Evidence map›Paper›PMID 26806546›Full record

Trial reportGynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology2016

Impact of a soy drink on climacteric symptoms: an open-label, crossover, randomized clinical trial.

Salvador Tranche, Carlos Brotons, Beatriz Pascual de la Pisa, Ramón Macías, Eduardo Hevia, Mercè Marzo-Castillejo

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04381026 (Study on the Effect of a Nutritional Supplement With Isoflavones on the Symptoms of Climacteric in Healthy Women), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04381026 nacompletednot on this mapstarted 2017, after this paper: background citation

Study on the Effect of a Nutritional Supplement With Isoflavones on the Symptoms of Climacteric in Healthy Women

TypeinterventionalSponsorNektium Pharma SLRan2017 to 2018Enrolled57ConditionsMenopause, Dietary Supplements, Quality of LifeArmsBotanical dry extracts combination, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
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.

Salvador Tranchea Sociedad Española de Medicina de Familia y Comunitaria (semFYC) , Spain .
Carlos Brotonsa Sociedad Española de Medicina de Familia y Comunitaria (semFYC) , Spain .
Beatriz Pascual de la Pisaa Sociedad Española de Medicina de Familia y Comunitaria (semFYC) , Spain .
Ramón Macíasa Sociedad Española de Medicina de Familia y Comunitaria (semFYC) , Spain .
Eduardo Heviaa Sociedad Española de Medicina de Familia y Comunitaria (semFYC) , Spain .
Mercè Marzo-Castillejoa Sociedad Española de Medicina de Familia y Comunitaria (semFYC) , Spain .

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe objective of this study is to evaluate the effects of a soy drink with a high concentration of isoflavones (ViveSoy®) on climacteric symptoms.

methodsAn open-label, controlled, crossover clinical trial was conducted in 147 peri- and postmenopausal women. Eligible women were recruited from 13 Spanish health centers and randomly assigned to one of the two sequence groups (control or ViveSoy®, 500 mL per day, 15 g of protein and 50 mg of isoflavones). Each intervention phase lasted for 12 weeks with a 6-week washout period. Changes on the Menopause Rating Scale and quality of life questionnaires, as well as lipid profile, cardiovascular risk and carbohydrate and bone metabolism were assessed. Statistical analysis was performed using a mixed-effects model.

resultsA sample of 147 female volunteers was recruited of which 90 were evaluable. In both sequence groups, adherence to the intervention was high. Regular consumption of ViveSoy® reduced climacteric symptoms by 20.4% (p = 0.001) and symptoms in the urogenital domain by 21.3% (p < 0.05). It also improved health-related quality life by 18.1%, as per the MRS questionnaire (p <0.05).

conclusionRegular consumption of ViveSoy® improves both the somatic and urogenital domain symptoms of menopause, as well as health-related quality of life in peri- and postmenopausal women.

Indexed as

Cross-Over StudiesFemaleHumansIsoflavonesMenopauseMiddle AgedSoybean ProteinsSoy MilkTreatment OutcomeIsoflavonesSoybean ProteinsEstrogensmenopauseurogenital system

Identifiers

PMID26806546
PMCPMC4898139

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.