What is the clinical evidence from this study?

Study design: RCT. Population: Stable angina (n=152). Intervention: Xuefu Zhuyu oral liquid vs. Placebo. Primary outcome: Change in average angina pain intensity from baseline to week 12 (VAS score) (Adjusted mean difference -0.63, 95% CI -1.12 to -0.14, p=0.012).

What question did this study set out to answer?

This study aims to assess the efficacy and safety of Xuefu Zhuyu oral liquid as an adjunctive treatment for stable angina.

May 3, 2026Open Access

Effects of Xuefu Zhuyu oral liquid as adjunctive treatment for stable angina: a randomized controlled trial

CWCao WencongGuangzhou University of Chinese Medicine SLShaojun LiaoGuangzhou University of Chinese Medicine LZLi ZhouGuangzhou University of Chinese Medicine

Key Result

Xuefu Zhuyu oral liquid as an adjunctive treatment for 12 weeks significantly reduced angina pain intensity compared to placebo (adjusted mean difference -0.63) in patients with stable angina.

Key Points

This study aims to assess the efficacy and safety of Xuefu Zhuyu oral liquid as an adjunctive treatment for stable angina.
Conducted a multicenter, randomized, double-blind, placebo-controlled trial across six hospitals in China.
Patients with stable angina received either Xuefu Zhuyu or a placebo for 12 weeks alongside standard therapy.
Follow-up extended for an additional 12 weeks to measure outcomes.
At week 12, the Xuefu Zhuyu group had an average pain reduction of 0.63 on the visual analog scale compared to placebo (95% CI, –1.12 to –0.14; P = 0.012).
Effect sustained at 24-week follow-up, showing a reduction of 0.47 on the pain scale (95% CI, –0.94 to –0.002; P = 0.049).
Use of rescue nitroglycerin was significantly lower in the Xuefu Zhuyu group at weeks 12 and 24 (P = 0.016 and P = 0.029 respectively).

Study Design

Type

RCT (n=152)

Blinding

Double-blind

Randomization

1:1

Multicenter

Yes

Structured PICO

Does Xuefu Zhuyu oral liquid reduce angina pain intensity in patients with stable angina?

Population

148 patients with stable angina (SA)

Intervention

Xuefu Zhuyu oral liquid (XZOL) for 12 weeks, added to standard antianginal therapy

Comparator

Matching placebo for 12 weeks, added to standard antianginal therapy

Outcome

Change in average angina pain intensity from baseline to week 12, measured on a 10-cm visual analog scale (VAS)patient reported

Adjunctive treatment with Xuefu Zhuyu oral liquid for 12 weeks significantly reduced angina pain intensity and the need for rescue nitroglycerin in patients with stable angina.

Main Result

Effect estimate: Adjusted mean difference -0.63 (95% CI -1.12 to -0.14)

Absolute Event Rate: -2.27% vs -1.85%

p-value: p=0.012

Limitations

Reliance on a subjective primary outcome (VAS for pain) makes the results susceptible to a significant placebo effect.
Maintaining effective blinding was a challenge due to the distinctive organoleptic properties (taste and smell) of the oral liquid.
Generalizability is limited as the trial was conducted exclusively in a Chinese population with a specific Chinese Medicine pattern.

Abstract

Background Stable angina (SA) remains a major cause of global disability. Xuefu Zhuyu oral liquid (XZOL), a traditional Chinese medicine, is used for SA in China, but rigorous evidence of its efficacy is lacking. We aimed to evaluate the efficacy and safety of XZOL as an adjunctive therapy for patients with SA. Methods We conducted a multicenter, randomized, double-blind, placebo-controlled trial across six hospitals in China. Between June 2020 and June 2022, eligible patients with SA were randomly assigned (1:1) to receive either XZOL or a matching placebo for 12 weeks, in addition to standard antianginal therapy. All participants were followed for an additional 12 weeks. The primary outcome was the change in average angina pain intensity from baseline to week 12, measured on a 10-cm visual analog scale (VAS). Results Of 263 patients screened, 148 were included in the full analysis set (74 per group). At week 12, patients receiving XZOL showed a reduction in VAS pain scores compared to placebo (adjusted mean difference, –0.63; 95% CI, –1.12 to –0.14; P = 0.012). This effect was sustained at the 24-week follow-up (–0.47; 95% CI, –0.94 to –0.002; P = 0.049). Furthermore, the XZOL group had significantly lower use of rescue nitroglycerin at both 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. Conclusion Adjunctive treatment with XZOL for 12 weeks significantly reduced angina pain intensity and the need for rescue medication in patients with stable angina, with a favorable safety profile. Clinical trial registration https://clinicaltrials.gov/ , ChiCTR1900026899.

AI से पूछें

Bookmark

View Full Paper