Meniett device in meniere disease: Randomized, double-blind, placebo-controlled multicenter trial.

OBJECTIVE To evaluate the efficacy of portable Meniett low-pressure pulse generator (Medtronic Xomed, Jacksonville, FL) in Meniere disease. STUDY DESIGN Randomized, double-blind, placebo-controlled, multicenter trial carried out in 17 academic medical centers. METHODS One hundred twenty-nine adults presenting Meniere disease (American Academy of Otolaryngology-Head and Neck Surgery criteria) not controlled by conventional medical treatment were included. The protocol included three phases: 1) placement of a transtympanic tube and evaluation of its effect (if resolution of symptoms, the patient was excluded); 2) randomization: 6-weeks treatment with Meniett (Medtronic Xomed) or placebo device; 3) removal of the device and 6-week follow-up period. The evaluation criteria were the number of vertigo episodes (at least 20 minutes with a 12-hour free interval) and the impact on daily life as assessed by self-questionnaires. RESULTS Ninety-seven patients passed to the second phase of the study: 49 and 48 patients received the Meniett (Medtronic Xomed) or the placebo device, respectively. In the placebo group, the number of vertigo episodes decreased from 4.3 ± 0.6 (mean ± standard error of the mean) during the first phase to 2.6 ± 0.5 after 6 weeks of treatment, and to 1.8 ± 0.8 after the removal of the device. Similar results were observed in the Meniett device (Medtronic Xomed) group: 3.2 ± 0.4 episodes during the first phase, 2.5 ± after 6 weeks of Meniett device (Medtronic Xomed) treatment, and 1.5 ± 0.2 after the third phase. CONCLUSION An improvement of symptoms was evidenced in all patients, with no difference between the Meniett (Medtronic Xomed) and the placebo device groups. The decrease in the number of vertigo episodes could be explained by an effect of the medical care. LEVEL OF EVIDENCE 1b. Laryngoscope, 2016 127:470-475, 2017.