Evidence map›Paper›PMID 15333452›Full record

Trial reportBMJ (Clinical research ed.)2004

Effect of lactobacillus in preventing post-antibiotic vulvovaginal candidiasis: a randomised controlled trial.

Marie Pirotta, Jane Gunn, Patty Chondros, Sonia Grover, Paula O'Malley, Susan Hurley, Suzanne Garland

Open access · bronzeAbstract readClinical TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 4 pooled it
5.7field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 134 citations in OpenAlex.

  1. Pooled it
  2. Treatment for recurrent vulvovaginal candidiasis (thrush).The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Guideline
  4. Probiotics for vulvovaginal candidiasis in non-pregnant women.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Local Probiotic Therapy for Vaginal Candida albicans Infections.Probiotics and antimicrobial proteins · 2015
    Trial
  6. Does eating yogurt prevent antibiotic-associated diarrhoea? A placebo-controlled randomised controlled trial in general practice.The British journal of general practice : the journal of the Royal College of General Practitioners · 2007
    Trial
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Comparison between the Efficacy ofEvidence-based complementary and alternative medicine : eCAM · 2022
    Article
  13. Article
  14. Evaluation of the Inhibitory Effects ofFrontiers in medicine · 2020
    Article
  15. Review
  16. Article
  17. Article
  18. Is it possible to prevent recurrent vulvovaginitis? The role of Lactobacillus plantarum I1001 (CECT7504).European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2016
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Marie PirottaDepartment of General Practice, 200 Berkeley Street, Carlton, Victoria, Australia, 3053. m.pirotta@unimelb.edu.au
Jane Gunn
Patty Chondros
Sonia Grover
Paula O'Malley
Susan Hurley
Suzanne Garland
Australian Association for Academic Primary Care · AURoyal Women's Hospital · AUUniversity of Melbourne · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo test whether oral or vaginal lactobacillus can prevent vulvovaginitis after antibiotic treatment.

designRandomised, placebo controlled, double blind, factorial 2x2 trial.

settingFifty general practices and 16 pharmacies in Melbourne, Australia.

participantsNon-pregnant women aged 18-50 years who required a short course of oral antibiotics for a non-gynaecological infection: 278 were enrolled in the study, and results were available for 235.

interventionsLactobacillus preparations taken orally or vaginally, or both, from enrollment until four days after completion of their antibiotic course.

main outcome measuresParticipants' reports of symptoms of post-antibiotic vulvovaginitis, with microbiological evidence of candidiasis provided by a self obtained vaginal swab.

resultsOverall, 55/235 (23% (95% confidence interval 18% to 29%)) women developed post-antibiotic vulvovaginitis. Compared with placebo, the odds ratio for developing post-antibiotic vulvovaginitis with oral lactobacillus was 1.06 (95% confidence interval 0.58 to 1.94) and with vaginal lactobacillus 1.38 (0.75 to 2.54). Compliance with antibiotics and interventions was high. The trial was terminated after the second interim analysis because of lack of effect of the interventions. Given the data at this time, the chances of detecting a significant reduction in vulvovaginitis with oral or vaginal lactobacillus treatment were less than 0.032 and 0.0006 respectively if the trial proceeded to full enrollment.

conclusionsThe use of oral or vaginal forms of lactobacillus to prevent post-antibiotic vulvovaginitis is not supported by these results. Further research on this subject is unlikely to be fruitful, unless new understandings about the pathogenesis of post-antibiotic vulvovaginitis indicate a possible role for lactobacillus.

Indexed as

LactobacillusAdministration, IntravaginalAdministration, OralAdultAnti-Bacterial AgentsCandidiasis, VulvovaginalDouble-Blind MethodFemaleHumansMiddle AgedTreatment OutcomeVulvovaginitisAnti-Bacterial Agents

Identifiers

PMID15333452
PMCPMC516107
OpenAlexW2135080179

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.