Effects of Raloxifene Combined with Low-dose Conjugated Estrogen on the Endometrium in Menopausal Women at High Risk for Breast Cancer.

OBJECTIVES: To compare the effects of low-dose conjugated estrogen (CE), raloxifene, and the combination thereof on the endometrium of postmenopausal women. METHODS: Postmenopausal women between 45 and 60 years of age, with Gail score≥1.67 and no endometrial disorders, were randomly assigned to receive low-dose CE (0.3 mg), raloxifene (60 mg), or combined therapy for 1 year. Transvaginal ultrasound was performed at baseline and every 3 months; the Kupperman Index was assessed at baseline and every 6 months. Endometrial biopsies were performed if endometrial thickness (ET) was ≥5 mm or if vaginal bleeding occurred. The primary outcome was the occurrence of ET≥5 mm over the one-year period. RESULTS: Seventy-three women were randomly assigned and analyzed on an intent-to-treat basis. Eight, three, and four women in the CE, raloxifene, and combination groups, respectively, exhibited ET≥5 mm. No genital bleeding was reported in the combination group. Endometrial biopsy revealed atrophy or polyps in all groups, with one patient in the CE group exhibiting a proliferative endometrium without atypia. At 6 months, there was a progressive increase in mean ET in the CE group, but not in the other two groups, with statistically significant differences at 6, 9, and 12 months. Mean scores for vasomotor symptoms and Kupperman Index favored the CE and combination groups over raloxifene. CONCLUSION: Combined raloxifene and low-dose CE decreased the severity of menopausal symptoms to a similar extent as CE alone and had similar effects as raloxifene alone on the endometrium.

Effects of raloxifene combined with low-dose conjugated estrogen on the endometrium in menopausal women at high risk for breast cancer

OBJECTIVES: To compare the effects of low-dose conjugated estrogen (CE), raloxifene, and the combination thereof on the endometrium of postmenopausal women. METHODS: Postmenopausal women between 45 and 60 years of age, with Gail score≥1.67 and no endometrial disorders, were randomly assigned to receive low-dose CE (0.3 mg), raloxifene (60 mg), or combined therapy for 1 year. Transvaginal ultrasound was performed at baseline and every 3 months; the Kupperman Index was assessed at baseline and every 6 months. Endometrial biopsies were performed if endometrial thickness (ET) was ≥5 mm or if vaginal bleeding occurred. The primary outcome was the occurrence of ET≥5 mm over the one-year period. RESULTS: Seventy-three women were randomly assigned and analyzed on an intent-to-treat basis. Eight, three, and four women in the CE, raloxifene, and combination groups, respectively, exhibited ET≥5 mm. No genital bleeding was reported in the combination group. Endometrial biopsy revealed atrophy or polyps in all groups, with one patient in the CE group exhibiting a proliferative endometrium without atypia. At 6 months, there was a progressive increase in mean ET in the CE group, but not in the other two groups, with statistically significant differences at 6, 9, and 12 months. Mean scores for vasomotor symptoms and Kupperman Index favored the CE and combination groups over raloxifene. CONCLUSION: Combined raloxifene and low-dose CE decreased the severity of menopausal symptoms to a similar extent as CE alone and had similar effects as raloxifene alone on the endometrium.

Estrogens plus raloxifene on endometrial safety and menopausal symptoms--semisystematic review.

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.

Efetividade do dispositivo intrauterino liberador de levonorgestrel (Mirena®) para a terapia de reposição hormonal na perimenopausa e pós-menopausa. / The effectiveness of the levonorgestrel-releasing intrauterine system (Mirena®) for hormone replacement therapy in the peri- and postmenopausal women

A utilização do dispositivo intrauterino (DIU) hormonal para a contracepção é uma constante no consultório de ginecologia da atualidade. Entretanto, outras indicações como o tratamento de algumas patologias ginecológicas benignas, e mais recentemente, o uso para terapia de reposição hormonal (TRH) no climatério têm chamado a atenção. Esta revisão tem como objetivo demonstrar os achados dos artigos publicados, desde 2001, sobre a avaliação do DIU de levonorgestrel (LNG) durante esta fase de turbulência hormonal feminina. No período do climatério, a mulher com útero intacto ganha vários benefícios com essa nova modalidade terapêutica associada ao estrogênio nas suas diversas formas de apresentação. Pode-se concluir que o DIU com LNG na mulher da perimenopausa e pós-menopausa pode ser utilizado para contracepção, alívio de sintomas vasomotores quando associado à terapia com estrogênio e alta resolutividade nos quadros de menorragia que frequentemente acometem a mulher durante esta fase da vida

There is a wide use of the levonorgestrel-releasing intrauterine system (LNG IUS) in recent years for hormonal contraception. However, other indications, as the treatment of some benign gynecological diseases and, more recently, for hormone replacement therapy in peri and postmenopausal women have happened. This review aimed to demonstrate the findings of articles published since 2001 on the use of the LNG IUS in the women's climacteric period. During this phase of life, women with intact uterus benefit of using this new modality of therapy associated with estrogen in their several forms of presentation. It can be concluded that LNG IUS in the peri and postmenopausal women can be used as a contraceptive method, to abbreviate hot flashes symptoms when associated with estrogen therapy and to solve menorrhagia that is a very common finding in this period