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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Detalles Bibliográficos
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
Descripción
Sumario: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.