Evidence map›Paper›PMID 31577697›Full record

ArticleMedicine2019

Efficacy and safety of Yukgunja-Tang for treating anorexia in patients with cancer: The protocol for a pilot, randomized, controlled trial.

Hwi-Joong Kang, Mi-Kyung Jeong, So-Jung Park, Hyeong-Joon Jun, Hwa-Seung Yoo

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

8 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
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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

5 authors at 3 institutions in 2 countries.

Hwi-Joong KangEast-West Cancer Center, Dunsan Korean Medicine Hospital of Daejeon University.
Mi-Kyung JeongClinical Medicine Division, Korea Institute of Oriental Medicine, Daejeon, Korea.
So-Jung ParkEast-West Cancer Center, Dunsan Korean Medicine Hospital of Daejeon University.
Hyeong-Joon JunEast-West Cancer Center, Dunsan Korean Medicine Hospital of Daejeon University.
Hwa-Seung YooEast-West Cancer Center, Dunsan Korean Medicine Hospital of Daejeon University.
Daejeon University · KRDunsan Korean Medicine Hospital · KRKorea Institute of Oriental Medicine · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnorexia is a common cause of malnutrition and is associated with negative effects on the quality of life (QOL) for patients with cancer. Management of appetite is the key to improving both the QOL and the prognosis for such patients. Yukgunja-tang (YGJT) is a traditional herbal medicine extensively prescribed in Korea as a remedy for various gastrointestinal syndromes. Currently, no standardized herbal medicine treatment exists for patients with cancer who are suffering from anorexia after surgery, chemotherapy, and/or radiotherapy. For that reason, this study aims to examine the efficacy and the safety of using YGJT to treat anorexia in such patients and to establish whether or not YGJT can be recommended as the primary therapy.

methodsWe will enroll 52 cancer patients diagnosed with anorexia. The enrolled participants will be randomly allocated to 2 groups: The control group will receive nutrition counseling, and the YGJT group will receive nutrition counseling and be administered YGJT at a dose of 3 g twice a day for 4 weeks (a total of 56 doses of 3.0 g per dose). The primary outcome of this study is the change in the score on the anorexia/cachexia subscale (A/CS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes are the changes in the FAACT score with the A/CS score excluded, the score on the Visual Analogue Scale (VAS) for appetite, the weight and the body mass index (BMI), and laboratory tests for compounds such as leptin, tumor necrosis factor-α (TNF-α), ghrelin, and IL-6. All variables related to the safety assessment, such as vital signs, electrocardiography results, laboratory test results (CBC, chemistry, urine test), and adverse events, will be documented on the case report form (CRF) at every visit.

conclusionThis study is the first randomized controlled trial to investigate the efficacy and the safety of using YGJT for treating patients with cancer-related anorexia in Korea. We designed this study based on previous research about YGJT. This study will serve as a pilot and provide data for planning further clinical trials on herbal medicine and cancer-related anorexia.

trial registrationClinical Research Information Service (CRIS), Republic of Korea, ID: KCT0002847. Registered retrospectively on 3 April 2018.

Indexed as

AdultAgedAged, 80 and overAnorexiaAppetiteBody Mass IndexBody WeightCachexiaDouble-Blind MethodDrugs, Chinese HerbalFemaleHematologic TestsHumansMaleMiddle AgedNeoplasmsDrugs, Chinese Herballiu-jun-zi-tang

Identifiers

PMID31577697
PMCPMC6783206
OpenAlexW2977888959

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.