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Treating acute exacerbations of COPD with Chinese herbal medicine to aid antibiotic use reduction (Excalibur): a randomised double-blind, placebo-controlled feasibility trial

Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Willcox, Merlin L.;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Hu, Xiao-Yang;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Oliver, Tom;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Thorne, Kerensa;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Boxall, Cherish;
Affiliation
Phoenix Medical Ltd ,Chelmsford ,United Kingdom
He, George;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Simpson, Catherine;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Brotherwood, Becci;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
O’Neil, Alice;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Waugh, Robert;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Tilt, Emma;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Trill, Jeanne;
Affiliation
Patient and Public Representative ,Southampton ,United Kingdom
Goward, Neville;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Francis, Nick;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Thomas, Michael;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Little, Paul;
Affiliation
School of Clinical and Experimental Sciences ,Faculty of Medicine ,University of Southampton ,Southampton ,United Kingdom
Wilkinson, Tom;
Affiliation
Centre for Evidence-based Chinese Medicine ,Beijing University of Chinese Medicine ,Beijing ,China
Liu, Jian-Ping;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Griffiths, Gareth;
Affiliation
Southampton Clinical Trials Unit ,University of Southampton ,Southampton ,United Kingdom
Moore, Michael

Background: Although many acute exacerbations of COPD (AECOPD) are triggered by non-bacterial causes, they are often treated with antibiotics. Preliminary research suggests that the Chinese herbal medicine “Shufeng Jiedu” (SFJD), may improve recovery and therefore reduce antibiotic use in patients with AECOPD. Aims: To assess the feasibility of conducting a randomised placebo-controlled clinical trial of SFJD for AECOPD in UK primary care. Methods: GPs opportunistically recruited patients experiencing an AECOPD. Participants were randomised 1:1 to usual care plus SFJD or placebo for 14 days. Participants, GPs and research nurses were blinded to treatment allocation. GPs could prescribe immediate, delayed or no antibiotics, with delayed prescribing encouraged where appropriate. Participants were asked to complete a participant diary, including EXACT-PRO and CAT™ questionnaires for up to 4 weeks. Outcomes included recruitment rate and other measures of study feasibility described using only descriptive statistics and with no formal comparisons between groups. We also conducted qualitative interviews with recruited and non-recruited COPD patients and clinicians, analysed using framework analysis. Results: Over 6 months, 19 participants (6 SFJD, 13 placebo) were recruited. Sixteen (84%) participants returned diaries or provided a diary by recall. Overall, 1.3 participants were recruited per 1,000 patients on the COPD register per month open. Median duration of treatment was 9.8 days in the intervention group vs 13.3 days in the placebo group. The main reason for discontinuation in both groups was perceived side-effects. in both groups. Point estimates for both the EXACT-PRO and CAT™ outcomes suggested possible small benefits of SFJD. Most patients and clinicians were happy to try SFJD as an alternative to antibiotics for AECOPD. Recruitment was lower than expected because of the short recruitment period, the lower incidence of AECOPD during the COVID-19 pandemic, patients starting antibiotics from “rescue packs” before seeing their GP, and workforce challenges in primary care. Conclusion: Recruitment was impaired by the COVID-19 pandemic. Nevertheless, we were able to demonstrate the feasibility of recruiting and randomising participants and identified approaches to address recruitment challenges such as including the trial medication in COPD patients’ “rescue packs” and delegating recruitment to a central trials team. Clinical Trial Registration: Identifier, ISRCTN26614726

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License Holder: Copyright © 2023 Willcox, Hu, Oliver, Thorne, Boxall, He, Simpson, Brotherwood, O’Neil, Waugh, Tilt, Trill, Goward, Francis, Thomas, Little, Wilkinson, Liu, Griffiths and Moore.

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