Randomized clinical trial comparing conjugated equine estrogens and isoflavones in postmenopausal women: a pilot study.
OBJECTIVE
The aim of this study was to evaluate the effects of isoflavone on the climacteric symptoms (Kupperman Menopausal index), vaginal pH, vaginal cytology (vaginal maturation index) and endometrium (evaluated by ultrasound and biopsy) in postmenopausal women.


METHODS
It was a single-center, 6-month, randomized, double-blind, estrogen-controlled trial. Seventy-nine women were randomly assigned to one of the two treatment groups: isoflavone (n=40): 300 mg of the standardized soy extract with a medium dose of 120 mg isoflavones/day as glycoside and aglycone (60 mg twice a day), or estrogen (n=39): one capsule of 0.625 mg conjugated equine estrogens and other capsule with glucose 0.625 mg (placebo).


RESULTS
After treatment, there was a decrease in the symptomatology in both estrogen and isoflavone groups. There was a significant decrease in vaginal pH, an increase in superficial vaginal cells and endometrium proliferation after 3 and 6 months of treatment in the estrogen group, but no differences were observed in the isoflavone group for these variables.


CONCLUSIONS
We concluded that the daily standardized soy extract with 120 mg isoflavones' effect on symptoms was similar to that from estrogen. Soy isoflavone has no effect on endometrium and vaginal mucosa during the treatment.
Kaari
Cristina
C
Department of Gynecology, Federal University of São Paulo, Escola Paulista de Medicina, Rua Monte Aprazível 327 Apto 72 Vila Nova Conceição, 04513-031 São Paulo, Brazil. criskaari@uol.com.br
Haidar
Mauro Abi
MA
Júnior
José Maria Soares
JM
Nunes
Márcia Gaspar
MG
Quadros
Luis Gerk de Azevedo
LG
Kemp
Cláudio
C
Stavale
João Noberto
JN
Baracat
Edmund C
EC
D000704:Analysis of Variance; D002979:Climacteric / Q000187:drug effects*; D004311:Double-Blind Method; D004717:Endometrium / Q000187:drug effects; D004967:Estrogens / Q000008:administration & dosage / Q000494:pharmacology*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage / Q000494:pharmacology*; D008875:Middle Aged; D010865:Pilot Projects; D017698:Postmenopause / Q000187:drug effects*; D016896:Treatment Outcome; D014621:Vagina / Q000187:drug effects
D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D007529:Isoflavones