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Clinical Trial
. 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)

Shunsuke Ohnishi  1 , Hidemichi Watari  2 , Maki Kanno  3 , Yoko Ohba  4 , Satoshi Takeuchi  5 , Tempei Miyaji  6 , Shunsuke Oyamada  7 , Eiji Nomura  3 , Hidenori Kato  4 , Toru Sugiyama  5 , Masahiro Asaka  8 , Noriaki Sakuragi  2 , Takuhiro Yamaguchi  6   9 , Yasuhito Uezono  10 , Satoru Iwase  11
Affiliations
Clinical Trial

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)

Shunsuke Ohnishi et al. J Gynecol Oncol. 2017 Sep.

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.

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

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Conflict of interest statement

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

Figures

Fig. 1
Fig. 1
CONSORT diagram. CONSORT, Consolidated Standards of Reporting Trials.
Fig. 2
Fig. 2
Proportion of subjects with primary and secondary endpoints. The primary endpoint was CC rate in the overall phase (0–120 hours), while others were included in the secondary endpoints. Data are presented as point estimates and 80% CI. CC, complete control; CI, confidence interval; CR, complete response. *p<0.200 from 2-tailed χ2 test vs. control group.
Fig. 3
Fig. 3
Kaplan-Meier plot of time to treatment failure (i.e., to first emesis or use of rescue medication). p=0.059 (log-rank test).
Fig. 4
Fig. 4
VAS results for degree of appetite (A) and severity of nausea (B). VAS, visual analogue scale.
See this image and copyright information in PMC

Comment in

References

    1. Basch E, Prestrud AA, Hesketh PJ, Kris MG, Somerfield MR, Lyman GH. Antiemetic use in oncology: updated guideline recommendations from ASCO. Am Soc Clin Oncol Educ Book. 2012:532–540. - PubMed
    1. Roila F, Herrstedt J, Aapro M, Gralla RJ, Einhorn LH, Ballatori E, et al. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol. 2010;21(Suppl 5):v232–43. - PubMed
    1. Schmoll HJ, Aapro MS, Poli-Bigelli S, Kim HK, Park K, Jordan K, et al. Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Ann Oncol. 2006;17:1000–1006. - PubMed
    1. Poli-Bigelli S, Rodrigues-Pereira J, Carides AD, Julie Ma G, Eldridge K, Hipple A, et al. Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Results from a randomized, double-blind, placebo-controlled trial in Latin America. Cancer. 2003;97:3090–3098. - PubMed
    1. Hesketh PJ, Grunberg SM, Gralla RJ, Warr DG, Roila F, de Wit R, et al. The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group. J Clin Oncol. 2003;21:4112–4119. - PubMed

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