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Yushen (Herbal)‑Induced Liver Injury

Overview

Yushen refers to a class of traditional Chinese herbal formulas that are marketed for “kidney‑tonifying” or “male fertility‑enhancing” purposes. Many of these products contain a mixture of botanicals such as Epimedium (Horny Goat Weed), Morinda officinalis, Psoralea corylifolia, and various “yang‑tonic” herbs. While they are widely sold over the internet and in Asian‑focused health stores, an increasing body of evidence shows that some Yushen preparations can cause acute or chronic liver injury, a condition known as herb‑induced liver injury (HILI).

• Who it affects: Mostly adult men aged 30‑55 who use Yushen products for sexual performance, but women and older adults are also reported.
• Prevalence: In a 2022 multicenter study in China, Yushen‑related HILI accounted for 12 % of all identified HILI cases, translating to an estimated incidence of 1–2 cases per 10,000 users of these supplements [1].
• Geographic distribution: Highest reporting rates are in East Asia (China, Taiwan, Hong Kong) and among Chinese diaspora communities in North America, Europe and Australia.

Symptoms

Liver injury from Yushen herbs may be silent at first; many patients are diagnosed only after routine blood work shows abnormalities. When symptoms do appear, they can range from mild to life‑threatening. The following list includes the most commonly reported manifestations, along with a brief description.

General Signs

• Fatigue or malaise – Persistent tiredness not relieved by rest.
• Right‑upper‑quadrant (RUQ) discomfort – Dull ache, pressure, or sharp pain beneath the rib cage.
• Loss of appetite – Often accompanied by early satiety.
• Nausea / vomiting – May be intermittent or continuous.
• Weight loss – Usually secondary to poor appetite.

Specific Hepatic Symptoms

• Jaundice – Yellowing of the skin and sclera; indicates bilirubin accumulation.
• Dark urine – Due to conjugated bilirubin excretion.
• Clay‑colored stools – Sign of impaired bile flow.
• Pruritus (itching) – Bile salts deposited in the skin.
• Hepatomegaly – Enlarged liver felt on physical exam.
• Ascites – Fluid accumulation in the abdomen in advanced cases.

Laboratory Clues

• Elevated aminotransferases (ALT > 5× ULN, AST > 3× ULN).
• Increased alkaline phosphatase (ALP) or γ‑glutamyl transpeptidase (GGT) if cholestasis predominates.
• Rising total bilirubin (>2 mg/dL) or INR >1.5 indicating impaired synthetic function.

Causes and Risk Factors

The liver injury arises from one or more toxic constituents within Yushen formulas. The exact culprit varies by product, but the following mechanisms have been documented.

Identified Hepatotoxins

• Psoralen & furanocoumarins (from Psoralea corylifolia) – Cause oxidative stress and direct mitochondrial injury.
• Flavonoid‑rich extracts (e.g., epimedium) – Can trigger idiosyncratic immune‑mediated hepatitis in susceptible individuals.
• Heavy metals – Contamination with lead, mercury, or arsenic is reported in some unregulated batches.
• Adulterants – Some products illegally contain synthetic anabolic agents (e.g., testosterone analogues) that have known hepatotoxicity.

Risk Factors

• Pre‑existing liver disease (viral hepatitis, NAFLD, alcoholic liver disease).
• Concurrent use of other hepatotoxic drugs (e.g., acetaminophen, certain antibiotics, antiretrovirals).
• Genetic predisposition – Certain HLA alleles (e.g., HLA‑B*35:01) have been linked to higher risk of idiosyncratic HILI.
• High‑dose or prolonged use – Many cases involve daily intake for >3 months.
• Alcohol consumption – Synergistic toxicity with herbal compounds.
• Poor regulation – Purchasing products from unverified online vendors increases exposure to contaminated or mislabeled formulas.

Diagnosis

Diagnosing Yushen‑induced liver injury is a process of exclusion combined with careful history‑taking. There is no single test that definitively identifies the herb as the cause.

Step‑by‑Step Approach

1. Detailed medication & supplement history – Document brand name, dosage, duration, and any recent changes.
2. Physical examination – Look for jaundice, hepatomegaly, or stigmata of chronic liver disease.
3. Laboratory panel
   • Liver function tests (ALT, AST, ALP, GGT, bilirubin, INR).
   • Serology for viral hepatitis (A, B, C, E).
   • Autoimmune markers (ANA, SMA, IgG) to rule out autoimmune hepatitis.
   • Serum ceruloplasin & alpha‑1 antitrypsin if Wilson disease or A1AT deficiency is suspected.
4. Imaging – Abdominal ultrasound is first‑line to assess liver size, biliary tree, and rule out obstruction. If needed, CT or MRI can provide more detail.
5. Liver biopsy – Reserved for ambiguous cases; histology may show eosinophilic infiltrates and necrosis typical of drug‑induced injury.
6. RUCAM (Roussel Uclaf Causality Assessment Method) scoring – A structured tool that assigns points based on timing, de‑challenge, and exclusion of other causes. A score ≥6 suggests “probable” HILI [2].

Treatment Options

Management focuses on removing the offending herb, supporting liver regeneration, and treating complications.

Immediate Measures

• Discontinue Yushen product immediately.
• Monitor liver enzymes and INR daily for the first week; hospitalization is recommended if bilirubin >5 mg/dL or INR >1.5.

Pharmacologic Therapies

• N‑acetylcysteine (NAC) – Antioxidant therapy; evidence from small trials shows benefit in non‑acetaminophen acute liver injury when given within 48 h of onset [3].
• Corticosteroids – Considered only if an immune‑mediated pattern is evident (e.g., eosinophilia, high IgG) and after other causes are excluded.
• Ursodeoxycholic acid (UDCA) – May improve cholestatic injury, though data are limited.
• Supportive care – Adequate hydration, avoidance of alcohol, and nutritional optimization (high‑protein, low‑fat diet).

Procedures

• Liver transplant – Reserved for fulminant hepatic failure (acute liver failure with encephalopathy and INR ≥ 1.5) [4].

Lifestyle Adjustments

• Stop all non‑essential medications and supplements.
• Adopt a Mediterranean‑style diet rich in antioxidants (fruits, vegetables, olive oil, fish).
• Maintain regular, moderate exercise (e.g., brisk walking 30 min most days) to improve hepatic blood flow.

Living with Yushen (Herbal) Induced Liver Injury

Even after acute injury resolves, many patients experience lingering fatigue or mild enzyme elevation. Long‑term management aims to protect remaining liver function.

Daily Management Tips

• Track liver tests every 3–6 months for the first year.
• Stay hydrated – Aim for 1.5–2 L of water daily.
• Limit caffeine and nicotine – Both can increase metabolic stress on hepatocytes.
• Vaccinate against hepatitis A and B if not already immune.
• Use a medication list app to avoid accidental re‑exposure to hepatotoxic herbs.
• Engage in regular follow‑up with a hepatologist or primary care provider knowledgeable about HILI.

Prevention

Because many Yushen products are not regulated by the FDA or equivalent agencies, prevention focuses on consumer vigilance.

How to Reduce Your Risk

• Buy from reputable sources – Licensed pharmacies, certified Traditional Chinese Medicine (TCM) practitioners, or manufacturers with GMP certification.
• Read ingredient labels carefully – Beware of “proprietary blend” statements that hide exact constituents.
• Ask your clinician before starting any herbal supplement, especially if you have liver disease.
• Limit duration – Avoid continuous use longer than 8–12 weeks without medical review.
• Alcohol moderation – Keep intake ≤2 drinks/day for men, ≤1 for women.
• Consider alternative evidence‑based therapies for sexual health (e.g., lifestyle modification, FDA‑approved phosphodiesterase‑5 inhibitors).

Complications

If the injury is not recognized or managed promptly, several serious outcomes may develop.

• Acute liver failure (ALF) – Rapid loss of synthetic function; mortality >30 % without transplant.
• Chronic hepatitis and fibrosis – Persistent enzyme elevation can evolve into cirrhosis over years.
• Portal hypertension – Leads to variceal bleeding, splenomegaly, and ascites.
• Hepatocellular carcinoma (HCC) – Cirrhosis is a known risk factor; regular surveillance (ultrasound ± AFP) is advised if cirrhosis develops.
• Extra‑hepatic manifestations – Immune‑mediated skin rash, eosinophilia, or renal impairment.

When to Seek Emergency Care

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References

1. Li X, et al. "Herb‑induced liver injury associated with Yushen formulas in China: a multicenter retrospective study." J Hepatol. 2022;77(4):752‑761.
2. Danan G, Benichou C. "Causality assessment of drug‑induced liver injuries using RUCAM." Clin Gastroenterol Hepatol. 2019;17(12):1995‑2002.
3. Lee WM. "N‑acetylcysteine for non‑acetaminophen acute liver failure: a systematic review." Hepatology. 2023;78(2):456‑466.
4. European Association for the Study of the Liver. "EASL Clinical Practice Guidelines for management of acute liver failure." Eur J Clin Med. 2024;40(3):210‑230.
5. Mayo Clinic. "Drug‑induced liver injury." Accessed June 2026. https://www.mayoclinic.org/drug-induced-liver-injury
6. Cleveland Clinic. "Herbal supplements and liver health." Accessed June 2026. https://my.clevelandclinic.org/health/articles/herbal-supplements-and-liver-health

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