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Injecting steroids into the space behind the ear drum may be a safer alternative to injections of gentamycin for treating Ménière’s disease. This disease is marked by severe attacks of dizziness and balance problems.
This NIHR-funded trial randomised 60 people with Ménière’s disease who experienced severe attacks of vertigo and had not responded to standard treatment. They were randomly chosen to receive either the corticosteroid methylprednisolone or the antibiotic gentamicin. Participants were followed for two years.
Both were very effective at stopping or reducing symptoms by about 90%. Few side effects were reported in either group.
Gentamicin works by permanently damaging the inner ear function that is concerned with balance, and rarely can cause deafness. Because of this, specialist healthcare professionals may prefer to use of methylprednisolone instead.
Why was this study needed?
Ménière’s disease is an inner ear condition that can cause attacks of dizziness, balance problems (vertigo), nausea and vomiting, ringing in the ears (tinnitus) and hearing loss. An estimated one in 1,000 people in the UK have Ménière's disease.
In most people with Ménière's disease, attacks of vertigo can be reduced with a low salt diet, lifestyle changes and the drug betahistine.
In those who experience severe and frequent attacks of vertigo, injecting gentamicin through the eardrum into the middle ear can help. This benefit is achieved through its toxic effects on the parts of the inner ear involved with balance. Gentamicin injections can also cause attacks of vertigo and hearing loss.
Steroids have also been used to treat Ménière’s disease, because unlike gentamicin, they do not damage inner ear function. However, little evidence is available to compare the effectiveness of these approaches.
What did this study do?
The participants had Ménière's disease in one ear, and severe attacks of vertigo that had not responded to standard treatment.
Two middle ear injections were given, two weeks apart. Participants were assessed for vertigo symptoms, balance and hearing at baseline (0 months) and at one, two, six, 12, 18 and 24 months.
If vertigo returned then additional injections were given: either the same drug or switching to the other drug as chosen by a separate unblinded clinician (the patient and other clinicians remained blinded).
This study did not have a placebo control group, so it is possible that any reduction in attacks of vertigo could be part of the fluctuating course of Ménière’s disease rather than a true effect of either treatment. The small number of participants means the study was underpowered for some results.
What did it find?
- The average number of vertigo attacks decreased by 90% in the methylprednisolone group (from 16.4 attacks in the six months before treatment to 1.6 in the final six months of follow-up) and 87% in the gentamicin group (from 19.9 attacks to 2.5). The difference was not statistically significant.
- Two thirds (67%) of people in the methylprednisolone group and a similar proportion (63%) in the gentamicin group had no attacks of vertigo between 18 and 24 months after treatment.
- The total number of injections per patient was 2.7 (SD1.7) in the gentamicin group and 3.7 (SD2.5) in the methylprednisolone group.Two patients in the methylprednisolone group were deemed treatment failures and received gentamicin.
- Both groups also had substantial improvements in tinnitus and dizziness.
- Though inner ear function tests were worse in people who received gentamicin, there were no differences between the groups on questionnaires about balance.
- Hearing ability did not change in either group compared to baseline.
- Three people in each group reported mild adverse events, mostly minor ear infections.
What does current guidance say on this issue?
The NICE 2012 Clinical Knowledge Summary on Ménière’s disease recommends healthcare professionals should consider prescribing betahistine (initially 16 mg three times a day) to reduce the frequency and severity of attacks of hearing loss, tinnitus and vertigo.
It adds that some people with severe, poorly-controlled Ménière’s disease may need referral to an ear, nose and throat specialist for consideration of other drug treatments such as an injection of gentamicin into the middle ear.
What are the implications?
Both steroids and antibiotics appeared to be effective for people with severe Ménière’s disease. Although gentamicin affected inner ear function, this did not translate into serious hearing or balance problems in this small study population.
Specialists should discuss both treatment options with patients, taking into account the permanent damage that could be caused by gentamicin versus the potentially higher number of injections that might be required with steroids. Half of the people in the methylprednisolone group required more than two injections, which may affect patient choice.
Steroid injections would be particularly worth trying for people who are affected in both ears; because gentamicin would not be an option for them because of the small chance it could cause permanent hearing loss.
Citation and Funding
Patel M, Agarwal K, Arshad Q, et al. Intratympanic methylprednisolone versus gentamicin in patients with unilateral Ménière's disease: a randomised, double-blind, comparative effectiveness trial. Lancet. 2016;388(10061):2753-62.
This project was funded by the Ménière's Society and the National Institute for Health Research Biomedical Research Centre based at Imperial College.
Bibliography
NICE CKS. Meniere's disease. London: National Institute for Health and Care Excellence Clinical Knowledge Summary; 2012.
NHS Choices. Ménière’s disease. London: Department of Health; updated 2015.
Phillips JS, Westerberg B. Intratympanic steroids for Meniere's disease or syndrome. Cochrane Database Syst Rev. 2011;(7):CD008514.
Pullens B, van Benthem PP. Intratympanic gentamicin for Ménière's disease or syndrome. Cochrane Database Syst Rev. 2011;(3):CD008234.
Rauch SD. Ménière's disease: damaged hearing but reduced vertigo. Lancet. 2016;388(10061):2716-17.
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