The Effects of Transtympanic Micropressure Treatment in People With Unilateral Ménière's Disease

Abstract

To evaluate the efficacy of a portable lowintensity alternating pressure generator, the Meniett device, in controlling the symptoms of Mé niè re's disease.Design: A randomized, placebo-controlled, doubleblind, multicenter clinical trial of 4 months' duration.Setting: Four study sites: 3 academic medical centers and 1 private practice.Patients: 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. I n t e r v e n t i o n :The Meniett device was selfadministered 3 times daily. The placebo Meniett device was identical but exerted no pressure. All participants had a tympanostomy tube inserted in the affected ear.Main Outcome Measures: 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. Results: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. Conclusion:The Meniett device is a minimally invasive, safe, and efficacious intermediate treatment for people with substantial vertigo uncontrolled by medical therapy.

Optimal management of Ménière’s disease

“…While a trend toward improvement in vertigo has been identified with this device,34,35 improvement also occurs in the natural history of the disease 30. A long-term follow-up showed 75% improvement in frequency and severity of spells,36 which is similar to the improvement in untreated patients.…”

Effect of transtympanic low-pressure therapy in patients with unilateral Menière's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial

“…In order to minimise problems with recall and perceptual variations, the present study used daily self-reporting in a standardised format, in analogy to Gates and colleagues' previous study. 4 The primary outcome parameters were vertigo score, number of definitive vertigo days and number of sick days.…”

Selected complex auditory disorders

“…A standard, unsealed tympanostomy tube is inserted into the affected ear, and intermittent overpressures from the device are selfadministered three times daily. In a study of 67 patients with unilateral Ménière's disease assigned randomly to treatment with this device or to a control group, treatment was effective for at least 4 months in controlling severity and number of vertigo attacks [48]. In view of the natural course of this disorder with its spontaneous remissions, further studies should be undertaken.…”