Objective To evaluate the relationship among the course，efficacy and safety on Bailemian therapy for anxiety in patients with somatic disease. Methods We retrieved the China journal full-text database(CNKI)，Wanfang database，China’s outstanding master’s/doctoral dissertation database，VIP science and technology periodical database，Cochrane library，PubMed，EMBASE and Chinese academic conference papers，collected and selected related literatures published before Dec，2016 on Bailemian therapy for anxiety. The Cochrane Collaboration’s tool，Stata and RevMan software were used for data analysis. Results Twelve literatures including 1 060 patients (536 in treatment group， 524 in control group) were included. The combined RR(95%CI)were 1.33(1.21-1.45) for efficiency and 0.42(0.26-0.70) for adverse-event. The difference of HAMA betweenBailemian and the control group was significant ［SMD=-0.36(-0.65- -0.07)］. The merged RR(95%CI) of effi-ciency were 1.34(1.16-1.54)，1.24(1.07-1.45)，1.36(1.15-1.60)，1.50(1.06-2.13) respectively，for the treat-ment of 2 weeks，4 weeks，8 weeks and 12 weeks. The merged SMD(95%CI) were -0.96(-1.85- -0.06)，-0.28 (-0.70-0.14) and -0.75(-1.36- -0.13) for the treatment of 2 weeks，4 weeks and 8 weeks respectively. And the RR(95%CI) of adverse events in the course of 4 and 8 weeks were 0.25(0.09-0.69) and 0.41(0.19-0.91). Conclusions Bailemian capsule is effective and safety to improve the symptoms of anxiety in patients with so-matic disease. The longer the courses is，the more significant of the efficacy on Bailemian therapy for anxiety is. It might be worth further popularizing in clinical use.