Comparison of High-Dose and Low-Dose Oral Corticosteroid treatment in Patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSHL)

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Comparison of High-Dose and Low-Dose Oral Corticosteroid treatment in Patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSHL)

Corresponding author: Dr. Katrin Eysel-Gosepath, Department of Otolaryngology, University Duesseldorf, Moorenstrasse 5, ENT Prac- tice Group, Chlodwigplatz 1, 50678 Cologne, Germany, Tel: 0049 2236 891081; Fax: 0049 2236 891082; Email: pek.eysel@t-online.de

Abstract

The aim of this retrospective observational study is to compare the effect of oral low-dose and oral high-dose glucocorticoid therapy in patients suffering from idiopathic sudden sensorineural hearing loss (ISSHL).

Methods

Data of 64 patients suffering from ISSHL without vertigo were analysed. 32 of them were treated in a private practice with 60 mg corticosteroid declining to 0 mg over 12 days (group 1), and the other 32 (group 2), received treatment in a university hospital with 250 mg for three days. Hearing ability before and after therapy was compared between the two groups and to the hearing of the unaffected ear.

Results

In both groups average hearing over all frequencies improved significantly after treatment without any difference between the groups. However, between 1000 Hz and 3000 Hz hearing improvement was significantly higher in the group with high-dose corticosteroid, but in comparison to the unaffected ear the general improvement of hearing over all frequencies was better for patients with low-dose therapy.

Conclusions

According to the results of this study, total recovery or at least satisfying improvement of hearing is possible under both treat- ments.

Keywords: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL) – Glucocorticoid Therapy – Oral 

Introduction

The etiology of idiopathic sudden sensorineural hearing loss (ISSHL) has been largely unknown so far. Various causes, such as vascular [1, 2], viral, cellular, immunologic and inflammatory disorders are discussed [1, 3, 4, 5]. On the other hand, clinical examination of the inner ear system is limited and detection of pathologic mechanisms usually impossible. This is the reason for a huge variety of existing therapies. In current literature there is no evidence to support the administration of peripher- al vasodilators, vasoactive substances [6, 7], antiviral therapy [8], or the recommendation of hyperbaric oxygen therapy [9]. Corticosteroids constitute the most common treatment for ISSHL because of their general systemic anti-inflammatory and immunosuppressive effects [10, 11]. In addition, receptors for corticosteroids could be detected in the animal as well as in the human cochlea, especially in the inner and outer hair cells and in the spiral ligament [11, 12, 13]. These findings suggest local effects of corticosteroids also in the cochlea [11]. During local, intratympanic application corticosteroids accumulate in the perilymph of the scala tympani [14] in an even higher con- centration than during systemic administration [15].

Nevertheless, current literature on this topic is predominat- ed by a strong discussion on the manner of administration (systemic oral or intravenous and/or local intratympanic in- jection) and the best dosage of corticosteroids for treatment of ISSHL [16, 17, 18, 19, 20, 21, 22, 23, 24]. Furthermore, the

degree of hearing loss, side-effects of corticosteroids and the patient’s conception have also to be considered when deciding on a treatment regime.

The aim of the present retrospective observational study is to compare the effect of two different dosages of oral corticoste- roids in patients suffering from ISSHL: high-dose versus low- dose therapy.

Patients and Methods

The present study assembles retrospective analyses of data from 64 patients who had presented with ISSHL within one year in two different institutes. Thirty-two of them had been treated in a private ENT practice with low-dose corticosteroid therapy, the other thirty-two received high-dose therapy treat- ment in the ENT department of a university hospital. Inclusion criteria for the analyses were patients with unilateral ISSHL not longer than 10 days before consultation and without any evidence of Menière’s disease, retrocochlear disease or ves- tibular disorders and without medical reasons prohibiting the administration of corticosteroids such as severe diabetes, pep- tic ulcer, glaucoma, uncompensated heart disease, psychiatric disease, chronic infections, or pregnancy. Hearing loss had to occur in at least three contiguous frequencies ≥ 30 dB HL. The investigations comply with the current laws of the country in which they were performed. They have been approved by the appropriate ethics committee of the responsible Univer-

sity and have been conducted in accordance with the ethical standards laid down in the Declaration of Helsinki and its later amendments.

Specific data of the patients before treatment onset are listed

in table 1.

Low-dose oral corticosteroid therapy started with 60mg for 2 days, continuing with 40mg for 2 days, 20mg for 2 days, 10mg for 2 days and 5mg for 4 days. High-dose therapy was admin- istered orally with 250mg corticosteroid for three consecutive days. All patients received a proton pump inhibitor during cor- ticosteroid treatment.

Pure tone audiograms were investigated in the following fre- quencies: 125, 250, 500, 1000, 2000, 3000, 4000, 6000 and

8000 Hz. In each group hearing was evaluated before and after therapy on the affected ear, the obtained data were compared with the hearing on the respective unaffected ear. It was pos- tulated that hearing had been symmetrical on both ears before the onset of ISSHL. After that the data of the two groups were compared.

Statistical analyses were done using SPSS® Version 23. Rela- tive frequencies, average and standard deviation were deter- mined in each group. Treatment results before and after ther- apy for each group separately were compared using t-test for paired samples, comparison of the results between the two groups was done by using t-test for independent samples.

Results

The distribution of the frequencies affected by ISSHL was ap- proximately similar in both groups. However, a slight differ- ence could be noticed for ISSHL concerning high frequencies (this occurred more often in group 1 “low dose”) and ISSHL concerning all frequencies (this occurred more often in group 2 “high dose”)(fig.1).

With 30 ± 14.03 dB, average hearing loss over all measured frequencies (125, 250, 500, 1000, 2000, 3000, 4000, 6000 and

8000 Hz) before treatment was found being slightly higher in the second group than in the first group with 27.59 ± 11.42 dB. This difference was especially observed in the high frequen- cies between 4000 and 8000 Hz (38.85 ± 24.26 dB in group 2 and 30.63 ±14.56 dB in group 1) but was not significant (fig. 2a and 2b).

In both groups hearing was improved after treatment. This was significant in both groups, regardless of the chosen thera- py (fig.2a and 2b).

However, the two groups differed when looking at single rang- es of frequency. Between 1000 Hz and 3000 Hz the hearing im- provement was higher in the group with highly dosed cortico- steroid. It was measured with 15.16 ± 15.11 dB whereas in the group treated with low-dose therapy hearing was improved with 8.28 ± 8.89 dB. This difference was statistically significant (fig. 2a and 2b).

Cite this article: Katrin Eysel-Gosepath. Comparison of High-Dose and Low-Dose Oral Corticosteroid treatment in Patients with Idiopathic Sudden Sensorineural Hearing Loss. J J Otolaryn. 2018, 4(1): 043.

Comparison between hearing capacity of the affected ear after treatment and hearing capacity of the unaffected ear was done under the presumption that hearing had been symmetrical on both ears before onset of ISSHL. Both groups reached the hear- ing of the unaffected ear nearly completely, with a slight ten- dency toward better results in the group with low-dose ther- apy, especially concerning the high frequencies between 4000 and 8000 Hz (fig. 2a and 2b).

This could also be noticed when looking at the rates of total remission (fig. 3). Total remission was assumed when frequen- cies of the hearing loss on the affected ear could reach the ref- erence point of the unaffected ear ± 10 dB. 75 % of the patients with low- dose therapy achieved total remission, as compared to 69% of the patients with high- dose treatment. However, this did not constitute a significant difference between the two groups. No recovery was noticed in 6% of the patients treated with high-dose corticosteroids and in 13% of the cases with low-dose therapy. There was no deterioration in any of the cas- es.

During and after treatment all patients of both groups were asked about side-effects of their corticosteroid therapy. None of them reported severe problems, examination of the patients could also not reveal any side-effects. There was no reason to stop the treatment in any case.

Discussion

The present study compares the effects of oral high-dose ver- sus oral low-dose corticosteroid therapy in 64 patients suf- fering from ISSHL. The distribution of the patients to the two treatment options was not randomized because the investi- gated treatments were done in two different institutes. In the university hospital, patients mainly introduced during emer- gency duty and were treated with high-dose corticosteroid. In the private practice the low-dose therapy predominates. Recovery of the average hearing loss was equal over all mea- sured frequencies in both groups although the hearing loss before onset of therapy was slightly different. In comparison to the unaffected ear general improvement of hearing over all frequencies and especially concerning the high frequencies be- tween 4000 Hz and 8000 Hz was even better for patients with low-dose therapy (fig. 2a and 2b). However, between 1000 Hz and 3000 Hz hearing improvement was higher in the group with high-dose corticosteroid. It was measured with 15.16 ±

15.11 dB whereas in the group with low-dose therapy hearing was improved with 8.28 ± 8.89 dB. This difference was statis- tically significant (fig. 2a and 2b). This point is of high clinical importance as hearing capacity in this range of frequencies is necessary for best speech comprehension.

Corticosteroids are commonly accepted for ISSHL treatment because of their anti- inflammatory, antioedematous and im- munosuppressive effects [10, 11]. Glucocorticoid receptors could be found in the cochlea, suggesting genomic mechanisms as well as nonspecific interactions [11, 25]. In 1980 Wilson et al. [26] already reported a positive effect of corticosteroid

therapy for patients with ISSHL. Nevertheless, the dosage of oral corticosteroids is still controversially discussed.

The German guidelines concerning therapy for ISSHL suggest a high-dose regime with 250 mg per day for three days [27]. Contrary to this advice numerous studies could not find any evidence for better results when using high-dose therapy com- pared to a low- dose regime with 60-80 mg descending to 0 mg over a period of 12-20 days [16, 19, 20, 22, 24, 28, 29, 30]. Moreover, in literature the range of spontaneous recovery is specified as being between 35% [26] and 65% [31]. Anoth- er factor which has to be considered is the degree of hearing loss before starting treatment. The prognosis for patients with a high degree of hearing loss or deafness seems to be worse compared to patients with mild hearing loss [20, 29, 30, 32].

Prognosis is impaired as well when vertigo, increased

body mass index, or hypercholesterinemia occur [19, 33]. Average hearing loss before treatment was 27.59 ± 11.42 dB in the first group of the present study (“low-dose group”) and 30

± 14.03 dB in the second group (“high-dose group”). This extent of hearing loss seems to be in a medium range for both groups. Some authors argue that improvement of hearing levels in this situation cannot be clearly attributed to either the therapy or spontaneous recovery [19, 28, 29, 34]. Furthermore, one could argue to suggest the possibility of waiting one or two days be- fore starting any oral treatment. But, to our experience, most of the patients are worried about their hearing loss regardless of its severity and demand treatment. The results of the pres- ent study and those of other authors [16, 22] suggest starting a low- dose corticosteroid treatment, which seems not to be inferior to high-dose therapy. This is an important point in re- gard to the possible side-effects of steroids. Although none of our patients reported problems during steroid intake, Nosra- ti-Zarenoe et Hultcrantz [29] describe serious gastrointestinal side-effects and negative effects on the cardiovascular system. Moreover, they observed patients suffering from ISSHL who experienced hearing improvement during reduction of stress with measurable reduction of intrinsic cortisol level. Accord- ing to our results, situation changes if hearing loss applies to the frequencies between 1000 and 3000 Hz. In those cases a high-dose corticosteroid therapy seems to be superior to the low-dose therapy. In order to achieve best guidelines for ade- quate treatment of ISSHL a multicenter study is necessary as it is planned to be undertaken in Germany [35].

Conclusion

According to the results of this study, total recovery or at least satisfying improvement of hearing is possible under both treatments.

Legends of the table and the figures:

Table 1: Specific data of the patients before treatment onset.

Figure 1: Frequencies affected by ISSHL in the two groups be- fore treatment.

Figure 2a and 2b: Average hearing loss and standard devia- tion before and after treatment and average hearin level of the unaffected ear in the two groups.

2a: group 1, low-dose therapy 2b: group 2, high-dose therapy

Figure 3: rates of remission for group 1 with low-dose therapy and group 2 with high-dose therapy.

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Tcomment: “I can encourage them. It’s an opportunity for

Cite this article: Katrin Eysel-Gosepath. Comparison of High-Dose and Low-Dose Oral Corticosteroid treatment in Patients with Idiopathic Sudden Sensorineural Hearing Loss. J J Oto- laryn. 2018, 4(1):043.

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