Evidence map›Paper›PMID 27933401›Full record

Trial reportEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2017

Improvement of abnormal vaginal flora in Ugandan women by self-testing and short use of intravaginal antimicrobials.

G Donders, G Bellen, F Donders, J Pinget, I Vandevelde, T Michiels, J Byamughisa

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 24% 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

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Review
  3. Bacterial Vaginosis: What Do We Currently Know?Frontiers in cellular and infection microbiology · 2021
    Review
  4. 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

7 authors at 4 institutions in 4 countries.

G DondersFemicare vzw, Clinical Research for Women, Gasthuismolenstraat 31, 3300, Tienen, Belgium. Gilbert.Donders@femicare.net.ORCID http://orcid.org/0000-0001-9890-6254
G BellenFemicare vzw, Clinical Research for Women, Gasthuismolenstraat 31, 3300, Tienen, Belgium.
F DondersDepartment of Obstetrics and Gynaecology, Gasthuisberg University Hospital, Leuven, Belgium.
J PingetSite Management Clinical Research, Faculty of Medicine, Janssens Pharma, Beerse, Belgium.
I VandeveldePharmacist, De Haan, Belgium.
T MichielsDepartment of Surgery, Gasthuisberg University Hospital, Leuven, Belgium.
J ByamughisaDepartment of Obstetrics and Gynaecology, Mulago University Hospital, Kampala, Uganda.
Universitair Ziekenhuis Leuven · BEJanssen (Belgium) · BEKuang Tien General Hospital · TWMulago Hospital · UG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The vaginal composition of African women is more often lactobacillus-deficient compared to that of women from other areas around the world. Lactobacillus-deficient microflora is a known risk factor for serious health problems, such as preterm birth, cervix cancer, and entrapment of human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). The aim of this study was to assess the effect of local vaginal antibiotic or antiseptic treatment on abnormal vaginal flora (AVF), aerobic vaginitis (AV), and bacterial vaginosis (BV) among women in rural, semi-urban, and urban areas in Uganda, as compared to placebo. In a double-blind, placebo-controlled, randomized trial, 300 women presenting for outpatient routine, follow-up, or medical care at Mulago Hospital in Kampala, Uganda, were enrolled to receive 6 days of treatment with vaginal rifaximin (RFX), dequalinium chloride (DQC), or placebo if they had an increased vaginal pH of >4.5 as determined by self-testing. At initial visit and at control visit after 4 weeks, a smear was taken for blinded wet mount microscopy to determine AVF, BV, AV, and Candida severity scores. As compared to placebo, both RFX or DQC treatments dramatically diminished BV prevalence and severity from the initial to follow-up visit: the BV score declined from 2.5 to 1.6 (p < 0.0001) and from 2.5 to 1.9 (p < 0.0001), respectively. Similarly, strong improvements in the AV score were seen in both treatment regimens: moderate and severe AV declined from AV scores of 6.3 to 3.6 (p = 0.003) and from 6.6 to 4.1 (p < 0.004), respectively. Also, women with AVF (deceased or absent lactobacilli) showed similar improvements when compared with placebo. Women with normal flora and Candida at the initial visit showed less Candida after 4 weeks in the group treated with DQC (p = 0.014). Even after a short duration of intravaginal treatment with local non-absorbable antiseptics or antibiotics produced significant, lasting improvements in the vaginal microbiome composition of women with disturbed vaginal microflora. As African women have high prevalences of BV, AV, and AVF, this approach could improve their odds to prevent health-compromising complications. Further studies assessing direct health outcomes are needed to substantiate this.

Indexed as

Self AdministrationAdolescentAdultAnti-Infective AgentsDequaliniumDiagnostic Tests, RoutineDouble-Blind MethodDysbiosisFemaleHumansHydrogen-Ion ConcentrationMiddle AgedPlacebosRifamycinsRifaximinTreatment OutcomeAnti-Infective AgentsDequaliniumPlacebosRifamycinsRifaximin

Identifiers

PMID27933401
OpenAlexW2560404294

What OpenQuestion holds

Textmetadata
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.