title: Clinical observation on trigonella foenum-graecum L. total saponins in combination with sulfonylureas in the treatment of type 2 diabetes mellitus.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of trigonella foenum-graecum L. total saponins (TFGs) in combination with sulfonylureas (SU) in the treatment of patients with type 2 diabetes mellitus (T2DM) not well controlled by SU alone.
  
  
  METHODS
  Sixty-nine T2DM patients whose blood glucose levels were not well controlled by oral sulfonylureas hypoglycemic drug were randomly assigned to the treated group (46 cases) and the control group (23 cases), and were given TFGs or placebo three times per day, 6 pills each time for 12 weeks, respectively. Meanwhile, the patients continued taking their original hypoglycemic drugs. The following indexes, including effects on traditional Chinese medicine (TCM) symptoms, fast blood glucose (FBG), 2-h post-prandial blood glucose (2h PBG), glycosylated hemoglobin (HbA1c), clinical symptomatic quantitative scores (CSQS), body mass index (BMI), as well as hepatic and renal functions, were observed and compared before and after treatment.
  
  
  RESULTS
  The efficacy on TCM symptoms was obviously better in the treated group than that in the control group (P<0.01), and there were statistically remarkable decreases in aspect of FBG, 2h PBG, HbA1c and CSQS in the treated group as compared to those in the control group (P<0.05 or P<0.01), while no significant difference was found in BMI, hepatic and renal functions between the two groups (P>0.05).
  
  
  CONCLUSIONS
  The combined therapy of TFGs with sulfonylureas hypoglycemic drug could lower the blood glucose level and ameliorate clinical symptoms in the treatment of T2DM, and the therapy was relatively safe.
authors.affiliation: Department of Integrated Chinese and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Fu-rong
authors.initials: FR
authors.lastname: Lu
authors.forename: Lin
authors.initials: L
authors.lastname: Shen
authors.forename: You
authors.initials: Y
authors.lastname: Qin
authors.forename: Lan
authors.initials: L
authors.lastname: Gao
authors.forename: Heng
authors.initials: H
authors.lastname: Li
authors.forename: Yi
authors.initials: Y
authors.lastname: Dai
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012503:Saponins / Q000008:administration & dosage* / Q000009:adverse effects; D013453:Sulfonylurea Compounds / Q000008:administration & dosage*; D029910:Trigonella
chemical_list: D012503:Saponins; D013453:Sulfonylurea Compounds