Background: Ménière’s disease (MD) is characterised by severe vertigo attacks and deafness. Intratympanic gentamicin ablates vestibular function, quells vertigo and is the standard treatment for refractory MD - but it can worsen hearing. Intratympanic corticosteroids may reduce vertigo without harming hearing but no RCT comparing steroids versus gentamicin is available.
Methods: In this comparative effectiveness trial, refractory unilateral MD patients, defined according to the American Academy of Otolaryngology, were double-blindly randomised (1:1 block-design) to intratympanic methylprednisolone (n=30, 62·5mg/ml) or gentamicin (n=30, 40mg/ml) and followed-up over two years at Charing Cross Hospital (Imperial NHS, London) and Leicester Royal Infirmary, Leicester, UK. Primary outcome was vertigo frequency over the final 6-months (18-24months post-injection) compared to a 6-month pre-injection baseline. Secondary outcomes were vestibular and auditory symptoms (validated questionnaires) and hearing preservation (audiometry). ClinicalTrials.gov:NCT00802529.
Findings: For intention-to-treat analysis i.e., all 60 patients, number of vertigo attacks/6months (primary outcome) fell from 19·9 to 2·5 [87%] in the gentamicin arm and 16·4 to 1·6 [90%] in the steroid arm (difference in absolute number of attacks in the final 6months -0·9; 95%CI -3·4 to 1·6). Both drugs reduced the number of vertigo attacks at 2 years (P<0·0001), with equal efficacy (P=0·51). For hearing preservation (secondary outcome), there was no difference (P=0·18) between drugs for hearing thresholds (final difference -2·45decibels, 95%CI -13·4 to 8·5). Both drugs reduced auditory and vestibular symptoms equally. As protocol, patients whose vertigo did not respond post-injection (‘non-responders’) were considered for additional injections by an unblinded physician (8 patients gentamicin vs. 15 patients steroid). Two ‘non-responders’ switched from steroid to gentamicin. Results were the same with per-protocol analysis. Both drugs were well tolerated with no safety concerns.
Interpretation: There was no statistical difference between gentamicin or steroid for vertigo control. Steroid injections are a non-ablative, effective treatment for refractory MD.