Due to a lack of robust evidence, it is not clear whether any oral medicines (tablets) used to treat Ménière's disease work to improve people's symptoms, despite their routine use in clinical practice. When used for other conditions, these medications may cause side effects. However, there was too little information from the studies in Ménière’s disease for us to know if there are serious risks from these treatments.
Larger, well-conducted studies are needed in order to identify whether some medications 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.
How is Ménière's disease treated?
Oral medications (tablets) are often used as the first treatment for Ménière's disease. Medications like betahistine and diuretics are commonly used, but other treatments have also been used, including corticosteroids and antiviral treatments. Other treatment options are also available (for example, injections into the ear or surgery).
What did we want to find out?
We wanted to find out:
- whether there was evidence that any oral medications work at reducing 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 treatment to either no treatment or sham (placebo) treatment.
What did we find?
We found 10 studies, which included a total of 848 people. They lasted between three months and two years. Most of the studies looked at treatment with betahistine, two studies looked at diuretics, one looked at corticosteroids and one looked at antivirals.
It is unclear whether betahistine has an effect on vertigo symptoms. It is also unclear whether it causes any harm. Although we found several studies, many did not report on the things we were interested in, or reported them at very different times, so we were not able to combine the results of different studies to get a more accurate answer.
It is also unclear whether diuretics have an effect on vertigo symptoms. We found no studies that reported on possible harms from this treatment.
Antivirals and corticosteroids
For each we only found one small study that looked at these treatments, so we are very uncertain whether they have any effect on vertigo.
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. This may be surprising, as some of these treatments are widely used for Ménière's disease. However, 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.
The evidence for systemic pharmacological interventions for Ménière's disease is very uncertain. There are few RCTs that compare these interventions to placebo or no treatment, and the evidence that is currently available from these studies is of 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-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. A number of pharmacological interventions have been used in the management of this condition, including betahistine, diuretics, antiviral medications and corticosteroids. The underlying cause of Ménière's disease is unknown, as is the way in which these treatments may work. The efficacy of these different interventions at preventing vertigo attacks, and their associated symptoms, is currently unclear.
To evaluate the benefits and harms of systemic pharmacological 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 betahistine, diuretics, antihistamines, antivirals or systemic 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. 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 848 participants. The studies evaluated the following interventions: betahistine, diuretics, antivirals and corticosteroids. We did not identify any evidence on antihistamines.
Seven RCTs (548 participants) addressed this comparison. However, we were unable to conduct any meta-analyses for our primary outcomes as not all outcomes were considered by every study, and studies that did report the same outcome used different time points for follow-up, or assessed the outcome using different methods. Therefore, we were unable to draw meaningful conclusions from the numerical results. Some data were available for each of our primary outcomes, but the evidence was low- or very low-certainty throughout. One study reported on the outcome 'improvement in vertigo' at 6 to ≤ 12 months, and another study reported this outcome at > 12 months. Four studies reported on the change in vertigo, but again all used different methods of assessment (vertigo frequency, or a global score of vertigo severity) or different time points. A single study reported on serious adverse events.
Two RCTs addressed this comparison. One considered the use of isosorbide (220 participants), and the other used a combination of amiloride hydrochloride and hydrochlorothiazide (80 participants). Again, we were unable to conduct any meta-analyses for our primary outcomes, as only one study reported on the outcome 'improvement in vertigo' (at 6 to ≤ 12 months), one study reported on change in vertigo (at 3 to < 6 months) and neither study assessed serious adverse events. Therefore, we were unable to draw meaningful conclusions from the numerical results. The evidence was all very low-certainty.
Other pharmacological interventions
We also identified one study that assessed antivirals (24 participants), and one study that assessed corticosteroids (16 participants). The evidence for these interventions was all very low-certainty. Again, serious adverse events were not considered by either study.