Ethics of Placebo Control in Trials for Idiopathic Sudden Sensorineural Hearing Loss

2016 ◽  
Vol 155 (1) ◽  
pp. 8-12 ◽  
Author(s):  
Miguel Maldonado Fernández ◽  
Susan Kornetsky ◽  
Laura Rubio Rodriguez
Keyword(s):  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing ◽  
Placebo Control ◽  
Cochrane Systematic Review ◽  
Sudden Loss ◽  
Randomized Controlled ◽  
Systemic Corticosteroids ◽  
Loss Of Hearing

Idiopathic sudden sensorineural hearing loss (ISSHL) involves sudden loss of hearing from cochlear or retrocochlear origin of unknown cause. Systemic corticosteroids may be considered in the management of ISSNHL. However, an updated Cochrane systematic review concludes that “the value of steroids in the treatment of idiopathic sudden sensorineural hearing loss remains unclear since the evidence obtained from randomized controlled trials is contradictory in outcome.” Therefore, a new clinical trial that addresses this question is mandatory. A first step in its design is to determine if placebo control would be ethically acceptable. We conclude that there is equipoise (uncertainty) about the use of corticosteroids for ISSHL. A new trial is justified—but with the inclusion of interim analyses to detect early imbalances on efficacy or safety and with the ability to stop the trial if needed.

scholarly journals Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial

2020 ◽  
Author(s):  
Huawei Li ◽  
Weiming Hao ◽  
Liping Zhao ◽  
Huiqian Yu
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Controlled Trial ◽  
Vestibular Function ◽  
Vestibular Dysfunction ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing ◽  
Hearing Outcome ◽  
Randomized Controlled

Abstract Background Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximately 28%-57% cases. Glucocorticoids, administered through oral or intratympanic way, is currently a regular and standard treatment for ISSNHL based on hearing outcome. However, little investigations have been conducted on the recovery process and treatment effects of glucocorticoids on vestibular dysfunctions of ISSNHL. This study aims to compare the efficacy of oral or intratympanic glucocorticoids in ISSNHL with vestibular dysfunction in terms of the pattern and trajectory of possible process of vestibular function recovery.Methods/Design A randomized, outcome-assessor- and analyst-blinded, controlled, clinical trial (RCT) will be carried out. A group of seventy-two patients with ISSNHL complaining of vestibular dysfunction appearing as vertigo, dizziness or imbalance will be recruited and randomized into two arms of either oral or intratympanic glucocorticoids therapy with a 1:1 allocation ratio. The primary outcomes will be vestibular function outcomes assessed by sensory organization test, caloric test, video head impulse test, and vestibular evoked myogenic potentials; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry. Assessment will be performed at baseline and at 1, 2, 4, and 8 weeks post-randomization. To our knowledge, this will be the first randomized controlled trial focusing on the prognosis of vestibular dysfunction in ISSNHL and the efficacy of glucocorticoids therapy for the vestibular dysfunction in this disease.Discussion This trial will be the first RCT study focusing on the progress and prognosis of vestibular dysfunction in ISSNHL. Efficacy of two commonly used therapies of glucocorticoids will be compared in both auditory and vestibular function fields, rather than in the hearing outcome alone. Trial registration ClinicalTrials.gov, NCT03974867. Registered on July 23, 2019.

Welche Behandlung wirkt beim Hörsturz am besten?

2018 ◽  
Vol 97 (07) ◽  
pp. 448-449
Author(s):  
Volker Schartinger
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Loss ◽  
Combination Therapy ◽  
Sensorineural Hearing Loss ◽  
Systemic Therapy ◽  
Controlled Trial ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing ◽  
Randomized Controlled

Ashtiani MK at al. Efficacy of systemic and intratympanic corticosteroid combination therapy versus intratympanic or systemic therapy in patients with idiopathic sudden sensorineural hearing loss: a randomized controlled trial. Eur Arch Otorhinolaryngol 2018; 275: 89–7 Iranische HNO-Ärzte verglichen die Heilungsraten einer Behandlung des idiopathischen Hörsturzes mit oralen und intratympanalen Kortikosteroidgaben in Mono- und Kombinationstherapien.

scholarly journals Systemic Steroid Application Caused Sudden Death of a Patient with Sudden Deafness

2013 ◽  
Vol 2013 ◽  
pp. 1-2 ◽  
Author(s):  
Eriko Ogino-Nishimura ◽  
Takayuki Nakagawa ◽  
Ichiro Tateya ◽  
Harukazu Hiraumi ◽  
Juichi Ito
Keyword(s):  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Severe Hypertension ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing ◽  
Systemic Steroid ◽  
Systemic Corticosteroids ◽  
Threatening Condition ◽  
Life Threatening ◽  
The Right

A 63-year-old man, who was diagnosed with sudden sensorineural hearing loss (SSHL), showed severe hypertension 10 hours after prednisolone administration. Subsequently, the patient suddenly died due to pulmonary edema. The autopsy indicated a pheochromocytoma in the right adrenal gland, and the cause of death was determined to be a pheochromocytoma crisis induced by systemic administration of prednisolone. Pheochromocytoma crisis is a life-threatening condition and can result from the use of corticosteroids. Physicians should consider the risk of a pheochromocytoma crisis due to systemic corticosteroids in the treatment of patients with sudden sensorineural hearing loss.

Hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss and tinnitus: a systematic review of randomized controlled trials

2005 ◽  
Vol 119 (10) ◽  
pp. 791-798 ◽  
Author(s):  
M Bennett ◽  
T Kertesz ◽  
P Yeung
Keyword(s):  
Hearing Loss ◽  
Randomized Controlled Trials ◽  
Sensorineural Hearing Loss ◽  
Hyperbaric Oxygen ◽  
Hyperbaric Oxygen Therapy ◽  
Oxygen Therapy ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing ◽  
Controlled Trials ◽  
Randomized Controlled

Background: Idiopathic sudden sensorineural hearing loss (ISSHL) and tinnitus are common. Hyperbaric oxygen therapy (HBOT) may improve hearing loss and/or reduce the intensity of tinnitus.Methods: We performed a systematic search of the literature for randomized controlled trials, and made pooled analyses of pre-determined clinical outcomes where possible.Results: Six trials contributed to this review (304 subjects). Pooled analysis suggested a significantly increased chance of a 25 per cent improvement in hearing threshold on pure tone average with HBOT (relative risk (RR) 1.39, 95 per cent confidence interval (CI) 1.05–1.84, p = 0.02; number-needed-to-treat 5, 95 per cent CI 3–20), but not a 50 per cent increase (RR 1.53, 95 per cent CI 0.85–2.78, p = 0.16). The significance of any improvement in tinnitus following HBOT could not be assessed due to poor reporting.Conclusions: HBOT improved hearing, but the clinical significance of the level of improvement is not clear. Routine application of HBOT to patients with ISSHL is not justified by this review. More research is needed.

scholarly journals Idiopathic Sudden Sensorineural Hearing Loss: Should Otoacoustic Emissions Be Added to the Monitoring Protocol? A Systematic Review

2020 ◽  
Vol 10 (1) ◽  
pp. 326
Author(s):  
Kaley Babich ◽  
Kathleen T. Dunckley
Keyword(s):  
Systematic Review ◽  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Otoacoustic Emissions ◽  
Sudden Sensorineural Hearing Loss ◽  
Outer Hair Cells ◽  
Sensorineural Hearing ◽  
Initial Onset ◽  
Loss Of Hearing ◽  
Hearing Outcomes

Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to a loss of hearing, most commonly unilateral, that occurs suddenly (≤72 h) with no identifiable cause or etiology. To date, there is no standard protocol to predict prognosis (hearing recovery) for patients with ISSNHL. However, studies have shown that changes in otoacoustic emissions (OAEs) often occur prior to changes in audiometric hearing thresholds. OAEs originate from the electrochemical motility of the outer hair cells (OHC) and reflect the integrity of the inner ear, specifically the cochlear amplifier. Therefore, OAEs may be useful as a prognostic predictive factor in patients with ISSNHL from the initial onset of symptoms through recovery. A systematic review of the literature was undertaken to assess the relationship between pure tone thresholds, OAEs, and subjective hearing improvement and/or recovery. Fourteen studies were identified for inclusion, and they overwhelmingly support the inclusion of OAEs in the protocol to monitor ISSNHL recovery. This finding supports the development of a standard diagnostic protocol that includes OAEs to predict patient hearing outcomes.

HBO2 for sudden sensorineural hearing loss

2020 ◽  
pp. 271-295
Author(s):  
Tracy Leigh LeGros ◽  
Heather Murphy-Lavoie ◽  
Keyword(s):  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Hearing Aids ◽  
Organ Of Corti ◽  
Abrupt Onset ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing ◽  
Retrospective Case ◽  
Randomized Controlled ◽  
Randomized Controlled Studies

Sudden sensorineural hearing loss (SSNHL) presents as an abrupt onset of hearing loss; 88% of these presentations are idiopathic (ISSHL). Many mechanisms of injury and etiopathologies have been postulated, but they share a common result – hypoxia of the organ of Corti leading to hair cell-cilia fusion, synaptic, dendritic swelling and sustained depolarization. Of all of the various treatments tried, only corticosteroids and hyperbaric oxygen (HBO2) therapy have shown benefit in randomized controlled trials (RCTs). This paper reviews the pathophysiology of SSNHL, the variety of treatments studied, and the best evidence (both retrospective case controlled and prospective randomized controlled studies) for the use of HBO2 and corticosteroids. The best results are obtained when these two treatments are combined and initiated within 14 days of symptom onset. HBO2 is given at 2-2.5 ATA for 90 minutes for 10-20 sessions. Steroids should be dosed at 1mg/kg/day and slowly tapered over two to three weeks. If a patient is not a good candidate for or refuses systemic steroids, good results have also been obtained using intratympanic (IT) steroids in combination with HBO2. Patients should be followed by and otolaryngologist before, during and following HBO2. For severe hearing loss treatment with HBO2 improves by 37.7 dB, 19.3dB for those with moderate loss and 15.6 dB improvement overall. These recoveries, on average, improve a patient’s hearing from ranges requiring hearing aids and sign language, to levels at which normal or near-normal hearing is restored.

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