Evidence map›Paper›PMID 31182140›Full record

ArticleTrials2019

Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial.

Xu Zhou, Dong-Mei Yan, Wei-Feng Zhu, Wen-Jun Liu, He-Yun Nie, Sheng Xu, Yi-Ping Jiang, Kun-He Zhang, Ying Fu, Yi-Ye Wan and 4 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03025152 (Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 26% 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.

NCT03025152 naterminatednot on this map

Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double-blinded, Parallel-group, Placebo-controlled Trial

TypeinterventionalSponsorJiangxi University of Traditional Chinese MedicineRan2016 to 2019Enrolled130ConditionsGastric Cancer, Gastrointestinal DiseaseArmsHou Gu Mi Xi, placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

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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

14 authors at 5 institutions in 1 country.

Xu ZhouEvidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Mei Ling Da Dao No. 1688, Nanchang, 330004, Jiangxi, China.
Dong-Mei YanEvidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Mei Ling Da Dao No. 1688, Nanchang, 330004, Jiangxi, China.
Wei-Feng ZhuEvidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Mei Ling Da Dao No. 1688, Nanchang, 330004, Jiangxi, China.
Wen-Jun LiuSchool of Food Science and Engineering, Inner Mongolia Agricultural University, Inner Mongolia, China.
He-Yun NieEvidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Mei Ling Da Dao No. 1688, Nanchang, 330004, Jiangxi, China.
Sheng XuEvidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Mei Ling Da Dao No. 1688, Nanchang, 330004, Jiangxi, China.
Yi-Ping JiangDepartment of Spleen, Stomach, Liver and Gallbladder Diseases, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Jiangxi, China.
Kun-He ZhangDepartment of Gastroenterology, First Affiliated Hospital of Nanchang University, Jiangxi, China.
Ying FuDepartment of Traditional Chinese Medicine, Second Affiliated Hospital of Nanchang University, Jiangxi, China.
Yi-Ye WanThird Department of Oncology, Jiangxi Provincial Cancer Hospital, Jiangxi, China.
Xin-Yu YuEvidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Mei Ling Da Dao No. 1688, Nanchang, 330004, Jiangxi, China.
Hong LiEvidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Mei Ling Da Dao No. 1688, Nanchang, 330004, Jiangxi, China.
Xin SunEvidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Mei Ling Da Dao No. 1688, Nanchang, 330004, Jiangxi, China. sunx79@hotmail.com.
Xiao-Fan ChenEvidence-based Medicine Research Center, School of Basic Medical Sciences, Jiangxi University of Traditional Chinese Medicine, Mei Ling Da Dao No. 1688, Nanchang, 330004, Jiangxi, China. cxf0733@163.com.ORCID http://orcid.org/0000-0001-6639-1313
Jiangxi University of Traditional Chinese Medicine · CNNanchang University · CNAffiliated Hospital of Jiangxi University of Traditional Chinese Medicine · CNInner Mongolia Agricultural University · CNJiangxi Provincial Cancer Hospital · CN

Funding

"1050" Young Talents Project and Scientific of Jiangxi University of Traditional Chinese Medicine 207/1141900102Health and Family Planning Commission of Jiangxi Province 2016B028Jiangzhong Pharmaceutical (group) Co., Ltd 2016918
6 · The paper itself

Abstract

backgroundSpleen qi deficiency (SQD), a syndrome based on traditional Chinese medicine (TCM) theory, is common in patients after radical gastrectomy. SQD manifests with chronic gastrointestinal disorders and systemic symptoms and is challenging to manage. Hou Gu Mi Xi (HGMX) is a dietary TCM formula for SQD. This study aims to evaluate the efficacy and safety of HGMX in patients with SQD who have undergone radical gastrectomy for gastric cancer. METHODS AND

designThis study is a multicenter, randomized, double-blind, placebo-controlled trial. One hundred thirty patients with SQD who have undergone radical gastrectomy for gastric cancer will be assigned to receive either HGMX or placebo for 2 years. The main outcome will be changes in SQD symptoms assessed by the Spleen Qi Deficiency Symptoms Grading and Quantifying Scale. The secondary outcomes will be changes in quality of life assessed by the Short Form 36 scale, performance status as assessed by the Eastern Cooperative Oncology Group Performance Status scale, body weight, and body mass index. Progression-free survival will also be assessed as a secondary outcome. Adverse events (AEs), severe AEs, and study withdrawal due to AEs will be recorded to evaluate the safety of HGMX. DISCUSSION: The results of this trial will provide initial evidence for the use of HGMX as an alternative and complementary intervention to manage chronic postoperative complications in patients who have undergone radical gastrectomy for gastric cancer.

trial registrationClinicalTrials.gov, NCT03025152 . Registered on 17 January 2017.

Indexed as

Medicine, Chinese TraditionalQiAdultAgedDouble-Blind MethodDrugs, Chinese HerbalGastrectomyHumansMiddle AgedMulticenter Studies as TopicOutcome Assessment, Health CarePostoperative ComplicationsRandomized Controlled Trials as TopicStomach NeoplasmsDrugs, Chinese HerbalGastric cancerHou Gu Mi XiRadical gastrectomyRandomized controlled trialSpleen qi deficiencyTraditional Chinese medicine

Identifiers

PMID31182140
PMCPMC6558912
OpenAlexW2950412282

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.