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The effect of Promensil, an isoflavone extract, on menopausal symptoms.
Climacteric 1999; 2(2):79-84C

Abstract

OBJECTIVES

The primary aim was to assess whether the use of an isoflavone extract containing 40 mg or 160 mg of total isoflavones affects the frequency of menopausal flushes and other symptoms. The secondary aims were assessments of possible effects on menopause symptom scores and biological measures of estrogen activity.

METHODS

A randomized, double-blind, placebo-controlled prospective trial of 37 postmenopausal women with symptoms of estrogen deficiency was performed over a 12-week period. The women were randomized to three treatment groups: placebo, 40 mg or 160 mg, delivered in tablet form.

RESULTS

There was no significant difference in the incidence of flushes between the three groups at trial conclusion. There was no difference between the groups in Greene Menopause Symptom Scores, vaginal pH, levels of follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG) or total cholesterol, liver function or blood parameters. A statistically significant increase in high-density lipoprotein (HDL) cholesterol of 18.1% (p = 0.038) occurred in the 40-mg group.

CONCLUSION

A large placebo response and inadvertent use of dietary isoflavones in the placebo group may have obscured a significant change in flushing frequency. Previous uncontrolled studies claiming a beneficial effect of foods with a high isoflavone content on menopausal symptoms may have been confounded by a large placebo response.

Authors+Show Affiliations

Caroline Chisholm Centre for Women and Children, Liverpool Hospital, Liverpool.No 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

11910671

Citation

Knight, D C., et al. "The Effect of Promensil, an Isoflavone Extract, On Menopausal Symptoms." Climacteric : the Journal of the International Menopause Society, vol. 2, no. 2, 1999, pp. 79-84.
Knight DC, Howes JB, Eden JA. The effect of Promensil, an isoflavone extract, on menopausal symptoms. Climacteric. 1999;2(2):79-84.
Knight, D. C., Howes, J. B., & Eden, J. A. (1999). The effect of Promensil, an isoflavone extract, on menopausal symptoms. Climacteric : the Journal of the International Menopause Society, 2(2), pp. 79-84.
Knight DC, Howes JB, Eden JA. The Effect of Promensil, an Isoflavone Extract, On Menopausal Symptoms. Climacteric. 1999;2(2):79-84. PubMed PMID: 11910671.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of Promensil, an isoflavone extract, on menopausal symptoms. AU - Knight,D C, AU - Howes,J B, AU - Eden,J A, PY - 2002/3/26/pubmed PY - 2002/4/20/medline PY - 2002/3/26/entrez SP - 79 EP - 84 JF - Climacteric : the journal of the International Menopause Society JO - Climacteric VL - 2 IS - 2 N2 - OBJECTIVES: The primary aim was to assess whether the use of an isoflavone extract containing 40 mg or 160 mg of total isoflavones affects the frequency of menopausal flushes and other symptoms. The secondary aims were assessments of possible effects on menopause symptom scores and biological measures of estrogen activity. METHODS: A randomized, double-blind, placebo-controlled prospective trial of 37 postmenopausal women with symptoms of estrogen deficiency was performed over a 12-week period. The women were randomized to three treatment groups: placebo, 40 mg or 160 mg, delivered in tablet form. RESULTS: There was no significant difference in the incidence of flushes between the three groups at trial conclusion. There was no difference between the groups in Greene Menopause Symptom Scores, vaginal pH, levels of follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG) or total cholesterol, liver function or blood parameters. A statistically significant increase in high-density lipoprotein (HDL) cholesterol of 18.1% (p = 0.038) occurred in the 40-mg group. CONCLUSION: A large placebo response and inadvertent use of dietary isoflavones in the placebo group may have obscured a significant change in flushing frequency. Previous uncontrolled studies claiming a beneficial effect of foods with a high isoflavone content on menopausal symptoms may have been confounded by a large placebo response. SN - 1369-7137 UR - https://www.unboundmedicine.com/medline/citation/11910671/The_effect_of_Promensil_an_isoflavone_extract_on_menopausal_symptoms_ L2 - http://www.tandfonline.com/doi/full/10.3109/13697139909025570 DB - PRIME DP - Unbound Medicine ER -