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Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial.
Arch Intern Med 2011; 171(15):1363-9AI

Abstract

BACKGROUND

Concerns regarding the risk of estrogen replacement have resulted in a significant increase in the use of soy products by menopausal women who, despite the lack of evidence of the efficacy of such products, seek alternatives to menopausal hormone therapy. Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms.

METHODS

The study design was a single-center, randomized, placebo-controlled, double-blind clinical trial conducted from July 1, 2004, through March 31, 2009. Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were randomly assigned, in equal proportions, to receive daily soy isoflavone tablets, 200 mg, or placebo. The primary outcome was changes in bone mineral density in the lumbar spine, total hip, and femoral neck at the 2-year follow-up. Secondary outcomes included changes in menopausal symptoms, vaginal cytologic characteristics, N -telopeptide of type I bone collagen, lipids, and thyroid function.

RESULTS

After 2 years, no significant differences were found between the participants receiving soy tablets (n = 122) and those receiving placebo (n = 126) regarding changes in bone mineral density in the spine (-2.0% and -2.3%, respectively), the total hip (-1.2% and -1.4%, respectively), or the femoral neck (-2.2% and -2.1%, respectively). A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group. No significant differences were found between groups in other outcomes.

CONCLUSIONS

In this population, the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00076050.

Authors+Show Affiliations

Geriatric Research, Education, and Clinical Center, Miami Veterans Affairs Healthcare System, USA. slevis@med.miami.eduNo 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, N.I.H., Extramural

Language

eng

PubMed ID

21824950

Citation

Levis, Silvina, et al. "Soy Isoflavones in the Prevention of Menopausal Bone Loss and Menopausal Symptoms: a Randomized, Double-blind Trial." Archives of Internal Medicine, vol. 171, no. 15, 2011, pp. 1363-9.
Levis S, Strickman-Stein N, Ganjei-Azar P, et al. Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. Arch Intern Med. 2011;171(15):1363-9.
Levis, S., Strickman-Stein, N., Ganjei-Azar, P., Xu, P., Doerge, D. R., & Krischer, J. (2011). Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. Archives of Internal Medicine, 171(15), pp. 1363-9. doi:10.1001/archinternmed.2011.330.
Levis S, et al. Soy Isoflavones in the Prevention of Menopausal Bone Loss and Menopausal Symptoms: a Randomized, Double-blind Trial. Arch Intern Med. 2011 Aug 8;171(15):1363-9. PubMed PMID: 21824950.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: a randomized, double-blind trial. AU - Levis,Silvina, AU - Strickman-Stein,Nancy, AU - Ganjei-Azar,Parvin, AU - Xu,Ping, AU - Doerge,Daniel R, AU - Krischer,Jeffrey, PY - 2011/8/10/entrez PY - 2011/8/10/pubmed PY - 2011/10/14/medline SP - 1363 EP - 9 JF - Archives of internal medicine JO - Arch. Intern. Med. VL - 171 IS - 15 N2 - BACKGROUND: Concerns regarding the risk of estrogen replacement have resulted in a significant increase in the use of soy products by menopausal women who, despite the lack of evidence of the efficacy of such products, seek alternatives to menopausal hormone therapy. Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms. METHODS: The study design was a single-center, randomized, placebo-controlled, double-blind clinical trial conducted from July 1, 2004, through March 31, 2009. Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were randomly assigned, in equal proportions, to receive daily soy isoflavone tablets, 200 mg, or placebo. The primary outcome was changes in bone mineral density in the lumbar spine, total hip, and femoral neck at the 2-year follow-up. Secondary outcomes included changes in menopausal symptoms, vaginal cytologic characteristics, N -telopeptide of type I bone collagen, lipids, and thyroid function. RESULTS: After 2 years, no significant differences were found between the participants receiving soy tablets (n = 122) and those receiving placebo (n = 126) regarding changes in bone mineral density in the spine (-2.0% and -2.3%, respectively), the total hip (-1.2% and -1.4%, respectively), or the femoral neck (-2.2% and -2.1%, respectively). A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group. No significant differences were found between groups in other outcomes. CONCLUSIONS: In this population, the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00076050. SN - 1538-3679 UR - https://www.unboundmedicine.com/medline/citation/21824950/Soy_isoflavones_in_the_prevention_of_menopausal_bone_loss_and_menopausal_symptoms:_a_randomized_double_blind_trial_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/archinternmed.2011.330 DB - PRIME DP - Unbound Medicine ER -