Efficacy and metabolic mechanism of decoction for replenishing kidney and dispelling turbid on abnormal uterine bleeding in obese PCOS based on single-arm objective performance criteria
Objective It is to explore the clinical efficacy and safety of decoction for replenishing kidney and dispelling turbid in the treatment of abnormal uterine bleeding in obese polycystic ovary syndrome(PCOS)by single-arm objective performance criteria,and to explore its mechanism by metabolomics technology.Methods Eighty patients who were diag-nosed as obese PCOS with abnormal uterine bleeding and identified as syndrome of splee-kidney deficiency and Yangming turbid-heat in the gynecology outpatient clinic of Beijing Hospital of Traditional Chinese Medicine from January 2022 to June 2023 were selected and treated with decoction for replenishing kidney and dispelling turbid for 12 weeks.The serum levels of sex hormones[testosterone(T),follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2),pro-gesterone(P),anti-mullerian hormone(AMH)]before and after treatment,pregnancy rate after treatment,basal body temperature(BBT)ovulation rate,Pictorial Blood Loss Assessment Chart(PBAC)scores,bleeding time,Chinese medi-cine syndrome scores,obesity indicators[weight,body mass index(BMI),waist circumference,hip circumference,waist-to-hip ratio],indicators of glucose and lipid metabolism[fasting insulin(FINS),fasting glucose(FPG),insulin re-sistance index(HOMA-IR),total cholesterol(TC),triacylglycerol(TG),low-density lipoprotein cholesterol(LDL-C),high-density lipoprotein cholesterol(HDL-C),apolipoprotein A1(Apo A1),apolipoprotein B(Apo B),small dense-low-density lipoprotein cholesterol(sdLDL-C),homocysteine(Hcy)],ultrasonographic indicators(endometrial thickness,o-varian volume,follicle number),inflammatory factor indicators[interleukin(IL)-2,IL-4,IL-6,IL-17,tumor necrosis factor-α(TNF-α)]before and after treatment and safety were observed,and metabolomics was used to screen the fecal dif-ferential metabolites and pathways before and after treatment in the patients.Results The serum level of T was(60.13±26.49)ng/dL after12 weeks of treatment,its upper limit of the95%confidence interval was lower than the target value and the point estimate was better than the target value.The pregnancy rate reached 26.67%(8/30)after treatment;the BBT ovulation rate and serum levels of HDL-C and Apo A1 were significantly higher than those before treatment(all P<0.05),and the PBAC scores,Chinese medicine syndrome scores,bleeding time,weight,BMI,waist circumference,hip circumference,waist-hip ratio,and serum levels of LH,LH/FSH,FPG,FINS,HOMA-IR,TC,LDL-C,Apo B,sd LDL-C,IL-2,IL-6,and TNF-α were significantly lower than those before treatment(all P<0.05),and the number of follicles was significantly less than that before treatment(all P<0.05);there were no serious adverse reactions occurred.Fecal metabolomics studies before and after treatment identified 96 differential metabolites and screened 71 pathways.Conclusion Decoction for replenishing kidney and dispelling turbid can is effective in the treatment of obesity and abnormal uterine bleeding in obese PCOS patients,it can increase the ovulation rate of BBT,promote pregnancy,correct hormonal imbal-ance,insulin resistance and disorders of glucose and lipid metabolism,and improve the state of ultrasound-induced ovarian polycystic degeneration and chronic inflammation with good safety.The decoction positively affects the metabolic pathways and modulates PCOS patients in several ways.
polycystic ovary syndromeabnormal uterine bleedingobesitydecoction for replenishing kidney and dis-pelling turbidmetabolomics
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