Objectives To evaluate the effect and safety of mycobacterium vaccae in the treatment of recurrent treated pulmonary tuberculosis. Methods We searched PubMed (1997 to 2006), VIP (1997 to 2006), Wanfang database (1997 to 2006), The Cochrane Central Register of Controlled Trials (Issue 4, 2006) and the National Research Register (1996 to 2006). Randomized controlled trials comparing the mycobacterium vaccae immunotherapy group and the control group were included. Two reviewers independently performed data extraction and quality assessment. Data were analyzed using RevMan 4.2.2 software by The Cochrane Collaboration. Results Eleven high quality trials were included. Meta-analyses showed that mycobacterium vaccae immunotherapy plus chemotherapy resulted in higher sputum negative conversion rate (RR=1.36, 95%CI 1.21 to 1.54), higher lesion absorption rate (RR=1.39, 95%CI 1.13 to 1.72), and lower lesion non-absorption rate (RR=0.46, 95%CI 0.36 to 0.60), compared with the control group. These differences were all statistically significant. No serious adverse events were reported. Conclusion As an adjunct to chemotherapy, mycobacterium vaccae is helpful for patients with recurrent treated pulmonary tuberculosis in terms of improving cell-medicated immunity, sputum negative conversion and X-ray manifestation. More high quality studies are needed for further analysis.