Comparison of three steroid regimes as a first-line treatment

for idiopathic sudden sensorineural hearing loss: a Trinidadian perspective.

Aaron Trinidade FRCS(ORL-HNS)1, Austin Trinidade FRCS2

1Ipswich Hospital, UK; 2SurgiMed Medical Centre, Trinidad & Tobago

INTRODUCTION: There is much debate over the efficacy of steroid usage in the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL) and if effective, debate over the best mode of administration. OBJECTIVE: To present a comparison of three routes of steroid administration in the management of ISSNHL. SETTING: A private ENT clinic in Trinidad, West Indies. METHODS & MATERIALS: Retrospective case series. Over an 8-year period, 71 adult patients underwent steroid therapy for ISSNHL: (1) oral steroids (OS) only (n=25); (2) OS followed by intratympanic steroid (ITS) salvage (n=28); (3) ITS only (n=18). Pre- and post-therapy audiograms were obtained and compared. Of the patients, 66.2% (n=47/71) were diabetic. RESULTS: (1) OS only group: 50% (n=12/25) improved by average 8 dB; (2) OS + ITS salvage group: 46% (n=13/28) improved by average 10 dB; (3) ITS only: 89% (n=16/18) improved by average 15 dB. The use of ITS only was found to be statistically better than OS only (p=0.006) and OS + salvage ITS (p=0.004). CONCLUSION: based on our data, ITS only therapy is statistically better than OS only or OS with salvage ITS. It may be considered as a first line of therapy in the management of ISSNHL, especially in a population where a high diabetic rate may preclude the use of a systemic alternative.

Abstract

In total, 71 adult patients presented with ISSNHL and were treated; 70.4% (n=50) were male and 29.6% (n=21) were female. The ages ranged from 26 to 63 years with a mean age of 37.6 years. Almost two-thirds of the population were diabetic (66.2%, n=47) of which most were Type 2 diabetics (n=45) and two were Type 1 diabetics. In the OS only group (n=25), 50% (n=12/25) improved by average 8 dB; in the OS + ITS salvage group (n=28), 46% (n=13/28) improved by average 10 dB; in the ITS only group (n=18), 89% (n=16/18) improved by average 15 dB. (Table 1) Using Χ2 testing, ITS only therapy was compared with OS only and OS followed by salvage ITS therapy, the null hypothesis being that ITS was not superior to the other methods in the management of ISSNHL. When compared with OS only, the result was found to be significant (p=0.006, Χ2 statistic=7.703) (Table 2). When compared with OS followed by salvage ITS therapy, the result was also significant (p=0.004, Χ2 statistic=8.478). (Table 3) In none of the diabetics did ITS adversely affect HbA1C levels.

Introduction

The study was conducted at a private ENT clinic in the city of San Fernando, Trinidad, West Indies, which has a population of approximately 50,200. The population is predominantly of Indian (37%), African (36%) or mixed (24%) descent. There is a high risk of diabetes mellitus Type 2 in Trinidad with over 40% of school children harbouring risk factors for its development7. Of these risks, ethnicity (Black Caribbean and South Asian) and rising obesity are the main ones. Confounding this is the problem of management of diabetes in primary care in Trinidad, which currently falls short of Caribbean guideline recommendations, and poor patient compliance with glycaemic control strategies. Over an 8-year period between 2005 and 2013, all patients presenting with ISSNHL were consecutively treated according to one of three regimes: (1) OS only (2005 – 2007); (2) OS followed by salvage ITS (2007 – 2011); or (3) ITS only (2011 – 2013). Prior to treatment, all patients underwent tuning fork testing and audiometry. OS therapy was administered as prednisolone 60 mg daily for 2 weeks; ITS was administered as 0.5 ml methylprednisolone 40mg/ml once weekly for 3 weeks. ITS administration was performed in the clinic setting through the anteroinferior quadrant of the tympanic membrane using a 22G spinal needle and with the patient lying with the head extended and turned to the opposite direction at an angle of 45 degrees. Tragal massage was then performed to facilitate passage of the steroid through the round window and the patient was asked to lie on the side with the treated ear facing upwards for fifteen minutes. Correct administration was assumed if the patient could taste the steroid. Serial audiograms were obtained weekly for 4 weeks post-therapy. All patients underwent the following blood investigations: full blood count, fasting blood sugar, HbA1C and lipid profile. Imaging was not routinely performed unless a retrocochlear lesion was suspected.

Methods and Materials

Based on this data, ITS therapy seems to be the treatment of choice in the management of ISSNHL when compared with OS only and OS followed by salvage ITS therapy. In addition, ITS does not seem to have an effect on glycaemic control in diabetics when compared with OS. Finally, though not statistically proven, there seems to be a correlation between the presence of diabetes and the onset of ISSNHL. With respect to its use as a first-line therapy, Filipo, et al, showed in randomised, triple-blinded controlled trial of 50 patients that ITS gave a statistically significant benefit over placebo. In a cohort of 122 patients, the same author showed that ITS daily for three days resulted in long-term benefit as evaluated at 10 days and 1 year post-therapy. In a large, retrospective multicentre study of 735 patients, Bae, et al, showed that there was no statistical difference between the use of ITS, OS or both in combination and recommended either as a first-line treatment for ISSNHL. These authors also go on to say that despite their similarity in outcome, ITS alone is recommended in patients with chronic ailments such as hypertension and diabetes. Whilst our data suggests ITS as a first-line therapy above other regimes, we agree with this statement. Regarding the role of diabetes in ISSNHL, as aforementioned, there is a potential causative link between the both. Aimoni, et al, have also found such a link in a case-control study of 141 patients matched for age and sex that on the univariate analysis, diabetes prevalence was higher in the ISSNHL group (15.6%) compared to controls (8.5%) (p=0.03). In addition, Ryu, et al, have found hyperglycaemic to be a negative prognostic factor in the recovery from ISSNHL. This has implications for our population in which diabetes prevalence is high and glycaemic control compliance is relatively low.

Discussion

ITS may be considered a first-line therapy in the management of ISSNHL, especially in populations where there is a high prevalence of diabetes, primary care management of it is sub-standard and patient compliance with glycaemic control is low.

Conclusions

Idiopathic sudden sensorineural hearing loss (ISSNHL) is a debilitating condition that can severely impact on a patient’s quality of life. Its aetiology is poorly understood but has been associated with toxic, viral, autoimmune, neoplastic and vascular conditions, although in a recent histopathological study a viral aetiology was thought to be most likely. Furthermore, it has been shown that there is a significant risk associated with ISSNHL and the presence of diabetes. It may be unilateral or bilateral, the latter having a bimodal distribution and being associated with a poorer prognosis for recovery. There has been much debate over the best method of steroid administration in the management of ISSNHL and also whether it is effective at all. Filipo, et al showed no difference between oral steroid (OS) and short-term intratympanic steroid (ITS) therapy in 256 patients divided into two treatment groups. Yang, et al showed good outcomes in patients undergoing ITS therapy which was further improved when combined with hyperbaric oxygen therapy. Conversely, in a recent meta-analysis, Crane, et al, showed that steroid use, regardless of the mode of administration, had no benefit over placebo except in cases where it was used as salvage therapy in cases where traditional methods had previously failed. Nonetheless, the mode of administration may be important in diabetics given that systemic steroids may adversely affect their glycaemic control. In this paper, we present a comparison of three different methods of steroid administration for ISSNHL in a Trinidadian population where the prevalence of Type 2 diabetes mellitus is high and compliance with hyperglycaemic control is relatively low.

Results

Figure 1. ISSNHL right ear 3 weeks post-indicent

Figure 2. Improvement in right hearing at week 4 after weekly ITS

Table 1. Outcomes of patients undergoing three methods of steroid therapy for idiopathic sudden sensorineural hearing loss.

Figure 3. Demonstration of ITS injection technique in out-patient setting

n Improvement % (n)

Average audiometric

improvement

OS

25

50% (12)

8 dB

OS + salvage ITS 28 46% (13) 10 dB

ITS 18 89% (16) 15 dB

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