Objective: The purpose is to evaluate systematically the efficacy and safety of Guishen Pill in the treatment of polycystic ovary syndrome (PCOS). Methods: Firstly, the clinical randomized controlled trials （RCT）, which were designed to explore Guishen Pill alone or combined with conventional western medicine (experimental group) comparing with conventional western medicine (control group) for the treatment of PCOS, were retrieved from the “CNKI, VIP, WanFang Data, PubMed, Cochrane Library” databases. Publication time was limited from the date of database establishment to February 17, 2020. Then the quality of selected literature and extracted valid data were evaluated. Finally, the risk bias was evaluated according to the cochrane system evaluation method and the meta-analysis was carried out by Revman 5.3. Results: Seven RCTs were included in this study, including 502 PCOS patients. The results of meta-analysis showed that compared with the control group, the experimental group had higher total response rate [RR=1.26, 95% CI(1.15,1.37), P<0.00001], pregnancy rate [RR=1.56 ,95% CI(1.27, 1.91), P<0.0001] and ovulation rate [RR=1.21, 95% CI(1.07, 1.37), P=0.002]. The two groups had statistically significant differences in ovarian volume [MD=2.17, 95% CI(1.37,2.97 ), P<0.00001], T [MD=0.95,95% CI(0.15,1.75), P=0.02] and LH [MD=7.55,95% CI(2.05,13.04), P=0.007]. No adverse reactions were found in the experimental group. Conclusion: Compared with conventional western medicine, Guishen Pill combined with conventional western medicine can significantly improved the pregnancy rate, ovulation rate，ovarian volume and sex hormones level with better safety in the treatment of PCOS.