus handicap Inventory (THI) and visual analogue scale (VAS) for loudness, awareness, and annoyance. We defined improvement as the reduction of more than 7 points or of more than 20% in the final THI score compared to the initial THI score. RESULTS: The initial mean hearing thresholds and VAS and THI scores of the two groups did not differ significantly. At 4 weeks after initial injection, the mean VAS and THI scores of both groups had significantly reduced. However, the improvement rate did not differ significantly between the groups (ITDI, 51.9%; ITNI, 59.3%). CONCLUSION: The results indicate that ITDI might not be more effective than ITNI for the treatment of acute unilateral tinnitus. Therefore, ITDI should not be considered as the main treatment for patients presenting with acute tinnitus as the primary symptom. LEVEL OF EVIDENCE: 1b. Laryngoscope, 128:184-188, 2018.