News Release

First randomised trial of traditional Chinese medicine for heart failure shows benefit

QUEST trial presented in a Hot Line Session today at ESC Congress 2023

Reports and Proceedings

European Society of Cardiology

Amsterdam, Netherlands – 26 Aug 2023: The traditional Chinese medicine qiliqiangxin reduces hospitalisation for heart failure and cardiovascular death in patients with heart failure and a reduced ejection fraction (HFrEF), according to late breaking research presented in a Hot Line session today at ESC Congress 2023.1


Qiliqiangxin is a traditional Chinese medicine extract obtained from 11 types of herbs (Table 1).2 In a pilot study, qiliqiangxin reduced N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels and improved heart failure symptoms in patients with HFrEF when added to established heart failure treatment.3 Preclinical studies have also indicated that qiliqiangxin has beneficial effects on attenuating myocardial fibrosis and cardiac remodelling.4-7


The QUEST trial evaluated the clinical efficacy and safety of qiliqiangxin on major heart failure outcomes in HFrEF patients. The trial was conducted at 133 hospitals in mainland China and Hong Kong SAR of China.


The trial enrolled adult HFrEF patients with a left ventricular ejection fraction of 40% or below and NT-proBNP of 450 pg/ml or higher who had been on a stable standardised baseline treatment regimen for at least two weeks prior to enrolment. Patients were randomised in a 1:1 fashion to receive qiliqiangxin (four capsules, three times daily) or placebo on top of standard medications for chronic heart failure. The primary endpoint was a composite of rehospitalisation for worsening heart failure or cardiovascular death.


A total of 3,110 patients were included in the analysis, with 1,555 randomised to qiliqiangxin and 1,555 randomised to placebo. The average age was 62 years and 72.1% were men. At baseline, the mean left ventricular ejection fraction was 32%, and the median NT-proBNP was 1730.80 pg/ml.


During a median follow up of 18.3 months, the primary endpoint occurred in 389 patients (25.02%) in the qiliqiangxin group and in 467 patients (30.03%) in the placebo group (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.68 to 0.90; p<0.001). This effect was related to both lower risks of rehospitalisation for worsening heart failure (HR, 0.76; 95% CI, 0.64 to 0.90; p=0.002) and cardiovascular death (HR, 0.83; 95% CI, 0.68 to 0.996; p=0.045) in the qiliqiangxin group. The effect of qiliqiangxin on the primary outcome was generally consistent across prespecified subgroups including in the subgroups defined according to age and NT-proBNP level, and in patients with or without angiotensin receptor/neprilysin inhibitors (ARNIs).


In terms of secondary endpoints, the decrease in serum NT-proBNP between baseline and three-month follow-up was greater in the qiliqiangxin group (-444.00 [interquartile range -1401.00 to 85.00]) than in the placebo group (-363.00 [interquartile range -1280.00 to 183.00]) (p=0.047), which was consist with the previous pilot study.3


Analysis of safety endpoints demonstrated no significant difference in all-cause mortality, which occurred in 221 patients (14.21%) in the qiliqiangxin group and 262 patients (16.85%) in the placebo group (HR, 0.84; 95% CI, 0.70 to 1.01; p=0.058). Qiliqiangxin capsules were well-tolerated, with no major differences between the two groups in adverse events including gastrointestinal symptoms, worsening renal function and increased liver enzymes.


Principal investigator Professor Xinli Li of the First Affiliated Hospital of Nanjing Medical University, Nanjing, China said: “To our knowledge, this was the first randomised, double-blind controlled trial of a traditional Chinese medicine for the treatment of chronic heart failure. Our findings demonstrate meaningful clinical benefit with qiliqiangxin in patients with HFrEF, which support the use of qiliqiangxin as an adjunct therapy for treating heart failure.”


Table 1: Ingredients of qiliqiangxin


Notes to editors


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Funding: National Key Technologies R&D Program (CN, Project No. 2017YFC1700500, 2017YFC1700505); Key Program of National Natural Science Foundation (CN, Project No. 81730106); General Program of National Natural Science Foundation (CN, 81970339, 82270394, 82200425). Shijiazhuang Yiling Pharmaceutical Co., Ltd. (Shijazhuang, People’s Republic of China) provided part of the funding and the study drug for this research. All funding sources were not involved in the design of the study and collection, enrolment, statistical analysis, interpretation of data and in writing the manuscript.


Disclosures: Prof. Xinli Li reports receiving grant support (all grant support listed paid to the First Affiliated Hospital with Nanjing Medical University) from Novartis and China Heart Failure Center, receiving lecture fees and consulting fees from AstraZeneca, Bayer, Novartis, Roche, and Yiling.


References and notes

1QUEST will be discussed during Hot Line 2 on Saturday 26 August at 08:30 to 10:00 CEST in room Amsterdam.

2Yao W, Cheang I, Liao S, et al. Study protocol for a randomized controlled trial: Qiliqiangxin in heart failUre: assESsment of reduction in morTality (QUEST). BMC Complement Med Ther. 2020;20:38.

3Li X, Zhang J, Huang J, et al. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol. 2013;62:1065-1072.

4Li F, Wang J, Song Y, et al. Qiliqiangxin alleviates Ang II-induced CMECs apoptosis by downregulating autophagy via the ErbB2-AKT-FoxO3a axis. Life Sci. 2021;273:119239.

5Gao RR, Wu XD, Jiang HM, et al. Traditional Chinese medicine qiliqiangxin attenuates phenylephrine-induced cardiac hypertrophy via upregulating PPARγ and PGC-1α. Ann Transl Med. 2018;6:153.

6Sun X, Chen G, Xie Y, et al. Qiliqiangxin improves cardiac function and attenuates cardiac remodelling in doxorubicin-induced heart failure rats. Pharm Biol. 2020;58:417-426.

7Lu Y, Xiang M, Xin L, et al. Qiliqiangxin modulates the gut microbiota and NLRP3 inflammasome to protect against ventricular remodeling in heart failure. Front Pharmacol. 2022;13:905424.


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