Abstract
Objective: This study was conducted to investigate the hypoglycemic effect and safety of Ojeok-san in patients with type 2 Diabetes Mellitus. Methods: We investigated type 2 diabetes mellitus patients at Kyung-Hee University Korean Medical Hospital who were administered Ojeok-san for at least one day between January 2012 and September 2020, basal characteristics and laboratory tests were reviewed retrospectively. The hypoglycemic effect of Ojeok-san was assessed by comparing fasting blood sugar (FBS) and two hours post-prandial plasma glucose (PP2) levels from before and after taking Ojeok-san. Subgroup analyses were conducted according to baseline hypoglycemic treatments and glycated hemoglobin levels (< or ≥6.5%). The safety of Ojeok-san was assessed by comparing levels of aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transferase, blood urea nitrogen, and creatinine. Results: After Ojeok-san administration, FBS and PP2 were significantly reduced to an average of 14.33 mg/dL and 27.67 mg/dL respectively. In the subgroup analysis, PP2 in patients receiving metformin mono therapy was significantly reduced to 28.67 mg/dL, and those receiving a dual therapy of metformin and DPP-4 inhibitor, it was significantly reduced to 32.33 mg/dL. In patients with glycated hemoglobin of lower than 6.5%, FBS was significantly reduced to 12.20 mg/dL, and both FBS and PP2 were significantly reduced, to 15.50 mg/dL and 40.00 mg/dL, respectively, in those with glycated hemoglobin levels of more than 6.5%. The safety profile showed no significant difference after Ojeok-san administration. Conclusions: Ojeok-san has significant hypoglycemic effects in patients with type 2 diabetes mellitus who are also taking hypoglycemic agents.