Ling Qu1, Xiaochun Liang2, Guoqing Tian2, Gaili Zhang1, Qunli Wu1, Xiumei Huang1, Yazhong Cui1, Yuling Liu3, Zhufang Shen3, Changqing Xiao4, Yingfen Qin5, Heng Miao6, Yongyan Zhang7, Ziling Li8, Shandong Ye9, Xuezhi Zhang10, Jing Yang11, Guiwen Cao12, Yi Li13, Gangyi Yang14, Ji Hu15, Xiaoyue Wang16, Zhengfang Li17, Yukun Li18, Xiuzhen Zhang19, Guangde Zhang20, Li Chen21, Wenjin Hua22, Ming Yu23, Chunyan Lu24, Xiaomei Zhang25, Hong Jiang26. 1. Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 2. Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China xcliang@vip.sina.com gq_tian@126.com. 3. Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. 4. Department of Endocrinology and Metabolism, The First Affiliated Hospital, Guangxi Medical University, Guangxi, China. 5. Department of Endocrinology, The First Affiliated Hospital, Guangxi Medical University, Guangxi, China. 6. Department of Endocrinology, The Second Affiliated Hospital, Nan Jing Medical University, Jiangsu, China. 7. Department of Endocrinology, Shengjing Hospital of China Medical University, Liaoning, China. 8. Department of Endocrinology, Inner Mongolia Baogang Hospital, Baotou, Inner Mongolia Autonomous Region, China. 9. Department of Endocrinology, The First Affiliated Hospital of University of Science and Technology of China (USTC), Division of Life Sciences and Medicine, USTC, Hefei, Anhui, China. 10. Traditional Chinese Medicine and Integrative Medicine Department, Peking University First Hospital, Beijing, China. 11. Department of Endocrinology, The First Affiliated Hospital, Shanxi Medical University, Shanxi, China. 12. Department of Endocrinology, The Fourth Affiliated Hospital, Jilin University, Jilin, China. 13. Department of Traditional Chinese Medicine, Beijing Hospital, Beijing, China. 14. Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical University, Chongqing, China. 15. Department of Endocrinology, The Second Affiliated Hospital, Suzhou University, Jiangsu, China. 16. Department of Endocrinology, The First People's Hospital of Yueyang, Hunan, China. 17. Department of Endocrinology, The Second Affiliated Hospital, Kunming Medical University, Yunnan, China. 18. Department of Endocrinology, The Third Affiliated Hospital, Hebei Medical University, Hebei, China. 19. Department of Endocrinology, Tongji Hospital, Tongji University, Shanghai, China. 20. Department of Endocrinology, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing, China. 21. Department of Endocrinology, Qilu Hospital, Shandong University, Shandong, China. 22. Department of Endocrinology, The Third People's Hospital of Wuxi, Jiangsu, China. 23. Department of Endocrinology, Central Hospital of Putuo District, Shanghai, China. 24. Department of Endocrinology, West China Hospital, Sichuan University, Sichuan, China. 25. Department of Endocrinology, The First Affiliated Hospital of Bengbu Medical College, Anhui, China. 26. Department of Endocrinology, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning, China.
Abstract
OBJECTIVE: This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids [SZ-A]) in the treatment of type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled noninferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (n = 360) or acarbose group (n = 240). The primary efficacy end point was the change of glycosylated hemoglobin (HbA1c) compared with baseline. In addition, adverse events (AEs), severe AEs (SAEs), treatment-related AEs (TAEs), and gastrointestinal disorders (GDs) were monitored. RESULTS: After treatment for 24 weeks, the change in HbA1c was -0.93% (95% CI -1.03 to -0.83) (-10.2 mmol/mol [-11.3 to -9.1]) and -0.87% (-0.99 to -0.76) (-9.5 mmol/mol [-10.8 to -8.3]) in the SZ-A and acarbose groups, respectively, and the least squares mean difference was -0.05% (95% CI -0.18 to 0.07) (-0.5 mmol/mol [-2.0 to 0.8]) between the two groups, with no significant difference on the basis of covariance analysis (P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group (P < 0.01), but no differences for AEs or SAEs between the two groups were observed (P > 0.05). CONCLUSIONS: SZ-A exhibited equivalent hypoglycemic effects to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than acarbose treatment, suggesting good safety.
OBJECTIVE: This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids [SZ-A]) in the treatment of type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled noninferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (n = 360) or acarbose group (n = 240). The primary efficacy end point was the change of glycosylated hemoglobin (HbA1c) compared with baseline. In addition, adverse events (AEs), severe AEs (SAEs), treatment-related AEs (TAEs), and gastrointestinal disorders (GDs) were monitored. RESULTS: After treatment for 24 weeks, the change in HbA1c was -0.93% (95% CI -1.03 to -0.83) (-10.2 mmol/mol [-11.3 to -9.1]) and -0.87% (-0.99 to -0.76) (-9.5 mmol/mol [-10.8 to -8.3]) in the SZ-A and acarbose groups, respectively, and the least squares mean difference was -0.05% (95% CI -0.18 to 0.07) (-0.5 mmol/mol [-2.0 to 0.8]) between the two groups, with no significant difference on the basis of covariance analysis (P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group (P < 0.01), but no differences for AEs or SAEs between the two groups were observed (P > 0.05). CONCLUSIONS: SZ-A exhibited equivalent hypoglycemic effects to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than acarbose treatment, suggesting good safety.
Authors: Vlado Perkovic; Meg J Jardine; Bruce Neal; Severine Bompoint; Hiddo J L Heerspink; David M Charytan; Robert Edwards; Rajiv Agarwal; George Bakris; Scott Bull; Christopher P Cannon; George Capuano; Pei-Ling Chu; Dick de Zeeuw; Tom Greene; Adeera Levin; Carol Pollock; David C Wheeler; Yshai Yavin; Hong Zhang; Bernard Zinman; Gary Meininger; Barry M Brenner; Kenneth W Mahaffey Journal: N Engl J Med Date: 2019-04-14 Impact factor: 91.245