Evidence map›Paper›PMID 40156342›Full record

Trial reportIntegrative cancer therapies

Efficacy of Rikkunshito on Chemotherapy-Induced Nausea and Vomiting in Patients With Uterine Corpus or Cervical Cancer Treated With Cisplatin-Based Regimen-Placebo-controlled, Double-Blind, Randomized Confirmatory Study (JORTC-KMP03).

Yosuke Konno, Shunsuke Ohnishi, Shinichiro Minobe, Eiji Nomura, Takayuki Nagasawa, Etsuko Fujimoto, Tatsuru Ohara, Shin Nishio, Hisamori Kato, Yoshihito Yokoyama and 12 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Integrative cancer therapies. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Yosuke KonnoHokkaido University Graduate School of Medicine, Sapporo, Japan.ORCID 0000-0002-6022-9689
Shunsuke OhnishiHokkaido University, Sapporo, Japan.
Shinichiro MinobeNational Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.
Eiji NomuraOji General Hospital, Tomakomai, Japan.
Takayuki NagasawaIwate Medical University, Morioka, Japan.
Etsuko FujimotoNational Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Tatsuru OharaSt. Marianna University, Kawasaki, Japan.
Shin NishioKurume University School of Medicine, Kurume, Japan.ORCID 0000-0003-2526-630X
Hisamori KatoKanagawa Cancer Center, Yokohama, Japan.
Yoshihito YokoyamaHirosaki University Graduate School of Medicine, Hirosaki, Japan.
Etsuko MiyagiYokohama City University School of Medicine, Yokohama, Japan.
Hideki TokunagaTohoku University, Sendai, Japan.
Koji NishinoNiigata University Graduate School of Medical and Dental Science, Niigata, Japan.ORCID 0000-0001-6218-8641
Akira KikuchiNiigata Cancer Center Hospital, Niigata, Japan.
Yoshio YoshidaUniversity of Fukui, Fukui, Japan.
Takashi IwataKeio University School of Medicine, Tokyo, Japan.
Daito NoguchiThe Jikei University School of Medicine, Tokyo, Japan.
Wataru KudakaUniversity of the Ryukyus, Graduate School of Medicine, Okinawa, Japan.
Shunsuke OyamadaJapanese Organisation for Research and Treatment of Cancer (JORTC), Tokyo, Japan.
Keisuke AriyoshiJapanese Organisation for Research and Treatment of Cancer (JORTC), Tokyo, Japan.ORCID 0009-0002-8896-2572
Kota KiharaJapanese Organisation for Research and Treatment of Cancer (JORTC), Tokyo, Japan.
Hidemichi WatariHokkaido University Graduate School of Medicine, Sapporo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe current standard treatment for chemotherapy-induced nausea and vomiting (CINV) with standard antiemetics is insufficient. Rikkunshito, a Japanese traditional herbal medicine, has been shown to improve cisplatin-induced anorexia and functional dyspepsia, and our exploratory study found that rikkunshito has an additive beneficial effect on CINV in patients with uterine corpus and cervical cancer receiving cisplatin containing chemotherapy (JORTC KMP-02).

methodsOne hundred eighty patients with uterine corpus or cervical cancer who were scheduled to receive treatment with a cisplatin based regimen as initial chemotherapy were enrolled across 17 Japanese institutions. Patients were randomized with a 1:1 equal allocation ratio to the rikkunshito group or placebo groups and given oral administration on days 1 to 5 with standard antiemetics (granisetron, aprepitant, and dexamethasone). The primary endpoint was complete response (CR; no vomiting or rescue medication) during the delayed phase (24-120 hours after cisplatin treatment). The secondary endpoints were complete control (CC; CR without significant nausea) and total control (TC; CR without nausea) rates during the overall (0-120 hours), acute (0-24 hours), and delayed phases, as well as the CR rate during the overall and acute phases, time to treatment failure, degree of nausea and appetite during the overall phase, and adherence to the intervention.

resultsThe CR rate in the delayed phase was similar between the rikkunshito group and control groups (50.6% vs 58.9%,

conclusionRikkunshito had no additive effect on CINV prevention in patients with uterine corpus or cervical cancer who were treated with a cisplatin based regimen and standard antiemetics. CLINICAL

trial registrationhttps://jrct.mhlw.go.jp/re/reports/detail/66957, identifier jRCT1011190007.

Indexed as

Antineoplastic AgentsCisplatinDrugs, Chinese HerbalNauseaUterine Cervical NeoplasmsUterine NeoplasmsVomitingAdultAgedAntiemeticsAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodFemaleHumansMiddle AgedTreatment OutcomeAntiemeticsAntineoplastic AgentsCisplatinDrugs, Chinese Herballiu-jun-zi-tangcervical cancerchemotherapy-induced nausea and vomitingcisplatinherbal medicineRikkunshitouterine corpus cancer

Identifiers

PMID40156342
PMCPMC11954530

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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 Socratic graph.