Efficacy of Shufeng Jiedu Capsules in the treatment of sepsis: A prospective, randomized, placebo-controlled trial

Abstract

IntroductionSepsis is a potentially life-threatening complication after infection and the second-leading cause of death in non-coronary intensive care plural - units. The aim of this trial was to evaluate the efficacy and safety of Shufeng Jiedu Capsules (SFJDC) as a complementary medicine in the treatment of sepsis. MethodsHospital inpatients diagnosed with sepsis and who met the trial inclusion/exclusion criteria were randomly allocated into one of two groups; a combination group (antibiotics and SFJDC) and a routine care group (antibiotics and placebo group). The primary outcome was severity assessed by the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. Secondary outcomes included the SOFA score, the traditional Chinese medicine (TCM) symptom score, and 28-day mortality. Additional outcomes included indices of infection (such as the level of procalcitonin (PCT), C reactive protein (CRP), and white blood cell (WBC) count). ResultsOf 150 patients admitted between July 2016–2017, 129 patients meeting the inclusion criteria were randomly assigned to either the combination group (n = 66) or a single antibiotics group (n = 63). The APACHE II score, the TCM symptom score, the level of CRP, the neutrophil-lymphocyte ratio (NLR) and the healing rate differed significantly between the two groups on the 7th day of hospitalization(p = 0.046, p = 0.020, p = 0.009, p = 0.001, and p < 0.01, respectively). Mortality at 28 days was 3.03 % in the combination group and 7.93 % in the single antibiotics group according to Per-protocol analysis (p = 0.400). However, the healing rate differed significantly between the two groups (p < 0.01).The incidence of adverse events did not differ significantly between the 2 groups. ConclusionA combination of antibiotics and SFJDC in the treatment of sepsis was superior to routine antibiotic treatment since combination therapy reduces the inflammatory response and improves prognosis for septic patients.