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Published on: March 27, 2018
Efficacy and safety of Huxin formula in patients after CABG: a multicenter, double-blind, randomized clinical trial
Yu Lin1, Yun-Fei Wang, Dong-Qun Lin
1Heart Center, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Insights
Huxin Formula showed no primary outcome benefits after coronary artery bypass grafting (CABG). However, it improved angina symptoms in some patients and cardiac function in those with three-vessel disease without adverse effects.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Coronary artery bypass grafting (CABG) is a common treatment for coronary artery disease.
- Evaluating novel therapeutic agents post-CABG is crucial for improving patient outcomes.
- Huxin Formula's efficacy and safety following CABG required investigation.
Purpose of the Study:
- To assess the efficacy and safety of Huxin Formula compared to placebo in patients after CABG.
- To determine the impact of Huxin Formula on major adverse cardiac events and angina symptoms.
- To evaluate the effect of Huxin Formula on cardiac function and patient-reported outcomes.
Main Methods:
- A multicenter, double-blind, randomized, controlled trial was conducted.
- 270 patients undergoing CABG were randomized to receive either Huxin Formula or placebo for 6 months.
- Primary endpoints included death, myocardial infarction, repeat revascularization, and readmission; secondary endpoints assessed angina frequency and severity.
Main Results:
- No significant differences were observed between groups for primary endpoints.
- Huxin Formula significantly reduced angina pectoris frequency and severity in patients with New York Heart Association cardiac function class II after 90 days.
- Patients with three-vessel disease showed improved cardiac function in the control group compared to the Huxin Formula group after 360 days.
Conclusions:
- Huxin Formula did not demonstrate superiority in primary outcomes for post-CABG patients.
- The formula may offer benefits in symptom relief for angina and potentially improve cardiac function in specific patient subgroups.
- No significant adverse reactions were reported, suggesting a favorable safety profile.
Background:
Coronary artery bypass grafting (CABG) is widely used in the treatment of coronary artery disease. A multicenter, double-blind, randomized, controlled clinical trial was designed to evaluate the efficacy and safety of Huxin Formula post CABG.
Patients And Methods:
270 inpatients with coronary heart disease participated in this study. CABG patients in the control group were treated with placebo, while patients in the experimental group were treated with Huxin Formula 1 week after the surgery. All patients were treated for 6 months and followed up for another 6 months. The main outcomes (death, nonfatal myocardial infarction, repeat revascularization, and readmission) were assessed 360 days after treatment, and secondary outcomes (frequency and scores of angina pectoris, etc.) were assessed 0, 90, 180, 270, and 360 days after treatment.
Results:
Our results showed no significant difference between the 2 groups for the primary endpoints. In patients with cardiac function class II (New York Heart Association), the score of angina pectoris was significantly lower (3.88 ± 3.86 vs. 5.45 ± 3.59) and the frequency of angina pectoris attacks was less (0.96 ± 1.01 vs. 1.36 ± 0.94) after 90 days of treatment with Huxin Formula compared to placebo (p < 0.05). In patients with 3 coronary vessel lesions, the cardiac function class (1.14 ± 0.35 vs. 1.05 ± 0.21) after 360 days was significantly higher in the control group compared to the treatment group (p < 0.05). There were no obvious adverse reactions.
Conclusion:
Huxin Formula may improve cardiac function of patients with 3 coronary vessel lesions and relieve symptoms of patients with cardiac function class II but failed to show superiority in primary outcomes.
