Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial
Abstract Background Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. The benefit of intratympanic compared to systemic treatment is the reduc...
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doaj-ec31bbae76944aaea98fec9306bf15002021-02-07T12:31:24ZengBMCTrials1745-62152020-02-012111810.1186/s13063-020-4077-xIntratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trialWeiqiang Yang0Xiaoling Li1Jiatao Zhong2Xueshuang Mei3Hongyu Liu4Le Yang5Liming Lu6Hongyi Hu7Department of Otorhinolaryngology, Peking University Shenzhen HospitalThe Eighth Affiliated Hospital of Sun Yat-sen UniversityDepartment of Otorhinolaryngology, Peking University Shenzhen HospitalDepartment of Otorhinolaryngology, Peking University Shenzhen HospitalDepartment of Otorhinolaryngology, Peking University Shenzhen HospitalDepartment of Otorhinolaryngology, Peking University Shenzhen HospitalClinical Research and Data Centre, South China Research Centre for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese MedicineDepartment of Otorhinolaryngology, Peking University Shenzhen HospitalAbstract Background Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. The benefit of intratympanic compared to systemic treatment is the reduced systemic steroid exposure and associated systemic adverse effects. Intratympanic corticosteroid administration may have potential benefits over standard systemic therapies. Methods/design The proposed study is a prospective, randomized superiority trial. A total of 96 patients (48 in each group) will be randomized into the experimental or control group. Patients in the experimental group will receive four 1-mL doses of 40 mg/mL of methylprednisolone over a 1-week period, with a dose administered every 2 days via tympanic membrane injection into the middle ear. The control group will be administered intravenous methylprednisolone (1 mg/kg/day, maximal dose 60 mg/day) for 5 days. The primary outcome for this study is the change in hearing threshold from the first audiogram to the 30-day follow-up audiogram. Secondary outcome measures will include pure-tone average (PTA) at 90-day follow up, visual analog tinnitus scale, visual analog vertigo scale, visual analog aural fullness scale, fasting blood glucose and 2-h postprandial blood glucose during treatment, and the change in glycosylated hemoglobin (HbA1C) levels. Vital signs and otological physical examination will be performed at each follow-up visit. Discussion The efficacy and safety of intratympanic methylprednisolone compared to intravenous methylprednisolone will be investigated in patients with diabetes mellitus and SSNHL. This trial may provide strong evidence for the efficacy and safety of intratympanic corticosteroid treatment and important clinical information for the treatment of patients with diabetes mellitus and SSNHL. Trial registration ChiCTR, ChiCTR1800015954. Registered on 2 May 2018, Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=25326.https://doi.org/10.1186/s13063-020-4077-xSudden sensorineural hearing lossDiabetesRandomized controlled trialIntratympanic methylprednisoloneIntravenous methylprednisolone |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Weiqiang Yang Xiaoling Li Jiatao Zhong Xueshuang Mei Hongyu Liu Le Yang Liming Lu Hongyi Hu |
spellingShingle |
Weiqiang Yang Xiaoling Li Jiatao Zhong Xueshuang Mei Hongyu Liu Le Yang Liming Lu Hongyi Hu Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial Trials Sudden sensorineural hearing loss Diabetes Randomized controlled trial Intratympanic methylprednisolone Intravenous methylprednisolone |
author_facet |
Weiqiang Yang Xiaoling Li Jiatao Zhong Xueshuang Mei Hongyu Liu Le Yang Liming Lu Hongyi Hu |
author_sort |
Weiqiang Yang |
title |
Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial |
title_short |
Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial |
title_full |
Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial |
title_fullStr |
Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial |
title_full_unstemmed |
Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial |
title_sort |
intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2020-02-01 |
description |
Abstract Background Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL). Systemic and intratympanic corticosteroids are the two primary treatments for SSNHL in patients with diabetes mellitus. The benefit of intratympanic compared to systemic treatment is the reduced systemic steroid exposure and associated systemic adverse effects. Intratympanic corticosteroid administration may have potential benefits over standard systemic therapies. Methods/design The proposed study is a prospective, randomized superiority trial. A total of 96 patients (48 in each group) will be randomized into the experimental or control group. Patients in the experimental group will receive four 1-mL doses of 40 mg/mL of methylprednisolone over a 1-week period, with a dose administered every 2 days via tympanic membrane injection into the middle ear. The control group will be administered intravenous methylprednisolone (1 mg/kg/day, maximal dose 60 mg/day) for 5 days. The primary outcome for this study is the change in hearing threshold from the first audiogram to the 30-day follow-up audiogram. Secondary outcome measures will include pure-tone average (PTA) at 90-day follow up, visual analog tinnitus scale, visual analog vertigo scale, visual analog aural fullness scale, fasting blood glucose and 2-h postprandial blood glucose during treatment, and the change in glycosylated hemoglobin (HbA1C) levels. Vital signs and otological physical examination will be performed at each follow-up visit. Discussion The efficacy and safety of intratympanic methylprednisolone compared to intravenous methylprednisolone will be investigated in patients with diabetes mellitus and SSNHL. This trial may provide strong evidence for the efficacy and safety of intratympanic corticosteroid treatment and important clinical information for the treatment of patients with diabetes mellitus and SSNHL. Trial registration ChiCTR, ChiCTR1800015954. Registered on 2 May 2018, Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=25326. |
topic |
Sudden sensorineural hearing loss Diabetes Randomized controlled trial Intratympanic methylprednisolone Intravenous methylprednisolone |
url |
https://doi.org/10.1186/s13063-020-4077-x |
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