Background: Some authorities have advocated Mycobacterium vaccae immunotherapy for treating tuberculosis and other infections caused by mycobacteria.
Objectives: To assess the effects of Mycobacterium vaccae as an adjunct to chemotherapy for treating tuberculosis.
Search strategy: We searched the Cochrane Infectious Diseases Group trials register, the Cochrane Controlled Trials register, Medline, Embase and reference lists of articles. We also contacted organisations and individuals working in the field.
Selection criteria: Randomised and quasi-randomised trials using whole, killed Mycobacterium vaccae for patients with tuberculosis.
Data collection and analysis: One reviewer assessed trial quality and extracted data.
Main results: Six trials met the inclusion criteria. There was no effect on mortality (three trials, OR 1.01, 95% CI 0.51 to 1.99). No consistent effect on sputum negativity or sputum culture was shown. Most immunotherapy recipients experienced local adverse reactions (two trials, OR 18.2, 95% CI 9 to 37), some of which progressed to ulceration and scarring.
Reviewer's conclusions: Immunotherapy with Mycobacterium vaccae does not appear to benefit patients with tuberculosis.