OBJECTIVETo evaluate the efficacy and safety of Jiangtang Xiaozhi Capsule (JTXZC) in treating type 2 diabetes mellitus (T2DM) patients of qi-yin deficiency and inter-obstruction between phlegm and stasis.

METHODSAdopting prospective, randomized, controlled trial design, 73 T2DM patients of qi-yin deficiency and inter-obstruction between phlegm and stasis syndrome, were randomly assigned to two groups, the pioglitazone tablet group (36 cases) and the JTXZC group (37 cases). The therapeutic course for all was 8 weeks. The body weight, height, body mass index (BMI), waistline (WC), hipline, waist-to-hip ratio (WHR), and scoring for Chinese medicine (CM) symptoms assessment were observed. The fasting blood glucose (FBG), 2-h postprandial blood glucose (PBG), glycated hemoglobin (HbA1c), plasma total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), plasma insulin (FINS) were detected. The HOMA-IR was also calculated. The safety indices such as liver and renal functions, adverse reactions were also observed.

RESULTSThe levels of HbA1c were lowered after treatment in the two groups after 8 weeks of treatment, showing statistical difference when compared with before treatment (-0.59% +/- 1.99% and -0.27% +/- 2.73%, P < 0.05). The PBG level also decreased with statistical difference (-1.71 +/- 2.52 mmol/L and -0.72 +/- 4.17 mmol/L, P < 0.05), but there was no statistical difference between the two groups. The body weight, BMI, TG obviously decreased (P < 0.05). The CM symptoms efficacy and CM symptom scoring were significantly reduced in the two groups (P < 0.01). Besides, better effects were shown in the JTXZC group (P < 0.05). No severe adverse event occurred in either group during the therapeutic course. There was no statistical difference in the incidence of adverse events (P > 0.05).

CONCLUSIONSJTXZC showed similar therapeutic effects to pioglitazone. They both could effectively im- prove clinical symptoms with no severe adverse reaction.