Andrew Flower1, Kim Harman2, Merlin Willcox3, Beth Stuart4, Michael Moore5. 1. Primary Care & Population Science, Faculty of Medicine, University of Southampton, UK. Electronic address: andrewflower24@gmail.com. 2. Primary Care & Population Science, Faculty of Medicine, University of Southampton, UK. Electronic address: k.harman@soton.ac.uk. 3. Primary Care & Population Science, Faculty of Medicine, University of Southampton, UK. Electronic address: m.l.willcox@soton.ac.uk. 4. Primary Care & Population Science, Faculty of Medicine, University of Southampton, UK. Electronic address: bls1@soton.ac.uk. 5. Primary Care & Population Science, Faculty of Medicine, University of Southampton, UK. Electronic address: mvm198@soton.ac.uk.
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE: Chinese herbal medicine (CHM) is a widely used traditional intervention that may have a role to play in addressing the global problem of antimicrobial resistance in conditions such as recurrent urinary tract infections (RUTIs). AIM OF THE STUDY: To evaluate the feasibility of administering standardised and individualised formulations of CHM for RUTIs as a Clinical Trial of an Investigational Medicinal Product (CTIMP) within primary care of the UKs National Health Service (NHS). MATERIALS AND METHODS: Regulatory approval was applied for a placebo controlled, double blinded randomised controlled feasibility trial comparing a) standardised CHM vs placebo administered via General practitioners, and b) individualised CHM vs placebo administered by an experienced CHM practitioner. Primary feasibility outcomes included: gaining regulatory approval, recruitment, randomisation, retention, safety and the relevance of outcomes measures. RESULTS: Regulatory approval for testing CHM as a CTIMP was successfully obtained. Recruitment to the trial was slow and non-NHS self help networks were required to find participants for the individualised arm (n = 31). Retention and data collection in the standardised arm (n-30) were problematic, but these were acceptable in the individualised arm. The use of a daily symptom diary was not a suitable outcome measure for women with continuous infection. Other measures showed promising preliminary data for the individualised arm on improvement in symptoms, and reduction in antibiotic use during and after the trial. CONCLUSION: CHM can fulfil the demanding requirements of a CTIMP study but it may not be feasible at this point in time to recruit and treat via NHS primary care. However acceptable rates of recruitment and retention via self-help groups and promising preliminary results in the individualised arm suggest it would be worth testing this approach in a full trial.
ETHNOPHARMACOLOGICAL RELEVANCE: Chinese herbal medicine (CHM) is a widely used traditional intervention that may have a role to play in addressing the global problem of antimicrobial resistance in conditions such as recurrent urinary tract infections (RUTIs). AIM OF THE STUDY: To evaluate the feasibility of administering standardised and individualised formulations of CHM for RUTIs as a Clinical Trial of an Investigational Medicinal Product (CTIMP) within primary care of the UKs National Health Service (NHS). MATERIALS AND METHODS: Regulatory approval was applied for a placebo controlled, double blinded randomised controlled feasibility trial comparing a) standardised CHM vs placebo administered via General practitioners, and b) individualised CHM vs placebo administered by an experienced CHM practitioner. Primary feasibility outcomes included: gaining regulatory approval, recruitment, randomisation, retention, safety and the relevance of outcomes measures. RESULTS: Regulatory approval for testing CHM as a CTIMP was successfully obtained. Recruitment to the trial was slow and non-NHS self help networks were required to find participants for the individualised arm (n = 31). Retention and data collection in the standardised arm (n-30) were problematic, but these were acceptable in the individualised arm. The use of a daily symptom diary was not a suitable outcome measure for women with continuous infection. Other measures showed promising preliminary data for the individualised arm on improvement in symptoms, and reduction in antibiotic use during and after the trial. CONCLUSION: CHM can fulfil the demanding requirements of a CTIMP study but it may not be feasible at this point in time to recruit and treat via NHS primary care. However acceptable rates of recruitment and retention via self-help groups and promising preliminary results in the individualised arm suggest it would be worth testing this approach in a full trial.
Authors: Stacy M Lenger; Christine M Chu; Chiara Ghetti; Michael J Durkin; Zoe Jennings; Siobhan Sutcliffe; Jerry L Lowder Journal: Female Pelvic Med Reconstr Surg Date: 2022-06-01 Impact factor: 1.913