Taoren Honghua Jian Regulate NLRP3 Inflammasome of Coronary Artery Disease Patients: A Multi-Center, Double-Blind, Randomized Controlled Trial

Objective: This multicenter, double-blind, randomized controlled trial sought to assess the clinical efficacy of Taoren Honghua Jian (THJ) in patients with coronary artery disease (CAD) exhibiting Qi stagnation and blood stasis syndrome, and investigated its effect on NLRP3 inflammasome expression in peripheral blood mononuclear cells (PBMCs). Methods: One hundred and twenty eligible CAD patients from three Shanghai hospitals were randomized to receive either the THJ granule (18.3 g, twice daily) or placebo for four weeks, with a four-week follow-up. Traditional Chinese Medicine Syndrome Score (TCMSS), Seattle Angina Questionnaire (SAQ), and lipid levels were measured before and after treatments. NLRP3 inflammasome components were examined in PBMCs using quantitative PCR, whereas plasma inflammatory cytokines were detected using ELISA. Results: A total of 120 participants participated in the trial. The THJ group showed reduced TCMSS compared to the placebo group ( P < 0.01). After four weeks of intervention, the THJ group scored considerably higher on five SAQ aspects compared to the placebo group ( P < 0.01). However, lipid levels showed no significance. In PBMCs, THJ lowered mRNA expression of NLRP3 inflammasome components (NLRP3, ASC, caspase-1, IL-1β, IL-18) ( P < 0.01). Patients in the THJ group showed significantly lower plasma levels of IL-1β, IL-2, and IL-18 following therapy compared to the placebo group ( P < 0.01). Conclusion: THJ reduces angina symptoms and improves quality of life in CAD patients, which suggests that it suppresses NLRP3-related transcriptional activity and hence reduces pro-inflammatory cytokine production. These data suggest that THJ might be an effective adjuvant treatment for inflammation-driven coronary atherosclerosis. Keywords: Taoren Honghua Jian, coronary artery disease, Qi stagnation and blood stasis, NLRP3, randomized controlled trial