Adjunctive Xuefu Zhuyu oral liquid lowers angina pain scores and nitroglycerin use in stable angina.
This multicenter, randomized, double-blind, placebo-controlled trial enrolled 148 patients with stable angina across six hospitals in China. The study included a full analysis set with 74 participants per group. Treatment duration involved 12 weeks of therapy followed by an additional 12 weeks of follow-up, totaling 24 weeks. The primary outcome focused on pain intensity changes.
Xuefu Zhuyu oral liquid served as adjunctive therapy compared to matching placebo. At week 12, the adjusted mean difference in angina pain intensity was -0.63 on a 10-cm visual analog scale (95% CI, -1.12 to -0.14; P = 0.012). This reduction in pain scores remained significant at week 24 with an adjusted mean difference of -0.47 (95% CI, -0.94 to -0.002; P = 0.049). Secondary outcomes assessed nitroglycerin consumption.
Rescue nitroglycerin use was significantly lower in the intervention group at week 12 (2.7% vs. 13.5%; P = 0.016) and week 24 (2.7% vs. 12.2%; P = 0.029). Adverse events were comparable between groups, and the safety profile was described as favorable. Serious adverse events and discontinuations were not reported. No significant safety concerns were identified during the trial period.
While the study demonstrates statistical significance for pain reduction and medication use, the setting was limited to six hospitals in China. The evidence supports potential utility as an adjunctive treatment but requires confirmation in broader populations. Generalizability to other regions may be limited by the specific geographic location.