Evidence map›Paper›PMID 31464626›Full record

ArticleTrials2019

Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial.

Ying Ding, Xia Zhang, Xianqing Ren, Wensheng Zhai, Liyun He, Jianping Liu, Chen Yao, Shanshan Han, Long Wang

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 NCT03591471 (Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 25% 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.

NCT03591471 phase1 / phase2unknown statusnot on this map

Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation

TypeinterventionalSponsorHenan University of Traditional Chinese MedicineRan2014 to 2018Enrolled500ConditionsHenoch-Schönlein Purpura NephritisArmsGlycosides Of Tripterygium Wilfordii Hook(GTW), Sulfotanshinone Sodium Injection, Chinese herbs based on syndrome differentiation, Prednisone Acetate Tablets, Benazepril Hydrochloride Tablets
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Interventions for preventing and treating kidney disease in IgA vasculitis.The Cochrane database of systematic reviews · 2023
    Review
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  7. Proteomic Study on the Reproductive Toxicity ofFrontiers in pharmacology · 2022
    Article
  8. Review
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  10. Article
  11. 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

9 authors at 4 institutions in 1 country.

Ying DingPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCM, Zhengzhou, China. dingying3236@sina.com.ORCID http://orcid.org/0000-0002-0172-1091
Xia ZhangPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCM, Zhengzhou, China.
Xianqing RenPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCM, Zhengzhou, China.
Wensheng ZhaiPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCM, Zhengzhou, China.
Liyun HeClinical Evaluation Department, China Academy of Chinese Medical Sciences, Beijing, China.
Jianping LiuEvidence-Based Medicine Center, Beijing University of TCM, Beijing, China.
Chen YaoMedical Statistics Department, Peking University First Hospital, Beijing, China.
Shanshan HanPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCM, Zhengzhou, China.
Long WangPediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCM, Zhengzhou, China.
First Affiliated Hospital of Henan University of Traditional Chinese Medicine · CNBeijing University of Chinese Medicine · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNPeking University · CN

Funding

Ministry of Science and Technology of the People's Pepublic of China 2013BAI02B00
6 · The paper itself

Abstract

backgroundHenoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. Currently, the treatment for HSPN is always selected based on the Kidney Disease Improving Global Outcomes guidelines; however, this approach may lead to undertreatment, especially in patients with persistent proteinuria that does not reach nephrotic levels and/or hematuria and those with a pathological classification between grades 1 and 3 according to the International Study of Kidney Disease in Children. This study was performed to evaluate the curative effect and safety of a traditional Chinese medicine (TCM) integrated treatment program in this type of HSPN.

methodsThis multicenter, open-label, large-sample, randomized controlled trial was performed in China and included 500 children with HSPN exhibiting mild pathological patterns. The treatment group to control group ratio was 2:1, and each group was further stratified into two types, light and heavy, according to urinary protein quantification and pathological type. The treatment group received tripterygium glycosides (TGs), tanshinone IIa sodium sulfonate injection, and Chinese herbs selected based on syndrome differentiation in TCM. The heavy and light subgroups received treatment courses and dosages of TG. In the control groups, the light group received benazepril hydrochloride tablets, low molecular weight heparin calcium injection, dipyridamole tablets, and a Chinese medicine placebo, while the heavy group received the same treatment plus prednisone. All groups were treated for 3 months and then followed up for 9 months. The efficacy and safety of the treatments were then evaluated among the groups. DISCUSSION: Currently, few treatments are available for HSPN patients with mild pathological patterns indicating light to moderate proteinuria and/or hematuresis. In this large-sample study, we provide a new approach for HSPN that includes an integrated treatment program that incorporates TCM.

trial registrationClinical Trials.gov, NCT03591471 . Re-registered on 19 July 2018.

Indexed as

TripterygiumAbietanesAdolescentAge FactorsChildChild, PreschoolChinaDrugs, Chinese HerbalDrug Therapy, CombinationFemaleGlycosidesHumansIgA VasculitisMaleMulticenter Studies as TopicNephritisAbietanesDrugs, Chinese HerbalGlycosidestanshinoneHenoch-Schönlein purpura nephritisStudy protocolTraditional Chinese medicineTripterygium glycosides

Identifiers

PMID31464626
PMCPMC6716925
OpenAlexW2970542983

What OpenQuestion holds

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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.