A comparison study of metformin only therapy and metformin combined with Chinese medicine jianyutangkang therapy in patients with type 2 diabetes: A randomized placebo-controlled double-blind study.

The aim of this 26-week, double-blind, controlled clinical trial, was to compare the efficacy of monotherapy (metformin only) with combination therapy (Chinese medicine prescription JianYuTangKang [JYTK] plus metformin) on type 2 diabetes. All patients on metformin were randomized to receive authenticated JYTK (59 patients) or placebo JYTK (53 patients), 4.5g daily, for 26 weeks. Patients also received information regarding diet and exercise. Fasting plasma glucose (FPG) and glycosylated hemoglobin (HbA1C) level, and a lipid profile were measured before, during, and after the treatment. The results of the treatment group (JYTK plus metformin) were noninferior to those of the control group (metformin plus placebo) at 8 and 18 weeks. After 26 weeks of treatment, FPG levels decreased to 6.1±1.0mmol/L in the treatment group and 7.0±1.5mmol/L in the control group (p<0.01). HbA1C levels after 26 weeks were also significantly decreased in the treatment group compared with the control group (p<0.01). In addition, lipid profiles were also significantly different between the two groups. Integrated traditional Chinese and Western medicine therapy (JYTK plus metformin) for patients with type 2 diabetes mellitus may not only help improve glycemia and insulin sensitivity, but also help to modify the diabetes related lipid equilibrium. And thereby provides a basis for a novel, effective, and safe approach, to treat type 2 diabetic patients.

RCT Entities:   Population Interventions Outcomes