Objective: To systematically evaluate the clinical efficacy of Kuntai Capsules combined with Diane-35 in the treatment of polycystic ovarian syndrome (PCOS). Methods: The randomized controlled trials (RCTs) of Kuntai Capsules combined with Diane-35 in the treatment of PCOS from databases establishment to April 2020 were searched in Chinese and English databases, and then meta-analysis was performed using RecMan 5.3 software. Results: A total of 132 articles were collected and 14 studies were included. The total sample size was 1254 cases, including 627 cases in the experimental group and 627 cases in the control group. Meta-analysis showed that the combined group was significantly superior to the single group in terms of overall response rate (OR=5.53,95％CI[3.25,9.41],P<0.01), ovulation rate (OR=3.54,95％CI[2.13,5.88],P<0.01), and pregnancy rate (OR=3.21,95％CI[2.00, 5.14],P<0.01). In terms of serum sex hormone levels, the combined group was significantly better than the singer group for the regulation of follicle-stimulating hormone (FSH) (MD=-2.09,95％CI[-2.16,-2.01],P<0.01), luteinizing hormone (LH) (MD=-2.15,95％CI[-2.35,-1.95],P<0.01), estrogen (E2) (MD=36.47,95％CI[34.97,37.96],P<0.01), and testosterone (T) (MD=-1.95,95％CI[-2.77,-1.14],P<0.01). In addition, the combined group also showed some advantages over the single group in improving the level of insulin resistance (HOMA-IR) and pancreatic beta cells function (HOMA-β). Conclusion: Kuntai Capsules combined with Diane-35 had certain efficacy advantage in the treatment of PCOS compared with control group. However, the data indicate that the methodological quality of the studies are low, there was potential publication bias, no define conclusion could be drawn, and more high-quality RCTs studies are needed for further validation.