Evidence Explorer / MS-N038

TRADITIONAL JAPANESE KAMPO & NEUROPATHY

Goshajinkigan to prevent oxaliplatin neuropathy

Evidence label: Potential harm / do not use for prevention outside research · Clinical goal: prevent oxaliplatin-associated peripheral neuropathy

Evidence at a glance

• Traditional context: Goshajinkigan (TJ-107) is a multi-herb Kampo formula used in Japan for symptoms including numbness; traditional use is not proof of benefit.
• Population: people with colon cancer receiving adjuvant mFOLFOX6.
• Result: a blinded phase III trial stopped early; grade 2 or worse neuropathy was more frequent with Goshajinkigan.

What was studied

The multicenter GENIUS trial planned 310 participants and compared Goshajinkigan with placebo during adjuvant FOLFOX. The primary endpoint was time to grade 2 or worse neuropathy.

An interim safety review recommended stopping the trial. One hundred eighty-two participants were evaluable: 89 in the Kampo group and 93 with placebo. The precise granule dose should be verified from the full protocol; the PubMed abstract reports a value that appears inconsistent with standard Kampo labeling.

What the evidence shows

Grade 2 or worse neuropathy occurred in 50.6% with Goshajinkigan and 31.2% with placebo. Goshajinkigan was associated with higher neuropathy incidence (hazard ratio 1.908; P=.007).

Earlier smaller phase II reports suggested possible benefit, but the larger phase III result did not confirm it and instead raised a harm signal. The formula should not be used to prevent oxaliplatin neuropathy outside research.

Limits and uncertainty

The study stopped early, which limits precision, but stopping followed a prespecified safety review and the direction of effect was unfavorable.

Goshajinkigan is a multi-herb formulation; related Kampo products or differently manufactured preparations are not automatically equivalent.

Safety and practical context

Multi-herb Kampo formulas can produce herb–drug interactions, electrolyte effects, allergy or contamination risk. Ingredient identity and manufacturing quality matter.

Preventing neuropathy must not come at the cost of more neuropathy. Report numbness, tingling, pain, balance difficulty or functional loss early so oxaliplatin dose and schedule can be reassessed.

Questions for the care team

• Why consider this formula despite the stopped phase III trial?
• What ingredients and quality controls are documented for the exact product?
• How will patient-reported function and neuropathy guide oxaliplatin decisions?

Sources

• GENIUS randomized phase III trial (PMID 25627820)
• Earlier GONE randomized phase II trial (PMID 24121454)
• Later multicenter randomized phase II study (PMID 34916380)
• ASCO chemotherapy-induced peripheral neuropathy guideline update (PMID 32663120)

Literature searched: October 15, 2026 · Record appraised: October 15, 2026

Educational evidence summary, not personal medical advice. Research regimens describe what was studied; they are not personal prescribing instructions and should not replace cancer treatment or individualized supportive care.