[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).

Randomized, placebo-controlled study on efficacy, safety and tolerability of drug-induced defibrinogenation for sudden sensorineural hearing loss: the lessons learned.

PURPOSE: Disturbance of cochlear microcirculation is discussed as final common pathway of various inner ear diseases. Hyperfibrinogenemia causing increased plasma viscosity is a possible factor for a critical reduction of cochlear blood flow that might lead to sudden sensorineural hearing loss (SSHL). The aim was to determine the efficacy and safety of drug-induced defibrinogenation by ancrod for SSHL. METHODS: Double-blind, randomized, placebo-controlled, multicenter, parallel group, phase II (proof-of-concept) study (planned enrollment: 99 patients). Patients received an infusion of ancrod or placebo (day 1) followed by subcutaneous administrations (day 2, 4, 6). Primary outcome was the change in pure tone audiogram air conduction average until day 8. RESULTS: The study was terminated early due to slow recruiting (31 enrolled patients: 22 ancrod, 9 placebo). A significant improvement of hearing loss was registered in both groups (ancrod: - 14.3 dB ± 20.4 dB, - 39.9% ± 50.4%; placebo: - 22.3 dB ± 13.7 dB, - 59.1% ± 38.0%). A statistically significant group-difference was not detected (p = 0.374). Placebo response of 33.3% complete and 85.7% at least partial recovery was observed. Plasma fibrinogen levels were reduced significantly by ancrod (baseline: 325.2 mg/dL, day 2: 107.2 mg/dL). Ancrod was tolerated well, no adverse drug reaction was of severe intensity, no serious adverse events occurred. CONCLUSION: Ancrod reduced fibrinogen levels that support its mechanism of action. The safety profile can be rated positively. Since the planned number of patients could not be enrolled, no efficacy conclusion can be drawn. The high rate of placebo response challenges clinical trials for SSHL and needs to be considered in future investigations. Trial registrations This study was registered in the EU Clinical Trials Register, EudraCT-No. 2012-000066-37 at 2012-07-02.

Intratympanic corticosteroid injection as a first-line treatment of the patients with idiopathic sudden sensorineural hearing loss compared to systemic steroid: A systematic review and meta-analysis.

OBJECTIVES: The current study aimed to investigate if there is a difference in the use of intratympanic steroid therapy (IST), compared to systemic steroid treatment (SST), as an initial treatment for patients with sudden sensorineural hearing loss (SSNHL) by a meta-analysis design performed on the mean pure-tone average (PTA) improvement and the complete recovery rate. METHODS: A systematic literature review was performed on randomized controlled trials published from 1990 to August 2020 in some databases including PubMed/MEDLINE, Scopus, Embase, Web of Science, Cochrane library/CENTRAL, Ovid, ProQuest, Google Scholar, and clinical trials.gov. The primary outcomes of interest were pure-tone average improvement and complete recovery rates. RESULTS: Six eligible studies with 496 patients (250 patients in the IST group and 246 subjects in the SST group) were included in this study. The pooled standardized mean difference of the PTAs was estimated as 0.07 (95% CI = -0.10 to 0.25; I2 = 0.0%, P = 0.668), and the pooled odds ratio of complete recovery rate was obtained as 1.00 (95% CI = 0.66 to 0.151; I2 = 31.6, P = 0.199). Moreover, the pooled standardized mean difference of pure-tone average for the intratympanic steroid treatment group compared to the patients with oral steroid treatment was 0.07 (95% CI = -0.12 to 0.26; I2 = 0.0%, P = 0.526). CONCLUSIONS: The current study demonstrated that the effect of intratympanic injection of corticosteroid, as a first-line treatment, is not statistically different from the systemic route in improving the hearing outcomes among patients with SSNHL.

[Tolerance and acceptance of intratympanic injections]. / Toleranz und Akzeptanz der intratympanalen Injektion.

BACKGROUND: Intratympanic steroids are a therapeutic component in sudden hearing loss related to cochlear affection. Little has been published on patients' acceptance and tolerance to date. MATERIALS AND METHODS: A total of 84 patients were asked about health conditions and circumstances surrounding their intratympanic therapy. RESULTS: The patients comprised 38 women and 46 men, aged 57.2 years on average, who had mostly been referred by their ENT physician for second-line treatment. Reported were injection pain by 3.6%, discomfort by 22.6%, tolerability by 67.9%, and painlessness by 41.7% (more than one answer possible). Whereas 77.4% recommended intratympanic treatment, reasons for no recommendation were lack of efficacy and an unpleasant sensation. CONCLUSION: The majority of patients rated intratympanic therapy as bearable and recommendable. Close patient guidance seems to be an important part of the treatment.

[Glucocorticosteroids in the treatment of acute neurosensory hearing loss. The current state of the problem. Part 2]. / Glyukokortikosteroidy v lechenii ostroi neirosensornoi tugoukhosti. Sovremennoe sostoyanie problemy. Chast' 2.

Modern literature data are presented on the choice of a drug for hormonal therapy in acute neurosensory hearing loss of various origins, the doses used for systemic therapy, the features and methods of intratympanic administration of glucocorticosteroids, and the evaluation of the effectiveness of treatment with this group of drugs.

Effectiveness of Ginkgo biloba diterpene lactone in the treatment of sudden sensorineural hearing loss.

PURPOSE: To evaluate the effectiveness of systemic Ginkgo biloba diterpene lactone therapy for sudden sensorineural hearing loss. METHODS: This retrospective review investigated 56 patients with unilateral sudden sensorineural hearing loss. Among them, 26 patients received conventional therapy (group C, intravenous methylprednisolone), and 30 received conventional therapy supplemented with Ginkgo biloba diterpene lactone (group G). Pure tone audiometry was measured before treatment and 1 month after treatment. The average pure tone audiometry gain, pure tone audiometry gain at each frequency, pure tone audiometry gain according to initial hearing loss, and rate of effectiveness were defined as functionally relevant recovery of hearing and compared between the two groups. RESULTS: The average pure tone audiometry gain was significantly greater in group G (20.6 ± 15.1 dB) than in group C (11.9 ± 13.3 dB) (p = 0.025), with similar trends at 250, 1 k, and 8 k Hz. In the subgroup of patients with profound hearing loss (initial pure tone audiometry >70 dB), hearing gain was significantly higher in group G (26.7 ± 14.4 dB) than in C (5.5 ± 9.0 dB) (p = 0.034). In the mild-moderate hearing loss subgroup (initial pure tone audiometry ≤70 dB), the pure tone audiometry gain did not differ significantly (group G: 18.4 ± 14.3 dB; group C: 13.0 ± 13.4 dB) (p = 0.209). The overall rate of effectiveness was 73.3% and 57.7% in groups G and C, respectively; however, the difference was statistically insignificant (p = 0.218). CONCLUSIONS: Compared with conventional therapy alone, supplementary systemic administration of Ginkgo biloba diterpene lactone to treat sudden sensorineural hearing loss could improve hearing recovery, especially, in patients with profound hearing loss.

Cogan syndrome: An autoimmune eye and ear disease with systemic manifestations.

Cogan syndrome (CS) is a rare vasculitis seen primarily in young adults. It predominantly affects eyes, ears and the heart with characteristic findings of interstitial keratitis, sensorineural hearing loss and vestibular dysfunction. A high index of suspicion is required to diagnose this rare disorder. It is one of the few vasculitis which can involve vessels of all sizes: small, medium and large. Coexistence of inflammatory bowel disease (IBD) in Cogan syndrome has been described in the literature. Immunosuppressive agents such as corticosteroids with or without steroid sparing agents are the standard of care. Early diagnosis and treatment are the cornerstone of treatment to prevent permanent damage to the ears and eyes. We describe a patient with Cogan syndrome with large vessel vasculitis and IBD. Our patient was treated with glucocorticoids and methotrexate.

Effect of Antioxidant Vitamins as Adjuvant Therapy for Sudden Sensorineural Hearing Loss: Systematic Review Study.

IMPORTANCE: Sudden sensorineural hearing loss (SSNHL) is an otological emergency of unknown etiology. Recent reports showed that antioxidant drugs can benefit patients with SSNHL. This study attempted to evaluate the effect of adding antioxidant vitamins as an adjuvant therapy alongside with corticosteroids. OBJECTIVE: To evaluate the effects of the 3 major antioxidant vitamins (A, C, and E) as an adjuvant therapy, administered with corticosteroids, for the treatment of SSNHL in adult patients (≥18 years). DATA SOURCES: MEDLINE, EMBASE, PubMed, Web of Science and Cochrane electronic databases from January 1, 1995, through September 25, 2017. STUDY SELECTION: Published studies of adult patients who received antioxidant vitamins (A, C, E, or any combination of these vitamins) as an adjuvant therapy in addition to the regular treatment (corticosteroids) for SSNHL. Quality assessment was performed using the Cochrane Collaboration Tool for Assessing Risk of Bias. DATA EXTRACTION: Each study had a control group (conventional treatment + placebo) and a trial group (antioxidant vitamin(s) + conventional treatment). RESULTS: From 446 manuscripts identified in the literature, 3 studies were included in the review with 279 patients. The most common vitamins used to treat SSNHL were the 3 major antioxidant vitamins A, C, and E, combined sometimes with other antioxidants such as selenium. CONCLUSIONS AND RELEVANCE: The success of the treatment is increased in patients who received antioxidant vitamins in combination with conventional therapy.

[Local drug therapy for inner ear hearing loss]. / Lokale Medikamententherapie bei Innenohrschwerhörigkeit.

The indications for local drug therapy of inner ear hearing loss include sudden sensorineural hearing loss, Menière's disease, autoimmune-associated hearing loss, ototoxicity as a side effect of other therapies, acute acoustic trauma and improvement of the safety and performance of cochlear implants. Various drugs are currently being used and tested for local treatment of inner ear hearing loss, including glucocorticoids, growth factors, apoptosis inhibitors, antioxidants, TNF-α inhibitors and antibodies. To further a better understanding of pharmacokinetics and the development of rational pharmacotherapy of the inner ear, the"liberation, absorption, distribution, metabolism, elimination" (LADME) principle can be applied to local therapy of the inner ear. Local application strategies can be differentiated into intratympanic applications to the middle ear cavity and direct intralabyrinthine or intracochlear applications.

[The transtympanic administration of steroids for the treatment of acute sensorineural hearing impairment].

UNLABELLED: The objective of the present study was to compare the effectiveness of two methods (transtympanic and intravenous) administration of steroids and standard therapy for the treatment of the patients presenting with acute sensorineural hearing impairment (OSNHI). MATERIALS AND METHODS: The study included 56 patients with this pathology. 18 of them were given transtympanic injections of steroids; 10 others received steroids intravenously in the combination with standard therapy. 28 patients were treated by the standard therapy alone. The effectiveness of the treatment was estimated by means of tonal threshold audiometry. RESULTS: None of the patients in the first group enjoined total normalization of hearing. Its improvement by 10-29 dB was documented in 22 (78.6%) patients. In the second group hearing improved by 15-20 dB in 4 (40%) and by 5-10 dB in 6 (60%) patients. In the third group, 14 (77.7%) patients reported improvement of hearing and reduced noise as early as the first puncture. By the time of discharge from the hospital, their hearing improved by 30-40 dB while the 15-20 dB improvement was documented in 2 (11.1%) patients and the 5-10 dB improvement in another 2 (11.1%) patients. The study has demonstrated the high effectiveness of glucocorticoid therapy especially in the case of transtympanic administration of these steroids.

[The experience with the use of neuromedin preparations for the treatment of sensorineural impairment of hearing].

The objective of the present study was to evaluate the effectiveness of the application of neuromedin for the treatment of sensorineural loss of hearing of different etiology. A total of 230 patients at the age varying from 20 to 60 years presenting with sensorineural impairment of hearing were available for the observation. Neuromedin was administered intramuscularly at 15 mg/day (1.5% solution at a dose of 1.0 ml) for 10 day; thereafter, the patients took 20 mg neuromedin tablets thrice daily during one month. The majority of the patients reported an improvement of hearing and speech intelligibility. Complete restoration of hearing was documented in certain patients presenting with acute sensorineural impairment of hearing.

Batroxobin can improve the efficacy of combination therapy for profound sudden sensorineural hearing loss greater than but not less than 100 dB HL.

OBJECTIVE: To investigate the effects of combination therapy with and without batroxobin, and the frequency of batroxobin use on the prognosis of profound sudden sensorineural hearing loss. METHODS: Hearing recovery in the batroxobin group (231 patients) and non-batroxobin group (56 patients) was compared. The correlation between the number of times batroxobin was used and hearing recovery was analysed. RESULTS: The decrease in hearing threshold and overall improvement rate in the batroxobin group with hearing loss exceeding 100 dB HL was significantly higher than that in the non-batroxobin group. There was no linear correlation between the number of times batroxobin was used and the overall improvement rate. Using batroxobin two to three times achieved a therapeutic effectiveness plateau. CONCLUSION: Batroxobin can improve the efficacy of combination therapy for profound sudden sensorineural hearing loss exceeding 100 dB HL, and using batroxobin two to three times yields the maximum overall improvement rate.

Actinomycetoma in a patient with pre-existing sensorineural hearing loss: a linezolid-based treatment paradigm.

Mycetoma is a chronic granulomatous infectious disease with a triad of subcutaneous swelling, discharging sinuses and the presence of granules. The infection may occur following minor trauma or penetrating thorn injury. We report a case of a man in his 40s with a history of thorn prick 9 years ago, followed by the formation of painless discharging sinuses on the right foot for the past 2 years. Clinical, local epidemiological, histopathological examination and Gram stain confirmed the diagnosis of actinomycetoma. Prior to initiating the Welsh regimen, a pretreatment assessment of the patient's auditory function was conducted through pure tone audiometry, indicating the existence of pre-existing high-frequency bilateral sensorineural hearing loss. The patient was treated with linezolid as an alternative to amikacin, at a dosage of 600 mg two times per day, leading to complete resolution within 3 weeks. This underscores linezolid's efficacy as a safe and cost-effective alternative for actinomycetoma, without causing ototoxic side effects.

[Intratympanic steroid administration: use in the treatment of profound idiopathic sudden sensorineural hearing loss]. / Intratympanale Dexamethasongabe: Nutzen in der Behandlung des hochgradigen Hörsturzes.

BACKGROUND: Therapy for idiopathic sudden sensorineural hearing loss is still controversial. Although there are no evidenced-based studies, therapy with systemic steroids is widely accepted as the gold standard. Intratympanic administration of steroids appears to be an alternative or additional method of management without the disadvantage of systemic side effects and, therefore, makes therapy accessible for patients with contraindication for systemic steroids. MATERIAL AND METHODS: This retrospective analysis compares the audiometric results of 25 patients who were treated with standard therapy (prednisolone, hydroxyethyl starch, pentoxyfylline) with 23 patients who additionally received intratympanic steroids (IT group). A total of 4 injections were administered within 10 days. The solution used consisted of 0.3 ml dexamethasone (8 mg/ml) and 0.2 ml hyaluronic acid 0.2%. The pure-tone average (PTA) was evaluated prior to and 3 months after treatment. RESULTS: The PTA 3 months after treatment showed an improvement of 48 dB in the IT group and 38 dB in the standard treatment group. The IT group achieved better recovery with an average PTA improvement of 68% compared to the standard treatment group with an average improvement of 59%. Neither result reached significance. CONCLUSION: Combination therapy with intratympanic steroids showed a tendency for better hearing results without serious side effects. However, because current evidence is not adequate, randomized placebo-controlled multicenter studies are needed.

Sudden onset hearing loss--causes, investigations and management.

BACKGROUND: Sudden onset hearing loss (SOHL) has a number of causes, ranging from the simple and reversible to the profound and permanent. The sequelae of a sudden loss of hearing can be significant. OBJECTIVE: This article seeks to address the various aetiologies of SOHL, how they can be diagnosed at the earliest opportunity, and outlines the methods of investigation and management. DISCUSSION: SOHL causes great concern for the patient. It is when there is a 30 dB or greater hearing loss over less than 72 hours. History and examination, with discerning use of investigations, can identify whether the hearing loss is of conductive or sensorineural origin; and those individuals who have a potentially reversible hearing loss that can be addressed quickly and in an appropriate fashion. However, in the majority of cases of sudden sensorineural hearing loss (SSNHL), no cause is identified and it is considered idiopathic SSNHL. In these patients, high dose oral prednisolone may improve hearing outcome, particularly if started early.

Preclinical prospects of investigational agents for hearing loss treatment.

INTRODUCTION: : Hearing loss has a high prevalence, with aging, noise exposure, ototoxic drug therapies, and genetic mutations being some of the leading causes of hearing loss. Health conditions such as cardiovascular disease and diabetes are associated with hearing loss, perhaps due to shared vascular pathology in the ear and in other tissues. AREAS COVERED: : Issues in the design of preclinical research preclude the ability to make comparisons regarding the relative efficacy of different drugs of interest for possible hearing loss prevention or hearing restoration. This has not slowed the advancement of candidate therapeutics into human clinical testing. There is a robust pipeline with drugs that have different mechanisms of action providing diverse candidate therapies and opportunities for combination therapies to be considered. EXPERT OPINION: : Much of the preclinical research literature lacks standard study design elements such as dose response testing, and lack of standardization of test protocols significantly limits conclusions regarding relative efficacy. Nonetheless, the many positive results to date have supported translation of preclinical efforts into clinical trials assessing potential human benefits. Approval of the first hearing loss prevention therapeutic is a major success, providing a pathway for other drugs to follow.

Delivery of Dexamethasone to the Round Window Niche by Saturated Gelatin Sponge for Refractory Sudden Sensorineural Hearing Loss: A Preliminary Study.

OBJECTIVE: The aim of this study was to evaluate the hearing outcome of dexamethasone sodium phosphate (DSP) delivery to the round window niche by saturated gelatin sponge for refractory sudden sensorineural hearing loss. PATIENTS: Twenty patients with unilateral sudden sensorineural hearing loss with an improvement of pure-tone average (PTA) less than 10 dB after primary systemic treatment with steroids. INTERVENTIONS: Delivery of DSP to the round window niche via saturated sponge gelatin for 2 weeks. MAIN OUTCOME MEASURES: Pure-tone audiometry was taken at the beginning and 4 to 8 weeks after the end of the salvage treatment. RESULTS: PTA thresholds were improved at least 10 dB in 11 of 20 patients (55%) by a mean value of 11.9 dB. The hearing threshold at 500, 1000, and 2000 Hz were improved after salvage treatment, but there was no significant change at 4000 Hz. The PTAs also recovered after the salvage treatment. CONCLUSIONS: Delivery of DSP to the round window niche via saturated gelatin sponge is a simple and feasible way to treat refractory sudden sensorineural hearing loss with a risk of permanent tympanic membrane perforation.