Imperial College London
Alternate

ProfessorAdolfoBronstein

Faculty of Medicine, Department of Brain Sciences

Emeritus Clinical Professor Head of Neuro-otology Unit
 
 
 
//

Contact

 

+44 (0)20 3313 5525a.bronstein

 
 
//

Assistant

 

Miss Lorna Stevenson +44 (0)20 3313 5525

 
//

Location

 

10 L15bLab BlockCharing Cross Campus

//

Summary

 

Publications

Citation

BibTex format

@article{Patel:2016:10.1016/S0140-6736(16)31461-1,
author = {Patel, M and Agarwal, K and Arshad, Q and Hariri, M and Rea, P and Seemungal, BM and Golding, JF and Harcourt, JP and Bronstein, AM},
doi = {10.1016/S0140-6736(16)31461-1},
journal = {The Lancet},
pages = {2753--2762},
title = {Intratympanic methylprednisolone versus gentamicin in patients with unilateral Ménière's disease: a randomised, double-blind, comparative effectiveness trial},
url = {http://dx.doi.org/10.1016/S0140-6736(16)31461-1},
volume = {388},
year = {2016}
}
Download

RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BACKGROUND: 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. METHODS: 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. FINDINGS: 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)
AU  - Patel,M
AU  - Agarwal,K
AU  - Arshad,Q
AU  - Hariri,M
AU  - Rea,P
AU  - Seemungal,BM
AU  - Golding,JF
AU  - Harcourt,JP
AU  - Bronstein,AM
DO  - 10.1016/S0140-6736(16)31461-1
EP  - 2762
PY  - 2016///
SN  - 0140-6736
SP  - 2753
TI  - Intratympanic methylprednisolone versus gentamicin in patients with unilateral Ménière's disease: a randomised, double-blind, comparative effectiveness trial
T2  - The Lancet
UR  - http://dx.doi.org/10.1016/S0140-6736(16)31461-1
UR  - http://www.ncbi.nlm.nih.gov/pubmed/27865535
UR  - http://hdl.handle.net/10044/1/42982
VL  - 388
ER  -
Download