Transtympanic gentamicin vs. steroids in refractory Ménière's disease

• Research type

  Research Study

• Full title

  Effectiveness of Transtympanic Steroids in unilateral Ménière's disease: a Randomised Controlled Double-Blind Trial.

• IRAS ID

  5193

• Contact name

  Adolfo M Bronstein

• Sponsor organisation

  Imperial College London

• Eudract number

  2008-004803-78

• ISRCTN Number

  NCT00802529

• Research summary

  Meniere's disease is a chronically progressive disease of the inner ear. It damages both the hearing and balance function of the ear, causing deafness and severe dizzy attacks. Some patients respond well to conservative treatment (low salt diet and oral drugs) but 20-30% patients struggling with unpredictable vertigo attacks require alternative treatment options. Currently the more frequently used treatment is to apply gentamicin via injections or tubes (grommets) through the ear drum. Although this is very effective in controlling vertigo, gentamicin can cause deterioration of hearing in approximately 25% of the treated patients and profound hearing loss in 7%. In the last 10-15 years there has been use of non ear-toxic drugs, such as steroids, claiming similar control of the vertigo without additional hearing loss or even some hearing improvement. Unfortunately, however, this has not been fully proven. The main aim of the study funded by Meniere's Society, therefore, is to conduct a randomised controlled trial comparing the two. We hope to establish whether steroids are equally effective in controlling vertigo with less hearing side effects. In Charing Cross Hospital, thirty patients with refractory Meniere's disease will be randomly allocated to each gentamicin or steroid (methylprednisolone) treatment. The patients will receive two transtympanic injections under local anaesthesia at an interval of two weeks. They will be followed up regularly for 24 months clinically and with specialised audio-vestibular tests. A secondary aim is to look for the presence of inner ear-specific immune mediated Meniere's disease in our patients with new techniques (inner ear specific Western blot). This relates to the fact that steroids are effective in immune mediated disorders. Finally, the third aim is to apply a new balance test called the unilateral utricular centrifugation test. It allows quantification of unilateral vestibular function when routine (caloric) tests are contraindicated due to presence of grommets

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  08/H0712/95

• Date of REC Opinion

  19 Dec 2008

• REC opinion

  Further Information Favourable Opinion