Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
This trial aims to compare transtympanic steroids against the standard treatment (transtympanic gentamicin) in refractory unilateral Meniere's disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial|
- control of vertigo attacks as determined by validated questionnaires and as per committee on hearing and equilibrium guidelines [ Time Frame: acute and long term ] [ Designated as safety issue: No ]
- changes in hearing outcome as determined by hearing tests (Pure Tone Audiometry, Speech Discrimination Scores) [ Time Frame: acute and long term ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Experimental: Steroid (Methylprednisolone)||
2 transtympanic injections at interval of two weeks.
|Active Comparator: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00802529
|Imperial college Healthcare NHS Trust|
|London, United Kingdom|
|Principal Investigator:||Adolfo M Bronstein, PhD, FRCP||Imperial College London|