Background Diabetes mellitus is a risk factor for sudden sensorineural hearing loss (SSNHL), possibly as a result of microvascular damage, increased blood viscosity and embolic and thrombotic episodes.
Aim To perform a prospective, randomized clinical trial to determine the therapeutic effect of lipo-prostaglandin E1 (lipo-PGE1) on SSNHL in Korean patients with Type 2 diabetes.
Methods The study group consisted of 270 consecutive Korean patients (130 male, 140 female) in whom SSNHL was diagnosed. Patients were classified as diabetic or non-diabetic by the new American Diabetes Association criteria. With the approval of the institute ethics committee, patients were randomly assigned to treatment with of 10 µg lipo-PGE1 (lipo-PGE1 group) given as a continuous infusion over 5 days, or saline (placebo group). In addition, all patients studied were treated with 48 mg methylprednisolone for 5 days.
Results The overall recovery rates after treatment were 51.5% in diabetic and 64.2% in non-diabetic patients. In diabetic patients, there was a significantly higher rate of hearing improvement in the lipo-PGE1 group (64.7%) compared with the placebo group (37.5%), whereas, in non-diabetic patients, there was no significant difference in rate of hearing improvement between the lipo-PGE1 group (70.3%) and the placebo group (58.3%).
Conclusion Lipo-PGE1 may have beneficial effects in the treatment of SSNHL in Korean patients with Type 2 diabetes.