Efficacy and safety of Dachaihu decoction for sepsis: A randomized controlled trial

Sepsis is a critical condition characterized by multi-organ dysfunction (MODS) that presents significant treatment challenges. Traditional Chinese medicine (TCM), particularly Dachaihu decoction (DCH), has shown potential in addressing sepsis-related complications.

To comprehensively evaluate the efficacy and safety of DCH in the treatment of sepsis.

Eligible septic patients were randomly assigned to either the DCH or control group in a 1:1 ratio. The intervention course lasted for 3 days. Primary outcomes were 28-day all-cause mortality, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Secondary outcomes were assessed through various clinical parameters, including: (1) inflammatory markers; (2) liver function indices; (3) renal function markers; (4) gastrointestinal function metrics and (5) coagulation parameters.

70 septic patients were included in the full analysis set. No significant difference in 28-day all-cause mortality was observed between the control and DCH groups (10 (28.6 %) vs. 9 (25.7 %), p = 0.788). However, DCH significantly reduced SOFA score (-3.0 (interquartile range, IQR, -5.5, -2.0) vs. 0.0 (IQR, -3.5, 0.0), p = 0.025), APACHE II score (-4.0 (IQR, -8.0, -2.0) vs. 0.0 (IQR, -2.0, 2.0), p < 0.001), aspartate transaminase (-12.70 (IQR, -76.15, -3.35) vs. 2.40 (IQR, -8.05, 10.55), p = 0.001), total bilirubin (-2.30 (IQR, -7.45, 3.62) vs. 1.80 (IQR, -2.35, 11.25), p = 0.028), acute gastrointestinal injury grade (R¯, 26.04 vs. 44.96, p < 0.001), gastrointestinal dysfunction score (-5.0 (IQR, -6.0, -2.5) vs. -1.0 (IQR, -2.0, 0.5), p < 0.001), serum intestinal fatty acid-binding protein (-334.5 (IQR, -375.4, -288.8) vs. -34.8 (IQR, -104.2, -34.0), p < 0.001), and increased citrulline levels (6.97 (IQR, 6.76, 7.62) vs. 0.70 (IQR, -1.30, 2.83), p < 0.001), and also inhibiting platelet loss (-2.0 (IQR, -30.5, 45.5) vs. -26.0 (IQR, -65.0, 9.5), p = 0.043). Additionally, DCH demonstrated improvements in inflammation, renal function, and coagulation, with fewer serious adverse events reported in the DCH group (2.44 % vs. 7.32 %, p = 0.305).

DCH is both effective and safe in treating septic MODS. Nonetheless, further research is required to refine study designs and enhance outcomes for septic patients.