Meniett clinical trial: long-term follow-up.
OBJECTIVE: To delineate 2-year efficacy of Meniett device therapy in people with classic, unilateral, Ménière's disease unresponsive to traditional medical treatment. DESIGN: A 2-year long-term unblinded follow-up after a prior randomized, placebo-controlled, multicenter clinical trial of the Meniett device for Ménière's disease. SETTING: Follow-up was performed remotely by using diaries and questionnaires mailed to the data coordinating center by the participants. Those who failed to mail their diaries were interviewed by telephone. PARTICIPANTS: Sixty-one study participants agreed to use the Meniett device and report their symptoms for 2 years. All had active, unilateral cochleovestibular disease. Outcomes are available for 58 participants; 2 were unavailable for follow-up and 1 was excluded because of a concurrent condition that precluded Meniett device use. INTERVENTIONS: Participants were advised to adhere to a low-sodium diet, use the Meniett device 3 times daily, and maintain a patent tympanostomy tube in the affected ear. Diuretic and vestibular suppressant medications were used as needed. MAIN OUTCOME MEASURES: Outcomes were based on the participants' daily diary, questionnaires, and telephone interviews. Three different analyses were prepared: tracking of vertigo frequency throughout the study, comparison of vertigo frequency before and at the end of Meniett device use (American Academy of Otolaryngology-Head and Neck Surgery Foundation reporting guideline), and Kaplan-Meier estimates of vertigo remission and recurrence. RESULTS: Vertigo levels gradually improved for most but not all participants. American Academy of Otolaryngology-Head and Neck Surgery Foundation class A (remission) or class B (greatly improved) results occurred in 67% (39/58) of participants, and class F (dropped out to receive surgical therapy) results occurred in 24%. Of the 44 nondropout participants, 39 (89%) had American Academy of Otolaryngology-Head and Neck Surgery Foundation group A or B outcomes. People who went into remission were highly likely (80%) to remain in remission long term; participants who achieved remission (20/43; 47%) did so within the first year of follow-up. CONCLUSIONS: Use of the Meniett device was associated with a significant reduction in vertigo frequency in about two thirds of the participants, and this improvement was maintained long term. Therapy with the Meniett device is a safe and effective option for people with substantial vertigo uncontrolled by medical therapy.
Gates, GA; Verrall, A; Green, JD; Tucci, DL; Telian, SA
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