Effect of raloxifene and low-dose percutaneous 17beta-estradiol on menopause symptoms and endometrium--a randomized controlled trial.

OBJECTIVE

To investigate the effects on climacteric symptoms and endometrium of percutaneous low-dose 17beta-estradiol associated with raloxifene in postmenopausal women.

DESIGN

randomized placebo-controlled study.

METHOD

Fifty-two postmenopausal women with moderate to severe hot flushes were randomized to receive either 60 mg raloxifene (RLX; n=20), 0.5 mg percutaneous 17beta-estradiol associated to 60 mg raloxifene (RLX+E2; n=16) or placebo (PLC; n=16). Climacteric symptoms (Kupperman index) and vaginal bleeding were evaluated. At baseline and at the end of the study endometrial thickness was measured and endometrial samples were collected for histological study.

RESULTS

At baseline, the mean Kupperman index was 23.7+/-1.8 in RLX group, 22.9+/-1.9 in RLX+E2 group and 22.6+/-1.9 in the placebo group (NS). After 3 months, there was a significant reduction in Kupperman index mean values in both groups, but no statistical difference was observed between groups. However, RLX+E2 and placebo were significantly superior to RLX in reducing hot flush severity (p<0.05). Endometrial thickness did not change in both groups. The association of percutaneous low-dose 17beta-estradiol to raloxifene was not associated with proliferation of endometrium neither in hysteroscopies nor in endometrial biopsies at the third month of treatment. No vaginal bleeding was reported during the study.

CONCLUSIONS

The association of percutaneous low dose of 17beta-estradiol with raloxifene exerted favorable effects on hot flushes severity of postmenopausal women, providing a safe profile in endometrium at least in short-term therapy.