OBJECTIVE:Vaginal dystrophy due to hypo-oestrogenism takes advantage of local and systemic oestrogens to balance the vaginal ecosystem and improve tissue hydration. Women who do not accept/tolerate hormone therapy can useintravaginal isoflavones to relieve vaginal dryness. The aim of this study was to investigate the clinical effect of a vaginal gel formulation containing isoflavones compared with no topical treatment in women with vaginal dystrophy. MATERIAL AND METHODS: In a multicentre, controlled, parallel-group study, menopausal women with vaginal dystrophy were randomized to vaginal gel (EG) or no topical treatment (NT) for 4 weeks. EG contained isoflavones, Lactobacillus sporogenes, Calendula officinalis extract and lactic acid (Estromineral Gel, Rottapharm-Madaus). All patients received daily oral isoflavones plus L. sporogenes. Clinical evaluations were performed at time 0, 2 and 4 weeks. RESULTS:186 women were recruited, 103 in the EG group and 83 in the NT group, mean age 53.7 years, postmenopausal for 4.1 years. The severity of itching, burning, vulvovaginal erythema, vaginal dryness and dyspareunia were significantly reduced during EG treatment compared with the NT group. CONCLUSIONS: The combination of oral and topical isoflavones was shown to be more effective than oral treatment alone in reducing the problems of postmenopausal vaginal dystrophy.
RCT Entities:
OBJECTIVE:Vaginal dystrophy due to hypo-oestrogenism takes advantage of local and systemic oestrogens to balance the vaginal ecosystem and improve tissue hydration. Women who do not accept/tolerate hormone therapy can use intravaginal isoflavones to relieve vaginal dryness. The aim of this study was to investigate the clinical effect of a vaginal gel formulation containing isoflavones compared with no topical treatment in women with vaginal dystrophy. MATERIAL AND METHODS: In a multicentre, controlled, parallel-group study, menopausal women with vaginal dystrophy were randomized to vaginal gel (EG) or no topical treatment (NT) for 4 weeks. EG contained isoflavones, Lactobacillus sporogenes, Calendula officinalis extract and lactic acid (Estromineral Gel, Rottapharm-Madaus). All patients received daily oral isoflavones plus L. sporogenes. Clinical evaluations were performed at time 0, 2 and 4 weeks. RESULTS: 186 women were recruited, 103 in the EG group and 83 in the NT group, mean age 53.7 years, postmenopausal for 4.1 years. The severity of itching, burning, vulvovaginal erythema, vaginal dryness and dyspareunia were significantly reduced during EG treatment compared with the NT group. CONCLUSIONS: The combination of oral and topical isoflavones was shown to be more effective than oral treatment alone in reducing the problems of postmenopausal vaginal dystrophy.