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A multicentre randomized clinical trial on efficacy and safety of huxin formula in patients undergoing percutaneous
Huan-Lin Wu1, Yun-Fei Wang1, Jun-Zhe Li1
1Heart Center, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510020, China.
Insights
Huxin Formula, a modified traditional Chinese medicine, was evaluated for patients after percutaneous coronary intervention (PCI). While not superior in primary outcomes, it improved quality of life for specific patient groups, showing safety.
Area of Science:
- Cardiology
- Traditional Chinese Medicine
- Clinical Pharmacology
Background:
- Percutaneous coronary intervention (PCI) is a common treatment for coronary artery disease.
- Existing PCI treatments have limitations in preventing restenosis and enhancing quality of life.
- Huxin Formula, a modified traditional Chinese medicine, is used clinically for coronary heart disease.
Purpose of the Study:
- To evaluate the efficacy and safety of Huxin Formula in patients undergoing PCI.
- To assess the impact of Huxin Formula on restenosis and quality of life post-PCI.
Main Methods:
- A multicentre, double-blind, randomized controlled clinical trial was conducted.
- Patients undergoing PCI were assigned to either Huxin Formula treatment or a control group.
- Primary and secondary outcomes, including quality of life scores and adverse events, were monitored.
Main Results:
- No significant difference was observed between groups for primary and secondary outcomes.
- Patients with ejection fraction (EF) >50% showed higher quality of life scores in the treatment group.
- Patients with unstable angina experienced significantly improved quality of life scores at 360 days with Huxin Formula (P < 0.05).
- No obvious adverse reactions were reported for Huxin Formula.
Conclusions:
- Huxin Formula is a safe treatment option for patients post-PCI.
- Huxin Formula demonstrates benefits in improving quality of life for patients with unstable angina.
- Further research may be needed to explore its specific benefits in certain patient subgroups.
Abstract:
Percutaneous coronary intervention (PCI) is widely used in clinical treatment of coronary artery disease. However, the effects of PCI on preventing restenosis after revascularization and improving the quality of life were not satisfying. Huxin Formula is formulated by modifying an experienced Chinese medicine formula and has been widely used in clinical practice due to its marked effects on coronary heart disease. A multicentre double-blind randomized controlled clinical trial was designed to evaluate the effects and safety of Huxin Formula in patients undergoing PCI. Our results showed that there was no significant difference between the two groups in main outcomes. For patients with ejection fraction (EF) >50%, score of the quality of life scale was higher in treatment group compared with control group. For patients with unstable angina, score of the quality of life scale in 360 days was significantly higher in treatment group compared with control group (P < 0.05). No obvious adverse reaction was found in the use of Huxin Formula. In conclusion, Huxin Formula, believed to be a safe treatment for patients after PCI, has benefits in improving the quality of life in patients with unstable angina though it failed to show superiority in primary and secondary outcomes.
