The Efficacy of Guizhi Fuling Capsule or Kuntai Capsule Combined With Diane-35 and Metformin in Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis

Background: Polycystic ovary syndrome (PCOS) is one of the most common reproductive endocrine metabolic diseases. Combined use of metformin and diane-35 has better curative effect in regulating serum hormone level (LH, FSH, T and E2) than using metformin alone. Traditional Chinese medicine (TCM) can also be used to treat PCOS. According to some studies, the combined use of metformin and diane-35 and TCM have achieved better curative effect than combining metformin and diane-35 in the treatment of patients with PCOS. Methods: Computerized searches of the science, Medline, VIP, Wan Fang and China HowNet (CNKI) databases were conducted to identify eligible randomized controlled trials (RCTs) from the data obtained up to March 1, 2022. The Cochrane Collaboration risk of bias tool was used to assess the risk of bias in individual RCTs, and R software( version 4.0.3) was used for data statistical analysis. Results: Nine RCTs involving 1035 patients were included. Comparing to D+M, significant reduce of LH( mean difference [MD]: −1.93, 95% confidence interval [CI]: -3.44, -0.42;Unit:U/L P＜0.01; I2=89%)、T(MD: -1.44, 95%CI -2.59, -0.30;Unit:nmol/L P＜0.01; I2=98%) and significant increase of E2(MD: 31.43, 95%CI 24.54, 38.33;Unit:pmol/L P＜0.01; I2=96%) were shown in TCM+D+M. Comparing to D+M, TCM+D+M group has higher ovulation rate(RR 1.14 95%CI 1.07,1.22; P=0.42; I2=0%) and higher pregnancy rate(RR 1.29 95%CI 1.15,1.44; P=0.37; I2=7%). There is no significant difference between the two therapies in FSH changes (MD: −1.00, 95%CI -2.27, 0.28;Unit:U/L P＜0.01; I2=95%).Subgroup analysis showed that compared with the Guizhi Fuling capsule group, the Kuntai capsule group had more FSH reduction and E2 increase more. In other outcome indicators, the two subgroup did not show significant differences. Conclusion: Kuntai Capsule + Diane-35 + Metformin is better than Guizhi Fuling Capsule in reducing FSH, and it is also better in increasing E2. There was no significant difference between the two in LH and T hormones. There was no significant difference between Kuntai Capsules + Diane-35 + Metformin and Guizhi Fuling Capsules + Diane-35 + Metformin. As for the effect in lessen insulin resistance, Kuntai Capsule+Diane-35+Metformin was significantly better than Guizhi Fuling Capsules+Diane-35+Metformin.