Evidence map›Paper›PMID 26210791›Full record

Trial reportTrials2015

BASIC study: is intravaginal boric acid non-inferior to metronidazole in symptomatic bacterial vaginosis? Study protocol for a randomized controlled trial.

Melinda Zeron Mullins, Konia M Trouton

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00799214 (Back to BASICS), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.9field-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.

NCT00799214 phase2 / phase3completednot on this map

Back to BASICS: Boric Acid, Alternate Solution for Intravaginal Colonization, Comparing Intravaginal Metronidazole to Boric Acid in Women Symptomatic for Bacterial Vaginosis

TypeinterventionalSponsorUniversity of British ColumbiaRan2014 to 2016Enrolled13ConditionsBacterial VaginosisArmsPlacebo, Boric acid, Metronidazole
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
  2. Vaginal Sheets withGels (Basel, Switzerland) · 2023
    Article
  3. Article
  4. Article
  5. Review
  6. 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

2 authors at 1 institution in 1 country.

Melinda Zeron MullinsDepartment of Family Practice, University of British Columbia, 3rd Floor David Strangway Building, 5950 University Boulevard, Vancouver, British Columbia, BC V6T 1Z3, Canada. melindazeron@hotmail.com.
Konia M TroutonDepartment of Family Practice, University of British Columbia, 3rd Floor David Strangway Building, 5950 University Boulevard, Vancouver, British Columbia, BC V6T 1Z3, Canada. konia.trouton@viha.ca.
University of British Columbia · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBacterial vaginosis is associated with increased transmission of sexually transmitted infections, preterm labor, post-surgical infections, and endometritis. Current treatment for symptomatic bacterial vaginosis includes antibiotics, such as metronidazole, which are 70-80 % effective at one month after treatment and result in high recurrence rates and secondary candida infections. Intravaginal boric acid has been used for over a hundred years to treat vaginal infections, such as bacterial vaginosis. Boric acid is inexpensive, accessible, and has shown to be an effective treatment for other infections, such as vaginal candidiasis. To date, there has been no clinical trial evaluation of boric acid effectiveness to treat bacterial vaginosis. METHODS/

designThe BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) trial is a randomized, double-blinded, multicenter study. The study will enroll a minimum of 240 women of 16-50 years of age who are symptomatic with bacterial vaginosis. Eligible participants will have Amsel and Nugent scores confirming bacterial vaginosis. Women who are pregnant or menopausal or have other active co-infections will be excluded. Consenting participants who meet exclusion and inclusion criteria will be randomly assigned to one of three treatment groups: boric acid, metronidazole, or an inert placebo. Self-administration of treatment intravaginally for 10 days will be followed by clinical assessment at 7 and 30 days (days 17 and 40, respectively) after the end of the treatment phase. Primary outcome is a non-inferiority, per-protocol comparison of the effectiveness of boric acid with that of metronidazole at day 17, as measured by the Nugent score in 16-50 year olds. Secondary outcomes include: non-inferiority, intention-to-treat comparison of effectiveness of boric acid with that of metronidazole at day 17, analysis for both per-protocol and intention-to-treat at day 40, and safety considerations, including adverse effects requiring patient discontinuation of treatment. DISCUSSION: This study will be the first to determine whether intravaginal boric acid is non-inferior to metronidazole in the treatment of bacterial vaginosis in symptomatic women.

trial registrationClinicalTrials.gov NCT00799214, registered online Nov 10, 2008.

Indexed as

Administration, IntravaginalAdolescentAdultAnti-Bacterial AgentsBoric AcidsBritish ColumbiaClinical ProtocolsDouble-Blind MethodFemaleHumansIntention to Treat AnalysisMetronidazoleMiddle AgedRemission InductionResearch DesignTime FactorsAnti-Bacterial Agentsboric acidBoric AcidsMetronidazole

Identifiers

PMID26210791
PMCPMC4514959
OpenAlexW1767685303

What OpenQuestion holds

Textmetadata
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.