Efeitos de um esquema combinado-contínuo de terapia hormonal de baixa dose (estradiol e acetato de noretisterona) e da tibolona sobre a qualidade de vida de mulheres sintomáticas, na pós-menopausa: estudo duplo-cego, randomizado

Abstract

As a consequence of the hypoestrogenism that sets in during the perimenopause, there appear vasomotor symptoms, vaginal atrophy, sexual dysfunction, urinary symptoms, as well as increased risk of cardiovascular disease and osteoporosis. These signs and symptoms can interfere in the quality of life of climacteric women. The interest in studying quality of life has increased in several fields of human activity, since it is essential that an increase in life expectancy be accompanied by better quality of life. This should be evaluated with regard to the physical, social, psychological and spiritual domains. Several factors are related to the quality of life of climacteric women, such as education, marital status, paid work, family income, morbidities, marital, family, social and sexual difficulties, as well as lifestyle. The symptoms that arise at this stage, resulting from hypoestrogenism, are capable of worsening the quality of life of these women. To improve these symptoms, the use of hormonal therapy (HT) either with estrogen or another drug, such as tibolone, has been recommended. The issue of quality of life, despite its importance nowadays, is unfortunately still not widely studied in Brazil. Most studies have been carried out in other countries, and it is not possible to apply their results to the situation in Brazil, because of cultural and socio-economic differences. The importance of HT in the improvement of menopausal symptoms is indisputable; however the results of studies showing the impact of therapy on the quality of life of postmenopausal women are still conflicting. Apart from that, these studies use different estrogens and progestins, different schemes, doses of drugs and ways of administering them, with different results. Due to the importance of the topic, the purpose of this study is to compare the effects of a combined, continuous, low-dose hormone terapy (LD-HT) with the effects of tibolone and with the control group as regards to the quality of life for symptomatic postmenopause women. One hundred seventy-four women were selected and randomized into three groups: group 1 was treated with 2.5 mg / day of tibolone, group 2 with 50 mg calcium carbonate / 200 IU vitamin D3 / day (control) and group 3 with 1 mg oestradiol / 0.5 mg of norethindrone acetate / day (LD-HT). One hundred and thirty women completed the study. No significant difference in the time of menopause and quality of life before initiation of treatment was found among the three groups. The Women's Health Questionnaire (WHQ) was applied to the three groups before the use of medication and after 4, 8 and 12 weeks of treatment. Evaluation of quality of life by domains, over time, showed an improvement in the eight domains studied, in all three groups, at the end of treatment. The LD-HT was higher than the tibolone and calcium supplement / vitamin D3 as regards to the vasomotor symptoms. Tibolone, compared to the E2/NETA scheme and supplementary Ca / vitamin D3 group had a better response to issues related to the sexual function. Conclusions: There was improved quality of life in the three study groups. Tibolone was effective in improving the quality of life of patients, acting mainly on issues related to the sexual function and was better than LD-HT in this domain. The estrogen-progesterone combination was also effective in improving quality of life in the post-menopause, showing a better response in vasomotor symptoms.