Clinical trial NCT00802529: Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Official title: Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Meniere's Disease
Keywords: Meniere's disease
transtympanic steroids
Randomised controlled trial
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: Medical Research Council
First posted: 2008-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.

Detailed description: Meniere's disease is characterised by episodic spontaneous vertigo attacks with hearing loss, ringing sounds and fullness in the ear. In one out of five patients, standard first line medical treatment is not effective in controlling vertigo attacks. For these incapacitated patients, gentamicin injections through the ear drum is a well established minimally invasive treatment. Major surgery of the balance organs or nerve, risking complete hearing loss, CSF leak, meningeal infections, are rarely performed nowadays. Gentamicn is very effective in controlling vertigo and acts by chemical ablation of end organs. As hearing and balance organs are entwined around each other, gentamicin treatment does not come without the risk of hearing loss. In fact, meta-analysis shows hearing deterioration in 13% to 35% percent of gentamicin treated patients. On the other hand, steroids are drug of choice for autoimmune inner ear disease and commonly used for sudden hearing loss. They are non toxic drugs without any known side effects during local treatment in ear. We will compare the two in this randomised, double blind trial.

Eligibility criteria: Inclusion Criteria:

* Patients with unilateral Ménière's disease (definite or probable, according to Committee on Hearing and Equilibrium guidelines, 1995) with hearing loss and presenting with recurrent vertigo, not responding to medical treatment for at least 6 months will be included. There should be normal, age appropriate hearing in the contralateral ear.

Exclusion Criteria:

* Patients with Ménière's disease in later stages (not having vertigo attacks).
* Age: patients older than 70 years at the start of the trial.
* Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
* Active additional neuro-otological disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma) and thus will make the objective follow up difficult.
* Concurrent ear pathology that may interfere with transtympanic treatment (e.g. active middle ear disease).
* Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
* History of known adverse/allergic reaction to steroids or gentamicin.

Primary outcomes:
measure: Vertigo Attacks
timeFrame: 6month pre-enrollment baseline, 18-24 months after initial treatment
Secondary outcomes:
measure: Change in Hearing
timeFrame: Baseline, 1,2,6,12,18 and 24months after initial treatment
measure: Change in Speech Discrimination
timeFrame: Baseline, 1,2,6,12 and 24months after initial treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial college Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Adolfo M Bronstein, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel M, Agarwal K, Arshad Q, Hariri M, Rea P, Seemungal BM, Golding JF, Harcourt JP, Bronstein AM. Intratympanic methylprednisolone versus gentamicin in patients with unilateral Meniere's disease: a randomised, double-blind, comparative effectiveness trial. Lancet. 2016 Dec 3;388(10061):2753-2762. doi: 10.1016/S0140-6736(16)31461-1. Epub 2016 Nov 17.