Abstract:Objective: To investigate the effect of Taohong Siwutang on heart rate variability, blood lipids and C reactive protein (CRP) of patients of phlegm and blood stasis type diabetes mellitus with atherosclerosis. Method: A total of 120 patients of phlegm and blood stasis type diabetes mellitus with atherosclerosis were selected and randomly divided into control group and experiment group, with 60 cases in each group. The two groups of patients were given conventional therapy, namely metformin 0.25 g·d-1, and acarbose 50 mg·d-1 or injection with insulin. The control group was orally given isosorbide dinitrate and Danshen dripping pills, 10 pills each time, 1 times a day. In addition to the conventional therapy, experiment group was orally given with 200 mL warm Taohong Siwutang. One course of treatment was four weeks. The two groups were treated continuously for 4 weeks. Heart rate variability, blood lipids, blood glucose, CRP level and adverse reactions were compared between two groups after the treatment. Result: Compared with control group, the total clinical effective rate was higher in experimental group after treatment (P<0.05). Compared with before treatment, the normal 24 h normal R-R standard deviation of NN intervals (SDNN), the adjacent R-R root mean square successive difference (RMSSD), and the percentage of adjacent normal R-R difference >50 ms (PNN50) of two groups of patients were increased (P<0.05). Compared with control group, SDNN, RMSSD and PNN50 levels were higher in treatment group(P<0.05). Compared with before treatment, fasting blood glucose (FPG), 2 h postprandial blood glucose (PBG) and glycosylated hemoglobin (HBA1c) were decreased (P<0.05). Compared with control group, fasting blood glucose, postprandial 2 h blood glucose and glycosylated hemoglobin levels were lower in experiment group (P<0.05). Total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), CRP, high-density lipoprotein cholesterol (HDL-C) were higher in two groups after treatment (P<0.05). Compared with control group, TC, LDL-C, TG and CRP levels were lower, while HDL-C level was higher in experiment group (P<0.05). Conclusion: Taohong Siwutang has a significant clinical efficacy on patients of phlegm and blood stasis type diabetes mellitus with atherosclerosis, and can regulate heart rate variability and down-regulate the level of CRP, with a high safety. Therefore, it is suitable for clinical application and promotion.