Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind,Placebo-Controlled Multicenter Clinical Study

Ling QU; Xiao-chun LIANG; Guo-qing TIAN; Gai-li ZHANG; Qun-li WU; Xiu-mei HUANG; Ya-zhong CUI; Yu-ling LIU; Zhu-fang SHEN; Guo-qing MA; Hao LU; Yi LI; Hong JIANG; Xi-yan YANG; Guang-de ZHANG; Chen-hua YANG

doi:10.1007/s11655-021-2885-9

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Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind,Placebo-Controlled Multicenter Clinical Study

Original Article | Updated：2022-03-29

- Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind,Placebo-Controlled Multicenter Clinical Study
- Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind,Placebo-Controlled Multicenter Clinical Study
- Chinese Journal of Integrative Medicine 2022年28卷第4期页码：304-311
- Affiliations：
  
  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.Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing (100050), China
  3.Department of Endocrinology,the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine, Haerbin (150001), China
  4.Department of Endocrinology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai (201203), China
  5.Department of Traditional Chinese Medicine, Beijing Hospital,Beijing (10005), China
  6.Department of Endocrinology, the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang (110034), China
  7.Department of Geriatrics, the First Affiliated Hospital of Tianjin University of Chinese Medicine, Tianjin (300073), China
  8.Department of Endocrinology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
  9.Department of Endocrinology, Affiliated Hospital of Henan Academy of Traditional Chinese Medicine, Zhengzhou (450003), China
- Author bio：
  
  Prof. LIANG Xiao-chun, E-mail: Xiaochun_Liang@yeah.net
- Funds：
  
  the National Major Science and Technology Projects of China(2013ZX09101005)
- DOI：10.1007/s11655-021-2885-9
  中图分类号：
- 纸质出版日期：2022-04，
  
  网络出版日期：2022-01-19，
  
  录用日期：2021-09-06
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Ling QU, Xiao-chun LIANG, Guo-qing TIAN, 等. Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind,Placebo-Controlled Multicenter Clinical Study[J]. Chinese Journal of Integrative Medicine, 2022,28(4):304-311.

Ling QU, Xiao-chun LIANG, Guo-qing TIAN, et al. Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind,Placebo-Controlled Multicenter Clinical Study[J]. Chinese Journal of Integrative Medicine, 2022,28(4):304-311.
Ling QU, Xiao-chun LIANG, Guo-qing TIAN, 等. Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind,Placebo-Controlled Multicenter Clinical Study[J]. Chinese Journal of Integrative Medicine, 2022,28(4):304-311. DOI： 10.1007/s11655-021-2885-9.

Ling QU, Xiao-chun LIANG, Guo-qing TIAN, et al. Efficacy and Safety of Mulberry Twig Alkaloids Tablet for Treatment of Type 2 Diabetes: A Randomized, Double-Blind,Placebo-Controlled Multicenter Clinical Study[J]. Chinese Journal of Integrative Medicine, 2022,28(4):304-311. DOI： 10.1007/s11655-021-2885-9.

摘要

目的

通过多中心随机双盲安慰剂对照试验评价桑枝总生物碱片 (Sangzhi alkaloids

SZ-A) 治疗2型糖尿病患者的有效性和安全性.

方法

200例受试者被随机分成桑枝总生物碱片组 (

=100) 和安慰剂对照组 (

=100) 组

干预时间16周. 采用DAS临床试验中央随机系统申请随机号和配发药物. 主要疗效指标包括治疗后的HbA1c水平较基线的变化

次要疗效指标包括治疗后HbA1c

7%和

6.5%的比例

空腹血糖 (静脉血浆

FBG) 、餐后1h血糖 (静脉血浆

1h-PBG) 、餐后2h血糖 (静脉血浆

2h-PBG) 、餐后血糖曲线下面积 (AUC

0-2h

) 、体重及体重指数 (BMI) 较基线变化值及实测值. 安全性指标包括不良事件 (AEs) 、严重不良事件 (SAEs) 、治疗相关不良事件 (TAEs) 及胃肠道症状 (GDs) 的发生率

两组间治疗后血压、血常规、肝肾功能较本组基线变化值的差异.

结果

治疗16周后SZ-A组HbA1c较基线变化值-0.80% (95% CI-0.98%~-0.62%)

安慰剂组-0.09% (95% CI-0.27%~0.09%)

协方差分析组间比较差异具有统计学意义 (

0.001) . SZ-A组HbA1c

7%和6.5%达标率分别为46.8%和29.9%

均高于安慰剂组 (21.6%和10.8%)

两组间比较差异均具有统计学意义 (

=0.001

=0.003) . 治疗16周时FPG、1h-PBG、2h-PBG及AUC

0-2h

实测值和较基线变化值于SZ-A组与安慰剂比较

差异均具有统计学意义 (

0.001) . 两组间体重和BMI比较无统计学差异 (

0.05) . AEs、TAEs及GDs发生率两组间比较差异有统计学意义 (

=0.010

=0.005

=0.006) . SAEs发生率两组间比较差异均无统计学意义(

=1.000).

结论

SZ-A是一种有效的治疗2型糖尿病的药物

安全性良好. 项目注册http://www.chictr.org.cn/showproj.aspx?proj=60117 (ChiCTR2000038550).

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 (

=100) or placebo (

=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 (AUC

0-2h

)

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 AUC

0-2h

differed significantly between groups (

0.001)

but differences were not significant in body weight and BMI (

0.05). The incidence rates of AEs

TAEs

and GDs differed significantly between groups (

=0.010

=0.005

and

=0.006

respectively)

whereas the incidence rates of SAEs showed no significant differences between groups (

=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)]

关键词

Keywords

type 2 diabetes mellitusmulberry twig alkaloids tablets (Sangzhi alkaloids)efficacysafetyplacebo

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