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

Autor: Forleo F; Department of Gynecology, Ospedale del Mare, Napoli, Naples, Italy., Pelosi FM; Department of Gynecology, Ospedale G. Moscati, Aversa, Caserta, Italy., Bianco L; Department of Gynecology, Ospedale G. Moscati, Aversa, Caserta, Italy., Petrella V; Department of Clinical Pathology, ASL Caserta-Ospedale G. Moscati, Aversa, Caserta, Italy.
Jazyk: angličtina
Zdroj: The journal of obstetrics and gynaecology research [J Obstet Gynaecol Res] 2024 Apr; Vol. 50 (4), pp. 647-654. Date of Electronic Publication: 2024 Jan 28.
DOI: 10.1111/jog.15878
Abstrakt: 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.
(© 2024 Japan Society of Obstetrics and Gynecology.)
Databáze: MEDLINE
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