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Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms.
J Obstet Gynaecol Res 2009; 35(6):1083-90JO

Abstract

AIM

The aim of the present study was to assess the efficacy and safety of a standardized compound based on an extract of soy phytoestrogens, with high doses of isoflavones in the management of menopausal hot flushes.

METHODS

A total of 180 women aged 40-65 years with a minimum of five moderate-to-severe hot flushes in the last 7 days at baseline and absence of menstruation for at least 6 months participated in a 12-week prospective, randomized, double-blind, placebo-controlled multicenter trial. After a 2-week run-in period, women received one tablet a day of 80 mg isoflavones (corresponding to 60 mg of genistein) or a matching placebo.

RESULTS

The mean daily number of moderate-to-severe hot flushes decreased in both study groups, but the reduction was greater in the isoflavones arm at 6 (36.2%) and 12 weeks (41.2%) than in the placebo arm (24.0% at 6 weeks, 29.3% at 12 weeks), with a difference of 1.1 (95% CI [-2.0 to -0.06]) (P = 0.038) at 6 weeks and 1.1 (95% CI [-2.05 to -0.15]) (P = 0.023) at 12 weeks. Similar findings were obtained for hot flushes of any intensity. The Kupperman index decreased in both study groups. Relief of hot flushes was greater when time to menopause was >or=12 months and in cases of BMI >or=27 kg/m(2).

CONCLUSION

In daily practice conditions, high doses of isoflavones, particularly genistein, can be used for the management of hot flushes in postmenopausal women not treated with hormone replacement therapy due to their superior efficacy to placebo and very good safety profile.

Authors+Show Affiliations

Gynecology and Obstetrics Department, San Raffaele Hospital, Milano, Italy.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

20025635

Citation

Ferrari, Augusto. "Soy Extract Phytoestrogens With High Dose of Isoflavones for Menopausal Symptoms." The Journal of Obstetrics and Gynaecology Research, vol. 35, no. 6, 2009, pp. 1083-90.
Ferrari A. Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms. J Obstet Gynaecol Res. 2009;35(6):1083-90.
Ferrari, A. (2009). Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms. The Journal of Obstetrics and Gynaecology Research, 35(6), pp. 1083-90. doi:10.1111/j.1447-0756.2009.01058.x.
Ferrari A. Soy Extract Phytoestrogens With High Dose of Isoflavones for Menopausal Symptoms. J Obstet Gynaecol Res. 2009;35(6):1083-90. PubMed PMID: 20025635.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms. A1 - Ferrari,Augusto, PY - 2009/12/23/entrez PY - 2009/12/23/pubmed PY - 2010/5/26/medline SP - 1083 EP - 90 JF - The journal of obstetrics and gynaecology research JO - J. Obstet. Gynaecol. Res. VL - 35 IS - 6 N2 - AIM: The aim of the present study was to assess the efficacy and safety of a standardized compound based on an extract of soy phytoestrogens, with high doses of isoflavones in the management of menopausal hot flushes. METHODS: A total of 180 women aged 40-65 years with a minimum of five moderate-to-severe hot flushes in the last 7 days at baseline and absence of menstruation for at least 6 months participated in a 12-week prospective, randomized, double-blind, placebo-controlled multicenter trial. After a 2-week run-in period, women received one tablet a day of 80 mg isoflavones (corresponding to 60 mg of genistein) or a matching placebo. RESULTS: The mean daily number of moderate-to-severe hot flushes decreased in both study groups, but the reduction was greater in the isoflavones arm at 6 (36.2%) and 12 weeks (41.2%) than in the placebo arm (24.0% at 6 weeks, 29.3% at 12 weeks), with a difference of 1.1 (95% CI [-2.0 to -0.06]) (P = 0.038) at 6 weeks and 1.1 (95% CI [-2.05 to -0.15]) (P = 0.023) at 12 weeks. Similar findings were obtained for hot flushes of any intensity. The Kupperman index decreased in both study groups. Relief of hot flushes was greater when time to menopause was >or=12 months and in cases of BMI >or=27 kg/m(2). CONCLUSION: In daily practice conditions, high doses of isoflavones, particularly genistein, can be used for the management of hot flushes in postmenopausal women not treated with hormone replacement therapy due to their superior efficacy to placebo and very good safety profile. SN - 1447-0756 UR - https://www.unboundmedicine.com/medline/citation/20025635/Soy_extract_phytoestrogens_with_high_dose_of_isoflavones_for_menopausal_symptoms_ L2 - https://doi.org/10.1111/j.1447-0756.2009.01058.x DB - PRIME DP - Unbound Medicine ER -