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Standardised Chinese herbal treatment delivered by GPs compared with individualised treatment administered by practitioners of Chinese herbal medicine for women with recurrent urinary tract infections (RUTI): study protocol for a randomised controlled trial

Standardised Chinese herbal treatment delivered by GPs compared with individualised treatment administered by practitioners of Chinese herbal medicine for women with recurrent urinary tract infections (RUTI): study protocol for a randomised controlled trial
Standardised Chinese herbal treatment delivered by GPs compared with individualised treatment administered by practitioners of Chinese herbal medicine for women with recurrent urinary tract infections (RUTI): study protocol for a randomised controlled trial
Background

In the UK urinary tract infections (UTIs) are the commonest bacterial infection presented by women within primary care. Recurrent urinary tract infections (RUTIs) are defined as three episodes of UTI in the last 12 months, or two episodes in the last 6 months. Between 20-30% of women who have had one episode of UTI will have a RUTI, around 25% of these will develop subsequent recurrent episodes. RUTIs can have a significant negative effect on quality of life, and have a high impact on health care costs as a result of outpatient visits, diagnostic tests and prescriptions. Chinese herbal medicine (CHM) has a recorded history of treating the symptoms of UTIs for over 2000 years. More recent clinical research in China has provided some preliminary evidence that CHM can alleviate the symptoms of UTIs and reduce the rate of recurrence but more rigorous investigation is required.

Methods/design

The RUTI trial is a double blind, randomised, placebo controlled feasibility trial. A total of 80 women will be randomised to ‘individualised’ herbs prescribed by Chinese herbal practitioner, or to ‘standardised’ herbs provided by Primary care clinicians. Both arms will have herbs for prevention of UTIs and treatment of acute episodes. Treatment duration is for 16 weeks.
The primary outcomes are the number of episodes of recurrent UTIs during the trial period and after 6 months follow up, and the number of days of symptoms rated moderately bad or worse based on patient diaries. Secondary outcomes will assess participant expectations and beliefs, adherence to the treatment, adverse events, health economics, and provide quantitative and qualitative assessments of the impact of recurrent infections on the lives of women.

Discussion

The RUTI trial is the first instance of CHM delivered as a Clinical Trial of an Investigatory Medicinal Product in the UK. This study provides important information regarding the feasibility and acceptability of researching and using CHM in Primary care. Once completed it will provide provisional estimates of the variance of change in continuous outcomes to inform a power calculation for a larger, more definitive trial.

Trial registration: EudraCT number 2013-004657-24 Registered 5th September 2014.
NHS ethics ref: 14/LO/1425
urinary tract infection, chinese herbal medicine, primary care, feasibility
1740-7745
1-9
Flower, Andrew
5256a2c8-6e74-49be-acc8-463ed3c18c6a
Harman, Kim
de036b2f-da30-4cb7-bfaf-d709e84ca825
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Bishop, Felicity
1f5429c5-325f-4ac4-aae3-6ba85d079928
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Lampert, Nicholas
2c14a30b-4037-45e1-8980-30afe0e88eb9
Flower, Andrew
5256a2c8-6e74-49be-acc8-463ed3c18c6a
Harman, Kim
de036b2f-da30-4cb7-bfaf-d709e84ca825
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Bishop, Felicity
1f5429c5-325f-4ac4-aae3-6ba85d079928
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Lampert, Nicholas
2c14a30b-4037-45e1-8980-30afe0e88eb9

Flower, Andrew, Harman, Kim, Lewith, George, Moore, Michael, Bishop, Felicity, Stuart, Beth and Lampert, Nicholas (2016) Standardised Chinese herbal treatment delivered by GPs compared with individualised treatment administered by practitioners of Chinese herbal medicine for women with recurrent urinary tract infections (RUTI): study protocol for a randomised controlled trial. Clinical Trials, 17 (358), 1-9. (doi:10.1186/s13063-016-1471-5).

Record type: Article

Abstract

Background

In the UK urinary tract infections (UTIs) are the commonest bacterial infection presented by women within primary care. Recurrent urinary tract infections (RUTIs) are defined as three episodes of UTI in the last 12 months, or two episodes in the last 6 months. Between 20-30% of women who have had one episode of UTI will have a RUTI, around 25% of these will develop subsequent recurrent episodes. RUTIs can have a significant negative effect on quality of life, and have a high impact on health care costs as a result of outpatient visits, diagnostic tests and prescriptions. Chinese herbal medicine (CHM) has a recorded history of treating the symptoms of UTIs for over 2000 years. More recent clinical research in China has provided some preliminary evidence that CHM can alleviate the symptoms of UTIs and reduce the rate of recurrence but more rigorous investigation is required.

Methods/design

The RUTI trial is a double blind, randomised, placebo controlled feasibility trial. A total of 80 women will be randomised to ‘individualised’ herbs prescribed by Chinese herbal practitioner, or to ‘standardised’ herbs provided by Primary care clinicians. Both arms will have herbs for prevention of UTIs and treatment of acute episodes. Treatment duration is for 16 weeks.
The primary outcomes are the number of episodes of recurrent UTIs during the trial period and after 6 months follow up, and the number of days of symptoms rated moderately bad or worse based on patient diaries. Secondary outcomes will assess participant expectations and beliefs, adherence to the treatment, adverse events, health economics, and provide quantitative and qualitative assessments of the impact of recurrent infections on the lives of women.

Discussion

The RUTI trial is the first instance of CHM delivered as a Clinical Trial of an Investigatory Medicinal Product in the UK. This study provides important information regarding the feasibility and acceptability of researching and using CHM in Primary care. Once completed it will provide provisional estimates of the variance of change in continuous outcomes to inform a power calculation for a larger, more definitive trial.

Trial registration: EudraCT number 2013-004657-24 Registered 5th September 2014.
NHS ethics ref: 14/LO/1425

Text
The RUTI protocol manuscript-revised 13-05-16.docx - Accepted Manuscript
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s13063-016-1471-5 - Version of Record
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More information

Accepted/In Press date: 4 July 2016
e-pub ahead of print date: 27 July 2016
Published date: 2016
Keywords: urinary tract infection, chinese herbal medicine, primary care, feasibility
Organisations: Primary Care & Population Sciences

Identifiers

Local EPrints ID: 399277
URI: https://eprints.soton.ac.uk/id/eprint/399277
ISSN: 1740-7745
PURE UUID: af57f81b-261d-44ee-ad25-796af948b53a
ORCID for Kim Harman: ORCID iD orcid.org/0000-0002-5173-7753
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509
ORCID for Felicity Bishop: ORCID iD orcid.org/0000-0002-8737-6662

Catalogue record

Date deposited: 15 Aug 2016 09:22
Last modified: 08 Oct 2019 05:16

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Contributors

Author: Andrew Flower
Author: Kim Harman ORCID iD
Author: George Lewith
Author: Michael Moore ORCID iD
Author: Felicity Bishop ORCID iD
Author: Beth Stuart
Author: Nicholas Lampert

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