Clinical Efficacy and Adverse Reactions of Lianggu Decoction Combined with Clomiphene in the Treatment of Patients with Obesity Related PCOS infertility postprint

Abstract: Background　Polycystic ovary syndrome（PCOS） is an extremely common endocrine disorder among women of reproductive age. Patients with obese PCOS often experience insulin resistance，leading to dysregulation of glucose and lipid metabolism，abnormal pancreatic function and subsequently ovulatory disorders，resulting in infertility. Clomiphene can improve ovulatory function in PCOS patients，but it is also associated with a variety of adverse effects with long-term use，and the phenomenon of clomiphene resistance can easily occur. Currently，the clinical efficacy and adverse reactions of Lianggu Decoction in the intervention of obesity PCOS infertility are not clear. Objective　To investigate the effects of Lianggua decoction combined with Clomiphene on insulin resistance，ovarian blood flow dynamics，and pregnancy in obese PCOS infertile patients. Methods　A total of 127 obese PCOS infertile patients admitted to Reproductive Medicine Department of Cangzhou Integrated Traditional Chinese and Western Medicine Hospital from February 2022 to December 2023 were selected as the research object. According to the random grouping principle，they were divided into an observation group of 63 cases and a control group of 64 cases. The control group was treated with clomiphene，starting on the 5th day of menstruation，at a dosage of 40 mg per time，twice a day for a continuous 5 days. The observation group was treated with Lianggu Decoction in addition to the treatment received by the control group，taking 150 mL of the decoction brewed from traditional Chinese medicinal herbs，twice a day，warm and taken in the morning and evening for a continuous 14 days. The treatment cycle lasted one month，and both groups of patients underwent continuous treatment for 3 cycles. The differences in laboratory test indicators between the two groups including fasting insulin （FINS），insulin resistance index（HOMA-IR），pancreatic β-cell function index（HOMA-β），fasting blood glucose （FPG），triglycerides（TG），total cholesterol（TC），body mass index（BMI），ovarian hemodynamic indicators ［peak systolic velocity（PVS），resistance index（RI），pulsatility index（PI），estrogen（E2），luteinizing hormone（LH），testosterone（T），follicle-stimulating hormone（FSH） were compared. Ovulation rate，pregnancy rate and abortion rate were used as outcome indexes，clinical efficacy and incidence of adverse reactions were recorded，and the differences between the two groups were compared. Results　After 3 cycles of treatment，the experimental group had lower levels of BMI，FPG，TG，TC，FINS，HOMA-IR，RI，serum E2，T，LH，and FSH compared to the control group，while the HOMA-β，PVS，and PI were higher than those in the control group，with all differences reaching statistical significance （P<0.05）. The ovulation rate and clinical pregnancy rate in the experimental group were higher than in the control group，while the miscarriage rate was lower in the experimental group，with all differences being statistically significant（P<0.05）. The total effective rate in the experimental group was higher than that in the control group，and the difference was statistically significant（χ2 =6.698，P<0.05）. The incidence of adverse reactions in the experimental group showed no statistical difference compared to the control group（χ2 =0.192，P>0.05）. Conclusion　The combination of Lianggua Tang and Clomiphene is effective in treating obese PCOS infertility，improving insulin resistance，glucose and lipid metabolism，hormone levels，and ovarian blood flow dynamics，and increasing pregnancy rate.