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

Russo, Francesca; Nguyen, Yann; Seta, Daniele De; Bouccara, D.; Sterkers, Olivier; Ferrary, Évelyne; Bernardeschi, Danièle

doi:10.1002/lary.26197

Cited by 28 publications

(8 citation statements)

References 29 publications

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“…We did not find any systematic reviews that matched our inclusion criteria. The systematic search identified four nonrandomized trials 23 24 25 26 ( Table 1 ) and two RCTs 27 28 ( Table 2 ).…”

Section: Resultsmentioning

confidence: 99%

“…In all studies, the intervention was treatment with a VTI. However, in the studies by Russo et al 28 and Barbara et al, 26 a part of the study-group proceeded to the next phase of the trial, which was treatment with a Meniett device. The age-range was not mentioned in the studies by Russo et al 28 and Kitahara et al, 27 but the mean age of the VTI-groups was 52 and 46.7 years old, respectively.…”

Section: Resultsmentioning

confidence: 99%

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Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence

Grønlund

Devantier

Edemann-Callesen

et al. 2020

Int Arch Otorhinolaryngol

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Introduction Menière disease (MD) is a disorder characterized by episodes of vertigo, sensorineural hearing loss, tinnitus and aural fullness. Objectives To assess the effect of ventilation tube insertion (VTI) on vertiginous episodes in patients (≥ 18 years old) with MD. Data Synthesis A systematic literature search on randomized clinical trials (RCTs), nonrandomized trials and other systematic reviews was performed. The Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) approach was used to assess the overall certainty of evidence.Two RCTs and four nonrandomized studies were identified. Data extraction was only possible for one RCT. Results showed that the number of patients with no vertigo attacks significantly increased following active treatment (relative risk 1.52; [95% confidence interval: 1.19–1.94]). The quality of evidence was rated as low. None of the nonrandomized trials included a proper control group, which hindered data extraction and quality assessment. Conclusion There are currently no RCTs that specifically assess the efficacy of VTI in patients with MD. Current limited data suggest a considerable positive effect on the number of vertiginous episodes in patients with MD. However, due to poor evidence, a fluctuating course and a substantial placebo-effect associated with MD-treatment, no solid conclusion(s) regarding the efficacy of VTI can be made. There is a need for high-quality RCTs.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence

Grønlund

Devantier

Edemann-Callesen

et al. 2020

Int Arch Otorhinolaryngol

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“….Russo et al showed a 26% resolution of vertigo attacks after insertion of the transtympanic tube, which was a factor in excluding certain patients from a study to evaluate the effect of a low-pressure pulse generator (Meniett). Most authors who have studied the Meniett device have concluded that it is a factor that affects the experimental results [11]. Sugawara et al offered a similar opinion on ventilation tubes that may improve vertigo, but have no effect on hearing outcomes [12].…”

Section: Discussionmentioning

confidence: 99%

Comparison of the effect Of three treatment interventions for the control of Meniere’s disease: a randomized control trial

Shafei

Qotb

2020

Egypt J Otolaryngol

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Background Intratympanic (IT) dexamethasone, with or without ventilation tube, is widely used to control vertigo in Meniere’s disease (MD) patients. Some authors believe that the tube on its own has a role in the control of MD symptoms. The authors’ goal was to compare the effects of them on multiple sets of patients. A three arms randomized control trial was conducted on 60 patients ( both males and females; age range, 30–60 years; mean age, 47 years) who were diagnosed with MD according to the 1995 American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Foundation guidelines. The study was conducted at the Otolaryngology Department between May 2016 and May 2018. They were divided into three groups, with 20 patients in each group. The first group received direct IT dexamethasone, the second group received IT dexamethasone through a grommet tube, and the third received saline through grommet. Results No treatment modality showed statistically significant improvement regarding both hearing and vertigo control at follow-up periods. However, comparison of patients with disease duration of 1 year and patients with duration of 5 years in the total sample of patients showed that patients with 1-year duration showed statistically significant higher percentage of improvement in pure tone audiometry (PTA) and vertigo control at all follow-up periods. Conclusions No golden standard in MD treatment; however, initial improvement may be explained as a result of the anti-inflammatory effect of steroids and/or the pressure release due to tube insertion; yet, the progressive course of the disease may diminish that improvement over time. Thus, early intervention either by direct IT injection or through grommet tube or by grommet placement alone can affect treatment outcomes.

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“…Many studies support the presence of a prominent placebo effect, which makes this pathology a challenge for management and evaluation. 4,5 All the complications have been reported. The procedure is definitely similar to the one used in patients with multiple sclerosis, but the type of patient is completely different.…”

Section: Letter To the Editormentioning

confidence: 99%

In Response to Letter to the Editor Regarding Chronic Cerebrospinal Venous and Menière's Disease: Interventional Versus Medical Therapy

Attanasio

Califano

Bruno³

et al. 2020

The Laryngoscope

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

Abstract: 1b. Laryngoscope, 2016 127:470-475, 2017.

Cited by 28 publications

References 29 publications

Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence

Vertiginous Episodes in Menière Disease following Transmyringeal Ventilation Tube Insertion: A Systematic Review on the Current State of Evidence

Comparison of the effect Of three treatment interventions for the control of Meniere’s disease: a randomized control trial

In Response to Letter to the Editor Regarding Chronic Cerebrospinal Venous and Menière's Disease: Interventional Versus Medical Therapy

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