Evidence map›Paper›PMID 31567873›Full record

Trial reportMenopause (New York, N.Y.)2020

Retrospective analysis of phytoSERM for management of menopause-associated vasomotor symptoms and cognitive decline: a pilot study on pharmacogenomic effects of mitochondrial haplogroup and APOE genotype on therapeutic efficacy.

Yiwei Wang, Gerson Hernandez, Wendy J Mack, Lon S Schneider, Fei Yin, Roberta D Brinton

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Menopause (New York, N.Y.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01723917 (Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline), which is not on this map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01723917 nacompletednot on this map

Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline

TypeinterventionalSponsorUniversity of Southern CaliforniaRan2012 to 2015Enrolled71ConditionsHot Flashes, Memory LossArmsPhytoSERM tablet, placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
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  11. The novel estrogen receptor beta agonist EGX358 andFrontiers in aging neuroscience · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Yiwei WangSchool of Pharmacy, University of Southern California, Los Angeles, CA.
Gerson HernandezSchool of Pharmacy, University of Southern California, Los Angeles, CA.
Wendy J MackKeck School of Medicine, University of Southern California, Los Angeles, CA.
Lon S SchneiderKeck School of Medicine, University of Southern California, Los Angeles, CA.
Fei YinSchool of Pharmacy, University of Southern California, Los Angeles, CA.
Roberta D BrintonSchool of Pharmacy, University of Southern California, Los Angeles, CA.
University of Arizona · USUniversity of Southern California · US

Funding

Timing of Menopausal Hormone Therapy across Perimenopause to Menopause Transition: Neuroimmune System in BrainP01AG026572 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI ROBERTA EILEEN BRINTON · 2006 to 2026
$53.7M
VASCULAR RISK AND COGNITIVE STATUS IN A LATINO POPULATIONP50AG005142 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI BRASKIE, MEREDITH NICOLE · 1985 to 2019
$41.0M
USCADRC Diversity Supplement PachicanoP30AG066530 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI HELENA Chang CHUI, ARTHUR W TOGA · 2020 to 2026
$27.8M
Aging and Estrogenic Control of the Bioenergetic System in BrainR37AG053589 · NIA · UNIVERSITY OF ARIZONA · PI ROBERTA EILEEN BRINTON · 2017 to 2026
$4.2M
Estrogen Receptor-beta phytoSERMs for Management of Menopause and Memory DeclineR01AG033288 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI SCHNEIDER, LON S · 2010 to 2012
$1.6M
Estrogen-Induced Neuroprotective Mitochondrial MechanismR01MH067159 · NIMH · UNIVERSITY OF SOUTHERN CALIFORNIA · PI BRINTON, ROBERTA DIAZ · 2003 to 2007
$1.3M
NIA NIH HHS P01 AG026572NIA NIH HHS P30 AG066530NIA NIH HHS P50 AG005142NIA NIH HHS R01 AG033288NIA NIH HHS R37 AG053589NIMH NIH HHS R01 MH067159
6 · The paper itself

Abstract

objectivePhytoSERM is a selective estrogen receptor beta (ERβ) modulator comprised of three phytoestrogens: genistein, daidzein, and S-equol. The PhytoSERM formulation promotes estrogenic action in the brain while largely inactive or inhibitory in reproductive tissue. A phase Ib/IIa clinical trial (ClinicalTrial.gov ID: NCT01723917) of PhytoSERM demonstrated safety and pharmacokinetics profile of PhytoSERM. While this study was not powered for efficacy analysis, we conducted a pilot, retrospective analysis to identify potential responders to PhytoSERM treatment, and to determine the optimal populations to pursue in a phase II clinical trial of efficacy of the PhytoSERM formulation.

methodsIn this retrospective analysis involving 46 participants (n = 16, placebo; n = 18, 50 mg/d PhytoSERM; and n = 12, 100 mg/d PhytoSERM), the therapeutic effect of PhytoSERM was stratified by 2 genetic risk modulators for Alzheimer's disease: mitochondrial haplogroup and APOE genotype.

resultsOur retrospective responder analysis indicated that participants on 50 mg of daily PhytoSERM (PS50) for 12 weeks significantly reduced hot flash frequency compared with their baseline (mean [95% CI])-1.61, [-2.79, -0.42], P = 0.007). Participants on 50 mg of PhytoSERM also had significantly greater reduction in hot flash frequency at 12 weeks compared with the placebo group (-1.38, -0.17 [median PS50, median placebo], P = 0.04). Fifty milligrams of daily PhytoSERM also preserved cognitive function in certain aspects of verbal learning and executive function. Our analysis further suggests that mitochondrial haplogroup and APOE genotype can modify PhytoSERM response.

conclusionOur data support a precision medicine approach for further development of PhytoSERM as a safe and effective alternative to hormone therapy for menopause-associated hot flash and cognitive decline. While definitive determination of PhytoSERM efficacy is limited by the small sample size, these data provide a reasonable rationale to extend analyses to a larger study set powered to address statistical significance.

Indexed as

HaplotypesMenopauseApolipoproteins ECognitionCognitive DysfunctionDouble-Blind MethodEquolFeasibility StudiesFemaleGenisteinHot FlashesHumansIsoflavonesMiddle AgedMitochondriaPhytoestrogensApoE protein, humanApolipoproteins EdaidzeinEquolGenisteinIsoflavonesPhytoestrogensSelective Estrogen Receptor Modulators

Identifiers

PMID31567873
PMCPMC7100617
OpenAlexW2974455366

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.