Role of Mycobacterium indicus pranii in clinical outcomes in patients with sepsis: A systematic review and meta-analysis of randomised controlled trials

Khushboo Saran; Swathy S Iyengar; Nitesh Sinha; Kumar Abhishek; Amit Kumar; Jay Prakash

doi:10.4103/ija.ija_726_23

Role of Mycobacterium indicus pranii in clinical outcomes in patients with sepsis: A systematic review and meta-analysis of randomised controlled trials

Indian J Anaesth. 2023 Dec;67(12):1029-1035. doi: 10.4103/ija.ija_726_23. Epub 2023 Dec 13.

Authors

Khushboo Saran¹, Swathy S Iyengar², Nitesh Sinha³, Kumar Abhishek⁴, Amit Kumar⁵, Jay Prakash⁶

Affiliations

¹ Department of Pathology, Gandhi Nagar Hospital, Central Coalfields Limited, Kanke, Ranchi, Jharkhand, India.
² Department of Neuroanaesthesia, People Tree Institute of Neurosciences, Bengaluru, Karnataka, India.
³ Department of Cardiac Anaesthesia, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India.
⁴ Department of Trauma Critical Care, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India.
⁵ Department of Laboratory Medicine, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India.
⁶ Department of Critical Care Medicine, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, India.

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.

Keywords: Catheter-related bloodstream infections; Mycobacterium indicus pranii; Mycobacterium welchii; meta-analysis; mortality; sepsis; sequential organ failure assessment score systematic review; vasopressor; ventilator-associated pneumonia.