Clinical Efficacy Of Jiawei Xiaoyao Powder In The Treatment Of Newly Diagnosed Type 2diabetes With Liver Stagnation And Spleen Deficiency

Objective: The purpose of this study was to observe the clinical efficacy of Jiawei Xiaoyao Powder combined with metformin in the treatment of newly diagnosed type 2 diabetes mellitus with liver depression and spleen deficiency,and to explore the effectiveness and safety of Jiawei Xiaoyao Powder,so as to provide theoretical guidance and research basis for the wide application of Jiawei Xiaoyao Powder.Methods: From January 2022 to October 2022,a total of 74 subjects who met the inclusion and exclusion criteria in the Department of Endocrinology,Shijiazhuang Hospital of Traditional Chinese Medicine(East Campus),Hebei Province were continuously included in this study.According to the basic principle of complete randomization,the included subjects were divided into control group(EJSGZ)and treatment group(EJSGXYSJWZ),with 37 cases in each group.Both groups received basic treatment of diabetes.EJSGZ was treated with metformin hydrochloride tablets(0.5g,3 times a day,oral after breakfast,lunch and dinner).EJSGXYSJWZ was treated with Jiawei Xiaoyao Powder(200ml,twice a day,orally after breakfast and dinner)combined with metformin hydrochloride tablets(0.5g,3 times a day,orally after breakfast,lunch and dinner).The treatment cycle was 12 weeks,and the situation and adverse events were recorded,as well as the changes of fasting blood glucose before and after treatment,2h postmeal blood glucose,glycated hemoglobin,fasting insulin,insulin resistance index,self-rating scale for depression,self-rating scale for anxiety,quantitative score of TCM syndrome and safety indicators.The changes of blood glucose level,insulin level,mood fluctuation and TCM symptoms were observed.Statistical analysis software IBM SPSS Statistics 26.0 was used for data processing,and the differences of the above indicators between the two groups of subjects after different treatment schemes were compared,and the curative effect was comprehensively evaluated.Results: In the course of this clinical trial,4 cases were lost to follow-up,and a total of 70 cases were finally completed,35 cases each of EJSGZ and EJSGXYSZ.After recording the data and statistical analysis,the following results were obtained:(1)Before treatment,there was no significant difference in baseline data(gender,age,height,weight)(P >0.05).(2)In terms of blood glucose indexes,fasting blood glucose,2h postprandial blood glucose and glycated hemoglobin in two groups were statistically significant compared with those before treatment(P < 0.05);There were significant differences in fasting blood glucose,2 h postprandial blood glucose and glycosylated hemoglobin between the two groups(P < 0.05).(3)In terms of insulin indexes,fasting insulin and insulin resistance index were significantly different between the two groups compared with those before treatment(P < 0.05);There were significant differences in insulin resistance index and fasting insulin between the two groups(P < 0.05).(4)In the mood self-rating scale,before and after treatment,there was no statistically significant difference in EJSGZ in the depression self-rating scale and anxiety self-rating scale(P > 0.05),but there was statistically significant difference in EJSGXYSJWZ in the depression self-rating scale and anxiety self-rating scale(P < 0.05);There were statistically significant differences in self-rating depression scale and self-rating anxiety scale between the two groups(P < 0.05).(5)In the total score of TCM syndrome quantification,there was a statistically significant difference in the total score of TCM syndromes between the two groups before and after treatment(P < 0.05).The difference between the two groups was statistically significant(P < 0.05).In the single score of TCM syndromes,before and after treatment,there were statistically significant differences between the two groups in hypochondriac pain,abdominal distension,emotional depression or irritability,fatigue,sighing,borborygmus,pulse string or threadiness(P < 0.05).In addition,EJSGXYSJWZ also had statistically significant differences in poor appetite,loose stools,thin white or greasy tongue coating(P < 0.05).There were significant differences between the two groups in hypochondriac pain,emotional depression or irritability,poor appetite,loose stools,fatigue,sighing,thin white or greasy tongue coating(P < 0.05).In summary,in the determination of the efficacy of the main test indicators,the total effective rate of EJSGZ was 65.71 %,and the total effective rate of EJSGXYSJWZ was 88.6 %.The difference between the two groups was statistically significant(P < 0.05);in the determination of syndrome efficacy,the total effective rate of EJSGZ was 57.19 %,and the total effective rate of EJSGXYSZ was 85.71 %.The difference between the two groups was statistically significant(P < 0.05).In terms of safety : the safety indexes of the two groups before and after treatment were within a reasonable range,which was a normal physiological fluctuation.The incidence of adverse reactions in EJSGZ was 11.42 %,and there was no obvious adverse reaction in EJSGXYSJWZ.There was no significant difference between the two groups(P > 0.05).Conclusion: Both groups can regulate blood glucose and insulin secretion,improve mood and TCM syndromes in the treatment of newly diagnosed type 2 diabetes mellitus with liver depression and spleen deficiency.Among them,EJSGXYSJWZ applied Jiawei Xiaoyao Powder combined with western medicine metformin in improving fasting blood glucose,postprandial 2h blood glucose,glycosylated hemoglobin,fasting insulin level insulin resistance index,self-rating depression scale,self-rating anxiety scale,TCM syndrome quantitative score index.The advantages are significant,and no adverse reactions occur,which has clinical promotion value.