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 E(1) (lipo-PGE(1)) 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 microg lipo-PGE(1) (lipo-PGE(1) 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-PGE(1) 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-PGE(1) group (70.3%) and the placebo group (58.3%). CONCLUSION:Lipo-PGE(1) may have beneficial effects in the treatment of SSNHL in Korean patients with Type 2 diabetes.
RCT Entities:
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 E(1) (lipo-PGE(1)) 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 microg lipo-PGE(1) (lipo-PGE(1) 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-diabeticpatients. In diabeticpatients, there was a significantly higher rate of hearing improvement in the lipo-PGE(1) group (64.7%) compared with the placebo group (37.5%), whereas, in non-diabeticpatients, there was no significant difference in rate of hearing improvement between the lipo-PGE(1) group (70.3%) and the placebo group (58.3%). CONCLUSION:Lipo-PGE(1) may have beneficial effects in the treatment of SSNHL in Korean patients with Type 2 diabetes.
Authors: Hyung-Jo Yoon; Marianna Dakanali; Darcy Lichlyter; Willy M Chang; Karen A Nguyen; Matthew E Nipper; Mark A Haidekker; Emmanuel A Theodorakis Journal: Org Biomol Chem Date: 2011-03-24 Impact factor: 3.876