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GAZZETTA MEDICA ITALIANA ARCHIVIO PER LE SCIENZE MEDICHE
A Journal on Internal Medicine and Pharmacology
Indexed/Abstracted in: BIOSIS Previews, EMBASE, Scopus, Emerging Sources Citation Index
Gazzetta Medica Italiana Archivio per le Scienze Mediche 2008 June;167(3):97-103
Evaluation of efficacy and tolerability of Fitostimoline vaginal ovules (Damor Farma-ceutici) in the treatment of vaginal inflammation and vulvar dystrophy: a double-blind randomized controlled trial
Mollica G., Bonaccorsi G., Martinello R.
Istituto di Clinica Ostetrica e Ginecologica Facoltà di Medicina, Università di Ferrara Arcispedale (Azienda Ospedaliera) S. Anna, Ferrara, Italia
The study population was 100 outpatients (age range, 18-70 years) presenting with vaginal inflammation; 50 women (mean age, 53 years; range, 24-70) were randomly assigned to receive treatment with the study product (treatment group); 50 women (mean age, 46.1 years; range, 23-67) were randomly assigned to placebo treatment (placebo group). Two subjects in the treatment group dropped out of the study because of resolution of admission symptoms; four subjects in the placebo group dropped out because of lack of response to the placebo; one subject in the placebo group was lost to follow-up, another dropped out because of poor compliance. Changes in admission symptoms (vaginal dryness, pain, burning, local and regional itching, discharge, dysuria, abdominal pain, erythema and vulvar edema) were clinically evaluated at each visit and assigned a total symptom score. At the end of the study, the subjects and the investigator gave a global assessment of the product’s efficacy and tolerability. Clinical blood chemistry tests at base line and final assessment were performed to determine the product’s systemic tolerability. Resolution of signs and symptoms in the treatment group was rapid, with a clinically and statistically significant change versus base line and versus the changes observed in the placebo group. At final assessment 68% of subjects in the treatment group and 4.4% of those in the placebo group were asymptomatic. Results of tolerability tests were unremarkable in both groups. No adverse events occurred during the study.