A placebo-controlled study of the doses and efficacy of

Introduction: Preclinical studies have demonstrated the potential of Methods: After curative resection, we used a 1:1:1 ratio to randomly assign patients with CRC with persistent OIPN (defined by a visual analogue scale [VAS] numbness score ≥40 mm) to the low-dose (L.E.M. 300 mg twice daily [bid]), high-dose (L.E.M. 900 mg bid), and placebo groups. The primary endpoint of this double-blind, placebo-controlled phase 2 trial was the reduction in the VAS numbness score in the low-dose group compared with that in the placebo group at 12 weeks. Adverse events (AEs) and quality of life were evaluated. Results: Forty-five patients were randomly assigned to the placebo (n = 15), low-dose (n = 15), and high-dose (n = 15) groups. At 12 weeks, no significant difference in the reduction of the VAS numbness score was observed when the low-dose and placebo groups were compared (-12.20 [95% confidence interval {CI}; -34.54 to 10.14] Discussion: High-dose L.E.M. extract resulted in a clinically meaningful improvement in VAS numbness scores without severe toxicity. Clinical Trial Registration: https://jrct.mhlw.go.jp/en-latest-detail/jRCTs051210085, identifier jRCTs051210085.