Genistein aglycone: A new therapeutic approach to reduce endometrial hyperplasia

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• 作者：Aless ; ra Bitto ; Roberta Granese ; Onofrio Triolo ; Daniela Villari ; Daniele Maisano ; Domenico Giordano ; Domenica Altavilla ; Herbert Marini ; Elena Bianca Adamo ; Piero Antonio Nicotina ; Rosario D’ ; A
• 关键词：Genistein aglycone ; Endometrial hyperplasia ; Estrogen receptor beta-1 ; Hysteroscopy
• 刊名：Phytomedicine
• 出版年：2010
• 出版时间：September 2010
• 年：2010
• 卷：17
• 期：11
• 页码：844-850
• 全文大小：617 K

文摘

Objective

Endometrial hyperplasia without cytological atypia is commonly treated with progestins, but other treatment regimes may be available with equivalent efficacy and low side effects.

Design

A randomized double-blind, placebo and progesterone-controlled clinical trial to evaluate the effects of genistein aglycone in reducing endometrial hyperplasia.

Patients

A group of 56 premenopausal women with non-atypical endometrial hyperplasia were enrolled and received: genistein aglycone (n = 19; 54 mg/day); norethisterone acetate (n = 19; 10 mg/day on days 16–25 of the menstrual cycle) or placebo (n = 18) for 6 months.

Measurements

Hysteroscopy was performed with biopsies and symptomology assessed at baseline, 3 and 6 months of administration. The effect on estrogen (ER) and progesterone receptors (PR) expression in uterine biopsies were assessed after 3 and 6 months. For each treatment follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), sex hormone-binding globulin (SHBG) and progesterone (PG) levels were also evaluated.

Results

After 6 months, 42 % of genistein aglycone-administered subjects had a significant improvement of symptoms (histologically confirmed in the 29 % ) compared to 47 % of norethisterone acetate subjects (histologically confirmed in the 31 % ), but only 12 % in the placebo group with 19 % exhibiting worsening symptoms and increased endometrial thickness. No significant differences were noted for hormone levels for any treatment, but immunohistochemical analysis revealed significantly reduced staining for ER-α and PR and enhanced ER-β1 staining in genistein-administered subjects associated with a complete regression of bleeding.

Conclusions

These results suggest that genistein aglycone might be useful for the management of endometrial hyperplasia without atypia in women that cannot be treated with progestin.