The frequency and duration of side-effects associated with the use of oral metronidazole; A prospective study of VITA trial participants.
Antibiotic
adverse drug event
treatment
Journal
International journal of STD & AIDS
ISSN: 1758-1052
Titre abrégé: Int J STD AIDS
Pays: England
ID NLM: 9007917
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
medline:
13
10
2023
pubmed:
3
7
2023
entrez:
3
7
2023
Statut:
ppublish
Résumé
The tolerability of metronidazole is often perceived as being poor and in particular as being a cause of gastrointestinal side effects, but the frequency, severity and duration of adverse effects (AE) is not well characterised. This study assessed the frequency and type of metronidazole associated AEs in women treated for bacterial vaginosis. An exploratory study of participants from the lactic acid gel versus metronidazole for treating bacterial vaginosis (VITA) randomised controlled trial. In this sub-study, women aged ≥16 years, diagnosed with bacterial vaginosis and who received oral MTZ (400 mg twice daily, for 7 days) were followed up prospectively over 2 weeks. Baseline demographic and clinical data, and self-reported data on the incidence, time to onset, and duration of AEs were analysed. 155 women were included, of whom 64% (99/155) reported at least one metronidazole AE, including 47% (72/155) who reported gastrointestinal symptoms (nausea and/or vomiting [52/155], abdominal pain [31/154] or diarrhoea [31/154]) mostly within 3 days of starting treatment and resolving within 5 days of onset. Treatment discontinuation occurred in 8% (12/148) overall and AEs were given as the reason for discontinuing in only 3% (4/148). Overall, metronidazole side effects occurred commonly, but resolved within a few days and had a limited impact on treatment completion.
Sections du résumé
BACKGROUND
The tolerability of metronidazole is often perceived as being poor and in particular as being a cause of gastrointestinal side effects, but the frequency, severity and duration of adverse effects (AE) is not well characterised. This study assessed the frequency and type of metronidazole associated AEs in women treated for bacterial vaginosis.
METHODS
An exploratory study of participants from the lactic acid gel versus metronidazole for treating bacterial vaginosis (VITA) randomised controlled trial. In this sub-study, women aged ≥16 years, diagnosed with bacterial vaginosis and who received oral MTZ (400 mg twice daily, for 7 days) were followed up prospectively over 2 weeks. Baseline demographic and clinical data, and self-reported data on the incidence, time to onset, and duration of AEs were analysed.
RESULTS
155 women were included, of whom 64% (99/155) reported at least one metronidazole AE, including 47% (72/155) who reported gastrointestinal symptoms (nausea and/or vomiting [52/155], abdominal pain [31/154] or diarrhoea [31/154]) mostly within 3 days of starting treatment and resolving within 5 days of onset. Treatment discontinuation occurred in 8% (12/148) overall and AEs were given as the reason for discontinuing in only 3% (4/148).
CONCLUSION
Overall, metronidazole side effects occurred commonly, but resolved within a few days and had a limited impact on treatment completion.
Identifiants
pubmed: 37395087
doi: 10.1177/09564624231179505
doi:
Substances chimiques
Anti-Bacterial Agents
0
Metronidazole
140QMO216E
Banques de données
ISRCTN
['ISRCTN14161293']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
897-902Déclaration de conflit d'intérêts
Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JDCR reports personal fees from GSK Pharma and Bayer Pharma, as well as ownership of shares in GSK Pharma and AstraZeneca Pharma; and is author of the UK and European Guidelines on Pelvic Inflammatory Disease; is a Member of the European Sexually Transmitted Infections Guidelines Editorial Board; He is an NIHR Journals Library Editor and associate editor of Sexually Transmitted Infections journal. He is an officer of the International Union against Sexually Transmitted Infections (treasurer), and a charity trustee of the Sexually Transmitted Infections Research Foundation (chair). OA declares no competing interests.