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Objective: To evaluate the effects of Chinese medicine Dingkun Pill(定坤丹) alone or in combination with Diane-35 on patients with polycystic ovary syndrome (PCOS).Methods: This is a prospective randomized controlled trial conducted at Peking Union Medical College Hospital Beijing,China,from December 2016 to September 2017.Totally 117 PCOS patients were randomly assigned to the Dingkun Pill group (38 cases),Diane-35 group (40 cases),or combined group (39 cases).Patients in the Dingkun Pill group or Diane-35 group took daily 7 g of oral Dingkun Pill or 1 tablet of oral Diane-35,respectively,for 21 consecutive days followed by 7 drug-free days.And the combined group received a combination of Dingkun Pill and Diane-35.The treatment course was 3 months.Fasting plasma glucose and insulin,total cholesterol (TC),low-density lipoprotein cholesterol (LDL-C),triglycerides (TG),free fatty acids (FFA) and sex hormones were analyzed,quantitative insulin sensitivity check index (QUICKI) was calculated,and menstruation and acne scores were recorded at baseline and after 3-month treatment.Results: Compared with before treatment,QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P＜0.05);TC,LDL-C and FFA decreased significantly in the Dingkun Pill group (P＜0.01),LDL-C also decreased obviously in the Diane-35 group (P＜0.01),while TC increased significantly in the combined group (P＜0.01),TG increased significantly in all groups (P＜0.01);total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P＜0.01);acne scores were improved in all groups (P＜0.01).After treatment,TC and FFA in the Dingkun Pill group were significantly lower than the Diane-35 group (P＜0.05 or P＜0.01);TT was lower and regular menstruation rate was higher in the Diane-35 and combined groups than the Dingkun Pill group (P＜0.01),and no differences were observed between Diane-35 group and combined group (P＞0.05).Conclusions: Dingkun Pill showed better effects than Diane-35 in improving insulin sensitivity,lowering TC and FFA.Diane-35 was more efficient in regulating menstruation and lowering androgen than Dingkun Pill.Combination of Dingkun Pill and Diane-35 may be a better choice to regulate menstruation,lower androgens while improve glucose metabolism in PCOS patients.(Registered on ClinicalTrials.gov,registration No.NCT03264638)