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)

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


Objective: 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.

Methods: 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.

Results: 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.

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

Keywords: Anorexia; Antiemetics; Nausea; Rikkunshito; Vomiting.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anorexia / chemically induced
  • Anorexia / prevention & control
  • Antiemetics / administration & dosage
  • Antineoplastic Agents / adverse effects*
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects*
  • Drugs, Chinese Herbal / therapeutic use*
  • Female
  • Humans
  • Japan
  • Middle Aged
  • Nausea / chemically induced
  • Nausea / prevention & control
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects*
  • Uterine Cervical Neoplasms / drug therapy*
  • Uterine Neoplasms / drug therapy*
  • Vomiting / chemically induced
  • Vomiting / prevention & control


  • Antiemetics
  • Antineoplastic Agents
  • Drugs, Chinese Herbal
  • liu-jun-zi-tang
  • Paclitaxel
  • Cisplatin