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Soy isoflavone supplements for the treatment of menopausal hot flashes: the Women’s Isoflavone Soy Health (WISH) trial

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Title	Soy isoflavone supplements for the treatment of menopausal hot flashes: the Women’s Isoflavone Soy Health (WISH) trial
Author	Chien, ChunJu
Author email	chunjuc@usc.edu; chienchunju@gmail.com
Degree	Master of Science
Document type	Thesis
Degree program	Biostatistics
School	Keck School of Medicine
Date submitted	2010
Restricted until	Unrestricted
Date published	2010-11-07
Advisor (committee chair)	Mack, Wendy
Advisor (committee member)	Azen, Stanley Karim, Roksana
Abstract	Background: Isoflavone soy protein (ISP) is used as an alternative to steroidal hormone therapies for alleviating menopausal hot flash symptoms; however, the reported efficacy of soy isoflavones on hot flashes is inconsistent. Objective: The primary aim of the study was to compare the efficacy of 25 g of isoflavone soy protein versus placebo twice per day in altering hot flash frequency and severity among postmenopausal women. Design, Setting, and Participants: This is an ancillary analysis among a subset of 101 postmenopausal women participanting of the Women's Isoflavone Soy Health (WISH) trial, who experienced 5 or more hot flashes per week at baseline. WISH was a randomized, double-blind, placebo-controlled, single center trial including 350 healthy postmenopausal women.designed to evaluate the effect of isoflavon soy on the carotid artery intima-media thickness (CIMT). The study participants were between the ages of 44 to 72 years with no clinically evident ardiovascular disease (CVD). Intervention: Participants were randomly assigned to 25 g soy isoflavone product containing 85 mg of isoflavones (45 mg genistein, 35 mg daidzein and 5 mg glycitein) or milk protein matched placebo (0 mg isoflavones) daily for 2.5-3 years. Main Outcome Measures: Among the 101 participants with at least 5 weekly flashes at baseline, the primary endpoints were the frequency of hot flashes and hot flash composite scores calculated from the product of the daily frequency and severity rating using flushing diaries completed over the trial. Secondary outcome measures included the change in hot flashes number and composite scores from baseline.; Results: Of the 101 postmenopausal women, 53 subjects were randomly assigned to isoflavone soy protein (ISP) and 48 subjects were assigned to placebo. The treatment groups did not significantly differ on the daily number of hot flashes, composite scores, or the change in hot flash frequency or composite scores over the trial. The reduction in mean hot flash frequency from baseline to 30 months was similar for the ISP (1.33/day) and the placebo group (1.33/day). Among ISP-treated women, the change in plasma glycitein from baseline was inversely associated with the change in hot flash severity (gamma = -0.35, p=0.02); this association was not observed in the placebo group. ISP-treated women who were consistent equol-producers significantly differed on the on-trial mean change of hot flash frequency, plasma genistein, plasma gaidzein, and plasma glycitein from the placebo-treated women (all p<0.05). Conclusions: These randomized clinical trial data indicate that ISP do not alleviate hot flash symptoms in postmenopausal women. Subgroup and ancillary analyses suggested an association between achieved glycitenin concentrations and reduction of hot flashes.
Keyword	hot flash; isoflavone; postmenopausal; glycitein; equol-producer
Language	English
Part of collection	University of Southern California dissertations and theses
Publisher (of the original version)	University of Southern California
Place of publication (of the original version)	Los Angeles, California
Publisher (of the digital version)	University of Southern California. Libraries
Provenance	Electronically uploaded by the author
Type	texts
Legacy record ID	usctheses-m3518
Rights	Chien, ChunJu
Repository name	Libraries, University of Southern California
Repository address	Los Angeles, California
Repository email	http://www.usc.edu/isd/libraries/services/ask_a_librarian/email/
Filename	etd-CHIEN-4163
Archival file	uscthesesreloadpub_Volume26/etd-CHIEN-4163.pdf