Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial - PubMed (original) (raw)

Randomized Controlled Trial

Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial

Oghenekome Gbinigie et al. BMJ Open. 2021.

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).

Keywords: clinical trials; primary care; urinary tract infections.

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Conflict of interest statement

Competing interests: OG receives funding from the National Institute of Health Research (NIHR) SPCR and the Wellcome Trust. CCB is a senior investigator of the NIHR; clinical director of the University of Oxford Primary Care and Vaccines Collaborative Clinical Trials Unit; clinical director of the NIHR Oxford Community Medtech and Invitro diagnostics Cooperative; and salaried general practitioner for the Cwm Taf Morgannwg University Health Board. He has received funding from many public funding bodies for primary care research related to the management of common infections. He received payment for contributing to Advisory Boards for Pfizer in 2019, Roche Diagnostics in 2020, and for contributing to an Advisory Board for Janssen Pharmaceuticals about respiratory syncytial virus treatment and vaccination from Janssen Pharmaceuticals in 2020, and holds an unrestricted grant from Janssen Pharmaceuticals for contributing to research on respiratory syncytial virus. CH reports he has received expenses and fees for his media work. He is director of the CEBM at the University of Oxford, and editor-in-chief of BMJ Evidence-Based Medicine and an NIHR senior investigator. JA, NW, MM, ADH and A-MB have no conflicts of interest to declare.

Figures

Figure 1

CONSORT diagram showing the flow of trial participants. *Group 1—immediate antibiotics alone (control); group 2—immediate antibiotics and immediate cranberry capsules; group 3—immediate cranberry capsules and delayed antibiotics. CONSORT, Consolidated Standards of Reporting Trials.

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Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial - PubMed (original) (raw)