The Laryngoscope · 2025
A Trial of Semicircular Canal Plugging vs. Intratympanic Gentamicin for Menière's Disease.
СтатьяРандомизированное исследованиеСравнительное исследованиеEquivalence TrialПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Zhang Daogong, Li Xiaofei, Van de Berg Raymond, Lyu Yafeng, Dayimu Alimu, Song Yongdong, Duan Maoli, Jian Huirong, Li Yawei, Wang Jing, Chen Yueling, Ai Yu, Jiang Fan, Xu Lei, Han Yuechen, Li Na, Fan Zhaomin, Wang Haibo
Аннотация
BACKGROUND: Menière's disease (MD) can lead to disabling vertigo attacks with hearing loss. Triple semicircular canal plugging (TSCP) surgery is a new treatment for MD, but high-quality evidence is scarce. This study aimed to assess the long-term efficacy and safety of TSCP.
METHODS: In a single-center, open-label, randomized non-inferiority trial, MD patients were assigned to either TSCP or intratympanic gentamicin injections, with 24 months of follow-up. The primary outcome measure was the effective vertigo control rate. Secondary outcome measurements included the mean and median number of vertigo attacks post-intervention, audiovestibular symptom scale scores, audiovestibular test results, and time to balance recovery.
RESULTS: A total of 66 patients (33 TSCP and 33 gentamicin) were randomized. The effective vertigo control rate in the TSCP group (97%) was non-inferior to the gentamicin group (85%) (p value = 0.012,95% CI = -2.8% to 27.1%). The TSCP group showed more improvement in audiovestibular symptoms compared to the gentamicin group, regarding the VSS (5.7, 95% CI = 0.30-11.0, p value = 0.038), DHI (10.7, 95% CI = 3.1-18.3, p value = 0.006), and FLS (0.5, 95% CI = 0.1-1.0, p value = 0.025). Semicircular canal function was significantly reduced in TSCP, as measured by video Head Impulse Testing (p value = 0.001) and the caloric test (p value < 0.001). Otolith responses were more preserved in the TSCP group. The TSCP group demonstrated a significantly shorter median time to balance recovery (p value < 0.001).
CONCLUSION: The effective vertigo control rate in the TSCP group is non-inferior to intratympanic gentamicin, with a higher vertigo control rate.
TRIAL REGISTRATION: ChiCTR1900023606 LEVEL OF EVIDENCE: 2.
METHODS: In a single-center, open-label, randomized non-inferiority trial, MD patients were assigned to either TSCP or intratympanic gentamicin injections, with 24 months of follow-up. The primary outcome measure was the effective vertigo control rate. Secondary outcome measurements included the mean and median number of vertigo attacks post-intervention, audiovestibular symptom scale scores, audiovestibular test results, and time to balance recovery.
RESULTS: A total of 66 patients (33 TSCP and 33 gentamicin) were randomized. The effective vertigo control rate in the TSCP group (97%) was non-inferior to the gentamicin group (85%) (p value = 0.012,95% CI = -2.8% to 27.1%). The TSCP group showed more improvement in audiovestibular symptoms compared to the gentamicin group, regarding the VSS (5.7, 95% CI = 0.30-11.0, p value = 0.038), DHI (10.7, 95% CI = 3.1-18.3, p value = 0.006), and FLS (0.5, 95% CI = 0.1-1.0, p value = 0.025). Semicircular canal function was significantly reduced in TSCP, as measured by video Head Impulse Testing (p value = 0.001) and the caloric test (p value < 0.001). Otolith responses were more preserved in the TSCP group. The TSCP group demonstrated a significantly shorter median time to balance recovery (p value < 0.001).
CONCLUSION: The effective vertigo control rate in the TSCP group is non-inferior to intratympanic gentamicin, with a higher vertigo control rate.
TRIAL REGISTRATION: ChiCTR1900023606 LEVEL OF EVIDENCE: 2.