Traditional Chinese medicine shows benefit in HFrEF patients

Treatment with qiliqiangxin (QLQX), a traditional Chinese medicine (TCM), significantly reduces the risk of hospitalization due to heart failure (HF) and cardiovascular (CV) death in patients with HF and reduced ejection fraction (HFrEF), according to the QUEST* trial presented at ESC 2023.

QLQX capsule is a TCM extract obtained from 11 herbs, including astragaliradix, ginseng radix et rhizoma, aconiti lateralis radix preparata, Salvia miltiorrhiza radix et rhizoma, semen descurainiae lepidii, alismatis rhizoma, polygonati odorati rhizoma, cinnamomi ramulus, carthami flos, periploca cortex, and citri reticulatae pericarpium. [J Am Coll Cardiol 2013;62:1065-1072]

QLQX has been approved in China since 2004 for the treatment of chronic heart failure (CHF). “It best reflects the concept of ‘diuretic, vasodilator, and cardiotonic agents’ for the treatment of HF in modern medicine,” said lead author Professor Xinli Li from the First Affiliated Hospital of Nanjing Medical University, Nanjing, China.

In a previous study, patients with CHF on a standard background therapy for HF who received QLQX had significant reductions in N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels and improvements in New York Heart Association functional status, left ventricular ejection fraction, and quality of life during 12 weeks of treatment, suggesting that QLQX could be used in combination therapy for CHF. [J Am Coll Cardiol 2013;62:1065-1072]

In the current study, researchers sought to further assess the efficacy and safety of long-term use of QLQX in patients with HFrEF.

The prospective, double-blind, placebo-controlled, multicentre study included 3,110 patients with HFrEF (mean age 63 years, 70 percent male) who were recruited from 133 hospitals in mainland China and Hong Kong SAR. Baseline mean LVEF was 32 percent and median NT-proBNP level was 1,692 pg/mL. Participants were randomized in a 1:1 ratio to receive either QLQX (four capsules, thrice daily) or placebo (n=1,555 in each group) on top of their standard medications for CHF.

At a median follow-up of 18.3 months, QLQX significantly reduced the risk of the primary composite endpoint of CV death and HF hospitalization by 22 percent compared with placebo (hazard ratio [HR], 0.78; p<0.001). [ESC 2023, Hot Line Session 2]

When individual components of the composite endpoint were evaluated separately, QLQX was also associated with lower risks of HF hospitalization (HR, 0.76; p=0.002) and CV death (HR, 0.83; p=0.045) vs placebo.

The effect of QLQX on the primary outcome was generally consistent across the prespecified subgroups of patients with ischaemic aetiology (HR, 0.76; p<0.001) and those who did not receive Western guideline-directed medical therapies, such as triple therapy with RAASi+Beta-blocker+MRA (HR, 0.74; p=0.003) or baseline ARNI** (HR, 0.77; p=0.012).

“These risk reductions were substantial and clinically important,” Li noted.

In terms of the safety endpoints, there was no significant difference in all-cause mortality (14.21 percent vs 16.85 percent; p=0.058) or adverse events (82.83 percent vs 84.18 percent; p=0.334) between the QLQX and placebo arms. “QLQX capsules are generally safe and well tolerated,” said Li.

“To our knowledge, this was the first randomized, double-blind controlled trial of a TCM for the treatment of CHF. Our findings [further] demonstrate meaningful clinical benefit with QLQX in patients with HFrEF, which support the use of QLQX as an adjunct therapy for treating HF,” Li said in a press release.

The QLQX capsule may be explored further as a new treatment option for patients with HFrEF, he suggested.

“This trial provides long-term outcomes that are much needed for QLQX in HFrEF, and this is remarkable,” commented invited discussant Professor Carolyn Lam from the National Heart Centre Singapore, who is unaffiliated with the study.

“We now have scientifically rigorous evidence for a traditional medicine used by millions with HF in China,” she added. “QUEST sets a new bar for clinical evidence with traditional medicines, which really challenges the precise reductionist approach of Western medicine.”