Clinical Observation Of Auricular Acupoint Pressure Pill Combined With Banxiaxiexin Decoction In The Treatment Of PCOS IR With Stomach Heat And Spleen Deficiency

Objective:A randomized controlled clinical trial was conducted to evaluate the efficacy and safety of Auricular-pressure pills combined with Banxiaxiexin decoction in the treatment of PCOS complicated with IR in the type of stomach heat and spleen deficiency.Method:Patients who met the inclusion criteria and went to the gynecological clinic of Guang ’anmen Hospital,China Academy of Chinese Medical Sciences from December 2020 to December 2022 were selected and divided into observation group and control group according to random envelope method.The control group was given the drug Banxiaxiexin decoction,which was decocted by Guang ’anmen Hospital,China Academy of Chinese Medical Sciences,150ml each time,twice a day,taking it 30 minutes after meals;observation group was treated with Chinese medicine combined with auricular point pressure pills.The treatment was performed once a week and kept for 5 days each time.A total of 12 weeks were treated.The Cumulative BBT biphasic rate,the Periodic BBT biphasic rate,female hormone levels,menstrual cycle scores,FINS and 1h and 2h postprandial insulin,area under the insulin curve,HOMA-IR,FPG and 1h and 2h postprandial glucose,area under the glucose curve,lipid levels,height,weight,waist circumference,hip circumference,BMI,WHR,TCM symptom scores,liver and kidney function were compared between the two groups before and after treatment,and adverse reactions such as allergy or nausea,vomiting,diarrhea were recorded during treatment,and were calculated.Results:1.A total of 60 patients were included in this study,including 30 cases in the observation group and 30 cases in the control group;4 cases were excluded,including 2 cases in the observation group and 2 cases in the control group;a total of 56 cases,28 cases in the observation group and 28 cases in the control group,were finally completed observation,complete data and included in the statistics.2.Treatment was for 12 weeks,with 4 weeks as a menstrual cycle,and a total of 84 menstrual cycles in each of the two groups.In the observation group,21 patients in the observation group had biphasic BBT,the Cumulative BBT biphasic rate was 75.0%;a total of 42 times of BBT biphasic,the Periodic BBT biphasic rate was 50%.In the control group,16 patients showed biphasic BBT,the Cumulative BBT biphase rate was 57.1%;a total of 29 times of BBT biphasic,the Periodic BBT biphasic rate was 34.5%.The Periodic BBT biphasic rate in the observation group was better than that in the control group(P<0.05).There was no significant difference in BBT dual-phase rate between the two groups(P>0.05).3.Compared with before treatment,FINS,P1h-INS,P2h-INS,area under the curve of insulin and HOMA-IR in the observation group after treatment were significantly decreased(P<0.01;P<0.01;P<0.05;P<0.01;P<0.01).FINS in the control group decreased significantly(P<0.05).There was no significant difference in the related indicators of glucose metabolism between the two groups(P>0.05).4.Compared with before treatment,T,AND in the observation group decreased after treatment(all P<0.05).In the control group,AND decreased(P<0.05),and T did not change significantly(P>0.05).There was no significant difference between the two groups(P>0.05).5.Compared with before treatment,the menstrual cycle of the observation group and the control group were significantly improved after treatment(P<0.01;P<0.05),and the observation group was better than the control group(P<0.05).6.Compared with before treatment,no significant changes were observed in CHO,TG,LDL and HDL-C in the two groups after treatment compared with those before treatment(P>0.05);and no significant differences were observed between the two groups(P>0.05).7.Compared with before treatment,BMI and WHR in the observation group were significantly lower after treatment(all P<0.01).In the control group,BMI decreased(P<0.05).After treatment,there was no significant difference in BMI and WHR between the two groups(P>0.05).8.Compared with before treatment,the TCM symptom scores of the two groups were significantly lower after treatment(all P<0.01).And the observation group was significantly better than the control group(P>0.05).9.Compared with before treatment,the PCOS Quality of Survival Scale scores in the observation group significantly improved and SAS and SDS scores significantly decreased after treatment(all P<0.01);the PCOS Quality of Survival Scale scores in the control group significantly improved and SDS scores decreased(P<0.01;P<0.05),and no significant changes were seen in SAS compared with that before treatment(P>0.05).SAS and SDS scores in the observation group were significantly lower than those in the control group after treatment(P<0.05).10.During the treatment,there were no adverse reactions and allergic phenomena in the two groups.The liver function and renal function indexes of the two groups before and after treatment were normal.Conclusion:1.Auricular acupoint pressing pills combined with Banxiaxiexin decoction can improve ovulation disorder,adjust menstrual cycle,lower serum T and improve IR status in PCOS IR with stomach heat and spleen deficiency type,potentially regulate blood lipid level,improve clinical symptoms and negative emotions,and improve survival quality in PCOS IR patients with stomach heat and spleen deficiency,and the efficacy is better than that of Chinese medicine alone.2.Auricular acupoint pressing pills combined with Banxiaxiexin decoction is safe in the treatment of PCOS IR with stomach heat and spleen deficiency.