Key result
Huxin Formula failed to show superiority in primary outcomes compared to control in patients undergoing PCI, though it improved quality of life scores at 360 days in those with unstable angina (P<0.05).
Why the study?
Does Huxin Formula improve outcomes and quality of life in patients undergoing percutaneous coronary intervention?
RCT
Double-blind
randomized
Yes
Does Huxin Formula improve outcomes and quality of life in patients undergoing percutaneous coronary intervention?
Huxin Formula did not improve primary outcomes after PCI but may safely improve quality of life in the subgroup of patients with unstable angina.
Huxin Formula lacks superiority for primary post-PCI outcomes; challenges complementary therapy expectations and leaves QoL benefit open for confirmation.
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.
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Wu et al. (2014) conducted an RCT in Coronary artery disease undergoing percutaneous coronary intervention. Huxin Formula vs. control group was evaluated on main outcomes. Huxin Formula failed to show superiority in primary outcomes compared to control in patients undergoing PCI, though it improved quality of life scores at 360 days in those with unstable angina (P<0.05).
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