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Qing-Xin-Jie-Yu Granule for patients with stable coronary artery disease (QUEST Trial): A multicenter,
Jingen Li1, Zhuye Gao2, Lijing Zhang3
1Department of Cardiology, Dongzhimen Hospital, The First Affiliated Hospital of Beijing University of Chinese Medicine, Beijing, China; Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Insights
Adding Qing-Xin-Jie-Yu Granule (QXJYG) to standard therapy reduced cardiovascular events in stable coronary artery disease (SCAD) patients. This traditional Chinese medicine may offer further protection against heart attack and stroke.
Area of Science:
- Cardiology
- Traditional Chinese Medicine
- Pharmacology
Background:
- Patients with stable coronary artery disease (SCAD) face ongoing cardiovascular event risk despite optimal secondary prevention.
- Traditional Chinese Medicine (TCM) offers potential complementary therapies for cardiovascular disease management.
Purpose of the Study:
- To evaluate the efficacy of Qing-Xin-Jie-Yu Granule (QXJYG), a TCM prescription, as an adjunct to standard therapy for reducing cardiovascular events in SCAD patients.
- To assess the impact of QXJYG on a composite endpoint including cardiovascular death, nonfatal myocardial infarction (MI), and coronary revascularization.
Main Methods:
- A multicenter, double-blinded, randomized trial involving 1500 SCAD patients.
- Patients were assigned to receive either QXJYG or a placebo for 6 months, with a subsequent 6-month follow-up period.
- Primary outcome: composite of cardiovascular death, nonfatal MI, and coronary revascularization. Secondary analysis included a composite of cardiovascular death, nonfatal MI, and ischemic stroke.
Main Results:
- No significant difference was observed for the primary composite outcome between the QXJYG and placebo groups (1.59% vs. 1.62%).
- However, the addition of QXJYG significantly reduced the risk of the composite 'hard' endpoint (cardiovascular death, nonfatal MI, ischemic stroke) by 0.99% (0.31% vs. 1.30%).
- Adverse event rates were comparable between the QXJYG and placebo groups.
Conclusions:
- The addition of Qing-Xin-Jie-Yu Granule (QXJYG) to standard therapy demonstrated a significant reduction in the risk of nonfatal myocardial infarction and a composite endpoint including cardiovascular death, nonfatal MI, and stroke in SCAD patients.
- QXJYG may represent a valuable complementary treatment for improving cardiovascular outcomes in patients with stable coronary artery disease.
Background And Aim:
Despite optimal secondary preventive treatment, patients with stable coronary artery disease (SCAD) remain at high risk of cardiovascular events. This multicenter, double-blinded, randomized trial sought to determine whether the addition of Qing-Xin-Jie-Yu Granule (QXJYG), a traditional Chinese medicine prescription, to standard therapy would further reduce risk of cardiovascular events in patients with SCAD.
Methods:
A total of 1500 patients with documented SCAD were randomly assigned in a 1:1 ratio to QXJYG or placebo for 6 months, and followed up for another 6 months. The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction (MI) and coronary revascularization. Near the end of the trial, but before unblinding, a commonly used composite 'hard' endpoint composed of cardiovascular death, nonfatal myocardial infarction and ischemic stroke was additionally analyzed.
Results:
During a median follow-up of 12 months, no significant difference of the primary outcome between the two groups was observed (1.59% vs. 1.62%; hazard ratio, 0.41; 95% CI, 0.13-1.28). However, absolute risk of the composite 'hard' endpoint was reduced by 0.99% (0.31% vs. 1.30%; hazard ratio, 0.06; 95%CI, 0.01 to 0.53). No difference of adverse events between the two groups was observed.
Conclusion:
In patients with SCAD, the addition of QXJYG to standard therapy was associated with reduced risk of nonfatal MI and the composite 'hard' endpoint of cardiovascular death, nonfatal MI and stroke. (http://www.chictr.org.cn/showproj.aspx?proj=5200, ChiCTR-TRC-13004370).
