To evaluate the effect of Zhibitai Capsule (脂必泰胶囊) on the patients with type 2 diabetes mellitus (T2DM) complicated with metabolic syndrome (MS) of accumulation of phlegm and blood stasis syndrome by observing triglyceride-glucose (TyG) index and other indicators.

According to the random number table method, 80 cases of T2DMcomplicated with MS of accumulation of phlegm and blood stasis syndrome were randomly divided into treatment group and control group, with 40 cases in each group. Both groups were given lifestyle intervention and basic treatment such as reducing blood glucose, lowering blood pressure and losing weight according to the specific condition of the patients. The control group was given the basic treatment and atorvastatin calcium tablet for lipid regulation, one tablet orally at bedtime for a total of 8 weeks. The treatment group was supplemented with Zhibitai Capsule, twice a day, 1 capsule for each time, and the course of treatment was 8 weeks. The changes in TCMsyndrome scores, body mass index (BMI), waist circumference, systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting blood glucose (FBG), blood glucose after 2 hours of oral glucose tolerance test (2 h BG), glycosylated hemoglobin (HBA1 c), fasting insulin (INS), insulin after 2 hours of oral glucose tolerance test (INS-2 h), total cholesterol (TC), triglycerides (TG), low density dilipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), TyG index, homeostasis model IR index (HOMA-IR) of the two groups were observed before and after the treatment.

The total effective rate of the treatment group was 82.5% (33/40) after treatment, which was higher than 57.5% (23/40) of the control group (P<0.05) . After treatment, the TCM syndrome scores of the two groups were lower than those before treatment (P<0.01). The TCMsyndrome scores of the treatment group after treatment were lower than those of the control group (P<0.01) . After treatment, the levels of FBG, 2 h BG, HBA1 c, SBP, DBP, TC, TG, LDL-C, TyG index and HOMA-IR of both groups were lower than those before. HDL-C was higher than that before treatment (P<0.01). The values of BMI, waist circumference, INS and INS-2 h had no significant difference (P>0.05). The levels of FBG, 2 h BG, HBA1 c, TyG index and HOMA-IR of the treatment group after treatment were lower than those of the control group (P<0.05 or P<0.01) . There were no significant differences in BMI, waist circumference, INS, INS-2 h, SBP, DBP, TC, TG, LDL-C or HDL-C compared with those of the control group (P>0.05) .

Zhibitai Capsule can reduce the TCM syndrome scores of T2DM complicated with MS patients, reduce their blood glucose, blood lipids, TyG, HOMA-IR and IR, thereby improving the clinical symptoms and the clinical efficacy of TCMsyndromes.