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Indexed/Abstracted in: BIOSIS Previews, EMBASE, Scopus, Emerging Sources Citation Index
Online ISSN 1827-1812
Mollica G., Bonaccorsi G., Martinello R.
Clinica Ostetrica e Ginecologica Università di Ferrara Ospedale S. Anna, Ferrara, Italia
In this double-blind randomized controlled trial versus placebo, the treatment efficacy and tolerability of Fitostimoline vaginal cream were evaluated in 100 women presenting with vaginal inflammation and vulvar dystrophy. The study population was randomly assigned to receive either the study product or a placebo. During the 80-day study period, the regimen was three 20-day treatment cycles with one 10-day interval between each (corresponding to the menstrual cycle). Treatment efficacy as measured by changes in signs and symptoms between the two groups showed a net difference in the treatment group versus the placebo group, with a statistically significant improvement in the reduction and regression of admission symptoms (vaginal dryness, pain, burning, itching, discharge, dysuria, pelvic pain, vulvar and/or vaginal erythema and edema). In the treatment group, 5 patients were asymptomatic at the end of the first cycle (after 20 days), 24 after the second cycle, and 36 after the third cycle. In the placebo group, symptoms regressed in only 2 patients. In the treatment group, clinical signs resolved in 17 patients after the first cycle, in 36 after the second cycle, and in 39 after the third cycle. In the placebo group, clinical signs resolved in only 1 patient after the second cycle and in 4 after the third cycle. Blood chemistry tests showed that systemic tolerability of the study product was good. Final assessment of treatment efficacy was significantly better in the treatment group than the placebo group (90% vs 10%), confirming the study product’s efficacy in the treatment of vaginal inflammation and vulvar dystrophy.