Classical formula Taohe Chengqi decoction as an adjuvant therapy for sepsis - a systematic review and meta-analysis of randomized controlled trials.

Objectives: This systematic review aimed to evaluate the clinical efficacy and safety of Taohe Chengqi (THCQ) decoction as an adjuvant therapy for sepsis, and to provide evidence for clinical practice. Methods: Eight databases were systematically searched from inception until June 2024. The study included randomized controlled trials (RCTs) involving sepsis patients, where THCQ was used as an adjunctive therapy alongside conventional treatments. The primary outcome assessed was 28-day mortality rates, secondary outcomes included severity scores, inflammatory and coagulation markers, and adverse events. Two authors independently conducted the literature screening, data extraction, and evaluation of methodological quality. Meta-analysis was performed using RevMan 5.4.1 and Stata 17 software. The Risk of Bias (ROB) 2.0 and GRADE were employed for quality assessment. Results: A total of sixteen RCTs involving 1,034 participants were included. Most of the studies were rated as having "some concerns" according to the ROB 2.0. Compared with conventional treatments, THCQ plus conventional treatments resulted in lower 28-day mortality rate (RR = 0.57, 95% CI [0.38, 0.86]; low-certainty), lower Acute Physiology and Chronic Health Evaluation II score (APACHE-Ⅱ) (MD = -2.37, 95% CI [-3.12, -1.63]; low-certainty), lower Sequential Organ Failure Assessment score (SOFA) (MD = -1.41, 95% CI [-2.12, -0.70]; low-certainty), lower white blood cell (WBC) (MD = -1.78 109/L, 95% CI [-2.97, -0.59]; low-certainty), lower procalcitonin (PCT) (MD = -1.20 ng/mL, 95% CI [-1.71, -0.69]; low-certainty), lower C-reactive protein (CRP) (MD = -9.82 mg/L, 95% CI [-13.98, -5.66]; low-certainty), and no serious adverse effects were observed (RR = 0.67, 95% CI [0.12, 3.71]; very low-certainty). Conclusion: Chinese medicine formula THCQ may offer potential benefits as an adjunctive treatment for sepsis patients, suggesting a reduction in the 28-day mortality rate, improvements in inflammatory markers, and enhancement of coagulation function, with no severe adverse reactions observed. Given the low quality of the included studies, the findings should be interpreted with caution. Future large-scale, multicenter RCTs are needed to confirm these findings and provide robust evidence. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024562595, identifier CRD42024562595.