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J Gynecol Oncol. 2017 Sep;28(5):e44. doi: 10.3802/jgo.2017.28.e44. Epub 2017 Mar 17.

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).

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Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Department of Obstetrics and Gynecology, Oji General Hospital, Tomakomai, Japan.
Division of Gynecologic Oncology, National Hospital Organization, Hokkaido Cancer Center, Sapporo, Japan.
Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Japan.
Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Biostatistics, Japanese Organisation for Research and Treatment of Cancer, Tokyo, Japan.
Cancer Preventive Institute, Health Sciences University of Hokkaido, Tobetsu, Japan.
Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.
Division of Cancer Pathophysiology, Group for Translational Research, National Cancer Center Research Institute, Tokyo, Japan.
Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.



Rikkunshito, an herbal medicine, is widely prescribed in Japan for the treatment of anorexia and functional dyspepsia, and has been reported to recover reductions in food intake caused by cisplatin. We investigated whether rikkunshito could improve chemotherapy-induced nausea and vomiting (CINV) and anorexia in patients treated with cisplatin.


Patients with uterine cervical or corpus cancer who were to receive cisplatin (50 mg/m² day 1) and paclitaxel (135 mg/m² day 0) as first-line chemotherapy were randomly assigned to 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 complete control (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.


The CC rate in the overall phase was significantly higher in the rikkunshito group than 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 to treatment failure (p=0.059). Appetite assessed by visual analogue scale (VAS) appeared to be superior in the rikkunshito group from day 2 through day 6.


Rikkunshito provided additive effect for the prevention of CINV and anorexia.


Anorexia; Antiemetics; Nausea; Rikkunshito; Vomiting

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Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

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