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Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial.
Trials. 2020 Feb 03; 21(1):135.T

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.

Authors+Show Affiliations

Department of Otorhinolaryngology, Peking University Shenzhen Hospital, Shenzhen, China. Hearing and Balance Function Medical Engineering Laboratory, Shenzhen, China.The Eighth Affiliated Hospital of Sun Yat-sen University, Shenzhen, China.Department of Otorhinolaryngology, Peking University Shenzhen Hospital, Shenzhen, China. Hearing and Balance Function Medical Engineering Laboratory, Shenzhen, China.Department of Otorhinolaryngology, Peking University Shenzhen Hospital, Shenzhen, China. Hearing and Balance Function Medical Engineering Laboratory, Shenzhen, China.Department of Otorhinolaryngology, Peking University Shenzhen Hospital, Shenzhen, China. Hearing and Balance Function Medical Engineering Laboratory, Shenzhen, China.Department of Otorhinolaryngology, Peking University Shenzhen Hospital, Shenzhen, China.Clinical Research and Data Centre, South China Research Centre for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China. lulimingleon@126.com.Department of Otorhinolaryngology, Peking University Shenzhen Hospital, Shenzhen, China. hyihu@sina.com. Hearing and Balance Function Medical Engineering Laboratory, Shenzhen, China. hyihu@sina.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32014060

Citation

Yang, Weiqiang, et al. "Intratympanic Versus Intravenous Corticosteroid Treatment for Sudden Sensorineural Hearing Loss in Diabetic Patients: Proposed Study Protocol for a Prospective, Randomized Superiority Trial." Trials, vol. 21, no. 1, 2020, p. 135.
Yang W, Li X, Zhong J, et al. Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial. Trials. 2020;21(1):135.
Yang, W., Li, X., Zhong, J., Mei, X., Liu, H., Yang, L., Lu, L., & Hu, H. (2020). Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial. Trials, 21(1), 135. https://doi.org/10.1186/s13063-020-4077-x
Yang W, et al. Intratympanic Versus Intravenous Corticosteroid Treatment for Sudden Sensorineural Hearing Loss in Diabetic Patients: Proposed Study Protocol for a Prospective, Randomized Superiority Trial. Trials. 2020 Feb 3;21(1):135. PubMed PMID: 32014060.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial. AU - Yang,Weiqiang, AU - Li,Xiaoling, AU - Zhong,Jiatao, AU - Mei,Xueshuang, AU - Liu,Hongyu, AU - Yang,Le, AU - Lu,Liming, AU - Hu,Hongyi, Y1 - 2020/02/03/ PY - 2019/11/06/received PY - 2020/01/15/accepted PY - 2020/2/5/entrez PY - 2020/2/6/pubmed PY - 2020/2/6/medline KW - Diabetes KW - Intratympanic methylprednisolone KW - Intravenous methylprednisolone KW - Randomized controlled trial KW - Sudden sensorineural hearing loss SP - 135 EP - 135 JF - Trials JO - Trials VL - 21 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/32014060/Intratympanic_versus_intravenous_corticosteroid_treatment_for_sudden_sensorineural_hearing_loss_in_diabetic_patients:_proposed_study_protocol_for_a_prospective,_randomized_superiority_trial L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-4077-x DB - PRIME DP - Unbound Medicine ER -
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