Intratympanic Corticosteroid Research Articles

Efficacy of intratympanic corticosteroid, intravenous batroxobin and combined treatment for sudden sensorineural hearing loss with type-2 diabetes

Background: Intratympanic corticosteroid (IC), intravenous batroxobin (IB) as the treatment for sudden sensorineural hearing loss (SSNHL) has been reported. However, the data on combination therapy (CT) was scarce.Objective: The aim of this retrospective study was to compare the efficacy of IC, IB, and CT in the treatment of SSNHL with diabetes.Material and Methods: A total of 212 SSNHL patients with diabetes, who were initially treated within 14 days of onset of disease, were divided into three groups by treatment modality. The hearing recovery was evaluated by the results of pure-tone test after completion of treatment. The prognostic factors, including age, severity of initial hearing loss, duration to onset of treatment, and audiometric curve type, were further compared.Results: There was a significant difference in hearing recovery by the treatment (p < .05). Recovery rates in the CT group were significantly higher in patients with early treatment than with delayed treatment (p = .021). However, duration and recovery rate was not significantly correlated in IC and IB group (p > .05). In patients recieving early treatment, the recovery rate in CT group was significantly higher than that in IC (p = .013) and IB group (p = .029). Regardless of treatment, the recovery rates were higher in patients with flat and ascending audiograms (p < .05).Conclusions and Significance: Patients receiving combined therapy, especially in the early stage of SSNHL, could achieve significantly superior recovery in the treatment of SSNHL with diabetes, compared with those using IC or IB alone.

Hereditary bilateral sudden sensorineural hearing loss

The aim of our study is to demonstrate acausal link between two distinct diagnoses, the hereditary hearing loss, and the sudden sensorineural hearing loss. Sudden sensorineural hearing loss is an emergency condition in otolaryngology and a rare diagnosis in childhood. Most often it only affects one ear and its cause remains unknown. We present a clinical study of a 10-year-old female patient presenting with bilateral sudden sensorineural hearing loss analyzed by Sanger sequencing of the GJB2 gene. The subject was referred to the hospital for bilateral sudden hearing loss which developed 3 days before the admission. Audiometric testing confirmed bilateral asymmetric sensorineural hearing loss. All routine diagnostic procedures including MRI and CT imaging showed normal results. She was treated with intravenous and intratympanic corticosteroids followed by hyperbaric oxygen therapy with partial hearing recovery in one ear. DNA analysis of the GJB2 gene identified biallelic c.35delG deletion. The subject had no other affected family members and her auditory development to that time was normal. Our finding extends the knowledge on phenotype variability in GJB2 variants. We suggest considering genetic testing in pediatric cases of bilateral sudden sensorineural hearing loss (Tab. 1, Fig. 4, Ref. 24).

Audiological outcomes in sudden sensorineural hearing loss with presumed inner ear hemorrhage.

To explore the hearing outcomes and prognostic factors in patients with sudden sensorineural hearing loss resulting from inner ear hemorrhage. 42 patients (22 male and 20 female) were recruited from January 2016 to December 2017. Intravenous methylprednisolone and/or intratympanic corticosteroid were used as salvage therapy. The main measures included systemic risk factors and audiometric outcomes as proposed by American Academy of Otolaryngology-Head and Neck Surgery Hearing Loss Scale. All individuals were assessed at baseline, discharge (2 weeks post-treatment) and at 1, 3 and 6 months. The mean ages of patients were 39.3 ± 14.8 yrs. Cardiovascular disorders were seen in 19.0-33.3% of cases. Restoration of hearing and speech discrimination abilities were assessed at the first month post-treatment versus initial levels (95.5 ± 15.5 vs. 109.2 ± 9.6 dB, p = 0.000; and 17.6 ± 24.4 vs. 1.3 ± 4.0%, p = 0.003, respectively). Word recognition scores continued to recover at month 6 (38.7 ± 35.4%, p = 0.000), whereas puretone ceased to change (90.8 ± 16.2 dB, p = 0.139). The final percentages of complete, partial and no recovery were 0%, 57.1% and 42.9% respectively. The prognosis was independent of accompanying systemic risk factors as analyzed in this study. Intratympanic intervention was associated with improved word recognition scores, although intravenous corticosteroid was not. Profound sudden sensorineural hearing loss caused by inner ear hemorrhage often has an unsatisfactory prognosis. However, this cohort did experience partial audiological recovery with delayed onset. Immediate and effective intratympanic corticosteroid may have therapeutic potential for this intractable disease.

Eficacia del corticoide intratimpánico como tratamiento de rescate en sordera súbita neurosensorial idiopática

IntroductionIdiopathic sudden sensorineural hearing loss (ISSHL) is defined as an abrupt hearing loss of at least 30dB of unknown cause. The hearing response obtained after intratympanic steroid injection as a salvage treatment after a prior failure of initial systemic steroid treatment was analysed. Material and methodAn observational study was performed on 125 cases of ISSHL who were diagnosed from 2006 to 2014. Sixteen achieved complete recovery after one week according to Siegel's criteria. The remaining 109 cases were analysed in two groups: one that received intratympanic corticosteroid salvage therapy (treatment group) and one that did not (control group). The recovery was analysed after 6 months and 2 years of follow-up. ResultsThe difference between each group at baseline were not statistically significant. After systemic treatment for 7 days, PTA in the control group was 53.13dB and 66.11dB in the treatment group (P<.01). After 6 months, the mean PTA improvement was 10.84dB in the treatment group, and 1.13dB in the control group, a significant difference (P<.0001). Only 10 cases achieved full hearing recovery after intratympanic corticosteroid salvage therapy, none of the patients did so in the control group. ConclusionIntratympanic corticosteroid rescue for ISSHL acheived hearing improvement for the cases with failure of initial systemic corticosteroid treatment. However, this treatment did not provide complete hearing recovery according to Siegel's criteria in most cases.

Association of Vertigo With Hearing Outcomes in Patients With Sudden Sensorineural Hearing Loss

Sudden sensorineural hearing loss (SSHL) accompanied by vertigo may portend a negative prognosis in the hearing outcome. To investigate the association of vertigo with prognosis of hearing variables in SSHL. A literature search of eligible studies was performed in PubMed, Web of Science, and Embase from September 26, 1973, through September 26, 2017. Studies published in English were retrieved with no restrictions on the date of publication. References were identified by screening the proceedings of relevant reviews, and annual meeting and other correlative papers were scanned manually for enrollment. All original research studies and retrospective or prospective studies focusing on the role of vertigo in the prognosis for the hearing outcome of SSHL were systematically retrieved. Studies that did not include data regarding the association between the rate of hearing recovery and vertigo were excluded, as were reviews, comments, case reports, editorials, letters, and practice guidelines. Data were extracted and evaluated by 2 researchers. Data extracted included research type, number of participants with or without vertigo, treatment regime, definition of pure-tone average, criteria for hearing improvement, and length of follow-up. The quality of included studies was evaluated using the Newcastle-Ottawa Scale (scores range from 0-9, with a score of ≥6 indicating a high-quality study). The data were synthesized in Mantel-Haenszel models; the aggregate results were estimated in forest plots. Association of vertigo with the prognosis for the hearing outcome of SSHL. Of the 4814 unique patients identified in 10 studies, 1709 were included in the SSHL group with vertigo and 3105 were included in SSHL group without vertigo. The Newcastle-Ottawa Scale score of each study selected was greater than 7. The recovery rate of hearing was 42.13% in the group with vertigo, compared with 60.29% in the group without vertigo. Vertigo was significantly associated with a worse hearing recovery (odds ratio, 2.22; 95% CI, 1.54-3.20; I2 = 74%). Similar results were obtained in subgroup analyses of the grading system using the Siegel criteria and systemic corticosteroid therapy. However, no association of vertigo with the prognosis of SSHL was observed within the subgroup receiving intratympanic corticosteroids (odds ratio, 1.78; 95% CI, 0.64-4.94; I2 = 70%). Current evidence revealed that vertigo may be negatively associated with hearing recovery in patients with SSHL, except in a subgroup that received intratympanic corticosteroids. Corticosteroid injection may be more effective for treatment of SSHL accompanied by vertigo; future studies are needed to determine whether treatment of vertigo might contribute to the recovery of SSHL.

Analysis of related factors of coins foreign bodies crossing the esophagus in 204 cases of children

Objective:To evaluate the effect of systemic and intratympanic dexamethasone combination therapy on sudden deafness.Method:A total of 98 patients randomly divided into three groups: an intravenous corticosteroid (systemic corticosteroid monotherapy group); an intratympanic corticosteroid (IT monotherapy group); and a combination therapy group (IT plus systemic combination group). All patients were treated additionally with ginkgo-damole and mecobalamine and proton pomp inhibitor. An audiometry was performed before and after the therapies in all patients. Result:Of the total of 98 patients, 39 were receiving systemic corticosteroids, 28 received intratympanic(IT) corticosteroids, and 31 were receiving a combination of the two. A total of 65 patients (66.3%) responded positively to corticosteroid therapy. No significant differences were observed between the three groups (systemic group, IT and combination therapy group) in their overall response to treatment (P=0.61). Patients who suffered from concomitant tinnitus and dizziness responded less positively to the treatment (P=0.00）. Positive family history of SSNHL seems to be negative prognostic factors in the response to treatment (P=0.02).The response to treatment was not related to the initial severity of hearing loss (P=0.68) and pattern (P=0.28). Conclusion:This study did not find any difference in the rate of hearing improvement between systemic, intratympanic, and combined corticosteroid therapy for sudden hearing loss.

Observation and prevention measures against adverse reaction to intratympanic corticosteroid injections

Objective:To investigate clinical characteristic and incidence of the adverse reaction to tympanic injection. The incidence rates of adverse reaction were also compared after improvement of anesthetic method and changed ratio of methylprednisolone. Method: A retrospective analysis of 712 cases (1 928 injections) of receiving injection in a medical center, to explore the overall and classified adverse reactions, as well as effects of age and gender and frequency on adverse reactions. According to the clinical characteristics of the early stage, the incidence of adverse reaction was observed after the application of anesthesia warming method and the change of methylprednisolone ratio. Result: Adverse reaction was found in 76 cases which included 62 cases of mild reactions, 4 cases of severe reactions and 10 cases of glucocorticoid-related reactions. Overall, 10.67% of patients had adverse reactions. There was no correlation between adverse reactions and age, gender or frequency. The incidence of vertigo was decreased after the application of improved anesthesia (P<0.05). The incidence of pain of joint methylprednisolone-and-lidocaine injection was lower than that of methylprednisolone injection (P<0.05). Conclusion: Intratympanic injection is a safe treatment, to some extent, although there is low incidence of adverse effects of it. At the same time, anesthetic warming method and changing the ratio of methylprednisolone can further reduce the incidence of vertigo and pain.

Intratympanic steroid use for idiopathic sudden sensorineural hearing loss: current otolaryngology practice in Germany and Austria.

The frequency of the use of intratympanic steroids (ITS) as a treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) in Europe is still unknown and remains a contentious issue amongst otolaryngologists. We undertook a survey of otolaryngologists in Germany and Austria to establish if there is any professional consensus with which to form a protocol for its use. A survey of 21 questions was distributed electronically to otolaryngologists in Germany and Austria and data on demographics, indications for intratympanic treatment, procedure, follow-up, and outcomes were analysed. We received 908 responses. 49.1% of otolaryngologists used ITS for ISSNHL. Of those otolaryngologists who use ITS, 73.7% do not use it as primary treatment. 20.6% use ITS in conjunction with oral steroids for primary treatment and only 5.8% use ITS as monotherapy for primary treatment. 90.5% use ITS as salvage therapy. 81.1% do not consider the use of ITS after 2 weeks from the onset of symptoms. 8.3% used a tympanostomy tube and while the most commonly used steroid was dexamethasone at a concentration of 4mg/ml (61%), a wide variety or other steroids and concentrations were used. This survey illustrates wide variation of current practice of intratympanic corticosteroid injection for ISSHL in Germany and Austria. In the absence of high-level evidence, knowing what current practice is allows clinicians to assess what they do against what their colleagues are doing, and if they do something very different, make them question their practice. Moreover, the obtained data will help to direct future clinical trials with the aim to compare the outcomes of more commonly used protocols.

Treatment of cisplatin-induced ototoxicity by intra-tympanic corticosteroid injection

Background: Cisplatin is a common chemotherapeutic drug often causes ototoxicity attributed to the formation of reactive oxygen and nitrogen species damaging critical inner ear structures. Steroids have been shown to reduce the formation of reactive oxygen species, and thus, may reduce ototoxicity. In this study, intratympanic corticosteroid injection is proved to help the recovery of cisplatin ototoxicity. Objectives: The objective of this study was to assess the efficacy of intratympanic corticosteroid injection in the treatment of cisplatin ototoxicity. Patients and Methods: This study was applied on 20 patients that have sensorineural hearing loss caused by cisplatin, which was used as a chemotherapeutic agent for the treatment of their malignancies. All cases were subjected to intratympanic corticosteroid injection. All patients were exposed to pure-tone audiometry before and after the procedure. Results: Significant increases in the average pure-tone thresholds (PTTs) at 8000 Hz were found in both the study and control groups after the cumulative dose: 43.15 ± 15.557 dBHL and 55.7 ± 13.2589 dBHL, a value of P = 0.0004 and <0.001, respectively. Significant increases in the average PTTs at 6000 Hz were found in both the study and control groups after the cumulative dose: 39.7 ± 11.885 dBHL and 52.6 ± 7.456 dBHL, a value of P = <0.001 and <0.001, respectively. Conclusion: Intratympanic corticosteroid injection appears to have the only minimal therapeutic effect to cisplatin-induced hearing loss, especially for 6000 and 8000 HZ.

Methylprednisolone Versus Dexamethasone for Control of Vertigo in Patients with Definite Meniere's Disease: A Randomized Clinical Trial

Introduction: Definite Meniere's diseaseis associated with two or more definitive periods of vertigo along with hearing loss, plus tinnitus or aural fullness or both. This study aimed to compare the effect of intratympanic dexamethasone and methylprednisolone on the functional-level scale of pure-tone audiometry (PTA), and class outcome measures of vertigo. Materials and Methods: In this clinical study, 69 patients with definite Meniere's disease, referred to the tertiary otolaryngology center, were randomly assigned to two groups: 36 patients were treated with intratympanic dexamethasone (4mg/dl) and 33 patients were treated with intratympanic methylprednisolone (40mg/dl). Each group received three weekly injections. After a follow-up of 1 and 6 months, PTA changes and vertigo control were evaluated. Results: There was no statistically significant difference between the two groups with regard to control of vertigo (P=0.866, P=0.879 for 1 and 6 months post injection, respectively). PTA improvement was statistically significantly higher in the methylprednisolone group (P=0.006). Conclusion: In summary, intratympanic corticosteroid is an effective treatment for Meniere's disease and can prevent other invasive treatments. Intratympanic methylprednisolone can improve hearing level to a greater extent than intratympanic dexamethasone, but the two groups were similarly beneficial in controlling vertigo. However, there was a trend toward a more sustained benefit with methylprednisolone.

Diagnostics and Therapy of Idiopathic Sudden Sensorineural Hearing Loss

This article reviews recent aspects of diagnostics, differential diagnostics and evidence in systemic and local therapy of idiopathic, sudden, sensorineural hearing loss (ISSHL). Since a number of disorders can be accompanied by sudden hearing loss a meaningful and targeted diagnostic strategy is of utmost importance. An important differential diagnosis of sudden hearing loss are intralabyrinthine schwannomas (ILS). The incidence of ILS is probably significantly underestimated. This may be due to the lack of awareness or lack of explicit search for an intralabyrinthine tumor on MRI or an inappropriate MRI technique ('head-MRI' instead of 'temporal bone-MRI' with too high slice thickness) for the evaluation of sudden hearing loss. Therefore, the request to the radiologist should specifically include the question for (or exclusion of) an ILS. With special MRI techniques, it is today possible to visualize an endolymphatic hydrops. The evidence in the therapy of ISSHL is - with respect to quality not quantity of studies - unsatisfying. The value of systemically (low dose) or intratympanically applied corticosteroids in the primary treatment of ISSHL is still unclear. In order to investigate the efficacy and safety of high dose corticosteroids in primary treatment for ISSHL a national, multicenter, three-armed, randomized, triple-blind controlled clinical trial is currently performed in Germany (http://hodokort-studie.hno.org/). After insufficient recovery of threshold with systemic therapy of ISSHL, intratympanic corticosteroid therapy appears to be associated with a significantly higher chance of improvement of hearing threshold than no therapy or placebo. Both, hearing gain and final hearing thresholds, however, appear to be independent of the start of secondary therapy. Based on the currently available data from clinical studies, no recommendation can be made with respect to type of corticosteroid and specifics of the intratympanic application protocol.

Intratympanic (IT) Therapies for Menière's Disease: Some Consensus Among the Confusion.

Aminoglycosides and corticosteroids are commonly used to treat Menière's disease. Intratympanic (IT) administration of these medications allows high inner ear concentrations without significant adverse systemic effects. As a direct result, IT therapy has grown in popularity. Recent studies have compared patient outcomes between IT aminoglycosides and corticosteroids. This review summarizes these findings. Trials comparing IT corticosteroids to IT placebo or oral therapy have had conflicting results. Most recently, Lambert et al. investigated the effect of IT dexamethasone in a sustained-release formulation compared to placebo. Their findings demonstrated improvement in some secondary measures of vertigo with the sustained-release formulation.IT gentamicin is known to be effective in controlling vertigo in Menière's disease. In a recent study from 2016, Patel et al compared IT gentamicin and IT methylprednisolone in a double-blind, randomized controlled trial and identified no significant differences between the two in vertigo control. IT injections of aminoglycosides and corticosteroids can improve vertigo control. Hearing and vestibular loss however may result with IT aminoglycosides. Corticosteroids demonstrate limited hearing loss but may not have the same efficacy in controlling vertigo. Further investigation in the etiology of Menière's disease is needed to tailor the proposed treatment to suit the disease mechanism.

Are intratympanic corticosteroids effective for Ménière’s disease?

Ménière’s disease affects the inner ear and its main symptoms are vertigo, hearing loss and fluctuating aural symptoms. Nowadays, there are many therapeutic alternatives, being the use of intratympanic corticosteroids one that has become popular. To answer this question, we searched in Epistemonikos database, which is maintained by screening multiple databases. We identified four systematic reviews including 15 studies overall, of which seven were randomized trials. We extracted data and generated a summary of findings table using the GRADE approach. We concluded intratympanic corticosteroids probably do not decrease tinnitus, and might not decrease vertigo, hearing loss or aural fullness sensation in Ménière’s disease. Intratympanic corticosteroids probably do not cause important adverse effects.

Efficacy of oral vs. intratympanic corticosteroids in sudden sensorineural hearing loss.

The current standard treatment for sudden sensorineural hearing loss (SSNHL) comprises of tapered course of oral corticosteroids. Intratympanic steroids are introduced as another modality of treatment, but management of SSNHL continues to be debatable. The present study was designed to evaluate the efficacy of steroids given orally and by the intratympanic route. A prospective, randomized, open-labeled study was conducted involving 42 patients. These were randomly divided into two groups; group I patients received oral prednisone tapered over 14 days, and group II patients were treated with intratympanic methylprednisolone (40 mg/mL). One milliliter of the drug solution containing 40 mg of the drug (40 mg/mL) was injected into the middle ear cavity through the trans-tympanic route. The drug was injected twice a week for 2 weeks. The total duration of the study was 60 days, and hearing outcome was assessed on the basis of change in pure tone average. An improvement of 18.24±8.72 dB was recorded in group I patients treated with oral prednisone in comparison to 14.68±12.88 dB improvement in group II. Statistically significant improvement in hearing was observed in both groups, but it was not significant when group I and group II were compared. The post-treatment outcomes among patients who receive either oral prednisone or intratympanic methylprednisolone within 2 weeks of onset of symptoms were comparable. The outcomes were affected by degree of hearing loss and association of SSNHL with vertigo.

Our experiences on intratympanic dexamethasone usage to vertigo control in m&amp;#233;ni&amp;#232;re disease / Meniere hastaliginda vertigo kontrolunde intra timpanik deksametazon kullanimi ile ilgili tecrubelerimiz

Objective: Meniere disease is a disorder defined with vertigo and disequilibrium attacks and followed by a considerable normal equilibrium until to the next vertigo attack. The frequency of these attacks changes not only patient to patient but also in particular patient himself/herself in varying degree. Although there are studies about intratympanic corticosteroid injection treatment for the disease in the literature, the long-term efficacy of this minimally invasive treatment modality is obscure regarding with this issue. In this study, we aimed to verify long-term results in the use of intratympanic dexamethasone in patients with Meniere disease. Materials and Methods: This is a retrospective study that was performed in a tertiary referral center in which eleven patients with vertigo due to Meniere disease were evaluated. Intratympanic dexamethasone was infiltrated to diseased ear of these patients. The ratio between the number of vertigo episodes in the 6 months prior to treatment and the number of episodes in the six months between the 18th and 24th month after treatment (according to the norms of the American committee for the hearing and the equilibrium, 1995) were examined. Results: All patients improved significantly. Treatment was repeated after one year in one of the patients. Conclusion: Similarly with the published literature, the use of intratympanic dexamethasone may be useful to control vertigo due to Meniere disease to avoid or to be a prior step to other more invasive treatments.

Intratympanic corticosteroid for sudden hearing loss: does it really work?

IntroductionSudden deafness is characterized by an abrupt hearing loss of at least 30dB in three sequential frequencies in the standard pure tone audiogram over three days or less. Treatment is based on its etiology, and oral corticosteroids are widely used. Intratympanic corticosteroids are included as primary or secondary treatment when there is no improvement with the use of oral corticosteroids. ObjectiveTo determine the effectiveness of therapy with intratympanic steroids in sudden deafness. MethodsA systematic review was performed of publications on the topic in the databases of PubMed/MEDLINE, with the keywords: sudden deafness, sudden hearing loss, and corticosteroids. ResultsThirty scientific studies were analyzed. As to the objectives of the study analyzed, 76.7% sought to evaluate the use of intratympanic therapy salvage after failure to conventional treatment, and intratympanic therapy was used as the primary treatment 23.3% of the studies. ConclusionIntratympanic corticosteroid therapy is prescribed primarily when there is failure of conventional therapy and when it is limited to use systemic corticosteroids, such as the diabetic patient.

Intra-tympanic corticosteroid for the treatment of Primary immune-mediated sensorineural hearing loss

IntroductionDevelopment of sensorineural hearing loss [SNHL] leads to severe handicap that affects patient’s job, home and life. Therefore, otologists should diagnose potentially treatable disorders to improve and/or even stabilize hearing. Aim of workEvaluation of intra-tympanic corticosteroids for the treatment of different types of SNHL. Subjects and methodsIntra-tympanic injection of steroid under local anesthesia of 51 patients suffering from immune-mediated SNHL. Audiological evaluation was done pre & post-injection. ResultsHearing improvement of 23.41dB by pure tone audiometry occurred in 43.2% of patients. Speech discrimination scores had improved by 30.1% in 78.4% of patients. ConclusionIntra-tympanic steroid injection is a safe and promising tool for the treatment of immune-mediated SNHL.

Intratympanic corticosteroids injections: a systematic review of literature.

The objective of the study was to determine the evidence of intratympanic steroids injections (ITSI) for efficacy in the management of the following inner ear diseases: Ménière's disease, tinnitus, noise-induced hearing loss (NIHL) and idiopathic sudden sensorineural hearing loss (ISSNHL). The data sources were literature review from 1946 to December 2014, PubMed and Medline. A systematic review of the existing literature was performed. Databases were searched for all human prospective randomized clinical trials using ITSI in at least one treatment group. The authors identified 29 prospective randomized clinical trials investigating the benefits of an intratympanic delivery of steroids. Six articles on Ménière's disease were identified, of which one favored ITSI over placebo in vertigo control. Of the five randomized clinical trials on tinnitus therapy, one study found better tinnitus control with ITSI. The only available trial on NIHL showed significant hearing recovery with combination therapy (ITSI and oral steroids therapy). Seventeen studies were identified on ISSNHL, of which 10 investigated ITSI as a first-line therapy and 7 as a salvage therapy. Studies analysis found benefits in hearing recovery in both settings. Due to heterogeneity in treatment protocols and follow-up, a meta-analysis was not performed. Given the low adverse effects rates of ITSI therapy and good patient tolerability, local delivery should be considered as an interesting adjunct to the therapy of the ISSNHL and NIHL. Only one article over six where ITSI therapy offers potential benefits to patients with Ménière's disease in the control of tinnitus and vertigo was found. ITSI does not seem to be effective in the treatment of tinnitus.

A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment.

BackgroundTo date, no therapeutic option has been established for sudden deafness refractory to systemic corticosteroids. This study aimed to examine the efficacy and safety of topical insulin-like growth factor-1 (IGF-1) therapy in comparison to intratympanic corticosteroid therapy.MethodsWe randomly assigned patients with sudden deafness refractory to systemic corticosteroids to receive either gelatin hydrogels impregnated with IGF-1 in the middle ear (62 patients) or four intratympanic injections with dexamethasone (Dex; 58 patients). The primary outcome was the proportion of patients showing hearing improvement (10 decibels or greater in pure-tone average hearing thresholds) 8 weeks after treatment. The secondary outcomes included the change in pure-tone average hearing thresholds over time and the incidence of adverse events.ResultsIn the IGF-1 group, 66.7% (95% confidence interval [CI], 52.9–78.6%) of the patients showed hearing improvement compared to 53.6% (95% CI, 39.7–67.0%) of the patients in the Dex group (P = 0.109). The difference in changes in pure-tone average hearing thresholds over time between the two treatments was statistically significant (P = 0.003). No serious adverse events were observed in either treatment group. Tympanic membrane perforation did not persist in any patient in the IGF-1 group, but did persist in 15.5% (95% CI, 7.3–27.4%) of the patients in the Dex group (P = 0.001).ConclusionsThe positive effect of topical IGF-1 application on hearing levels and its favorable safety profile suggest utility for topical IGF-1 therapy in patients with sudden deafness.Trial registrationUMIN Clinical Trials Registry Number UMIN000004366, October 30th, 2010.

Corticothérapie intratympanique de rattrapage pour les surdités brusques sévères ou profondes

Intratympanic corticosteroids (IT) have been proposed to treat idiopathic sensorineural hearing loss (SNHL). The aim of this study was to evaluate the results of intratympanic steroids as a salvage treatment for severe SNHL in a control group study. A regimen of three IT steroids was offered to patients who failed a 7-days intravenous steroid treatment. Eighty-four patients underwent IT salvage treatment (IT GROUP). Their outcomes were compared with those of 255 control patients with severe SNHL who received the same intravenous steroid regimen without salvage IT steroid therapy (CONTROL GROUP). Types of SNHL were classified into five subgroups according to their audiogram patterns. The initial pure tone averages (PTA) were 77 ± 29 dB and 78 ± 35 dB in the IT GROUP and the CONTROL GROUP, respectively (p = 0.68). Fifty-six percent of the patients in the IT GROUP had a hearing improvement of > 15 dB after one month. The average hearing improvements after one month were 26.5 ± 28 dB and 27.9 ± 24 dB in the IT GROUP and the CONTROL GROUP, respectively (p = 0.67). However, for patients with a type E audiogram pattern (total deafness), there was a substantial hearing gain. Although intratympanic steroids failed to show a global auditory benefit as a salvage treatment for the whole population of patients with severe SNHL, our data suggest that a salvage treatment with intratympanic dexamethasone may be offered to patients with total deafness for whom the first systemic treatment has failed.