Material and Methods
The study was conducted at Otolaryngology Department of
AORN“S.G.Moscati” between January 2005 and May 2015.We selected 72
consecutive patients(28 males and 44 females, mean age 49.5 years,
range:21-78 years) with disabling unilateral Ménière’s disease treated
with ITG. Patients included in the study were not responsive to
conservative therapies(lifestyle change, diuretics, salt-restricted
diet, steroid or betahistine). Inclusion criteria for this study were:
definite diagnosis of MD based on criteria of the 1995 Equilibrium
Committee2, lack of response to medical therapy for
six months with invalidating vertigo attacks, unilateral MD,
satisfactory hearing in the contralateral ear, no previous treatment
with surgical conservative procedures or intratympanic steroid
injections, absence of hypersensitivity to aminoglycosides. All patients
included in the study met the inclusion criteria. After a detailed
explanation of the procedure, a written consent was obtained. To exclude
other inner ear diseases, all patients were submitted to magnetic
resonance with contrast. Before intratympanic treatment all patients
underwent a neuro-otological examination, including evaluation of
spontaneous, positional and positioning nystagmus, head shaking test,
subjective visual vertical test, Romberg and stepping test. A caloric
test was used to evaluate the vestibular semicircular canal
excitability. Otomicroscopic examination was performed to evaluate
tympanic membrane. All patients underwent to tympanometry and pure tone
audiometry. Pure tone average(PTA) was calculated on air conduction
thresholds at 500, 1000, 2000 and 3000dB. Before treatment all patients
filled out a questionnaire about number of vertigo, so to calculate a
monthly rate of vertigo.We use gentamicin sulfate at a concentration of
40mg/ml, the intratympanic injection was performed with a 25G spinal
needle in our ambulatory. Without local anesthesia, 0,2-0,3 mL of
gentamicin was injected into the affected ear through posterior-inferior
quadrant of tympanic membrane. Patient was instructed to maintain a
supine position with the head 30 degree tilted toward the healthy side
avoiding to swallow for at least 30 min. The same procedure was carried
out the following two days. After treatment audiometric revaluation was
performed at 3 and 7 days after the third injection. In absence of
vertigo patients were revaluated after 1-3-6-12 months and then every
year. The follow up ranged from 2 to12 years(mean follow-up 7 years).
The aim of the study was to evaluate hearing threshold changes and
vertigo control after ITG treatment.The t student test was used to
compare outcomes. For quantitative variables, descriptive statistics
were computed as mean and Standard Deviation(SD) or median and
Interquartile Range(IQR 25th to
75thpercentiles), if they were not normally
distributed, and as absolute frequency and percentage for qualitative
variables. The reporting guideline followed in this study was STROBE
statement.