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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)

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...

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Autores principales: Ohnishi, Shunsuke, Watari, Hidemichi, Kanno, Maki, Ohba, Yoko, Takeuchi, Satoshi, Miyaji, Tempei, Oyamada, Shunsuke, Nomura, Eiji, Kato, Hidenori, Sugiyama, Toru, Asaka, Masahiro, Sakuragi, Noriaki, Yamaguchi, Takuhiro, Uezono, Yasuhito, Iwase, Satoru
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Asian Society of Gynecologic Oncology; Korean Society of Gynecologic Oncology 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5540714/
https://www.ncbi.nlm.nih.gov/pubmed/28657216
http://dx.doi.org/10.3802/jgo.2017.28.e44
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author Ohnishi, Shunsuke
Watari, Hidemichi
Kanno, Maki
Ohba, Yoko
Takeuchi, Satoshi
Miyaji, Tempei
Oyamada, Shunsuke
Nomura, Eiji
Kato, Hidenori
Sugiyama, Toru
Asaka, Masahiro
Sakuragi, Noriaki
Yamaguchi, Takuhiro
Uezono, Yasuhito
Iwase, Satoru
author_facet Ohnishi, Shunsuke
Watari, Hidemichi
Kanno, Maki
Ohba, Yoko
Takeuchi, Satoshi
Miyaji, Tempei
Oyamada, Shunsuke
Nomura, Eiji
Kato, Hidenori
Sugiyama, Toru
Asaka, Masahiro
Sakuragi, Noriaki
Yamaguchi, Takuhiro
Uezono, Yasuhito
Iwase, Satoru
author_sort Ohnishi, Shunsuke
collection PubMed
description 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/m(2) day 1) and paclitaxel (135 mg/m(2) 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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spelling pubmed-55407142017-09-01 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) Ohnishi, Shunsuke Watari, Hidemichi Kanno, Maki Ohba, Yoko Takeuchi, Satoshi Miyaji, Tempei Oyamada, Shunsuke Nomura, Eiji Kato, Hidenori Sugiyama, Toru Asaka, Masahiro Sakuragi, Noriaki Yamaguchi, Takuhiro Uezono, Yasuhito Iwase, Satoru J Gynecol Oncol Original Article 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/m(2) day 1) and paclitaxel (135 mg/m(2) 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. Asian Society of Gynecologic Oncology; Korean Society of Gynecologic Oncology 2017-09 2017-03-17 /pmc/articles/PMC5540714/ /pubmed/28657216 http://dx.doi.org/10.3802/jgo.2017.28.e44 Text en Copyright © 2017. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Ohnishi, Shunsuke
Watari, Hidemichi
Kanno, Maki
Ohba, Yoko
Takeuchi, Satoshi
Miyaji, Tempei
Oyamada, Shunsuke
Nomura, Eiji
Kato, Hidenori
Sugiyama, Toru
Asaka, Masahiro
Sakuragi, Noriaki
Yamaguchi, Takuhiro
Uezono, Yasuhito
Iwase, Satoru
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)
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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)
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5540714/
https://www.ncbi.nlm.nih.gov/pubmed/28657216
http://dx.doi.org/10.3802/jgo.2017.28.e44
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