The RUTI trial: a multi-centred, 16 week, double blind, placebo controlled, feasibility study comparing standardised Chinese herbal treatment, delivered by GPs, with individualised treatment administered by practitioners of Chinese herbal medicine, for women with Recurrent Urinary Tract Infections. Study protocol for a Randomised Controlled Trial

摘要

BackgroundIn 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/designThe 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.DiscussionThe 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