Gates George A, Green J Douglas, Tucci Debara L, Telian Steven A
Department of Otolaryngology-Head and Neck Surgery, University of Washington School of Medicine, Seattle, USA.
Arch Otolaryngol Head Neck Surg. 2004 Jun;130(6):718-25. doi: 10.1001/archotol.130.6.718.
To evaluate the efficacy of a portable low-intensity alternating pressure generator, the Meniett device, in controlling the symptoms of Ménière's disease.
A randomized, placebo-controlled, double-blind, multicenter clinical trial of 4 months' duration.
Four study sites: 3 academic medical centers and 1 private practice.
Sixty-seven people aged 33 to 71 years with established, active, unilateral cochleovestibular Ménière's disease randomly assigned to a treatment or control group. Five cases were excluded (2 dropouts, 3 protocol violations), leaving 62 evaluable cases.
The Meniett device was self-administered 3 times daily. The placebo Meniett device was identical but exerted no pressure. All participants had a tympanostomy tube inserted in the affected ear.
Participants rated vertigo and activity each day on a symptom report card. Hearing tests, electrocochleography, and questionnaires were completed at baseline, 2 months, and 4 months.
The treatment group experienced significantly less severe vertigo, fewer days with definitive vertigo, and fewer days lost from work (sick days) during the follow-up period than did the control group. Hearing and electrocochleographic results did not differ between the groups. Outcomes did not differ by age, gender, laterality, or duration of symptoms. Outcomes were affected by vestibular loss and baseline level of vertigo. The tympanostomy tube had no short-term effect on vertigo symptoms. There were no complications from using the Meniett device.
The Meniett device is a minimally invasive, safe, and efficacious intermediate treatment for people with substantial vertigo uncontrolled by medical therapy.
评估便携式低强度交变压力发生器（Meniett 装置）控制梅尼埃病症状的疗效。
一项为期 4 个月的随机、安慰剂对照、双盲、多中心临床试验。
四个研究地点：3 个学术医疗中心和 1 个私人诊所。
67 名年龄在 33 至 71 岁之间、确诊为活动性单侧耳蜗前庭梅尼埃病的患者，随机分为治疗组或对照组。排除 5 例（2 例退出，3 例违反方案），剩余 62 例可评估病例。
Meniett 装置每日自行使用 3 次。安慰剂 Meniett 装置外观相同但不产生压力。所有参与者在患耳插入鼓膜造孔管。
参与者每天在症状报告卡上对眩晕和活动情况进行评分。在基线、2 个月和 4 个月时完成听力测试、耳蜗电图检查和问卷调查。
在随访期间，治疗组的眩晕严重程度明显低于对照组，明确眩晕天数更少，误工天数（病假天数）更少。两组的听力和耳蜗电图检查结果无差异。结果在年龄、性别、患侧或症状持续时间方面无差异。结果受前庭功能丧失和眩晕基线水平影响。鼓膜造孔管对眩晕症状无短期影响。使用 Meniett 装置无并发症。
对于药物治疗无法控制的严重眩晕患者，Meniett 装置是一种微创、安全且有效的中期治疗方法。
