Enhancing the therapeutic potential of intravenous glycerol for Meniere's disease: Robust results from an extensive patient cohort.

INTRODUCTION: Meniere's disease (MD) is an idiopatic condition characterized by recurrent attacks of vertigo, hearing loss, tinnitus, and aural fullness, affecting quality of life. Intravenous glycerol has shown potential as a therapeutic option. This study evaluates its efficacy in a larger patient cohort. MATERIALS AND METHODS: Retrospective study with 168 patients having unilateral MD unresponsive to dietary restrictions. Intravenous 10 % glycerol with 0.9 % sodium chloride was administered for six months. Audio-vestibular assessments and questionnaires were used. RESULTS: Significant improvements in vertigo control observed. 7.1 % achieved complete control, and 58.3 % had substantial control. Quality of life measures improved, and audiometry thresholds remained unchanged. No major adverse events reported. DISCUSSION: Intravenous glycerol effectively controlled vertigo and improved MD patients' quality of life. Limitations include lack of a control group and a relatively short-term follow-up. Future prospects include randomized controlled trials and optimization of treatment protocols. CONCLUSION: Intravenous glycerol shows promise as a therapeutic option for MD, with notable improvements in vertigo control and quality of life. Further research is needed for validation and optimization.

Efficacy of high dose systemic versus combined (systemic and intratympanic) corticosteroid therapy in idiopathic sudden sensorineural hearing loss: A prospective randomized trial and risk factor analysis.

The pathophysiology and the proper treatment of idiopathic sudden sensorineural hearing loss (ISSNHL) are an ongoing subject of debate. Locally or systemic administered corticosteroids are the most accepted drugs of treatment in reference to ISSNHL (idiopathic sudden sensorineural hearing loss), however, no strong evidence nor guidelines regarding their effectiveness yet exists. In our prospective, randomized, controlled trial 78 participants were enrolled. Patients were randomly assigned based on the day of admission to two groups according to treatment: group SS (n = 43) received intravenous systemic methylprednisolone alone, and group CT (n = 35) received intratympanic dexamethasone + systemic methylprednisolone. The primary outcome was to compare the hearing outcomes between the treatment groups based on different, widely accepted categories (Siegel, Kanzaki, modified Siegel and PTA4 gain). In consideration of the secondary outcome, we examined the effect of the various risk factors on the hearing improvement. No differences were detected regarding hearing improvement between the two groups, based on any criteria [Siegel's criteria (p = 0.604); Kanzaki's criteria (p = 0.720); modified Siegel's criteria (p = 0.524) and PTA 4 gain (p = 0.569)]. However, several clinical factors such as vertigo (p = 0.039), or cardiovascular comorbidity (p = 0.02) and the severity of initial hearing loss (p = 0.033) were found to bear a significant impact upon the hearing outcome. To the best of our knowledge, this is the first randomized controlled trial comparing high dose systemic and combination corticosteroid therapy in ISSNHL patients. Our findings suggest coexisting cardiovascular comorbidity, vertigo and severity of the initial hearing loss may bear a significantly higher impact upon hearing improvement, than the additional intratympanic steroid administration. The presented trial was registered in the European Union Drug Regulating Authorities Clinical Trials Database (name: Combinated systemic and intratympanic steroid therapy in idiopathic sudden sensorineural hearing loss, No.: 2017-000658-20) and with the ethical approval of The National Institute of Pharmacy and Nutrition (OGYÉI) (protocol No.: 7621, on 2017.02.16.).

Salvage therapy for refractory sudden sensorineural hearing loss (RSSNHL): a systematic review and network meta-analysis.

OBJECTIVE: Approximately 30-50% of sudden sensorineural hearing loss (SSNHL) patients show poor response to systemic steroid therapy. Additionally, the most appropriate treatment for patients with refractory sudden sensorineural hearing loss (RSSNHL) is unknown. This study aimed to explore the best treatment for RSSNHL. DESIGN: Using a frequentist contrast-based model and PRISMA guidelines, this study compared five salvage regimes: intratympanic injection of steroids (ITS), hyperbaric oxygen (HBO) therapy, post auricle steroid injection (PSI), ITS combined with HBO therapy, and continued systemic steroids. STUDY SAMPLE: We searched the PubMed, EMBASE, Web of Science, and Cochrane Library databases for randomised controlled trials and cohort studies comparing treatment regimens for RSSNHL. RESULTS: Compared with the control group (no additional treatment), PSI and ITS demonstrated significant improvements. The mean hearing gain was greater after PSI (11.1 dB [95% CI, 4.4-17.9]) than after ITS (7.7 dB [95% CI, 4.8-10.7]). When a restricted definition of RSSNHL was used, the ITS + HBO therapy showed the largest difference in improvement for pure tone average compared with the control group (14.5 dB [95% CI, 4.2-25.0]). CONCLUSIONS: The administration of either PSI or ITS leads to the greatest therapeutic effect in patients with RSSNHL. However, a consensus on the definition of RSSNHL is needed.

[Role of intratympanic glucocorticoid treatment in sudden hearing loss]. / Stellenwert der intratympanalen Glukokortikoidtherapie in der Behandlung des Hörsturzes.

Idiopathic sudden sensorineural hearing loss (ISSNHL) is one of the most common diseases in otolaryngology. Its etiology remains unknown. Furthermore, there is only a low level of evidence for the efficacy of established treatment modalities. In addition to systemic glucocorticoids, intratympanic corticosteroid treatment (ICT) has become increasingly important for treatment of ISSNHL. Different application strategies and treatment regimens have been described; however, uniform standards do not yet exist. ICT may be used for primary treatment as well as salvage therapy. Current data from meta-analyses show no benefit of intratympanic versus systemic primary therapy for sudden hearing loss (moderate evidence) but suggest a benefit of intratympanic secondary treatment over no treatment or placebo (high effect size, low evidence). Regarding combination of systemic and local glucocorticoid therapy in primary treatment of hearing loss, there may be a small benefit over systemic treatment alone (low effect size, low evidence).

Injectable Poloxamer Hydrogel Formulations for Intratympanic Delivery of Dexamethasone.

BACKGROUND: In this study, we prepared and evaluated an injectable poloxamer (P407) hydrogel formulation for intratympanic (IT) delivery of dexamethasone (DEX). METHODS: DEX-loaded P407 hydrogels were characterized in terms of thermogelation, drug loading capacities, particle size, and drug release. The in vivo toxicity and drug absorption of the DEX-loaded P407 formulation after IT injection were evaluated using an animal model by performing histopathological analysis and drug concentration measurements. RESULTS: The P407 hydrogel effectively solubilized hydrophobic DEX and demonstrated a sustained release compared to the hydrophilic DEX formulation. The in vivo study showed that the hydrogel formulation delivered considerable drug concentrations to the inner ear and displayed a favorable safety profile without apparent cytotoxicity or inflammation. CONCLUSION: P407 hydrogel can be useful as an injectable inner ear delivery formulation for hydrophobic drugs due to their biocompatibility, drug-solubilizing capacity, thermogelation, and controlled release.

Intratympanic Triamcinolone Acetonide as a Salvage Treatment for Idiopathic Sudden Sensorineural Hearing Loss.

INTRODUCTION: Intratympanic steroid (ITS) injections represent an increasingly used salvage treatment option for patients with idiopathic sudden sensorineural hearing loss -(ISSHL) after systemic treatment. The most effective corticosteroid for this treatment modality still remains unclear. Triamcinolone acetonide has been used for ITS treatment in various clinical settings. However, there are limited clinical data of its usage in the therapeutic management of ISSHL. The aim of this study was to determine the efficacy of intratympanic triamcinolone acetonide injections as a salvage treatment for ISSHL. METHODS: We conducted a retrospective chart review on patients affected by ISSHL with insufficient hearing recovery after primary systemic corticosteroid therapy and who were treated with intratympanic triamcinolone acetonide as a salvage therapy between January 2014 and August 2019. The patients were divided into groups according to their degree of hearing recovery, and we evaluated potential predictors of hearing recovery. Audiometric results were then compared to historic studies using dexamethasone or methylprednisolone. RESULTS: One-hundred and fifty-two patients received up to 3 intratympanic injections with triamcinolone acetonide at 1-week intervals. The mean hearing improvement due to ITS salvage treatment was 15.9 ± 18.9 dB. Complete hearing recovery was noted in 15 patients (9.9%), while 73 patients (48%) obtained partial recovery, and 64 patients (42.1%) had no recovery. Primary systemic treatment delay, hearing improvement by primary systemic treatment, and severity of initial hearing loss were identified as significant predictors of hearing improvement. The first of the 3 injections resulted in the greatest hearing improvement. CONCLUSION: The use of triamcinolone acetonide in ITS salvage treatment resulted in similar hearing improvements as the use of the commonly used corticosteroids, namely, dexamethasone and methylprednisolone. Longer treatment delays, lower hearing improvement by primary systemic treatment, and higher initial hearing loss are associated with poorer prognoses of hearing recovery.

Efficacy of Various Corticosteroid Treatment Modalities for the Initial Treatment of Idiopathic Sudden Hearing Loss: A Prospective Randomized Controlled Trial.

OBJECTIVE: To evaluate the efficacy of systemic and intratympanic steroid treatment in patients with idiopathic sudden sensorineural hearing loss (ISSNHL). METHODS: Ninety patients who met the inclusion criteria were randomly divided into 3 groups (n = 30 per group). Group I patients were given oral methylprednisolone (MEPD) tablets, group II received intravenous MEPD injection, and group III received intratympanic MEPD injection. Pure-tone average (PTA) hearing threshold was recorded before and after treatment as well as 1 month later. The general efficacy rate was the ratio of patients whose hearing improved by >10 dB in each group. RESULTS: Thirty-two of the 60 patients (53.3%) in groups I and II together showed a hearing improvement of >10 dB hearing level (HL) in the pure-tone audiogram, compared to 21 patients (70%) in group III, respectively. The mean improvements were 16.1, 14.3, and 21.6 dB HL measured in Groups I, II, and III, respectively. Both the general efficacy rate and hearing improvement were significantly greater in group III than in groups I and II. CONCLUSIONS: Our study showed that intratympanic injection rendered better treatment efficacy than systemic administration.

Intratympanic administration of alpha-lipoic acid-loaded pluronic F-127 nanoparticles ameliorates acute hearing loss.

We used antioxidant-containing nanoparticles (NPs) to treat acute hearing loss. Alpha-lipoic acid (ALA) served as the antioxidant; we employed Pluronic F127 to fabricate NPs. In vitro, ALA-NPs protected cells of the organ of Corti in HEI-OC1 mice, triggering nuclear translocation of NRF2 and increases in the levels of antioxidant proteins, including Nrf2, HO-1, SOD-1, and SOD-2. In vivo, the hearing of mice that received ALA-NP injections into the middle ear cavity was better preserved after induction of ototoxicity than in control animals. The cochlear Nrf2 level increased in test mice, indicating that the ALA-NPs protected hearing via the antioxidant mechanism observed in vitro. ALA-NPs effectively protected against acute hearing loss by activating the Nrf2/HO-1 pathway.

Evaluation and comparison of the efficacy of long-acting betamethasone and dexamethasone as injections in the treatment of idiopathic sudden hearing loss.

INTRODUCTION & OBJECTIVE: The aim of the present study was to determine the efficacy of long-acting betamethasone, and its comparison with Dexamethasone as an intratympanic injection in the treatment of Sudden Sensorineural Hearing Loss (SSNHL). MATERIALS AND METHODS: Thirty-one patients who do not respond to systemic steroids and poor prognosis patients were enrolled in this study. The patients divided randomly into two groups: 1- Dexamethasone and 2- Long acting betamethasone. Dexamethasone (0.4 ml/mg) or long-acting betamethasone (0.1 ml/mg) was slowly injected (0.4 to 0.6 cc) into the superior-anterior area of the tympanic membrane as 6 injections twice a week for a total of 3 weeks. Right after the treatment and one, two and six months after completion of treatment, an audiometry was performed and compared with the pre-injection values. RESULTS: Speech Reception Threshold (SRT) showed improvements in both groups immediately after treatment and in the follow-up period, compared to baseline. Speech Discrimination Score (SDS) also improved in both groups directly after treatment and at one-month follow-up. The hearing improvement in the Dexamethasone group was clinically better than in the Beta group, but due to the non-parametric data, it was not possible to analyze the hearing improvement process in the variable group. CONCLUSION: According to the results obtained in this study, intratympanic corticosteroid injection in the treatment of patients with SSNHL has positive and promising results on improving hearing level.

Differences in hearing recovery following intratympanic alone or intravenous dexamethasone with rescue intratympanic steroids for sudden sensorineural hearing loss: A randomised trial.

OBJECTIVES: This study aimed to evaluate hearing improvement at different frequencies and the safety of intratympanic (IT) and intravenous (IV) administration of dexamethasone for sudden sensorineural hearing loss (SSNHL). METHODS: SSNHL patients were randomly divided into two groups within 72 hours after onset and received 24 days of dexamethasone therapy. Group A received IT dexamethasone once every other day for 24 days. Group B received IV dexamethasone for 12 days, followed by IT dexamethasone once every other day for the following 12 days. Hearing recovery and side effects were compared. RESULTS: Subgroup analysis was performed to look for variation in hearing improvement in high frequency, low frequency and overall hearing at different time points. There was no evidence of a difference in hearing outcomes between IT dexamethasone and sequential IV plus IT treatments. Side effects of steroids were observed within 90 days after treatment. The local adverse effects of IT injection were mild. The systemic side effects in group B were more serious than those in group A. CONCLUSIONS: IT dexamethasone was safer than IV dexamethasone, and there was no evidence of a difference in hearing outcomes between IT dexamethasone and sequential IV plus IT treatments. It is necessary to make individualised treatment decisions according to the patient's condition.

Effect of video-assisted information prior to intratympanic steroid injection on patient anxiety.

OBJECTIVE: Patients may be afraid when they receive knowledge that medications are injected into the middle ear through the tympanic membrane using a fine needle during intratympanic treatment. The aim of this study was to evaluate the effect of video-assisted information prior to intratympanic steroid injection on patient anxiety. STUDY DESIGN: Prospective, Non-randomized, controlled trial. SETTING: Tertiary academic medical center. METHODS: A total of 85 patients who had an indication for intratympanic treatment due to idiopathic sudden sensorineural hearing loss and tinnitus were included in this prospective study. 40 cases received video-assisted information before intratympanic steroid injection in the study group, while 45 cases were verbally informed face-to-face in the control group. Then, patient anxiety was measured using the Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI). RESULTS: The mean VAS score was 3.58 ± 3.37 (mean rank = 42.09) in the study group and 3.87 ± 3.56 (mean rank = 43.81) in the control group. The mean STAI-S score was 37.03 ± 10.637 in the study group and 39.11 ± 11.783 in the control group. The mean STAI-T score was 40.18 ± 9.151 in the study group and 38.73 ± 11.438 in the control group. It was found that there were no statistically significant differences in the mean VAS, STAI-S and STAI-T scores between the two groups (p > 0.05). CONCLUSION: We revealed that video-assisted information prior to intratympanic steroid injection had no superiority in reducing anxiety over face-to-face verbal information.

Therapeutic role of intravenous glycerol for Meniere's disease. Preliminary results.

PURPOSE: Osmotic diuretics such as glycerol are used for diagnostic purposes in patients with a suspect of Meniere's disease (MD). Scientific evidence in the animal model and in humans has shown that glycerol can induce a reduction in endolymphatic hydrops; however, its use for therapeutic purposes in MD has never been reported. The aim of this study was to evaluate the effectiveness on symptom control of intravenous glycerol in a sample of patients with definite unilateral MD not responsive to dietary restrictions. MATERIALS AND METHODS: Forty patients with unilateral intractable MD were included in the study. After audio-vestibular evaluation, patients were treated with intravenous 10% glycerol with 0.9% sodium chloride, 0.5 g/kg ml once a day for 2 consecutive days every fifteen days for six months. Vertigo attacks were evaluated before and after therapy and categorized into classes A-F according to the 2015 Equilibrium Committee criteria. Tinnitus and quality of life were evaluated through the Tinnitus Handicap Inventory and the Functionality Level Scale questionnaires. RESULTS: Before treatment, patients had an average of 3.2 vertigo attacks/month; during the six months after treatment the average number of attacks/month decreased to 1.2 (p < 0.0001). At the end of the study period, 25 patients (62.5%) were in Class B vertigo control; 10 patients (25%) in Class C; and 5 patients (12.5%) in Class D. No patients were in Class A, E and F. No hearing deterioration was found in all treated patients. Quality of life according to administered questionnaires improved after treatment. CONCLUSIONS: In our sample, intravenous infusion of glycerol for two consecutive days every fifteen days for six months based on the patient's weight improved vertigo attacks and reduced the discomfort generated by tinnitus raising quality of life in patients with unilateral MD unresponsive to dietary restrictions.

Intratympanic application of triamcinolone in sudden hearing loss-radiologic anatomy in cone beam CT and its' correlation to clinical outcome.

PURPOSE: To evaluate temporal bone cone-beam CT in patients with idiopathic sudden sensorineural hearing loss (ISSNHL) being treated with primary and secondary intratympanic (IT) triamcinolone and to possibly correlate these results to the clinical outcome. METHODS: Retrospective analysis of patients treated with IT triamcinolone for ISSNHL at our department in 2018. Pre- and post-therapeutic audiologic examinations included four-tone average (FTA) at 0.5, 1, 2 and 3 kHz. Using a clinical questionnaire, pre-therapeutic CBCT scans were re-evaluated looking at items, which might interfere with adequate drug diffusion into the inner ear (e.g. bony overhangs or secondary membranes at the round or oval window). RESULTS: Thirty-one patients were included. Twenty-four (77%; group A) had experienced ineffective systemic steroid therapy before and seven (23%; group B) received primary IT injections. Four group A-patients (21%) and two group B-patients (33%) showed a post-therapeutic FTA improvement of more than 15 dB HL. Bony overhangs at the round window niche (RWN) were present in seven cases (26%), a secondary membrane at the RWN in four (15%) and soft tissue in eight (30%) cases, respectively. CONCLUSION: Most patients present radiological findings in CBCT imaging, which might interfere with drug diffusion through the RW membrane. Interestingly, soft or bony tissue obstructing the RWN or the OWN was found in 50% of patients, who showed improvement of hearing. We conclude that radiologic 'tiny' findings are either clinically irrelevant or improvement in hearing is independent from intratympanic drug delivery.

Low-dose intratympanic gentamicin administration for unilateral Meniere's disease using a method based on clinical symptomatology: Preliminary results.

PURPOSE: There are many therapeutic options for Meniere's disease (MD); intratympanic (IT) gentamicin has been proposed for intractable cases although controversy about dosage and method exists. The purpose of this study was to assess the efficacy and safety of low-dose IT gentamicin on vertigo attacks in MD using a clinical symptomatology-based method in which administration was repeated only if vertigo attacks recurred, with a 2-week interval between injections. MATERIALS AND METHODS: Forty-eight patients with unilateral intractable MD were included in the study. All patients received one to five IT injections with 0.5 ml of 10 mg of gentamicin (80 mg/2 ml) with an interval of 2 weeks between injections. Vertigo attacks were evaluated before and after therapy and categorized into classes A-F according to the 2015 Equilibrium Committee criteria. Audiovestibular assessment with pure tone audiometry, vestibular bed-side examination and video head impulse test was performed. RESULTS: Before treatment patients had an average of 4.4 vertigo attacks/month; after treatment the average number decreased to 0.52. The majority of patients (77%) reached Class A vertigo control with 5 or less gentamicin injections. VOR gain was unaffected in the healthy side and significantly reduced in the affected side. No hearing deterioration was found in all treated patients. CONCLUSIONS: Low-dose IT gentamicin administration based on clinical symptomatology can produce a satisfactory control of vertigo attacks after treatment; such protocol had an effect mainly on the vestibular function as demonstrated by the significant reduction in VOR gain in the affected side avoiding a cochlear damage.

[Systemic and local therapy options for sudden sensorineural hearing loss in diabetics]. / Systemische und lokale Hörsturztherapie bei Diabetes mellitus.

Sudden sensorineural hearing loss is not an emergency, but an urgency. Depending on severity, the disease may have a major impact on quality of life. Gold standard in Germany is a systemic, high-dosage glucocorticoid therapy. During oral or intravenous therapy with glucocorticoids, systemic side effects may occur. Especially in diabetics, this therapy may cause acute prominent disorders in glucose metabolism and therefore may be contraindicated. An alternative therapeutic option is intratympanic injection of steroids into the middle ear. Hereby the systemic side effects are absent and only local otologic complications may occasionally occur.

Round Window Niche Drilling with Intratympanic Steroid Is a Salvage Therapy of Sudden Hearing Loss.

OBJECTIVE: To explore the effectiveness and safety of round window niche drilling combined with intratympanic methylprednisolone injection for the salvage treatment of sudden sensorineural hearing loss (SSNHL) and its associated tinnitus after failed primary treatment. METHOD: SSNHL patients who showed a less than 10-dB improvement of pure-tone average after receiving standard systemic treatment and intratympanic steroid injection were enrolled. All included patients were randomly divided into two groups (control and study). Patients in the study group received round window niche drilling combined with daily intratympanic methylprednisolone for 7 times; the control group received only daily intratympanic methylprednisolone for 7 times. One month after treatment, the improvements of PTA, speech discrimination score (SDS), tinnitus and the incidence of adverse events were analyzed. RESULTS: 20 patients (10 for each group) were included in this study. The baseline between two groups showed no statistical significance. Patients in the study group experienced an average hearing improvement of 20.38 dB, SDS 19.3 compared with 2.1 dB and SDS 2.0 in the control group. None (0%) in the control group and 4 patients (40%) showed marked recovery, 5 patients (50%) showed slight improvement of hearing in the study group after 1 month. All patients in the study group showed significant recovery of tinnitus. Both tinnitus handicap inventory and a symptom visual analogue scale between two groups revealed statistical differences (p < 0.001, p = 0.002, respectively). None in the control and study groups experienced vertigo, infection and facial paralysis. CONCLUSION: Round window niche drilling increases the contact area and time of methylprednisolone. It is an effective and safe salvage therapy of idiopathic SSNHL and its induced tinnitus.

The Efficacy of Concurrent or Sequential Intravenous and Intratympanic Steroid for Idiopathic Sudden Sensorineural Hearing Loss.

OBJECTIVE: The purpose of this retrospective study was to investigate the difference in treatment outcomes for patients with idiopathic sudden sensorineural hearing loss (SSNHL) undergoing concurrent or sequential intravenous (IV) and intratympanic (IT) steroid therapies. METHODS: Patients with idiopathic SSNHL admitted to Taipei Veterans Hospital from August 2011 to August 2012 were enrolled. Patients were treated with both IV dexamethasone 5 mg b.i.d. for 5 days, then tapered over 6 days, and IT injections of dexamethasone 5 mg daily. The administration of IV and IT steroids was given either concurrently or sequentially (IV steroid was administered from days 1-5 followed by IT steroid treatment starting on day 4 or day 5). The hearing outcomes of the concurrent and sequential groups were analyzed. RESULTS: Overall, after ≥2 months following treatment, across frequencies ranging from 250 to 8,000 Hz and pure-tone average (PTA) assessments, hearing improvements were similar between treatment groups, except at the frequencies of 4,000 and 8,000 Hz where the concurrent treatment group had greater hearing gain than the sequential group (4,000 Hz: 30.68 ± 28.96 vs. 14.52 ± 24.06 dB, respectively, p = 0.042; 8,000 Hz: 22.62 ± 23.59 vs. 7.67 ± 21 dB, p = 0.030). Across frequencies and PTA assessments, a similar percentage of patients had ≥20-dB gains in hearing compared with patients treated sequentially, except at 8,000 Hz where a greater percentage of patients in the concurrent group (57.1%) than the sequential group (23.3%) (p = 0.014) had ≥20-dB hearing gains. CONCLUSION: The findings suggest that both concurrent and sequential treatment improve hearing in patients with idiopathic SSNHL, and that concurrent treatment may show greater benefit than sequential therapy, particularly at high frequencies.

Comparison of Two Different Treatment Protocols Using Systemic and Intratympanic Steroids with and without Hyperbaric Oxygen Therapy in Patients with Severe to Profound Idiopathic Sudden Sensorineural Hearing Loss: A Randomized Controlled Trial.

OBJECTIVES: This study aimed to investigate the efficacy of simultaneous steroid and hyperbaric oxygen therapy (HBOT) in patients with severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL), which has a poor prognosis. METHODS: Sixty patients diagnosed with severe to profound ISSNHL (≥70 dB HL) were randomly divided into two groups in a prospective controlled trial: an oral steroid + intratympanic steroid injection (ITSI) group (control group) and an oral steroid + ITSI + HBOT group (study group). Pure-tone audiometry (PTA) results and word discrimination scores (WDS) were compared between the two groups before treatment and 10 days and 1, 2, and 3 months after treatment. Hearing improvement was assessed using the modified American Academy of Otolaryngology-Head and Neck Surgery criteria. Analyses were by both intention to treat and per protocol. RESULTS: A total of 58 patients completed the 3-month follow-up, and 2 patients in the study group were excluded due to follow-up loss in the per-protocol analysis. In the intention-to-treat and per-protocol analyses, the study group showed significantly better hearing levels than did the control group at 500 Hz (p < 0.05) 1 month after treatment and at 1 kHz (p < 0.05) 3 months after treatment. However, the average PTA values and PTA at 2, 4, and 8 kHz showed no significant difference. WDS improvement was significantly higher in the study group compared to the control group 3 months after treatment by both per-protocol (66.4 ± 13.3 and 56.7 ± 19.1%, respectively; p = 0.029) and intention-to-treat analyses (65.9 ± 14.1 and 56.7 ± 19.1%, respectively; p = 0.035). The sum of complete and partial hearing recovery for the study group was significantly higher than that for the control group by per-protocol analysis (60.7 vs. 33.3%; p = 0.037) and intention-to-treat analysis (60.0 vs. 33.3%; p = 0.038). CONCLUSION: These results demonstrate that the addition of HBOT to steroid combination therapy does not improve the average PTA values in severe to profound ISSNHL; however, it was associated with a better outcome at 500 Hz 1 month after treatment and, at 1 kHz, WDS 3 months after treatment. The sum of complete and partial hearing recovery was significantly higher for the study group than for the control group.

Intratympanic injection of dexamethasone after failure of intravenous prednisolone in simultaneous bilateral sudden sensorineural hearing loss.

PURPOSE: This study aimed to analyze outcomes of intratympanic injection of dexamethasone after failure of intravenous prednisolone in simultaneous bilateral sudden sensorineural hearing loss (SSNHL). MATERIALS AND METHODS: The cases of simultaneous bilateral SSNHL treated in our hospital from March 2007 to March 2018 were retrospectively analyzed. During the earlier period (March 2007 to February 2012), the cases were treated by intravenous prednisolone only, and classified into group A. During the late period (February 2012 to March 2018), intratympanic injection of dexamethasone after failure of intravenous prednisolone therapy was employed to treat simultaneous bilateral SSNHL, and these patients were enrolled in group B. Effective rates of the two treatment modalities in groups A and B were compared. RESULTS: In group A, 3 of 40 ears obtained complete recovery, and 4 ears achieved partial recovery after intravenous prednisolone treatment, with the effective rate of only 17.5% (7/40 ears). In contrast, 6 of 44 ears in group B achieved complete recovery, and 10 ears got partial recovery, with the effective rate of 36.4% (16/44 ears). There was significant difference in the effective rate between the two groups. CONCLUSION: Intratympanic injection of dexamethasone after failure of intravenous prednisolone therapy was a better choice for simultaneous bilateral SSNHL compared to traditional intravenous prednisolone therapy.

Systemic, intratympanic and combined administration of steroids for sudden hearing loss. A prospective randomized multicenter trial.

PURPOSE: The purpose of this prospective, randomized, multicenter clinical trial was to compare the therapeutic efficacy of systemic versus intratympanic versus combined administration of steroids in the treatment of idiopathic sudden sensorineural hearing loss. METHODS: 102 patients with an up to 14 days history of idiopathic sudden sensorineural hearing loss were randomized to 1 of 3 arms and followed prospectively. Group A (35 patients) received prednisolone intravenously followed by methylprednisolone orally, whereas Group B (34 patients) were administered intratympanic methylprednisolone. Patients in Group C (33 patients) were administered the combination of the above-mentioned treatment modalities. The patients were followed-up with pure tone audiograms on days 1 (initiation of treatment), 3, 5, 10, 30 and 90. RESULTS: The final mean hearing gain was 29.0 dB HL for Group A, 27.0 dB HL for Group B and 29.8 dB HL for Group C. The differences between the three groups were not statistically significant. When hearing improvement was assessed according to Siegel's criteria, no statistically significant difference was recorded either. Furthermore, patients younger than 60 years old achieved significantly better hearing outcomes. CONCLUSIONS: The results demonstrated that systemic, intratympanic and combined steroid administration have similar results in the primary treatment of idiopathic sudden hearing loss. Younger patients are more likely to achieve better hearing outcomes.