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Qiliqiangxin capsule adjunctive therapy reduces cardiovascular death and hospitalization in patients with heart failure with reduced ejection fractionA Traditional Chinese Capsule Meets Modern Heart Failure Trials

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Key Takeaway
Note reduced cardiovascular death and hospitalization risk with Qiliqiangxin capsule in HFrEF, though safety data are absent.

A systematic review and meta-analysis examined the efficacy of Qiliqiangxin capsule used as adjunctive therapy in patients with heart failure with reduced ejection fraction (HFrEF). The analysis pooled data from studies involving a total sample size of 5,580 patients, comparing the addition of Qiliqiangxin capsule to conventional treatments alone. The setting and specific study phases were not reported in the source data.

Regarding efficacy, the meta-analysis reported a reduced risk of cardiovascular death with a relative risk (RR) of 0.82 (95% CI [0.69, 0.96], P = 0.02). Hospitalization for heart failure was also reduced, with an RR of 0.78 (95% CI [0.67, 0.91], P = 0.001). The risk of composite cardiovascular events decreased by 18% (RR = 0.82, 95% CI [0.73, 0.92], P = 0.0005). Furthermore, left ventricular ejection fraction increased by a mean difference (MD) of 7.14 (95% CI [6.75, 7.54], P < 0.05), while left ventricular end-diastolic diameter decreased by an MD of -5.25 (95% CI [-5.75, -4.75], P < 0.05). Improvements were also observed in NYHA class (RR = 1.19, 95% CI [1.14, 1.25]), NT-proBNP levels (SMD = -2.01, 95% CI [-2.26, -1.95], P < 0.05), and 6-min walking distance (MD = 44.80, 95% CI [42.37, 47.22], P < 0.05).

Safety and tolerability data were not reported for adverse events, serious adverse events, or discontinuations. The follow-up duration was not reported. As this is a meta-analysis of studies where the study phase was not reported, causal attribution is limited. The absence of safety data and the lack of reported follow-up duration represent significant limitations to the current evidence base.

A centuries-old formula steps into modern trials

Imagine a heart failure pill built from 11 different plants — including Huang Qi (astragalus), Ren Shen (ginseng), and Dan Shen (red sage).

That's Qiliqiangxin (QLQX), a traditional Chinese medicine formulation developed from principles dating back centuries.

For years, it was used mostly in China. Now, researchers are putting it through the same statistical tests Western drugs face — and the results are drawing international attention.

Heart failure with reduced ejection fraction, or HFrEF (heart failure with reduced pumping), affects millions of people worldwide.

Modern treatments — ACE inhibitors, beta blockers, SGLT2 inhibitors, sacubitril/valsartan — have made a real difference. But many patients still decline, get hospitalized, or die earlier than hoped.

So researchers keep looking for additions, not replacements. That's where adjunctive (add-on) therapies come in.

Old view vs. the more careful look

For a long time, Western cardiologists viewed traditional Chinese medicines with skepticism — often fairly, given that few had been tested in rigorous randomized trials.

What's changing: Chinese research teams are increasingly running well-designed randomized controlled trials on traditional formulas.

This new meta-analysis pooled 24 such trials on QLQX, covering 5,580 patients, and asked a simple question: does adding this capsule to standard heart failure care actually help?

How it works, in simple terms

Qiliqiangxin's name roughly translates to "strengthening the heart with qi."

In traditional Chinese medicine terms, it aims to tonify qi, activate blood circulation, and promote diuresis.

In modern biological terms, researchers have identified several possible effects: reducing heart muscle stress, calming inflammation, improving how heart cells use energy, and helping the body shed excess fluid.

Think of it as trying to support the heart from several angles at once — similar in philosophy to combination therapy in modern medicine.

The study at a glance

The authors searched seven research databases through February 2025 for randomized controlled trials of QLQX in HFrEF patients.

Two independent reviewers screened the studies and rated their quality using the standard Cochrane RoB 2.0 tool. They used the GRADE system to assess how trustworthy the combined evidence was.

Twenty-four trials — nearly all conducted in China — met inclusion criteria.

The headline numbers were meaningful.

Compared to standard treatment alone, adding QLQX reduced the risk of cardiovascular death by about 18%, hospitalization for heart failure by about 22%, and combined cardiovascular events by 18%. Evidence quality was rated as moderate by GRADE.

Heart function measures also improved: the left ventricular ejection fraction rose, chamber size shrank slightly, NT-proBNP (a blood marker of heart strain) fell, and patients walked further in a standard 6-minute walk test.

These are promising numbers — but they come with important caveats.

A re-engagement moment

Here's where it gets delicate.

A formula rooted in centuries of traditional practice, backed by moderate-quality modern data, but with almost all trials done in a single country — that's an unusual mix.

The question isn't whether QLQX deserves dismissal (it doesn't) or whether it's proven beyond doubt (it isn't). It's whether the evidence is strong enough for wider adoption outside China.

QLQX is already included in China's national heart failure guidelines as an adjunctive option.

Elsewhere, cardiologists tend to take a more cautious view. They respect the tradition and welcome the growing evidence base, but want to see large multicenter trials in diverse populations — including long-term safety data and head-to-head comparisons with modern guideline-directed medications.

This is how integration typically unfolds: promising regional data, followed by international trials, followed by gradual acceptance if results hold.

If you live in a region where QLQX is available and prescribed by a qualified cardiologist, discuss with that doctor whether it's appropriate for your case.

If you live outside China, QLQX is generally not part of standard treatment. Don't order it online or use it to replace proven therapies.

Do not stop or replace your current heart failure medications based on early research. Modern HFrEF drugs have decades of evidence behind them, and changes should always involve your cardiologist.

Honest limitations

The meta-analysis has real weaknesses to respect.

Nearly all trials came from China, which raises concerns about whether results will replicate in other populations and health systems. Individual trial quality varied. Blinding — a key feature of rigorous trials — was inconsistent.

Follow-up times were relatively short, so effects over many years remain unclear. Interactions with newer heart failure drugs, like SGLT2 inhibitors, weren't well studied.

Large, multicenter, international randomized controlled trials are needed to confirm these findings.

Some are already being planned. Studies using standardized outcomes, long-term follow-up, and more diverse populations would help move QLQX from regional acceptance to global consideration.

In the meantime, this analysis supports respecting traditional knowledge while also insisting on modern standards of proof — a balance medicine will keep navigating as more traditional therapies meet rigorous testing.

Study Details

Study typeMeta analysis
EvidenceLevel 1
Follow-up240.0 mo
PublishedApr 2026
View Original Abstract ↓
ETHNOPHARMACOLOGICAL RELEVANCE: The Qiliqiangxin (QLQX) capsule is a prominent traditional Chinese medicine formulation developed based on the collateral disease theory, specifically for the treatment of heart failure (HF). Its composition includes 11 medicinal botanicals, such as Huang Qi, Ren Shen, and Dan Shen, and is designed to tonify qi, activate blood circulation, and promote diuresis. Supported by over 20 years of extensive clinical application, modern pharmacological research, and stringent quality control, QLQX has been incorporated into the national heart failure guidelines in China. AIM OF THE STUDY: This study evaluates the efficacy and safety of QLQX as adjunctive therapy for heart failure with reduced ejection fraction (HFrEF). METHODS: We systematically searched seven databases until February 24, 2025, for randomized controlled trials (RCTs) evaluating QLQX in patients with HFrEF. Two independent researchers screened trials, extracted data, and assessed the risk of bias using the Cochrane RoB 2.0 tool. Meta-analyses were conducted for efficacy and safety outcomes, with evidence quality evaluated through the GRADE framework. RESULTS: Twenty-four RCTs (n = 5580) were included. Compared with conventional treatments (CTs) alone, QLQX adjunctive therapy significantly reduced the risk of cardiovascular death (RR = 0.82, 95 %CI [0.69, 0.96], P = 0.02), hospitalization for HF (RR = 0.78, 95 %CI [0.67, 0.91], P = 0.001), and composite cardiovascular events by 18 % (RR = 0.82, 95 %CI [0.73, 0.92], P = 0.0005), with evidence quality rated as moderate. QLQX significantly improved cardiac function parameters compared to controls: increased left ventricular ejection fraction (MD = 7.14, 95 % CI [6.75, 7.54], P < 0.05), reduced left ventricular end-diastolic diameter (MD = -5.25, 95 % CI [-5.75, -4.75], P < 0.05), improved NYHA class (RR = 1.19, 95 %CI [1.14, 1.25]), decreased NT-proBNP (SMD = -2.01, 95 %CI [-2.26, -1.95], P < 0.05), and increased 6-min walking distance (MD = 44.80, 95 %CI [42.37, 47.22], P < 0.05). CONCLUSION: QLQX adjunct therapy effectively reduces cardiovascular death and HF hospitalization while improving cardiac function in HFrEF, with favorable safety. Large-scale multicenter RCTs with extended follow-up are required to confirm long-term benefits and address existing study limitations.
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