Zhang Zhenyuan, Gao Qin, Li Sisi, Zeng Ziyu, Zhang Yi
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Department of Traditional Chinese Medicine, Shanghai Tongji Hospital, Tongji University of Medicine, Shanghai, 200071, China.
Contemp Clin Trials Commun. 2023 Jul 16;35:101166. doi: 10.1016/j.conctc.2023.101166. eCollection 2023 Oct.
Herbal medicine as complementary ways are needed for patients who refuse to take medicine for life. Early intervention and lifestyle could delay the time of taking drugs.
To assess the efficacy of Granules vs Sitagliptin in patients who diagnosed T2D.
This is a randomized, double-blind trial. T2D patients were randomly assigned in a 1:1 ratio to Granules and Sitagliptin(50 mg), an anti-diabetic medicine group, for 12 weeks. Before randomization, the consenting participants were subjected to 2 weeks of screening, followed by twelve weeks of intervention. The primary outcome was change from baseline in glycosylated haemoglobin (HbA1C) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) calculation at 12 week.
We recruited 103 patients, 84 patients participated in the clinical trial and finally 79 patients finished., the least square mean change in HbA1c and HOMA-IR from baseline was similar in both groups, in which HbA1c (6.93 ± 0.76, = 0.007) and 2hPG (10.87 ± 2.20, = 0.016) for the Control group, and HbA1c (6.76 ± 0.67, < 0.001) and 2hPG (10.52 ± 2.46, = 0.019).
This study revealed that the herbal medicine Xiaoke Granules provides effective glycaemic control with similar safety and immunogenicity profile to Sitagliptin among T2D patients treated for 12 weeks. This study strongly suggests further studies and utilization of Granules usage for controlling hyperglycemia among T2D patients.
ClinicalTrials: ChiCTR1900026782.
对于拒绝终身服药的患者，草药作为补充治疗方法是必要的。早期干预和生活方式改变可以延迟用药时间。
评估颗粒剂与西格列汀对2型糖尿病患者的疗效。
这是一项随机双盲试验。2型糖尿病患者按1:1比例随机分为颗粒剂组和抗糖尿病药物西格列汀（50毫克）组，治疗12周。随机分组前，同意参与的受试者先接受2周筛查，然后进行12周干预。主要结局指标是12周时糖化血红蛋白（HbA1C）较基线的变化以及稳态模型评估估计的胰岛素抵抗（HOMA-IR）计算值。
我们招募了103名患者，84名患者参与了临床试验，最终79名患者完成试验。两组HbA1c和HOMA-IR较基线的最小二乘均值变化相似，其中对照组的HbA1c（6.93±0.76，P = 0.007）和2小时血糖（10.87±2.20，P = 0.016），以及颗粒剂组的HbA1c（6.76±0.67，P < 0.001）和2小时血糖（10.52±2.46，P = 0.019）。
本研究表明，在接受12周治疗的2型糖尿病患者中，中药消渴颗粒在血糖控制方面效果显著，其安全性和免疫原性与西格列汀相似。本研究强烈建议进一步研究并将颗粒剂用于2型糖尿病患者的高血糖控制。
ClinicalTrials: ChiCTR1900026782。
