Clinical efficacy of anti-IL-5 monoclonal antibody mepolizumab in the treatment of eosinophilic otitis media

Objective

Eosinophilic otitis media (EOM) is an intractable otitis media characterized by a highly viscous effusion containing eosinophils, and it is mostly associated with bronchial asthma. Recently, anti-IL-5 therapy using mepolizumab has been reported to be effective for patients with severe and refractory eosinophilic bronchial asthma. EOM shows accumulation of eiosinophils in the middle ear effusion and most EOM patients have high numbers of peripheral blood eosinophils. Therefore, we carried out a retrospective study to determine whether anti-IL-5 therapy is also effective in the treatment of EOM.

Successful treatment of eosinophilic otitis media associated with severe bronchial asthma with an anti-IL-5 monoclonal antibody,mepolizumab

Eosinophilic otitis media (EOM), which is characterized by the accumulation of eosinophils in middle ear effusion and the middle ear mucosa, is a refractory type of otitis media that is often associated with asthma. Although an early diagnosis and appropriate treatment are necessary to prevent the progression of hearing loss in patients with EOM, there are currently no well-established treatments for this condition. We treated a 60-year-old male patient with asthma and EOM. The patient’s asthma was poorly controlled, despite the use of high-dose inhaled corticosteroids, long-acting beta-agonist treatment, and the regular use of systemic corticosteroids. Mepolizumab, an anti-IL-5 monoclonal antibody, was started to treat the patient’s refractory asthma. At 4 months after the initiation of mepolizumab treatment, the patient’s asthma, hearing, and middle ear effusion improved. The present case suggests that mepolizumab therapy can control EOM and asthma.     

Diagnostic criteria of eosinophilic otitis media, a newly recognized middle ear disease

Objective

Eosinophilic otitis media (EOM) is a newly recognized intractable middle ear disease, characterised by the accumulation of eosinophils in middle ear effusion and middle ear mucosa. Since EOM patients show gradual or sudden deterioration of hearing, it is important to properly diagnose EOM and to start adequate treatment for EOM. We aimed to investigate the clinical risk factors of EOM and to establish the diagnostic criteria of EOM.

Patients and methods

We reviewed 138 patients with EOM and 134 age-matched patients with the common type of otitis media with effusion or chronic otitis media as controls. We analyzed the incidence of the following clinical variables in both groups: bilaterality of otitis media, viscosity of middle ear effusion, formation of granulation tissue in the middle ear, response to the treatment for otitis media, deterioration of bone conduction hearing level, and association with other diseases such as bronchial asthma, chronic rhinosinusitis, nasal polyposis, and allergic rhinitis.

Results

A high odds ratio was obtained from an association with bronchial asthma (584.5), resistance to conventional treatment for otitis media (232.2), viscous middle ear effusion (201.6), association with nasal polyposis (42.17), association with chronic rhinosinusitis (26.49), bilaterality (12.93), and granulation tissue formation (12.62). The percentage of patients with EOM who were positive for two or more among the highest four items was 98.55%.

Conclusion

A patient who shows otitis media with effusion or chronic otitis media with eosinophil-dominant effusion (major criterion) and with two or more among the highest four items (minor criteria), can be diagnosed as having EOM. Patients with ear symptoms should have the proper diagnosis of EOM using the proposed diagnostic criteria, and then can receive adequate treatment, resulting in prevention of deterioration of hearing and quality of life.     

Risk factors associated with severity of eosinophilic otitis media

Objective

Eosinophilic otitis media (EOM) is an intractable otitis media associated with bronchial asthma. Clinical characteristics of EOM are apparent, but severe EOM, which is unresponsive to ongoing treatments, can occur. The present study aimed to investigate potential risk factors associated with the severity of EOM.

Methods

We scored the EOM severity of 26 patients according to quantity of middle ear effusion (MEE), thickness of the middle ear mucosa, use of topical and oral corticosteroids, and use of antibiotics, all measured over a 3-month period. The scores for four 3-month periods (1 year) were averaged. We analyzed the prevalence of clinical variables by partial regression: sex, age, body mass index (BMI), duration of bronchial asthma, association of aspirin-intolerant asthma, Lund–Mackay score for sinusitis, mastoid pneumatization, width of the bony Eustachian tube at the tympanic orifice, percentage of eosinophils and immunoglobulin E in peripheral blood, and association of allergic rhinitis. Duration of bronchial asthma was defined as the period from onset of bronchial asthma to the age of first consultation at our hospital. Samples of MEE were taken for bacterial culture.

Results

The average severity score was 6.6 (out of 16). The severity score in the pathogen-positive MEE group was significantly higher than that in the pathogen-negative MEE group (p < 0.05). The score was not significantly different between the seasons. Linear multiple regression analysis showed that BMI and the duration of bronchial asthma significantly affected the EOM severity score (p < 0.05). The presence of aspirin intolerant asthma tended to be correlated with the severity score. The Lund–Mackay score tended to be negatively correlated with it.

Conclusions

There is a significant association between the severity of EOM and obesity, as well as with the duration of bronchial asthma.     

Eosinophilic otitis media diagnosis using flow cytometric immunophenotyping

Objectives: (1) To assess the ability of flow cytometric immunophenotyping to detect and quantitate eosinophils in patients with eosinophilic otitis media (EOM). (2) to evaluate the association of EOM to bronchial asthma.

Methods: Twenty-one patients with chronic otorrhea or middle ear effusion (MEE) were included in this prospective cohort study. Group I composed of 10 patients (14 ears) and associated to bronchial asthma. Group II included 11 patients (11 ears) without bronchial asthma. Samples of MEE were sent for flow cytometric analysis at initial presentation. Patients with positive eosinophils on flow cytometric immunophenotyping were analyzed after one-month course of dexamethasone eardrops.

Results: EOM was diagnosed in all patients of group I and in three patients of group II. The mean eosinophils percentage was 43.5% and 14.2% for group I and group II, respectively (p?=?.006). Those patients showed a significant response to dexamethasone eardrops, both on clinical examination and on flow cytometric analysis with a decrease in eosinophil levels post-treatment. However, this improvement was temporary and symptoms recurred after treatment cessation. Bronchial asthma was not associated to all patients with EOM.

Conclusion: Diagnosis of EOM remained mostly clinical; flow cytometry immunophenotyping of MEE may be helpful as an additional tool in diagnosis and monitoring the response to treatment, particularly in non-asthmatic patients.     

Periostin in middle ear mucosa according to eosinophilic otitis media severity: Middle ear pathology-based treatment

ObjectiveEosinophilic otitis media (EOM) is an intractable disorder associated with bronchial asthma and chronic rhinosinusitis with nasal polyposis. Periostin is an extracellular matrix protein secreted by fibroblasts in response to interleukin (IL)-4 and/or IL-13 and is a known marker for eosinophilic disorders. We assessed serum periostin levels and expression of periostin in the middle ear mucosa according to three grade of EOM severity (grade1 to 3).Methods68 patients of blood and serum samples were corrected by whom diagnose bilateral EOM in Jichi Medical University Saitama Medical Center from January 2015 to June 2017.Immunohistochemical evaluation was performed to 18 EOM middle ears mucosa samples, which cauterized in tree groups and compared to that of chronic otitis media (COM).ResultsSerum periostin levels was significantly higher in EOM patients than in COM patients (EOM, 125.0 ± 45.5 ng/mL; COM, 79.4 ± 38.3 ng/mL; P<0.0001). The expression of periostin immunopositivity in the EOM middle ear mucosa was significantly greater in severe cases (grade3 samples) than others (grade1 and grade2 samples) (P <0.001 and P = 0.011, respectively). Periostin was expressed at the lamina propria especially in severe EOM cases and the cases had little response to glucocorticoids treatment.ConclusionThis study showed that periostin in the middle ear mucosa was correlated with EOM severity, and EOM with highly expressed periostin had difficulty in glucocorticoids treatment.     

Eustachian tube function in patients with eosinophilic otitis media associated with bronchial asthma evaluated by sonotubometry

OBJECTIVE: To determine eustachian tube function in patients with asthma and with or without eosinophilic otitis media (EOM), a new middle ear disease entity with a highly viscous middle ear effusion containing many eosinophils and usually associated with bronchial asthma. One of the most important causes of otitis media (OM) is eustachian tube dysfunction. DESIGN: Retrospective case review. SETTING: A referral center. PATIENTS: Twenty patients with EOM and patients with asthma but without OM. MAIN OUTCOME MEASURES: We studied eustachian tube function using sonotubometry and a questionnaire. Sonotubometry was also performed on 13 control patients with chronic otitis media (COM) and 7 normal controls. RESULTS: The tubal opening duration was significantly longer in patients with EOM than in patients with asthma but without OM, controls with COM, and normal controls, indicating the presence of patulous eustachian tubes in patients with EOM. Responses to the questionnaire also supported the presence of patulous eustachian tubes in the patients with EOM. CONCLUSIONS: The presence of a patulous eustachian tube may be a major cause of EOM in patients with bronchial asthma. In patients with asthma who have a helper T-cell 2-dominant predisposition, a patulous eustachian tube easily allows the entry of antigenic materials into the middle ear, causing eosinophil-dominant inflammation.     

嗜酸性中耳炎的研究新进展

嗜酸性中耳炎(EOM)其显著特点是中耳腔中的黏液中含有大量的嗜酸性粒细胞,常合并支气管哮喘或变应性鼻炎.传统的治疗中耳炎的方法,如:鼓膜切开、抗生素消炎、乳突根治术等并不能取得良好的效果.经过临床治疗发现,全身或局部运用类固醇类激素及生物靶向治疗,效果显示优于传统治疗.因嗜酸性中耳炎相对少见,临床表现并不典型,发现时已...     

Intractable otitis media - Pathogenesis and treatment of Eosinophilic otitis media (EOM) and otitis media with Antineutrophil cytoplasmic antibody (ANCA) -associated vasculitis (OMAAV)

Intractable otitis media is resistant to antimicrobial therapy, tympanostomy ventilation tube insertion, and surgery. In children, intractable acute otitis media, pathological tympanic membrane due to prolonged otitis media with effusion (OME), tympanic membrane atelectasis, and adhesive otitis media are common. Contrarily, in adults, otitis media caused by drug-resistant pathogens, tuberculous otitis media, cholesterol granuloma, malignant otitis externa (skull base osteomyelitis), eosinophilic otitis media (EOM), and otitis media with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (OMAAV) are common and require differentiation. Among them, EOM is increasing along with eosinophilic upper respiratory tract diseases, such as bronchial asthma and eosinophilic chronic rhinosinusitis (ECRS), a subgroup of chronic rhinosinusitis with nasal polyps (CRSwNP). EOM is associated with adult-onset bronchial asthma and is characterized by viscous middle ear effusion and middle ear mucosa thickness with eosinophilic infiltration, which requires treatment with glucocorticoids according to disease activity and symptoms. Recently, OMAAV was proposed because of the similarities in clinical features and therapeutic effects. The clinical course of OMAAV is characterized by a relatively rapid increase in the bone conductive hearing threshold, which progresses over 1-2 months, without response to antimicrobial agents or tympanostomy ventilation tube insertion, and in some cases, is complicated by facial paralysis and hypertrophic pachymeningitis. This new concept may explain the pathogenesis and clinical presentation of many cases of intractable otitis media, the cause of which was previously unknown. Although making a diagnosis of OMAAV is relatively easy based on the clinical course, such as vascular dilatation of the tympanic membrane and positive ANCA titer, it is often difficult because the ANCA titer becomes negative with previous administration of glucocorticoids. In adults with intractable otitis media, ANCA titers must be measured before glucocorticoid administration. Treatment consisted of remission induction therapy with a combination of glucocorticoids and immunosuppressive drugs.     

Eosinophilic otitis media; state-of-the-art diagnosis and treatment

Eosinophilic otitis media (EOM) is an intractable otitis media with highly viscous middle ear effusion and is usually associated with bronchial asthma. Since the diagnostic criteria of EOM were established in 2011, the concept of EOM has been known worldwide. EOM is caused by Type 2 inflammation in the respiratory tract, similar to bronchial asthma and eosinophilic rhinosinusitis. With the appreciation of Type 2 inflammatory diseases, EOM is no longer considered to be a rare disease and should be specifically treated to improve quality of life. The diagnosis of EOM needs to be reconsidered because many reports have described varying pathogenesis and mechanisms of rare middle ear conditions. Systemic and topical administration of corticosteroids is presently the most effective treatment to control EOM. However, EOM treatments are developing because various biologics have been used to treat patients with bronchial asthma with and without eosinophilic rhinosinusitis and EOM. Surgical intervention is also no longer contraindicated with the use of biologics. These advances represent the beginning of a new stage of basic and clinical research for EOM. This review focuses on the diagnosis and treatment of EOM based on the most recent advances regarding EOM.     

Effectiveness of myringoplasty in patients with eosinophilic otitis media

ObjectiveTo determine whether myringoplasty can be an effective tool to control eosinophilic otitis media and improve hearing.MethodsSeverity scores for patients with eosinophilic otitis media with or without myringoplasty were retrospectively analyzed. Surgical outcomes were assessed and compared to those of patients with control: chronic otitis media with tympanic membrane perforation.ResultsThe average eosinophilic otitis media severity score for the patients with myringoplasty was significantly lower after than before surgery (P = 0.004), although the score for the group without myringoplasty remained stable during the study period. The success rate for graft uptake was 87.5%, and a statistically significant improvement was observed in the postoperative air conduction hearing level within the speech range (mean ± standard deviation; 41.5 ± 12.3 to 34.6 ± 9.22 dB; P = 0.0026) for patients with eosinophilic otitis media.ConclusionMyringoplasty contributed to decreased postoperative eosinophilic otitis media severity scores and should be considered to protect the patients from recurrent bacterial infections and pathogenic antigen parasitism in the middle ear.     

Risk factors for bacterial infection to cause sensorineural hearing loss in eosinophilic otitis media

ObjectiveEosinophilic otitis media (EOM) is an intractable type of otitis media in which sensorineural hearing loss (SNHL) progresses over time. Clinically, bacterial infection complicates the course of EOM, making it challenging to control otorrhea/middle ear effusion (MEE) from infected ears, and accelerates the progression of SNHL. In this study, we focused on infection, one of the risk factors for SNHL in EOM, and analyzed factors associated with it.MethodsIn this cohort study, we evaluated 144 ears of 72 patients diagnosed with bilateral EOM. Patients visited our hospital once every 1–3 months and received intratympanic or systematic administration of steroids when otorrhea/MEE was observed. Several investigations, including blood tests, otorrhea/MEE cytology, bacterial culture tests, and respiratory function tests, were performed. In the otorrhea/MEE cytology, the leukocyte fraction was measured.ResultsTwo risk factors for SNHL in EOM were middle ear mucosal thickening (p <0.01) and infection (p <0.05). Compared to the group with <40% neutrophils in otorrhea/MEE samples, groups with 40–70% and ≥70% neutrophils had a significantly higher bone conduction hearing level (p <0.01, p <0.05, respectively). Two risk factors associated with the occurrence of infection in EOM were tympanic membrane (TM) perforation (p <0.01) and the coincidence of otorrhea/MEE and rhinorrhea in bacterial culture test results (p <0.001). A positive correlation was observed between TM perforation and infection (p <0.001). Our analysis of the relationship between the frequency of intratympanic corticosteroids administration and the time-period until the occurrence of TM perforation showed that >4 intratympanic administrations/year significantly increased the risk of perforation (p<0.001). Pseudomonas aeruginosa was isolated from otorrhea/MEE samples, while Pseudomonas aeruginosa and fungi, detected in cultures of rhinorrhea samples, were significantly related to the deterioration of bone conduction hearing levels.ConclusionThe risk factors associated with the occurrence of infection in patients with EOM were TM perforation and the coincidence of otorrhea/MEE and rhinorrhea in bacterial culture test results. Since TM perforation is likely to occur even due to intratympanic corticosteroids administration, it is necessary to confirm whether the frequency of treatment is appropriate and try a less invasive technique of administration. Furthermore, Pseudomonas aeruginosa infection poses a high risk for the development of SNHL, and clinicians should be alert to this possibility, even if the bacteria were identified only in cultures of rhinorrhea samples.     

Middle ear implants: functional gain in mixed hearing loss

Osseous atresia and chronic otitis media are diseases benefit with middle ear implants. Surgery for atresia is technically complicated, has significant number of complications and functional results are often poor. The osseointegrated hearing aids are an alternative. They provide a very good functional gain, but have many problems with the skin and osseointegration. In chronic otitis media, the ossiculoplasty solved partially the hearing problem. Unfortunately in some cases of otitis media and in open cavities fitted with conventional hearing aids the gain is unsatisfactory.AimTo determine the usefulness of an active middle ear implant.Material and methodLongitudinal Study. Vibrant-Soundbrigde was implanted in 8 patients with severe mixed hearing loss. 4 patients had chronic otitis media and 4 had unilateral atresia. The placement of the stimulator (FMT or Floating Mass Transducer) was in 5 patients on round window, 2 in stapes and one in the oval window.ResultsFunctional gain was 35 dB, 40 dB, 48.7 dB and 50 dB for the frequencies 500, 1000, 2000 and 4000 Hz, respectively.ConclusionVibrant-Soundbrigde is an excellent option in hearing recovery in severe and profound mixed hearing loss. It also provides an excellent functional gain in diseases difficult to treat with conventional hearing aids.     

Cochlear implantation in a patient with eosinophilic otitis media

Eosinophilic otitis media is an intractable middle ear disease with gelatinous mucoid fluid containing eosinophils associated with bronchial asthma and nasal allergy that sometimes induces deterioration of sensorineural hearing loss. Here, we report a case of eosinophilic otitis media in a 50-year-old woman who received a Nucleus 22 multi-channel cochlear implant in the right ear at the age of 42 years. She had received treatment for bronchial asthma, chronic sinusitis with nasal allergy and otitis media with effusion since the age of 30 years and had noted bilateral sudden deafness and vertigo at the age of 35 years. Preoperative CT and MRI showed cochlear ossification in the left ear, in which mastoidectomy was performed as treatment of eosinophilic otitis media. Long-term follow-up revealed that cochlear implant is indicated for deafness induced by eosinophilic otitis media, and an early decision for cochlear implant surgery is necessary. Steroid administration was remarkably useful in controlling eosinophilic otitis media in patients with bronchial asthma and chronic sinusitis with nasal allergy.     

A case of Churg-Strauss syndrome with refractory otitis media

Objective

Churg–Strauss syndrome (CSS) is known as autoimmune vasculitis with peripheral eosinophilia after bronchial asthma and rarely has otological findings. We present a case of CSS with refractory otitis media and discuss the relationship between otological symptoms of CSS and eosinophilic otitis media.

Case report

A 60-year-old woman had suffered from recurrent sinusitis for 8 years, and also otitis media with effusion for 4 months. Eruption with peripheral eosinophilia was found in the lower legs; therefore, she was diagnosed with CSS. She was treated with systemic administration of predonisolone, intratympanic injection of betamethasone, and betamethasone nasal spray; thereafter, eosinophilia, otitis media and sinusitis rapidly improved.

Conclusion

The features of eosinophilic otitis media are similar to the otological symptoms of CSS. It should be considered whether patients with eosinophilic otitis media have early phase CSS.     

Clinical features of 22q11.2 deletion syndrome related to hearing and communication

Abstract

Background: Individuals with 22q11.2 deletion syndrome (22q11.2DS) exhibit various phenotypes.

Objective: To compare the clinical and otorhinolaryngological features of Japanese patients with 22q11.2DS with those of patients reported in Western literature.

Materials and methods: We retrospectively assessed the medical records of 17 Japanese patients with 22q11.2DS and compared our findings with previously reported findings in Western literature.

Results: Hearing loss was the most frequent complaint (n?=?8, 47%), followed by articulation disorders and/or nasopharyngeal closure failure (n?=?4, 24%) and language development delay (n?=?2, 12%). Ten patients (59%) had hearing loss regardless of the chief complaint (total 15 ears – mild, 9; moderate, 6). Four patients had bilateral hearing loss. One patient (6%) underwent tympanostomy tube placement for refractory exudative otitis media, another (6%) underwent myringoplasty, and three patients (18%) underwent tympanoplasties for chronic otitis media or middle ear malformation. Previous studies in Western countries reported similar results in terms of frequency of hearing loss, severity of hearing loss, and the percentage of middle ear malformations.

Conclusions: The otorhinolaryngological characteristics of Japanese patients with 22q11.2DS were similar to those in Western countries. Hearing loss was primarily caused by disorders like otitis media and middle ear malformation.

Significance: Our findings may aid treatment planning for Asian patients with 22q11.2DS.     

Defibrinogenation Therapy for Idiopathic Sudden Sensorineural Hearing Loss in Comparison with High-dose Steroid Therapy

Objective--The efficacy of defibrinogenation therapy for idiopathic sudden sensorineural hearing loss was studied in comparison with high-dose steroid therapy.

Material and methods--Eighty-eight consecutive patients with hearing levels &gt;40 dB and who had suffered hearing loss for ≤30 days were enrolled: 40 patients for high-dose steroid therapy (PSL group) and 48 for defibrinogenation therapy (BX group). Hearing recovery was evaluated by grade assessment and by the improvement in hearing compared to the unaffected contralateral ear.

Results--The overall hearing outcomes of the two groups were roughly equivalent. However, with regard to patients with initial hearing levels &lt;80 dB, the hearing improvement rate of the BX group was significantly worse than that of the PSL group (61.2%±7.3% vs 88.7%±8.9%; p&lt;0.05), whereas in patients with initial hearing levels ≥80 dB, the hearing outcomes did not differ between the 2 groups. Three patients in the PSL group manifested hyperglycemia while no serious side-effects were observed in the BX group.

Conclusion--These results indicate that high-dose steroid therapy should be employed in preference to defibrinogenation therapy for patients with moderate hearing loss, whereas defibrinogenation therapy has an advantage for those with severe hearing loss, in view of its lower frequency of side-effects.     

Vestibular and cochlear nerve enhancement on MRI and its correlation with vestibulocochlear functional deficits in patients with Ramsay Hunt syndrome

ObjectiveThe correlation between enhancement of the vestibulocochlear nerves on gadolinium-enhanced magnetic resonance imaging (MRI) and vestibulocochlear functional deficits was examined in patients with Ramsay Hunt syndrome (RHS).MethodsNineteen patients with RHS who showed herpes zoster oticus, peripheral facial palsy, and vertigo were enrolled. Canal paresis (CP) in the caloric test, abnormal response to ocular and cervical vestibular myogenic potentials (oVEMP and cVEMP), and refractory sensorineural hearing loss were evaluated. MRI images perpendicular to the internal auditory canal were reconstructed to identify the superior (SVN) and inferior vestibular nerves (IVN) and the cochlear nerve (CV). The signal intensity increase (SIinc) of the four-nerve enhancement was calculated as an index.ResultsAmong RHS patients, 79%, 53%, 17% and 26% showed CP in the caloric test, abnormal responses to oVEMP and cVEMP, and refractory sensorineural hearing loss, respectively. SIinc rates of the SVN were significantly increased in RHS patients with CP in the caloric test, and with abnormal responses to oVEMP and cVEMP. SIinc rates of the SVN tended to increase in RHS patients with refractory sensorineural hearing loss (p = 0.052). SIinc rates of the IVN were significantly increased in RHS patients with abnormal responses to oVEMP and cVEMP, and refractory sensorineural hearing loss, but not in those with CP in the caloric test. SIinc rates of the CN were significantly increased in RHS patients with CP in the caloric test, abnormal response to oVEMP and refractory sensorineural hearing loss, but not in those with abnormal response to cVEMP.ConclusionIn patients with RHS, the origin of vertigo may be superior vestibular neuritis, which is affected by reactive varicella-zoster virus from the geniculate ganglion of the facial nerve through the faciovestibular anastomosis. The results also suggested that in some RHS patients, inferior vestibular neuritis contributes to the development of vertigo and that the origin of refractory sensorineural hearing loss is cochlear neuritis.     

The effectiveness of hyperbaric oxygen therapy on the final outcome of patients with sudden sensorineural hearing loss

PurposeTo evaluate the therapeutic effect of the combination of systemic steroids (SS) and hyperbaric oxygen therapy (HBOT) in patients with idiopathic sudden sensorineural hearing loss (SSNHL).Materials and methodsFifty patients with idiopathic sudden sensorineural hearing loss were allocated into 2 groups: the control group received Dexamethasone IV (SS) and the therapy group received Dexamethasone IV combined with 15 sessions of hyperbaric oxygen therapy (SS + HBOT) as initial treatment. Hearing assessment was performed at the admission to hospital and 3 months after the onset of treatment. Siegel's criteria were used to evaluate the hearing outcomes. Prognostic factors were identified by linear regression analyses.ResultsHearing improvement rate was 64 % in the therapy group and 56 % in the control group, difference which was not statistically significant (p = 0.369). Furthermore, when patients of each group were categorized into 5 subgroups by disease severity (mild, moderate, moderate to severe, severe, profound), differences in treatment outcome between the subgroups of the same severity were not significant. A descending type audiogram curve was proven an unfavorable prognostic factor in both groups, as it led to a significantly lower hearing gain (30 dB) compared to other curve shapes (b = ?29.10, 95 % CI = ?56.39, ?1.82).ConclusionsThe addition of hyperbaric oxygen therapy to systemic steroids caused no significant hearing improvement, despite a mild tendency toward a greater improvement rate within the combination group. More prospective randomized trials with larger series of patients could shed even more light on the effectiveness of combination therapy (SS + HBOT) in patients affected by SSNHL.     

Outcomes research analysis of continuous intratympanic glucocorticoid delivery in patients with acute severe to profound hearing loss: Basis for planning randomized controlled trials

Conclusions. The data presented herein form the basis for conducting randomized placebo-controlled clinical trials evaluating the safety and efficacy of salvage treatment in patients with idiopathic sudden severe sensorineural hearing loss (but not anacusis) refractory to initial systemic therapy. Comparison of different application protocols and drug delivery systems will allow assessment of the value of continuous versus intermittent intratympanic glucocorticoid drug delivery. Objectives. To describe and critically evaluate the results of continuous intratympanic glucocorticoid delivery in patients with acute unilateral severe and profound sensorineural hearing loss refractory to initial systemic therapy and to compare the outcome with a historical control group. Material and methods. In a retrospective chart review, treatment results were analyzed in 23 patients with acute severe and profound hearing loss and failure of systemic standard therapy who received a continuous intratympanic delivery of glucocorticoids as a salvage treatment. Audiological results were compared within the local therapy group and with the results of an historical control group who did not receive salvage treatment. The study and control groups were matched with respect to hearing loss after initial systemic treatment failure. Results. The average pure-tone threshold after intratympanic salvage treatment showed a statistically significant improvement of 15?dB (95% CI?7–24 dB; p<0.001). After exclusion of patients with complete anacusis, i.e. a non-measurable hearing threshold, the local therapy group showed a significantly better improvement (mean 19?dB; 95%?CI?6–32 dB) than the historical control group (mean 5?dB;?95%?CI ??2–11 dB; p<0.05).