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Narrative review of Shenfu Injection for sepsis-induced gastrointestinal injury and septic shockA Chinese herbal therapy may protect the gut during septic shock

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Key Takeaway
Consider Shenfu Injection potential for sepsis GI injury, but efficacy claims remain insufficient.

This narrative review evaluates Shenfu Injection in the context of sepsis-induced acute gastrointestinal injury and septic shock. The scope includes a synthesis of mechanistic basis and preclinical findings alongside available clinical evidence. The authors note substantial heterogeneity in study design, models, interventions, and outcomes as a primary limitation. Small sample size and single-center design are also cited as constraints. Insufficient methodological reporting further limits the strength of the conclusions drawn.

The mechanistic analysis suggests Shenfu Injection exerts effects through multiple targets. These include inhibiting the Toll-like receptor 4/Nuclear factor kappa B signaling pathway to reduce intestinal inflammation. The drug upregulates tight junction proteins such as zonula occludens-1 and Occludin, reducing epithelial cell apoptosis. It also modulates immune molecules to protect the physical and immune barriers of the intestinal mucosa. Improvements in microcirculation and tissue perfusion are also described as potential mechanisms.

Clinical evidence suggests potential benefits in selected physiological and surrogate endpoints. However, absolute numbers and effect sizes are not reported for these outcomes. The review concludes that validation through high-quality multicenter randomized controlled trials and further mechanistic studies are needed. Current clinical evidence remains insufficient to support definitive efficacy claims regarding Shenfu Injection.

This could change how we protect the gut in sepsis

For years, the idea was to treat the infection and hope the gut healed on its own. But research now shows the gut isn’t just a victim. It’s an active driver of sepsis. Damage here can spark a chain reaction that overwhelms the body.

SFI flips the script. Instead of just fighting germs, it may help shore up the gut’s defenses. Preclinical studies show it works on multiple fronts.

Think of the gut lining like a tightly locked gate. Proteins such as ZO-1 and occludin act as the bolts, holding cells together. In sepsis, inflammation throws those bolts off. SFI appears to reinforce them.

It also dials down a key inflammation pathway called TLR4/NF-κB. Imagine this as a switch that, when stuck “on,” floods the gut with damaging chemicals. SFI may help flip it back.

Another benefit? Better blood flow. In animal models, SFI improves microcirculation in the gut. That means more oxygen and nutrients reach damaged tissues, helping them survive.

Some studies even suggest SFI may help balance gut bacteria, though this area needs more proof.

The gut is not just a bystander in sepsis

A structured review of both animal and human studies found consistent signals of benefit. In rodents, SFI reduced gut injury, lowered inflammation, and improved survival.

In humans, small clinical trials report better blood pressure stability, lower markers of gut damage, and improved organ function. One study noted patients on SFI had lower levels of a protein called intestinal fatty acid binding protein (I-FABP), a sign of less gut cell injury.

But there's a catch.

Most human studies are small, often with fewer than 100 patients. They’re done at single hospitals, mostly in China. Many don’t fully describe their methods, making it hard to trust the results completely.

Also, SFI contains aconite, a plant that can be toxic if not processed correctly. It affects the heart and nerves. Cases of arrhythmia and even death have been linked to poor-quality aconite products.

While SFI is standardized, quality control remains a concern. Not all batches may be equal.

Experts say the biological logic is sound. The gut is a key battlefield in sepsis. Any treatment that strengthens its barrier could have ripple effects across the body.

But they urge caution.

SFI is not ready for use outside of research settings in most countries. It’s not approved by the FDA or EMA. In China, it’s used under strict protocols.

For patients and families, this means: don’t ask for SFI at your local hospital. It’s not available, and self-treating with herbal aconite products could be dangerous.

The biggest hurdle now is evidence. To move forward, large, multicenter trials are needed. These would test SFI against placebo in diverse patient groups, with clear outcomes like survival, ICU stay, and infection rates.

Some researchers are already planning such trials. But funding and regulatory approval take time.

For now, SFI remains a promising idea, not a proven fix. It highlights a shift in thinking: protecting the gut may be as important as fighting the infection itself.

The road ahead will require careful science. But for patients facing septic shock, even a small edge could make a life-or-death difference.

Study Details

Study typeMeta analysis
EvidenceLevel 1
PublishedMay 2026
View Original Abstract ↓
Shenfu Injection (SFI) is a standardized botanical drug derived from two Chinese medicinal herbs Panax ginseng C.A.Mey. and Aconitum carmichaelii Debeaux. SFI is historically used for “restoring yang and reversing collapse.” It is now widely applied in the treatment of septic shock. The gastrointestinal tract is considered the “engine” of sepsis, and its injury can lead to mucosal barrier disruption and secondary infection. The aim of this narrative review was to summarize the mechanistic basis, preclinical findings and available clinical evidence regarding the role of SFI in sepsis-induced acute gastrointestinal injury (AGI), while critically appraising the strengths and limitations of the current evidence base. A structured literature search of major English- and Chinese-language databases was performed. Preclinical and clinical studies were screened according to predefined inclusion criteria. Due to substantial heterogeneity in study design, models, interventions and outcomes, a quantitative meta-analysis was not performed. Research indicates SFI exerts effects through multiple targets: inhibiting the Toll-like receptor 4/Nuclear factor kappa B signaling (TLR4/NF-κB) pathway to reduce intestinal inflammation; upregulating tight junction (TJ) proteins such as zonula occludens-1 (ZO-1) and Occludin, reducing epithelial cell apoptosis, and modulating immune molecules to protect the physical and immune barriers of the intestinal mucosa; improving microcirculation and tissue perfusion; and potentially modulating gut microbiota composition. Although available clinical studies suggest potential benefits in selected physiological and surrogate endpoints, but most are constrained by small sample size, single-center design, and insufficient methodological reporting. Careful attention is also warranted to safety considerations, particularly aconite-related toxicity, standardization of preparation, and quality control, also warrant careful attention. Overall, SFI shows potential in stabilizing hemodynamics and maintaining the intestinal barrier, but current clinical evidence remains insufficient to support definitive efficacy claims. Validation through high-quality multicenter randomized controlled trials and further mechanistic studies are needed.
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