Evidence map›Paper›PMID 31088247›Full record

Observational studyThe Journal of international medical research2019

Acceptability, tolerability, and effects on symptoms and signs of vulvovaginitis of a non-soap, herbal-based intimate hygiene solution (Zelesse®).

Misericordia Guinot, Jose Eliseo Blanco, Juan Luis Delgado, Raquel Oliva, Luis Manuel San Frutos, Ibone Huerta, Syra Velasco, Concepción Nieto

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in The Journal of international medical research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 33% 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

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Observational
  3. 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

8 authors at 1 institution in 1 country.

Misericordia Guinot1 Private gynecology office of Dra. Misericordia Guinot Gasull. Pasaje de Llavallol, Barcelona, Spain.
Jose Eliseo Blanco2 Private gynecology clinic of Dres. Blanco y Pacheco. Avenida Juan Carlos I, Murcia, Spain.
Juan Luis Delgado3 Private gynecology office Dr. Juan Luis Delgado. Jara, Cartagena (Murcia), Spain.
Raquel Oliva4 Private gynecology office of Dra. Oliva. San Antonio, Totana (Murcia), Spain.
Luis Manuel San Frutos5 Sanchinarro Medical Center. Ana de Austria, Madrid, Spain.
Ibone Huerta6 Medical Department, ITF Research Pharma S.L.U. San Rafael, Alcobendas (Madrid), Spain.
Syra Velasco6 Medical Department, ITF Research Pharma S.L.U. San Rafael, Alcobendas (Madrid), Spain.ORCID https://orcid.org/0000-0002-1560-9439
Concepción Nieto6 Medical Department, ITF Research Pharma S.L.U. San Rafael, Alcobendas (Madrid), Spain.
Hospital Universitario HM Sanchinarro · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the acceptability, tolerability, and effects on vulvovaginitis symptoms and signs of a non-soap, herbal-based intimate solution (Zelesse®).

methodsWe conducted a prospective, observational, multicenter study including adult women with symptoms and signs of vulvovaginitis with various etiologies, including candidiasis, trichomoniasis, bacterial vaginosis, and atrophic and irritative vaginitis. The presence and intensity of signs (edema, erythema, vaginal discharge) and symptoms (pruritus) of vulvovaginitis were evaluated before and after 5-15 days of daily use of Zelesse® alone or as a coadjuvant in antimicrobial therapy. Variables following a normal distribution and categorical variables were analyzed using the Student t-test and chi-square or Fisher's exact test, respectively.

resultsA total 137 women were enrolled in the study; 87 (63.5%) women received concomitant antimicrobials and 50 (36.5%) used Zelesse® only. Global symptom scores and frequency of patients with vulvovaginitis signs and symptoms, and their mean intensity, decreased after treatment in both patient groups. Vaginal pH and (in the Zelesse®-only group) vaginal flora remained unaltered. The product was safe, well tolerated, and highly accepted by patients.

conclusionsZelesse®, the non-soap herbal-based solution in this study, may represent a safe and effective option for symptomatic relief of vulvovaginitis.

Indexed as

PhytotherapySeverity of Illness IndexAdultAnti-Bacterial AgentsFemaleFollow-Up StudiesHumansHygieneMaximum Tolerated DosePrognosisProspective StudiesSolutionsSpainVulvovaginitisAnti-Bacterial AgentsSolutionsaloe veraburdockchamomileintimate hygienepruritusVulvovaginitis

Identifiers

PMID31088247
PMCPMC6567706
OpenAlexW2945554237

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.