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Otology & Neurotology

32:393Y397 Ó 2011, Otology & Neurotology, Inc.

Combined Intratympanic and Systemic Use of Steroids


for Idiopathic Sudden Sensorineural Hearing Loss

Necmi Arslan, Haldun O?uz, Münir Demirci, Mustafa AsNm yafak, Ahmet Islam,
Selda KargNn Kaytez, and Erdal Samim

Ministry of Health, Ankara Training and Research Hospital, ENT Clinic, Ankara, Turkey

Objective: To compare hearing results in idiopathic sudden at 5th day, 12.1 and 7.5 dB at 10th day, and 13.0 and 8.8 dB
hearing loss patients treated with systemic steroids alone or at 15th day. The mean and median PTA gains for combined
combined intratympanic and steroids. treatment (CT) group were 12.5 and 7.5, 17.8 and 13.8, 21.8 and
Study Design: Prospective. 20.0 dB, respectively.
Setting: Tertiary referral hospital. Results: Both the mean and the median PTA gains were sta-
Patients: Idiopathic sudden sensorineural hearing loss patients. tistically significantly different between SCT and CT groups.
Interventions: The patients in the systemic therapy group re- According to improved hearing results (more than 10 dB gain),
ceived consecutive administration of 100 mg intravenous meth- there was statistically significant difference between SCT and
ylprednisolone in the first day, 80 mg/day oral prednisolone in CT groups. None of the patients had an important complication.
3 divided doses for the next 2 days, and continued with oral Conclusion: The results of this study suggest that adding
administration of steroids by tapering the dose 20 mg in every intratympanic methylprednisolone to systemic therapy in-
2 days. The patients in the combined treatment group received creases the probability of hearing recovery in ISSHL patients.
intratympanic injection of methylprednisolone (an approximate Key Words: Hearing lossVIntratympanicVSensorineural hearing
dose of 0.5 ml of 125 mg/ml). A total of 5 injections on alter- lossVSteroidVSudden hearing loss.
nate days were performed.
Main Outcome Measures: The mean and median PTA gains
of systemic corticosteroid therapy (SCT) group were 7.5 and 5 dB Otol Neurotol 32:393Y397, 2011.

Sudden hearing loss is an otologic event that needs effects and contraindications as a systemic drug, local
urgent treatment. Although it is thought to originate mainly intratympanic use of steroids is gaining popularity among
from viral, vascular, or immunologic causes, the etiopatho- otology centers.
genesis of the disease is unknown, so the disease is usu-
ally called idiopathic sudden sensorineural hearing loss
(ISSHL). It is commonly defined as greater than 20 dB
of hearing loss in at least 3 consecutive audiometric fre- MATERIALS AND METHODS
quencies, occurring within 3 days or less (1). It has a The patients with the diagnosis of sudden-onset hearing loss
reported incidence of 5 to 20 per 100,000 patients per were hospitalized, and a standard package of tests was performed.
year (1). Recovery rate in untreated patients ranges from These tests include physical examination, routine hematologic
28% to 65%, mostly resolving within 2 weeks of onset of and biochemical blood tests, pure-tone audiometry, tympano-
symptoms (1Y3). metry, and temporal bone magnetic resonance imaging.
Although the methods of treatment of ISSHL patients Inclusion criterion for the study was an ISSHL with minimum
vary among different centers, systemic steroid therapy is 20 dB hearing loss in 3 consecutive octaves that have occurred
within a course of 3 days. Patients with history, symptoms or
the most commonly used modality for treatment of sudden
findings of acoustic trauma or barotrauma, Ménière’s disease
hearing loss (4). However, because of its important adverse or other peripheral vertigo, tumors, autoimmune disease, coagu-
lopathy or small vessel disease, syphilis, hypothyroidism, and
ototoxic drug use were excluded from the study. Patients with a
Address correspondence and reprint requests to Haldun O?uz, M.D., contraindication to use systemic steroids, such as uncontrolled
Saglik Bakanligi, Ankara Egitim ve Arastirma Hastanesi, 2. Kulak Burun diabetes mellitus and hypertension or cardiovascular disease,
Bogaz Klinigi, 06340, Cebeci, Ankara, Turkey; E-mail: drhoguz@gmail.com also were left out of the study. One hundred fifty-eight of 175
This study has no financial disclosure and conflict of interest to declare. patients with a diagnosis of ISSHL that were treated between

393

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394 N. ARSLAN ET AL.

TABLE 1. Descriptive statistics of the systemic corticosteroid therapy and combined treatment groups (decibels)
SCT (mean T standard deviation) (range, median) CT (mean T standard deviation) (range, median)
Pretreatment, 500 Hz loss 62.8 T 23.5 (15Y100, 60) 64.6 T 24.0 (10Y100, 65)
5th day of treatment, 500 Hz loss 53.9 T 26.9 (5Y100, 55) 51.3 T 27.4 (10Y100, 40)
10th day of treatment, 500 Hz loss 48.1 T 27.9 (10Y100, 45) 45.7 T 26.4 (5Y100, 35)
15th day of treatment, 500 Hz loss 48.3 T 29.3 (10Y100, 40) 42.4 T 25.6 (0Y100, 35)
Pretreatment, 1,000 Hz loss 61.7 T 25.1 (15Y100, 60) 65.9 T 23.8 (10Y100, 70)
5th day of treatment, 1,000 Hz loss 55.0 T 27.5 (5Y100, 50) 51.4 T 28.4 (10Y100 ,50)
10th day of treatment, 1,000 Hz loss 49.0 T 28.8 (5Y100, 45) 45.3 T 28.0 (5Y100, 40)
15th day of treatment, 1,000 Hz loss 48.8 T 30.3 (10Y100, 45) 42.3 T 26.8 (0Y100, 35)
Pretreatment, 2,000 Hz loss 62.4 T 26.0 (10Y100, 60) 64.5 T 25.0 (10Y100, 65)
5th day of treatment, 2,000 Hz loss 54.3 T 25.6 (0Y100, 55) 51.0 T 30.0 (5Y100, 50)
10th day of treatment, 2,000 Hz loss 49,8 T 29.0 (5Y100, 45) 45.6 T 29.0 (5Y100, 40)
15th day of treatment, 2,000 Hz loss 49.5 T 30.5 (5Y100, 45) 41.5 T 29.0 (5Y100, 35)
Pretreatment, 4,000 Hz loss 65.1 T 25.8 (5Y100, 65) 67.7 T 25.6 (5Y100, 70)
5th day of treatment, 4,000 Hz loss 58.9 T 27.5 (0Y100, 60) 58.9 T 29.1 (5Y100, 60)
10th day of treatment, 4,000 Hz loss 56.8 T 27.5 (5Y100, 55) 55.1 T 26.0 (5Y100, 60)
15th day of treatment, 4,000 Hz loss 57.8 T 28.6 (5Y100, 55) 50.5 T 29.4 (0Y100, 50)
Pretreatment, PTA 63.0 T 22.9 (22.5Y100, 62.5) 65,7 T 22.0 (25Y100, 63.8)
5th day of treatment, PTA 55.5 T 25.8 (3.75Y100, 55) 53.0 T 26.7 (12.5Y100, 48.8)
10th day of treatment, PTA 51.0 T 26.1 (8.75Y100, 46.3) 48.0 T 26.0 (12.5Y100, 40)
15th day of treatment, PTA 51.1 T 27.4 (12.5Y100, 45) 44.2 T 25.5 (7.5Y100, 37.5)

January 2003 and October 2008 were eligible for inclusion to All values in the tables are defined as mean T standard devia-
the study. Besides the following regimen, patients were advised tion. Significance between SCT and CT groups was determined
to have low-salt diet. using Student’s t test. A p value was accepted significant if it is
Audiologic evaluation was performed before the beginning less than 0.05.
of treatment and at 5th, 10th, and 15th days of treatment. Pure- The study was accepted by the institutional ethics board; all
tone hearing thresholds were obtained for 500, 1,000, 2,000, and patients were informed about the procedure, and an informed
4,000 Hz. Pure-tone average (PTA) was calculated according consent was obtained.
to these 4 frequencies. The hearing results were classified as
‘‘failed’’ (hearing gain, G10 dB) or ‘‘improved’’ (hearing gain,
Q10 dB). RESULTS
The patients were randomized according to their date of
referral to the outpatient or emergency otolaryngology clinics. Forty-eight (65.8%) of the SCT group and 54 (63.5%)
The patients that were referred at odd and even days were in- of the CT group were male subjects. The sex distribution
volved in systemic corticosteroid therapy (SCT) and combined between groups was not statistically significant. The
treatment (CT) groups, respectively. mean age T standard deviation for SCT and CT groups
were 48.4 T 15.2 (range, 19Y80) and 47.8 T 13.1 (range,
SCT Protocol 18Y75), respectively. Pretreatment and posttreatment pure
Seventy-three of the 158 patients were treated with a 9-days tone audiologic findings are given on Table 1. The dis-
course of SCT. SCT consisted of consecutive administration of tribution of patients according to duration of their symp-
100 mg intravenous methylprednisolone in the first day, 80 mg/d toms before treatment is shown in Table 2. There was no
oral prednisolone in 3 divided doses for the next 2 days, and statistically significant difference according to the duration
continued with oral administration of steroids by tapering the dose
20 mg in every 2 days. The patients also received dextran 40000, of symptoms. The baseline characteristics of patients are
5 ml/kg per day IV, for the first 5 days of treatment. given in Table 3. There were not any significant difference
according to age, sex, side, presence of tinnitus, vestibular
CT Protocol symptoms, and history of upper respiratory tract infection.
Eighty-five patients consisted of the second arm of the study. The mean and median PTA gains of the SCT group were
These patients were given the same SCT as the first group. In 7.5 and 5 dB at 5th day, 12.1 and 7.5 dB at 10th day, and
addition, they also received intratympanic injection of cortico- 13.0 and 8.8 dB at 15th day. The mean and median PTA
steroids as a CT modality. Methylprednisolone (an approximate
dose of 0.5 ml of 125 mg/ml) was injected with a 22-gauge needle
and 1-ml syringe through the posteroinferior quadrant of the TABLE 2. Distribution of patients according to duration
tympanic membrane of the affected ear. Patients were lying in of symptoms before the beginning of treatment
supine position during the procedure without any anesthetic ap- SCT CT
plication. The injections were performed by use of an operating
microscope, and the treated ear was kept in a superior position for 1Y7 days 50 55
15 minutes after the injection. The patient was requested not to 8Y15 days 15 24
move and swallow as long as he/she can. A total of 5 injections 16Y23 days 7 2
24Y30 days 1 4
on alternate days were performed. During the treatment period Total 73 85
and for 3 days after the last injection, dry ear precautions were
recommended. SCT indicates systemic corticosteroid therapy; CT, combined treatment.

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INTRATYMPANIC AND SYSTEMIC USE OF STEROIDS 395

TABLE 3. The baseline characteristics of systemic


corticosteroid therapy and combined treatment patients
SCT CT
No. of patients 73 85
Sex (male) 48 54
Side (right) 44 42
Tinnitus positive 65 70
Vestibular symptoms present 14 23
Upper respiratory tract infection 16 15

gains for the CT group were 12.5 and 7.5, 17.8 and 13.8,
21.8 and 20.0 dB, respectively. Both the mean and the
median PTA gains were statistically significantly ( p G 0.05)
different between SCT and CT groups at 5th, 10th, and
15th days (Tables 3 and 4; Fig. 1). When the potential gain
achievable is taken into consideration, the significance
also was statistically significant ( p G 0.05; Fig. 2).
According to improved hearing results (910 dB gain),
there were statistically significant difference between FIG. 1. Mean PTA gain and standard deviation of systemic and
combined groups at 5th, 10th, and 15th days of treatment.
SCT and CT groups at 5th, 10th and 15th days (Fig. 3).
None of the patients had an important complication,
namely, treatment-required vertigo or otalgia, nystagmus, use of steroids also may be limited because of medical
otitis media, tinnitus, and tympanic membrane perforation. contraindications, such as diabetes mellitus, hypertension,
peptic ulcer, and immunosuppression.
DISCUSSION Intratympanic use of drugs was pioneered by Schuknecht
(16) and Beck and Schmidt (17) for the treatment of ver-
Different modalities have been used for the treatment of tigo. Intratympanic steroid may be applied to the tympanic
ISSHL, which include steroids, histamine, carbogen, hepa- cavity by direct injection, by placing a round window
rin, antivirals, calcium channel blockers, triiodobenzoic pledget, or by pumping through a special sustained-release
acid derivatives, diuretics, piracetam, caroverine, mag- catheter (18,19). Intratympanic use of steroids have very
nesium sulphate, and more (3,5,6). Currently, systemic important advantages, namely, the inner ear with ISSHL
steroid therapy is the most commonly used modality for can be targeted directly, a higher concentration of steroids
treatment of sudden hearing loss (4,7). However, espe- in the perilymph can be obtained (2,20Y24), and the well-
cially when used for long-term, systemic steroid use has known systemic side effects of steroids are prevented
many adverse reactions. Cardiovascular, musculoskele-
tal, gastrointestinal, dermatologic, neurologic, and endo-
crine problems are among the most cited ones (8). The
disease in some of the ISSHL patients resolve spontane-
ously, so it is difficult to balance its benefits and commonly
reported adverse reactions.
The effect of steroids in treatment of ISSHL is thought
to originate from its anti-inflammatory activity and its
ability to increase cochlear blood flow (9). Systemic ste-
roid treatment is ideally applied within 7 days, and dif-
ferent success rates are reported, ranging between 49%
and 79% (2,7,10Y15). However, its use may be limited
because of the above-mentioned adverse effects. Systemic

TABLE 4. Mean pure tone average gain T standard deviation


at 5th, 10th, and 15th days of treatment
SCT CT
PTA gain, 5th day 7.5 T 15.3 12.5 T 15.8
PTA gain, 10th day 12.1 T 17.5 17.8 T 17.5
PTA gain, 15th day 13.0 T 19.0 21.8 T 18.4
FIG. 2. Mean PTA gain as a percentage (%) of potential gain
CT indicates combined treatment; PTA, pure tone average; SCT, achievable and standard deviation of systemic and combined
systemic corticosteroid therapy. groups at 5th, 10th, and 15th days of treatment.

Otology & Neurotology, Vol. 32, No. 3, 2011

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396 N. ARSLAN ET AL.

The results of this study suggest that adding intra-


tympanic methylprednisolone to systemic therapy increases
the probability of hearing recovery in ISSHL patients.

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