Objective To assess the efficacy and safety of Guizhifuling capsule versus western medicine in the treatment of uterine myoma. Methods Randomized controlled trials (RCTs) involving Guizhifuling capsule versus western medicine in the treatment of uterine myoma were identified from CBM (1978 to 2009), VIP (1989 to 2009), WANFANG Database (1998 to 2009), CNKI (1979 to 2009). We also manually searched relevant journals from Tianjin University of Traditional Chinese Medicine. Data were extracted and evaluated by two reviewers independently with a specially designed extraction form. The Cochrane Collaboration’s RevMan 5.0.22 software was used for data analyses. Results A total of 8 trials involving 798 patients were included. The results of meta-analyses showed that, a) the mean uterine myoma volume in the experimental group was different when compared with the mifepristone group (WMD= 0.64, 95%CI 0.56 to 0.71); b) no difference was found between the experimental group and the mifepristone group in serums hormone level, such as, follicle-stimulating hormone (WMD= 2.40, 95%CI –?3.09 to 7.89), luteinizing hormone (WMD= 1.22, 95%CI –?1.05 to 3.49), estriol (WMD= 11.07, 95%CI –?7.70 to 29.84), and P (WMD= 0.52, 95%CI –?0.33 to 1.37); c) As for clinical symptoms effective rate, significant difference was noted between the experimental group and the mifepristone group, such as, menorrhagia (RR= 0.49, 95%CI 0.25 to 0.94), dysmenorrheal (RR= 0.12, 95%CI 0.04 to 0.38), and bellyache and abdominal distension (RR= 0.28, 95%CI 0.12 to 0.62); d) In terms of the total effective rate, significant differences were noted between the experimental group and the mifepristone group (RR= 1.16, 95%CI 1.02 to 1.32); and e) Four trials reported the long-term follow-up results in which the experimental group was better than that in the control group.Conclusion The treatment of uterine myoma by Guizhifuling capsule plus mifepristone is superior to that by mifepristone alone in reducing uterine myoma volume, clinical symptom, and long-term follow-up results. Singly using Guizhifuling capsule is not inferior to western medicine. Further large-scale trials are required to define the role of Guizhifuling capsule in the treatment of uterine myoma.