Objective

2

To observe the clinical effect and safety of

Banxia Xiexin Decoction

（半夏泻心汤） in treating type 2 diabetes mellitus （T2DM） and to explore the possible mechanism.

Methods

2

Eighty-two T2DM patients with cold and heat in complexity syndrome were randomly divided into treatment group （

Banxia Xiexin Decoction

prepared granules， one dose， twice a day） and control group （oral glimepiride tablets， 1mg per day）， with 41 cases in each group. After 12 weeks of treatment， traditional Chinese medicine （TCM） syndrome scores， and levels of glucagon-like peptide-1 （GLP-1） before meals and 0.5 h， 1 h， 2 h and 3 h after meals were compared between the two groups before and after treatment， and the area under the curve of GLP-1 from 0 to 3 h after the meal （GLP-1

（0-3 h）

-AUC） was calculated. The glycated hemoglobin （HbA1c） was tested before and after treatment. The oral glucose tolerance test （OGTT） was used to test the blood glucose levels before the meal and 0.5 h， 1 h， 2 h， and 3 h after the meal， and the area under the curve of glucose from 0 to 3 h after the meal （OGTT

（0-3 h）

-AUC） was calculated to test the gastrointestinal hormones including gastrin （Gas）， motilin （MLT）， somatostatin （SS）， blood lipids including cholesterol （TC）， triglycerides （TG）， low-density lipoprotein cholesterol （LDL-C）， high-density lipoprotein cholesterol （HDL-C）， and body mass index （BMI） in two groups before and after treatment. The effects regarding TCM syndromes and blood glucose were determined， and the safety was evaluated.

Results

2

Finally， thirty-six cases in each group completed the trial. The total effective rate regarding TCM syndromes in the treatment group was 77.78%， significantly higher than 44.44% in the control group （

P

＜0.01）； the total effective rate regarding blood glucose was 50.00% and 66.67% in the treatment and control group， respectively， with no significant difference between groups （

P

＞0.05）. After treatment， the levels of GlP-1

（0-3 h）

-AUC， HDL-C， SS and GLP-1 at each time point in the treatment group significantly increased， while the TCM syndrome score and the levels of HbA1c， glucose （1h and 2 h after the meal）， TC， LDL-C， BMI， Gas and MLT were significantly reduced （

P

＜0.05）. Compared to those in the control group， the TCM syndrome score and the levels of Gas， MTL， BMI and LDL-C in the treatment group significantly decreased after treatment， while the levels of GlP-1

（0-3 h）

-AUC， glucose （before the meal and 0.5 h， 1 h after the meal）， and OGTT

（0-3 h）

-AUC significantly increased （

P

＜0.05）. There were no abnormalities of the safety indicators in both groups， and no serious adverse events occurred.

Conclusion

2

Banxia Xiexin Decoction

can improve the TCM syndromes of T2DM patients with cold and heat in complexity syndrome， and is safe. It can reduce blood glucose possibly by promoting the secretion of serum GLP-1， regulating gastrointestinal hormones， and correcting lipid metabolism.