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)
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Acknowledgments
The authors would like to thank Prof. ZHENG Qing-shan, Pharmaceutical Clinical Research Center of Shanghai University of Traditional Chinese Medicine, for his statistical support. In addition, we thank the participants, experimenters, and researchers for their participation. We thank LetPub (https://www.letpub.com) for its linguistic assistance during the preparation of this manuscript. Prof. LIANG **ao-chun is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
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Qu L wrote the manuscript and performed clinical research on the patients at the center. Liang XC and Tian GQ were responsible for the project design, coordination, article review, and clinical research. Liu YL and Shen ZF were responsible for drug development. Zhang GL, Wu QL, Huang XM, Cui YZ, Ma GQ, Lu H, Li Y, Jiang H, Yang XY, Zhang GD, and Yang CH were responsible for clinical research at their corresponding centers.
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We confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this study that could have influenced its outcome.
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Supported by the National Major Science and Technology Projects of China (No. 2013ZX09101005)
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Qu, L., Liang, Xc., Tian, Gq. 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. Chin. J. Integr. Med. 28, 304–311 (2022). https://doi.org/10.1007/s11655-021-2885-9
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DOI: https://doi.org/10.1007/s11655-021-2885-9