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Randomized placebo-controlled trial of an isoflavone supplement and menopausal symptoms in women.
Climacteric 1999; 2(2):85-92C

Abstract

OBJECTIVE

To test the hypothesis that increasing the intake of isoflavones by dietary supplementation may produce a therapeutic effect in reducing the incidence and severity of hot flushes in menopausal women.

METHODS

Fifty-one postmenopausal women were randomized to placebo and active (one tablet per day of a 40-mg isoflavone supplement) groups in a cross-over design trial. After a 1-week run-in period, subjects were commenced on a 12-week period of treatment (active or placebo), followed by a 1-month placebo wash-out period, then crossed over to the alternative treatment regimen for a further 14 weeks. Symptom diaries were maintained throughout the trial and at the start and end of treatment. Plasma sex hormone binding globulin (SHBG) assay, full blood count, biochemical profiles, vaginal swabs and vaginal ultrasound scans were performed and isoflavones determined in 24-h urine collections by high-pressure liquid chromatography (HPLC) analysis.

RESULTS

There was no significant difference between active and placebo groups in the reduction in hot flushes between start and finish time-points. Analysis performed on interim data time-points revealed a substantially greater reduction in flushing in the active group than placebo at 4 and 8 weeks after commencement of treatment, but this was not statistically significant. There were no significant differences between groups for Greene scores or in SHBG levels, hematological or biochemical parameters and vaginal swab or ultrasound findings. The combined values for all subjects, regardless of treatment group, revealed a strong negative correlation between the level of urinary isoflavone excretion and the incidence of hot flushes.

CONCLUSIONS

These data do not indicate a therapeutic benefit from dietary supplementation with isoflavones in women experiencing menopausal symptoms, but do indicate that the apparent placebo effect in many studies of menopausal symptoms may be attributable to dietary sources of isoflavones. The study also demonstrates that 3 months of isoflavone supplementation did not cause adverse events or endometrial changes.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, University of Sydney, Royal North Shore Hospital, St Leonards 2056, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

11910672

Citation

Baber, R J., et al. "Randomized Placebo-controlled Trial of an Isoflavone Supplement and Menopausal Symptoms in Women." Climacteric : the Journal of the International Menopause Society, vol. 2, no. 2, 1999, pp. 85-92.
Baber RJ, Templeman C, Morton T, et al. Randomized placebo-controlled trial of an isoflavone supplement and menopausal symptoms in women. Climacteric. 1999;2(2):85-92.
Baber, R. J., Templeman, C., Morton, T., Kelly, G. E., & West, L. (1999). Randomized placebo-controlled trial of an isoflavone supplement and menopausal symptoms in women. Climacteric : the Journal of the International Menopause Society, 2(2), pp. 85-92.
Baber RJ, et al. Randomized Placebo-controlled Trial of an Isoflavone Supplement and Menopausal Symptoms in Women. Climacteric. 1999;2(2):85-92. PubMed PMID: 11910672.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized placebo-controlled trial of an isoflavone supplement and menopausal symptoms in women. AU - Baber,R J, AU - Templeman,C, AU - Morton,T, AU - Kelly,G E, AU - West,L, PY - 2002/3/26/pubmed PY - 2002/4/20/medline PY - 2002/3/26/entrez SP - 85 EP - 92 JF - Climacteric : the journal of the International Menopause Society JO - Climacteric VL - 2 IS - 2 N2 - OBJECTIVE: To test the hypothesis that increasing the intake of isoflavones by dietary supplementation may produce a therapeutic effect in reducing the incidence and severity of hot flushes in menopausal women. METHODS: Fifty-one postmenopausal women were randomized to placebo and active (one tablet per day of a 40-mg isoflavone supplement) groups in a cross-over design trial. After a 1-week run-in period, subjects were commenced on a 12-week period of treatment (active or placebo), followed by a 1-month placebo wash-out period, then crossed over to the alternative treatment regimen for a further 14 weeks. Symptom diaries were maintained throughout the trial and at the start and end of treatment. Plasma sex hormone binding globulin (SHBG) assay, full blood count, biochemical profiles, vaginal swabs and vaginal ultrasound scans were performed and isoflavones determined in 24-h urine collections by high-pressure liquid chromatography (HPLC) analysis. RESULTS: There was no significant difference between active and placebo groups in the reduction in hot flushes between start and finish time-points. Analysis performed on interim data time-points revealed a substantially greater reduction in flushing in the active group than placebo at 4 and 8 weeks after commencement of treatment, but this was not statistically significant. There were no significant differences between groups for Greene scores or in SHBG levels, hematological or biochemical parameters and vaginal swab or ultrasound findings. The combined values for all subjects, regardless of treatment group, revealed a strong negative correlation between the level of urinary isoflavone excretion and the incidence of hot flushes. CONCLUSIONS: These data do not indicate a therapeutic benefit from dietary supplementation with isoflavones in women experiencing menopausal symptoms, but do indicate that the apparent placebo effect in many studies of menopausal symptoms may be attributable to dietary sources of isoflavones. The study also demonstrates that 3 months of isoflavone supplementation did not cause adverse events or endometrial changes. SN - 1369-7137 UR - https://www.unboundmedicine.com/medline/citation/11910672/Randomized_placebo_controlled_trial_of_an_isoflavone_supplement_and_menopausal_symptoms_in_women_ L2 - http://www.tandfonline.com/doi/full/10.3109/13697139909025571 DB - PRIME DP - Unbound Medicine ER -