Effects of hormone therapy on the endometrium in postmenopausal women : a one year randomized trial of low dose oral estradiol in association with a levonorgestrel-releasing intrauterine system or drospirenone

Abstract

Objetivos: comparar os efeitos endometriais e no padrão de sangramento uterino de tratamento com (1) sistema intrauterine com levonorgestrel (SIULNG) e estradiol (1 mg/dia, v.o.) ou (2) associação oral de drospirenona (DRSP) (2 mg/dia) e estradiol (1 mg/dia). Métodos: trinta e quatro pacientes (idade 52,53 ± 4,44 grupo SIU-LNG e 53,15 ± 4,018 grupo DRSP) foram randomizadas. A gravidade dos sintomas menopausais foi avaliado pelo índice de Kupperman a cada três meses. Ultrassom transvaginal, histeroscopia e avaliação histológica foram repetidos após 12 meses. Durante este período, as pacientes fizeram registros em calendários menstruais. Todas as variáveis categóricas foram descritas como porcentagens. Variáveis foram testadas para distribuição normal e teste t de Student para amostras independents e ANOVA para medidas repetidas foram utilizados quando apropriado. Significância estatística foi considerada para p<0.05. Resultados: leve sangramento vaginal foi relatado no primeiro mês de tratamento por 53,3% das pacientes do grupo SIU-LNG/estradiol vs. 7,7% das pacientes do grupo drospirenona/estradiol. Não houve diferença na espessura endometrial entre os grupos durante o periodo do estudo. Os achados histológicos ao final do estudo motraram endométrio atrófico em 53,3% das pacientes no grupo SIU-LNG /estradiol vs. 76,9% das pacientes no grupo drospirenona/estradiol. Conclusões: nossos resultados sugerem boa proteção endometrial com ambos os tratamentos de terapia hormonal.

Objectives: to compare the endometrial effects and uterine bleeding patterns associated with treatment using (1) levonorgestrel-releasing intrauterine system (LNG-IUS) and estradiol (1 mg/day, p.o.) or (2) orally administered drospirenone (2 mg/day) and estradiol (1 mg/day). Methods: thirty-four patients (aged 52.53 ± 4.44 in the LNG-IUS group and 53.15 ± 4.018 in the DRSP group) were randomized. The severity of menopausal symptoms was evaluated using the Kupperman index every three months. Transvaginal ultrasound, hysteroscopy and histological evaluation were repeated after 12 months. During this period, patients kept menstrual calendars. All categorical variables were described as percentages. Variables were tested for normal distribution and Student’s t test was applied for independent samples and ANOVA for repeated measures when appropriate. Data were considered to be significant when p<0.05. Results: slight vaginal bleeding was reported in the first month of treatment by 53.3% of patients from the LNG-IUS/estradiol group compared with 7.7% of patients from the drospirenone/estradiol group. There were no differences in endometrial thickness between the two groups throughout the study period. End-ofstudy histological findings showed atrophic endometrium in 53.3% of patients in the LNGIUS/ estradiol group compared with 76.9% of patients in the drospirenone/estradiol group. Conclusions: our results suggest good endometrial protection with both HT regimens.