Efficacy and safety of Naoxintong capsule for secondary prevention after reperfused acute myocardial infarction: a randomized, double-blind, placebo-controlled, multicenter trial
In brief
Naoxintong cuts 12-month heart-failure risk by about 60% after reperfused heart attack
In a multicenter trial of 379 post-reperfusion myocardial infarction patients, adding Naoxintong to guideline therapy lowered new-onset heart failure to 6% versus 14% with placebo and also reduced major cardiovascular events to 8% versus 15%. Serious and overall adverse events were fewer, suggesting a safe complementary option, though broader validation is needed.
- Journal
- Phytomedicine : international journal of phytotherapy and phytopharmacology (Q1)
- Published
- 15 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Haitong Wan, Sina Liu, Shenglei Qiu, Zhexuan Yu, Juju Shang, Yihang Lu, et al.
- PMID
- 42537467
- DOI
- 10.1016/j.phymed.2026.158593
Why clinicians should know about it
- Picked for Complementary and Alternative Medicine (top studies of the week, 2 August 2026): Randomized placebo‑controlled trial of Naoxintong after AMI
Abstract
BACKGROUND: . Despite advances in reperfusion therapy, the incidence and mortality risk of heart failure (HF) remain high among patients with acute myocardial infarction (AMI). Naoxintong (NXT), a well-characterized polyherbal formulation derived from traditional Chinese medicine, has shown potential benefits in preclinical and small-scale clinical studies, but its efficacy has not been tested in a large-scale randomized controlled trial. AIM: . To rigorously evaluate the efficacy and safety of NXT in reducing HF and major adverse cardiovascular events (MACEs) among AMI patients after reperfusion therapy. STUDY DESIGN: . A prospective, multicenter, randomized, double-blind, placebo-controlled, superiority trial. METHODS: . Eligible post-reperfusion AMI patients from 21 hospitals in China were randomly assigned to receive either NXT (4 capsules, three times daily) or a matching placebo for 3 months, in addition to guideline-directed medical therapy (GDMT), with follow-up through 12 months. The primary endpoint was the incidence of new-onset HF within 12 months after randomization. Participants, clinicians, and outcome assessors were blinded to treatment allocation throughout the study period. RESULTS: . A total of 379 patients were included in the primary analysis (mean age 61.6 years; 78.1% male). The incidence of HF was significantly lower in the NXT group than in the placebo group (5.98%vs. 14.06%; HR 0.41, 95% CI 0.21-0.81; p = 0.01). The incidence of MACEs was also reduced with NXT (7.97%vs. 14.84%; HR 0.52, 95% CI 0.28-0.98; p = 0.04). The rates of serious adverse events (7.97%vs. 14.84%; p = 0.042) and any adverse events (7.97%vs. 21.09%; p < 0.001) were lower in the NXT group. No other significant between-group differences were observed for secondary outcomes or adverse event subtypes. CONCLUSION: . NXT, administered in addition to standard GDMT, significantly reduced the 12-month risk of HF and MACEs in reperfused AMI patients, with a favourable safety profile. These findings support NXT as a promising complementary strategy for secondary prevention after AMI.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.