Dataset Information

Evaluation of Sudden Sensory-Neural Hearing Loss Patients Treated with Systemic Steroids with Additional Intratympanic Dexamethasone Injection in Different Intervals; a Clinical Trial Study.

ABSTRACT: Sudden Sensory-Neural Hearing Loss (SSNHL) is one of the most important otologic emergency. Although adding intratympanic (IT) steroids to systematic steroid may be beneficial, the exact timing of the IT injections to provide the best response needs further investigations. To compare different protocols in treting sudden sensorineural hearing loss. We performed a clinical trial study on 120 patients from October 2021 to February 2022. All patients were prescribed 1 mg/Kg daily oral prednisolone. After randomization to three groups, the control group received standard twice a week IT steroid injections in 12 days (four total injections) while intervention groups 1 and 2 received once and twice a day IT injections for ten days. Audiometric study repeated 10-14 days after the last injection and assessed based on the Siegel criteria. We used the Chi-Square, Analysis of Variance (ANOVA), Kruskal-Wallis's tests where appropriate. The most clinical improvement was found in the standard treatment group, and group-2 had the greatest number of patients with no improvement; however, no overall significant difference was observed among the three groups (p-value: 0.066; Pearson Chi-Square). Less frequent IT injections in patients already on systemic steroids provide similar results to more frequent injections.

Supplementary information

The online version contains supplementary material available at 10.1007/s12070-023-03641-4.

SUBMITTER: Nourizadeh N

PROVIDER: S-EPMC10188730 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Evaluation of Sudden Sensory-Neural Hearing Loss Patients Treated with Systemic Steroids with Additional Intratympanic Dexamethasone Injection in Different Intervals; a Clinical Trial Study.

Nourizadeh Navid N Rezaiee Naeeme N Rajati Mohsen M Dabiri Sasan S Afzalzadeh Mohamad Reza MR Hasanabadi Kimia K

Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India 20230315 Suppl 1

Sudden Sensory-Neural Hearing Loss (SSNHL) is one of the most important otologic emergency. Although adding intratympanic (IT) steroids to systematic steroid may be beneficial, the exact timing of the IT injections to provide the best response needs further investigations. To compare different protocols in treting sudden sensorineural hearing loss. We performed a clinical trial study on 120 patients from October 2021 to February 2022. All patients were prescribed 1 mg/Kg daily oral prednisolone. ...[more]

PMID: 37206837

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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.

Project description:Glucocorticoids are the first-line treatment for sensorineural hearing loss, but little is known about the mechanism of their protective effect or the impact of route of administration. The recent development of hollow microneedles enables safe and reliable sampling of perilymph for proteomic analysis. Using these microneedles, we investigate the effect of intratympanic (IT) versus intraperitoneal (IP) dexamethasone administration on guinea pig perilymph proteome. Guinea pigs were treated with IT dexamethasone (n = 6), IP dexamethasone (n = 8), or untreated for control (n = 8) 6 h prior to aspiration. The round window membrane (RWM) was accessed via a postauricular approach, and hollow microneedles were used to perforate the RWM and aspirate 1 μL of perilymph. Perilymph samples were analyzed by liquid chromatography-mass spectrometry-based label-free quantitative proteomics. Mass spectrometry raw data files have been deposited in an international public repository (MassIVE proteomics repository at https://massive.ucsd.edu/) under data set # MSV000086887. In the 22 samples of perilymph analyzed, 632 proteins were detected, including the inner ear protein cochlin, a perilymph marker. Of these, 14 proteins were modulated by IP, and three proteins were modulated by IT dexamethasone. In both IP and IT dexamethasone groups, VGF nerve growth factor inducible was significantly upregulated compared to control. The remaining adjusted proteins modulate neurons, inflammation, or protein synthesis. Proteome analysis facilitated by the use of hollow microneedles shows that route of dexamethasone administration impacts changes seen in perilymph proteome. Compared to IT administration, the IP route was associated with greater changes in protein expression, including proteins involved in neuroprotection, inflammatory pathway, and protein synthesis. Our findings show that microneedles can mediate safe and effective intracochlear sampling and hold promise for inner ear diagnostics.

Project description:BackgroundThe standard treatment of idiopathic sudden sensorineural hearing loss (ISSNHL) constitutes of systemic oral corticosteroid. Although oral corticosteroid might revert the acute deafness, some patients with ISSNHL display a more treatment refractory course. For these patients, corticosteroid installed directly into the middle ear has become a more frequent treatment, due to the potential benefits of a high, local concentration compared to a systemic administration. As such, for patients being refractory to standard treatment, intratympanic injection of a high dosage of corticosteroid as salvage therapy may be beneficial.ObjectivesTo evaluate the efficacy of intratympanic corticosteroid (ITC) as a salvage treatment of ISSNHL.MethodsA systematic literature search was performed in relevant databases. Both randomized trials and observational studies were considered for inclusion. The risk of bias was evaluated using the Cochrane risk of bias tool (randomized trials) or ROBINS-I tool (observational studies). Meta-analysis was performed to investigate the improvement of PTA (dB) and number of patients displaying recovery following salvage ITC injections. Occurrence of serious side effects was investigated. Finally, the certainty of the evidence was evaluated using the GRADE approach.ResultsEleven relevant studies were identified (4 randomized trials and 7 observational studies). Both observational and randomized trials showed that salvage ITC significantly increased the number of patients displaying recovery. No serious adverse events were identified in any of the included studies. The certainty of evidence ranged from moderate to very low, due to risk of bias, imprecision, and heterogeneity.ConclusionCollectively, our findings indicate that salvage ITC treatment may be a beneficial and safe treatment for patients with sudden hearing loss, who otherwise are refractory to standard treatment approaches. However, the evidence level indicates need for a cautious interpretation of especially the magnitude of effect and thus the extrapolation on how much the individual may improve from this treatment. Furthermore, it remains to be investigated whether treatment outcomes may vary across different patient groups presenting with ISSNHL. This potential variation in treatment response should be kept in mind, when counselling the patient.Trial registration numberThe protocol is registered in PROSPERO. Registration number: CRD42019130586.

Dataset Information

Evaluation of Sudden Sensory-Neural Hearing Loss Patients Treated with Systemic Steroids with Additional Intratympanic Dexamethasone Injection in Different Intervals; a Clinical Trial Study.

Supplementary information

Publications

Evaluation of Sudden Sensory-Neural Hearing Loss Patients Treated with Systemic Steroids with Additional Intratympanic Dexamethasone Injection in Different Intervals; a Clinical Trial Study.

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