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Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial.
JAMA. 2003 Jul 09; 290(2):207-14.JAMA

Abstract

CONTEXT

Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have increased interest in other therapies for menopausal symptoms. Dietary supplements containing isoflavones are widely used as alternatives to hormonal therapies for hot flashes, but there is a paucity of data supporting their efficacy.

OBJECTIVE

To compare the efficacy and safety of 2 dietary supplements derived from red clover with placebo in symptomatic menopausal women.

DESIGN, SETTING, AND PARTICIPANTS

Randomized, double-blind, placebo-controlled trial of menopausal women, aged 45 to 60 years, who were experiencing at least 35 hot flashes per week. The study was conducted between November 1999 and March 2001 at 3 US medical centers and included women who were recently postmenopausal (mean [SD], 3.3 [4.5] years since menopause) experiencing 8.1 hot flashes per day. Women were excluded if they were vegetarians, consumed soy products more than once per week, or took medications affecting isoflavone absorption.

INTERVENTION

After a 2-week placebo run-in, 252 participants were randomly assigned to Promensil (82 mg of total isoflavones per day), Rimostil (57 mg of total isoflavones per day), or an identical placebo, and followed-up for 12 weeks.

MAIN OUTCOME MEASURE

The primary outcome measure was the change in frequency of hot flashes measured by participant daily diaries. Secondary outcome measures included changes in quality of life and adverse events.

RESULTS

Of 252 participants, 246 (98%) completed the 12-week protocol. The reductions in mean daily hot flash count at 12 weeks were similar for the Promensil (5.1), Rimostil (5.4), and placebo (5.0) groups. In comparison with the placebo group, participants in the Promensil group (41%; 95% confidence interval [CI], 29%-51%; P =.03), but not in the Rimostil group (34%; 95% CI, 22%-46%; P =.74) reduced hot flashes more rapidly. Quality-of-life improvements and adverse events were comparable in the 3 groups.

CONCLUSION

Although the study provides some evidence for a biological effect of Promensil, neither supplement had a clinically important effect on hot flashes or other symptoms of menopause.

Authors+Show Affiliations

Division of General Internal Medicine, Department of Medicine, University of California, San Francisco 94143, USA. jtice@medicine.ucsf.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

12851275

Citation

Tice, Jeffrey A., et al. "Phytoestrogen Supplements for the Treatment of Hot Flashes: the Isoflavone Clover Extract (ICE) Study: a Randomized Controlled Trial." JAMA, vol. 290, no. 2, 2003, pp. 207-14.
Tice JA, Ettinger B, Ensrud K, et al. Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial. JAMA. 2003;290(2):207-14.
Tice, J. A., Ettinger, B., Ensrud, K., Wallace, R., Blackwell, T., & Cummings, S. R. (2003). Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial. JAMA, 290(2), 207-14.
Tice JA, et al. Phytoestrogen Supplements for the Treatment of Hot Flashes: the Isoflavone Clover Extract (ICE) Study: a Randomized Controlled Trial. JAMA. 2003 Jul 9;290(2):207-14. PubMed PMID: 12851275.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial. AU - Tice,Jeffrey A, AU - Ettinger,Bruce, AU - Ensrud,Kris, AU - Wallace,Robert, AU - Blackwell,Terri, AU - Cummings,Steven R, PY - 2003/7/10/pubmed PY - 2003/7/16/medline PY - 2003/7/10/entrez SP - 207 EP - 14 JF - JAMA JO - JAMA VL - 290 IS - 2 N2 - CONTEXT: Clinical trials demonstrating increased risk of cardiovascular disease and breast cancer among women randomized to hormone replacement therapy have increased interest in other therapies for menopausal symptoms. Dietary supplements containing isoflavones are widely used as alternatives to hormonal therapies for hot flashes, but there is a paucity of data supporting their efficacy. OBJECTIVE: To compare the efficacy and safety of 2 dietary supplements derived from red clover with placebo in symptomatic menopausal women. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled trial of menopausal women, aged 45 to 60 years, who were experiencing at least 35 hot flashes per week. The study was conducted between November 1999 and March 2001 at 3 US medical centers and included women who were recently postmenopausal (mean [SD], 3.3 [4.5] years since menopause) experiencing 8.1 hot flashes per day. Women were excluded if they were vegetarians, consumed soy products more than once per week, or took medications affecting isoflavone absorption. INTERVENTION: After a 2-week placebo run-in, 252 participants were randomly assigned to Promensil (82 mg of total isoflavones per day), Rimostil (57 mg of total isoflavones per day), or an identical placebo, and followed-up for 12 weeks. MAIN OUTCOME MEASURE: The primary outcome measure was the change in frequency of hot flashes measured by participant daily diaries. Secondary outcome measures included changes in quality of life and adverse events. RESULTS: Of 252 participants, 246 (98%) completed the 12-week protocol. The reductions in mean daily hot flash count at 12 weeks were similar for the Promensil (5.1), Rimostil (5.4), and placebo (5.0) groups. In comparison with the placebo group, participants in the Promensil group (41%; 95% confidence interval [CI], 29%-51%; P =.03), but not in the Rimostil group (34%; 95% CI, 22%-46%; P =.74) reduced hot flashes more rapidly. Quality-of-life improvements and adverse events were comparable in the 3 groups. CONCLUSION: Although the study provides some evidence for a biological effect of Promensil, neither supplement had a clinically important effect on hot flashes or other symptoms of menopause. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/12851275/Phytoestrogen_supplements_for_the_treatment_of_hot_flashes:_the_Isoflavone_Clover_Extract__ICE__Study:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.290.2.207 DB - PRIME DP - Unbound Medicine ER -