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Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial
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 g...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903114/ https://www.ncbi.nlm.nih.gov/pubmed/33619202 http://dx.doi.org/10.1136/bmjopen-2020-046791 |
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author | Gbinigie, Oghenekome Allen, Julie Williams, Nicola Moore, Michael Hay, Alastair D Heneghan, Carl Boylan, Anne-Marie Butler, Christopher C |
author_facet | Gbinigie, Oghenekome Allen, Julie Williams, Nicola Moore, Michael Hay, Alastair D Heneghan, Carl Boylan, Anne-Marie Butler, Christopher C |
author_sort | Gbinigie, Oghenekome |
collection | PubMed |
description | 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). |
format | Online Article Text |
id | pubmed-7903114 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-79031142021-03-09 Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial Gbinigie, Oghenekome Allen, Julie Williams, Nicola Moore, Michael Hay, Alastair D Heneghan, Carl Boylan, Anne-Marie Butler, Christopher C BMJ Open Infectious Diseases 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). BMJ Publishing Group 2021-02-22 /pmc/articles/PMC7903114/ /pubmed/33619202 http://dx.doi.org/10.1136/bmjopen-2020-046791 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Infectious Diseases Gbinigie, Oghenekome Allen, Julie Williams, Nicola Moore, Michael Hay, Alastair D Heneghan, Carl Boylan, Anne-Marie Butler, Christopher C Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial |
title | Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial |
title_full | Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial |
title_fullStr | Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial |
title_full_unstemmed | Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial |
title_short | Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? A feasibility randomised trial |
title_sort | does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (cuti)? a feasibility randomised trial |
topic | Infectious Diseases |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7903114/ https://www.ncbi.nlm.nih.gov/pubmed/33619202 http://dx.doi.org/10.1136/bmjopen-2020-046791 |
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