title: 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.
abstract: In the UK, urinary tract infections (UTIs) are the most common bacterial infection presented by women in 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 and 30 % of women who have had one episode of UTI will have an RUTI, and approximately 25 % of these will develop subsequent recurrent episodes. RUTIs can have a significant negative effect on the 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 treatments for the symptoms of UTIs for more than 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.
  
  
  
  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 a 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 in the 6 months of 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 and health economics and provide quantitative and qualitative assessments of the impact of recurrent infections on the lives of women.
  
  
  
  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.
  
  
  
  EudraCT, 2013-004657-24 . Registered on 5 September 2014.
authors.affiliation: Health Research, Complementary and Integrated Medicine Research, University of Southampton, Aldermoor Close, Southampton, SO16 5ST, UK. Andrew.Flower@soton.ac.uk.
authors.forename: Andrew
authors.initials: A
authors.lastname: Flower
authors.affiliation: Primary Care & Population Science, University of Southampton, Southampton, UK.
authors.forename: Kim
authors.initials: K
authors.lastname: Harman
authors.affiliation: Health Research, Complementary and Integrated Medicine Research, University of Southampton, Southhampton, UK.
authors.forename: George
authors.initials: G
authors.lastname: Lewith
authors.affiliation: Primary Care & Population Science, University of Southampton, Southampton, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Moore
authors.affiliation: Psychology, University of Southampton, Faculty of Social, Human and Mathematical Sciences, Southampton, UK.
authors.forename: Felicity L
authors.initials: FL
authors.lastname: Bishop
authors.affiliation: Primary Care & Population Science, University of Southampton, Southampton, UK.
authors.forename: Beth
authors.initials: B
authors.lastname: Stuart
authors.affiliation: Birmingham Centre for Chinese Medicine, Birmingham, B14 6DT, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Lampert
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D004739:England; D005240:Feasibility Studies; D005260:Female; D058005:General Practitioners; D006801:Humans; D055118:Medication Adherence; D008875:Middle Aged; D017060:Patient Satisfaction; D012008:Recurrence; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D004365:Drugs, Chinese Herbal
keywords: Chinese herbal medicine; Primary care; Urinary tract infection; feasibility