Clinical Observation Of Modified Xiangshaliujunzi Decoction In Treating Prediabetes (Spleen Deficiency And Phlegm Dampness Type)

Objective: To observe and analyze the clinical efficacy of modified Xiangshaliujunzi decoction on the patients with spleen deficiency and phlegm dampness type of pre-diabetes,evaluate its effectiveness,feasibility and safety,and tap the advantages of traditional Chinese medicine,so as to provide clinical reference for the treatment and drug development of the patients with spleen deficiency and phlegm dampness type of pre-diabetes in the future.Methods: From January 2022 to October 2022,70 patients with prediabetes(spleen deficiency and phlegm dampness syndrome)who met the inclusion criteria and were collected in the outpatient department,ward and health examination center of the Endocrine Department of Shijiazhuang City Hospital of Traditional Chinese Medicine were selected.These patients were randomly divided into a control group and a treatment group with 35 cases in each group by using the digital table method.Both the treatment group and the control group were given lifestyle intervention(health education,diet guidance,exercise guidance,weight control guidance,and psychological support).The treatment group was treated with modified Xiangshaliujunzi Decoction.The treatment time of both groups was one course of treatment(90 days).The fasting blood glucose(FPG),postprandial 2h blood glucose(2h PG),glycosylated hemoglobin(Hb A1c),fasting serum insulin(FINS),insulin resistance index(HOMA-IR),and pancreatic islets were observed in the two groups β Cell function index(HOMA-β)、 Changes of blood lipid indicators(TC,TG,HDL-C,LDL-C),body weight,body mass index(BMI),waist hip ratio(WHR)and TCM syndrome score before and after treatment.After collecting and sorting clinical research data,data processing and statistical analysis were conducted through SPSS 27.0 software,so as to comprehensively analyze the therapeutic effect of modified Xiangsha liujunzi Decoction on the treatment of spleen deficiency and phlegm dampness diabetes in the early stage.Results:(1)Compared before and after treatment,FPG,2h PG in the two groups and Hb A1 c in the treatment group were significantly lower than before,(P<0.01),while Hb A1 c in the control group was lower than before,the difference is statistically significant(P<0.05);After treatment,there was significant difference in FPG and 2h PG between the two groups(P<0.01),and there was significant difference in Hb A1 c between the two groups(P<0.05).(2)Compared before and after treatment,FINS in the treatment group and HOMA-IR,HOMA-β in both groups were improved significantly(P<0.01),while FINS in the control group were improved,the difference was statistically significant(P<0.05).After treatment,there were significant differences in FINS and HOMA-IR between the two groups(P<0.01),but no significant differences in HOMA-β between the two groups(P>0.05).(3)Compared before and after treatment,TC,TG in the treatment group and LDL-C in the two groups were significantly decreased compared with before,the difference was significant(P<0.01);TC and TG in the control group were decreased compared with before,the difference was statistically significant(P<0.05);HDL-C in the two groups had no statistically significant(P>0.05).After treatment,there were statistically significant differences in TC and LDL-C between the two groups(P<0.05),but no statistically significant differences in TG and HDL-C between the two groups(P>0.05).(4)Before and after treatment,the body weight,BMI and WHR of the two groups were decreased,and the differences were significant(P<0.01).After treatment,there were statistically significant differences in body weight and BMI between the two groups(P<0.05),but no statistically significant differences in WHR between the two groups(P>0.05).(5)After treatment,the total scores of TCM syndrome in the two groups decreased compared with before,and the difference was significant(P<0.01);After treatment,the difference between groups was significant(P<0.01).After treatment,the scores of each single symptom of TCM in the control group were lower than before,the difference was statistically significant(P<0.05),and the scores of each single symptom of TCM in the treatment group were significantly lower than before,the difference was significant(P<0.01).After treatment,the scores of each single symptom of TCM were significantly different between the two groups(P<0.01).(6)The total effective rate of the TCM syndrom was 61.76% in the control group and 88.24% in the treatment group,the difference was statistically significant(P<0.05).The total effective rate of the control group was 52.94%,and the treatment group was 85.29%,the difference was statistically significant(P<0.05).(7)There were no obvious adverse reactions in the two groups during the treatment.Conclusion:(1)Modified Xiangshaliujunzi decoction is effective in the treatment of pre-diabetes(spleen deficiency and phlegm dampness type),and can effectively improve the clinical symptoms of patients.(2)On the basis of lifestyle intervention,modified Xiangshaliujunzi decoction can reduce FPG,2h PG and Hb A1c;Reduce FINS,improve IR,and increase islets β Cell function;Reduce the levels of TC,TG and LDL-C in blood lipids;Reduce weight,BMI and WHR,except for improving isletsβ cell function,TG reduction and WHR reduction is similar to that of lifestyle intervention,all of them had better efficacy than simple lifestyle intervention.Especially in reducing FPG,reducing 2h PG,reducing FINS,improving IR and improving symptoms of traditional Chinese medicine,it shows significant advantages,and has good safety,worthy of promotion and application in clinical treatment.