| Objective:To assess the clinical effectiveness of the Jianpi Huatan Prescription in treating spleen deficiency and phlegm-dampness type Polycystic Ovary Syndrome(PCOS),and to compare its efficacy and safety with metformin and lifestyle modifications in relation to sex hormone levels(LH,FSH,LH/FSH,T),blood glucose levels(FPG,FINs,HOMA-IR),blood lipid levels(TG,TC,HDL-C,LDL-C),Body Mass Index(BMI),Waist-to-Hip Ratio(WHR),Traditional Chinese Medicine(TCM)symptom scores,and black thorn skin score.The aim of this study is to provide a treatment approach that is safe,effective,and highly adherent for patients with spleen deficiency and phlegm-dampness type PCOS.Methods:Study participants were selected from patients who visited the gynecology outpatient department at the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine between January 2022 and December 2022.Utilizing a randomized controlled research design,80 patients with spleen deficiency and phlegm-dampness type PCOS who complied with the inclusion criteria were chosen and randomly divided into a control group(40 cases)and an experimental group(40 cases).The control group received metformin hydrochloride tablets(Glucophage),while the experimental group was treated with the Jianpi Huatan Prescription in addition to the metformin therapy.The treatment course lasted for three months.Changes in clinical indicators and symptom scores were observed and compared before and after treatment for both groups in order to evaluate the clinical effectiveness.Results:1.The study comprised 80 cases,with 40 cases in both the experimental and control groups.Of these,37 cases were completed in the experimental group,while the control group completed 38 cases,resulting in an overall dropout rate of 6.25%.2.Regarding the overall effectiveness,the experimental group showed an effective rate of 83.78%,while the control group showed an effective rate of 73.68%.Statistical analysis indicated that the difference between the two groups was statistically significant(P<0.05),suggesting that the overall effectiveness of the experimental group was superior to that of the control group.3.Intra-group comparisons showed a significant decrease in sex hormone levels(LH,FSH,LH/FSH,T),blood glucose levels(FPG,FINs,HOMA-IR),blood lipids levels(TG,TC,HDL-C,LDL-C),BMI,WHR,TCM syndrome score,and black thorn skin score in both groups after treatment,with statistical significance(P<0.05).4.Inter-group comparisons revealed that after 3 months of treatment,the experimental group showed significant improvements compared to the control group in terms of reducing sex hormones(LH,FSH,LH/FSH,T),blood glucose levels(FPG,FINs,HOMA-IR),blood lipids levels(TG,TC,HDL-C,LDL-C),BMI,WHR,TCM syndrome score,and black thorn skin score(P<0.05).FPG and WHR showed no significant difference between the two groups after treatment(P>0.05).Conclusion:1.The administration of Jianpi Huatan Prescription can effectively improve sex hormone levels(LH,FSH,LH/FSH,T),blood glucose levels(FPG,FINs,HOMA-IR),blood lipids levels(TG,TC,HDL-C,LDL-C),BMI,WHR,TCM syndrome score,and black thorn skin score in PCOS patients with spleen deficiency and phlegm-dampness type.2.The combination of Jianpi Huatan Prescription with western medicine treatment and lifestyle modification can better treat patients with PCOS with spleen deficiency,phlegm and dampness,which is safe,effective and with few side effects,it is suitable for use and promotion in future clinical treatment. |