Efficacy and safety of oral administration of a product based on hydroxytyrosol as preventive therapy for recurrent vulvo-vaginal candidosis: a prospective observational pilot study.

OBJECTIVE: The aim of the study is to evaluate the efficacy and safety of hydroxytyrosol for the prevention of the vulvar vaginal candida infections recurrence. PATIENTS AND METHODS: This study is a prospective observational pilot study. Eligible subjects were at least 18 years old, with at least 4 documented episodes of vulvovaginal candidiasis in the last 12 months. Patients were instructed to therapy (2 tabs daily for the first month and then 1 tab daily for 2 other months). Each capsule consists of hydroxytyrosol (HT) and other components: tea tree oil, tabebuia, juglans regia, and copper. Clinical and microbiological assessments took place at baseline and 12 weeks after. The impact on Quality of Life (QoL) was evaluated with the SF-36 and the Patient Global Impression of Improvement (PGI-I) after 3 months of treatment was calculated. RESULTS: Sixty patients were enrolled in the study. In the last 1 year the mean number of previous infections was 5.83 ± 2.76. Forty-nine patients (83%) did not have candida episodes during 3 months of treatment. A significant reduction in clinical symptoms, vaginal signs, such as pruritus, burning and vulvar erythema (< 0.0001). The SF-36 showed a significant change (55.67±8.43 vs. 84.56±11.56, p < 0.0001) and the total success at PGI-I was reported in 54 patients (90%). CONCLUSIONS: The HT-based product is effective and safe in preventing recurrent candida episodes and improves the quality of life and sexual function of treated women.

A medical device containing purified bovine colostrum (Monurelle Biogel) in the treatment of vulvovaginal atrophy in postmenopausal women: Retrospective analysis of urinary symptoms, sexual function, and quality of life.

OBJECTIVE: This study assessed the effectiveness and safety of a medical device containing purified bovine colostrum (Monurelle Biogel; Zambon, Bresso, Italy) in improving vulvovaginal atrophy (VVA), sexual function, urinary symptoms, and quality of life (QoL) in postmenopausal women. METHODS: In all, 172 postmenopausal women with VVA were included in the study. All women were treated with vaginal Monurelle Biogel daily for 12 weeks. Patients underwent clinical examinations, completed a 3-day voiding diary, and had VVA graded using the Vaginal Health Index (VHI) at baseline and 12 weeks. Patients also completed the Female Sexual Function Index (FSFI), overactive bladder questionnaire (OAB-Q), and the Urogenital Distress Inventory (UDI-6), among others. RESULTS: After 12 weeks, there were significant increases in mean (± SD) VHI (12.53 ± 3.67 vs. 19.31 ± 3.49; P < .0001), the number of patients engaging in regular sexual activity 102 (59.3%) vs. 144 (83.7%), and in the total FSFI score (21.64 ± 2.99 vs. 28.16 ± 1.93; P < .0001) compared with baseline. In addition, there were significant reductions in the mean number of 24-hour voids (9.57 ± 2.12 vs. 7.13 ± 1.22; P < .0001), urgent micturition episodes per 24 hours (1.75 ± 0.76 vs. 1.14 ± 0.87; P = .001), nocturia episodes (1.58 ± 0.85 vs. 0.97 ± 1.18; P = .0002), and urinary incontinence episodes per 24 hours (0.74 ± 0.59 vs. 0.28 ± 0.52; P = .003). Finally, after 12 weeks treatment, there were significant differences in UDI-6 (7.85 ± 0.81 vs. 5.56 ± 1.40), OAB-Q symptom (53.60 ± 12.57 vs. 22.08 ± 9.63), and OAB-Q health-related QoL (21.75 ± 8.51 vs. 69.34 ± 14.59) scores compared with baseline (P < .0001 for all). The Patient Impression of Global Improvement scale revealed global improvement in 143 women (83.14%). CONCLUSIONS: Monurelle Biogel is an effective treatment for VVA in postmenopausal women, improving sexual life, urinary symptoms, and QoL.