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. 2023 Feb 24;2(2):CD015249.
doi: 10.1002/14651858.CD015249.pub2.

Surgical interventions for Ménière's disease

Ambrose Lee  1 , Katie E Webster  2 , Ben George  3 , Natasha A Harrington-Benton  4 , Owen Judd  5 , Diego Kaski  6 , Otto R Maarsingh  7 , Samuel MacKeith  8 , Jaydip Ray  9 , Vincent A Van Vugt  7 , Martin J Burton  10
Affiliations

Surgical interventions for Ménière's disease

Ambrose Lee et al. Cochrane Database Syst Rev. .

Abstract

Background: Ménière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. First-line treatments often involve dietary or lifestyle changes, medication or local (intratympanic) treatments. However, surgery may also be considered for people with persistent or severe symptoms. The efficacy of different surgical interventions at preventing vertigo attacks, and their associated symptoms, is currently unclear.

Objectives: To evaluate the benefits and harms of surgical interventions versus placebo or no treatment in people with Ménière's disease.

Search methods: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 September 2022.

Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs in adults with definite or probable Ménière's disease comparing ventilation tubes, endolymphatic sac surgery, semi-circular canal plugging/obliteration, vestibular nerve section or labyrinthectomy with either placebo (sham surgery) or no treatment. We excluded studies with follow-up of less than three months, or with a cross-over design (unless data from the first phase of the study could be identified). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were: 1) improvement in vertigo (assessed as a dichotomous outcome - improved or not improved), 2) change in vertigo (assessed as a continuous outcome, with a score on a numerical scale) and 3) serious adverse events. Our secondary outcomes were: 4) disease-specific health-related quality of life, 5) change in hearing, 6) change in tinnitus and 7) other adverse effects. We considered outcomes reported at three time points: 3 to < 6 months, 6 to ≤ 12 months and > 12 months. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We included two studies with a total of 178 participants. One evaluated ventilation tubes compared to no treatment, the other evaluated endolymphatic sac decompression compared to sham surgery. Ventilation tubes We included a single RCT of 148 participants with definite Ménière's disease. It was conducted in a single centre in Japan from 2010 to 2013. Participants either received ventilation tubes with standard medical treatment, or standard medical treatment alone, and were followed up for two years. Some data were reported on the number of participants in whom vertigo resolved, and the effect of the intervention on hearing. Our other primary and secondary outcomes were not reported in this study. This is a single, small study and for all outcomes the certainty of evidence was low or very low. We are unable to draw meaningful conclusions from the numerical results. Endolymphatic sac decompression We also included one RCT of 30 participants that compared endolymphatic sac decompression with sham surgery. This was a single-centre study conducted in Denmark during the 1980s. Follow-up was predominantly conducted at one year, but additional follow-up continued for up to nine years in some participants. Some data were reported on hearing and vertigo (both improvement in vertigo and change in vertigo), but our other outcomes of interest were not reported. Again, this is a single, very small study and we rated the certainty of the evidence as very low for all outcomes. We are therefore unable to draw meaningful conclusions from the numerical results. AUTHORS' CONCLUSIONS: We are unable to draw clear conclusions about the efficacy of these surgical interventions for Ménière's disease. We identified evidence for only two of our five proposed comparisons, and we assessed all the evidence as low- or very low-certainty. This means that we have very low confidence that the effects reported are accurate estimates of the true effect of these interventions. Many of the outcomes that we planned to assess were not reported by the studies, such as the impact on quality of life, and adverse effects of the interventions. Consensus on the appropriate outcomes to measure in studies of Ménière's disease is needed (i.e. a core outcome set) in order to guide future studies in this area and enable meta-analyses of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits.

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Conflict of interest statement

Ambrose Lee: none known.

Katie Webster: none known.

Natasha A Harrington‐Benton: Natasha Harrington‐Benton is the Director of the Ménière's Society, a national charity supporting people with vestibular conditions. The Ménière's Society supports research in various ways, including distributing surveys and/or providing grant funding for projects studying vestibular conditions. Some of the studies they have previously funded may be included in the review. They do not carry out the research themselves and are not directly involved in projects.

Owen Judd: none known.

Diego Kaski: none known.

Otto R Maarsingh: none known.

Samuel MacKeith: Samuel MacKeith is the Assistant Co‐ordinating Editor of Cochrane ENT, but had no role in the editorial process for this review. He sees patients with Ménière's disease in his NHS and private practice and is the co‐director of a company providing private vestibular function testing services.

Jaydip Ray: none known.

Vincent A Van Vugt: none known.

Martin J Burton: Martin Burton undertook private practice until March 2020 and saw some patients with Ménière's disease. He is the Co‐ordinating Editor of Cochrane ENT, but had no role in the editorial process for this review.

Figures

1
1
Flow chart of study retrieval and selection.
2
2
The Cochrane Pregnancy and Childbirth Trustworthiness Screening Tool
3
3
Risk of bias summary (our judgements about each risk of bias item for each included study).
4
4
Risk of bias graph (our judgements about each risk of bias item presented as percentages across all included studies).
1.1
1.1. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 1: Improvement in frequency of vertigo (complete resolution) at > 12 months
1.2
1.2. Analysis
Comparison 1: Ventilation tubes versus no treatment, Outcome 2: Change in hearing: improvement in hearing at > 12 months
2.1
2.1. Analysis
Comparison 2: Endolymphatic sac decompression versus placebo (sham surgery), Outcome 1: Improvement in vertigo (complete resolution)
2.2
2.2. Analysis
Comparison 2: Endolymphatic sac decompression versus placebo (sham surgery), Outcome 2: Change in vertigo
2.3
2.3. Analysis
Comparison 2: Endolymphatic sac decompression versus placebo (sham surgery), Outcome 3: Change in hearing
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD015249

References

References to studies included in this review

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Publication types