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 tria...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)。展开更多
Objective: To assess the ef?cacy and safety of the Chinese medicine Dingkun Pill(定坤丹,DKP) on insulin resistance in women with polycystic ovary syndrome(PCOS).Methods: A total of 117 women with PCOS were randomly as...Objective: To assess the ef?cacy and safety of the Chinese medicine Dingkun Pill(定坤丹,DKP) on insulin resistance in women with polycystic ovary syndrome(PCOS).Methods: A total of 117 women with PCOS were randomly assigned to Group A(38 women),Group B(40 women),or Group C(39 women) in a randomization sequence with SAS software and a 1:1:1 allocation ratio using random block sizes of 6,and were given 7 g of oral DKP daily(Group A),1 tablet of Diane-35 orally daily(Group B),or 7 g of oral DKP daily plus 1 tablet of Diane-35 orally daily(Group C).Patients took all drugs cyclically for 21 consecutive days,followed by 7 drug-free days.The treatment course for the 3 groups was continued for 3 consecutive months.Oral glucose tolerance tests(OGTT)were performed before treatment and again after 2 and 3 months of therapy,respectively,and homeostasis model assessment for insulin resistance(HOMA-IR) and quantitative insulin sensitivity check index(QUICKI) were calculated.Results: Of 117 women with PCOS,110 completed the entire course of therapy: 35 in Group A,36 in Group B,and 39 in Group C.After treatment,all three groups showed signi?cant decreases in fasting glucose: at1 h glucose decreased signi?cantly in Group A(by 0.5±1.4 mmol/L,P=0.028) and Group C(by 0.5±1.2 mmol/L,P=0.045); while showing a tendency to increase in Group B(by 0.4±1.9 mmol/L,P=0.238).HOMA-IR decreased signi?cantly in Group C [by 0.5(–2.2 to 0.5) m IU mmol/L2,P=0.034].QUICKI was signi?cantly increased in Groups A and C(by 0.009±0.02,P=0.033 and by 0.009±0.027,P=0.049,respectively),while no change was observed in Group B.Repeated-measure ANOVA showed that the absolute changes in all parameters(except for glucose at1 h),including glucose and insulin levels at all time-points during OGTT and in HbA1 c,HOMA-IR,and QUICKI,were not signi?cantly different among the 3 groups after treatment(P>0.05).Conclusion: DKP or DKP combined with Diane-35 produce a slight improvement in insulin sensitivity compared with Diane-35 alone in PCOS patients(Trial Registration: Clinical Trials.gov,NCT03264638).展开更多
文摘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)。
文摘Objective: To assess the ef?cacy and safety of the Chinese medicine Dingkun Pill(定坤丹,DKP) on insulin resistance in women with polycystic ovary syndrome(PCOS).Methods: A total of 117 women with PCOS were randomly assigned to Group A(38 women),Group B(40 women),or Group C(39 women) in a randomization sequence with SAS software and a 1:1:1 allocation ratio using random block sizes of 6,and were given 7 g of oral DKP daily(Group A),1 tablet of Diane-35 orally daily(Group B),or 7 g of oral DKP daily plus 1 tablet of Diane-35 orally daily(Group C).Patients took all drugs cyclically for 21 consecutive days,followed by 7 drug-free days.The treatment course for the 3 groups was continued for 3 consecutive months.Oral glucose tolerance tests(OGTT)were performed before treatment and again after 2 and 3 months of therapy,respectively,and homeostasis model assessment for insulin resistance(HOMA-IR) and quantitative insulin sensitivity check index(QUICKI) were calculated.Results: Of 117 women with PCOS,110 completed the entire course of therapy: 35 in Group A,36 in Group B,and 39 in Group C.After treatment,all three groups showed signi?cant decreases in fasting glucose: at1 h glucose decreased signi?cantly in Group A(by 0.5±1.4 mmol/L,P=0.028) and Group C(by 0.5±1.2 mmol/L,P=0.045); while showing a tendency to increase in Group B(by 0.4±1.9 mmol/L,P=0.238).HOMA-IR decreased signi?cantly in Group C [by 0.5(–2.2 to 0.5) m IU mmol/L2,P=0.034].QUICKI was signi?cantly increased in Groups A and C(by 0.009±0.02,P=0.033 and by 0.009±0.027,P=0.049,respectively),while no change was observed in Group B.Repeated-measure ANOVA showed that the absolute changes in all parameters(except for glucose at1 h),including glucose and insulin levels at all time-points during OGTT and in HbA1 c,HOMA-IR,and QUICKI,were not signi?cantly different among the 3 groups after treatment(P>0.05).Conclusion: DKP or DKP combined with Diane-35 produce a slight improvement in insulin sensitivity compared with Diane-35 alone in PCOS patients(Trial Registration: Clinical Trials.gov,NCT03264638).
