Evidence map›Paper›PMID 28657216›Full record

Trial reportJournal of gynecologic oncology2017

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, Hidemichi Watari, Maki Kanno, Yoko Ohba, Satoshi Takeuchi, Tempei Miyaji, Shunsuke Oyamada, Eiji Nomura, Hidenori Kato, Toru Sugiyama and 5 more

Open access · diamondAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of gynecologic oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Prevalence and predictors of long-delayed (> 120 h) chemotherapy-induced nausea and vomiting (CINV)-a systematic review and individual patient data meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Recent Advances inMetabolites · 2022
    Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 2 countries.

Shunsuke OhnishiDepartment of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.ORCID https://orcid.org/0000-0003-1194-4149
Hidemichi WatariDepartment of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.ORCID https://orcid.org/0000-0002-4189-6187
Maki KannoDepartment of Obstetrics and Gynecology, Oji General Hospital, Tomakomai, Japan.ORCID https://orcid.org/0000-0001-7396-0385
Yoko OhbaDivision of Gynecologic Oncology, National Hospital Organization, Hokkaido Cancer Center, Sapporo, Japan.
Satoshi TakeuchiDepartment of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Japan.ORCID https://orcid.org/0000-0001-8868-6462
Tempei MiyajiDepartment of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Shunsuke OyamadaDepartment of Biostatistics, Japanese Organisation for Research and Treatment of Cancer, Tokyo, Japan.ORCID https://orcid.org/0000-0002-8130-6815
Eiji NomuraDepartment of Obstetrics and Gynecology, Oji General Hospital, Tomakomai, Japan.
Hidenori KatoDivision of Gynecologic Oncology, National Hospital Organization, Hokkaido Cancer Center, Sapporo, Japan.ORCID https://orcid.org/0000-0002-2153-5843
Toru SugiyamaDepartment of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka, Japan.
Masahiro AsakaCancer Preventive Institute, Health Sciences University of Hokkaido, Tobetsu, Japan.
Noriaki SakuragiDepartment of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.ORCID https://orcid.org/0000-0002-0653-8325
Takuhiro YamaguchiDepartment of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.ORCID https://orcid.org/0000-0002-7961-9417
Yasuhito UezonoDivision of Cancer Pathophysiology, Group for Translational Research, National Cancer Center Research Institute, Tokyo, Japan. yuezono@ncc.go.jp.ORCID https://orcid.org/0000-0003-1208-1453
Satoru IwaseDepartment of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.ORCID https://orcid.org/0000-0002-7976-4569
Hokkaido University · JPIwate Medical University · JPNational Hospital Organization Hokkaido Medical Center · JPOji General Hospital · JPThe University of Tokyo · JPHealth Sciences University of Hokkaido · JPJapanese Foundation For Cancer Research · JPNational Cancer Research Institute · GBTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveRikkunshito, 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.

methodsPatients 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.

resultsThe 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.

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

Indexed as

AdultAgedAnorexiaAntiemeticsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCisplatinDrugs, Chinese HerbalFemaleHumansJapanMiddle AgedNauseaPaclitaxelUterine Cervical NeoplasmsUterine NeoplasmsAntiemeticsAntineoplastic AgentsCisplatinDrugs, Chinese Herballiu-jun-zi-tangPaclitaxelAnorexiaAntiemeticsNauseaRikkunshitoVomiting

Identifiers

PMID28657216
PMCPMC5540714
OpenAlexW2595133824

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.