title: A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study.
abstract: 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01099046.
authors.affiliation: Department of Otolaryngology, Nara Medical University, Kashihara-city, Nara, Japan.|Department of Otolaryngology, Osaka Rosai Hospital, Sakai-city, Osaka, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kitahara
authors.affiliation: Department of Physiology, Okazaki Research Institute, Okazaki-city, Aichi, Japan.
authors.forename: Hidehiko
authors.initials: H
authors.lastname: Okamoto
authors.affiliation: Department of Otolaryngology, Osaka Rosai Hospital, Sakai-city, Osaka, Japan.
authors.forename: Munehisa
authors.initials: M
authors.lastname: Fukushima
authors.affiliation: Department of Otolaryngology, Nara Medical University, Kashihara-city, Nara, Japan.
authors.forename: Masaharu
authors.initials: M
authors.lastname: Sakagami
authors.affiliation: Department of Otolaryngology, Nara Medical University, Kashihara-city, Nara, Japan.
authors.forename: Taeko
authors.initials: T
authors.lastname: Ito
authors.affiliation: Department of Otolaryngology, Nara Medical University, Kashihara-city, Nara, Japan.
authors.forename: Akinori
authors.initials: A
authors.lastname: Yamashita
authors.affiliation: Department of Otolaryngology, Nara Medical University, Kashihara-city, Nara, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Ota
authors.affiliation: Department of Otolaryngology, Nara Medical University, Kashihara-city, Nara, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Yamanaka
mesh_terms: D000328:Adult; D000368:Aged; D001621:Betahistine / Q000627:therapeutic use*; D019468:Disease Management; D004326:Drinking; D005260:Female; D005500:Follow-Up Studies; D034381:Hearing Loss / Q000453:epidemiology* / Q000628:therapy; D006801:Humans; D008297:Male; D008575:Meniere Disease / Q000378:metabolism / Q000628:therapy*; D008875:Middle Aged; D008876:Middle Ear Ventilation / Q000379:methods*; D010865:Pilot Projects; D012890:Sleep; D016896:Treatment Outcome; D014667:Vasopressins / Q000097:blood*; D014717:Vertigo / Q000453:epidemiology* / Q000209:etiology
chemical_list: D014667:Vasopressins; D001621:Betahistine