Abstract
BACKGROUND AND AIMS: Sepsis-induced immunosuppression appears to be reversible with immunomodulatory drugs. Mycobacterium indicus pranii (MIP) stimulates the Th1 type of immune response. This systematic review and meta-analysis of randomised controlled trials (RCTs) was aimed to find out if MIP is effective at improving clinical outcomes in sepsis patients. METHODS: The databases (PubMed, Google Scholar, Web of Science, and Cochrane Library), along with preprint servers until June 2023, were searched. The methodology was evaluated using the 'Cochrane Collaboration risk of bias-2 tool' for RCT. The study included patients more than 18 years of age with sepsis within 48 h of first organ dysfunction. The primary outcome was 28-day mortality, and secondary outcomes were the length of stay in the intensive care unit (ICU), days on vasopressor support, ventilator-associated pneumonia (VAP), secondary infections, catheter-related bloodstream infections (CRBSI), and the delta sequential organ failure assessment (SOFA) score. RESULTS: The meta-analysis included two studies with 252 participants. In a pooled analysis, mortality in the MIP group was 43% lower than in the control (RR: 0.57, 95%CI: 0.33-1); however, this difference was statistically not significant. We observed the days on a vasopressor day (standardised mean difference [SMD]: 0.38; 95%CI: -1.20 to 0.44), length of ICU stay (SMD: 0.46; 95%CI: -1.44 to 0.51), secondary infection (RR: 0.75; 95%CI: 0.19-3.01), VAP (RR: 0.6; 95%CI: 0.28-1.56), CRBSI (RR: 0.97, 95%CI: 0.14-6.98), delta SOFA score (SMD: 0.88, 95%CI: -1.66 to - 0.10) between the two groups. CONCLUSIONS: Our findings observed preliminary evidence in the trends for a positive association of MIP with better outcomes in sepsis patients.