Chinese Herbal Medicine Tianqi Reduces Progression From Impaired Glucose Tolerance to Diabetes: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial
Chinese Herbal Medicine Tianqi Reduces Progression From Impaired Glucose Tolerance to Diabetes: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial
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DOI：
10.1210/jc.2013-3276
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发表时间：
2014-02-01
影响因子：
5.8
通讯作者：
Tong, Xiaolin
中科院分区：
文献类型：
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作者：
Lian, Fengmei;Li, Guangwei;Tong, Xiaolin
背景：生活在糖尿病前期状态会显着增加患者患糖尿病和心血管疾病的风险。田七胶囊含有10种中草药，在中国被用于治疗2型糖尿病（T2 DM）。目的：本研究的目的是评估田七是否在12个月的治疗过程中预防糖耐量减低（IGT）受试者的T2 DM。方法：IGT患者以双盲方式随机分配接受田七（n = 210）或安慰剂（n = 210）治疗12个月。每3个月进行一次口服葡萄糖耐量试验，以评估糖尿病的发展或恢复正常葡萄糖耐量。所有受试者接受相同的生活方式教育。主要终点是IGT转化为T2 DM。观察体重和体重指数。结果：420例IGT患者中，389例完成试验，其中田七组198例，安慰剂组191例。在12个月的试验结束时，田七组有36名受试者（18.18%）和安慰剂组有56名受试者（29.32%）患上了糖尿病（P = 0.01）。田七组和安慰剂组在研究结束时糖耐量正常的受试者数量存在显著差异（分别为n = 125，63.13%和n = 89，46.60%; P = 0.001）。考克斯的比例风险模型分析显示，与安慰剂相比，田七降低了32.1%的糖尿病风险。试验期间未发生严重不良事件。在12个月的试验中，田七组和安慰剂组之间的体重和体重指数变化无统计学差异。结论：田七胶囊治疗12个月可显著降低IGT受试者中T2 DM的发病率，并且这种草药使用安全。
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 end point 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.