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)

Overview

Journal J Gynecol Oncol

Specialties Gynecology & Obstetrics
Oncology

Date 2017 Jun 29

PMID 28657216

Citations 22

Authors

Shunsuke Ohnishi

Hidemichi Watari

Maki Kanno

Yoko Ohba

Satoshi Takeuchi

Tempei Miyaji

Shunsuke Oyamada

Eiji Nomura

Hidenori Kato

Toru Sugiyama

Masahiro Asaka

Noriaki Sakuragi

Takuhiro Yamaguchi

Yasuhito Uezono

Satoru Iwase

Affiliations

Soon will be listed here.

Abstract

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.

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