Abstract:

Objective To investigate the therapeutic effect of a modified Wumei Pill in the treatment of diabetic gastroparesis （DGP） and its impact on insulin-like growth factor-1 （IGF-1） and transmembrane protein 16A （ANO1）， based on the theory of regulating both cold and heat conditions. Methods A total of 108 patients with DGP who were admitted to the Department of Traditional Chinese Medicine of Xuancheng People's Hospital from January 2022 to June 2025 were randomly divided into the control group （n = 54） and the Wumei Pill group （n = 54） by using a random number table. The control group received treatment with Mosapride Dispersible Tablets， whereas the Wumei Pill group was treated with Mosapride Dispersible Tablets plus modified Wumei Pill. The treatment course for both groups was 4 weeks. The clinical efficacy of the two groups after 4-week treatment was compared. The Traditional Chinese Medicine （TCM） syndrome score， intestinal flora， glucose metabolism， IGF-1， ANO1， gastrointestinal hormones， and gastric emptying levels were evaluated and compared respectively before treatment and 4 weeks after treatment. Meanwhile， the safety during the treatment period was recorded and compared. Results After 4 weeks of treatment， the total effective rate of the Wumei Pill group reached 88.89% （48/54）， which was significantly higher than that of the control group （72.22%， 39/54） （P < 0.05）. When compared with the pre - treatment status， after 4 weeks of treatment， the levels of serum pepsinogen Ⅰ （PG Ⅰ）， pepsinogen Ⅱ （PG Ⅱ）， and IGF-1， as well as the colony numbers of Bifidobacterium， Lactobacillus， and Bacteroides in fecal samples， increased in both groups. Moreover， these values were significantly higher in the Wumei Pills group （P < 0.05）. In comparison to the pre - treatment situation， after 4 weeks of treatment， the TCM syndrome scores （including epigastric fullness， acid reflux， and loose stools）， serum gastrin （GAS）， fasting blood glucose （FBG）， 2-hour postprandial blood glucose （2hPG）， ANO1 levels， and the colony numbers of Enterobacterium and yeast in fecal samples decreased in both groups. Notably， the levels in the Wumei Pill group were significantly lower （P < 0.05）. When compared with the pre-treatment period， the gastric emptying time of both groups was shortened after 4 weeks of treatment， and it was significantly shorter in the Wumei Pill group （P < 0.05）. Conclusions Based on mosapridi dispersive tablets， the application of modified Wumei Pills in the treatment of DGP using the cold-heat combined regulation method has a better therapeutic effect. It could regulate the expression of gastrointestinal hormones and intestinal flora， improve glucose metabolism， increase the level of IGF-1， reduce the level of ANO1， improve traditional Chinese medicine syndromes， and promote gastric emptying， with good safety.

Key words: balancing cold and heat, modified Wumei Pill, diabetic gastroparesis, efficacy, gastrointestinal hormones, intestinal flora, insulin-like growth factor-1, transmembrane protein 16A