| OBJECTIVE:To evaluate the clinical effectiveness and safety of Banxiaxiexin Decoction in the treatment of patients with polycystic ovarian syndrome(PCOS)hyperinsulinemia(HI),providing clinical evidence for traditional Chinese medicine treatment of PCOS.METHODS:Patients with PCOS HI(stomach heat and spleen deficiency)who met the inclusion criteria were selected when they were consulted at Guang’anmen Hospital,China Academy of Traditional Chinese Medicine from May 2018 to November 2019.Patients were divided into the traditional Chinese medicine(TCM)group and the control group,on the base of block random.The traditional Chinese medicine group was treated with Banxiaxiexin Decoction,and the control group was treated with metformin.Taking 12 weeks as the course of treatment,the glucose metabolism,reproduction,lipid metabolism,and safety indicators of the two groups were observed and compared before and after treatment.They are fasting insulin(FINS),fasting glucose(FG),homeostasis model assessment-insulin resistance index(HOMA-IR),normal insulin compliance rate;female hormones(testosterone,estradiol,follicle-stimulating hormone,luteinizing hormone,prolactin),menstrual cycle scores,basal body temperature biphasic rate;lipids(high-density lipoprotein,low-density lipoprotein,cholesterol,triglyceride);body mass indexes(BMI),waist-hip ratio(WHR);TCM symptom scores;liver and kidney function(alanine transaminase,aspartate transaminase,creatinine,blood urea nitrogen),as far as the incidences of diarrhea,nausea,and vomiting during treatment.Analyze the results statistically.RESULTS:1.A total of 72 patients were included,including 54 cases in the TCM group and 18 cases in the control group.10 cases were excluded,including 7 cases in the TCM group and 3 cases in the control;a total of 62 cases completed the observation with complete data and entered analysis,including 47 cases in the TCM group and 15 cases in the control.2.Compared with before treatment,FINS and HOMA-IR in the traditional Chinese medicine group were significantly declined after treatment(P<0.01),while FINS and HOMA-IR in the control group had a downward trend with no statistical significance(P>0.05).The rate of FINS normal compliance in the Chinese medicine group was 48.9%,and the rate was 40%in the control group.There were no significant differences in FINS,HOMA-IR,and FINS compliance rates between the two groups after treatment(P>0.05).3.Compared with before treatment,T in both group showed a downward trend after treatment,while FSH and E2 showed an upward trend(P>0.05).There was no significant difference in the levels of reproductive hormones between the two groups after treatment(P>0.05).4.Compared with before treatment,the menstrual cycle scores of the two groups were significantly declined(P<0.01),and there was no significant difference between the TCM group and the control(P>0.05).After 12 weeks of treatment,the number of patients recovering biphasic BBT in the Chinese medicine group was 24(51.1%),and the Periodic BBT biphasic rate of the TCM group was 28.9%,while it was 13.3%and 8.9%of the control group.There was a significant difference between the two groups(P<0.05,P<0.01).5.After treatment in the Chinese medicine group,there was a negative correlation between the incidence of BBT and the level of FINS(r=-0.315,P=0.04).6.Compared with before treatment,LDL-C,CHO and TG in both groups showed a downward trend after treatment(P>0.05),and HDL-C in the TCM group showed an upward trend(P>0.05).After treatment in the TCM group,BMI decreased(P<0.05),and WHR tended to decrease(P>0.05).After treatment,there was no significant difference in blood lipid,BMI and WHR between the two groups..7.Compared with before treatment,the TCM symptom score of the Chinese medicine group was significantly declined after treatment(P<0.01),while the TCM symptom score of the control group had a tendency to decrease with no statistically significant difference(P>0.05).There was no significant difference between the two groups after treatment(P>0.05).8.Compared with before treatment,the ALT and AST of the TCM group decreased after treatment(P<0.05),and there was no significant difference in the control group(P>0.05).There was no significant change in Cr and BUN before and after treatment in both groups(P>0.05),which were within the normal range.During the treatment period,no adverse reactions occurred in the Chinese medicine group,and the incidence of adverse reactions in the control group was 26.7%.CONCLUSION:1.Banxiaxiexin Decoction can effectively reduce FINS levels and improve insulin sensitivity in patients with PCOS HI(stomach heat and spleen deficiency).2.Banxiaxiexin Decoction can improve the clinical symptoms of patients with PCOS HI(stomach heat and spleen deficiency),and improve the menstrual condition of the patient,as much as help improve the ovulation function.3.Banxiaxiexin Decoction for the treatment of PCOS HI with stomach heat and spleen deficiency has certain safety. |
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