Herbal-based injection may reduce mortality in sepsis patients: EXIT-SEP trial

To further investigate the protective role of Xuebijing injection in sepsis, Songqiao Liu, Southeast University, Nanjing, Jiangsu, China, and colleagues aimed to determine the effect of XBJ versus placebo on 28-day mortality among sepsis patients in a multicenter, randomized double-blind, placebo-controlled trial (EXIT-SEP).

The trial was conducted in ICUs (intensive care units) at 45 sites, comprising 1817 sepsis patients present for below 48 hours. Patients aged 18 to 75 years with a Sequential Organ Failure Assessment score of 2 to 13 were enrolled.

Nine hundred eleven patients received an intravenous infusion of XBJ (100 mL), and 906 received volume-matched saline placebo every 12 hours for five days. The study's primary outcome was 28-day mortality.

The authors reported the following findings:

• Among the 1817 randomized patients (mean age, 56.5 years; 66.0% men), 96.9% completed the trial.
• In these patients, the 28-day mortality rate significantly differed between the placebo and XBJ groups (26.1% versus 18.8% patients, respectively). The absolute risk difference was 7.3 percentage points.
• The incidence of adverse events was 25.3% in the placebo group and 22.9% in the XBJ group.

"In this randomized clinical trial of sepsis patients, an IV infusion of XBJ at a dose of 100 mL every 12 hours for five days remarkably reduced 28-day mortality and had a safety profile acceptable within this clinical trial's context," the researchers concluded.

Reference:

Liu S, Yao C, Xie J, et al. Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis: The EXIT-SEP Randomized Clinical Trial. JAMA Intern Med. Published online May 01, 2023. doi:10.1001/jamainternmed.2023.0780