The RUTI trial: a feasibility study of Chinese herbal medicine (CHM) for women with Recurrent Urinary Tract Infections (RUTIs)

Conference: 
SAPC ASM 2016 - Dublin
Talk Code: 
P2.20
Presenter: 
Kim Harman
Co-authors: 
Andrew Flower, Beth Stuart, Nick Lampert, Michael Moore, Felecity Bishop, George Lewith
Author institutions: 
University of Southampton, Birmingham Centre for Chinese Medicine

Problem

This trial will compare standardised CHM for RUTIs administered via General Practitioner (GP) clinics, with routine individualised CHM treatment delivered by a CHM practitioner. The trial aims (1) to obtain UK regulatory approval for CHM as a Clinical Trial of an Investigational Medicinal Product (CTIMP); (2) to compare the effect sizes of individualised, standardised and placebo treatments in reducing the frequency and severity of RUTIs; (3) to investigate the feasibility of administering CHM via GP practices. There is a need to find alternatives to antibiotics because of increasing resistance.

Approach

Applications for regulatory and ethical approval have been made to the appropriate UK authorities, the Medicines Healthcare Regulatory Authority (MHRA) and the Integrated Research Application Service (IRAS). Eighty women between the ages of 18-65, with a history of RUTIs, will be identified from GP medical records using standard search criteria. Women will be allocated to standardised or individualised treatment according to their UK location, and then randomised to verum and placebo treatments, resulting in 4 arms of 20 women.

Feasibility outcomes include descriptive information relating to trial regulation, recruitment, blinding, retention, compliance, adverse effects, data acquisition and an estimation of treatment effects based primarily on the number and severity of episodes of recurrent UTIs during the trial period.

 

Findings

For the first time regulatory and ethical approval to investigate CHM as a CTIMP has been obtained from the UK authorities. This has required the supply of herbal granules from China produced under Australian Therapeutic Goods Administration (TGA) Good Manufacturing Practice (GMP) standards; further testing for authentication, bio-burden, contamination and stability in the UK; and the production of herbal capsules by a company with CTIMP Manufactures Authorisation. It has also been established that the routine practice of individualised CHM does not constitute a CTIMP. The trial is now recruiting participants.

By the time of the conference we hope to have recruited most participants and have early data to share.

Consequences

It is possible to obtain regulatory approval to conduct a CTIMP using Chinese medicine within the NHS. This may encourage further integrative medicine practitioners to conduct high quality RCTs within the NHS.

An alternative approach to RUTIs as an antibiotic sparing practice will be evaluated for feasibility.

 

Submitted by: 
Kim Harman
Funding acknowledgement: 
The trial is funded by a Post Doctoral fellowship from the NIHR for Dr Andrew Flower. Service support costs for GP involvement has been secured via NIHR funding networks. The Chinese herb supplier, Phoenix Medical, agreed to fund some of the costs of providing and dispensing the Chinese herbal medicines. Additional funding has been provided by The University of Southampton and the Register of Chinese Herbal Medicine.