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Clinical manifestations in menopause with modifications to hormone replacement therapy. Multicentre clinical trial comparing mixed hormones (conjugated estrogens plus medroxyprogesterone vs. estradiol valerate plus cyproterone acetate)

Abstract:

BACKGROUND: Women in the menopause present multiple signs and symptoms as a consequence of estrogen deficiency. There are several drug treatments and different recommended dosages for hormone-replacement therapy (HRT). We evaluated the efficacy of two different hormonal regimens with estrogen and progestogen in perimenopausal women. METHODS: An open, multicentric, randomized clinical study was designed to compare two different combined hormonal preparations (conjugated estrogens 0,625 mg daily for 21 days plus medroxyprogesterone acetate 5 mg from days 11 through 21 - group A, and estradiol valerate 2 mg daily for 21 days plus cyproterone acetate 1 mg from days 11 through 21, group B). 104 healthy climacteric women with flashes, nocturnal sweats and other symptoms due to estrogen deficiency were recruited between april 1993 and december 1995. We report on 87 women see for a period of one year with follow-up visits after recruitment and one, three, six, nine and twelve months of HRT. Statistical analysis was performed to ascertain differences in proportions between groups and for changes during treatment time. We used ANOVA and chi-square or Fisher's test, with a level of significance p < 0,05. All analyses were done using 6.01 (CDC, 1994). RESULTS: After one year of hormone-replacement therapy with combined estrogen and progestogen, both preparations reduced the prevalence of hot flashes (group A = 75.5%, p < 0.0001, group B = 83.3%, p < 0,00001); the response to HRT was most pronounced during the first three months of treatment. The frequency of hot flashes was also significantly reduced by both regimens (p < 0.00001), in particular for those reported as severe (more than 5 episodes per day), which almost disappeared after three months of therapy. Episodes of night sweats were significantly reduced in both groups, and also specially those perceived by women as severe. Important relief of symptoms like insomnia, sleep disturbances, depressive mood, palpitations and dyspareunia was also recorded. There were no changes in body mass index and no thromboembolic disorders ocurred. The most common side effects in both groups were breast tenderness, nausea, edema and headache, ocurring most commonly at the beginning of HRT. CONCLUSIONS: In perimenopausal women, HRT with two different combined estrogen and progestogen preparations was well tolerated and showed equal efficacy for the relief of the most common climacteric symptoms.