Intratympanic corticosteroids for Meniere's disease.
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SUBMITTER: Webster KE
PROVIDER: S-EPMC9969957 | biostudies-literature | 2023 Feb
REPOSITORIES: biostudies-literature
Publications
Intratympanic corticosteroids for Ménière's disease.
Webster Katie E KE Lee Ambrose A Galbraith Kevin K Harrington-Benton Natasha A NA Judd Owen O Kaski Diego D Maarsingh Otto R OR MacKeith Samuel S Ray Jaydip J Van Vugt Vincent A VA Westerberg Brian B Burton Martin J MJ
The Cochrane database of systematic reviews 20230227
<h4>Background</h4>Ménière's disease is a condition that causes recurrent episodes of vertigo, associated with hearing loss and tinnitus. Corticosteroids are sometimes administered directly into the middle ear to treat this condition (through the tympanic membrane). The underlying cause of Ménière's disease is unknown, as is the way in which this treatment may work. The efficacy of this intervention in preventing vertigo attacks, and their associated symptoms, is currently unclear.<h4>Objectives ...[more]
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Project description:PurposeWe aimed to evaluate the efficacy of gentamicin compared to corticosteroids for the treatment of Meniere's disease.MethodsAn extensive search was conducted in PubMed, Embase, and Web of Science until May 2024. For continuous outcomes, pooled effect estimates were determined by calculating the weighted mean difference (WMD), while for binary outcomes, the risk ratio (RR) was used, each accompanied by their respective 95% confidence intervals (CIs). Heterogeneity among the studies was assessed using Cochran's I 2 and Q statistics.ResultsA total of 12 studies were selected, involving 694 patients. Our analysis found that the gentamicin group demonstrates superior vertigo control rates compared to the corticosteroid group (RR: 1.36, 95% CI: 1.13 to 1.65, p < 0.001). In subgroup analysis, the gentamicin group showed a higher vertigo control rates at 6 months compared to the corticosteroid group (RR: 1.69, 95% CI: 1.28 to 2.24, p < 0.001); however, there was no statistically significant difference between the two groups at 12 months (RR: 1.48, 95% CI: 0.88 to 2.49, p = 0.14). Regarding changes in pure tone average, the corticosteroid group was superior to the gentamicin group (WMD: 4.41, 95% CI: 3.31 to 5.52, p < 0.001).ConclusionOur study suggests that the intratympanic gentamicin group achieves higher vertigo control rates, whereas the corticosteroid group demonstrates better improvement in pure tone averages. However, the high heterogeneity in vertigo control rates warrants caution. Larger sample-sized randomized controlled trials are needed to further validate these findings.
| S-EPMC11424416 | biostudies-literature
Project description: Not available
| S-EPMC9307133 | biostudies-literature
Project description:ObjectiveTo evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Ménière's disease.Study designRandomized, double-blind, placebo-controlled, Phase 2b study over 5 months.SettingFifty-two academic and community otolaryngology centers.PatientsOne hundred fifty four patients (77 per group) aged 18 to 85 years inclusive.InterventionSingle intratympanic injection of OTO-104 (12 mg dexamethasone) or placebo.Main outcome measuresEfficacy (vertigo) and safety (adverse events, otoscopy, audiometry, tympanometry).ResultsPrimary endpoint (change from baseline in vertigo rate at Month 3) was not statistically significant (placebo [-43%], OTO-104 [-61%], P = 0.067). Improvements with OTO-104 were observed in prospectively defined secondary endpoints number of days with definitive vertigo, (Month 2 [P = 0.035], Month 3 [P = 0.030]), vertigo severity (Months 2-3, P = 0.046) and daily vertigo counts (Month 2, P = 0.042), and in some Short Form-36 (SF-36) subscales (Month 2 bodily pain P = 0.039, vitality P = 0.045, social functioning P = 0.025). No difference in tinnitus loudness or tinnitus handicap inventory (THI-25) was observed. OTO-104 was well tolerated; no negative impact on safety compared with placebo. Persistent tympanic membrane perforation was observed in two OTO-104 treated patients at study end.ConclusionOTO-104 was well-tolerated, did not significantly affect change from baseline in vertigo rate, but did reduce number definitive vertigo days, vertigo severity, and average daily vertigo count compared with placebo during Month 3. Results provide insight into analyzing for a vertigo treatment effect and support advancing OTO-104 into Phase 3 clinical trials for the treatment of Ménière's disease symptoms.
| S-EPMC5414596 | biostudies-literature
Project description:ObjectiveTo determine the efficacy of intratympanic OTO-104 for the treatment of Ménière's disease.Study designsThree randomized, double-blind, placebo-controlled, multicenter studies of OTO-104 in patients with Ménière's disease.SettingThe United States and throughout Europe.PatientsIndividuals with Ménière's disease aged 18 to 85 years.InterventionsAll three studies were conducted according to a similar protocol, whereby after a 1-month lead-in period, eligible patients received a single intratympanic injection of either 12 mg OTO-104 (otic formulation of dexamethasone in thermosensitive poloxamer) or placebo (1:1) and were observed for 3 months.Main outcome measuresThe primary efficacy endpoint was measured by the number of definitive vertigo days (DVDs) at month 3. Secondary objective was OTO-104 safety and tolerability including adverse events, audiometry, tympanometry, and otoscopic examinations.ResultsAlthough OTO-104 demonstrated numerically greater reductions in DVD compared with placebo across all three studies, statistical significance versus placebo (primary efficacy endpoint) was only achieved in one study, the AVERTS-2 study (n = 174, p = 0.029). Secondary vertigo efficacy endpoints were statistically significant at month 3 in that study including vertigo severity, the effect of vertigo on daily activity (days at home sick or bedridden), and vertigo frequency. In the AVERTS-1 study, which did not meet the primary endpoint, a subgroup analysis of the 115 patients (69.7% of study population) who did not previously receive intratympanic steroid injections demonstrated that OTO-104 patients had significantly lower mean DVD at month 3 than patients receiving placebo (1.9 for OTO-104 versus 3.0 for placebo; p = 0.045). Importantly, a significant placebo response was observed across studies in Ménière's disease patients. OTO-104 and the intratympanic injection procedure were well tolerated.ConclusionsIn all three high-quality, randomized, double-blind, placebo-controlled, multicenter studies, a single intratympanic injection of 12 mg OTO-104 demonstrated numerically greater reductions in vertigo versus placebo in patients with Ménière's disease, but statistical separation from placebo was demonstrated in only one of the studies. OTO-104 was safe and well tolerated.(Otonomy, Inc. funded; NCT02717442, NCT02612337, NCT03664674).
| S-EPMC10289225 | biostudies-literature
Project description:Gentamicin is used as a therapeutic agent for Ménière's disease because of its vestibulotoxicity causing chemo-ablation of the vestibular sensory epithelia. Its use has increased in recent years. However, there is still no consensus about the dose regimen of gentamicin in the treatment of Ménière's disease. In this study two different dose regimen treatment protocols are compared in a placebo controlled study design. The primary objective is to quantify the treatment effect on dizziness, the secondary objective is hearing evaluation.We performed a randomized, double-blind, placebo-controlled study in adults with unilateral Ménière's disease according to the AAO-HNS guidelines resistant to conservative medication. Three groups received four injections, administered weekly (four intratympanic injections with 40 mg/mL gentamicin solution, two injections gentamicin solution and two injections of placebo in random order, or four injections with placebo). Outcome measures were the score on the Dizziness Handicap Inventory and pure tone audiometry (PTA). Intended follow-up was 2 years.During follow-up one patient exceeded the accepted amount of hearing loss. Further, enrollment was very slow (until 12 months between two patients) and new insights showed an apparent benefit of intratympanic gentamicin treatment (ITG). Therefore we performed an unscheduled interim analysis which showed that PTA threshold shifts reached the stopping criteria in two more patients. Because of this, this study was ended. Of the three patients with the significant PTA threshold shift two were enrolled in the gentamicin group.No conclusions can be drawn concerning doses regimens. Now that new publications have shown that ITG treatment can be an effective and safe treatment, a placebo-controlled randomized controlled trial may not pass the ethical committee because of these recent reports in literature. Still, a dose regimen study (without placebo) on ITG treatment needs to be performed.This trial was registered in The University Medical Center Utrecht/ Gelre hospital Apeldoorn. Protocol ID: 07/343, EudraCT number 2006-005913-37.
| S-EPMC4141100 | biostudies-literature
Project description:IntroductionMenière's disease (MD) is a multifactorial disease characterised by recurring vertigo, tinnitus and fluctuating sensorineural hearing loss as typical clinical symptoms. For patients with MD with poor response to non-invasive treatments, it is recommended to use intratympanic gentamicin treatment. The destruction of vestibular organs by gentamicin may cause residual vestibular symptoms, notably unsteadiness. However, most previous clinical studies paid little attention to this issue. Currently, vestibular rehabilitation treatment (VRT) has been proven to be an effective method for controlling vestibular symptoms and has been applied to patients with various vestibular diseases. The aim of this study is to investigate the efficacy of VRT versus usual care in MD patients who experience persistent unsteadiness for 1 month after intratympanic gentamicin treatment, in order to understand whether VRT has a positive impact on balance maintenance and vertigo control in patients with MD.Methods and analysisRandomised, assessor-blinded, controlled clinical trials will be used to compare the efficacy of balance function before and after VRT. Patients with MD who experience chronic unsteadiness for 1 month after intratympanic gentamicin treatment will be recruited and receive VRT, mainly including gaze stability training, gait rehabilitation, vestibular habituation training, etc. The outcomes assessments will be conducted at baseline and at eighth week and sixth month post-randomisation. The primary outcome will be the improvements in vestibular function quantified through the Functional Gait Assessment. The secondary outcomes will include sensory organisation test, vestibular laboratory tests (video head impulse test, caloric test and vestibular evoked myogenic potentials), Menière's disease outcomes questionnaire, visual vertigo analogue scale and vestibular activities and participation measure.Ethics and disseminationThis trial received ethical approval from the Institutional Review Board of Eye and ENT Hospital of Fudan University (reference number 2024020). The study results will be disseminated via peer-reviewed journals and conferences.Trial registration numberNCT06143462.
| S-EPMC11848666 | biostudies-literature
Project description:Our understanding of the genetic basis of Ménière's disease (MD) is still limited. Although the familial clustering and the geographical and racial differences in incidence strongly suggest a certain role for genetic factors in the development of MD, no convincing evidence for an association with any gene exists, at present. In this review, starting from rational bases for a genetic approach to MD, we explored the numerous reports published in literature and summarize the recent advances in understanding of the genetic fundaments of the disease.
| S-EPMC4293923 | biostudies-literature
Project description:(1) Background: Vestibular migraine (VM) and Menière's disease (MD) share multiple features in terms of clinical presentations and auditory-vestibular functions, and, therefore, more accurate diagnostic tools to distinguish between the two disorders are needed. (2) Methods: The study was of retrospective design and examined the data of 69 MD patients, 79 VM patients and 72 MD with migraine patients. Five vestibular autorotation test (VAT) parameters, i.e., horizontal gain/phase, vertical gain/phase and asymmetry were subjected to logistic regression. The receiver operating characteristic (ROC) curves were generated to determine the accuracy of the different parameters in the differential diagnosis of MD and VM. (3) Results: Our results showed that the horizontal gain of VAT significantly outperformed other parameters in distinguishing MD and VM. In addition, the sensitivity, specificity and accuracy of the horizontal gain were 95.7%, 50.6% and 71.6%, respectively, for the differentiation between VM and MD. In most MD patients, the horizontal gain decreased in the range of 3-4 Hz, while in most VM patients, horizontal gain increased in the range between 2-3 Hz. More MD with migraine patients had an increased horizontal gain when the frequency was less than 5.0 Hz and had a decreased horizontal gain when the frequency was greater than 5.0 Hz. (4) Conclusion: Our study suggested the VAT, especially the horizontal gain, as an indicator, may serve as a sensitive and objective indicator that helps distinguish between MD and VM. Moreover, VAT, due to its non-invasive and all-frequency nature, might be an important part of a test battery.
| S-EPMC9688433 | biostudies-literature
Project description:Ménière's disease (MD) represents a heterogeneous group of relatively rare disorders with three core symptoms: episodic vertigo, tinnitus, and sensorineural hearing loss involving 125 to 2,000 Hz frequencies. The majority of cases are considered sporadic, although familial aggregation has been recognized in European and Korean populations, and the search for familial MD genes has been elusive until the last few years. Detailed phenotyping and cluster analyses have found several clinical predictors for different subgroups of patients, which may indicate different mechanisms, including genetic and immune factors. The genes associated with familial MD are COCH, FAM136A, DTNA, PRKCB, SEMA3D, and DPT. At least two mechanisms have been involved in MD: (a) a pro-inflammatory immune response mediated by interleukin-1 beta (IL-1?), tumor necrosis factor alpha (TNF?), and IL-6, and (b) a nuclear factor-kappa B (NF-?B)-mediated inflammation in the carriers of the single-nucleotide variant rs4947296. It is conceivable that microbial antigens trigger inflammation with release of pro-inflammatory cytokines at different sites within the cochlea, such as the endolymphatic sac, the stria vascularis, or the spiral ligament, leading to fluid imbalance with an accumulation of endolymph. Computational integration of clinical and "omics" data eventually should transform the management of MD from "one pill fits all" to precise patient stratification and a personalized approach. This article lays out a proposal for an algorithm for the genetic diagnosis of MD. This approach will facilitate the identification of new molecular targets for individualized treatment, including immunosuppressant and gene therapy, in the near future.
| S-EPMC6097350 | biostudies-literature
Project description:ImportanceTo our knowledge, evidence-based recommendations on the intratympanic vs systemic administration of corticosteroids for the treatment of idiopathic sudden sensorineural hearing loss remain unestablished, and contradictory conclusions have been reported in previous meta-analyses.ObjectiveTo compare recovery from idiopathic sudden sensorineural hearing loss based on systemic, intratympanic, or a combined treatment with corticosteroids as first-line treatment.Data sourcesWe adhered to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We searched PubMed, Embase, OvidSP, CINAHL, and Cochrane Library from January 1, 1966, to July 1, 2018. This study was registered in the International Prospective Register of Systematic Reviews (CRD42018109314).Study selectionWe included randomized studies. Included studies must have excluded identifiable causes. Corticosteroids must have been administered solitarily. We excluded studies that did not define hearing loss as a minimum 30 dB within 72 hours.Data extraction and synthesisWe identified 170 titles, of which 56 (32.9%) were eligible for full-text screening. We independently extracted data. We applied a fixed-effects model to investigate our objectives.Main outcomes and measureWe aimed to (1) estimate the difference in mean pure tone average (PTA) gain in decibels from intratympanic treatment vs systemic treatment and (2) investigate odds ratios for recovery between the different treatment groups.ResultsWe included 7 eligible studies. A total of 710 patients were allocated to receive either intratympanic treatment (IT group, 235 [33%]), systemic treatment (ST group; 325 [46%]) or combined intratympanic and systemic treatment (CB group; 150 [21%]). The PTA was measured by taking the mean of 4 frequencies: 4 studies measured at 500, 1000, 2000, and 3000 Hz and 3 studies measured at 500, 1000, 2000, and 4000 Hz. The ST group had a 2.01-dB higher PTA gain (95% CI, -5.61 dB to 1.59 dB; P?=?.96; I2?=?0%) compared with the IT group and the odds for achieving complete recovery was not significantly different at an odds ratio of 0.94 (95% CI, 0.61 to 1.44; P?=?.19; I2?=?34.5%). For the CB group vs the ST group, the odds ratio was 1.11 (95% CI, 0.68 to 1.82; P?=?.75; I2?=?0%). The analysis of the CB group vs IT group comprised only 2 studies.Conclusions and relevanceThis study does not suggest that corticosteroid delivered intratympanically is more beneficial than systemic treatment in the case of moderate to severe idiopathic sudden sensorineural hearing loss. There were no indications that combined treatment was associated with improved hearing outcomes compared with either systemic or intratympanic treatment.
| S-EPMC7068668 | biostudies-literature