Kitahara Tadashi, Okamoto Hidehiko, Fukushima Munehisa, Sakagami Masaharu, Ito Taeko, Yamashita Akinori, Ota Ichiro, Yamanaka Toshiaki
Department of Otolaryngology, Nara Medical University, Kashihara-city, Nara, Japan.
Department of Otolaryngology, Osaka Rosai Hospital, Sakai-city, Osaka, Japan.
PLoS One. 2016 Jun 30;11(6):e0158309. doi: 10.1371/journal.pone.0158309. eCollection 2016.
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.
ClinicalTrials.gov NCT01099046.
梅尼埃病是一种常见的内耳疾病,发病率为每10万人中有15 - 50例。由于精神/身体压力以及随后应激激素血管加压素的增加被认为会引发梅尼埃病,我们开展了一项试点研究,以寻求新的治疗干预措施,即管理血管加压素分泌来治疗这种疾病。我们在2010年至2012年期间招募了297例确诊的梅尼埃病患者,进行一项随机对照开放标签试验,将第一组(对照组)给予传统口服药物,第二组给予大量饮水,第三组给予鼓膜通气管,第四组给予在黑暗中睡眠。263例患者完成了计划的2年随访,其中包括对眩晕、听力、血浆血管加压素浓度以及压力/心理因素变化的评估。在2年时,第一组54.3%的患者眩晕得到完全控制,第二组为81.4%,第三组为84.1%,第四组为80.0%(统计学上第一组<第二组 = 第三组 = 第四组)。第一组7.1%的患者听力得到改善,第二组为35.7%,第三组为34.9%,第四组为31.7%(统计学上第一组<第二组 = 第三组 = 第四组)。第二组、第三组和第四组的血浆血管加压素浓度下降幅度大于第一组(统计学上第一组<第二组 = 第三组 = 第四组)