Impact of Transdermal Estrogens Treatment on Postmenopausal Symptoms and Health-related Quality of Life: an Italian Multicentre Trial

Abstract

Summary Objective To compare efficacy, tolerability and health-related quality of li- fe (HRQoL) of two transdermal therapy systems (TDS) for hor- mone replacement therapy (HRT). Design Randomised, controlled, parallel group, open label trial. Set- ting: 12 centres in Italy. Patients and Interventions: a study po- pulation of 142 postmenopausal women was randomised on a 1:1 basis to treatment with one of two estradiol patches, FemSe- ven® (Bracco) and Systen® (Cilag). Methods After a screening period of 1 to 3 weeks, the patients were divi- ded in two groups and treated for a period of 16 weeks. FemSe- ven was administered once and Systen twice a week, both at a delivery route of 50 µg of estradiol daily. To assess the efficacy of treatment, Kupperman's Index (KI) and the difference in the number of weekly hot flushes were calculated before, after one month and at the end of treatment. To verify local tolerability, patients were asked to refer the occurrence of skin reactions. Ge- neral tolerability was measured by reporting of other menopau- sal symptoms and by recording over-all satisfaction with therapy by the end of the study. To evaluate HRQoL at baseline and af- ter treatment, two validated questionnaires, the Psychological General Well Being Index (PGWBI) and the Women Health Que- stionnaire (WHQ), were performed. Results Both treatments significantly reduced the KI score from baseline to the final visit (p = 0.001). Both formulations were well tolera- ted with no reported withdrawals due to skin reactions. The PGWBI scores improved in both groups at single item and sum- mary level. However, the effect size (ES) of the change was higher in the Femseven than in the Systen group. The WHQ scores showed marked improvements in both groups, with the exception of five items in which the ES failed to detect significant changes. Conclusions In summary, this study showed an equivalent efficacy and tole- rability of two transdermal estradiol patches and confirmed a positive impact of HRT on HRQoL in menopausal woman, sug- gesting that HRT has a beneficial effect on psychological well- being and menopausal symptoms.