Long-term effect of transtympanic intermittent pressure therapy using a tympanic membrane massage device for intractable meniere's disease and delayed endolymphatic hydrops.

BACKGROUND: A 12-month follow-up study showed that middle ear pressure treatment with a transtympanic membrane massage (TMM) device had a similar effect to a Meniett device. OBJECTIVES: The effects of pressure treatment with a TMM device were retrospectively compared to the effects of treatment with a Meniett device in patients with Meniere's disease (MD) and delayed endolymphatic hydrops (DEH) who were followed for a minimum of 24 months. MATERIALS AND METHODS: Twenty-seven patients were treated with the TMM device and 14 patients were treated with a Meniett device. The insertion of a transtympanic ventilation tube was necessary for the Meniett device but not for the TMM device. RESULTS: In patients treated with the TMM and Meniett devices, the frequency of vertigo significantly improved at 19-24 months after treatment. The distribution of vertigo at 19-24 months after treatment did not differ between the patients treated with the two types of devices. Pressure treatment for 8 months or more was suitable to achieve remission. CONCLUSIONS AND SIGNIFICANCE: Middle ear pressure treatment for 8 months or more with a TMM or Meniett device was equally effective and provided minimally invasive treatment options for intractable MD and DEH.

Effects of transtympanic intermittent pressure therapy using a new tympanic membrane massage device for intractable Meniere's disease and delayed endolymphatic hydrops: a prospective study.

BACKGROUND: The retrospective study showed that the effect of the middle ear pressure treatment by the tramstympanic membrane massage (TMM) device was similar to that of the Meniett device. OBJECTIVES: The new TMM device named EFET device was prospectively evaluated in patients with Meniere's disease (MD) and delayed endolymphatic hydrops (DEH) and we compared the effects to the Meniett device. MATERIALS AND METHODS: 23 ears of 19 patients were treated with an EFET device, and 17 ears of 15 patients were treated with the Meniett device. All patients suffering from intractable MD and DEH were treated for 4 months. The insertion of a transtympanic ventilation tube was necessary for the Meniett device, but not the EFET device. RESULTS: In patients treated by the EFET and Meniett devices, the frequency of vertigo significantly improved after treatment. The distribution of vertigo outcomes at 4 months after treatment did not differ between patients treated with the both devices. CONCLUSIONS AND SIGNIFICANCE: Middle ear pressure treatment by the EFET device is effective and provides minimally invasive options for intractable MD and DEH like the Meniett device.

Clinical long-term effects of surgical treatment for intractable Meniere's disease: a more than 13-year follow-up after pressure treatment and further surgical treatment for intractable vertigo.

Background: Meniere's disease appears to be a complex inner ear disorder and also remains a controversial and often difficult disease as regards determination of diagnosis, pathogenesis and especially optimal treatment.Aims/objectives: To investigate the long-term effects of progressive surgical treatment in the management of the vertigo attacks of intractable Meniere's disease.Material and methods: Eighteen patients with medically intractable and active Meniere's disease were opted to try Meniett pulse generator (Meniett), endolymphatic sac decompression (ESD) and triple semicircular canal occlusion (TSCO) in order to control the attacks of vertigo. Patients were indicated on the symptom report card the maximum level of vertigo, activity and stress.Results: Of 18 patients with medically intractable and active Meniere's disease during mean 165-month follow-up, the attacks of vertigo were effectively controlled in 14 patients by Meniett (77.78%), 2 patients by Meniett and ESD (11.11%), 2 patients by Meniett, ESD and TSCO (11.11%).Conclusions and significance: It is of great importance for intractable Meniere's disease to select surgically combined treatment process including Meniett, ESD and TSCO to effectively control the attacks of vertigo and a long-term follow-up.

The Clinical Benefit of Device Therapy for Meniere's Disease in Adults: Systematic Review and Meta-Analysis.

OBJECTIVES: This study aimed to assess the clinical benefit of device therapy on controlling the symptoms of Meniere's disease (MD). MATERIALS AND METHODS: We searched PubMed, Embase, the Cochrane Library, China National Knowledge Internet, and Wanfang Data before January 13, 2018. We selected randomized controlled clinical trials, case-controlled studies, and cohort studies that dealt with outcomes of device therapy for the treatment of MD. RESULTS: Sixteen trials met our inclusion criteria. The use of device therapy resulted in improved vertigo control, which was described as a reduction in the number of vertigo days by month (weighted mean difference [WMD]: 3.15, 95% confidence interval [CI]: 2.00-4.31), in the number of vertigo episodes by month (WMD: 7.37, 95% CI: 2.40-12.35), and in the vertigo visual analog score (WMD: 41.51, 95% CI: 34.68-48.34). In addition, the overall complete vertigo control (class A) rate was 50% (95% CI: 37%-64%). The device therapy also reduced the number of sick days by month (WMD: 4.56, 95% CI: 2.15-6.97), and the functional level improved (WMD: 2.66, 95% CI: 2.15-3.17). The electrocochleographic parameters decreased. The device therapy proved beneficial for hearing changes (WMD: 3.19, 95% CI: 0.66-5.71). No publication bias was found in the funnel plot and the results of Egger's test. CONCLUSION: This study showed that the device therapy might reduce vertigo attacks and sick days in patients with MD. Additionally, the function level and hearing level may improve after the device therapy. In addition, the decrease in electrocochleographic parameters showed that inner ear electrophysiology improved after device therapy.

Delayed Effect of Active Pressure Treatment on Endolymphatic Hydrops.

OBJECTIVE: To identify eventual correlations between the effect of low-pressure treatment and endolymphatic hydrops in Ménière patients. MATERIAL AND METHODS: The study group consisted of subjects affected by definite Ménière disease (2015) and a severe degree of disability, who received a ventilation tube with or without a low-pressure treatment before undergoing a surgical procedure (vestibular neurectomy). After the placement of the ventilation tube, the subjects were either left alone with the tube or received 1 month of self-administered low-pressure therapy with a portable device. In all subjects, an electrocochleography (ECochG) was performed and specific questionnaires - Dizziness Handicap Inventory (DHI) and Functional Scale Level (FSL) - were completed before starting either arm of treatment, at the end of treatment, and then 3 and 6 months later. RESULTS: All selected subjects presented with an ECochG pattern that was indicative of endolymphatic hydrops before starting either treatment. At the end of pressure treatment, 80% showed symptomatic improvement while maintaining the hydropic ECochG pattern. At the 3-month control stage, the hydropic pattern resulted normalized (<0.5) in all the improved subjects. CONCLUSIONS: Although 1 month of low-pressure treatment provided a positive symptomatological outcome, normalization of the hydropic ECochG parameters occurred only at a later time. Therefore, it is possible to assume that endolymphatic hydrops could be concurrent with a non-symptomatic stage of Ménière disease, and that the anti-hydropic effect of the low-pressure treatment, if any, would present with a certain delay after its completion.

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.

Meniett Therapy for Ménière's Disease: An Updated Meta-analysis.

OBJECTIVE: To re-evaluate the efficacy of Meniett therapy for the treatment of Ménière's disease (MD). DATA SOURCES: PubMed, Embase, Cochrane Library, Clinicaltrials.gov, ChiCTR, and the CNKI database were searched for articles in English and Chinese published before August 31, 2015. STUDY SELECTION: Included in this meta-analysis were studies that dealt with outcomes of Meniett therapy for the treatment of MD, including randomized controlled clinical trials, case-control studies, and prospective or retrospective cohort studies, with sample sizes of ≥ 10 subjects. DATA EXTRACTION: Keywords included endolymphatic hydrops, Ménière's disease, pressure, Meniett, and transtympanic micropressure treatment. DATA SYNTHESIS: Fourteen studies were included, involving a total of 345 MD patients. Data were analyzed using the Meta package in R. Dichotomous outcomes were expressed as risk ratios with 95% confidence intervals, and weighted mean differences with 95% confidence intervals were used to present continuous outcomes. Heterogeneity of the included studies was quantitatively assessed by χ(2) and I tests. Fixed-effects models were used for I(2) <50%; otherwise, random-effects models were used. Funnel plots were constructed to test the publication bias. CONCLUSION: This study showed that Meniett therapy may prevent vertigo attacks and substantially reduce its frequency in MD patients. It may also alleviate the functional deficit. The impact of Meniett therapy on hearing remains uncertain. The optimal effect might maintain for approximately 18 months. This meta-analysis suggested that Meniett therapy may be a useful second-line therapy in the treatment of MD.

Positive pressure therapy for Ménière's disease or syndrome.

BACKGROUND: Ménière's disease is an incapacitating disease in which recurrent attacks of vertigo are accompanied by hearing loss, tinnitus and/or aural fullness, all of which are discontinuous and variable in intensity. A number of different therapies have been identified for patients with this disease, ranging from dietary measures (e.g. a low-salt diet) and medication (e.g. betahistine (Serc®), diuretics) to extensive surgery (e.g. endolymphatic sac surgery). The Meniett® low-pressure pulse generator (Medtronic ENT, 1999) is a device that is designed to generate a computer-controlled sequence of low-pressure (micro-pressure) pulses, which are thought to be transmitted to the vestibular system of the inner ear. The pressure pulse passes via a tympanostomy tube (grommet) to the middle ear, and hence to the inner ear via the round and/or oval window. The hypothesis is that these low-pressure pulses reduce endolymphatic hydrops. OBJECTIVES: To assess the effects of positive pressure therapy (e.g. the Meniett device) on the symptoms of Ménière's disease or syndrome. SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 6 June 2014. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing positive pressure therapy (using the Meniett or a similar device) with placebo in patients with Ménière's disease. The primary outcome was control of vertigo; secondary outcomes were loss or gain of hearing, severity of tinnitus, perception of aural fullness, functional level, complications or adverse effects, and sick days. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, assessed risk of bias and extracted data. We contacted authors for additional data. Where possible, we pooled study results using a fixed-effect, mean difference (MD) meta-analysis and tested for statistical heterogeneity using both the Chi² test and I² statistic. This was only possible for the secondary outcomes loss or gain of hearing and sick days. We presented results using forest plots with 95% confidence intervals (Cl). MAIN RESULTS: We included five randomised clinical trials with 265 participants. All trials were prospective, double-blind, placebo-controlled randomised controlled trials on the effects of positive pressure therapy on vertigo complaints in Ménière's disease. Overall, the risk of bias varied: three out of five studies were at low risk, one was at unclear risk and one was at high risk of bias. Control of vertigo For the primary outcome, control of vertigo, it was not possible to pool data due to heterogeneity in the measurement of the outcome measures. In most studies, no significant difference was found between the positive pressure therapy group and the placebo group in vertigo scores or vertigo days. Only one study, at low risk of bias, showed a significant difference in one measure of vertigo control in favour of positive pressure therapy. In this study, the mean visual analogue scale (VAS) score for vertigo after eight weeks of treatment was 25.5 in the positive pressure therapy group and 46.6 in the placebo group (mean difference (MD) -21.10, 95% CI -35.47 to -6.73; scale not stated - presumed to be 0 to 100). Secondary outcomes For the secondary outcomes, we carried out two pooled analyses. We found statistically significant results for loss or gain of hearing . Hearing was 7.38 decibels better in the placebo group compared to the positive pressure therapy group (MD) (95% CI 2.51 to 12.25; two studies, 123 participants). The severity of tinnitus and perception of aural fullness were either not measured or inadequate data were provided in the included studies. For the secondary outcome functional level , it was not possible to perform a pooled analysis. One included study showed less functional impairment in the positive pressure group than the placebo group (AAO-HNS criteria, one- to six-point scale: MD -1.10, 95% CI -1.81 to -0.39, 40 participants); another study did not show any significant results. In addition to the predefined secondary outcome measures, we included sick days as an additional outcome measure, as two studies used this outcome measure and it is a complementary measurement of impairment due to Ménière's disease. We did not find a statistically significant difference in sick days. No complications or adverse effects were noted by any study. AUTHORS' CONCLUSIONS: There is no evidence, from five included studies, to show that positive pressure therapy is effective for the symptoms of Ménière's disease. There is some moderate quality evidence, from two studies, that hearing levels are worse in patients who use this therapy. The positive pressure therapy device itself is minimally invasive. However, in order to use it, a tympanostomy tube (grommet) needs to be inserted, with the associated risks. These include the risks of anaesthesia, the general risks of any surgery and the specific risks of otorrhoea and tympanosclerosis associated with the insertion of a tympanostomy tube. Notwithstanding these comments, no complications or adverse effects were noted in any of the included studies.

Systematic review and meta-analysis of Meniett therapy for Meniere's disease.

OBJECTIVES/HYPOTHESIS: To perform a systematic review and meta-analysis of micropressure treatment for Meniere's disease (MD). DATA SOURCES: Medline, Ovid, Web of Science, and Cochrane Library search of the literature from January 1996 to December 2012. REVIEW METHODS: Systematic literature review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Inclusion criteria required definitive diagnosis of unilateral MD, treatment with Meniett device, vertigo control results, and hearing results before and after treatment. Randomized controlled trials and other types of case-control studies were included. Improvements in vertigo, American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) functional score, and pure tone average (PTA) were assessed. Funnel plots were used to detect bias and Q test was used to assess for heterogeneity. Random effects model was used for meta-analysis. T test was used to assess for significance. RESULTS: Of 113 abstracts screened, 18 studies met criteria for review and 12 were used for meta-analysis. Eight studies reported hearing evaluation and the improvement in PTA after Meniett treatment was significant (P = 0.0085). Data could not be combined for AAO-HNS functional score due to heterogeneity. However, there was a trend toward improvement. Of six studies reporting frequency of vertigo, Meniett treatment significantly reduced frequency of vertigo (P = < .0001). LIMITATIONS: Much of the data used in the analysis was derived from retrospective or level 4 studies. The average follow-up was only 5 months, and there were low number of patients in the treatment and control groups. CONCLUSION: The Meniett device is a safe, nondestructive treatment for patients' refractory to medical therapy for MD.