Effects of Xuefu Zhuyu Granules on Patients with Stable Coronary Heart Disease: A Double-Blind, Randomized, and Placebo-Controlled Study.

Abstract

Despite advances in the drug treatment strategy for stable coronary heart disease (CHD), the mortality of CHD continues to rise. New or adjuvant treatments would be desirable for CHD. Xuefu Zhuyu granules are derived from the formula of traditional Chinese medicine. To determine whether Xuefu Zhuyu granules might have adjuvant effects on stable CHD, we conducted a controlled clinical trial. Patients with stable CHD were enrolled and randomly assigned to receive Xuefu Zhuyu granules or placebo for 12 weeks in addition to their standard medications for the treatment of CHD. The primary endpoints comprise the Canadian Cardiovascular Society Angina Grading Scale (CCS class), echocardiographic measures, Seattle Angina Questionnaire (SAQ), and coronary artery CT. The secondary endpoints included the parameters of nailfold capillary measurement and cutaneous blood perfusion (CBP). After 12 weeks of follow-up, there was a great improvement of the Canadian Cardiovascular Society Angina Grading Scale (CCS class) in the Xuefu Zhuyu group compared with the placebo group (p < 0.01). Also, a decrease was found in the percentage of patients with CCS class II in the Xuefu Zhuyu group between follow-up at 12 weeks and baseline (p < 0.01). We observed a significant increase in SAQ scores of physical limitation (p < 0.01) and treatment satisfaction (p < 0.05) in patients receiving Xuefu Zhuyu treatment at 12 weeks in comparison with those at baseline, but not in placebo treatment (p > 0.05). Amelioration in coronary artery stenosis in the Xuefu Zhuyu group was noted (p < 0.05). Xuefu Zhuyu granule treatment led to great improvements in cutaneous blood perfusion at follow-up of 12 weeks compared with placebo (p < 0.05). These findings suggest that on a background of standard medications, Xuefu Zhuyu granules have the ability to further improve the prognosis of patients with stable CHD.