A randomized double-blind placebo-controlled clinical trial on the efficacy and safety of herbal medicine San-jia-fu-mai (SJFM) in the treatment of atrial fibrillation and heart failure with preserved ejection fraction (yin depletion syndrome)

Pharmacological Research - Modern Chinese Medicine Pub Date : 2025-01-18 DOI:10.1016/j.prmcm.2025.100575

Yang Yang, Sizhao Li, Yujie Liu, Yunhu Song, Bing Hou, Shuaishuai Zhou, Dachang Xie

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Abstract

Objective

To evaluate the safety and efficacy of San-jia-fu-mai (SJFM) in patients with heart failure with preserved ejection fraction (HFpEF) and atrial fibrillation (AF).

Methods

110 patients with HFpEF and AF were randomized in a double-blind, placebo-controlled trial to receive either SJFM or placebo for 12 weeks. Both groups received optimal medication therapy, including dapagliflozin. The primary endpoint was the improvement of KCCQ grade, Secondary endpoints included KCCQ score, E/e', NT-proBNP, and sRAGE, assessed at baseline and 4-week intervals for 12 weeks.

Results

After excluding 8 patients (4 in each group), 51 patients in each group (SJFM and placebo) completed the study and were included in the analysis. Both groups showed significant decreases in E/e′, NT-proBNP, and sRAGE at weeks 4, 8, and 12 compared with baseline (P < 0.05). Both groups showed significant increases in KCCQ score at weeks 4, 8, and 12 compared with baseline (P < 0.05). Furthermore, The SJFM group showed significantly greater decreases in NT-proBNP and sRAGE at weeks 4, 8, and 12 compared with the placebo group (P < 0.05). Significant improvements in KCCQ and E/e′ were observed in the SJFM group at weeks 8 and 12. At week 12, the SJFM group showed a significantly greater improvement in KCCQ grade (94.12 % vs. 68.63 %; χ² = 9.14, P < 0.05). No serious adverse events were reported.

Conclusion

SJFM demonstrated good efficacy, safety, and tolerability in patients with AF and HFpEF, suggesting its potential as a therapeutic option. The name of the trial register is “The effect of gliflozin combined with Fumai decoction on cardiac function and prognosis in patients with heart failure and atrial fibrillation with preserved ejection fraction”. The trial was registered at http://itmctr.ccebtcm.org.cn/.

Abstract Image

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中药散家复脉（SJFM）治疗保留射血分数（阴虚证）型房颤心衰的疗效和安全性的随机双盲安慰剂对照临床试验

目的评价三甲复脉（SJFM）治疗心力衰竭伴保射血分数（HFpEF）合并心房颤动（AF）患者的安全性和有效性。方法在双盲、安慰剂对照试验中，110例HFpEF和AF患者随机接受SJFM或安慰剂治疗，为期12周。两组均接受最佳药物治疗，包括达格列净。主要终点是KCCQ分级的改善，次要终点包括KCCQ评分、E/ E′、NT-proBNP和sRAGE，在基线和4周间隔进行评估，共12周。结果在排除8例患者（每组4例）后，SJFM组和安慰剂组各有51例患者完成研究并纳入分析。与基线相比，两组在第4、8和12周的E/ E′、NT-proBNP和sRAGE均显著降低(P <；0.05)。两组患者在第4周、第8周和第12周的KCCQ评分均较基线显著升高(P <；0.05)。此外，与安慰剂组相比，SJFM组在第4周、第8周和第12周时NT-proBNP和sRAGE的下降幅度显著更大(P <；0.05)。SJFM组在第8周和第12周观察到KCCQ和E/ E '的显著改善。在第12周，SJFM组KCCQ评分显著提高(94.12% vs 68.63%；χ²= 9.14,P <；0.05)。无严重不良事件报告。结论sjfm对房颤和HFpEF患者具有良好的疗效、安全性和耐受性，提示其有作为治疗方案的潜力。试验登记的名称为“格列净联合复脉汤对保留射血分数的心力衰竭心房颤动患者心功能及预后的影响”。该试验已在http://itmctr.ccebtcm.org.cn/上注册。

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来源期刊

Pharmacological Research - Modern Chinese Medicine

CiteScore

1.60

自引率

0.00%

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