Due to a lack of robust evidence, it is not clear whether any types of surgery used to treat Ménière's disease work to improve people's symptoms. There was no information regarding the potential for serious risks from these treatments.
Larger, well-conducted studies are needed in order to identify whether surgery may be effective, and assess whether there are any harmful effects of treatment.
Further work also needs to be done to find out how best to measure the symptoms of people with Ménière's disease, in order to assess whether treatments are beneficial or not. This should include the development of a 'core outcome set' - a list of things that should be measured in all studies on Ménière's disease.
What is Ménière's disease?
Ménière's disease is a condition that affects the inner ear. It causes repeated attacks of dizziness or vertigo (a spinning sensation), together with hearing problems, tinnitus (ringing, humming or buzzing noises in the ears) and a feeling of fullness or pressure in the ear. It usually affects adults, and starts in middle age. Although it is a relatively uncommon condition, it can have a large impact on quality of life.
How is Ménière's disease treated?
There is a lot of variation in how Ménière's disease is treated in different places (both nationally and internationally). Currently there is no agreement on the best treatment strategy. Lifestyle and dietary advice and oral medications are often used as the initial treatment for Ménière's disease. Sometimes other treatments - such as injections into the ear - may also be used. If these treatments do not work, or if people have very severe symptoms, then surgery may be considered.
What did we want to find out?
We wanted to find out:
- whether there was evidence that any types of surgery work to reduce the symptoms of Ménière's disease;
- whether the treatments might cause any harm.
What did we do?
We searched for studies that compared different types of surgery to either no treatment or sham surgery.
What did we find?
We found two studies, which included a total of 178 people.
The first study evaluated ventilation tubes (sometimes known as grommets) - small tubes that are inserted into the eardrum. It was unclear whether this treatment made a difference to vertigo symptoms, and the study did not report on potential harms of the surgery.
Endolymphatic sac decompression
The second study looked at a specific type of surgery on the 'endolymphatic sac' - a fluid filled part of the inner ear. The surgery involved placing a small tube to help drain fluid from this sac. People in this study either received this surgery, or a type of sham surgery, which should not have affected their symptoms of Ménière's disease at all. Again, it was unclear whether this treatment made a difference to vertigo symptoms, and the study did not report on potential harms of the surgery.
What are the limitations of the evidence?
We have very little confidence in the evidence because the two studies conducted were small and had problems in their conduct, which means that the results may be unreliable. Larger, well-conducted studies are needed to try and work out how effective the different treatments really are.
How up-to-date is this evidence?
This evidence is up-to-date to September 2022.
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.
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.
To evaluate the benefits and harms of surgical interventions versus placebo or no treatment in people with Ménière's disease.
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.
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).
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.
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.
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.