Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study.
10.1007/s11655-021-2885-9
- Author:
Ling QU
1
;
Xiao-Chun LIANG
2
;
Guo-Qing TIAN
1
;
Gai-Li ZHANG
1
;
Qun-Li WU
1
;
Xiu-Mei HUANG
1
;
Ya-Zhong CUI
1
;
Yu-Ling LIU
3
;
Zhu-Fang SHEN
3
;
Guo-Qing MA
4
;
Hao LU
5
;
Yi LI
6
;
Hong JIANG
7
;
Xi-Yan YANG
8
;
Guang-de ZHANG
9
;
Chen-Hua YANG
10
Author Information
1. Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China.
2. Department of Traditional Chinese Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China. Xiaochun_Liang@yeah.net.
3. Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100050, China.
4. Department of Endocrinology, the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Haerbin, 150001, China.
5. Department of Endocrinology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
6. Department of Traditional Chinese Medicine, Beijing Hospital, Beijing, 10005, China.
7. Department of Endocrinology, the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang, 110034, China.
8. Department of Geriatrics, the First Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin, 300073, China.
9. Department of Endocrinology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
10. Department of Endocrinology, Affiliated Hospital of Henan Academy of Traditional Chinese Medicine, Zhengzhou, 450003, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
efficacy;
mulberry twig alkaloids tablets (Sangzhi alkaloids);
placebo;
safety;
type 2 diabetes mellitus
- MeSH:
Alkaloids;
Blood Glucose;
Diabetes Mellitus, Type 2/drug therapy*;
Double-Blind Method;
Glycated Hemoglobin A;
Humans;
Hypoglycemic Agents/therapeutic use*;
Morus;
Tablets/therapeutic use*;
Treatment Outcome
- From:
Chinese journal of integrative medicine
2022;28(4):304-311
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To assess the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids, SZ-A) for treatment of type 2 diabetes in a randomized, double-blind, placebo-controlled multicenter clinical trial.
METHODS:A total of 200 patients were randomized to receive SZ-A (n=100) or placebo (n=100) for 16 weeks. The data analysis system for electronic data capture clinical trial central randomization system was used for randomization and dispensing of drugs. The primary outcome was the change in glycosylated hemoglobin (HbA1c) level. The secondary outcome included the proportions of cases with HbA1c <7.0% and HbA1c <6.5%, fasting blood glucose (FBG), postprandial blood glucose (PBG), area under curve for the PBG (AUC0-2h), body weight, and body mass index (BMI). Adverse events (AEs), severe adverse events (SAEs), treatment-related adverse events (TAEs), gastrointestinal disorders (GDs), blood pressure, routine blood tests, and liver and kidney function were monitored.
RESULTS:Compared with baseline, the change of HbA1c at week 16 was -0.80% (95% CI: -0.98% to -0.62%) and -0.09% (95% CI: -0.27% to 0.09%) in SZ-A group and placebo group, respectively. The proportion of patients with HbA1c <7% and <6.5% was higher in the SZ-A group than in the placebo group (46.8% vs. 21.6% and 29.9% vs. 10.8%). The observed values and changes in FBG, 1 h-PBG, 2 h-PBG, and AUC0-2h differed significantly between groups (P<0.001), but differences were not significant in body weight and BMI (P>0.05). The incidence rates of AEs, TAEs, and GDs differed significantly between groups (P=0.010, P=0.005, and P=0.006, respectively), whereas the incidence rates of SAEs showed no significant differences between groups (P=1.000).
CONCLUSION:SZ-A are effective and safe for treatment of type 2 diabetes. The protocol was registered in http://www.chictr.org.cn/showproj.aspx?proj=60117 (ChiCTR2000038550).
