Objective:

2

To assess the efficacy and safety of the Chinese medicine Dingkun Pill (定坤丹

DKP) on insulin resistance in women with polycystic ovary syndrome (PCOS).

Methods:

2

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:

2

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 significant decreases in fasting glucose: at 1 h glucose decreased significantly 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 significantly in Group C [by 0.5 (–2.2 to 0.5) mIU mmol/L

2

P

=0.034]. QUICKI was significantly 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 at 1 h)

including glucose and insulin levels at all time-points during OGTT and in HbA1c

HOMA-IR

and QUICKI

were not significantly different among the 3 groups after treatment (

P

>

0.05).

Conclusion:

2

DKP or DKP combined with Diane-35 produce a slight improvement in insulin sensitivity compared with Diane-35 alone in PCOS patients (Trial Registration: ClinicalTrials.gov

NCT03264638).