Evidence map›Paper›PMID 12825971›Full record

ArticleDrug safety2003

Relative risk of vaginal candidiasis after use of antibiotics compared with antidepressants in women: postmarketing surveillance data in England.

Lynda Wilton, Monika Kollarova, Emma Heeley, Saad Shakir

Registry-linked trialAbstract readComparative Study
PubMed Publisher
In one paragraph

Article in Drug safety, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03250208 (Probiotics and the Female Urinary Microbiome ProFUM Trial), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.0field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03250208 nacompletednot on this mapstarted 2017, after this paper: background citation

Probiotics and the Female Urinary Microbiome ProFUM Trial (Probiotics Effect on the Female Urinary Microbiome)

TypeinterventionalSponsorLoyola UniversityRan2017 to 2018Enrolled8ConditionsHealthyArmsProbiotic, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 46 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. A Combination of Polybacterial MV140 andFrontiers in immunology · 2020
    Article
  7. Article
  8. Article
  9. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 2 countries.

Lynda WiltonDrug Safety Research Unit, Southampton, United KingdomUniversity of Portsmouth, Portsmouth, United Kingdom. linda.wilton@dsru.org
Monika Kollarova
Emma Heeley
Saad Shakir
Drug Safety Research Unit · GBComenius University Bratislava · SKUniversity of Portsmouth · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVaginal candidiasis is a common infection in women. The microflora of the vagina are influenced by a number of factors, including pregnancy, oral contraceptive use, menses and diabetes mellitus. Previous antibiotic use is generally accepted to be a risk factor for vaginal candidiasis but the published evidence to support this is limited.

aimTo determine the relative risk of vaginal candidiasis following the use of antibiotics compared with antidepressants in prescription-event monitoring (PEM) studies.

methodsUsing data from postmarketing surveillance studies of six antibiotics and six antidepressants, conducted using the observational cohort technique of PEM, the number of reports of vaginal candidiasis was determined in women aged > or =16 years, in each of the first 7 weeks following a prescription for one of these drugs. The relative risks for vaginal candidiasis following the use of these antibiotics and for each of the individual antibiotics compared with antidepressants were calculated for each week and for the overall 7-week period. Women treated with antidepressants were the most suitable comparator group from the PEM database, as they were of a similar age range and the studies were conducted at a similar time period to those of the antibiotics. Also, there was no pharmacological plausibility for vaginal candidiasis being associated with antidepressants.

resultsThere were 188 reports of vaginal candidiasis in 31 588 women, aged > or =16 years, treated with antibiotics and 70 in the 45 492 treated with antidepressants. The relative risk for vaginal candidiasis (antibiotic/antidepressants), was highest in the second week, 10.70 (95% CI 4.86-23.55) but was also significantly greater in the first and third weeks after the start of treatment. The risk was also higher in each of the 3 weeks after starting the course for five of the antibiotics, compared individually to the group treated with antidepressants, the exception being fosfomycin, which had a much smaller cohort.

conclusionThis study shows a significant increase in the risk of developing vaginal candidiasis following the use of the antibiotics studied (ciprofloxacin, ofloxacin, norfloxacin, cefixime, azithromycin and fosfomycin) compared with that after taking the antidepressants fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine and nefazodine in these PEM studies.

Indexed as

AdultAntidepressive AgentsAnti-Infective AgentsCandidiasis, VulvovaginalCohort StudiesEnglandFemaleHumansProduct Surveillance, PostmarketingRiskAntidepressive AgentsAnti-Infective Agents

Identifiers

PMID12825971
OpenAlexW1999638937

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.