Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Meniere's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Steroid (Methylprednisolone)

Group Type EXPERIMENTAL

Methylprednisolone

Intervention Type DRUG

2 transtympanic injections at interval of two weeks.

Gentamicin

Group Type ACTIVE_COMPARATOR

Gentamicin

Intervention Type DRUG

2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.

Interventions

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Methylprednisolone

2 transtympanic injections at interval of two weeks.

Intervention Type DRUG

Gentamicin

2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No