Abstract
BackgroundDiabetes 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/designThe 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.DiscussionThe 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 registrationChiCTR, ChiCTR1800015954. Registered on 2 May 2018, Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=25326.
Highlights
Diabetes mellitus is associated with risk of sudden sensorineural hearing loss (SSNHL)
The efficacy and safety of intratympanic methylprednisolone compared to intravenous methylprednisolone will be investigated in patients with diabetes mellitus and SSNHL
Several studies have demonstrated that systemic corticosteroid administration in patients with diabetes mellitus and SSNHL had no advantage in hearing improvement when compared to other treatments [7,8,9,10]
Summary
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 incidence of SSNHL is 1.54-fold higher in patients who have diabetes mellitus compared to patients who do not [4]. The standard treatment for SSNHL is systemic corticosteroid administration, this treatment results in loss of glycemic control in patients with diabetes mellitus. Long-term hyperglycemia in patients with diabetes mellitus may lead to microangiopathy of the inner ear, which results in sensorineural hearing loss [5]. Several studies have demonstrated that systemic corticosteroid administration in patients with diabetes mellitus and SSNHL had no advantage in hearing improvement when compared to other treatments [7,8,9,10]. Hyperglycemia may further affect the prognosis in SSNHL and patients with diabetes mellitus may be required to increase their insulin intake [9]
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