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OBJECTIVES: To determine the feasibility of conducting a randomised trial of the effectiveness of cranberry extract in reducing antibiotic use by women with symptoms of acute, uncomplicated urinary tract infection (UTI). DESIGN: Open-label feasibility randomised parallel group trial. SETTING: Four general practices in Oxfordshire. PARTICIPANTS: Women aged 18 years and above presenting to general practice with symptoms of acute, uncomplicated UTI. INTERVENTIONS: Women were randomly assigned using Research Electronic Data Capture in a 1:1:1 ratio to: (1) immediate antibiotics alone (n=15); (2) immediate antibiotics and immediate cranberry capsules for up to 7 days (n=15); or (3) immediate cranberry capsules and delayed antibiotics for self-initiation in case of non-improvement or worsening of symptoms (n=16). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome measures were: rate of recruitment of participants; numbers lost to follow-up; proportion of electronic diaries completed by participants; and acceptability of the intervention and study procedures to participants and recruiters. Secondary outcomes included an exploration of differences in symptom burden and antibiotic use between groups. RESULTS: Four general practitioner practices (100%) were opened and recruited participants between 1 July and 2 December 2019, with nine study participants recruited per month on average. 68.7% (46/67) of eligible participants were randomised (target 45) with a mean age of 48.4 years (SD 19.9, range 18-81). 89.1% (41/46) of diaries contained some participant entered data and 69.6% (32/46) were fully complete. Three participants (6.5%) were lost to follow-up and two (4.4%) withdrew. Of women randomly assigned to take antibiotics alone (controls), one-third of respondents reported consuming cranberry products (33.3%, 4/12). There were no serious adverse events. CONCLUSIONS: It appears feasible to conduct a randomised trial of the use of cranberry extract in the treatment of acute, uncomplicated UTI in general practice. TRIAL REGISTRATION NUMBER: ISRCTN Registry (ID: 10399299).

Original publication

DOI

10.1136/bmjopen-2020-046791

Type

Journal article

Journal

BMJ Open

Publication Date

22/02/2021

Volume

11

Keywords

clinical trials, primary care, urinary tract infections