학술논문
Additive effect of rikkunshito, an herbal medicine, on chemotherapy-induced nausea, vomiting, and anorexia in uterine cervical or corpus cancer patients treated with cisplatin and paclitaxel: results of a randomized phase II study (JORTC KMP-02)
Document Type
Article
Author
Source
Journal of Gynecologic Oncology, 28(5), pp.1-10 Sep, 2017
Subject
Language
English
ISSN
2005-0399
2005-0380
2005-0380
Abstract
Objective: Rikkunshito, an herbal medicine, is widely prescribed in Japan for the treatmentof anorexia and functional dyspepsia, and has been reported to recover reductions in foodintake caused by cisplatin. We investigated whether rikkunshito could improve chemotherapyinducednausea and vomiting (CINV) and anorexia in patients treated with cisplatin. Methods: Patients with uterine cervical or corpus cancer who were to receive cisplatin (50 mg/m2day 1) and paclitaxel (135 mg/m2day 0) as first-line chemotherapy were randomly assignedto the rikkunshito group receiving oral administration on days 0–13 with standard antiemetics,or the control group receiving antiemetics only. The primary endpoint was the rate of completecontrol (CC: no emesis, no rescue medication, and no significant nausea) in the overall phase(0–120 hours). Two-tailed p<0.20 was considered significant in the planned analysis. Results: The CC rate in the overall phase was significantly higher in the rikkunshito groupthan in the control group (57.9% vs. 35.3%, p=0.175), as were the secondary endpoints:the CC rate in the delayed phase (24–120 hours), and the complete response (CR) rates(no emesis and no rescue medication) in the overall and delayed phases (63.2% vs. 35.3%, p=0.095; 84.2% vs. 52.9%, p=0.042; 84.2% vs. 52.9%, p=0.042, respectively), and time totreatment failure (p=0.059). Appetite assessed by visual analogue scale (VAS) appeared to besuperior in the rikkunshito group from day 2 through day 6. Conclusion: Rikkunshito provided additive effect for the prevention of CINV and anorexia