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A Trial of Semicircular Canal Plugging vs. Intratympanic Gentamicin for Menière's Disease
Daogong Zhang1,2,3,4, Xiaofei Li1,2,3,4, Raymond Van de Berg5
1Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial ENT Hospital, Shandong University, Jinan, Shandong, China.
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.
