Meniere Disease treated with transcutaneous auricular vagus nerve stimulation combined with betahistine Mesylate: A randomized controlled trial

• Published in: Brain stimulation Vol. 16; no. 6; pp. 1576 - 1584
• Main Authors: Wu, Dong, Liu, Bo, Wu, Yunqing, Wang, Yu, Sun, Jingyi, Yang, Jun, Duan, Jinping, Liu, Gang, Cao, Kai, Zhang, Yi, Rong, Peijing
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2023; Elsevier
• Subjects: Betahistine; Caloric test; Meniere disease; RCT; taVNS; vHIT; RCT; vHIT; Meniere disease; Caloric test; Betahistine; taVNS
• ISSN: 1935-861X; 1876-4754
• DOI: 10.1016/j.brs.2023.10.003

Meniere Disease is a clinical condition defined by hearing loss, tinnitus, and aural fullness symptoms, there are currently no any medications approved for its treatment. To determine whether taVNS as an adjunctive therapy could relieve symptoms and improve the quality of life in patients with Meniere disease. In this Single-center, single blind, randomized trial, participants were assigned to transcutaneous auricular vagus nerve stimulation (taVNS) group and sham taVNS group. The primary outcome measures comprised Tinnitus Handicap Inventory, Dizziness Handicap Inventory, Pure Tone Auditory, Visual analogue scale of aural fullness. Secondary outcome measures comprised the 36-Item Short Form Health Survey, video head impulse test, and the caloric test. After 12 weeks, the THI (−11.00, 95%CI, −14.87 to −7.13; P < 0.001), DHI (−47.26, 95%CI, −50.23 to −44.29; P < 0.001), VAS of aural fullness (−2.22, 95%CI, −2.95 to −1.49; P<0.01), and Pure Tone Thresholds (−7.07, 95%CI, −9.07 to −5.06; P<0.001) were significantly differed between the two groups. In addition, SF36(14.72, 95%CI, 11.06 to 18.39; P < 0.001), vHIT (RD, 0.26, 95 % CI, −0.44 to −0.08, RR, 0.43, 95 % CI, 0.22 to 0.83, P < 0.01), and the caloric test (RD, −0.24, 95 % CI, −0.43 to −0.04, RR, 0.66, 95 % CI, 0.44 to 0.95, P = 0.02) have significant difference between two group, respectively. These findings suggest that taVNS combined with Betahistine Mesylate relieve symptoms and improve the quality of life for patients with Meniere Disease. taVNS can be considered an adjunctive therapy in treatment of Meniere Disease. ClinicalTrials.gov Identifier: NCT05328895. •This randomized clinical trial included 92 participants. Symptoms of MD were improved with taVNS plus Betahistine Mesylate therapy compared with sham taVNS plus Betahistine Mesylate in 12 weeks treatment.•The study conducted a comprehensive assessment of the efficacy of tVNS, using THI, DHI, PTA, VAS of aural fullness, SF-36, vHIT, and Caloric Test.•This RCT suggests taVNS can be considered an adjunctive MD therapy in relieving symptoms and improving the quality of life.