title: Beneficial effects of a Coriolus versicolor-based vaginal gel on cervical epithelization, vaginal microbiota and vaginal health: a pilot study in asymptomatic women.
abstract: To assess the effect of a 12-day treatment using a vaginal gel based on niosomes containing hyaluronic acid, ß-glucan, alpha-glucan oligosaccharide, Coriolus versicolor, Asian centella, Azadirachta indica and Aloe vera on vaginal microbiota, cervical epithelization and vaginal health.
  
  
  
  Open-label, prospective pilot study conducted in asymptomatic women in daily practice. Cervical epithelization was evaluated by colposcopy using an ectopy epithelization score (from 5: no ectopy to 1: severe ectopy and bleeding), vaginal microbiota using the VaginaStatus-Diagnostic test (Instiüt für Mikroökologie, Herborn, Germany) and further rated by the investigator using a 5-point Liker scale (from 5: normal to 1: very severe deterioration in which all evaluated species were altered), and vaginal health using the Vaginal Health Index.
  
  
  
  In 21 women, a positive effect to improve epithelization of the cervical mucosa, with a mean score of 4.42 at the final visit as compared to 3.09 at baseline (P < 0.0001) (43% improvement). In 10 women, there was a trend of improving of vaginal microbiota status, with a mean score of 4.0 at the final visit vs. 3.3 at baseline (P = NS) (21.2% improvement). In 11 women, the Vaginal Health Index increased from 19.0 at baseline to 22.3 at the final visit (P = 0.007). The concentration of Lactobacillus spp. increased 54.5% of women and pH decreased from 4.32 to 4.09.
  
  
  
  These encouraging preliminary results provide the basis for designing a randomized controlled study, and for potential use in human papilloma virus infection.
  
  
  
  ISRCTN77955077 . Registration date: February 15, 2017. Retrospectively registered.
authors.affiliation: Gynecology and Obstetrics Department, Instituto Palacios de Medicina y Salud de la Mujer, C/Antonio Acuña 9, E-28009, Madrid, Spain. spalacios@institutopalacios.com.
authors.forename: Santiago
authors.identifier: 0000-0003-2229-1200
authors.initials: S
authors.lastname: Palacios
authors.affiliation: Gynecology and Obstetrics Department, Clínica Sagrada Familia, Barcelona, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Losa
authors.affiliation: Gynecology and Obstetrics Department, SOMDEX-Clínica Tres Torres, Women´s Health Institute, Barcelona, Spain.
authors.forename: Damián
authors.initials: D
authors.lastname: Dexeus
authors.affiliation: Senior Consultant on Gynecologic Oncology. Former President of the Spanish Association of Colposcopy and Cervical Pathology, Palma de Mallorca, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Cortés
mesh_terms: D000328:Adult; D002582:Cervix Mucus / Q000382:microbiology; D003127:Colposcopy / Q000379:methods; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D007778:Lactobacillus / Q000254:growth & development; D064307:Microbiota / Q000187:drug effects; D010865:Pilot Projects; D011446:Prospective Studies; D013030:Spain; D014621:Vagina / Q000382:microbiology*; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use
chemical_list: D014622:Vaginal Creams, Foams, and Jellies
keywords: Cervical epithelization; Coriolus versicolor; Niosomes; Vaginal gel; Vaginal health; Vaginal microbiota