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 (REDCap) 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 outcomes 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 GP practices (100%) were opened and recruited participants between 1st July and 2nd 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 to 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: ISRCTN registry, ID: 10399299. Registered prospectively on 24th January 2019
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 (REDCap) 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 outcomes 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 GP practices (100%) were opened and recruited participants between 1st July and 2nd 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 to 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: ISRCTN registry, ID: 10399299. Registered prospectively on 24th January 2019
Original language | English |
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Article number | e046791 |
Number of pages | 18 |
Journal | BMJ Open |
Volume | 11 |
Issue number | 2 |
DOIs | |
Publication status | Published - 22 Feb 2021 |
Bibliographical note
Funding Information:Funding This work was supported by the NIHR School for Primary Care Research (grant reference number: SPCR-2014-10043). Indena SpA supplied Redicran capsules to the trial at no cost. OG’s time is funded by the Wellcome Trust (grant reference number: 203921). CH received funding support from the NIHR SPCR Evidence Synthesis Working Group (project 390) and the NIHR Oxford BRC. A-MB receives funding from the NIHR School for Primary Care Research.
Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.
Keywords
- urinary tract infection
- vaccinium macrocarpon
- general practice
- primary health care
- clinical trial