The Clinical Study On The Efficacy And Safety Of Modified Wumei Decoction Treating Type2Diabetes Mellitus(Pattern Of Exuberant Heat Damaging Liquid)

Objective:Preliminary to observe the clinical efficacy and safety of Modified Wumei Decoction in treating type2diabetes mellitus patients (pattern of exuberant heat damaging liquid).Methods:80cases were recruited, and divided into2groups in a multicenter, randomized, controlled study.41patients in trial group were treated with Modified Wumei Decoction and39patients in control group were treated with metformin tablets. Basic therapy were operated among all patients.At12weeks after treatment, we observed the change of indexes including blood glucose(FPG,2hPG), glycosylated hemoglobin(HbAlc), Body weight, body mass index (BMI), fasting insulin (FINS), HOMA insulin resistance (HOMA IR), Li Guangwei index (ISI), HOMA islet beta cell function index (HOMA-beta), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C),and the clinical syndrome,also the blood routine, urine and stool routine, liver and kidney function, electrocardiogram (ECG) and other safety indicators, At the same time, the adverse reactions and their incidence and severity were observed. And comprehensive efficacies as well as safety were evaluated.Results:1. After12months’ observation period, FBG、2hPG、HbAlc were lower compared with before treatment (P<0.05) in both groups.2.Weight, BMI decreased significantly (P<0.01) in both groups, but the difference was not statistically significant (P>0.05) between the two groups after treatment; BMI subgroup analysis suggested that in BMI<23Kg/m2, patients the change of BMI was not obvious compared with before treatment in both groups, while in BMI≥23Kg/m2patients, BMI decreased significantly, especially in overweight patients With a BMI≥25kg/m2, and the trial group decreased lower than the control group (P<0.05).3. Ln(ISI) were increased (P<0.05) while Ln(HOMA-IR) decreased (P<0.05), and no difference between the two groups after treatment (P>0.05); FINS,difference was not statistically significant (P>0.05) before and after treatment; Ln(HOMA-beta), difference was statistically significant (P<0.05) in trail group,but not in the control group (P>0.05).4.TC, TG, HDL-C, LDL-C,difference was not statistically significant (P>0.05) before and after treatment.5.TCM symptoms were improved after treatment (P<0.05), and the trail group is better than the control group (P<0.05).6.there was no clinically significant safety index in the testing process, and a low incidence of adverse reactions, so the clinical application was safe.Conclusions:Modified Wumei Decoction can effectively reduce blood glucose and glycoslated hemoglobin in early type2diabetes(pattern of exuberant heat damaging liquid). The effect is identical with metformin.At the same time it can improve the patient’s clinical symptoms significantly, aiso lose weight,increase insulin sensitivity and improve insulin resistance, while the incidence of adverse reactions is low.