Due to a lack of robust evidence, it is not clear whether corticosteroids given into the ear (intratympanic corticosteroids) work to improve symptoms for people with Ménière's disease. It is also not clear whether there are any risks associated with treatment.
Larger, well-conducted studies are needed in order to identify whether this treatment may be effective, and to assess whether there are any harmful effects.
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.
How is Ménière's disease treated?
Oral medications (tablets) are often used as the first treatment for Ménière's disease. If these treatments do not control the symptoms, then corticosteroids may be given directly in the ear. This is most commonly given as an injection through the ear drum, but may be done by placing a grommet - a tiny tube - in the eardrum, and giving the corticosteroids as drops into the ear.
What did we want to find out?
We wanted to find out:
- whether there was evidence that intratympanic corticosteroids work at reducing the symptoms of Ménière's disease;
- whether this treatment might cause any serious harms, or other side effects (such as causing a hole in the eardrum).
What did we do?
We searched for studies that compared intratympanic corticosteroids to either no treatment or sham (placebo) treatment.
What did we find?
We found 10 studies, which included a total of 952 people. They lasted between three months and two years.
- When people considered whether their vertigo had improved, there was very little difference between those who had received intratympanic corticosteroids and those who had received no treatment (or sham treatment) at either six months to one year, or up to two years of follow-up.
- When people counted the number of vertigo episodes they had, we found that intratympanic corticosteroids might reduce the number of episodes, but only by a small amount. This was the case when people were seen at three to six months, but we are not sure if the effect would also be seen at longer follow-up times.
- It is unclear whether intratympanic corticosteroids increase the chance of experiencing serious medical problems (serious adverse effects).
What are the limitations of the evidence?
We have very little confidence in the evidence because most of the studies conducted were very small and had problems in their conduct, which means that the results may be unreliable. We also found two large studies that have not been published, therefore their results could not be included in this review. We understand that these studies found that intratympanic corticosteroids were not effective. If we had been able to include these data then some conclusions of this review might be different.
Larger, well-conducted studies are needed to try and work out how effective the different treatments really are. In addition, the people conducting those studies must make sure that the results are available, regardless of the findings of the study.
How up-to-date is this evidence?
This evidence is up-to-date to September 2022.
The evidence for intratympanic corticosteroids in the treatment of Ménière's disease is uncertain. There are relatively few published RCTs, which all consider the same type of corticosteroid (dexamethasone). We also have concerns about publication bias in this area, with the identification of two large RCTs that remain unpublished. The evidence comparing intratympanic corticosteroids to placebo or no treatment is therefore all 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. 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-analysis of the results. This must include appropriate consideration of the potential harms of treatment, as well as the benefits. Finally, we would also highlight the responsibility that trialists have to ensure results are available, regardless of the outcome of their study.
Ménière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. Corticosteroids are sometimes administered directly into the middle ear to treat this condition (through the tympanic membrane). The underlying cause of Ménière's disease is unknown, as is the way in which this treatment may work. The efficacy of this intervention in preventing vertigo attacks, and their associated symptoms, is currently unclear.
To evaluate the benefits and harms of intratympanic corticosteroids 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 a diagnosis of Ménière's disease comparing intratympanic corticosteroids with either placebo 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 (including tympanic membrane perforation). 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 10 studies with a total of 952 participants. All studies used the corticosteroid dexamethasone, with doses ranging from approximately 2 mg to 12 mg.
Improvement in vertigo
Intratympanic corticosteroids may make little or no difference to the number of people who report an improvement in their vertigo at 6 to ≤ 12 months follow-up (intratympanic corticosteroids 96.8%, placebo 96.6%, risk ratio (RR) 1.00, 95% confidence interval (CI) 0.92 to 1.10; 2 studies; 60 participants; low-certainty evidence) or at more than 12 months follow-up (intratympanic corticosteroids 100%, placebo 96.3%; RR 1.03, 95% CI 0.87 to 1.23; 2 studies; 58 participants; low-certainty evidence). However, we note the large improvement in the placebo group for these trials, which causes challenges in interpreting these results.
Change in vertigo
Assessed with a global score
One study (44 participants) assessed the change in vertigo at 3 to < 6 months using a global score, which considered the frequency, duration and severity of vertigo. This is a single, small study and the certainty of the evidence was very low. We are unable to draw meaningful conclusions from the numerical results.
Assessed by frequency of vertigo
Three studies (304 participants) assessed the change in frequency of vertigo episodes at 3 to < 6 months. Intratympanic corticosteroids may slightly reduce the frequency of vertigo episodes. The proportion of days affected by vertigo was 0.05 lower (absolute difference -5%) in those receiving intratympanic corticosteroids (95% CI -0.07 to -0.02; 3 studies; 472 participants; low-certainty evidence). This is equivalent to a difference of approximately 1.5 days fewer per month affected by vertigo in the corticosteroid group (with the control group having vertigo on approximately 2.5 to 3.5 days per month at the end of follow-up, and those receiving corticosteroids having vertigo on approximately 1 to 2 days per month). However, this result should be interpreted with caution - we are aware of unpublished data at this time point in which corticosteroids failed to show a benefit over placebo.
One study also assessed the change in frequency of vertigo at 6 to ≤ 12 months and > 12 months follow-up. However, this is a single, small study and the certainty of the evidence was very low. Therefore, we are unable to draw meaningful conclusions from the numerical results.
Serious adverse events
Four studies reported this outcome. There may be little or no effect on the occurrence of serious adverse events with intratympanic corticosteroids, but the evidence is very uncertain (intratympanic corticosteroids 3.0%, placebo 4.4%; RR 0.64, 95% CI 0.22 to 1.85; 4 studies; 500 participants; very low-certainty evidence).