|Efficacy and Safety of Traditional Chinese Medicine for Diabetes: A Double-Blind, Randomised, Controlled Trial|
|Ji, Linong1; Tong, Xiaolin2; Wang, Hongyuan3; Tian, Haoming4; Zhou, Huimin5; Zhang, Lili6; Li, Qifu7; Wang, Yizhong8; Li, Hongmei9; Liu, Min10; Yang, Hongjie11; Gao, Yanbin12; Li, Yan13; Li, Quanmin14; Guo, Xiaohui15; Yang, Gangyi16; Zhang, Zhongai17; Zhou, Zhiguang18; Ning, Guang19; Chen, Yingli1; Paul, Sanjoy20; Evidence-Based Med Res Xiaoke Pill|
|WOS标题词||Science & Technology|
|研究领域[WOS]||Science & Technology - Other Topics|
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%.
Findings: In drug naive 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 naive 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 naive group and 20.1% and 18.9% in the metformin group.
Interpretation: 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.
Trial Registration: Chinese Clinical Trial Register number, ChiCTR-TRC-08000074
|作者单位||1.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China|
2.China Acad Chinese Medicial Sci, Guanganmen Hosp, Beijing, Peoples R China
3.Peking Univ, Sch Publ Hlth, Beijing 100871, Peoples R China
4.Sichuan Univ, West China Hosp, Chengdu 610064, Peoples R China
5.Hebei Med Univ, Hosp 1, Shijiazhuang, Peoples R China
6.China Aerosp Corp, Cent Hosp, Beijing, Peoples R China
7.China Meitan Gen Hosp, Beijing, Peoples R China
8.PLA Second Artillery, Gen Hosp, Beijing, Peoples R China
9.Peking Univ Tradit Chinese & Western Med, Affiliated Hosp 3, Beijing, Peoples R China
10.Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China
11.Guangzhou Univ Tradit Chinese Med, Affiliated Hosp 1, Guangzhou, Guangdong, Peoples R China
12.Shanghai Univ Tradit Chinese Med, Yueyang Hosp Integrated Tradit Chinese & Western, Shanghai, Peoples R China
13.Beijing Univ Tradit Chinese Med, Dongfang Hosp, Beijing, Peoples R China
14.Zhongshan Univ, Sun Yai Sen Mem Hosp, Zhongshan, Peoples R China
15.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
16.Chongqing Med Univ, Affiliated Hosp 2, Chongqing, Peoples R China
17.Cent S Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China
18.Shanghai Jiao Tong Univ, Ruijin Hosp, Shanghai 200030, Peoples R China
19.Univ Queensland, Queensland Clin Trials & Biostat Ctr, Sch Populat Hlth, Brisbane, Qld 4072, Australia
20.Nanjing Hosp Tradit Chinese Med, Nanjing, Jiangsu, Peoples R China
|Ji, Linong,Tong, Xiaolin,Wang, Hongyuan,et al. Efficacy and Safety of Traditional Chinese Medicine for Diabetes: A Double-Blind, Randomised, Controlled Trial[J]. PLOS ONE,2013,8(2).|
|APA||Ji, Linong.,Tong, Xiaolin.,Wang, Hongyuan.,Tian, Haoming.,Zhou, Huimin.,...&Evidence-Based Med Res Xiaoke Pill.(2013).Efficacy and Safety of Traditional Chinese Medicine for Diabetes: A Double-Blind, Randomised, Controlled Trial.PLOS ONE,8(2).|
|MLA||Ji, Linong,et al."Efficacy and Safety of Traditional Chinese Medicine for Diabetes: A Double-Blind, Randomised, Controlled Trial".PLOS ONE 8.2(2013).|