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MS-N161 · Kampo formulation · Neuropathy prevention · Predominantly lung cancer · Randomized phase II trial · Appraised 28 October 2026

Can the Japanese Kampo formula goshajinkigan prevent clinically important neuropathy during carboplatin–paclitaxel chemotherapy?

Evidence at a glance

  • Evidence label: Promising small open-label phase II signal; confirmatory trial needed
  • Benefit: Grade 2 or worse neuropathy occurred in 9/32 (28.1%) with goshajinkigan and 17/33 (51.5%) with control; the prespecified unstratified analysis favored treatment.
  • Certainty: Low. The trial was small and open label, 80% of participants had lung cancer, and the supportive stratified analysis was less precise and did not meet its stated threshold.
  • Risk: The formula contains ten crude drugs, including processed aconite and cinnamon bark. Grade 3–5 adverse events were common in both arms during chemotherapy and were not significantly different.

What was studied

Sixty-five adults across seven Japanese centers were randomized 1:1 to no prophylaxis or TJ-107 goshajinkigan granules during at least four carboplatin–paclitaxel courses. Each 7.5 g of granules contained 4.5 g dried extract made from Rehmannia, Achyranthes, Cornus, Dioscorea, Plantago, Alisma, Poria, Moutan, cinnamon and processed aconite. The primary endpoint was time to grade 2 or worse neuropathy.

What the evidence found

Grade 2 or worse neuropathy occurred in 28.1% versus 51.5%; unstratified HR 0.34 (90% CI 0.16–0.72; P=0.013). After stratifying for cancer type and age, HR was 0.48 (90% CI 0.22–1.02; P=0.101). Time to treatment failure did not differ. Grade 3–5 adverse events occurred in 75.0% versus 63.6% (P=0.422), without a clear treatment-attributed excess.

How to interpret it

The result conflicts with an earlier negative record for goshajinkigan during oxaliplatin. Different chemotherapy mechanisms and populations make these distinct questions, but neither result validates over-the-counter mixtures. An open-label assessment of a subjective toxicity is vulnerable to expectation and ascertainment bias.

Practical safety context

Processed aconite can be toxic if formulation or processing is wrong. Multi-herb Kampo products may also cause allergy, electrolyte disturbances, liver injury or lung injury, and can interact with medicines. Use only a quality-controlled product under oncology and pharmacy review; do not self-mix crude herbs.

Questions for the care team

  • Is the available product the same standardized TJ-107 formulation?
  • How will neuropathy be assessed before each paclitaxel dose?
  • What symptoms or laboratory changes would require stopping the formula?

Funding and conflicts

Supported by the Clinical Research Encouragement Fund of Okayama University Hospital and the Chugoku Occupational Health Association. The accessible report did not identify commercial product funding.

Sources

Last literature search: 28 October 2026. Record appraisal: 28 October 2026. This page is educational and does not replace individualized medical advice. Symptom, biomarker or observational findings must not be interpreted as proof of tumor control, recurrence prevention or longer survival unless those outcomes were directly tested.