Evidence map›Paper›PMID 37161454›Full record

Trial reportBMC women's health2023

Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial.

Jonathan D C Ross, Clare Brittain, Jocelyn Anstey Watkins, Joe Kai, Miruna David, Mara Ozolins, Louise Jackson, Zainab Abdali, Trish M Hepburn, Frances Griffiths and 5 more

Open access · goldAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC women's health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 20% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Bacterial vaginosis.Nature reviews. Disease primers · 2025
    Review
  5. Article
  6. Review
  7. Genetic predictors for bacterial vaginosis in women living with and at risk for HIV infection.American journal of reproductive immunology (New York, N.Y. : 1989) · 2024
    Article
  8. 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

15 authors at 5 institutions in 2 countries.

Jonathan D C RossDepartment of GU Medicine, University Hospitals Birmingham NHS Foundation Trust, Whittall Street Clinic, Whittall Street, Birmingham, B4 6DH, UK.
Clare BrittainNottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.
Jocelyn Anstey WatkinsDivision of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Joe KaiCentre for Academic Primary Care, School of Medicine, University of Nottingham, University Park, NG7 2RD, UK.
Miruna DavidClinical Microbiology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, B15 2GW, UK.
Mara OzolinsNottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.
Louise JacksonHealth Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Zainab AbdaliHealth Economics Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK.
Trish M HepburnNottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, NG7 2RD, UK. trish.hepburn@nottingham.ac.uk.ORCID 0000-0002-0936-6696
Frances GriffithsDivision of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Alan MontgomeryNottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.
Jane DanielsNottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.
Alice ManleyDepartment of GU Medicine, University Hospitals Birmingham NHS Foundation Trust, Whittall Street Clinic, Whittall Street, Birmingham, B4 6DH, UK.
Gillian DeanElton John Research Centre, Sussex House, 1 Abbey Road, Brighton, BN2 1ES, UK.
Lindsay K Armstrong-BuisseretNottingham Clinical Trials Unit, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.
University of Nottingham · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of Birmingham · GBUniversity of the Witwatersrand · ZAUniversity of Warwick · GB

Funding

Department of Health 15/110/02
6 · The paper itself

Abstract

backgroundBacterial vaginosis is a common and distressing condition for women. Short-term antibiotic treatment is usually clinically effective, but recurrence is common. We assessed the effectiveness of intravaginal lactic acid gel versus oral metronidazole for treating recurrent bacterial vaginosis.

methodsWe undertook an open-label, multicentre, parallel group, randomised controlled trial in nineteen UK sexual health clinics and a university health centre. Women aged ≥ 16 years, with current bacterial vaginosis symptoms and a preceding history of bacterial vaginosis, were randomised in a 1:1 ratio using a web-based minimisation algorithm, to 400 mg twice daily oral metronidazole tablets or 5 ml once daily intravaginal lactic acid gel, for 7 days. Masking of participants was not possible. The primary outcome was participant-reported resolution of symptoms within 2 weeks. Secondary outcomes included time to first recurrence of symptoms, number of recurrences and repeat treatments over 6 months and side effects.

resultsFive hundred and eighteen participants were randomised before the trial was advised to stop recruiting by the Data Monitoring Committee. Primary outcome data were available for 79% (204/259) allocated to metronidazole and 79% (205/259) allocated to lactic acid gel. Resolution of bacterial vaginosis symptoms within 2 weeks was reported in 70% (143/204) receiving metronidazole versus 47% (97/205) receiving lactic acid gel (adjusted risk difference -23·2%; 95% confidence interval -32.3 to -14·0%). In those participants who had initial resolution and for whom 6 month data were available, 51 of 72 (71%) women in the metronidazole group and 32 of 46 women (70%) in the lactic acid gel group had recurrence of symptoms, with median times to first recurrence of 92 and 126 days, respectively. Reported side effects were more common following metronidazole than lactic acid gel (nausea 32% vs. 8%; taste changes 18% vs. 1%; diarrhoea 20% vs. 6%, respectively).

conclusionsMetronidazole was more effective than lactic acid gel for short-term resolution of bacterial vaginosis symptoms, but recurrence is common following both treatments. Lactic acid gel was associated with fewer reported side effects.

trial registrationISRCTN14161293 , prospectively registered on 18

Indexed as

Drug-Related Side Effects and Adverse ReactionsVaginosis, BacterialAmbulatory Care FacilitiesFemaleHumansLactic AcidMetronidazoleLactic AcidMetronidazoleBacterial vaginosisLactic acidMetronidazoleRecurrenceSexual healthSide effects

Identifiers

PMID37161454
PMCPMC10169495
OpenAlexW4376132839

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.