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

2017 ◽  
Vol 275 (1) ◽  
pp. 89-97 ◽  
Author(s):  
Mohammadtaghi Khorsandi Ashtiani ◽  
Farzad Firouzi ◽  
Shahin Bastaninejad ◽  
Sasan Dabiri ◽  
Sevil Nasirmohtaram ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Loss ◽  
Combination Therapy ◽  
Sensorineural Hearing Loss ◽  
Systemic Therapy ◽  
Controlled Trial ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing ◽  
Randomized Controlled

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 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.

scholarly journals Healthy lifestyle consultation based on traditional Chinese medicine versus routine patient education in the treatment of idiopathic sudden sensorineural hearing loss after failure of systemic therapy: study protocol for a clinical randomised trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Ying-ping Fei ◽  
Yun Zheng ◽  
Dan Lai ◽  
Ping Zhong ◽  
Jing-zhe Lu ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Sensorineural Hearing Loss ◽  
Systemic Therapy ◽  
Lifestyle Modification ◽  
Healthy Lifestyle ◽  
Randomised Trial ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing

Abstract Background Idiopathic sudden sensorineural hearing loss (ISSNHL) is a major cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear. Traditional Chinese medicine (TCM) has been used to treat diseases for thousands of years and is popular and widely practiced in Asia. TCM includes guidance on a healthy lifestyle. In recent decades, the relationship between lifestyle and disease has been emphasised; an unhealthy lifestyle may lead to illnesses. Thus, this study aims to compare the efficacy of lifestyle modification based on TCM with the usual consultation of ISSNHL after failure of a 2-week systemic therapy to provide a scientific basis for clinical decisions. Methods This study is a clinical randomised trial that involves 56 patients diagnosed with ISSNHL but who have had incomplete recovery after initial management (at least 2 weeks of routine Western medical treatment). The study is performed in accordance with the sudden hearing loss clinical guideline of the American Academy of Otolaryngology–Head and Neck Surgery, published in 2012. Participants are randomly distributed into two groups: the healthy lifestyle modification group based on TCM and the control group (1:1 ratio). Patient follow-up lasts for 3 months. The primary outcome measure is the effective rate of hearing improvement, which is defined as the proportion of patients with at least 15 dB of improvement in the average thresholds of hearing loss frequency. The secondary outcome measures are improvements in word recognition score, Tinnitus Handicap Inventory and visual analogue scale for ear blockage and dizziness. Assessments are made at baseline and after lifestyle modification for 1 and 3 months. Discussion The efficacy of healthy lifestyle modification based on a TCM programme for patients with ISSNHL with incomplete recovery after failure of initial systemic therapy is determined in this trial. Positive results will provide clinical evidence on the effects of a TCM-based healthy lifestyle, which could be recommended as salvage therapy for patients with ISSNHL. Trial registration Chinese Clinical Trial Registry, ChiCTR-INR-17011459. Registered on 22 May 2017.

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.

Combination Therapy for Sudden Sensorineural Hearing Loss

2009 ◽  
Vol 141 (2_suppl) ◽  
pp. P76-P76
Author(s):  
Alex Battaglia ◽  
Roberto Cueva ◽  
Raoul Burchette
Keyword(s):  
Hearing Loss ◽  
Combination Therapy ◽  
Sensorineural Hearing Loss ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing

scholarly journals Healthy lifestyle consultation based on traditional Chinese medicine versus routine patient education in the treatment of idiopathic sudden sensorineural hearing loss after failure of systemic therapy: Study protocol for a clinical randomised trial

2019 ◽  
Author(s):  
Yingping Fei ◽  
Yun Zheng ◽  
Dan Lai ◽  
Ping Zhong ◽  
Jing-zhe Lu ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Sensorineural Hearing Loss ◽  
Systemic Therapy ◽  
Lifestyle Modification ◽  
Healthy Lifestyle ◽  
Randomised Trial ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing

Abstract Background: Idiopathic sudden sensorineural hearing loss (ISSNHL) is an important cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear . Traditional Chinese medicine (TCM) has been used for treating diseases for thousands of years and is popular and widely practic ed in Asia. TCM includes guidance on healthy lifestyle. In recent decades, the relationship between lifestyle and disease has been emphasised. Moreover, an unhealthy lifestyle may lead to illnesses . Thus, this study aims to compare the efficacy of lifestyle modification based on TCM with the usual consultation of ISSNHL after failure of a 2 weeks systemic therapy to provide a scientific basis for clinical decisions. Methods: This study is a clinical randomised trial that involves 56 patients diagnosed with ISSNHL but with incomplete recovery after initial management (at least 2 weeks routine Western medical treatment). The study is performed in accordance with the sudden hearing loss clinical guideline of the American Academy of Otolaryngology – Head and Neck Surgery , which is published in 2012 . Participants are randomly distributed into two groups, namely, the healthy lifestyle modification group based on TCM and the control group (1:1 ratio). Patient follow-up lasted for 3 months. The primary outcome measure is the effective rate of hearing improvement, which is defined as the proportion of patients with at least 15 dB improvement in the average thresholds by the hearing loss frequency . The secondary outcome measures are the improvements in word recognition score, tinnitus handicap inventory for tinnitus and visual analogue scale for ear blockage and dizziness. Assessments are made at baseline after lifestyle modification for 1 and 3 months. Discussion: The efficacy of healthy lifestyle modification based on a TCM programme for patients with ISSNHL with incomplete recovery after failure of initial systemic therapy is determined in this trial. Positive results provide clinica l evidence on the effects of TCM - based healthy lifestyle, which could be recommended as salvage therapy for patients with ISSNHL.

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