Background: Mycobacterium vaccae has been advocated for immunotherapy in the treatment of tuberculosis and other infections caused by mycobacteria.
Objectives: The objective of this review was to assess the effects of Mycobacterium vaccae 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 of preparations of whole, killed Mycobacterium vaccae in patients with tuberculosis.
Data collection and analysis: One reviewer assessed trial quality and extracted data.
Main results: Four trials met the inclusion criteria. There was no effect on mortality (2 trials, RR 1.01, 95% CI 0.50 to 2.04); no consistent effect on sputum negativity or sputum culture; and a high level of adverse reactions.
Reviewer's conclusions: Immunotherapy with Mycobacterium vaccae does not appear to benefit patients with tuberculosis.