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Efficacy and safety of a soy isoflavone extract in postmenopausal women: a randomized, double-blind, and placebo-controlled study.
Maturitas 2007; 58(3):249-58M

Abstract

OBJECTIVE

To investigate the efficacy of soy isoflavone on climacteric symptoms in postmenopausal women.

DESIGN

In this double-blind, randomized, placebo-controlled study, a total of 80 women (mean age = 55.1 years), who reported 5 or more hot flush episodes per day, were randomized to receive either 250 mg of standardized soy extract (Glycine max AT) a total of 100mg/day of isoflavone (n = 40) or placebo (n = 40). Exclusion criteria included: contra-indication for hormone therapy (HT), chronic gastrointestinal diseases, and users of HT within the preceding 6-months. For 10-months, climacteric symptoms were evaluated using a score card and the menopausal Kupperman index. Compliance and safety were also assessed. At baseline and the end of the study, lipid and hormonal profiles, as well as vaginal, mammographic and ultrasonographic parameters were measured. The t-test, Wilcoxon test and ANOVA were used in the statistical analysis.

RESULTS

At baseline, the mean number of hot flushes was 9.6 +/- 3.9 per day in the isoflavone group and 10.1+/-4.9 in the placebo group (p>0.05). After 10 months, there was a significant reduction in frequency of hot flushes among isoflavone users when compared to those on placebo (3.1 +/- 2.3 and 5.9 +/- 4.3, respectively) (p<0.001). Kupperman index mean values showed a significant reduction in both groups. However, soy isoflavone was significantly superior to placebo, in reducing hot flush severity (69.9% and 33.7%, respectively) (p<0.001). Endometrial thickness, mammography, vaginal cytology, lipids and hormonal profile did not change in both groups. No serious adverse event related to isoflavone treatment was reported.

CONCLUSIONS

The soy isoflavone extract exerted favorable effects on vasomotor symptoms and good compliance, providing a safe and effective alternative therapeutic for postmenopausal women.

Authors+Show Affiliations

Department of Gynecology and Obstetrics, Botucatu Medical School, Sao Paulo State University-UNESP, Rubiao Junior, Botucatu, Sao Paulo 18618-970, Brazil. epetri@fmb.unesp.brNo 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

17913408

Citation

Nahas, Eliana A P., et al. "Efficacy and Safety of a Soy Isoflavone Extract in Postmenopausal Women: a Randomized, Double-blind, and Placebo-controlled Study." Maturitas, vol. 58, no. 3, 2007, pp. 249-58.
Nahas EA, Nahas-Neto J, Orsatti FL, et al. Efficacy and safety of a soy isoflavone extract in postmenopausal women: a randomized, double-blind, and placebo-controlled study. Maturitas. 2007;58(3):249-58.
Nahas, E. A., Nahas-Neto, J., Orsatti, F. L., Carvalho, E. P., Oliveira, M. L., & Dias, R. (2007). Efficacy and safety of a soy isoflavone extract in postmenopausal women: a randomized, double-blind, and placebo-controlled study. Maturitas, 58(3), pp. 249-58.
Nahas EA, et al. Efficacy and Safety of a Soy Isoflavone Extract in Postmenopausal Women: a Randomized, Double-blind, and Placebo-controlled Study. Maturitas. 2007 Nov 20;58(3):249-58. PubMed PMID: 17913408.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a soy isoflavone extract in postmenopausal women: a randomized, double-blind, and placebo-controlled study. AU - Nahas,Eliana A P, AU - Nahas-Neto,Jorge, AU - Orsatti,Fabio L, AU - Carvalho,Eduardo P, AU - Oliveira,Maria Luiza C S, AU - Dias,Rogerio, Y1 - 2007/10/29/ PY - 2007/03/29/received PY - 2007/08/20/revised PY - 2007/08/25/accepted PY - 2007/10/5/pubmed PY - 2008/2/20/medline PY - 2007/10/5/entrez SP - 249 EP - 58 JF - Maturitas JO - Maturitas VL - 58 IS - 3 N2 - OBJECTIVE: To investigate the efficacy of soy isoflavone on climacteric symptoms in postmenopausal women. DESIGN: In this double-blind, randomized, placebo-controlled study, a total of 80 women (mean age = 55.1 years), who reported 5 or more hot flush episodes per day, were randomized to receive either 250 mg of standardized soy extract (Glycine max AT) a total of 100mg/day of isoflavone (n = 40) or placebo (n = 40). Exclusion criteria included: contra-indication for hormone therapy (HT), chronic gastrointestinal diseases, and users of HT within the preceding 6-months. For 10-months, climacteric symptoms were evaluated using a score card and the menopausal Kupperman index. Compliance and safety were also assessed. At baseline and the end of the study, lipid and hormonal profiles, as well as vaginal, mammographic and ultrasonographic parameters were measured. The t-test, Wilcoxon test and ANOVA were used in the statistical analysis. RESULTS: At baseline, the mean number of hot flushes was 9.6 +/- 3.9 per day in the isoflavone group and 10.1+/-4.9 in the placebo group (p>0.05). After 10 months, there was a significant reduction in frequency of hot flushes among isoflavone users when compared to those on placebo (3.1 +/- 2.3 and 5.9 +/- 4.3, respectively) (p<0.001). Kupperman index mean values showed a significant reduction in both groups. However, soy isoflavone was significantly superior to placebo, in reducing hot flush severity (69.9% and 33.7%, respectively) (p<0.001). Endometrial thickness, mammography, vaginal cytology, lipids and hormonal profile did not change in both groups. No serious adverse event related to isoflavone treatment was reported. CONCLUSIONS: The soy isoflavone extract exerted favorable effects on vasomotor symptoms and good compliance, providing a safe and effective alternative therapeutic for postmenopausal women. SN - 0378-5122 UR - https://www.unboundmedicine.com/medline/citation/17913408/Efficacy_and_safety_of_a_soy_isoflavone_extract_in_postmenopausal_women:_a_randomized_double_blind_and_placebo_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5122(07)00255-1 DB - PRIME DP - Unbound Medicine ER -