Xuefu Zhuyu Oral Liquid as Adjunctive Therapy on Stable Angina: A Randomized Clinical Trial
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Background
Stable angina (SA) is a leading cause of disability worldwide, and there is increasing interest in nonpharmacological treatments. Xuefu Zhuyu oral liquid (XZOL) is a Chinese medicine that has been approved in China for the treatment of SA, but further studies are needed to establish its efficacy and safety. We aimed to provide a reliable assessment of the safety and efficacy of XZOL in patients with SA.
Methods
We did a multi-centre, randomised, double-blind, placebo-controlled trial at 6 hospitals in China. Participants were randomized into 2 treatment groups, and allocated to receive of either XZOL or matching placebo over 12 weeks and were followed-up for 12 weeks. The primary efficacy outcome was the average pain intensity of angina, which was measured by the change from baseline to week 12 on a 10-cm visual analogue scale.
Results
Of 263 patients screened, 148 participants were randomly assigned with primary outcome data in the ITT (intention-to-treat) population (74 in the XZOL group and 74 in the placebo group), and 99 participants in the PP (per-protocol) population (48 in the XZOL group and 51 in the placebo group). Mean change in VAS at week 12 were −2.27 in the XZOL group and −1.85 in the placebo group (difference - 0.52, 95% CI −0.99 to −0.05; P = 0.029) among the ITT population, and −2.54 in the XZOL group and −1.79 in the placebo group (difference −0.81, 95% CI −1.40 to −0.22; P = 0.007) among the PP population. The neutral results were shown in adjusted and sensitivity analyses. There was no significant difference in adverse events.
Conclusion
This randomised, placebo-controlled, double-blind, clinical trial showed XZOL was associated with a significantly greater reduction in the levels of pain intensity of angina over 12 weeks and was superior to placebo in alleviating SA.
