|Year : 2021 | Volume
| Issue : 1 | Page : 36-39
Effectiveness of intratympanic dexamethasone as salvage therapy in treating sudden sensorineural hearing loss
Bigyan Raj Gyawali, Rabindra Bhakta Pradhanaga, Pabina Rayamajhi
Department of ENT-HNS, Institute of Medicine, Tribhuvan University Teaching Hospital, Kathmandu, Nepal
|Date of Submission||05-Dec-2020|
|Date of Acceptance||18-May-2020|
|Date of Web Publication||26-Oct-2021|
Dr. Bigyan Raj Gyawali
Department of ENT-HNS, Institute of Medicine, Tribhuvan University Teaching Hospital, Maharjgunj Road, Kathmandu 44600
Source of Support: None, Conflict of Interest: None
Introduction: The steroid is the drug of choice in patients with sudden sensorineural hearing loss (SSNHL). Thirty to fifty percent of cases, despite receiving steroids may have incomplete recovery. Furthermore, there are a significant number of patients in whom systemic steroids are contraindicated such as cases with uncontrolled diabetes, uncontrolled hypertension, and pregnancy. Intratympanic steroids can play a vital role as salvage therapy in these cases. The aim of this study was to evaluate the effectiveness of intratympanic Dexamethasone as salvage therapy in cases who fail to respond with systemic steroids, who present late (>1 week) after the onset of symptoms and cases, in whom systemic steroids are contraindicated. Materials and Methods: This was a retrospective study conducted in the Department of ENT-Head and Neck Studies, T.U. Teaching Hospital, Kathmandu, Nepal. Approval from the Institutional Review Committee was taken. A prospectively set record data of cases with SSNHL receiving intratympanic Dexamethasone as a salvage therapy from April 2018 to April 2020 were analyzed for improvement in hearing outcome. We used SPSS version 25 for the statistical analysis. Chi-square test and Fisher's exact test were used to draw statistical co-relation. Value of P < 0.05 was considered statistically significant. Results: A total of 34 cases met the inclusion criteria. M: F was 3:1 with the majority of cases in the third–fifth decades of life. A total of 11 cases showed partial improvement and one case had complete improvement. There was no statistically significant co-relation between hearing outcome and time interval (from the onset of symptoms to intratympanic injection), level of hearing loss, comorbidities, and prior use of systemic steroid therapy (P > 0.05). Conclusion: Intratympanic Dexamethasone has audiological benefits as a salvage therapy in cases with SSNHL failing to respond with systemic steroid therapy.
Keywords: Intratympanic Dexamethasone, salvage therapy, sudden sensorineural hearing loss
|How to cite this article:|
Gyawali BR, Pradhanaga RB, Rayamajhi P. Effectiveness of intratympanic dexamethasone as salvage therapy in treating sudden sensorineural hearing loss. Indian J Otol 2021;27:36-9
|How to cite this URL:|
Gyawali BR, Pradhanaga RB, Rayamajhi P. Effectiveness of intratympanic dexamethasone as salvage therapy in treating sudden sensorineural hearing loss. Indian J Otol [serial online] 2021 [cited 2021 Dec 2];27:36-9. Available from: https://www.indianjotol.org/text.asp?2021/27/1/36/329100
| Introduction|| |
Sudden sensorineural hearing loss (SSNHL), an otological emergency, is defined as the sudden loss of hearing of more than 30 dB in three consecutive frequencies over a period of 72 h. The annual incidence is estimated to be 27/100,000. It can affect any age group; however, it is more common in fifth to sixth decades with no apparent gender predilection., Mostly idiopathic, definite cause for this entity can be found only in 7%–45% of cases. Although a wide range of causative factors have been mentioned in the literature, viral infection, vascular insufficiency and immune-mediated reactions are considered the noteworthy ones. Its natural history is still a topic of debate till date and so are the treatment modalities. So far, corticosteroid therapy has gained popularity as an effective modality of treatment.
Despite receiving steroid therapy via the oral or intravenous route, 30%–50% cases may show incomplete recovery. After the failure of response to initial therapy, the prognosis tends to worsen. Furthermore, there are a significant number of patients in whom systemic steroids are contraindicated such as cases with uncontrolled diabetes, uncontrolled hypertension (HTN), pregnancy, etc., The intratympanic steroid (ITS) can play a vital role as salvage therapy in these groups of patients. With less systemic toxicity and increased perilymphatic concentration, this therapy has gained popularity as one of the effective treatment modalities for SSNHL, more specifically as salvage therapy. The aim of our study was to evaluate the effectiveness of intratympanic Dexamethasone as salvage therapy in cases who fail to respond with systemic steroids, who present late (>1 week) after the onset of symptoms and cases in whom systemic steroids are contraindicated.
| Materials and Methods|| |
This was a retrospective study conducted in Ganesh Man Singh Memorial Academy for ENT-Head and Neck Studies, Maharajgunj Medical Campus, Tribhuvan University Teaching Hospital, Kathmandu, Nepal. Approval from the Institutional Review Committee was taken. A prospectively set record data of cases receiving intratympanic Dexamethasone as a salvage therapy from April 2018 to April 2020 were analyzed. SSNHL was diagnosed based on the definition criteria, as mentioned above. Indications for intratympanic Dexamethasone for cases with SSNHL in our study were:
- Cases for whom oral or I/V steroids were contraindicated, for example, uncontrolled DM, HTN, etc
- Cases presenting late (1–4 weeks) after the onset of symptoms
- Cases with no or partial response to oral or I/V steroids presenting within 1–4 weeks of the onset of symptoms.
Similarly, contraindications for intratympanic Dexamethasone in our study were
- Cases refusing to give consent for the procedure
- Cases with acute otitis externa, active middle ear infection, COM mucosal, and COM squamous
- Cases presenting late, i.e., >4 weeks after the onset of symptoms.
We evaluated the record data for the demographic profile, duration of symptoms, therapies received, comorbid factors, time of initiating intratympanic Dexamethasone, number of doses received, and Pure tone audiometry (PTA) response to intratympanic injections.
Intratympanic Dexamethasone was given as an OPD procedure under microscopic guidance with a one cc disposable plastic insulin syringe fitted with 26 G long needle. One milliliter dexamethasone of concentration (4 mg/ml) was drawn in the syringe. After applying topical anesthesia with 15% lignocaine spray, injection was made in the anterior superior quadrant to allow the maximum amount of drug to be delivered and to avoid injury to ossicles. The amount of drug delivered ranged from 0.3 to 0.5 ml. Patients were allowed lie supine with turning head to opposite side with injected ear faced up for 20 min to allow diffusion of the drug into the inner ear via round window membrane. Injection was given once a week. After two doses, PTA was repeated, and if there was no improvement compared to previous PTA, no further injections were given. If improvement on hearing was seen in PTA, four further doses with one dose/week were given for four consecutive weeks. PTA was repeated every week until the completion of therapy. Response to the treatment was described as follows in our study:
- Complete response: Hearing level within 10 dB of normal hearing ear
- Partial response: Improvement of >10 dB pure tone threshold
- No response: Improvement of <10 dB pure tone threshold.
We used SPSS version 25 (IBM Corp, New York, USA) for statistical analysis. Chi-square test and Fisher's exact test was used to draw statistical co-relation. P < 0.05 was considered statistically significant.
| Results|| |
A total of 42 record data were analyzed, of which eight cases had incomplete documentation and thus were excluded from the study. Out final sample size was 34. Of them, 26 were male and eight were female. The majority of cases were in their third to fifth decades of life [Table 1].
All 34 cases were unilaterally affected. The right ear was affected in 19 cases and left ear in 15 cases. Thirteen cases were found to have comorbid conditions. Type II diabetes mellitus (DM) was the most common comorbidity encountered [Table 2]. Sixteen cases had received steroid therapy, either oral or I/V before intratympanic injection and had no improvement in hearing. Eighteen cases received intratympanic injection without prior steroid therapy. Of them, two cases had uncontrolled Type II DM, one case had uncontrolled HTN, and three cases had chronic kidney disease secondary to Type II DM. The rest of the 12 cases presented late, i.e., after 2 weeks of the onset of symptoms, so they were considered for intratympanic steroids without prior trial of oral or I/V steroids.
|Table 2: Comorbidities on patients with sudden sensorineural hearing loss|
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Of 34 cases, 12 cases showed improvement in hearing. However, this was not statistically significant (P = 0.419). Eleven cases had partial improvement, and only one case had complete recovery of hearing to normal. Majority of cases (26) received salvage therapy very late, i.e., after 2 weeks from the onset of symptoms. Twenty-nine cases had severe to profound hearing loss, while only five cases had mild to moderate loss. Statistical significance could not be yielded when time interval from onset of symptoms to intratympanic injection, level of hearing loss, presence of co-morbidities, and prior use of systemic steroid therapy were compared to improvement in hearing (P > 0.05) [Table 3]. The case who had complete recovery of hearing had moderate hearing loss with no comorbid conditions, and intra-tympanic injection was initiated in the 2nd week of onset of symptoms following oral steroids for 14 days.
|Table 3: Hearing outcome following intratympanic Dexamethasone and it's co-relation with time interval (from onset of symptoms to intratympanic injection), level of hearing, comorbidities and prior use of systemic steroid therapy|
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| Discussion|| |
A myriad of treatment modalities have been studied so far for the treatment of SSNHL e.g., steroids, hyperbaric oxygen therapy, vasodilators and vasoactive substances, antiviral therapy, etc.,, Of them, steroids have been proven the most efficacious one. Despite having a proven role of steroids, 30%–50% cases still tend to have an incomplete recovery. Various factors are known to affect the outcomes of diseases such as age, duration, severity, and pattern of hearing loss, associated clinical features like vertigo and comorbidities. In cases who do not respond to systemic therapy, salvage ITS confers one of the best options.
The use of ITS in SSNHL was first described by Silverstein in 1996. Since then, ITS therapy has been practiced as one of the treatment modalities for SSNHL, mostly as salvage therapy. Increased perilymphatic concentration and less systemic adverse effects of steroids make this route an ideal one for salvage therapy. Clinical guidelines by AAO-HNS has recommended the use of ITS as salvage therapy. Similarly, Kitoh et al., based on a large cohort Japanese study, also have recommended ITS as salvage therapy, more preferably in severe hearing loss. There has been no consensus on type of steroid, its concentration and mode of delivery e.g., intratympanic injection, myringotomy with or without tube, round window catheter, etc., In this study, we evaluated the effectiveness of intratypmanic Dexamethasone as salvage therapy. The use of Dexamethasone was guided by the study of Ng et al. where they found an obvious outcome benefit of Dexamethasone over Methylprednisolone as salvage therapy.
In this study, of total cases, 11 showed partial improvement of hearing and one had a complete recovery. This finding could not yield statistical significance, so did the co-relation of improvement in hearing with time delay in initiation of salvage therapy, level of hearing loss, presence of comorbidities, and use of previous steroid therapies. In a retrospective review by Haynes et al., 40% of total cases showed some degree of improvement in PTA and speech discrimination score (SDS) after receiving intratympanic Dexamethasone (24 mg/ml) as salvage therapy. Similar to our study, there was no statistical co-relation between the improvement of hearing and the severity of hearing loss. However, the improvement in hearing was significantly associated with the earlier intratympanic injection. Similarly, Plonkte et al., in their RCT showed a better hearing improvement, although statistically insignificant in patients receiving intratympanic Dexamethasone (4 m/ml) via round window membrane catheter compared to placebo group. Another RCT by Wu et al. however, showed a statistical improvement in hearing by >10 dB and >15 dB in patients receiving intratympanic Dexamethasone (4 mg/ml) compared to placebo group. Park et al. compared simultaneously versus consecutive intratympanic Dexamethasone (5 mg/ml) along with systemic steroid in SSNHL. Although recovery in the hearing was seen in both groups, there was no statistically significant difference. Similarly, a prospective study by Dispenza et al. showed a statistically significant improvement in PTA thresholds in patients who received intratympanic Dexamethasone (4 mg/ml) following systemic steroid. Furthermore, nonsmokers compared to smokers, had a significant difference of hearing recovery. There was no statistical difference in hearing improvement between patients with salvage treatment delay of <20 days and >21 days. Another comparative study by Chou et al. between the effectiveness of intratympanic Dexamethasone (4 m/ml) and transtympanic steroid perfusion (TTSP) (Dexamethasone) as salvage therapy showed a statistically significant improvement in PTA thresholds in both groups. However, the degree of improvement was greater in TTSP group. Similar were the results for the speech discrimination score.
There were several limitations to our study. Small sample size was one of them. Furthermore, evaluation for speech discrimination score could have yielded more functional results. MRI of head and ABR is advised in cases who fail to respond with systemic therapy to rule out retrocochlear lesions. Although we performed MRI head only after failure to respond with salvage therapy, none of the patients had abnormal findings.
| Conclusion|| |
Intratympanic Dexamethasone has audiological benefits as a salvage therapy in cases with SSNHL failing to respond with systemic steroid therapy. A large prospective study should be conducted to establish the optimal dosage required for the best response.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]