| Objective: In this study,the clinical symptoms and relevant laboratory indicators of patients with type 2 diabetes mellitus(T2DM)with syndrome of interior dampness-heat were observed to investigate the clinical efficacy and safety of Qingre Huashi Tiaotang decoction.Methods: In this study,a randomized controlled study design was used.A total of 66 T2 DM patients with syndrome of interior dampness-heat who met the inclusion criteria were randomly divided into the treatment group 33 cases and the control group 33 cases.Patients in both groups were given diet,exercise and other basic treatment.Patients in the treatment group were given Qingre Huashi Tiaotang decoction(granulated sugar-free type).Patients in the control group were given metformin hydrochloride(gehua zhi).The treatment course was 12 weeks.On two groups of patients before and after treatment of traditional Chinese medicine clinical symptoms integral,fasting plasma glucose(FPG),blood sugar 2 hours after meal(2h PG),glycosylated hemoglobin(Hb A1c),insulin resistance(HOMA-IR),total cholesterol(TC),triglycerides(TG),high-density lipoprotein(HDL-C),low density lipoprotein(LDL-C),body mass index(BMI),and other indicators for statistical analysis.Results:1 Baseline data comparison: There were no significant differences in age,gender,disease course,BMI,TCM symptom scores,FPG,2h PG,Hb A1 c,HOMA-IR,TC,TG,HDL-C,LDL-C between the two groups before treatment(P>0.05),suggesting comparability.2 Comparison of TCM symptom efficacy and TCM symptom score: The total effective rate of TCM syndrome in the treatment group and the control group was 87.1% and 63.33%,respectively.The total effective rate of TCM syndrome in the treatment group was better than that in the control group(P<0.05).The total score of TCM symptoms in both groups was lower than that before treatment(P<0.05),the total symptom score of the treatment group was lower than that of the control group(P<0.05).After treatment,the scores of each single TCM symptom in the treatment group were all reduced(P<0.05),the scores of each item(except for chest thoracic abdominal distention and uncomfortable stool)in the control group were all reduced(P<0.05),the treatment group was superior to the control group in the improvement of chest thoracic abdominal distension,the heaviness of head and body,bitter mouth,uncomfortable stool and dark urine(P<0.05),there was no statistically significant difference in other symptoms(P>0.05)3 Comparison of blood glucose related indicators: In both groups,FPG,2h PG and Hb A1 c were lower than before treatment(P<0.05).There was no significant difference in FPG,2h PG and Hb A1 c between the two groups after treatment(P>0.05).4 Comparison of Insulin resistance index: HOMA-IR in both groups was lower than that before treatment(P<0.05).There was no statistical significant difference in HOMA-IR between the two groups after treatment(P>0.05).5 Comparison of blood lipid related indexes:TG and TC in the two groups were lower than before treatment(P<0.05),LDL-C in the control group was lower than that before treatment(P<0.05),and HDL-C was higher than that before treatment(P<0.05).There was no significant difference in TG and TC between the two groups after treatment(P>0.05).6 Comparison of BMI: BMI in both groups was lower than that before treatment(P<0.05),and there was no statistical significant difference in BMI between the two groups after treatment(P>0.05).7 Security index: After 12 weeks of treatment,the treatment group and control group in the patient’s vital signs,routine examinations of blood,urine and fecal,liver and kidney function,electrocardiogram have been not abnormal.Conclusion:1 Qingre Huashi Tiaotang decoction can effectively improve clinical symptoms of T2 DM patients with syndrome of interior dampness-heat,regulate glucose level and lipid metabolism,improve insulin resistance and reduce weight.2 Qingre Huashi Tiaotang decoction has good safety in this experiment. |
