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Genistein reduces the number and duration of hot flashes in peri/post menopausal women in a randomized, double‐blind, placebo‐controlled, multi‐center trial

2009· article· en· W139542259 on OpenAlexaff
James Elliott, Malkanthi Evans, Prachi Sharma, R Berman, Najla Guthrie

Bibliographic record

VenueThe FASEB Journal · 2009
Typearticle
Languageen
FieldMedicine
TopicPhytoestrogen effects and research
Canadian institutionsKGK Synergize (Canada)
Fundersnot available
KeywordsPlaceboMedicineAdverse effectPeriMenopauseRandomized controlled trialHot flashHormone replacement therapy (female-to-male)Internal medicineBreast cancerCancer

Abstract

fetched live from OpenAlex

Objective To evaluate the effectiveness of a safe, high‐purity, non‐plant derived, non‐allergenic, patent‐protected, proprietary genistein (geniVida) in alleviating hot flashes in peri/post menopausal women. Methods 84 peri/post menopausal women (minimum 7 hot flashes/day or 40/week) were enrolled in a randomized, placebo‐controlled, parallel, multi‐center ICH/GCP trial and given a 30 mg capsule of geniVida or a 30 mg placebo capsule daily with breakfast for 12 weeks. Measurements included daily hot flashes, FSH, 17 beta‐estradiol, endometrial thickness and adverse events. Results Women on geniVida had fewer hot flashes/day from baseline to 8 and 12 weeks vs. women on the placebo (p=0.045 and p=0.015, respectively). 61.5% of women on geniVida had 50% or greater reduction in daily hot flashes vs. 25.9% of women on placebo. 88.5% of women on geniVida had 25% or greater reduction in duration of daily hot flashes vs. 59.3% of women on placebo. Severity of hot flashes was not different between groups. There were no differences between the groups for FSH, 17 beta‐estradiol, endometrial thickness and adverse events. Conclusions geniVida genistein was demonstrated to have a significant benefit in reducing the number and duration of daily hot flashes in peri/post menopausal women and may be used to manage menopausal symptoms without hormone replacement. Supported by DSM Nutritional Products, Inc.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.001
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.003
Threshold uncertainty score0.010

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0010.001
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0020.001
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0030.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.026
GPT teacher head0.326
Teacher spread0.299 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations1
Published2009
Admission routes1
Has abstractyes

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