Intervention Study Of Fenxiao Pills On Damp-heat Constitution With Impaired Glucose Tolerance

Objective: In this study,by observing the intervention efficacy of Fenxiao Pills and lifestyle on people with impaired glucose tolerance and damp-heat constitution,and comparing the constitution scores of TCM and various test indicators,its effectiveness and safety were verified,so as to explore an optimal health management scheme to promote the transformation of constitution and improve impaired glucose tolerance.Methods : The observation objects of this study were from the medical examiners and recruited patients from the Treatment Center of Traditional Chinese Medicine Hospital Affiliated to Southwest Medical University.Subjects who met the diagnosis and inclusion criteria were screened.Based on the calculation results of the sample size,70 patients were selected and included in the group,according to the principle of randomization.Divide them into treatment group and control group with 35 cases each,and conduct clinical observation according to the single-blind,control method.In the treatment group,on the basis of giving lifestyle guidance,Fenxiao Pills were taken orally at the same time for 12 weeks of observation.The control group was only given lifestyle guidance such as diet allocation,exercise and exercise,and was observed for 12 weeks.Fill out and collect the "Self-Management Behavior Scale" every week,follow up and evaluate compliance with all subjects,and record adverse reactions.Before and after the intervention,the two groups of subjects were tested once each.Comparing the changes of blood lipid-related indicators(TG,HDL-C,LDL-C),blood glucose-related indicators(2h PG,FPG,Hb A1c),body mass index(BMI),waist-to-hip ratio(WHR)and TCM physical fitness score before and after.Statistical analysis was performed on the obtained data with SPSS 22.0 statistical software to evaluate the efficacy and safety of Fenxiao Pills’ intervention in people with impaired glucose tolerance and damp-heat constitution.Results:(1)There are seventy cases included in the study,and sixty-six cases were finally completed,including thirty-three cases in the Fenxiao Pills group and thirty-three cases in the lifestyle intervention group.The general baseline indicators of the two groups of subjects were not obviously different before treatment(P>0.05).(2)Analysis based on damp-heat constitution: In terms of the score of damp-heat constitution,neither the Fenxiao Pills group nor another group had obvious difference before intervention(P>0.05).After treatment,the constitution scores in the Fenxiao Pills group decreased to a greater extent than before(P<0.05),but the scores in the Fenxiao Pills group were lower than those in the lifestyle intervention group(P<0.05).(3)Analysis based on blood glucose related indicators: In terms of 2h PG,FPG and Hb A1 c,neither the Fenxiao Pills group nor another group had obvious difference before intervention(P>0.05).Both the Fenxiao Pills group and the lifestyle intervention group decreased at 2h PG,FPG and Hb A1 c after treatment compared to before intervention(P<0.05),and the two groups had similar effects in regulating FPG(P>0.05).However,the Fenxiao Pills group was better than the lifestyle intervention group in regulating 2h PG and Hb A1c(P<0.05).(4)Analysis based on blood lipid related indicators: In terms of TG,HDL-C and LDL-C,neither the Fenxiao Pills group nor another group had obvious difference before intervention(P>0.05).After treatment,TG and LDL-C in the two groups decreased compared with before intervention(P<0.05),but HDL-C did not improve(P﹥0.05).Moreover,the Fenxiao Pills group and the lifestyle intervention group had equivalent effects in regulating TG,HDL-C and LDL-C(P>0.05).(5)Other indicators: In terms of BMI and WHR,neither the Fenxiao Pills group nor the lifestyle intervention group had obvious difference before intervention.After treatment,the BMI and WHR of the two groups were lower than before intervention(P<0.05).(6)Neither the Fenxiao Pills group nor the lifestyle intervention group had any related adverse reactions during the intervention period.Conclusion:(1)Both groups of intervention methods can reduce the damp-heat constitution score of patients with impaired glucose tolerance and damp-heat constitution,and promote the transformation to a peaceful constitution,but the Fenxiao Pills group is better than the simple lifestyle intervention group.(2)Both groups of intervention methods can reduce FPG,2h PG and Hb A1 c in patients with impaired glucose tolerance and damp-heat constitution.But in the regulating of 2h PG and Hb A1 c,the Fenxiao Pills group is better than the simple lifestyle intervention group.(3)Both intervention methods can reduce TG and LDL-C in patients with impaired glucose tolerance and damp-heat constitution,but neither can improve HDL-C.(4)The two intervention methods can reduce the WHR and BMI of patients with impaired glucose tolerance and damp-heat constitution,and there is no significant difference.(5)Fenxiao pills have high safety and can be popularized and applied in clinical practice.