健脾祛湿化痰方治疗脾虚痰湿型多囊卵巢综合征随机双盲对照临床研究OA

Objective:To evaluate the clinical efficacy and safety of the Jianpi Qushi Huatan formula in treating spleen deficiency with phlegm-dampness pattern polycystic ovary syndrome(PCOS).Methods:A randomized,double-blind,placebo-controlled trial enrolled 64 patients with spleen deficiency and phlegm-dampness pattern PCOS,divided into an observation group and a control group(32 patients each).The observation group received oral administration of the Jianpi Qushi Huatan formula granules,while the control group received a placebo with identical appearance and odor.The treatment course lasted 3 months.Primary outcome measure:spontaneous ovulation rate.Secondary meas-ures:anthropometric parameters(body mass index,waist-to-hip ratio),clinical manifestations of hyper and rogenism(hirsutism,acne,alopecia),glucose and lipid metabolism indicators,sex hormone levels,quality of life scores(PCOSQ)and anxiety and depression scores(HADS-A/D).Results:The monthly spontaneous ovulation rate in the observation group was 48.89％,significantly higher than the 19.05％in the control group(P＜0.01).Post-treat-ment,the observation group demonstrated superior improvements compared to the control group in BMI,WHR,insu-lin resistance index,testosterone levels,and LH/FSH ratio(all P＜0.05).Additionally,the observation group exhibi-ted significantly enhanced quality of life scores(PCOSQ)and markedly reduced HADS-A/D(P＜0.05).No drug-re-lated adverse reactions occurred in either group.Conclusion:The Jianpi Qushi Huatan formula effectively promotes spontaneous ovulation in PCOS patients with spleen deficiency and phlegm-dampness pattern,improves metabolic disorders,hormone levels,and quality of life,with good safety.