Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial. Issue 2 (22nd February 2021)

• Record Type: Journal Article
• Authors: Gbinigie, Oghenekome; Allen, Julie; Williams, Nicola; Moore, Michael; Hay, Alastair D; Heneghan, Carl; Boylan, Anne-Marie; Butler, Christopher C
• Is Part Of: BMJ open. Volume 11:Issue 2(2021)
• Publication Date: 2021-02-22
• Subjects: urinary tract infections -- primary care -- clinical trials; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-046791
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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).