Evidence map›Paper›PMID 35109889›Full record

ArticleTrials2022

Efficacy and safety of traditional Chinese medicine in patients with acute exacerbation of idiopathic pulmonary fibrosis: study protocol for randomized, controlled, exploratory clinical trial.

Zhang Hailong, Li Jiansheng, Guo Wen, Wang Lu, Zhang Dong, Zhao Limin, Zhou Miao, Luo Weixian

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 29% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
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

8 authors at 3 institutions in 1 country.

Zhang HailongCo-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, China.
Li JianshengCo-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan Key Laboratory of Chinese Medicine for Respiratory Disease, Henan University of Chinese Medicine, Zhengzhou, China. li_js8@163.com.
Guo WenThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.
Wang LuThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.
Zhang DongThe First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.
Zhao LiminHenan Provincial People's Hospital, Zhengzhou, China.
Zhou MiaoThe Third Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.
Luo WeixianZhengzhou First People's Hospital, Zhengzhou, China.
First Affiliated Hospital of Henan University · CNHenan Provincial People's Hospital · CNZhengzhou People's Hospital · CN

Funding

the construction project of the characteristic discipline of Chinese medicine in Henan province, China STS-ZYX-2019028the Foundation for University Youth Key Teacher of Henan Province of China 2019GGJS107the Special Program for Scientific Research of Traditional Chinese Medicine from Henan Province, China in 2019 2019ZY2001
6 · The paper itself

Abstract

backgroundAt present, there is short of effective treatment for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF). The treatment of IPF with traditional Chinese medicine (TCM) has some advantages. However, the evidence is unclear whether TCM can be recommended as an effective therapy to treat AE-IPF. The purpose of the study is to explore the efficacy and safety of TCM for patients with AE-IPF.

methodsA randomized, double-blind, placebo-controlled, exploratory clinical trial will be performed. A total of 80 patients diagnosed with AE-IPF will be randomized into the intervention or control group. In addition to conventional treatment, the intervention group will be treated with Kangxianhuanji granule, and the control group will be given a placebo granule. The administration frequency is 10 g each time and two times daily. After 4 weeks of treatment, the patients were followed up for 12 weeks. The primary outcomes are treatment failure rate and all-cause mortality. Secondary outcome measures will include the length of hospitalization, overall survival, acute exacerbation rate, intubation rate, Modified British Medical Research Council (mMRC) score, the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis (SGRQ-I) score, and arterial blood gas analysis. DISCUSSION: TCM may be beneficial in IPF. However, it has never been evaluated in patients with AE-IPF, who are incredibly prone to respiratory failure and have a high mortality rate. It is the first clinical trial to explore the efficacy and safety of TCM in the treatment of AE-IPF. This result will provide a basis for further study, which provides a high-quality evidence for the treatment of AE-IPF with TCM.

trial registrationChinese Clinical Trial Registry ChiCTR1900026289 . Registered on 29 September 2019.

Indexed as

Idiopathic Pulmonary FibrosisMedicine, Chinese TraditionalDouble-Blind MethodHumansRandomized Controlled Trials as TopicTreatment OutcomeAcute exacerbationAE-IPFIdiopathic pulmonary fibrosisRandomized controlled trialTraditional Chinese medicine

Identifiers

PMID35109889
PMCPMC8809016
OpenAlexW4225727419

What OpenQuestion holds

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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.