Trial reportPloS one2012
Efficacy of oral metronidazole with vaginal clindamycin or vaginal probiotic for bacterial vaginosis: randomised placebo-controlled double-blind trial.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 6 of them syntheses that pooled 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.
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.
Who cites it
63 citing papers in PubMed, 6 syntheses or guidelines pooled it, 138 citations in OpenAlex.
- Probiotics are a good choice for the treatment of bacterial vaginosis: a meta-analysis of randomized controlled trial.Reproductive health · 2022Pooled it
- Effects of Pro/Prebiotics Alone over Pro/Prebiotics Combined with Conventional Antibiotic Therapy to Treat Bacterial Vaginosis: A Systematic Review.International journal of clinical practice · 2022Pooled it
- Probiotics, a promising therapy to reduce the recurrence of bacterial vaginosis in women? a systematic review and meta-analysis of randomized controlled trials.Frontiers in nutrition · 2022Pooled it
- Non-antibiotic treatment of bacterial vaginosis-a systematic review.Archives of gynecology and obstetrics · 2021Pooled it
- Probiotics for the Treatment of Bacterial Vaginosis: A Meta-Analysis.International journal of environmental research and public health · 2019Pooled it
- Hormonal contraception is associated with a reduced risk of bacterial vaginosis: a systematic review and meta-analysis.PloS one · 2013Pooled it
- Trial
- Oral Probiotics to Prevent Recurrent Vulvovaginal Infections During Pregnancy-Multicenter Double-Blind, Randomized, Placebo-Controlled Trial.Nutrients · 2025Trial
- Efficacy of Dequalinium Chloride vs Metronidazole for the Treatment of Bacterial Vaginosis: A Randomized Clinical Trial.JAMA network open · 2024Trial
- Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial.BMC women's health · 2023Trial
- Trial
- Combined oral contraceptive pill-exposure alone does not reduce the risk of bacterial vaginosis recurrence in a pilot randomised controlled trial.Scientific reports · 2019Trial
- Comparative proteomics reveal striking differences in biofilm formation and virulence potential ofJournal of bacteriology · 2026Article
- The Female Reproductive Microbiome: Mechanistic Insights and Bioengineering Perspectives.Biology · 2026Review
- Intravaginal Formulation Strategies for Vaginal Disorders: Optimizing Phytochemical and Biological Preparations-A Review.Molecules (Basel, Switzerland) · 2026Review
- Genome-scale metabolic modelling identifies vaginal microbiome members as potential probiotics.Nature microbiology · 2026Article
- Adjunctive probiotic therapy enhances metronidazole efficacy in bacterial vaginitis: a clinical trial on Iranian women.GMS hygiene and infection control · 2026Article
- Randomized trial of multi-strainContemporary clinical trials communications · 2025Article
- Formulation, development and characterization of fosfomycin tromethamine pessaries for the treatment of vaginal infections.Scientific reports · 2025Article
- Vaginal pharmacomicrobiomics modulates risk of persistent and recurrent bacterial vaginosis.NPJ biofilms and microbiomes · 2025Review
3 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo determine if oral metronidazole (MTZ-400 mg bid) with 2% vaginal clindamycin-cream (Clind) or a Lactobacillus acidophilus vaginal-probiotic containing oestriol (Prob) reduces 6-month bacterial vaginosis (BV) recurrence.
methodsDouble-blind placebo-controlled parallel-group single-site study with balanced randomization (1:1:1) conducted at Melbourne Sexual Health Centre, Australia. Participants with symptomatic BV [Nugent Score (NS) = 7-10 or ≥3 Amsel's criteria and NS = 4-10], were randomly allocated to MTZ-Clind, MTZ-Prob or MTZ-Placebo and assessed at 1,2,3 and 6 months. MTZ and Clind were administered for 7 days and Prob and Placebo for 12 days. Primary outcome was BV recurrence (NS of 7-10) on self-collected vaginal-swabs over 6-months. Cumulative BV recurrence rates were compared between groups by Chi-squared statistics. Kaplan-Meier, log rank and Cox regression analyses were used to compare time until and risk of BV recurrence between groups.
results450 18-50 year old females were randomized and 408 (91%), equally distributed between groups, provided ≥1 NS post-randomization and were included in analyses; 42 (9%) participants with no post-randomization data were excluded. Six-month retention rates were 78% (n = 351). One-month BV recurrence (NS 7-10) rates were 3.6% (5/140), 6.8% (9/133) and 9.6% (13/135) in the MTZ-Clind, MTZ-Prob and MTZ-Placebo groups respectively, p = 0.13. Hazard ratios (HR) for BV recurrence at one-month, adjusted for adherence to vaginal therapy, were 0.43 (95%CI 0.15-1.22) and 0.75 (95% CI 0.32-1.76) in the MTZ-Clind and MTZ-Prob groups compared to MTZ-Plac respectively. Cumulative 6-month BV recurrence was 28.2%; (95%CI 24.0-32.7%) with no difference between groups, p = 0.82; HRs for 6-month BV recurrence for MTZ-Clind and MTZ-Prob compared to MTZ-Plac, adjusted for adherence to vaginal therapy were 1.09(95% CI = 0.70-1.70) and 1.03(95% CI = 0.65-1.63), respectively. No serious adverse events occurred.
conclusionCombining the recommended first line therapies of oral metronidazole and vaginal clindamycin, or oral metronidazole with an extended-course of a commercially available vaginal-L.acidophilus probiotic, does not reduce BV recurrence.
trial registrationANZCTR.org.au ACTRN12607000350426.
Indexed as
Identifiers
What OpenQuestion holds
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.