Evidence map›Paper›PMID 29304768›Full record

Trial reportBMC infectious diseases2018

Long-term Lactobacillus rhamnosus BMX 54 application to restore a balanced vaginal ecosystem: a promising solution against HPV-infection.

Ettore Palma, Nadia Recine, Lavinia Domenici, Margherita Giorgini, Alessandra Pierangeli, Pierluigi Benedetti Panici

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 77 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 5 pooled it
5.0field-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.

NCT03372395 phase2completednot on this map

Lactobacilli Implementation to Restore a Balanced Vaginal Ecosystem: a Promising Solution Against Vaginosis, Vaginitis and HPV Infection

TypeinterventionalSponsorUniversity of Roma La SapienzaRan2015 to 2016Enrolled117ConditionsVaginal Infection, ASC-USArmsLactobacillus rhamnosus BMX 54
NCT05109533 nacompletednot on this map

Probiotics Role in HPV Clearance When Coexisting Vaginal Infections

TypeinterventionalSponsorAzienda Ospedaliero, Universitaria PisanaRan2018 to 2021Enrolled483ConditionsVaginal Infection, HPV InfectionArmsLactobacillus rhamnosus BMX 54, Lactobacillus reuteri RC-14, Lactobacillus rhamnosus GR-1
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 5 syntheses or guidelines pooled it, 128 citations in OpenAlex.

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17 more citing papers are in PubMed but not listed here.

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

6 authors at 1 institution in 1 country.

Ettore PalmaDepartment of Gynecological, Obstetric and Urologic Sciences, University "Sapienza" of Rome, Rome, Italy.
Nadia RecineDepartment of Gynecological, Obstetric and Urologic Sciences, University "Sapienza" of Rome, Rome, Italy.
Lavinia DomeniciDepartment of Gynecological, Obstetric and Urologic Sciences, University "Sapienza" of Rome, Rome, Italy. lavinia.domenici@uniroma1.it.ORCID 0000-0002-7518-8250
Margherita GiorginiDepartment of Gynecological, Obstetric and Urologic Sciences, University "Sapienza" of Rome, Rome, Italy.
Alessandra PierangeliDepartment of Molecular Medicine, University "Sapienza" of Rome, Rome, Italy.
Pierluigi Benedetti PaniciDepartment of Gynecological, Obstetric and Urologic Sciences, University "Sapienza" of Rome, Rome, Italy.
Sapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOver recent years, a growing interest has developed in microbiota and in the concept of maintaining a special balance between Lactobacillus and other bacteria species in order to promote women's well-being. The aim of our study was to confirm that vaginal Lactobacilli long-lasting implementation in women with HPV-infections and concomitant bacterial vaginosis or vaginitis might be able to help in solving the viral infection, by re-establishing the original eubiosis.

methodsA total of 117 women affected by bacterial vaginosis or vaginitis with concomitant HPV-infections were enrolled at Department of Gynecological Obstetrics and Urological Sciences, La Sapienza University, Rome, Italy between February 2015 and March 2016. Women were randomized in two groups, standard treatment (metronidazole 500 mg twice a day for 7 days or fluconazole 150 mg orally once a day for 2 consecutive days) plus short-term (3 months) vaginal Lactobacillus implementation (group 1, short probiotics treatment protocol group, n = 60) versus the same standard treatment plus long-lasting (6 months) vaginal Lactobacillus rhamnosus BMX 54 administration (group 2, treatment group, n = 57).

resultsAfter a median follow up of 14 months (range 9-30 months) the chance to solve HPV-related cytological anomalies was twice higher in probiotic long-term users (group 2) versus short probiotics implementation group (group 1) (79.4% vs 37.5%, p = 0.041). Moreover, a total HPV-clearance was shown in 11.6% of short schedule probiotics implementation patients compared to a percentage of 31.2% in vaginal Lactobacilli long term users (p = 0.044), assessed as negative HPV-DNA test documented at the end of the study period.

conclusionsThe consistent percentage of clearance of PAP-smear abnormalities and HPV-clearance obtained in long-term treatment group has been interestingly high and encouraging. Obviously, larger and randomized studies are warranted to confirm these encouraging results, but we believe that eubiosis re-establishment is the key to tackle effectively even HPV-infection.

trial registrationRetrospectively registered on PRS NCT03372395 (12/12/2017).

Indexed as

Lacticaseibacillus rhamnosusAdministration, IntravaginalAdultFemaleFluconazoleHumansMetronidazoleMicrobiotaPapillomavirus InfectionsProbioticsTreatment OutcomeVaginaVaginosis, BacterialFluconazoleMetronidazoleHPV infectionLactobacillus rhamnosus BMX 54Probiotics

Identifiers

PMID29304768
PMCPMC5756375
OpenAlexW2782223764

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.