Safety & tolerability 2015

Cordyceps militaris in adults with mild liver dysfunction: extract efficacy and safety — an RCT

A Korean RCT in people with mild liver dysfunction (ALT 1.5–3× above normal): Cordyceps militaris extract 1.5 g/day vs. placebo with a full lab panel, liver CT and symptom scales. The preparation was tolerated safely — neither hematology nor biochemistry showed alarming shifts; the authors state protection against fatty-disease progression as a possibility, not a proven fact.

Jang Y.S., et al. The Efficacy and Safety of Cordyceps militaris in Korean Adults Who Have Mild Liver Dysfunction. J Clin Nutr. 2015;7(3):81–89.

Rationale

Hepatic safety is the most sensitive question for mushroom extracts: the market sold cordyceps "for the liver" for decades, but most evidence was in animals. A Korean team chose the most vulnerable legal population — adults with already-elevated ALT (1.5–3× the upper limit of normal, mild liver dysfunction without hepatotonics or alcohol) — and tested whether the extract would worsen or improve their condition.

Methods

A single-center double-blind placebo-controlled RCT (Bundang Jesaeng Hospital, February 2013 – January 2014): C. militaris extract 1.5 g/day (two capsules twice daily) vs. identical placebo. Assessment — lab panel (leukocytes, hemoglobin, platelets, AST, ALT, GGT, LDH, alkaline phosphatase, bilirubin, urea, creatinine), liver CT and visual-analog scales for symptoms and fatigue.

Results

  • Safety: the preparation was used safely in patients with mild liver dysfunction — the authors specifically emphasize the absence of hepatotoxic shifts in this at-risk group.
  • On hepatocyte fat parameters the work reports a potential protective effect against fatty-disease/cirrhosis progression via suppressed lipid accumulation in hepatocytes — as a hypothesis consistent with preclinical data.

Conclusions

Cordyceps militaris extract is applicable as a functional product in people with mild liver dysfunction — one of the few human answers to "does cordyceps harm the liver" in a real population with already-elevated transaminases.

Worth noting

Strengths: a population with a real (though mild) hepatic background rather than healthy volunteers; a broad lab panel plus liver CT imaging, rare in supplement studies; double blinding and hospital protocol registration.

Limitations:

  1. Small size, one center — safety conclusions are cautious; no statistical power for rare adverse events.
  2. Publication in a local Korean journal — citability and replication are limited.
  3. ALT 1.5–3× ULN population — results transfer neither to healthy people (where there is nothing to improve) nor to patients with marked liver disease.
  4. Extract composition — standardization for cordycepin and polysaccharides is not disclosed; transfer to other commercial products is imprecise.

Sources

  1. DOI: 10.15747/jcn.2015.7.3.81
  2. E-ACNM: full article text