Intratympanic Steroid Administration Research Articles

Steroids for treatment of sudden sensorineural hearing loss: a meta-analysis of randomized controlled trials.

To systematically review the available evidence regarding steroid treatment for sudden sensorineural hearing loss (SSHL) and to update prior analyses when possible. OVID Medline. An electronic database search (OVID Medline) was performed with the objective of identifying all randomized controlled trials examining the use of steroids for the treatment of SSHL. The search was limited to English-language publications between January 1980 and June 2013. Reference lists were examined for additional articles. A total of 15 articles including 1,166 subjects were included in three separate analyses. Three articles (181 subjects) were included in the steroid versus placebo analysis, which resulted in an odds ratio of 1.52 (95% confidence interval [CI]: 0.83-2.77). Six articles (702 subjects) were included in the systemic versus intratympanic steroids analysis, which resulted in an odds ratio of 1.14 (95% CI: 0.82-1.59). Six articles (283 subjects) were included in the salvage treatment analysis, which resulted in an odds ratio of 6.04 (95% CI: 3.26-11.2). A meta-analysis of randomized controlled trials does not support the use of steroids over placebo in this condition, a finding consistent with previous analyses. Although systemic or intratympanic steroid administration does not have a significant treatment effect, steroids for salvage treatment of patients failing traditional therapy appear to have an effect. However, this result should be interpreted with caution given the poor quality of component trials. Implications for clinical practice and future trial design are discussed.

Effectiveness of intratympanic dexamethasone for refractory sudden sensorineural hearing loss

The purpose of this study was to investigate the effectiveness of intratympanic steroids in patients with idiopathic sudden sensorineural hearing loss who did not respond to initial systemic steroid therapy. This retrospective study involved 51 patients, who did not respond to systemic steroids as a first-line treatment. Initial systemic steroid therapy consisted of administration of methylprednisolon intravenously (250 mg) at the first day and followed by orally (1 mg/kg) tapering for 14 days. Twenty-one patients accepted intratympanic treatment, and the remaining 30 patients who refused intratympanic treatment were evaluated as the control group. Steroids (dexamethasone drops, 1 mg/mL) were administered through a ventilation tube. Hearing was assessed immediately before treatment and 2 months after treatment. Recovery of hearing was defined as an improvement of >20 dB in the pure tone average. We tested 250, 500, 1,000, 2,000, 4,000, and 8,000 Hz frequencies for the pure tone audiometric evaluation. Statistically Student's t test, Mann-Whitney U test, Chi-squared and Fisher's exact tests were used. The pure tone average improved in 47.6% of the intratympanic group and in 10% of the control group (p = 0.002), with pure tone average improvements of 19.9 ± 16.5 and 4.76 ± 9.6 dB in the intratympanic and control groups, respectively. When the hearing threshold at each frequency was analyzed, improvements at all frequencies were significantly greater in the intratympanic steroid group when compared with the control group (p < 0.01). Intratympanic steroid administration is an effective therapy for sudden sensorineural hearing loss in patients, who are refractory to primary systemic steroid therapy.

Sudden Sensorineural Hearing Loss: Results of intratympanic steroids as salvage treatment

ObjectiveThe aim of the present study was to verify the efficacy and the safety of intratympanic dexamethasone to treat sudden sensorineural hearing loss as salvage therapy. Materials and methodsA prospective study was conducted on patients affected by idiopathic sudden hearing loss who were treated before with some systemic therapy, but without recovery of the hearing The patients able to undergo the study, but who refused salvage treatment were considered as control group. A solution of Dexamethasone 4mg/ml was then injected through the posterior–inferior quadrant filling completely the middle ear. The follow-up in the following 6months included an audiogram every month. ResultsThe number of patients treated with salvage therapy was 36. The patients who refused treatment were further 10. The salvage treatment was done with a mean delay of 24.3days from the onset of symptoms. Mean hearing threshold after the onset of sudden hearing loss at PTA was 66.5dB. After the failed treatment the mean PTA was 59.6dB. The mean PTA after the intratympanic steroid administration was 46.8dB, with a mean improvement of 12.8dB. No hearing change was noted in the 10 patients who refused salvage therapy. The patients that assumed systemic steroid as first therapy showed a better PTA threshold after the salvage intratympanic treatment (p<0.01). A significant difference (p<0.05) of hearing recovery was evidenced between non-smoker patients and those with smoking habit. ConclusionsOur data showed that a salvage treatment with intratympanic dexamethasone should be suggested to all patients who failed the first systemic treatment. The systemic steroid therapy done before the salvage treatment seems to exert a protective role for the inner ear, as shown by our series. On the contrary the smoke habit is a negative prognostic factor in the hearing recovery.

Intratympanale Dexamethasongabe

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. 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. 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. 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.

Efficacy of intratympanic steroid administration on idiopathic sudden sensorineural hearing loss in comparison with hyperbaric oxygen therapy

The efficacy of intratympanic steroid administration was examined in comparison with hyperbaric oxygen (HBO) therapy in patients with idiopathic sudden sensorineural hearing loss (ISSNHL). Retrospective study. Two hundred seventy-six consecutive patients with ISSNHL (average hearing levels at 250, 500, 1,000, 2,000, and 4,000 Hz ≥ 40 dB; time from onset to treatment ≤30 days) were enrolled. All the patients were given intravenous hydrocortisone (400 mg/day) followed by tapered doses. In addition, 174 patients underwent HBO therapy (HBO group), and 102 patients received intratympanic dexamethasone injection (IT group). The hearing outcomes were evaluated by six indices; the cure rate, marked-recovery rate (percent of patients with hearing gains ≥30 dB), recovery rate (percent of patients with hearing gains ≥10 dB), hearing gain, hearing level after treatment, and hearing improvement rate compared to the unaffected contralateral ear. There was no significant difference in the cure rate, marked-recovery rate, hearing gain, hearing level after treatment, or hearing improvement rate between the two groups; however, the recovery rate was significantly higher in the IT group than in the HBO group (79.4% vs. 68.4%; P = .048). Multiple logistic regression analysis also showed that patients in the IT group were significantly more likely to recover than those in the HBO group (odds ratio: 2.045; 95% confidence interval: 1.097-3.812; P = .024). Systemic plus intratympanic steroid administration is more effective than systemic steroids plus HBO therapy, and can be a useful first-choice treatment for ISSNHL.

Are intra-tympanically administered steroids effective in patients with sudden deafness? Implications for current clinical practice

Over 60 years since its first report, sudden sensorineural hearing loss (SSNHL) still represents an ill-explained condition, with potentially devastating effects for the quality of life of previously well patients. The present study critically reviewed the available evidence regarding the efficacy of intra-tympanic steroid administration in the treatment of SSNHL. Factors affecting that efficacy were also explored. The literature was systematically reviewed in Medline and other database sources until July 2011, and analyzed through critical analysis of pooled data. The study selection included multi-center prospective randomized control trials, prospective randomized comparative, prospective comparative and prospective studies, retrospective comparative and retrospective studies. The total number of analyzed studies was 43. Intra-tympanic steroids appear to be effective as primary (strength of recommendation A), or salvage treatment (strength of recommendation B) in SSNHL. It is difficult to draw definite conclusions regarding the efficacy of combination therapy. The identification of a time window for effective treatment in the former two approaches yields a grade C strength of recommendation. Primary intra-tympanic treatment is the most effective modality in terms of complete hearing recovery (34.4% cure rate). There is not enough evidence to attribute treatment failures to impaired permeability of the round window membrane. Most complications of intra-tympanic treatment are minor, temporary, and conservatively managed. Intra-tympanic steroids can theoretically provide a more organ-specific treatment in patients with SSNHL. The observation that they seem effective both as primary and salvage treatment modalities with a very low complication rate may have serious implications for current clinical practice.

Intratympanic prednisolone therapy for sudden sensorineural hearing loss: A new protocol

Conclusion: Intratympanic administration of prednisolone at a dose of 62.5 mg/ml performed every day for 3 consecutive days is more efficacious than the therapeutic approaches described so far in the literature. Objectives: The aim of the study was to evaluate the overall success rate, morbidity, and prognostic factors of a new protocol of intratympanic steroid administration as a means of primary therapy for idiopathic sensorineural hearing loss. Methods: Overall, 34 patients presenting sudden unilateral sensorineural hearing loss of at least 30 dB over three frequencies that had developed within 72 h were treated once a day for 3 consecutive days with a single intratympanic injection of prednisone diluted in saline solution. Results: Following intratympanic therapy with prednisone, 16 patients (47%) reported complete recovery of sudden sensorineural hearing loss, with a pure tone average that returned within 25 dB; 11 patients (32.3%) showed improvement in hearing of more than 30 dB; 4 patients presented improvement in pure-tone average between 10 and 30 dB. Only three patients failed to improve following intratympanic injection.

Hearing outcomes of daily intratympanic dexamethasone alone as a primary treatment modality for ISSHL

Objective Intratympanic (IT) dexamethasone offers a good method for avoiding systemic side effects in patients with sudden idiopathic sensorineural hearing loss (ISSHL). However, in most studies, IT was used as a salvage treatment for patients whose hearing failed to improve with the initial systemic treatment, or as an addition to conventional oral steroid protocols. Therefore, we investigated the outcomes of IT steroid administration as a primary treatment modality for ISSHL. Study Design Randomized controlled study. Setting Tertiary referral center. Subjects and Methods Two treatment methods, IT dexamethasone or oral prednisolone, were randomly assigned to 63 participants. A group of 32 patients (IT group) with ISSHL received IT dexamethasone once a day for eight days. A separate group of 31 patients (oral group), received oral prednisolone, also for eight days. We compared the hearing outcomes in the two groups. Results We have found that the outcomes for patients treated with IT dexamethasone as a primary treatment modality for the management of ISSHL presented no difference in pure-tone averages or hearing recovery rate compared with patients treated with oral steroids. However, differences were noted for hearing thresholds according to frequency: the threshold improvement at low frequencies (250, 500, and 1000 Hz) was not statistically significant between groups; at high frequencies, particularly 4000 and 8000 Hz, the threshold improvement was statistically higher in the oral group than in the IT group. Conclusion IT dexamethasone might be a good primary treatment method for ISSHL; but, for the management of ISSHL, we should keep in mind the differences in hearing outcomes with regard to frequency.

Individual Differences in the Permeability of the Round Window

Many recent studies have reported on intratympanic gentamicin therapy for the treatment of intractable Ménière's disease. Intratympanic administration of steroids has also been used to treat sudden sensorineural hearing loss. These intratympanic drug therapies are based on the assumption that the drug administered intratympanically enters the inner ear through the round window membrane. We used magnetic resonance imaging (MRI) to evaluate whether and how intratympanically administered gadolinium (Gd) enters the inner ear. GD hydrate was injected intratympanically through the tympanic membrane using a 23-G needle into 61 ears of 55 patients with inner ear diseases. The injected Gd was diluted 8-fold in saline for injection into 58 ears and 16-fold for 3 ears. Three-dimensional fluid-attenuated inversion recovery (3D-FLAIR) imaging was performed using a 3-Tesla MRI unit 1 day after the intratympanic injection. In 53 of 61 ears, the Gd-containing inner ear was detected well as a high signal on 3D-FLAIR imaging. However, Gd was not visible in 2 ears with Ménière's disease and in 1 ear with profound deafness. The concentration of Gd in the perilymph was lower in 4 ears with Ménière's disease and 1 ear with delayed endolymphatic hydrops than after intratympanic administration of the 16-fold Gd dilution. Round window permeability was absent in 5% of ears, and 13% of ears had poor round window permeability. These results should be considered when planning intratympanic drug administration therapy to treat inner ear diseases.

Visualization of Endolymphatic Hydrops in Patients With Meniere's Disease

Recently, there have been many reports of intratympanic gentamicin therapy for the treatment of intractable Meniere's disease. Intratympanic administration of steroids has also been used to treat sudden sensorineural hearing loss. We attempted to visualize how the intratympanically administered drug enters the inner ear. Gadolinium hydrate diluted eightfold with saline was injected intratympanically through the tympanic membrane using a 23 G needle in nine patients with inner ear diseases. With a 3 Tesla magnetic resonance imaging (MRI) unit, three-dimensional fluid-attenuated inversion recovery (3D-FLAIR) imaging was performed. 3D-FLAIR MRI clearly revealed that the gadolinium entered the perilymphatic space and delineated the perilymphatic and endolymphatic spaces of the inner ear. In patients with endolymphatic hydrops, the perilymphatic space surrounding the endolymph was small or had disappeared. Gadolinium appeared first in the scala tympani of the basal turn of the cochlea and the perilymphatic space of the vestibule. One day after the intratympanic injection of gadolinium, the gadolinium was observed in almost all parts of the perilymph. Six days after the intratympanic injection, the gadolinium had almost disappeared from the inner ear. We reported the first visualization of endolymphatic hydrops in patients with Meniere's disease. The relationship between the image of the endolymphatic space and functional tests, such as electrocochleography and vestibular-evoked myogenic potential, must be examined in the near future. It is important for the development of intratympanic drug therapies for inner-ear diseases to investigate how the drugs enter and leave the inner ear.

Intratympanic steroid treatment in idiopathic sudden sensorineural hearing loss: A control study

Although systemic steroids in sudden sensorineural hearing loss (SSHL) appears to be the most effective and the most widely accepted treatment today, a significant number of patients do not respond to steroid treatment or they cannot receive steroids for medical reasons. Intratympanic (IT) administration of steroids appears to be an alternative or additional method of management without the side effects of intravenous steroids. The aim of this study is to investigate the effectiveness and safeness of IT administration of steroids in patients who had not responded to IV treatment and to compare treatment efficacy with controls. Our study consisted of 37 patients with SSHL who, at the end of 10 days of therapy with intravenous steroids as a 1st line treatment, had pure-tone 4-frequency (0.5, 1, 2, and 4 kHz) average (PTA) of worse than 30 dB or worse than 10 dB from the contralateral ear (defined as failed intravenous treatment). They were randomized into 2 groups, treatment and control. The 19 patients of the treatment group received approximately 0.5 mL sterile aqueous suspension of methylprednisolone acetate in a concentration of 80 mg/2 mL by direct injection. The procedure was carried out 4 times within a 15-day period. An audiogram was performed before each injection and approximately 1.5 months after the last session. All patients tolerated the procedure well. No perforation or infection was noticed in any of the patients at their last visit. With regard to the 19 patients who received intratympanic treatment, in 9 patients, the PTA threshold improved more than 10 db, in 10 patients there was no change greater than 10 db, and no patients deteriorated more than 10 db. In the control group, none of the patients showed any change greater than 10 db. The difference was statistically significant (P = 0.002). The treatment group showed an improvement in mean PTA of 14.9 dB, whereas the control group showed a deterioration of 0.8 dB, and this difference also was statistically significant (P = 0.0005). IT treatment (P = 0.0001), better post-IV PTA (P = 0.0008), and absence of vertigo (P = 0.02) were good predictors of the outcome. In contrast, sex, age, affected ear, days to admission, and pattern of the initial audiogram showed no significant influence on the outcome. IT steroid administration after failed intravenous steroids is a safe and effective treatment in sudden sensorineural hearing loss.

Intratympanic steroid perfusion for refractory sudden sensorineural hearing loss

Patients with sudden sensorineural hearing loss (SSHL) can benefit from systemic steroid therapy. Unfortunately, some patients are not candidates for steroid therapy due to concern over possible complications. Furthermore, not all patients will benefit from steroid administration. This study evaluates the potential benefits and safety of treating patients with SSHL refractory to oral steroids with intratympanic steroid therapy. A retrospective case review was performed on all patients who presented with sudden sensorineural hearing loss refractory to oral steroid therapy during the past year. Seventeen patients were identified. All patients underwent intratympanic steroid administration, via MicroWick placement and/or round window catheter placement. Nine patients with sudden sensorineural hearing loss showed an improvement with intratympanic steroid therapy, consisting of MicroWick placement with dexamethasone drop (Decadron) administration for 1-2 weeks and/or round window catheter placement with steroid perfusion. Only one of the patients presenting with hearing loss present for greater than 8 weeks benefited from intratympanic therapy. Complications were few and included tympanic membrane perforation, chronic otitis media, dysequilibrium, and dysguesia. Intratympanic steroid therapy can be beneficial in treating patients with sudden sensorineural hearing loss refractory to oral steroid use. C.