Zhongguo quanke yixue (Sep 2024)
The Efficacy of Yishen Quzhuo Formula Compared with Metformin in the Treatment of Polycystic Ovary Syndrome with Insulin Resistance: a Randomized Controlled Trial
Abstract
Background Polycystic ovary syndrome with insulin resistance (PCOS-IR) is recognized as one of the most challenging subtypes of PCOS to treat due to its intricate pathogenesis and significant individual variability. Although Metformin, as a first-line medication, can ameliorate blood glucose levels and enhance insulin sensitivity, its efficacy in regulating hormonal imbalances and improving ovarian function is limited. Additionally, its gastrointestinal side effects often hinder patient adherence. Objective To evaluate the efficacy and safety of Yishen Quzhuo Formula compared to metformin in the treatment of PCOS-IR. Methods A prospective study enrolled 102 PCOS-IR patients from June 2022 to October 2023 at the Department of Gynecology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University. Patients were randomly assigned in a 2∶1 ratio to the experimental group (n=68) treated with Yishen Quzhuo Formula or the control group (n=34) treated with metformin. The comparison was made between the two groups in terms of ovulation rate, pregnancy rate, sex hormones [follicle-stimulating hormone (FSH), luteinizing hormone (LH), LH/FSH ratio, testosterone (T), anti-Müllerian hormone (AMH) ], glucose and lipid metabolism indicators, BMI, waist-hip ratio (WHR), and incidence of adverse reactions. Results After treatment, the basal body temperature (BBT) ovulation rate in the experimental group increased compared to before treatment (P<0.05). Among patients with a desire for fertility in the experimental group, 13 cases resulted in pregnancy, while in the control group, with 5 such cases, only 1 resulted in pregnancy. The comparison of pregnancy rates between the two groups after treatment showed no statistically significant difference (χ2=1.154, P>0.05). After treatment, both groups showed a decrease in LH/FSH compared to before treatment (P<0.05). Following treatment, both groups showed a decrease in fasting plasma glucose (FPG), fasting insulin (FINS), homeostasis model assessment of insulin resistance (HOMA-IR), total cholesterol (TC), and triglycerides (TG) compared to before treatment (P<0.05). Following treatment, there was no statistically significant difference in high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) between the two groups compared to before treatment (P>0.05). After treatment, the waist circumference of the control group was lower than that of the experimental group (P<0.05). After treatment, the BMI, waist circumference, hip circumference, and waist hip ratio of both groups of patients decreased compared to before treatment (P<0.05). After treatment, alanine aminotransferase (ALT) and uric acid (UA) in the experimental group decreased compared to before treatment, while UA in the control group increased compared to before treatment (P<0.05). After treatment, there was no statistically significant difference in other indicators between the two groups compared to before treatment (P>0.05). During treatment, adverse reactions such as hypoglycemia, fatigue, epigastric discomfort, and diarrhea occurred in patients, with a lower incidence of adverse reactions in the experimental group (5/68, 7.35%) than in the control group (15/31, 48.39%) (χ2=20.404, P<0.001) . Conclusion Yishen Quzhuo Formula regulates hormone imbalance, improves glucose and lipid metabolism abnormalities, and is as effective as metformin in treating PCOS-IR. It exerts protective effects on liver and kidney function and exhibits superior tolerance over metformin in reducing adverse reactions. Given metformin's gastrointestinal side effects, patients demonstrate better tolerance and acceptance of Yishen Quzhuo Formula, thus warranting its clinical promotion and application.
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