Yangxinshi Tablet Improves Exercise Capacity for Patients with Coronary Heart Disease: Results from a Randomized, Double-Blind, Placebo-Controlled, and Multicenter Trial.

ABSTRACT

Objective: To assess the clinical effectiveness of Yangxinshi (YXS) tablets on exercise capacity and symptoms of anxiety and depression in patients with coronary heart disease (CHD). Methods and Results: A randomized, double-blind, placebo-controlled, multicenter clinical trial was performed to assess the effects of YXS tablets on exercise capacity and quality of life in patients with CHD. A total of 82 patients were included in this trial. Compared with the placebo group, the YXS group showed significant improvement in peak VO 2 (0.22 L/min vs 0.01 L/min; difference 0.1, 95% confidence interval (CI) 0.04-0.16, p = 0.000), peak Mets (0.58 vs 0.09; difference 0.3, 95% CI 0.12-0.47, p = 0.005), anaerobic threshold (AT) VO 2 (0.23 L/min vs 0.04 L/min; difference 0.12, 95% CI 0.07-0.18, p = 0.000), AT Mets (0.62 vs 0.16; difference 0.35, 95% CI 0.2-0.5, p = 0.001), and 6 minutes walking test (6MWT) (50.05 m vs 11.91 m; difference 29.92, 95% CI 18.78-41.07, p = 0.000). There were no differences in Hamilton anxiety rating scale (HAM-A score (1.97 vs 2.07; difference 2.03, 95% CI 0.99-3.06, p = 0.926) and Hamilton depression rating scale (HAM-D) score (1.06 vs 1.7; difference1.42, 95% CI 0.24-2.6, p = 0.592). Conclusions: In patients with CHD, YXS tablets, compared with placebo, could improve exercise capacity, without beneficial effects on anxiety and depression symptoms.