title: [Clinical study of Jiangtang Xiaozhi Capsule in treating type 2 diabetes mellitus patients].
abstract: OBJECTIVE
  To 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.
  
  
  METHODS
  Adopting 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.
  
  
  RESULTS
  The 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).
  
  
  CONCLUSIONS
  JTXZC showed similar therapeutic effects to pioglitazone. They both could effectively im- prove clinical symptoms with no severe adverse reaction.
authors.affiliation: Department of Endocrinology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing.
authors.forename: Zhu-Hong
authors.initials: ZH
authors.lastname: Chen
authors.forename: Cheng-Dong
authors.initials: CD
authors.lastname: Xia
authors.forename: Zi-Xiao
authors.initials: ZX
authors.lastname: Wei
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D000077205:Pioglitazone; D011446:Prospective Studies; D045162:Thiazolidinediones / Q000627:therapeutic use; D016710:Yin Deficiency
chemical_list: D001786:Blood Glucose; D004365:Drugs, Chinese Herbal; D045162:Thiazolidinediones; D000077205:Pioglitazone