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Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 2-year randomized, double-blind, placebo-controlled study.
Menopause. 2009 Mar-Apr; 16(2):301-6.M

Abstract

OBJECTIVE

To evaluate in a 24-month, prospective, randomized, double-blind, placebo-controlled study whether pure administration of the phytoestrogen genistein (54 mg/d) might reduce the number and severity of hot flushes in postmenopausal women, with no adverse effect on the endometrium and vagina.

METHODS

A total of 389 participants met the parent study criteria and were randomly assigned to receive the phytoestrogen genistein (n = 198) or placebo (n = 191). About 40% of participants in both groups did not experience hot flushes, and the evaluation was performed in a subgroup of 236 participants (genistein, n = 119; placebo, n = 117). Reductions from the baseline in the frequency and severity of hot flushes were the principal criteria of efficacy. Endometrial thickness was evaluated by ultrasonography. The maturation value was also used to determine hormonal action on the vaginal cells.

RESULTS

There were no significant differences in vasomotor symptoms between groups at the baseline (4.4 +/- 0.33 hot flushes per day in the genistein group and 4.2 +/- 0.35 hot flushes per day in the control group). After 12 months of genistein therapy, there was a significant reduction (-56.4%) in the mean number of hot flushes, with a significant difference compared with the control group. After 24 months, there was no further decrease in the number of hot flushes in both groups. No significant difference was found in mean endometrial thickness and the maturation value score between the two groups, either at the baseline or after 24 months.

CONCLUSIONS

The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on the endometrium and vagina, but after the first year, there was no further improvement in the decrease in hot flushes.

Authors+Show Affiliations

Department of Obstetrical and Gynaecological Sciences, Section of Pharmacology, AOU Policlinico G Martino, Messina, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19034051

Citation

D'Anna, Rosario, et al. "Effects of the Phytoestrogen Genistein On Hot Flushes, Endometrium, and Vaginal Epithelium in Postmenopausal Women: a 2-year Randomized, Double-blind, Placebo-controlled Study." Menopause (New York, N.Y.), vol. 16, no. 2, 2009, pp. 301-6.
D'Anna R, Cannata ML, Marini H, et al. Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 2-year randomized, double-blind, placebo-controlled study. Menopause. 2009;16(2):301-6.
D'Anna, R., Cannata, M. L., Marini, H., Atteritano, M., Cancellieri, F., Corrado, F., Triolo, O., Rizzo, P., Russo, S., Gaudio, A., Frisina, N., Bitto, A., Polito, F., Minutoli, L., Altavilla, D., Adamo, E. B., & Squadrito, F. (2009). Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 2-year randomized, double-blind, placebo-controlled study. Menopause (New York, N.Y.), 16(2), 301-6. https://doi.org/10.1097/gme.0b013e318186d7e2
D'Anna R, et al. Effects of the Phytoestrogen Genistein On Hot Flushes, Endometrium, and Vaginal Epithelium in Postmenopausal Women: a 2-year Randomized, Double-blind, Placebo-controlled Study. Menopause. 2009 Mar-Apr;16(2):301-6. PubMed PMID: 19034051.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of the phytoestrogen genistein on hot flushes, endometrium, and vaginal epithelium in postmenopausal women: a 2-year randomized, double-blind, placebo-controlled study. AU - D'Anna,Rosario, AU - Cannata,Maria Letizia, AU - Marini,Herbert, AU - Atteritano,Marco, AU - Cancellieri,Francesco, AU - Corrado,Francesco, AU - Triolo,Onofrio, AU - Rizzo,Piero, AU - Russo,Silvia, AU - Gaudio,Agostino, AU - Frisina,Nicola, AU - Bitto,Alessandra, AU - Polito,Francesca, AU - Minutoli,Letteria, AU - Altavilla,Domenica, AU - Adamo,Elena Bianca, AU - Squadrito,Francesco, PY - 2008/11/27/pubmed PY - 2009/10/29/medline PY - 2008/11/27/entrez SP - 301 EP - 6 JF - Menopause (New York, N.Y.) JO - Menopause VL - 16 IS - 2 N2 - OBJECTIVE: To evaluate in a 24-month, prospective, randomized, double-blind, placebo-controlled study whether pure administration of the phytoestrogen genistein (54 mg/d) might reduce the number and severity of hot flushes in postmenopausal women, with no adverse effect on the endometrium and vagina. METHODS: A total of 389 participants met the parent study criteria and were randomly assigned to receive the phytoestrogen genistein (n = 198) or placebo (n = 191). About 40% of participants in both groups did not experience hot flushes, and the evaluation was performed in a subgroup of 236 participants (genistein, n = 119; placebo, n = 117). Reductions from the baseline in the frequency and severity of hot flushes were the principal criteria of efficacy. Endometrial thickness was evaluated by ultrasonography. The maturation value was also used to determine hormonal action on the vaginal cells. RESULTS: There were no significant differences in vasomotor symptoms between groups at the baseline (4.4 +/- 0.33 hot flushes per day in the genistein group and 4.2 +/- 0.35 hot flushes per day in the control group). After 12 months of genistein therapy, there was a significant reduction (-56.4%) in the mean number of hot flushes, with a significant difference compared with the control group. After 24 months, there was no further decrease in the number of hot flushes in both groups. No significant difference was found in mean endometrial thickness and the maturation value score between the two groups, either at the baseline or after 24 months. CONCLUSIONS: The phytoestrogen genistein has been shown to be effective on vasomotor symptoms without an adverse effect on the endometrium and vagina, but after the first year, there was no further improvement in the decrease in hot flushes. SN - 1530-0374 UR - https://www.unboundmedicine.com/medline/citation/19034051/Effects_of_the_phytoestrogen_genistein_on_hot_flushes_endometrium_and_vaginal_epithelium_in_postmenopausal_women:_a_2_year_randomized_double_blind_placebo_controlled_study_ L2 - http://dx.doi.org/10.1097/gme.0b013e318186d7e2 DB - PRIME DP - Unbound Medicine ER -