The Effect of Dietary Soy Supplementation on Hot Flushes

OBJECTIVETo assess the effect of daily dietary supplementation of soy protein isolate powder on hot flushes in post-menopausal women. METHODSWe carried out a double-blind, parallel, multi-center, randomized placebo-controlled trial of 104 post-menopausal women. Fifty-one patients (age range 48–61 ye...

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Veröffentlicht in:Obstetrics and gynecology (New York. 1953) 1998-01, Vol.91 (1), p.6-11
Hauptverfasser: ALBERTAZZI, PAOLA, PANSINI, FRANCESCO, BONACCORSI, GLORIA, ZANOTTI, LAURA, FORINI, ELENA, ALOYSIO, DOMENICO DE
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container_end_page 11
container_issue 1
container_start_page 6
container_title Obstetrics and gynecology (New York. 1953)
container_volume 91
creator ALBERTAZZI, PAOLA
PANSINI, FRANCESCO
BONACCORSI, GLORIA
ZANOTTI, LAURA
FORINI, ELENA
ALOYSIO, DOMENICO DE
description OBJECTIVETo assess the effect of daily dietary supplementation of soy protein isolate powder on hot flushes in post-menopausal women. METHODSWe carried out a double-blind, parallel, multi-center, randomized placebo-controlled trial of 104 post-menopausal women. Fifty-one patients (age range 48–61 years) took 60 g of isolated soy protein daily and 53 patients (age range 45–62 years) took 60 g of placebo (casein) daily. The study lasted 12 weeks. Using analysis of covariance, we analyzed changes from baseline in mean number of moderate to severe hot flushes (including night sweats) during treatment. RESULTSSoy was significantly superior to placebo (P < .01 in reducing the mean number of hot flushes per 24 hours after 4, 8, and 12 weeks of treatment. In particular, women taking soy had a 26% reduction in the mean number of hot flushes by week 3 and a 33% reduction by week 4 (P < .001 by the Wilcoxon exact test). By the end of the 12th week, patients taking soy had a 45% reduction in their daily hot flushes versus a 30% reduction obtained with the placebo (P < .01). The overall rates of adverse effects were similar for soy and casein-placebo. Twenty-five patients dropped out of the study11 in the soy group and 14 in the placebo group. Gastrointestinal side effects were the most common cause of premature withdrawal from the study (seven patients in each group). CONCLUSIONSoy protein isolate added daily to the diet substantially reduced the frequency of hot flushes in climacteric women.
doi_str_mv 10.1016/s0029-7844(97)00597-8
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METHODSWe carried out a double-blind, parallel, multi-center, randomized placebo-controlled trial of 104 post-menopausal women. Fifty-one patients (age range 48–61 years) took 60 g of isolated soy protein daily and 53 patients (age range 45–62 years) took 60 g of placebo (casein) daily. The study lasted 12 weeks. Using analysis of covariance, we analyzed changes from baseline in mean number of moderate to severe hot flushes (including night sweats) during treatment. RESULTSSoy was significantly superior to placebo (P &lt; .01 in reducing the mean number of hot flushes per 24 hours after 4, 8, and 12 weeks of treatment. In particular, women taking soy had a 26% reduction in the mean number of hot flushes by week 3 and a 33% reduction by week 4 (P &lt; .001 by the Wilcoxon exact test). By the end of the 12th week, patients taking soy had a 45% reduction in their daily hot flushes versus a 30% reduction obtained with the placebo (P &lt; .01). The overall rates of adverse effects were similar for soy and casein-placebo. Twenty-five patients dropped out of the study11 in the soy group and 14 in the placebo group. Gastrointestinal side effects were the most common cause of premature withdrawal from the study (seven patients in each group). CONCLUSIONSoy protein isolate added daily to the diet substantially reduced the frequency of hot flushes in climacteric women.</description><identifier>ISSN: 0029-7844</identifier><identifier>EISSN: 1873-233X</identifier><identifier>DOI: 10.1016/s0029-7844(97)00597-8</identifier><identifier>PMID: 9464712</identifier><identifier>CODEN: OBGNAS</identifier><language>eng</language><publisher>New York, NY: The American College of Obstetricians and Gynecologists</publisher><subject>Biological and medical sciences ; Cohort Studies ; Dietary Supplements - adverse effects ; Double-Blind Method ; Female ; Gynecology. Andrology. 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METHODSWe carried out a double-blind, parallel, multi-center, randomized placebo-controlled trial of 104 post-menopausal women. Fifty-one patients (age range 48–61 years) took 60 g of isolated soy protein daily and 53 patients (age range 45–62 years) took 60 g of placebo (casein) daily. The study lasted 12 weeks. Using analysis of covariance, we analyzed changes from baseline in mean number of moderate to severe hot flushes (including night sweats) during treatment. RESULTSSoy was significantly superior to placebo (P &lt; .01 in reducing the mean number of hot flushes per 24 hours after 4, 8, and 12 weeks of treatment. In particular, women taking soy had a 26% reduction in the mean number of hot flushes by week 3 and a 33% reduction by week 4 (P &lt; .001 by the Wilcoxon exact test). By the end of the 12th week, patients taking soy had a 45% reduction in their daily hot flushes versus a 30% reduction obtained with the placebo (P &lt; .01). The overall rates of adverse effects were similar for soy and casein-placebo. Twenty-five patients dropped out of the study11 in the soy group and 14 in the placebo group. Gastrointestinal side effects were the most common cause of premature withdrawal from the study (seven patients in each group). CONCLUSIONSoy protein isolate added daily to the diet substantially reduced the frequency of hot flushes in climacteric women.</description><subject>Biological and medical sciences</subject><subject>Cohort Studies</subject><subject>Dietary Supplements - adverse effects</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Hot Flashes - diet therapy</subject><subject>Hot Flashes - metabolism</subject><subject>Hot Flashes - physiopathology</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Postmenopause - drug effects</subject><subject>Postmenopause - physiology</subject><subject>Puberal and climacteric disorders (male and female)</subject><subject>Soybean Proteins - administration &amp; dosage</subject><subject>Soybean Proteins - adverse effects</subject><subject>Soybean Proteins - therapeutic use</subject><subject>Time Factors</subject><issn>0029-7844</issn><issn>1873-233X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1998</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kFtLxDAQhYMoul5-gtAHEX2oTi7N5VHWKwg-qOBbSNMJW81u16ZF_Pdm3WVhwpCc78yQQ8gphSsKVF4nAGZKpYW4MOoSoDKq1DtkQrXiJeP8Y5dMtsgBOUzpEyAbDd8n-0ZIoSibEP02w-IuBPRD0YXitsXB9b_Fa5fPuFxGnONicEPbLYpcj91Q3McxzTAdk73gYsKTTT8i7_d3b9PH8vnl4Wl681x6IQQrA2dCBxVcY-qKIWWykrqBmnkaPDIJtWxqoMGwSnmVJZS1hrqhFGvnueJH5Hw9d9l33yOmwc7b5DFGt8BuTFYZqbkWMoPVGvR9l1KPwS77dp4_YynYVWL2dRWHXcVhjbL_iVmdfaebBWM9x2br2kSU9bON7pJ3MfRu4du0xRgYJQXPmFhjP10csE9fcfzB3s7QxWGWlwFIVkFJjdFA861cPTH-B2Y3gis</recordid><startdate>199801</startdate><enddate>199801</enddate><creator>ALBERTAZZI, PAOLA</creator><creator>PANSINI, FRANCESCO</creator><creator>BONACCORSI, GLORIA</creator><creator>ZANOTTI, LAURA</creator><creator>FORINI, ELENA</creator><creator>ALOYSIO, DOMENICO DE</creator><general>The American College of Obstetricians and Gynecologists</general><general>Elsevier Science</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>199801</creationdate><title>The Effect of Dietary Soy Supplementation on Hot Flushes</title><author>ALBERTAZZI, PAOLA ; PANSINI, FRANCESCO ; BONACCORSI, GLORIA ; ZANOTTI, LAURA ; FORINI, ELENA ; ALOYSIO, DOMENICO DE</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4442-f3248f7fad9b52e126568d0b2c1fce260b6db01f9257c768de6b80bd11ebac373</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1998</creationdate><topic>Biological and medical sciences</topic><topic>Cohort Studies</topic><topic>Dietary Supplements - adverse effects</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Hot Flashes - diet therapy</topic><topic>Hot Flashes - metabolism</topic><topic>Hot Flashes - physiopathology</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Postmenopause - drug effects</topic><topic>Postmenopause - physiology</topic><topic>Puberal and climacteric disorders (male and female)</topic><topic>Soybean Proteins - administration &amp; dosage</topic><topic>Soybean Proteins - adverse effects</topic><topic>Soybean Proteins - therapeutic use</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>ALBERTAZZI, PAOLA</creatorcontrib><creatorcontrib>PANSINI, FRANCESCO</creatorcontrib><creatorcontrib>BONACCORSI, GLORIA</creatorcontrib><creatorcontrib>ZANOTTI, LAURA</creatorcontrib><creatorcontrib>FORINI, ELENA</creatorcontrib><creatorcontrib>ALOYSIO, DOMENICO DE</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>ALBERTAZZI, PAOLA</au><au>PANSINI, FRANCESCO</au><au>BONACCORSI, GLORIA</au><au>ZANOTTI, LAURA</au><au>FORINI, ELENA</au><au>ALOYSIO, DOMENICO DE</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Effect of Dietary Soy Supplementation on Hot Flushes</atitle><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle><addtitle>Obstet Gynecol</addtitle><date>1998-01</date><risdate>1998</risdate><volume>91</volume><issue>1</issue><spage>6</spage><epage>11</epage><pages>6-11</pages><issn>0029-7844</issn><eissn>1873-233X</eissn><coden>OBGNAS</coden><abstract>OBJECTIVETo assess the effect of daily dietary supplementation of soy protein isolate powder on hot flushes in post-menopausal women. METHODSWe carried out a double-blind, parallel, multi-center, randomized placebo-controlled trial of 104 post-menopausal women. Fifty-one patients (age range 48–61 years) took 60 g of isolated soy protein daily and 53 patients (age range 45–62 years) took 60 g of placebo (casein) daily. The study lasted 12 weeks. Using analysis of covariance, we analyzed changes from baseline in mean number of moderate to severe hot flushes (including night sweats) during treatment. RESULTSSoy was significantly superior to placebo (P &lt; .01 in reducing the mean number of hot flushes per 24 hours after 4, 8, and 12 weeks of treatment. In particular, women taking soy had a 26% reduction in the mean number of hot flushes by week 3 and a 33% reduction by week 4 (P &lt; .001 by the Wilcoxon exact test). By the end of the 12th week, patients taking soy had a 45% reduction in their daily hot flushes versus a 30% reduction obtained with the placebo (P &lt; .01). The overall rates of adverse effects were similar for soy and casein-placebo. Twenty-five patients dropped out of the study11 in the soy group and 14 in the placebo group. Gastrointestinal side effects were the most common cause of premature withdrawal from the study (seven patients in each group). CONCLUSIONSoy protein isolate added daily to the diet substantially reduced the frequency of hot flushes in climacteric women.</abstract><cop>New York, NY</cop><pub>The American College of Obstetricians and Gynecologists</pub><pmid>9464712</pmid><doi>10.1016/s0029-7844(97)00597-8</doi><tpages>6</tpages></addata></record>
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subjects Biological and medical sciences
Cohort Studies
Dietary Supplements - adverse effects
Double-Blind Method
Female
Gynecology. Andrology. Obstetrics
Hot Flashes - diet therapy
Hot Flashes - metabolism
Hot Flashes - physiopathology
Humans
Medical sciences
Middle Aged
Postmenopause - drug effects
Postmenopause - physiology
Puberal and climacteric disorders (male and female)
Soybean Proteins - administration & dosage
Soybean Proteins - adverse effects
Soybean Proteins - therapeutic use
Time Factors
title The Effect of Dietary Soy Supplementation on Hot Flushes
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