Clinical effects of 17 beta-estradiol and norethisterone acetate in postmenopausal Thai women

Abstract

Objective: To compare the climacteric symptoms, the bleeding patterns, side effects, endometrial thickness, serum follicular stimulating hormone (FSH) and estradiol level in postmenopause Thai women who received this drug and placebo.

Study design: Double blind, randomized placebo controlled trial.

Material and method: Sixty postmenopausal women attending the menopause clinic at Chulalongkorn Hospital from July, 1996 to December, 1996, were enrolled in the study. The patients were randomized to receive the placebo or drug (17 beta-estradiol 2 mg and norethisterone acetate 1 mg) continuously. After 12 months, 13 patients in the drug group were switched to have placebo and 13 patients in the placebo were switched to the drug group. Recording of patient characteristics, physical and gynecologic examination, pap smear, breast examination and mammogram, climacteric symptom scores, transvaginal ultrasonography, serum FSH and Estradiol level were performed prior to the study. Physical examinations, breast palpitations, measurement of body weight and blood pressure, climacteric symptom scores and side effects were repeated at 3, 6, 12, 18 months. Gynecologic examination, pap smear, serum FSH and estradiol, transvaginal ultrasonography, were repeated at 12 months.

Results: The women in the drug group had fewer climacteric symptoms than baseline after 6 months. The incidence of amenorrhea was 74.0 per cent at 12 months. The incidence of abnormal uterine bleeding (spotting and breakthrough bleeding) was 37.0 per cent at 3 months, 29.6 per cent at 6 months, 25.9 per cent at 12 months and 7.1 per cent at 18 months. The women in the drug group had fewer climacteric symptoms than baseline after 6 months. Breast tenderness was the most common side effect. The endometrial thickness decreased significantly in the drug group. Serum FSH decreased and serum estradiol increased significantly in the drug group.

Conclusion: This combined regimen was more effective in relieving the climacteric symptoms in women who used the drug than those who used the placebo. There was a high incidence of amennorhoea after 12 months. But there was also a high frequency of abnormal bleeding in the first 3 months of treatment. Counseling on the bleeding pattern and common side effects should be conducted before starting the treatment to increase the compliance. This combined regimen proved to be a useful alternative for postmenopausal Thai women who prefer to avoid cyclic bleeding from sequential therapy.