Background: When genital atrophy exists, systemic hormone therapy (HT) has a timing until to induce vaginal proliferation and symptomatic relieve. Thus, in order to obtain a prompt improvement, the association of local therapy acting on the genital epithelium to the systemic treatment should be considered.
Objective: To evaluate the effects of a combined therapy consisting of vaginal estriol with transdermal 17-beta-estradiol (50 microg/day) plus medroxyprogesterone acetate (5 mg/day) per os in shortening the period of uro-genital symptoms.
Subjects and methods: In a randomized, double blind, controlled with placebo study, 27 women with climacteric symptoms and atrophic vaginitis were treated for 4 months with HT plus vaginal estriol 0.5 mg/day (group E) or placebo (group P). Patients use the local medication daily for the first 3 weeks and twice-weekly thereafter. Before entering in the study, patients were asked about HT and selected for inclusion. In the first visit, electible patients after written informed consent were randomized to receive HT plus local estriol or placebo. All the subjects had baseline studies, including medical history, physical examination, blood and urine analysis. In order to evaluate the effect of local treatment on urinary and genital symptoms, a score for genital, urinary and colposcopic complaints (0 minimum-100 maximum) was developed. This score and Blatt-Kuperman were recorded and performed in every control.
Results: There were no differences on climacteric symptoms relief between the two groups. Additionally, the improvement in urinary symptoms at the end of the study was similar for both groups (from 16.5 +/- 6.1 to 8.5 +/- 2.4 for E group and from 15.8 +/- 7.8 to 8.8 +/- 2.7 for P group; P < 0.01 versus basal); however, those women in group E reached significant improvement on urinary complaints since the first month of treatment. Additionally, a significant difference between E and P was observed at months 2 and 3, although no differences were detected at the end of the study. Papanicolaou smear showed reactive or reparative changes and karyopyknotic index exhibited a significant increase in superficial cells in both groups and at the end of the study.
Conclusions: Adding vaginal estriol to HRT may shorten the latency period for urinary symptoms.