Genistein aglycone: a new therapeutic approach to reduce endometrial hyperplasia.
Author(s): Bitto A, Granese R, Triolo O, Villari D, Maisano D, Giordano D, Altavilla D,
Marini H, Adamo EB, Nicotina PA, D'Anna R, Squadrito F.
Affiliation(s): Department of Clinical and Experimental Medicine and Pharmacology, c/o AOU
Policlinico G. Martino, Gazzi, Messina, Italy.
Publication date & source: 2010, Phytomedicine. , 17(11):844-50
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-alpha and PR and enhanced ER-beta1
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.
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