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Annette Thomas, RN, MS, PhD student Nancy Fugate Woods, PhD, RN, FAAN Ellen Sullivan Mitchell, PhD Janet Schnall MS, AHIIP Soy, Isoflavones, and Amino Acids for Symptom Clusters During the Menopausal Transition and Early Postmenopause: A Systematic Review

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Background Women have been reluctant to use HT since the publication of the WHI results and increasingly have become interested in CAM therapies Soy & Isoflavones may be a good alternative for women who experience Hot Flashes as well as other associated symptoms such as problems with cognition, sleep, mood, or pain.

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Background SoyIsoflavones Transformed by intestinal flora during digestion Phytoestrogen Regulates the estrogen levels in the body 30% of population can convert Diadzein into EQUOL Diadzein Genistein Glyceiti n

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Aim To review controlled clinical trials of Soy, Isoflavones, and Amino Acids on hot flashes and at least one other symptom that women experience during the menopausal transition (MT) and post menopause (PM) such as problems with sleep, cognitive function, mood, and pain

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Methods Of the 59 unique trials identified of nonpharmacologic therapies, 17 Soy, Isoflavone, & Amino Acid RCTs were systematically reviewed: 5 Soy protein 7 Isoflavone 2 Amino Acid 3 Mixtures

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Results Soy Protein StudyIntervention/ComparisonHot Flash SleepCog - fxn MoodPain Basaria 2009 20g soy protein vs. 20g whole milk protein NSNMNS+NM Hanachi 2008 12.5g soy protein in soymilk vs. soymilk + walking 1 hour ?NS Jou 2008 6g soy germ extract vs. roasted wheat +NSNMNS Welty 2007 25g soy protein (soy nuts) vs. TLC diet (low cholesterol) +NM + Lewis 2006 25g soy in soy flour muffins vs. ground flaxseed muffings vs. wheat flour muffins NSNM

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Results Isoflavones StudyIntervention/ComparisonHot Flashes Slee p Cog- fxn MoodPain Evans 2011 Synthetic Genistein (30mg) vs. Placebo +NM NSNM Carmignani 2010 Isoflavone powder (90mg) vs. HT vs. placebo +NM ++ Lee 2010 Rexflavone (135mg) vs. placebo ++NMNS+ Albertazzi 2005 Genistein (90mg) vs. placebo+ (HF>9) NSNMNSNM

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Results Isoflavones (contd) StudyIntervention/ComparisonHot Flashes SleepCog- fxn MoodPain Hildago 2005 Red Clover Isoflavone (80mg) vs. placebo +++++ Jou 2005 70mg isoflavone vs. 35mg isoflavone vs. placebo NS+NM+ Uesugi 2004 40mg isoflavone vs. placeboNS NMNS Key: + is significant for P