Evidence map›Paper›PMID 26635090›Full record

Trial reportBMC women's health2015

Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial.

Piotr B Heczko, Anna Tomusiak, Paweł Adamski, Artur J Jakimiuk, Grzegorz Stefański, Aleksandra Mikołajczyk-Cichońska, Magdalena Suda-Szczurek, Magdalena Strus

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC women's health, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01993524 (Efficacy and Safety Assessment of prOVag Dietary Supplement in Recurrent Bacterial Vaginitis. Multi-centre, Randomized, Double-blind, Placebo-controlled Clinical Study.), which is not on this map. Cited by 51 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 3 pooled it
5.3field-weighted citation impact, top 4% 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.

NCT01993524 nacompletednot on this map

Efficacy and Safety Assessment of prOVag Dietary Supplement in Recurrent Bacterial Vaginitis. Multi-centre, Randomized, Double-blind, Placebo-controlled Clinical Study.

TypeinterventionalSponsorIBSS Biomed S.A.Ran2009 to 2012Enrolled594ConditionsBacterial Vaginosis, Bacterial VaginitisArmsprobiotic, placebo
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 3 syntheses or guidelines pooled it, 101 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Probiotics for the Treatment of Bacterial Vaginosis: A Meta-Analysis.International journal of environmental research and public health · 2019
    Pooled it
  4. Trial
  5. Trial
  6. Orally administratedFrontiers in immunology · 2023
    Trial
  7. ProbioticFrontiers in cellular and infection microbiology · 2021
    Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Progress in interventions for vaginal microecology.Frontiers in cellular and infection microbiology · 2026
    Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Biomolecules · 2024
    Article
  20. Review
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

8 authors at 4 institutions in 1 country.

Piotr B HeczkoChair of Microbiology, Jagiellonian University Medical College, Krakow, Poland. piotr.heczko@pebeha.pl.
Anna TomusiakChair of Microbiology, Jagiellonian University Medical College, Krakow, Poland. a.tomusiak@uj.edu.pl.
Paweł AdamskiInstitute of Nature Conservation, Polish Academy of Sciences, Krakow, Poland. adamski@iop.krakow.pl.
Artur J JakimiukClinical Department of Obstetrics and Gynecology, Central Clinical Hospital of Ministry of Interior and Administration, Warsaw, Poland. jakimiuk@yahoo.com.
Grzegorz StefańskiIBSS BIOMED S.A, Krakow, Poland. grzegorz.stefanski@biomed.pl.
Aleksandra Mikołajczyk-CichońskaIBSS BIOMED S.A, Krakow, Poland. aleksandra.cichonska@biomed.pl.
Magdalena Suda-SzczurekIBSS BIOMED S.A, Krakow, Poland. magdalena.suda@biomed.pl.
Magdalena StrusChair of Microbiology, Jagiellonian University Medical College, Krakow, Poland. mbstrus@cyf-kr.edu.pl.
IBSS BIOMED (Poland) · PLJagiellonian University · PLMinistry of Interior and Administration · PLPolish Academy of Sciences · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis multicentre, randomised, double-blind, placebo-controlled trial was performed to determine whether the use of oral probiotic preparation (prOVag®) containing three Lactobacillus strains together with standard metronidazole treatment and also targeted antibiotic treatment (following the failure of metronidazole therapy) could reduce the recurrence rates of bacterial vaginosis (BV) and aerobic vaginitis (AV).

methodsPatients at private gynaecological clinics in Poland with histories of recurrent BV/AV and current symptoms were randomly allocated to receive metronidazole and probiotic or placebo, and assessed monthly on visits II and III-V. The total number of study visits was 5-6 (I, II, II bis - if applicable, III, IV, V). One probiotic or placebo capsule was administered with metronidazole/targeted antibiotic twice daily for 10 days; during follow up, patients took one capsule daily for 10 days perimenstrually. Clinical examination and vaginal swabbing were performed at each visit. Primary outcomes were clinical or microbiological BV/AV recurrence and probiotic safety. Secondary outcomes were vaginal pH, Nugent score, and Lactobacillus counts in the vaginal microbiota. Safety analysis was performed in 578 (probiotic, n = 285; placebo, n = 293) 18-50-year-old women who were randomised.

resultsBV/AV was confirmed microbiologically in 241 (probiotic, n = 118; placebo, n = 123) participants, who continued the trial. Data from 154 (probiotic, n = 73; placebo, n = 81) participants who completed the study were analysed to determine the efficacy of prOVag. Additional analyses included 37 (probiotic, n = 22; placebo, n = 15) participants who received targeted antibiotics and probiotics or placebo. prOVag lengthened the time to clinical relapse of BV/AV symptoms up to 51 % (p < 0.05) compared with placebo; AV relapse was delayed by up to 76 % (p < 0.05). Probiotic use also reduced and maintained low vaginal pH and Nugent score, and increased vaginal Lactobacillus counts following standard treatment.

conclusionThis study demonstrated that oral probiotics lengthened remission in patients with recurrent BV/AV and improved clinical and microbiological parameters.

trial registrationNCT01993524 ; 20 November 2013.

Indexed as

Administration, IntravaginalAdultAnti-Bacterial AgentsDietary SupplementsDouble-Blind MethodFemaleHumansMetronidazoleMiddle AgedPolandProbioticsVaginaVaginosis, BacterialAnti-Bacterial AgentsMetronidazole

Identifiers

PMID26635090
PMCPMC4669640
OpenAlexW2186206843

What OpenQuestion holds

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LicenceCC BY
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.