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Fertil Steril. 2004 Jul;82(1):145-8, quiz 265.

Endometrial effects of long-term treatment with phytoestrogens: a randomized, double-blind, placebo-controlled study.

Author information

  • 1AGUNCO, Obstetrics and Gynecology Centre, Rome, Italy. vittorio.unfer@lycos.com

Abstract

OBJECTIVE:

To determine the effects of 5 years of treatment with soy phytoestrogens on histological characteristics of endometrium in postmenopausal women.

DESIGN:

Randomized, double-blind, placebo-controlled study.

SETTING:

Centre of Perinatal and Reproductive Medicine, Department of Gynecological, Obstetrical, and Pediatric Sciences, University of Perugia, Italy.

PATIENT(S):

Three hundred seventy-six postmenopausal healthy women, all with intact uterus.

INTERVENTION(S):

Women were distributed in two different groups using randomized criteria: group A (n = 179) patients received soy tablets (150 mg of isoflavones per day) for 5 years; group B (n = 197) patients received identical appearing placebo tablets for 5 years.

MAIN OUTCOME MEASURE(S):

Results of endometrial histology from biopsies obtained at baseline, 30 months, and 5 years after the beginning of the treatment.

RESULT(S):

Two hundred ninety-eight women completed the 5-year treatment. No cases of malignancy were detected during biopsy. Seventy percent of women undergoing treatment with soy phytoestrogens had an endometrium classified as atrophic or nonassessable versus 81% receiving placebo. The occurrence of endometrial hyperplasia was significantly higher in group A (3.37% vs. 0%).

CONCLUSION(S):

Long-term treatment (up to 5 years) with soy phytoestrogens was associated with an increased occurrence of endometrial hyperplasia. These findings call into question the long-term safety of phytoestrogens with regard to the endometrium.

Comment in

PMID:
15237003
[PubMed - indexed for MEDLINE]
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