ArticleFrontiers in pharmacology2026
Exploratory assessment of the potential protective effects of Kampo treatment against low dose medical radiation: a single arm prospective observational study.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Low-dose computed tomography (CT) scans can induce DNA damage, including chromosomal aberrations (CAs) and DNA double-strand breaks, which may contribute to long-term cancer risk. D-limonene, a bioactive component present in several Kampo formulas, has shown radioprotective effects in preclinical studies; however, clinical evidence remains limited, and the gastrointestinal side effects associated with isolated D-limonene may restrict its clinical application. This single-arm observational pilot study aimed to evaluate whether Kampo formulas containing D-limonene could mitigate CT-induced cytogenetic damage and to generate preliminary data for designing a future definitive trial. Methods: Thirty-nine patients with functional dyspepsia received one of four D-limonene-containing Kampo formulas: bukuryoin, rikkunshito, heiisan, or nichinto. Peripheral blood lymphocytes were collected before and after Kampo treatment and exposed in vitro to CT radiation. Chromosomal aberrations were assessed using peptide nucleic acid fluorescence in situ hybridization (PNA-FISH), while DNA double-strand breaks were evaluated by γ-H2AX immunofluorescence. Wilcoxon signed-rank tests and linear mixedeffects models were used to assess radiation effects and Kampo-related interactions, and intraclass correlation coefficients (ICCs) were calculated to compare assay reliability. Results: CT exposure significantly increased CAs before Kampo treatment (p = 0.024), whereas this increase was attenuated after treatment (p = 0.417). However, neither the pre-post difference-in-differences analysis (p = 0.428) nor the CT × Kampo interaction in the mixed-effects model (β = -0.72; 95% CI, -2.19 to 0.75; p = 0.343) reached statistical significance. γ-H2AX showed a similar trend. PNA-FISH demonstrated higher measurement reliability than γ-H2AX immunofluorescence (ICC = 0.89 vs. 0.65). Sample size estimation based on PNA-FISH indicated that 275-295 evaluable participants per arm would be required for a future definitive trial. Discussion: Overall, Kampo formulas containing D-limonene showed a trend toward mitigating CT-induced cytogenetic injury, and PNA-FISH appeared to provide a more reliable endpoint than γ-H2AX. These exploratory findings support further investigation in a randomized controlled trial to determine whether D-limonene-containing Kampo formulas can meaningfully mitigate CT-associated genotoxicity in humans.
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