Evidence map›Paper›PMID 34663434›Full record

ArticleTrials2021

Integrated traditional Chinese and conventional medicine in the treatment of anemia due to lower-risk myelodysplastic syndrome: study protocol for a randomized placebo-controlled trial.

Qin Zheng, Haitao Xu, Luxi Song, Zeying Yan, Manqin Sun, Xia Peng, Yiling Jiang, Ling Shi, Aiping Zhang, Zhihao Wu and 2 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.1field-weighted citation impact, top 49% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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

12 authors at 2 institutions in 1 country.

Qin ZhengDepartment of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine), Shanghai, 201999, China.ORCID http://orcid.org/0000-0003-2551-6604
Haitao XuDepartment of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine), Shanghai, 201999, China.
Luxi SongDepartment of Hematology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 200233, Shanghai, China.
Zeying YanDepartment of Hematology, Rui Jin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, 200020, Shanghai, China.
Manqin SunDepartment of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Xia PengDepartment of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Yiling JiangDepartment of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine), Shanghai, 201999, China.
Ling ShiDepartment of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine), Shanghai, 201999, China.
Aiping ZhangDepartment of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine), Shanghai, 201999, China.
Zhihao WuDepartment of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine), Shanghai, 201999, China.
Jiahui LuDepartment of Hematology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China. lujiahui73@163.com.
Meihong LuoDepartment of Hematology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Hospital Affiliated to Shanghai University of Traditional Chinese Medicine), Shanghai, 201999, China. lmh021009@163.com.
Shanghai University of Traditional Chinese Medicine · CNShanghai Jiao Tong University · CN

Funding

Innovative Research Group Project of the National Natural Science Foundation of China 81774271Scientific Research Project of Shanghai Municipal Health and Family Planning Commission 20184Y0094Shanghai Municipal Health and Family Planning Commission Three-year Action Plan-Dominant Disease Cultivation Project (ZY(2018-2020) -ZYBZ-32)Shanghai Science and Technology Commission guided projects 17407931500the National Natural Science Foundation of China 81804021
6 · The paper itself

Abstract

backgroundErythropoiesis and iron homeostasis are closely related; anemia due to lower-risk myelodysplastic syndromes (MDS) remains difficult to treat. In the last decade, we have been committed to improving the regulation of iron metabolism using traditional Chinese medicine (TCM). Previous studies have found that the TCM Yi Gong San (YGS) can reduce the expression of transferrin by inhibiting hepcidin overexpression caused by inflammation, promote the outward transfer of intracellular iron, and improve the symptoms of anemia. Here, our study aimed to compare the efficacy of a conventional drug with YGS with that of conventional medicine with placebo to provide a scientific basis for making clinical decisions.

methodsA prospective, multicenter, double-blinded, randomized controlled clinical trial will be conducted to evaluate the therapeutic efficacy of conventional medicine combined with YGS with that of conventional medicine alone in the treatment of MDS. A total of 60 patients would be enrolled in this study, with each treatment group (conventional medicine + YGS and conventional medicine + placebo) comprising 30 patients. Oral medication would be administered twice daily for 3 months. All patients would be followed up throughout the 3-month period. The primary outcome was measured by assessing blood hemoglobin level. The secondary outcome was measured by assessing TCM symptom score, iron metabolism, hepcidin levels, and inflammatory factors. DISCUSSION: This trial would aim to demonstrate the effectiveness and feasibility of YGS in the treatment of lower-risk MDS anemia, as well as its impact on inflammatory factors and iron metabolism in patients with lower-risk MDS.

trial registrationChinese Clinical Trials Registry ( http://www.chictr.org.cn/ ) ChiCTR1900026774 .  Registered on October 21, 2019.

Indexed as

AnemiaDrugs, Chinese HerbalMyelodysplastic SyndromesChinaDouble-Blind MethodHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicDrugs, Chinese HerbalAnemia of lower-risk myelodysplastic syndromeClinical trialsTraditional Chinese medicineTreatment

Identifiers

PMID34663434
PMCPMC8522070
OpenAlexW3207811227

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.