Objective: To compare the effects of five different hormone replacement regimens on fibrocystic mastopathy in postmenopausal women.
Design: This was a randomized, prospective, clinical, case-control study.
Methods: Two hundred and twelve women with benign cystic mastopathy were studied. The largest diameters of the breast cysts were measured using ultrasonography at study entry. Forty-eight women were randomized to the control group and did not take any medication. One hundred and sixty-four women were randomized to the following study groups. Group I (n = 46) were given conjugated estrogen (0.625 mg/day) and medroxyprogesterone acetate (5 mg/day) continuously. Group II (n = 22) were given only conjugated estrogens (0.625 mg/day) continuously; these were hysterectomized women. Group III (n = 32) were given transdermal estrogen (50 microg/day) and medroxyprogesterone acetate (5 mg/day) continuously. Group IV (n = 32) were given only transdermal estrogen (50 microg/day) continuously; these were also hysterectomized women. Group V (n = 32) were given tibolone (2.5 mg/day) continuously. Hormone therapy was continued for 12 months. Every 3 months the women were rescanned using ultrasonography to determine cyst diameters and examine characteristics such as internal echogenicity, and thickness and regularity of the cyst wall. Statistical assessment used Students' t test and Friedman analysis.
Results: In the control group, there was no statistically significant change in cyst dimensions. However, tibolone was associated with a decrease in cyst dimensions which was statistically significant, but none of the other four hormone replacement therapy regimens caused any significant negative effect on the benign cystic mastopathy.