Evidence map›Paper›PMID 36539844›Full record

Trial reportTrials2022

Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial.

Danghan Xu, Jialing Li, Anqi Di, Peidan Yang, Xiaoyan Xie, Yiming Xu, Jun He

Open access · goldAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Trials, 2022. 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
0.2field-weighted citation impact, top 45% 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

7 authors at 3 institutions in 1 country.

Danghan Xu *The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
Jialing Li *The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
Anqi DiThe First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
Peidan YangThe First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, China.
Xiaoyan XieThe Second Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, 510006, China.
Yiming XuSchool of Basic Medicine, Guangzhou Medical University, Guangzhou, 511436, China.
Jun HeThe First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510405, China. hejunzj@gzucm.edu.cn.
First Affiliated Hospital of Guangzhou University of Chinese Medicine · CNGuangzhou Medical University · CNGuangzhou University of Chinese Medicine · CN

Funding

Guangdong Provincial Key Laboratory of Traditional Chinese Medicine and Acupuncture (Number 05)Guangzhou Municipal Science and Technology Bureau Number 202102010425Innovative Clinical Research Project of theFirst Affiliated Hospital of Guangzhou University of Chinese Medicine No.2019IIT04Natural Science Foundation of Guangdong Province Number 2018A030313270State Administration of Traditional Chinese Medicine of the People's Republic of China Number National Chinese Medicine Office Renjiao Letter [2021]271
6 · The paper itself

Abstract

backgroundSanfu herbal patch (SHP) is widely used in the prevention and treatment of bronchial asthma in China, but its efficacy and mechanism of action are not completely clear. This trial aims to determine the efficacy of SHP and the underlying mechanism. METHODS/

designWe will conduct a multi-centre parallel randomised controlled trial consisting of 72 participants with bronchial asthma recruited and randomly allocated at a ratio of 1:1 into two groups. The patients in one group will receive three courses of SHP treatment, and the patients in the other group will receive placebo treatment, with 24 weeks of follow-up evaluation for both groups. The primary outcome, i.e. forced expiratory volume in the first second (FEV1), which refers to the change in FEV1 from the beginning of the baseline to the end of 3 treatment sessions (TSs), will be assessed and compared via Student's t test or the Mann-Whitney U test. Other outcomes will include questionnaire surveys and laboratory indicators. Detailed and complete statistical analyses in a double-blinded fashion will be provided for evaluating this trial. DISCUSSION: The data we obtain will be examined based on the above statistical analysis, which will help to reduce the risk of external reporting bias and data-driven results.

trial registrationChinese Clinical Trial Registry ( http://www.chictr.org.cn ), ChiCTR1900024616. Registered on 19 July 2019.

Indexed as

AsthmaDrugs, Chinese HerbalAcupuncture PointsForced Expiratory VolumeHumansResearch DesignTreatment OutcomeDrugs, Chinese HerbalBronchial asthmaSanfu herbal patchStatistical analysis plan

Identifiers

PMID36539844
PMCPMC9764530
OpenAlexW4311949865

What OpenQuestion holds

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LicenceCC BY
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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.