Abstract：
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.
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.
摘要：
背景：梅尼埃病是一种由听力损失定义的临床疾病，耳鸣,和听觉饱胀症状，目前没有任何批准用于治疗的药物。
目的：确定taVNS作为辅助疗法是否可以缓解梅尼埃病患者的症状并改善其生活质量。
方法：在这个单中心中，单盲,随机试验,参与者被分为经皮耳迷走神经刺激(taVNS)组和假taVNS组.主要结果指标包括耳鸣障碍量表，头晕障碍库存，纯音听觉,听觉丰满度的视觉模拟量表。次要结果指标包括36项简短表格健康调查，视频头脉冲测试，和热量测试。
结果：12周后，THI（-11.00，95CI，-14.87至-7.13；P<0.001），DHI（-47.26，95CI，-50.23至-44.29；P<0.001），听觉饱满度的VAS（-2.22，95CI，-2.95至-1.49；P<0.01），纯音阈值（-7.07，95CI，-9.07至-5.06；P<0.001）在两组之间存在显着差异。此外,SF36（14.72，95CI，11.06至18.39；P<0.001），vHIT(RD,0.26，95%CI，-0.44至-0.08，RR，0.43,95%CI,0.22~0.83,P<0.01),和热量测试(RD，-0.24，95%CI，-0.43至-0.04，RR，0.66,95%CI,0.44~0.95,P=0.02)两组间有显著性差异,分别。
结论：这些发现表明，taVNS联合甲磺酸倍他司汀可缓解梅尼埃病患者的症状并改善其生活质量。taVNS可以被认为是治疗梅尼埃病的辅助疗法。
背景：ClinicalTrials.gov标识符：NCT05328895。
目的：确定taVNS作为辅助疗法是否可以缓解梅尼埃病患者的症状并改善其生活质量。
方法：在这个单中心中，单盲,随机试验,参与者被分为经皮耳迷走神经刺激(taVNS)组和假taVNS组.主要结果指标包括耳鸣障碍量表，头晕障碍库存，纯音听觉,听觉丰满度的视觉模拟量表。次要结果指标包括36项简短表格健康调查，视频头脉冲测试，和热量测试。
结果：12周后，THI（-11.00，95CI，-14.87至-7.13；P<0.001），DHI（-47.26，95CI，-50.23至-44.29；P<0.001），听觉饱满度的VAS（-2.22，95CI，-2.95至-1.49；P<0.01），纯音阈值（-7.07，95CI，-9.07至-5.06；P<0.001）在两组之间存在显着差异。此外,SF36（14.72，95CI，11.06至18.39；P<0.001），vHIT(RD,0.26，95%CI，-0.44至-0.08，RR，0.43,95%CI,0.22~0.83,P<0.01),和热量测试(RD，-0.24，95%CI，-0.43至-0.04，RR，0.66,95%CI,0.44~0.95,P=0.02)两组间有显著性差异,分别。
结论：这些发现表明，taVNS联合甲磺酸倍他司汀可缓解梅尼埃病患者的症状并改善其生活质量。taVNS可以被认为是治疗梅尼埃病的辅助疗法。
背景：ClinicalTrials.gov标识符：NCT05328895。
