title: Efficacy and safety of traditional chinese medicine for diabetes: a double-blind, randomised, controlled trial.
abstract: BACKGROUND
  Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history. The aim of this study is to establish the safety and efficacy of traditional Chinese medicine combined with glibenclamide to treat type 2 diabetes mellitus.
  
  
  METHODS
  In a controlled, double blind, multicentre non-inferiority trial, 800 patients with unsatisfactory glycemic control (fasting glucose 7-13 mmol/L and HbA1c 7-11%) were randomly assigned to receive Xiaoke Pill, a compound of Chinese herbs combined with glibenclamide, or Glibenclamide in two study groups - drug naive group, and patients previously treated with metformin monotherapy (metformin group). Outcome measures at 48 weeks were the incidence and rate of hypoglycemia, mean difference in HbA1c, and proportion of patients with HbA1c<6.5%.
  
  
  RESULTS
  In drug naïve group, the total hypoglycemia rate and the mild hypoglycemic episode in the Xiaoke Pill arm were 38% (p = 0.024) and 41% (p = 0.002) less compared to Glibenclamide arm; in Metformin group, the average annual rate of hypoglycemia was 62% lower in Xiaoke Pill arm (p = 0.003). Respective mean changes in HbA1c from baseline were -0.70% and -0.66% for Xiaoke Pill and Glibenclamide, with a between-group difference (95% CI) of -0.04% (-0.20, 0.12) in the drug naïve group, and those in metformin group were -0.45% and -0.59%, 0.14% (-0.12, 0.39) respectively. The respective proportions of patients with a HbA1c level <6.5% were 26.6% and 23.4% in the drug naïve group and 20.1% and 18.9% in the metformin group.
  
  
  CONCLUSIONS
  In patients with type 2 diabetes and inadequate glycaemic control, treatment with Xiaoke Pill led to significant reduction in risk of hypoglycemia and similar improvements in glycemic control after 48 weeks compared to Glibenclamide.
  
  
  BACKGROUND
  Chinese Clinical Trial Register number, ChiCTR-TRC-08000074.
authors: Peking University People's Hospital, Beijing, China. jiln@bjmu.edu.cn
authors: Linong
authors: L
authors: Ji
authors: Xiaolin
authors: X
authors: Tong
authors: Hongyuan
authors: H
authors: Wang
authors: Haoming
authors: H
authors: Tian
authors: Huimin
authors: H
authors: Zhou
authors: Lili
authors: L
authors: Zhang
authors: Qifu
authors: Q
authors: Li
authors: Yizhong
authors: Y
authors: Wang
authors: Hongmei
authors: H
authors: Li
authors: Min
authors: M
authors: Liu
authors: Hongjie
authors: H
authors: Yang
authors: Yanbin
authors: Y
authors: Gao
authors: Yan
authors: Y
authors: Li
authors: Quanmin
authors: Q
authors: Li
authors: Xiaohui
authors: X
authors: Guo
authors: Gangyi
authors: G
authors: Yang
authors: Zhongai
authors: Z
authors: Zhang
authors: Zhiguang
authors: Z
authors: Zhou
authors: Guang
authors: G
authors: Ning
authors: Yingli
authors: Y
authors: Chen
authors: Sanjoy
authors: S
authors: Paul
mesh_terms: D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional / Q000009:adverse effects*; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D008687:Metformin