Evidence map›Paper›PMID 36536462›Full record

ArticlePilot and feasibility studies2022

Treating Acute EXacerbations of COPD with Chinese HerbAL MedIcine to aid AntiBiotic Use Reduction (EXCALIBUR): study protocol of a randomised double-blind, placebo-controlled feasibility trial.

Xiao-Yang Hu, Tom Oliver, Merlin Willcox, Catherine Simpson, Kerensa Thorne, Jeanne Trill, Nick Francis, Beth Stuart, Michael Thomas, Paul Little and 3 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 34% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. 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

13 authors at 3 institutions in 2 countries.

Xiao-Yang HuPrimary Care, Population Science and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK. X.Hu@soton.ac.uk.ORCID http://orcid.org/0000-0002-3143-7999
Tom OliverSouthampton Clinical Trial Unit, University of Southampton, Southampton, UK.
Merlin WillcoxPrimary Care, Population Science and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
Catherine SimpsonSouthampton Clinical Trial Unit, University of Southampton, Southampton, UK.
Kerensa ThorneSouthampton Clinical Trial Unit, University of Southampton, Southampton, UK.
Jeanne TrillPrimary Care, Population Science and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
Nick FrancisPrimary Care, Population Science and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
Beth StuartPragmatic Trial Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Michael ThomasPrimary Care, Population Science and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
Paul LittlePrimary Care, Population Science and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
Jian-Ping LiuCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Gareth GriffithsSouthampton Clinical Trial Unit, University of Southampton, Southampton, UK.
Michael MoorePrimary Care, Population Science and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
University of Southampton · GBBeijing University of Chinese Medicine · CNQueen Mary University of London · GB

Funding

Innovate UK 104287-610239
6 · The paper itself

Abstract

backgroundAcute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major reason for consultations in primary care, hospital admissions, deterioration in function, and mortality. Despite the majority of exacerbations not being caused by bacteria, as many as 70% of patients who present in UK primary care with AECOPD are prescribed antibiotics as part of standard care. However, finding effective non-antibiotic treatments for COPD exacerbations is a priority to reduce antibiotic use. The Chinese herbal medicine Shufeng Jiedu® (SFJD) has the potential to reduce treatment failure and duration of hospital stay. This study aims to determine the feasibility of conducting a fully powered randomised, double blind, placebo-controlled clinical trial on SFJD for AECOPD in UK primary care.

methodsThis study is a phase III, two-arm individually double blind, randomised, placebo-controlled feasibility trial with nested qualitative study, coordinated by the Southampton Clinical Trial Unit (SCTU). Patients aged ≥ 40 years, with a current AECOPD, presenting with increased sputum purulence/volume, or breathlessness, and for whom the GP is considering use of antibiotics, will be eligible to participate. We aim to recruit seven eligible participants per month and randomise them to receive either the patent Chinese herbal medicine SFJD capsules or placebo for 14 consecutive days and to follow-up for 12 weeks. The primary outcomes include the feasibility of recruitment, study retention, and the percentage of diary completion. DISCUSSION: If this trial demonstrates the feasibility of recruitment, delivery, and follow-up, we will seek funding for a fully powered placebo-controlled trial of SFJD for the treatment of AECOPD in primary care.

trial registrationThis trial is registered via ISRCTN on 1 July 2021, identifier: ISRCTN26614726.

Indexed as

Chronic obstructive pulmonary diseaseExacerbationFeasibilityHerbal medicineQualitativeRandomised controlled trial

Identifiers

PMID36536462
PMCPMC9761047
OpenAlexW4312114324

What OpenQuestion holds

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Registered trials

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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.