Abstract
Ménière's disease is characterised by severe vertigo attacks and hearing loss. Intratympanic gentamicin, the standard treatment for refractory Ménière's disease, reduces vertigo, but damages vestibular function and can worsen hearing. We aimed to assess whether intratympanic administration of the corticosteroid methylprednisolone reduces vertigo compared with gentamicin. In this double-blind comparative effectiveness trial, patients aged 18-70 years with refractory unilateral Ménière's disease were enrolled at Charing Cross Hospital (London, UK) and Leicester Royal Infirmary (Leicester, UK). Patients were randomly assigned (1:1) by a block design to two intratympanic methylprednisolone (62·5 mg/mL) or gentamicin (40 mg/mL) injections given 2 weeks apart, and were followed up for 2 years. All investigators and patients were masked to treatment allocation. The primary outcome was vertigo frequency over the final 6 months (18-24 months after injection) compared with the 6 months before the first injection. Analyses were done in the intention-to-treat population, and then per protocol. This trial is registered with ClinicalTrials.gov, number NCT00802529. Between June 19, 2009, and April 15, 2013, 256 patients with Ménière's disease were screened, 60 of whom were enrolled and randomly assigned: 30 to gentamicin and 30 to methylprednisolone. In the intention-to-treat analysis (ie, all 60 patients), the mean number of vertigo attacks in the final 6 months compared with the 6 months before the first injection (primary outcome) decreased from 19·9 (SD 16·7) to 2·5 (5·8) in the gentamicin group (87% reduction) and from 16·4 (12·5) to 1·6 (3·4) in the methylprednisolone group (90% reduction; mean difference -0·9, 95% CI -3·4 to 1·6). Patients whose vertigo did not improve after injection (ie, non-responders) after being assessed by an unmasked clinician were eligible for additional injections given by a masked clinician (eight patients in the gentamicin group vs 15 in the methylprednisolone group). Two non-responders switched from methylprednisolone to gentamicin. Both drugs were well tolerated with no safety concerns. Six patients reported one adverse event each: three in the gentamicin group and three in the methylprednisolone group. The most common adverse event was minor ear infections, which was experienced by one patient in the gentamicin group and two in the methylprednisolone group. Methylprednisolone injections are a non-ablative, effective treatment for refractory Ménière's disease. The choice between methylprednisolone and gentamicin should be made based on clinical knowledge and patient circumstances. Ménière's Society and National Institute for Health Research Imperial Biomedical Research Centre.
Highlights
Ménière’s disease causes devastating vertigo attacks.[1]
In aggressive phases with frequent and severe vertigo episodes, intratympanic injections of gentamicin are effective.[3]. This treatment is a minimally invasive outpatient procedure, but, since the therapeutic effects rely on the ototoxic properties of gentamicin, patients are left with a permanent vestibular deficit.[4]
We recruited 60 patients with definite unilateral Ménière’s disease:[13 55] at the primary site and five at the secondary site. 30 patients were assigned to the gentamicin group (15 women, 12 right-sided) and 30 to the methylprednisolone group
Summary
Ménière’s disease causes devastating vertigo attacks.[1]. In the initial phases of the disease, no treatment decreases the frequency or intensity of the attacks.[2]. Corticosteroids, which do not harm inner ear function, have been used in Ménière’s disease,[7] but, so far, no double-blind, prospective, randomised controlled trial of steroids versus gentamicin has been done. In a doubleblind study,[8] control of vertigo after intratympanic administration of the steroid dexamethasone was reported, but the control group received placebo, not gentamicin; study numbers were small (n=22); and a Cochrane review did not fully support its conclusions.[5] In a trial of gentamicin versus dexamethasone treatment,[9] dexamethasone was inferior at controlling vertigo, but the study was non-masked. Opinions on the effectiveness of intratympanic steroid injections vary widely.[10,11,12]
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