Immunotherapy with Mycobacterium vaccae as an addition to chemotherapy for the treatment of pulmonary tuberculosis under difficult conditions in Africa.

A study to assess the impact of immunotherapy with Mycobacterium vaccae on the treatment of pulmonary tuberculosis was conducted under existing conditions in Kano, a large city in Northern Nigeria. Whilst it did not quite meet all the criteria of a well-controlled randomized or double-blind trial, the study produced results suggestive of a successful intervention. Immunotherapy with M. vaccae had a beneficial influence on clinical recovery and survival, whether given after 1, 2 or 3 weeks of chemotherapy, according to an assessment made 10-14 months after treatment. Approximately 3 weeks (19.8 days) after the onset of chemotherapy (SHRZ), 73% of the patients who received immunotherapy and 19% of those who received placebo (chemotherapy alone) had become sputum negative by microscopy for acid-fast bacilli (AFB). Similarly, a mean fall in erythrocyte sedimentation rate (ESR) of 25.4 +/- 2.50 mm and 4.0 +/- 2.29 mm was observed in the immunotherapy and placebo recipients respectively, at the same time of assessment. When weight was assessed in the two groups, it was observed that 3 weeks after starting chemotherapy, the recipients of immunotherapy had a mean weight gain of 2.90 +/- 0.24 kg whilst placebo recipients had a mean weight gain of only 0.55 +/- 0.17 kg. These parameters were re-evaluated, 10-14 months later. They showed that 11% of the recipients of the active intervention and 84.6% of placebo recipients still had demonstrable AFB in their sputum. The mean weight gain had increased to 7.91 +/- 1.03 kg and 2.04 +/- 0.94 kg in the immunotherapy and placebo recipients respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes