Lin QIU, Jiang-ling LIU, Hui MO, Li LI
Objective To investigate the efficacy and safety of Dingkundan in combination with drospirenone-ethinylestradiol tablets (Ⅱ) in the treatment of PCOS of kidney-deficiency and liver-stagnation type. Methods This trial enrolled 120 PCOS patients who attended Guangdong Women and Children Hospital from January 2023 to January 2024. Participants were divided into the experiemental group [Dingkundan + drospirenone-ethinylestradiol tablets(Ⅱ)] and the control group [drospirenone-ethinylestradiol tablets(Ⅱ)]. Changes in menstrual cycles, traditional Chinese medicine syndrome scores, physical features related to hyperandrogenism, serum sex hormones, metabolic indicators, ovarian volume and antral follicle count, ovulation rate and pregnancy rate, and liver and kidney functions before and after treatment were compared, and adverse reactions were also recorded. Results(1)The comparison of menstrual cycle recovery between the two groups of patients within 3 months after discontinuing medication showed significant differences (P<0.05).(2)Before and after treatment, the study group exhibited a greater reduction in body mass index compared to the control group (P<0.05). However, there were no significant statistical differences between the two groups regarding improvements in hirsutism as measured by the Ferriman-Gallwey score or acne severity as measured by the Pillsbury scale.(3)As for traditional Chinese medicine syndrome scores, the study group had a greater reduction(P<0.05).(4)In terms of endocrine parameters, the study group had a greater reduction in free androgen index, serum total testosterone, androstenedione, and luteinizing hormone/follicle-stimulating hormone ratio compared to the control group (P<0.05). Nonetheless, there were no significant statistical differences between the two groups in estradiol or follicle-stimulating hormone.(5)Regarding metabolism, the study group showed a greater reduction in fasting insulin, homeostasis model assessment of insulin resistance, triglycerides, total cholesterol, and serum uric acid, and a greater increase in high-density lipoprotein cholesterol, compared to the control group (P<0.05). However, there were no significant statistical differences between the two groups in fasting blood glucose, low-density lipoprotein cholesterol or homocysteine.(6)There were no significant statistical differences between the two groups in ovarian volume or antral follicle count (P>0.05).(7)The study group had a higher ovulation rate compared to the control group (P<0.05).(8)Both groups showed no abnormal liver or kidney function indicators, and the incidence of adverse reactions was not statistically different. Conclusions The combination of Dingkundan with drospirenone-ethinylestradiol tablets(Ⅱ)can improve menstrual cycles in patients with PCOS of kidney-deficiency and liver-stagnation type, reduce traditional Chinese medicine syndrome scores, lower total testosterone and androstenedione, improve glucose and lipid metabolism and uric acid metabolism, and increase ovulation rates. No increase in the incidence of adverse drug reactions has been observed.