Objective: The aim of this study was to summarize the evidence of endometrial safety and quality of life assessment in postmenopausal women taking raloxifene (RLX) + estrogens (E).
Methods: Clinical studies reporting RLX + E were identified using Medline and LILACS and through reviewing reference lists of highly significant publications. Articles published in Portuguese, Spanish, and English from the past 10 years were considered.
Results: Six corresponding clinical trials were identified. Different estrogen formulations, doses, and routes were used. The primary outcome of the selected studies also differed. Most of the studies found a benefit profile on RLX + E on women’s quality of life, satisfaction with the treatment, and vaginal dryness. Some studies showed an increased endometrial thickness after 3 months of treatment. Most biopsies revealed benign endometrial proliferation; only two women experienced endometrial hyperplasia, both of them after 24 weeks of treatment.
Conclusions: There are only a few clinical trials that evaluated endometrial safety and quality of life with RLX + E in postmenopausal women. The benefits shown on quality of life and endometrial safety are not certified. Larger studies are deemed necessary to define the better estrogen form and to evaluate the safety and efficacy of long-term use of RLX + E.
This semisystematic review article summarizes the available clinical trials on women on raloxifene plus estrogen.
From the Gynecology Department, Faculdade de Medicina da Universidade Federal de São Paulo, São Paulo, Brazil.
Received September 10, 2011; revised and accepted November 1, 2011.
Financial disclosure/conflicts of interest: None reported.
Address correspondence to: Andrea Lucia Bastos Carneiro, MD, PhD, Gynecology Department, Faculdade de Medicina da Universidade Federal de São Paulo, São Paulo, SP, Brazil. E-mail: firstname.lastname@example.org