Evidence map›Paper›PMID 31428894›Full record

Trial reportInvestigational new drugs2020

Prospective, randomized, cross-over pilot study of the effects of Rikkunshito, a Japanese traditional herbal medicine, on anorexia and plasma-acylated ghrelin levels in lung cancer patients undergoing cisplatin-based chemotherapy.

Tomoharu Yoshiya, Takahiro Mimae, Masaoki Ito, Shinsuke Sasada, Yasuhiro Tsutani, Kenichi Satoh, Takeshi Masuda, Yoshihiro Miyata, Noboru Hattori, Morihito Okada

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 22% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

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  9. Recent Advances inMetabolites · 2022
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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

10 authors at 2 institutions in 1 country.

Tomoharu YoshiyaDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3, kasumi, minami-ku, Hiroshima City, 734-8551, Japan.
Takahiro MimaeDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3, kasumi, minami-ku, Hiroshima City, 734-8551, Japan.
Masaoki ItoDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3, kasumi, minami-ku, Hiroshima City, 734-8551, Japan.
Shinsuke SasadaDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3, kasumi, minami-ku, Hiroshima City, 734-8551, Japan.
Yasuhiro TsutaniDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3, kasumi, minami-ku, Hiroshima City, 734-8551, Japan.
Kenichi SatohThe Center for Data Science Education and Research, Shiga University, 1-1-1, banba, Hikone, Shiga, 522-8522, Japan.
Takeshi MasudaDepartment of Molecular and Internal Medicine, Hiroshima University, 1-2-3, kasumi, minami-ku, Hiroshima, 734-8551, Japan.
Yoshihiro MiyataDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3, kasumi, minami-ku, Hiroshima City, 734-8551, Japan.
Noboru HattoriDepartment of Molecular and Internal Medicine, Hiroshima University, 1-2-3, kasumi, minami-ku, Hiroshima, 734-8551, Japan.
Morihito OkadaDepartment of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3, kasumi, minami-ku, Hiroshima City, 734-8551, Japan. morihito@hiroshima-u.ac.jp.
Hiroshima University · JPShiga University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose Anorexia induced by cytotoxic chemotherapy on delayed phase is a highly frequent adverse event. We aimed to determine the effects of rikkunshito (RKT) on chemotherapy-induced anorexia (CIA) in patients with lung cancer. Methods This prospective, randomized, cross-over pilot trial included 40 lung cancer patients scheduled to undergo cisplatin-based chemotherapy and randomized to either a group given RKT 7.5 g/day for 14 days (Group A, N = 20) or not (Group B, N = 20), then the treatments were switched. All patients received dexamethasone, palonosetron hydrochloride and aprepitant regardless of group assignment. Rescue drugs were allowed as required. The primary and key secondary endpoints were changes in caloric intake and in plasma acylated ghrelin (AG) levels, respectively. Average daily caloric intake during days 3 to 5 was compared with that on day 1 of each course. Results The primary and key secondary endpoints were analyzed in 31 patients (per protocol population) completing the study. Reduction rate of caloric intake was lower in RKT, than in control courses (18% vs. 25%, P = 0.025). Plasma AG levels significantly declined between days 1 and 3 in RKT (12.3 vs. 7.5 fmol/mL, P < 0.001) and control (10.8 vs. 8.6 fmol/mL, P < 0.001) courses. However, those obviously increased to 8.5 fmol/mL (P = 0.025) by day 5 in RKT course but not in control course (7.7 fmol/mL, P = 0.28). Conclusions Rikkunshito could mitigate CIA and ameliorate plasma AG levels during the delayed phase of CDDP-based chemotherapy in lung cancer patients. Clinical trial registration numbers: UMIN000010748.

Indexed as

PhytotherapyAcylationAdultAgedAnorexiaAntineoplastic AgentsCisplatinCross-Over StudiesDrugs, Chinese HerbalEnergy IntakeFemaleGhrelinHumansJapanLung NeoplasmsMaleAntineoplastic AgentsCisplatinDrugs, Chinese HerbalGhrelinliu-jun-zi-tangAntiemeticAppetite stimulationCisplatinCytotoxicityKampoMalignancy

Identifiers

PMID31428894
OpenAlexW2969569154

What OpenQuestion holds

Textmetadata
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.