Cardiology · Medical Literature
Taoren Honghua Jian Regulate NLRP3 Inflammasome of Coronary Artery Disease Patients: A Multi-Center, Double-Blind, Randomized Controlled Trial.
Abstract
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). 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. 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). 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.
Clinical relevance
In patients with stable coronary artery disease exhibiting Qi stagnation and blood stasis syndrome, does a four-week course of Taoren Honghua Jian (THJ) granule reduce Traditional Chinese Medicine Syndrome Scores, improve angina-related quality of life as measured by the Seattle Angina Questionnaire, and suppress NLRP3 inflammasome expression in peripheral blood mononuclear cells compared with placebo? __SNAPSHOT__ {"studyDesign":"Multicenter, double-blind, randomized controlled trial (RCT) with a matched placebo comparator","setting":"Three tertiary hospitals in Shanghai, China","sampleSize":"n=120 total (intervention arm and control arm sizes not individually specified in abstract; a parallel publication with overlapping authorship reports n=80 with 40 per arm — see clinicalInterpretation note)","population":"Adults with established coronary artery disease (CAD) meeting Traditional Chinese Medicine criteria for Qi stagnation and blood stasis syndrome; precise inclusion/exclusion criteria, age range, sex distribution, and comorbidity burden not reported in abstract","intervention":"Taoren Honghua Jian (THJ) granule 18.3 g orally twice daily for four weeks","comparator":"Matched placebo granule for four weeks","primaryOutcome":"Not explicitly designated as a single primary endpoint in the abstract; co-primary or co-equal outcomes appear to include: (1) Traditional Chinese Medicine Syndrome Score (TCMSS), (2) Seattle Angina Questionnaire (SAQ) domain scores, (3) NLRP3 inflammasome component mRNA expression in PBMCs (NLRP3, ASC, caspase-1, IL-1β, IL-18 by quantitative PCR), and (4) plasma inflammatory cytokines by ELISA. Lipid levels served as a secondary outcome.","followUp":"Four weeks of active treatment followed by a four-week post-treatment follow-up period (total observation window: eight weeks)","fundingSource":"Not reported in abstract"}
Key findings
The abstract, which appears truncated, reports the following direction-of-effect findings without providing absolute values, between-group differences, confidence intervals, effect sizes, or NNT/NNH. (1) TCMSS: THJ group showed statistically significantly lower (improved) TCMSS compared with placebo at four weeks (P < 0.01); magnitude of reduction not reported. (2) SAQ: THJ group scored significantly higher on all five SAQ domains compared with placebo at four weeks (P < 0.01); domain-specific scores and between-group differences not reported. (3) Lipid levels: No statistically significant between-group difference was observed for any lipid parameter (specific lipids measured and p-values not reported). (4) NLRP3 inflammasome mRNA expression in PBMCs: THJ reduced mRNA expression of NLRP3 inflammasome components compared with placebo; specific components showing significance, fold-changes, and p-values for each gene target are not available in the truncated abstract. (5) Plasma inflammatory cytokines (ELISA): Direction and statistical significance of cytokine results are not available due to abstract truncation. No cardiovascular hard endpoint data (MACE, mortality, hospitalization) were reported. Safety and adverse event data are not described in the available abstract. No NNT or NNH can be calculated from available data.
Practice implications
CRITICAL NOTE ON SAMPLE SIZE DISCREPANCY: The user-supplied abstract (published in Vascular Health and Risk Management, PMID 42004177, April 2026) reports n=120 participants, while a closely related parallel publication by an overlapping author group (Wang, Du, Feng et al., Chinese Journal of Integrative Medicine, March 2026, DOI 10.1007/s11655-026-4038-7) reports n=80 participants from the same three Shanghai hospitals with an identical design. Whether these represent the same trial with a discrepancy, two separate trials, or sequential enrollment phases cannot be determined from the abstract alone. Clinicians should verify sample size and participant overlap before drawing conclusions. Regarding clinical interpretation: (1) WHAT WAS ESTABLISHED: THJ granule demonstrated statistically significant improvement in TCM-specific symptom burden (TCMSS) and patient-reported angina-related quality of life (all five SAQ domains) versus placebo over four weeks. Suppression of NLRP3 inflammasome component mRNA in PBMCs was also observed, suggesting a mechanistic anti-inflammatory signal. (2) WHAT WAS NOT ESTABLISHED: No effect on lipid levels was demonstrated. No hard cardiovascular endpoints (MACE, mortality, recurrent MI, revascularization, or hospitalization) were assessed or reported, so no inference about prognostic benefit is warranted. Long-term safety was not evaluated. (3) POPULATION APPLICABILITY: Findings apply only to CAD patients who meet TCM criteria for Qi stagnation and blood stasis syndrome — a phenotype that requires specialized TCM diagnostic expertise to identify and has no direct validated equivalent in standard Western cardiovascular diagnostic classifications. Results cannot be generalized to unselected CAD populations. (4) INADEQUATELY REPRESENTED GROUPS: Patients outside Shanghai, non-Chinese ethnic populations, patients with acute coronary syndromes, heart failure, or renal/hepatic impairment, and those not meeting TCM syndromic criteria were likely excluded. Women and elderly patients may be underrepresented (not reported). (5) CLINICAL IMPORTANCE: Although statistical significance was achieved for symptom and quality-of-life outcomes, the clinical meaningfulness of TCMSS and SAQ improvements cannot be assessed without absolute values and minimal clinically important difference comparisons. NLRP3 mRNA suppression is a mechanistic biomarker finding; its translation to clinical cardiovascular benefit remains unproven. Only the abstract (apparently truncated) was available for review; full results including safety data, cytokine findings, and per-protocol analyses are inaccessible. Practice should not change based on this abstract alone. __LIMITATIONS__ Abstract appears truncated — key results for NLRP3 component-specific mRNA data, plasma cytokine ELISA findings, and safety/adverse event data are missing; full-text review is mandatory before any clinical application.,Unresolved sample size discrepancy between this publication (n=120) and a parallel 2026 publication with an overlapping author group from the same three hospitals (n=80); possible trial duplication, data overlap, or reporting inconsistency cannot be excluded from abstract data alone.,No hard cardiovascular endpoints assessed; all efficacy outcomes are symptom scores and biomarkers — surrogate endpoints with uncertain relationship to cardiovascular event reduction.,Short treatment duration (four weeks) and limited follow-up (four weeks post-treatment) are insufficient to evaluate durability of effect or long-term safety.,Patient selection requires TCM syndromic diagnosis (Qi stagnation and blood stasis), limiting generalizability to settings with TCM-trained practitioners and to the specific patient subgroup meeting this diagnostic criterion.,Single geographic/ethnic cohort (Shanghai, China) limits external validity.,Blinding integrity and randomization allocation concealment methods are not described in the abstract.,Background standard-of-care therapies (statins, antiplatelets, beta-blockers, ACE inhibitors/ARBs) and their equivalence between arms are not reported; differential background therapy could confound symptom and biomarker outcomes.,No sample size calculation, power analysis, or pre-specified primary endpoint hierarchy is described, raising concern for multiplicity when reporting significance across multiple outcomes at P < 0.01.,Funding source is not disclosed, precluding assessment of potential conflicts of interest.,NLRP3 mRNA suppression in PBMCs is a mechanistic biomarker; its clinical significance and relationship to downstream protein-level inflammasome activity, cytokine secretion, and plaque biology in this population are not established by this study. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This multicenter, double-blind RCT reports that Taoren Honghua Jian granule significantly improved TCM symptom scores and all five Seattle Angina Questionnaire domains, and suppressed NLRP3 inflammasome component mRNA in PBMCs, compared with placebo over four weeks in CAD patients with a specific TCM syndrome phenotype; no effect on lipids was observed and no hard cardiovascular endpoints were assessed. The abstract is truncated, a sample size discrepancy with a parallel publication from the same group requires resolution, and all reported outcomes are surrogates without established links to cardiovascular event reduction. This study is hypothesis-generating for TCM-integrative cardiology practice and should not be used to alter standard evidence-based CAD management pending full-text review, independent replication, and trials powered for clinical endpoints.