Fengmei Lian1, Guangwei Li, Xinyan Chen, Xiuzhi Wang, Chunli Piao, Jingfei Wang, Yuzhi Hong, Zhuoma Ba, Shentao Wu, Xiaoyan Zhou, Jiangming Lang, Yajun Liu, Rongfang Zhang, Jianjun Hao, Zhangzhi Zhu, Huilin Li, Hong Fang Liu, Aimei Cao, Zhu Yan, Yali An, Yujing Bai, Qiang Wang, Zhong Zhen, Chunhao Yu, Chong-Zhi Wang, Chun-Su Yuan, Xiaolin Tong. 1. Guang'anmen Hospital, China Academy of Chinese Medical Sciences (F.L., X.C., Y.B., Z.Zhe., X.T.), and China Academy of Chinese Medical Sciences (Z.Y.), Beijing 100053, China; Fuwai Hospital of Cardiovascular Disease (G.L., Y.A.), Beijing, China; Beijing Pinggu Hospital of Traditional Chinese Medicine (X.W.), Beijing 101200, China; The Affiliated Hospital to Changchun University of Chinese Medicine (C.P.), Changchun 130021, China; Beijing Mentougou Hospital of Traditional Chinese Medicine (J.W.), Beijing 102300, China; Hangzhou Hospital of Traditional Chinese Medicine (Y.H.), Hangzhou 310007, China; Qinghai Hospital of Traditional Chinese Medicine (Z.B.), Qinghai 810000, China; First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (S.W.), Tianjin 300192, China; Guangzhou Tianhe Hospital of Traditional Chinese Medicine (X.Z.), Guangzhou 510275, China; Foshan Hospital of Traditional Chinese Medicine (J.L.), Foshan, 528000 China; Beijing Huimin Hospital (Y.L.), Beijing, China; Yangquan First Municipal People's Hospital (R.Z.), Yangquan 045000, China; Guangzhou Huangpu Hospital of Traditional Chinese Medicine (J.H., Q.W.), Guangzhou 510700, China; First Affiliated Hospital of Guangzhou University of Chinese Medicine (Z.Zhu.), Guangzhou 510405, China; Shenzhen Hospital of Traditional Chinese Medicine (H.L.), Shenzhen 518033, China; Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (H.F.L.), Beijing 100700, China; Beijing Changping Hospital of Traditional Chinese Medicine (A.C.), Beijing 100200, China; and Tang Center for Herbal Medicine Research (C.Y., C.-Z.W., C.-S.Y.), University of Chicago, Chicago, Illinois 60637.
Abstract
CONTEXT: Living in a prediabetes state significantly increases a patient's risk for both diabetes and cardiovascular disease. Tianqi capsule, containing 10 Chinese herbal medicines, is used in China for the treatment of type 2 diabetes mellitus (T2DM). OBJECTIVE: The purpose of this study was to assess whether Tianqi prevented T2DM in subjects with impaired glucose tolerance (IGT) over the course of a 12-month treatment. METHODS:Individuals with IGT were randomly allocated in a double-blind manner to receive Tianqi (n = 210) or a placebo (n = 210) for 12 months. Oral glucose tolerance tests were conducted every 3 months to assess the development of diabetes or restoration to normal glucose tolerance. All subjects received the same lifestyle education. The primary endpoint was the conversion of IGT to T2DM. Body weight and body mass index were observed. Adverse effects were monitored. RESULTS: Of the 420 enrolled subjects with IGT, 389 completed the trial (198 in the Tianqi group and 191 in the placebo group). At the end of the 12-month trial, 36 subjects in the Tianqi group (18.18%) and 56 in the placebo group (29.32%) had developed diabetes (P = .01). There was a significant difference in the number of subjects who had normal glucose tolerance at the end of the study between the Tianqi and placebo groups (n = 125, 63.13%, and n = 89, 46.60%, respectively; P = .001). Cox's proportional hazards model analysis showed that Tianqi reduced the risk of diabetes by 32.1% compared with the placebo. No severe adverse events occurred in the trial. There were no statistical differences in body weight and body mass index changes between the Tianqi group and the placebo group during the 12-month trial. CONCLUSIONS: Treatment with a Tianqi capsule for 12 months significantly decreased the incidence of T2DM in subjects with IGT, and this herbal drug was safe to use.
RCT Entities:
CONTEXT: Living in a prediabetes state significantly increases a patient's risk for both diabetes and cardiovascular disease. Tianqi capsule, containing 10 Chinese herbal medicines, is used in China for the treatment of type 2 diabetes mellitus (T2DM). OBJECTIVE: The purpose of this study was to assess whether Tianqi prevented T2DM in subjects with impaired glucose tolerance (IGT) over the course of a 12-month treatment. METHODS: Individuals with IGT were randomly allocated in a double-blind manner to receive Tianqi (n = 210) or a placebo (n = 210) for 12 months. Oral glucose tolerance tests were conducted every 3 months to assess the development of diabetes or restoration to normal glucose tolerance. All subjects received the same lifestyle education. The primary endpoint was the conversion of IGT to T2DM. Body weight and body mass index were observed. Adverse effects were monitored. RESULTS: Of the 420 enrolled subjects with IGT, 389 completed the trial (198 in the Tianqi group and 191 in the placebo group). At the end of the 12-month trial, 36 subjects in the Tianqi group (18.18%) and 56 in the placebo group (29.32%) had developed diabetes (P = .01). There was a significant difference in the number of subjects who had normal glucose tolerance at the end of the study between the Tianqi and placebo groups (n = 125, 63.13%, and n = 89, 46.60%, respectively; P = .001). Cox's proportional hazards model analysis showed that Tianqi reduced the risk of diabetes by 32.1% compared with the placebo. No severe adverse events occurred in the trial. There were no statistical differences in body weight and body mass index changes between the Tianqi group and the placebo group during the 12-month trial. CONCLUSIONS: Treatment with a Tianqi capsule for 12 months significantly decreased the incidence of T2DM in subjects with IGT, and this herbal drug was safe to use.