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 Regi展开更多
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 Regi
