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Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: a multicenter, double-blind, randomized, placebo-controlled study.
Menopause 2000 Jul-Aug; 7(4):236-42M

Abstract

OBJECTIVE

To determine the safety and efficacy of an oral soy isoflavone extract for relief of menopausal hot flushes.

DESIGN

This was a double-blind, randomized, parallel group, outpatient, multicenter (15 sites) study. A total of 177 postmenopausal women (mean age = 55 years) who were experiencing five or more hot flushes per day were randomized to receive either soy isoflavone extract (total of 50 mg genistin and daidzin per day) or placebo. Physical examinations and endometrial and biochemical evaluations were performed upon admission and completion. Body weight, symptoms, and safety were evaluated at all visits.

RESULTS

Relief of vasomotor symptoms was observed in both groups. Decreases in the incidence and severity of hot flushes occurred as soon as 2 weeks in the soy group, whereas the placebo group experienced no relief for the first 4 weeks. Differences between evaluable subjects in both groups were statistically significant over 6 weeks (p = 0.03). Over 12 weeks, between-group differences approached significance (p = 0.08). Endometrial thickness evaluated by ultrasound, lipoproteins, bone markers, sex hormone-binding globulin and follicle-stimulating hormone, and vaginal cytology did not change in either group.

CONCLUSIONS

Soy isoflavone extract was effective in reducing frequency and severity of flushes and did not stimulate the endometrium. Soy isoflavone extracts provide an attractive addition to the choices available for relief of hot flushes.

Authors+Show Affiliations

Department of Clinical Affairs, Advanced Care Products, North Brunswick, New Jersey 08902, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

10914616

Citation

Upmalis, D H., et al. "Vasomotor Symptom Relief By Soy Isoflavone Extract Tablets in Postmenopausal Women: a Multicenter, Double-blind, Randomized, Placebo-controlled Study." Menopause (New York, N.Y.), vol. 7, no. 4, 2000, pp. 236-42.
Upmalis DH, Lobo R, Bradley L, et al. Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: a multicenter, double-blind, randomized, placebo-controlled study. Menopause. 2000;7(4):236-42.
Upmalis, D. H., Lobo, R., Bradley, L., Warren, M., Cone, F. L., & Lamia, C. A. (2000). Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: a multicenter, double-blind, randomized, placebo-controlled study. Menopause (New York, N.Y.), 7(4), pp. 236-42.
Upmalis DH, et al. Vasomotor Symptom Relief By Soy Isoflavone Extract Tablets in Postmenopausal Women: a Multicenter, Double-blind, Randomized, Placebo-controlled Study. Menopause. 2000;7(4):236-42. PubMed PMID: 10914616.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vasomotor symptom relief by soy isoflavone extract tablets in postmenopausal women: a multicenter, double-blind, randomized, placebo-controlled study. AU - Upmalis,D H, AU - Lobo,R, AU - Bradley,L, AU - Warren,M, AU - Cone,F L, AU - Lamia,C A, PY - 2000/7/29/pubmed PY - 2001/2/28/medline PY - 2000/7/29/entrez SP - 236 EP - 42 JF - Menopause (New York, N.Y.) JO - Menopause VL - 7 IS - 4 N2 - OBJECTIVE: To determine the safety and efficacy of an oral soy isoflavone extract for relief of menopausal hot flushes. DESIGN: This was a double-blind, randomized, parallel group, outpatient, multicenter (15 sites) study. A total of 177 postmenopausal women (mean age = 55 years) who were experiencing five or more hot flushes per day were randomized to receive either soy isoflavone extract (total of 50 mg genistin and daidzin per day) or placebo. Physical examinations and endometrial and biochemical evaluations were performed upon admission and completion. Body weight, symptoms, and safety were evaluated at all visits. RESULTS: Relief of vasomotor symptoms was observed in both groups. Decreases in the incidence and severity of hot flushes occurred as soon as 2 weeks in the soy group, whereas the placebo group experienced no relief for the first 4 weeks. Differences between evaluable subjects in both groups were statistically significant over 6 weeks (p = 0.03). Over 12 weeks, between-group differences approached significance (p = 0.08). Endometrial thickness evaluated by ultrasound, lipoproteins, bone markers, sex hormone-binding globulin and follicle-stimulating hormone, and vaginal cytology did not change in either group. CONCLUSIONS: Soy isoflavone extract was effective in reducing frequency and severity of flushes and did not stimulate the endometrium. Soy isoflavone extracts provide an attractive addition to the choices available for relief of hot flushes. SN - 1072-3714 UR - https://www.unboundmedicine.com/medline/citation/10914616/Vasomotor_symptom_relief_by_soy_isoflavone_extract_tablets_in_postmenopausal_women:_a_multicenter_double_blind_randomized_placebo_controlled_study_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=10914616.ui DB - PRIME DP - Unbound Medicine ER -