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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
刊名PLOS ONE
2013-02-27
DOI10.1371/journal.pone.0056703
8期:2
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Multidisciplinary Sciences
研究领域[WOS]Science & Technology - Other Topics
关键词[WOS]THERAPY
英文摘要

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

语种英语
WOS记录号WOS:000315519000033
引用统计
被引频次:27[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/67157
专题北京大学第二临床医学院
北京大学公共卫生学院_流行病与卫生统计学系
北京大学第一临床医学院_内分泌内科
北京大学第二临床医学院_口腔科
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
推荐引用方式
GB/T 7714
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).
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