A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere’s Disease—A Pilot Study

Meniere's disease, a common inner ear condition, has an incidence of 15–50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I < II = III = IV). Hearing was improved in 7.1% of patients in Group-I, 35.7% in Group-II, 34.9% in Group-III, and 31.7% in Group-IV (statistically I < II = III = IV). Plasma vasopressin concentrations decreased more in Groups-II, -III, and -IV than in Groups-I (statistically I < II = III = IV), although patients’ stress/psychological factors had not changed. Physicians have focused on stress management for Meniere’s disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere’s disease, even though these therapies did not alter reported mental/physical stress levels.
Trial Registration: ClinicalTrials.gov NCT01099046

梅尼埃病（Meniere's disease）是一种常见的内耳疾病，发病率为每10万人15~50例。由于精神/躯体应激及后续应激激素加压素（vasopressin）水平升高被认为可诱发梅尼埃病，本研究开展一项预试验，旨在探索新型治疗干预手段，即通过调控加压素分泌以治疗该病。
本研究于2010至2012年间纳入297例确诊梅尼埃病患者，开展一项随机对照开放标签试验，将受试者分为四组：对照组（I组）予传统口服药物治疗，II组予足量饮水干预，III组予鼓膜通气管置入术，IV组予黑暗环境睡眠干预。最终263例患者完成了为期2年的计划随访，随访内容包括眩晕、听力评估，血浆加压素浓度检测，以及应激/心理因素变化评估。
随访至2年时，I组患者眩晕完全控制率为54.3%，II组为81.4%，III组为84.1%，IV组为80.0%（统计学分析显示I组显著低于II、III、IV组，且II、III、IV组间无显著差异）。I组患者听力改善率为7.1%，II组为35.7%，III组为34.9%，IV组为31.7%（统计学分析显示I组显著低于II、III、IV组，且II、III、IV组间无显著差异）。II、III、IV组患者血浆加压素浓度下降幅度显著大于I组（统计学分析显示I组显著低于II、III、IV组，且II、III、IV组间无显著差异），但受试者的应激/心理因素未发生明显变化。
临床医师历来关注梅尼埃病的应激管理，但对于身处高压力社会环境的患者而言，完全规避应激并不现实。本预试验结果显示，通过足量饮水、鼓膜通气管置入及黑暗环境睡眠等方式降低加压素分泌的干预手段，用于治疗梅尼埃病具有可行性，尽管上述疗法并未改变受试者报告的精神/躯体应激水平。
试验注册：ClinicalTrials.gov NCT01099046