CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Add like
Add dislike
Add to saved papers

The effects of transtympanic micropressure treatment in people with unilateral Meniere's disease.

OBJECTIVE: To evaluate the efficacy of a portable low-intensity alternating pressure generator, the Meniett device, in controlling the symptoms of Ménière's disease.

DESIGN: A randomized, placebo-controlled, double-blind, 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.

INTERVENTION: 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.

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.

Full text links

We have located links that may give you full text access.
Can't access the paper?
Try logging in through your university/institutional subscription. For a smoother one-click institutional access experience, please use our mobile app.

For the best experience, use the Read mobile app

Mobile app image

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app

All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.

By using this service, you agree to our terms of use and privacy policy.

Your Privacy Choices Toggle icon

You can now claim free CME credits for this literature searchClaim now

Get seemless 1-tap access through your institution/university

For the best experience, use the Read mobile app