Abstract
Purpose
The purpose of this study was to evaluate the efficacy of combined therapy with steroid, carbogen inhalation, and lipoprostaglandin E 1 (lipo-PGE 1 ) treatment and compare the results with other treatment modalities in patients with idiopathic sudden sensorineural hearing loss (ISSNHL).
Subjects and methods
The study group consisted of 670 patients diagnosed with unilateral ISSNHL. Two hundred patients (DCP group) were treated with steroid, lipo-PGE 1 and carbogen inhalation combination therapy, 194 patients (DC group) with steroid and carbogen inhalation, and 276 patients (D group) with steroid medication only. The therapeutic effects of the treatment groups were evaluated 2 months after treatment, using pure tone averages. Siegel’s criteria for hearing improvement were used for the assessments.
Results
The overall recovery rate after treatment was 57.5%. For each group, the recovery rate was as follows: 67.0% in the DCP group, 52.6% in the DC group, and 53.9% in the D group. The DCP group had a significantly better improvement rate than the other 2 groups. In addition, the DCP treatment was better than the other 2 groups for patients: less than 50 years of age, with an initial hearing loss less than 90 dB HL, had treatment started within 1 week from the onset of hearing loss, had tinnitus or an ascending type audiogram, and/or had no vertigo.
Conclusion
Steroid, lipo-PGE 1 , and carbogen inhalation therapy was more effective than the other treatment modalities studied for patients with ISSNHL.
1
Introduction
Idiopathic sudden sensorineural hearing loss (ISSNHL) is a sudden, rapid, progressive, partial or complete, unilateral sensorineural hearing impairment with the occasional association of tinnitus or vertigo; the etiology of this condition is unknown. It is an otologic emergency requiring immediate and careful treatment. It was first described as a clinical disease entity in 1944 . The incidence of ISSNHL is reported to range from 5 to 20 per 100,000 persons in the general population. Vascular and viral etiologies have been considered to be the major causes of ISSNHL. Many different vasodilators, steroids, and antiviral agents have been used for treatment. Many treatment methods have been proposed and used; however, currently, there is no single successful method recommended for treatment.
Breathing a gas mixture with increased partial pressures of O 2 and CO 2 (carbogen) results in increased perilymph oxygen tension . Prostaglandin E 1 (PGE 1 ) is a prostanoid that has numerous biological actions such as inhibition of receptor-mediated stimulation of platelet aggregation, cytoprotection, vasodilation, and suppression of antibody formation . PGE 1 has been used to treat peripheral arterial occlusive disease and Raynaud phenomena because of its potent vasodilatory effects . Lipo-PGE 1 is a particle preparation and is believed to prevent rapid destruction of PGE 1 , enabling it to accumulate in vascular lesions . The purpose of this study was to evaluate the efficacy of combined therapy with steroid, carbogen inhalation, and lipo-PGE 1 treatment in patients with ISSNHL.
2
Materials and methods
We reviewed the medical records of all patients with ISSNHL from January 1993 to June 2008. Patients with unilateral ISSNHL with an average hearing level greater than 40 dB HL across 5 contiguous frequencies (250 Hz, 500 Hz, 1 kHz, 2 kHz, and 4 kHz) and previously untreated were included in this study. A total of 670 patients were divided into 3 different treatment groups: the DCP group (200 patients) was treated with steroid therapy, carbogen inhalation, and lipo-PGE 1 . The DC group (194 patients) was treated with steroid and carbogen inhalation. The D group (276 patients) was treated with steroid medication only. We evaluated and analyzed each therapeutic group according to the factors that were associated with recovery. These factors included age, degree of hearing loss, time of initial treatment, association of vertigo or tinnitus, and the shape of the initial audiogram. All patients were admitted to the hospital for 7 days for complete bed rest and treatment. All patients received steroid therapy. The steroid therapy included intravenous (IV) dexamethasone 20 mg BID (40 mg) for 4 days, 10 mg BID (20 mg) for 2 days and then the dose was tapered over 4 days. The carbogen inhalation (95% O 2 and 5% CO 2 ) therapy required inhalation of the gas mixture 8 times daily for 30 minutes during the hospital admission. Lipo-PGE 1 therapy included an IV infusion containing 10 μ L of lipo-PGE 1 daily during the hospital admission. All patients also received IV low-molecular-weight dextran, as well as oral and IV ginkgo biloba extract. Pure tone audiograms were obtained every day during the hospitalization and once a week during follow-up. The therapeutic effects of the treatment were evaluated 2 months after treatment in each group, using pure tone averages. Siegel’s criteria for hearing improvement were used for this study and the results are shown in Table 1 . The patients were divided into 4 categories according to their final hearing results based on Siegel’s criteria. For the statistical analysis, improvement was defined as follows: hearing results defined by type I, II, and III of Siegel’s criteria. No improvement was considered when the hearing results were defined as type IV of Siegel’s criteria. According to the level of the initial hearing loss, patients were divided into 4 classes of hearing loss: moderate (41–55 dB HL), moderate severe (56–70 dB HL), severe (71–90 dB HL), and profound (>91 dB HL). The shapes of the initial audiograms included 4 different types: flat, ascending, descending, and profound types. Statistically significant differences were tested for using the χ 2 test ( P < .05). Masan Samsung IRB approved this study.
| Type | Hearing recovery |
|---|---|
| I. Complete recovery | Patients whose final hearing level was better than 25 dB regardless of the size of the gain |
| II. Partial recovery | Patients who showed more than 15 dB of gain and whose final hearing level was between 25 and 45 dB |
| III. Slight improvement | Patients who showed more than 15 dB of gain and whose final hearing level was poorer than 45 dB |
| IV. No improvement | Patients who showed less than 15 dB of gain or whose final hearing level was poorer than 75 dB |
2
Materials and methods
We reviewed the medical records of all patients with ISSNHL from January 1993 to June 2008. Patients with unilateral ISSNHL with an average hearing level greater than 40 dB HL across 5 contiguous frequencies (250 Hz, 500 Hz, 1 kHz, 2 kHz, and 4 kHz) and previously untreated were included in this study. A total of 670 patients were divided into 3 different treatment groups: the DCP group (200 patients) was treated with steroid therapy, carbogen inhalation, and lipo-PGE 1 . The DC group (194 patients) was treated with steroid and carbogen inhalation. The D group (276 patients) was treated with steroid medication only. We evaluated and analyzed each therapeutic group according to the factors that were associated with recovery. These factors included age, degree of hearing loss, time of initial treatment, association of vertigo or tinnitus, and the shape of the initial audiogram. All patients were admitted to the hospital for 7 days for complete bed rest and treatment. All patients received steroid therapy. The steroid therapy included intravenous (IV) dexamethasone 20 mg BID (40 mg) for 4 days, 10 mg BID (20 mg) for 2 days and then the dose was tapered over 4 days. The carbogen inhalation (95% O 2 and 5% CO 2 ) therapy required inhalation of the gas mixture 8 times daily for 30 minutes during the hospital admission. Lipo-PGE 1 therapy included an IV infusion containing 10 μ L of lipo-PGE 1 daily during the hospital admission. All patients also received IV low-molecular-weight dextran, as well as oral and IV ginkgo biloba extract. Pure tone audiograms were obtained every day during the hospitalization and once a week during follow-up. The therapeutic effects of the treatment were evaluated 2 months after treatment in each group, using pure tone averages. Siegel’s criteria for hearing improvement were used for this study and the results are shown in Table 1 . The patients were divided into 4 categories according to their final hearing results based on Siegel’s criteria. For the statistical analysis, improvement was defined as follows: hearing results defined by type I, II, and III of Siegel’s criteria. No improvement was considered when the hearing results were defined as type IV of Siegel’s criteria. According to the level of the initial hearing loss, patients were divided into 4 classes of hearing loss: moderate (41–55 dB HL), moderate severe (56–70 dB HL), severe (71–90 dB HL), and profound (>91 dB HL). The shapes of the initial audiograms included 4 different types: flat, ascending, descending, and profound types. Statistically significant differences were tested for using the χ 2 test ( P < .05). Masan Samsung IRB approved this study.
| Type | Hearing recovery |
|---|---|
| I. Complete recovery | Patients whose final hearing level was better than 25 dB regardless of the size of the gain |
| II. Partial recovery | Patients who showed more than 15 dB of gain and whose final hearing level was between 25 and 45 dB |
| III. Slight improvement | Patients who showed more than 15 dB of gain and whose final hearing level was poorer than 45 dB |
| IV. No improvement | Patients who showed less than 15 dB of gain or whose final hearing level was poorer than 75 dB |
3
Results
There were 326 males and 344 females included in the analysis. The age of the patients ranged from 6 to 82 years, with a mean of 45.2 years. The pretreatment hearing levels were 71.1 ± 18.5 dB HL in the D group, 70.5 ± 18.7 dB HL in the DC group, and 72.8 ± 17.9 dB HL in the DCP group; there were no significant differences found among the 3 groups ( P = .422). Among the 670 patients, 385 (57.5%) patients were recovered. The rate of improvement for each group was as follows: 134 patients among the 200 patients (67.0%) in the DCP group showed hearing improvement, 102 patients among 194 patients (52.6%) in the DC group, and 149 patients among 276 patients (53.9%) in the D group ( Table 2 ). The recovery rate in the DCP group was significantly greater than in the other 2 groups (Fig. 1 ). Generally, patients who were younger than 50 years (68.6%) showed better recovery than patients older than 50 years (44.2%); these differences were statistically significant ( P < .01). In patients younger than 50 years of age, the rate of hearing improvement was significantly higher in the DCP group (79.6%) compared to the other 2 groups (63.9%) ( P = .003); however, not in patients more than 50 years of age ( P = .112) ( Table 3 ).
| Siegel’s type | D | DC | DCP |
|---|---|---|---|
| I | 42 (21%) | 30 (15.5%) | 50 (18.1%) |
| II | 49 (24.5%) | 40 (20.6%) | 58 (21%) |
| III | 43 (21.5%) | 32 (16.5%) | 41 (14.9%) |
| IV | 66 (33%) | 92 (47.4%) | 27 (46.0%) |
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