Transtympanic gentamicin and fibrin tissue adhesive for treatment of unilateral Menière's disease: effects on vestibular function.

OBJECTIVE

To determine the effects of transtympanic injections, with a mixture composed of gentamicin and fibrin tissue adhesive (FTA), on vestibular function of patients with intractable unilateral Menière's disease.

STUDY DESIGN

This was an open, prospective study.

SETTING AND PATIENTS

The study was performed at 2 tertiary referral centers. Twenty-six patients affected by "definite" unilateral Menière's disease, unresponsive to medical therapy for at least 6 months, were enrolled.

INTERVENTION

A buffered gentamicin solution mixed with FTA was injected in the middle ear until the development of bedside vestibular hypofunction signs and/or caloric weakness in the treated ear.

MAIN OUTCOME MEASURE

Vestibular function was evaluated by 3 bedside vestibular tests (observation of spontaneous nystagmus, head shaking test, and head thrust test) and by a caloric test. Tests were performed on days 10 and 30 after completion of treatment. Tests were also performed 3, 6, and 12 months from completion of the gentamicin-FTA protocol. The effects of treatment were also assessed in terms of hearing levels, control of vertigo, and disability status.

RESULTS

In 22 of the 26 patients, only 1 gentamicin-FTA injection was necessary to obtain 1 or more signs indicating a reduction of the vestibular function in the treated ear. Four patients needed another treatment because of the persistence of their incapacitating symptoms during the follow-up. Four patients needed more than 1 injection to obtain a vestibular hypofunction. None of the patients who received 1 or 2 injections presented hearing loss in direct temporal relationship to the treatment.

CONCLUSIONS

A mixture of gentamicin and fibrin glue makes it possible to considerably reduce the number of administrations in patients with intractable unilateral Menière's disease. Spontaneous nystagmus, post head shaking nystagmus, and a head thrust sign are the clinical signs that indicate onset or progression of unilateral vestibular hypofunction. These signs were obtained with only 1 injection in 81% of patients.