title: Mycobacterium vaccae as adjuvant therapy to anti-tuberculosis chemotherapy in never-treated tuberculosis patients: a meta-analysis.
abstract: OBJECTIVE
  To evaluate the effectiveness and safety of heat-killed M. vaccae added to chemotherapy of never-treated tuberculosis (TB) patients.
  
  
  METHODS
  The databases of Medline, Embase, Biosis, Cochrane Central Register of Controlled Trials, SCI, CBM, VIP and CNKI were searched. Randomized controlled trials (RCT) and Controlled clinical trials (CCT) comparing M. vaccae with or without a placebo-control injection as adjuvant therapy in the chemotherapy of never-treated TB patients were included. Two reviewers independently performed data extraction and quality assessment. Data were analyzed using RevMan 5.0 software by The Cochrane Collaboration.
  
  
  RESULTS
  Fifty four studies were included. At the end of the follow-up period, Pooled RR (Risk Ratio) and its 95% CI of sputum smear conversion rate were 1.07 (1.04, 1.10) in TB patients without complications, 1.17 (0.92, 1.49) in TB patients with diabetes mellitus, 1.02 (0.94, 1.10) in TB patients with hepatitis B, and 1.46 (0.21, 10.06) in TB patients with pneumosilicosis. In elderly TB patients the RR was 1.22 (1.13, 1.32). Analysis of each time point during the follow-up period showed that M. vaccae could help to improve the removal of acid-fast bacilli from the sputum, and promote improvement of radiological focal lesions and cavity closure. Compared with the control group, the differences in levels of immunological indicators of Th1 such as IL-2 and TNF-α were not statistical significant (P = 0.65 and 0.31 respectively), and neither was that of IL-6 produced by Th2 (P = 0.52). An effect of M. vaccae of prevention of liver damage was found in TB patients with hepatitis B (RR 0.20 and 95% CI (0.12, 0.33). No systemic adverse events were reported.
  
  
  CONCLUSIONS
  Added to chemotherapy, M. vaccae is helpful in the treatment of never-treated TB patients in terms of improving both sputum conversion and X-ray appearances.
authors: Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
authors: Xiao-Yan
authors: XY
authors: Yang
authors: Qun-Fei
authors: QF
authors: Chen
authors: You-Ping
authors: YP
authors: Li
authors: Si-Miao
authors: SM
authors: Wu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000995:Antitubercular Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005500:Follow-Up Studies; D006509:Hepatitis B / Q000150:complications; D006801:Humans; D008099:Liver / Q000473:pathology; D008875:Middle Aged; D009161:Mycobacterium / Q000276:immunology*; D011785:Quality Assurance, Health Care; D013183:Sputum / Q000382:microbiology; D016896:Treatment Outcome; D014376:Tuberculosis / Q000150:complications / Q000188:drug therapy* / Q000276:immunology*; D032581:Tuberculosis Vaccines / Q000276:immunology*; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D032581:Tuberculosis Vaccines