PMID- 33832957
OWN - NLM
STAT- MEDLINE
DCOM- 20211111
LR  - 20221207
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 44
IP  - 6
DP  - 2021 Jun
TI  - Efficacy and Safety of Mulberry Twig Alkaloids Tablet for the Treatment of Type 2 
      Diabetes: A Multicenter, Randomized, Double-Blind, Double-Dummy, and Parallel 
      Controlled Clinical Trial.
PG  - 1324-1333
LID - 10.2337/dc20-2109 [doi]
AB  - 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 (HbA(1c)) 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 HbA(1c) 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.
CI  - (c) 2021 by the American Diabetes Association.
FAU - Qu, Ling
AU  - Qu L
AUID- ORCID: 0000-0002-5504-7223
AD  - Department of Traditional Chinese Medicine, Peking Union Medical College 
      Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 
      Beijing, China.
FAU - Liang, Xiaochun
AU  - Liang X
AD  - 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.
FAU - Tian, Guoqing
AU  - Tian G
AUID- ORCID: 0000-0003-1262-2723
AD  - 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.
FAU - Zhang, Gaili
AU  - Zhang G
AD  - Department of Traditional Chinese Medicine, Peking Union Medical College 
      Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 
      Beijing, China.
FAU - Wu, Qunli
AU  - Wu Q
AD  - Department of Traditional Chinese Medicine, Peking Union Medical College 
      Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 
      Beijing, China.
FAU - Huang, Xiumei
AU  - Huang X
AD  - Department of Traditional Chinese Medicine, Peking Union Medical College 
      Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 
      Beijing, China.
FAU - Cui, Yazhong
AU  - Cui Y
AD  - Department of Traditional Chinese Medicine, Peking Union Medical College 
      Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 
      Beijing, China.
FAU - Liu, Yuling
AU  - Liu Y
AD  - Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union 
      Medical College, Beijing, China.
FAU - Shen, Zhufang
AU  - Shen Z
AD  - Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union 
      Medical College, Beijing, China.
FAU - Xiao, Changqing
AU  - Xiao C
AD  - Department of Endocrinology and Metabolism, The First Affiliated Hospital, 
      Guangxi Medical University, Guangxi, China.
FAU - Qin, Yingfen
AU  - Qin Y
AUID- ORCID: 0000-0002-8456-1678
AD  - Department of Endocrinology, The First Affiliated Hospital, Guangxi Medical 
      University, Guangxi, China.
FAU - Miao, Heng
AU  - Miao H
AD  - Department of Endocrinology, The Second Affiliated Hospital, Nan Jing Medical 
      University, Jiangsu, China.
FAU - Zhang, Yongyan
AU  - Zhang Y
AD  - Department of Endocrinology, Shengjing Hospital of China Medical University, 
      Liaoning, China.
FAU - Li, Ziling
AU  - Li Z
AD  - Department of Endocrinology, Inner Mongolia Baogang Hospital, Baotou, Inner 
      Mongolia Autonomous Region, China.
FAU - Ye, Shandong
AU  - Ye S
AD  - 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.
FAU - Zhang, Xuezhi
AU  - Zhang X
AD  - Traditional Chinese Medicine and Integrative Medicine Department, Peking 
      University First Hospital, Beijing, China.
FAU - Yang, Jing
AU  - Yang J
AD  - Department of Endocrinology, The First Affiliated Hospital, Shanxi Medical 
      University, Shanxi, China.
FAU - Cao, Guiwen
AU  - Cao G
AD  - Department of Endocrinology, The Fourth Affiliated Hospital, Jilin University, 
      Jilin, China.
FAU - Li, Yi
AU  - Li Y
AD  - Department of Traditional Chinese Medicine, Beijing Hospital, Beijing, China.
FAU - Yang, Gangyi
AU  - Yang G
AD  - Department of Endocrinology, The Second Affiliated Hospital, Chongqing Medical 
      University, Chongqing, China.
FAU - Hu, Ji
AU  - Hu J
AD  - Department of Endocrinology, The Second Affiliated Hospital, Suzhou University, 
      Jiangsu, China.
FAU - Wang, Xiaoyue
AU  - Wang X
AD  - Department of Endocrinology, The First People's Hospital of Yueyang, Hunan, 
      China.
FAU - Li, Zhengfang
AU  - Li Z
AD  - Department of Endocrinology, The Second Affiliated Hospital, Kunming Medical 
      University, Yunnan, China.
FAU - Li, Yukun
AU  - Li Y
AUID- ORCID: 0000-0002-7484-9803
AD  - Department of Endocrinology, The Third Affiliated Hospital, Hebei Medical 
      University, Hebei, China.
FAU - Zhang, Xiuzhen
AU  - Zhang X
AD  - Department of Endocrinology, Tongji Hospital, Tongji University, Shanghai, China.
FAU - Zhang, Guangde
AU  - Zhang G
AD  - Department of Endocrinology, Xiyuan Hospital, Chinese Academy of Chinese Medical 
      Sciences, Beijing, China.
FAU - Chen, Li
AU  - Chen L
AUID- ORCID: 0000-0001-7670-8062
AD  - Department of Endocrinology, Qilu Hospital, Shandong University, Shandong, China.
FAU - Hua, Wenjin
AU  - Hua W
AD  - Department of Endocrinology, The Third People's Hospital of Wuxi, Jiangsu, China.
FAU - Yu, Ming
AU  - Yu M
AD  - Department of Endocrinology, Central Hospital of Putuo District, Shanghai, China.
FAU - Lu, Chunyan
AU  - Lu C
AD  - Department of Endocrinology, West China Hospital, Sichuan University, Sichuan, 
      China.
FAU - Zhang, Xiaomei
AU  - Zhang X
AD  - Department of Endocrinology, The First Affiliated Hospital of Bengbu Medical 
      College, Anhui, China.
FAU - Jiang, Hong
AU  - Jiang H
AD  - Department of Endocrinology, The Second Affiliated Hospital of Liaoning 
      University of Traditional Chinese Medicine, Liaoning, China.
LA  - eng
SI  - ChiCTR/ChiCTR2000034289
SI  - figshare/10.2337/figshare.14128430
PT  - Equivalence Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210408
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 0 (Alkaloids)
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Tablets)
SB  - IM
MH  - *Alkaloids/therapeutic use
MH  - Blood Glucose
MH  - *Diabetes Mellitus, Type 2/drug therapy
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents
MH  - *Morus/chemistry
MH  - Tablets
MH  - Treatment Outcome
PMC - PMC8247493
EDAT- 2021/04/10 06:00
MHDA- 2021/11/12 06:00
PMCR- 2022/06/01
CRDT- 2021/04/09 05:48
PHST- 2020/08/24 00:00 [received]
PHST- 2021/02/17 00:00 [accepted]
PHST- 2021/04/10 06:00 [pubmed]
PHST- 2021/11/12 06:00 [medline]
PHST- 2021/04/09 05:48 [entrez]
PHST- 2022/06/01 00:00 [pmc-release]
AID - dc20-2109 [pii]
AID - 202109 [pii]
AID - 10.2337/dc20-2109 [doi]
PST - ppublish
SO  - Diabetes Care. 2021 Jun;44(6):1324-1333. doi: 10.2337/dc20-2109. Epub 2021 Apr 8.