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

• Published in: The journal of obstetrics and gynaecology research 2024-04, Vol.50 (4), p.647-654
• Main Authors: Forleo, Francesco, Pelosi, Fanny Mara, Bianco, Luigina, Petrella, Vincenzo
• Format: Article
• Language: English
• Subjects: Edema; Erythema; HPV; Human papillomavirus; Ovules; Safety; tyndallized lactic ferments; Vagina; vaginal douche; vaginal ovules; vulvovaginal symptoms; Vulvovaginitis
• ISSN: 1341-8076; 1447-0756
• DOI: 10.1111/jog.15878

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.