National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China academy of Chinese Medical Sciences, Beijing,100091, China.
Institute of Clinical Pharmacology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
Phytomedicine. 2024 Sep;132:155842. doi: 10.1016/j.phymed.2024.155842. Epub 2024 Jul 4.
Prediabetes strongly increases the risk of type 2 diabetes and cardiovascular events. However, lifestyle intervention, the first-line treatment for prediabetes currently, was inconsistently beneficial for glucose metabolism, and the conventional medicines, such as metformin, is controversial for prediabetes due to the possible side effects.
This study was designed to evaluate the effects of Zhenyuan Capsule, a Chinese patented medicine consisting of ginseng berry saponins extracted from the mature berry of Panax Ginseng, on the glucose metabolism of prediabetic patients as a complementary therapy.
In this randomized, double-Blinded, placebo-controlled, crossover trial, 195 participants with prediabetes were randomized 1:1 to receive either placebo followed by Zhenyuan Capsule, or vice versa, alongside lifestyle interventions. Each treatment period lasted 4 weeks with a 4-week washout period in between. The primary outcomes were the changes in fasting plasma glucose (FPG) and 2-h postprandial plasma glucose (2-h PG) from baseline. Secondary outcomes includes the changes in fasting and 2-h postprandial insulin and C-peptide, the homeostatic model assessment-insulin resistance (HOMA-IR) index and quantitative insulin sensitivity check index (QUICKI) from baseline. Blood lipids and adverse events were also assessed.
Compared with placebo, Zhenyuan Capsule caused remarkable reduction in 2-h PG (-0.98 mmol/l) after adjusting treatment order. Zhenyuan Capsule also reduced the fasting and 2-h postprandial levels of insulin and C-peptide, lowered HOMA-IR index (-1.26), and raised QUICKI index (+0.012) when compared to placebo. Additionally, a significant increase in high density lipoprotein cholesterol (HDL-C; +0.25 mmol/l) was found in patients with Zhenyuan Capsule. No serious adverse event occurred during the study.
Among prediabetic patients, Zhenyuan Capsule further reduced 2-h PG level, alleviated insulin resistance and raised HDL-C level on the background of lifestyle interventions. The study protocol is registered with the Chinese Clinical Trial Registry (ChiCTR2000034000).
糖尿病前期会显著增加 2 型糖尿病和心血管事件的风险。然而，生活方式干预作为糖尿病前期的一线治疗方法，对葡萄糖代谢的益处并不一致，而二甲双胍等常规药物对糖尿病前期的疗效也存在争议，因为其可能有副作用。
本研究旨在评估振源胶囊作为一种补充疗法对糖尿病前期患者葡萄糖代谢的影响。振源胶囊是一种中药专利药物，由人参果皂甙组成，从人参果中提取。
这是一项随机、双盲、安慰剂对照、交叉临床试验，共纳入 195 例糖尿病前期患者，按照 1:1 的比例随机分为两组，一组先接受安慰剂，然后再接受振源胶囊治疗，另一组先接受振源胶囊，然后再接受安慰剂治疗，同时接受生活方式干预。每个治疗期持续 4 周，期间有 4 周洗脱期。主要结局是空腹血糖（FPG）和餐后 2 小时血糖（2-h PG）自基线的变化。次要结局包括空腹和餐后 2 小时胰岛素和 C 肽、稳态模型评估-胰岛素抵抗指数（HOMA-IR）和定量胰岛素敏感性检查指数（QUICKI）自基线的变化。还评估了血脂和不良事件。
与安慰剂相比，振源胶囊在调整治疗顺序后可显著降低 2-h PG（-0.98mmol/L）。与安慰剂相比，振源胶囊还降低了空腹和餐后 2 小时胰岛素和 C 肽水平，降低了 HOMA-IR 指数（-1.26），提高了 QUICKI 指数（+0.012）。此外，还发现振源胶囊组的高密度脂蛋白胆固醇（HDL-C）水平显著升高（+0.25mmol/L）。研究期间未发生严重不良事件。
在糖尿病前期患者中，振源胶囊在生活方式干预的基础上，进一步降低了 2-h PG 水平，缓解了胰岛素抵抗，提高了 HDL-C 水平。该研究方案在中国临床试验注册中心（ChiCTR2000034000）注册。
