Efficacy and safety of ultra-low dose 0.005% estriol vaginal gel for the treatment of vulvovaginal atrophy in postmenopausal women with early breast cancer treated with nonsteroidal aromatase inhibitors: a phase II, randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To assess the efficacy and safety of ultra-low dose 0.005% estriol vaginal gel in women with breast cancer receiving nonsteroidal aromatase inhibitors (NSAIs) and experiencing treatment-related vulvovaginal symptoms and signs. METHODS: Women with hormone receptor-positive early breast cancer receiving NSAIs were randomized to either estriol vaginal gel or placebo for 12 weeks. Vaginal maturation, vaginal pH, and total and individual scores of symptoms and signs of vulvovaginal atrophy were assessed at baseline and at weeks 3 and 12; sexual functioning was also evaluated using the Female Sexual Functioning Index (FSFI) questionnaire, as well as circulating estrogens, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). RESULTS: Sixty-one women with a mean age of 59 years were included: 50 received 0.005% estriol vaginal gel and 11 received placebo. Active treatment significantly improved maturation value and pH, vaginal dryness and global scores of symptoms and signs. Active treatment also increased the total FSFI score and all the FSFI domains, with the exception of pain. Small oscillations were observed in FSH and LH, which remained within the postmenopausal range. Estriol levels increased initially and normalized by week 12, and estradiol and estrone remained mostly undetectable throughout the study. CONCLUSIONS: Ultra-low dose 0.005% estriol vaginal gel showed efficacy in improving the symptoms and signs of vulvovaginal atrophy. These results, together with minimal oscillations in hormonal levels throughout the treatment, support the use of ultra-low dose 0.005% estriol vaginal gel as a treatment option for vulvovaginal atrophy in women with breast cancer receiving NSAIs with an indication for treatment with vaginal estrogens. : Video Summary:http://links.lww.com/MENO/A531.

Video Summary:http://links.lww.com/MENO/A531.

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.