Real-world effectiveness and tolerability of Zelesse cream® for treating vulvovaginitis in adult women: an observational, prospective study.

OBJECTIVE: To assess the efficacy, acceptability, and tolerability of a vaginal cream based on plant extracts for treating signs and symptoms of vulvovaginitis (VV) (Zelesse cream®), either as monotherapy (non-infectious VV) or adjuvant to antimicrobial therapy (infectious VV). METHODS: This prospective, observational, multicenter study included women who attended outpatient offices for VV. The severity of signs (vaginal discharge, erythema, and edema) and symptoms (pruritus, burning, and dysuria) was assessed before and after 15±5 days of daily treatment with Zelesse cream on a 4-point scale (18-point global score). RESULTS: The study included 58 women aged 43.0±13.2 years, including 42 who were treated with Zelesse cream only and 16 who used Zelesse cream as adjuvant to antimicrobial therapy. All participants showed significantly reduced scores and absolute prevalence of individual signs and symptoms in both groups. Similarly, the median signs/symptoms decreased by 4.0 and 8.0 points in women using Zelesse only and those using Zelesse plus antimicrobial therapy, respectively. This product was well tolerated and had high acceptability. CONCLUSIONS: Zelesse cream relieves signs and symptoms of VV, either as monotherapy in non-infectious VV or as adjuvant to antimicrobial therapy in infectious VV. Future randomized, placebo-controlled trials with larger sample sizes are warranted.

The impact of genitourinary syndrome of menopause on well-being, functioning, and quality of life in postmenopausal women.

OBJECTIVE: Symptoms of genitourinary syndrome of menopause (GSM) are bothersome to middle-aged and older women, and affect their quality of life (QoL), sexuality, and daily activities. The objective of the study was to evaluate the impact of vaginal symptoms and GSM on the well-being, functioning, and QoL of postmenopausal women from Spain. METHODS: This study involved 423 postmenopausal women participating in the GENISSE study (a multicenter, cross-sectional, descriptive, observational study) who presented at least 1 vaginal symptom. All women completed the "day-to-day impact of vaginal aging" (DIVA) questionnaire. Analysis of total scores and subdomains of the questionnaire were performed in women diagnosed with GSM and those without the condition. RESULTS: In these women, the highest mean scores on the DIVA questionnaire were found in the sexual functioning domain long version (mean 1.8; SD 1.0), followed by the sexual functioning domain short version (mean 1.7; SD 1.1), self-perception and body image (mean 1.4; SD 1.1), activities of daily living (mean 0.7; SD 0.8), and emotional well-being (mean 0.7; SD 0.8) scales. A total of 299 women (70.7%) had vaginal symptoms with a diagnosis of GSM, whereas 124 (29.3%) had no GSM diagnosis. Scores on the DIVA questionnaire were significantly higher in women with a diagnosis of GSM than in those without this condition. CONCLUSIONS: Vaginal symptoms impact the well-being, functioning, and QoL of postmenopausal women, especially sexual function, self-perception, and body image. This impact is significantly higher in women with GSM. Identifying and treating patients affected by vaginal symptoms and GSM may be beneficial for improving their QoL.

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen®) in the Clinical Management of Acute Viral Diarrhea in Children.

This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001). The duration of diarrhea (median and interquartile range) was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377). The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children.