A Trial of Semicircular Canal Plugging vs. Intratympanic Gentamicin for Menière's Disease

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.