Efficacy and safety of vaginal formulations with tyndallized ferments in subjects with nonspecific vulvovaginitis: A randomized study in Italy.

Aim: In this study, we tested the efficacy, safety, and tolerability of vaginal ovules and a vaginal douche containing tyndallized ferments in women affected by nonspecific vulvovaginitis, with or without the human papillomavirus (HPV). Methods: The study included 91 female patients and had a random...

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Publicado en:Journal of Obstetrics & Gynaecology Research Vol. 50; no. 4; pp. 647 - 655
Autores principales: Forleo, Francesco, Pelosi, Fanny Mara, Bianco, Luigina, Petrella, Vincenzo
Formato: research tables/charts randomized controlled trial Journal Article
Publicado: Wiley-Blackwell Apr2024
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Apr2024
      vid: 50
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1111/jog.15878
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        atl: Efficacy and safety of vaginal formulations with tyndallized ferments in subjects with nonspecific vulvovaginitis: A randomized study in Italy.
      aug:
        au:
          Forleo, Francesco
          Pelosi, Fanny Mara
          Bianco, Luigina
          Petrella, Vincenzo
        affil: Department of Gynecology, Ospedale del Mare, Napoli Naples,, Italy
      sug:
        subj:
          Chemistry, Pharmaceutical
          Vulvovaginitis Drug Therapy
          Human
          Randomized Controlled Trials
          Random Assignment
          Female
          Italy
          Therapeutic Irrigation
          Vulvar Diseases
          Pruritus
          Edema
          Female
      ab: Aim: In this study, we tested the efficacy, safety, and tolerability of vaginal ovules and a vaginal douche containing tyndallized ferments in women affected by nonspecific vulvovaginitis, with or without the human papillomavirus (HPV). Methods: The study included 91 female patients and had a randomized, controlled sequential design, with parallel groups. Ovules and douche were tested and compared to a control group treated with sterile physiological solution. Total symptom score (TSS), individual signs and symptoms, therapeutic success were evaluated, as well as safety and tolerability. Results: The tyndallized ferments formulations (ovules and douche) had a safe and tolerable profile, and resulted in a significant decrease in TSS in patients affected by nonspecific vulvovaginitis, both at 5 and 10 days of treatment, when compared to a control group. The treatment was more effective than the control in reducing symptoms such as vulvar erythema, vulvar edema, itching, and burning. Patients affected by vulvovaginitis and HPV‐positive received a 30 days treatment either with ovules or ovules + douche, and we observed an improvement at Day 30 compared to Day 0, for both regimens. Conclusions: Our study suggests that topical treatment with tyndallized ferments is a safe and effective strategy to reduce symptoms of nonspecific vulvovaginitis.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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