Effectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial

ClinicalTrials.gov processed this data on June 19, 2019. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
 (See Contacts and Locations)
Verified June 2019 by Imperial College London, Imperial College Healthcare NHS Trust, Medical Research Council

Sponsor

Imperial College London

Information Provided by (Responsible Party)

Imperial College London

Clinicaltrials.gov Identifier

NCT00802529
Other Study ID Numbers: CRO1135
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Posted: October 24, 2016
Last Update Posted: June 27, 2019
Last Verified: June 2019
History of Changes

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Study 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.
Condition or Disease Intervention/Treatment
  • Meniere's Disease
  • Drug: Methylprednisolone
  • Drug: Gentamicin

Study Design

Study TypeInterventional
Actual Enrollment60 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleEffectiveness of Transtympanic Steroids in Unilateral Ménière's Disease: a Randomised Controlled Double-Blind Trial
Study Start DateApril 2009
Actual Primary Completion DateMay 2015
Actual Study Completion DateMay 2015

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Steroid (Methylprednisolone)
    • Steroid (Methylprednisolone)
  • Drug: Methylprednisolone
    • 2 transtympanic injections at interval of two weeks.
  • Gentamicin
    • Gentamicin
  • Drug: Gentamicin

    Outcome Measures

    Primary Outcome Measures

    1. Vertigo Attacks [6month pre-enrollment baseline, 18-24 months after initial treatment]
      The number of vertigo attacks between 18-24months follow-up were taken retrospectively during a face-to-face appointment at 24 months follow-up and compared to 6 month pre-enrollment baseline (as per Committee on Hearing and Equilibrium guidelines).

    Secondary Outcome Measures

    1. Change in Hearing [Baseline, 1,2,6,12,18 and 24months after initial treatment]
      Hearing was measured as ipsilesional pure-tone threshold at Baseline, 1month, 2months, 6months, 12month, 18months and 24 months follow-up. Hearing level was taken as the average threshold across 0.5, 1, 2 and 3KHz.
    2. Change in Speech Discrimination [Baseline, 1,2,6,12 and 24months after initial treatment]
      Speech discrimination was measured at Baseline, 1month, 2months, 6months, 12month and 24 months follow-up.

      Speech discrimination was assessed by means of ipsilesional suprathreshold word recognition (%). Arthur Boothroyd's isophonemic word lists (AB wordlists, Guymark, Southampton) comprising sets of 10 words were played to the ipsilesional ear at the low-frequency pure-tone threshold of 0·5, 1 and 2 kHz +30dB with masking sound in the contralesional ear if necessary. The formula for masking level was: low-frequency pure-tone threshold in ipsilesional ear - bone conduction mean threshold (0·5, 1 and 2KHz) in contralesional ear - 40dB. Speech loudness and masking were rounded to the nearest 5dB. Step increments and decrements of 10dB for speech loudness and masking were used to attain the maximum speech discrimination score.

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 70 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    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.

    Contacts and Locations

    Sponsors and Collaborators Imperial College London, Imperial College Healthcare NHS Trust, Medical Research Council
    Imperial College Healthcare NHS Trust, Medical Research Council
    Locations
    • Imperial college Healthcare NHS Trust | London, United Kingdom,
    Investigators
    • Principal Investigator: Adolfo M Bronstein, PhD, FRCP, Imperial College London