| Objective: To observe the effects of modification of Xiao Xian Xiong Decoction and Kuo Lou Mu Li Decoction on symptoms,islet ?-cell function,blood glucose and blood lipid related indexes,body mass index and blood pressure,etc.in patients with pre-diabetes and phlegm-heat syndrome.To investigate the related TCM theories and clinical significance of this prescription for patients with prediabetes and phlegm-heat syndrome.Methods: It's a randomized and controlled trial,70 patients with prediabetes who met the inclusion criteria and screened by the exclusion criteria were randomly divided into 2 groups by the method of random number table.Both treatment group and control group were given the basic treatments(diabetes health education which contains disease knowledge,diet instruction,physical exercise instruction,weight loss instruction and psychological support);then the treatment group plus the basic treatment with the decoction of "modification of Xiao Xian Xiong Decoction and Kuo Lou Mu Li Decoction ".After 12 weeks of observation,all the indexes both groups were recorded.The indexes include general data(vital signs,BMI),laboratory testing index(fasting and postprandial 2 hours blood glucose,Hb A1 c,fasting insulin,HOMA-?,HOMA-IR,blood lipid indexes,etc.),and TCM symptoms integral,safety indicator.The changes of these indexes were analyzed statistically using SPSS21.0 software.Results:(1)Evaluation of TCM efficacy: The scores of TCM symptoms in both groups decreased after treatment,the differences between before and after treatment had statistical significance in both two groups(P<0.01).The total effective rate of treatment group was approximately 84.85%,which in the control group was 30.30%.After treatment,the difference between the two groups had statistical significance(P<0.01).(2)Blood glucose index: Statistical differences of FPG,P2 h PG and Hb A1 c between before and after treatment were found in the control group(P<0.05),and the total effective rate of reducing blood glucose was 72.73%.There were significant differences between before and after treatment of FPG,P2 h PG and Hb A1 c in the treatment group(P<0.01),and the total effective rate of reducing blood glucose was 87.88%.After treatment,the difference of FPG,P2 h PG and Hb A1 c between the two groups was significant(P<0.01).(3)Islet ?-cell function and insulin resistance index: in the control group,islet ?-cell function index(HOMA-?)increased while the FINS and insulin resistance index(HOMA-IR)decreased,with significant difference between before and after treatment(P<0.01).In the treatment group,the islet ?-cell function index(HOMA-?)increased while the FINS and insulin resistance index(HOMA-IR)decreased,and the difference was significant between before and after treatment(P<0.01).After treatment,the statistical differences between the two groups were found in the indexes of FINS,HOMA-IR and HOMA-?(P<0.05),and the differences in FINS,HOMA-IR between the two groups were significant(P<0.01).(4)Blood lipid index: Statistical differences of TG and HDL-C before and after treatment were found in the control group(P<0.05),while there was no statistically difference in TC and LDL-C indexes between before and after treatment(P>0.05).The indexes of TC,TG and HDL-C in the treatment group were significantly different between before and after treatment(P<0.01).There was no statistical difference in LDL-C between before and after treatment(P>0.05).After treatment,there was no statistical difference in blood lipid index between the two groups(P>0.05).(5)BMI: The difference of BMI between before and after treatment in the control group was statistically significant(P<0.01).The difference of BMI between before and after treatment in the treatment group was statistically significant(P<0.01).After treatment,there was no statistically difference in BMI between the two groups(P>0.05).(6)Blood pressure: The difference between before and after treatment of SBP in the control group was statistically significant(P<0.01),while there is no statistical difference between before and after treatment of DBP(P>0.05).The differences of SBP and DBP in the treatment group between before and after treatment were statistically significant(P<0.01).After treatment,there were statistically significant differences of SBP and DBP between the two groups(P<0.01).(7)Safety indicator: All subjects' safety indicators(vital signs,electrocardiogram,blood routine,stool for routine,urine routine,liver function and kidney function)were normal during the treatment,and no adverse events occurred during the whole research.(8)Follow-up study: after 12 weeks of follow-up,no patients in both groups developed confirmed diabetes,and no adverse reaction or symptom of discomfort were observed.The follow-up data reflected that the modification of Xiao Xian Xiong Decoction and Kuo Lou Mu Li Decoction combined with basic treatment intervention decrease the incidence of diabetes in those with prediabetes in a degree.Conclusion: According to the analysis of the experimental results,the therapeutic effect of this prescription on the subjects mainly includes lowering blood glucose,regulating blood lipid,regulating blood pressure,controlling body weight,restoring pancreatic islet function to a certain extent,improving insulin resistance,and having less toxic and side effects.This study demonstrated that the adoption of lifestyle intervention has good significance for the improvement of various indicators of prediabetes patients.However,under the guidance of treatment principle which includes clearing heat,removing phlegm,nourishing Yin and promoting fluid production,and adopt” the modification of Xiao Xian Xiong Decoction and Kuo Lou Mu Li Decoction " in combination with lifestyle intervention to treat the subjects in prediabetic phase with phlegm-heat syndrome has more obvious curative effect advantages compared with the control group.According to the results of follow-up investigation,this therapeutic intervention in our research can effectively control the progression of prediabetes,which is worthy of more clinical application,and its internal mechanism of action is worthy for further study. |
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