The aim of this research project is to conduct a 16 week feasibility study of 80 women with Recurrent Urinary Tract Infections aged between 18-65 years comparing standardised Chinese herbal treatment versus placebo, delivered by GP practice nurses, with individualised herbal treatment versus placebo delivered by CHM practitioners.
As both GP and CHM practitioner options will provide verum and placebo treatments there will be 4 arms to this trial:
1. Active standardised CHM treatment delivered via GPs (n=20)
2. Placebo standardised CHM treatment delivered via GPs (n=20)
3. Active individualised treatment delivered via CHM practitioners (n=20)
4. Placebo individualised treatment delivered via CHM practitioners (n=20)
Analysis of these 4 groups should provide preliminary data on:
A. the effect size of individualised, standardised and placebo treatments in reducing the frequency and severity of recurrent UTIs.
B. on the feasibility of administering CHM via GP practices and via non-NHS CHM practitioner and, using the therapeutic environment in eliciting contextual treatment effects in the delivery of CHM.
This is the first UK CTIMP to be approved using Chinese Herbal Medicine.
Chief Investigators: Professor George Lewith and Dr Andrew Flower
Trial Manager: Kim Harman
Duration: January 2016- August 2016
FUNDER: NIHR Post Doc fellowship (Phoenix Medical, Register of Chinese Herbal Medicine and the Southampton Complementary Medicine Trust)
Contact: RUTI.trial@soton.ac.uk / Trial Manager Dr Kim Harman k.harman@soton.ac.uk
Website: https://www.southampton.ac.uk/ruti/about/index.page?
Andrew has been a practitioner of Chinese herbal medicine (CHM) since 1992. In 2011 he completed his PhD exploring the role of CHM in the treatment of endometriosis. He recently co-ordinated a team of researchers as part of the EU sponsored-Good Practice of TCM project, and was the lead author of the resultant Guidelines for randomised controlled trials of CHM.
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Kim is working as a trial manager for two trials both aimed at helping reduce the use of antibiotics. Her clinical background working in infections helps both understand the need for this and the tensions of working as a clinician and researcher.
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