Evidence map›Paper›PMID 34288973›Full record

Trial reportPloS one2021

Influence of a new botanical combination on quality of life in menopausal Spanish women: Results of a randomized, placebo-controlled pilot study.

Laura López-Ríos, Miguel A Barber, Julia Wiebe, Rubén P Machín, Tanausú Vega-Morales, Ricardo Chirino

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2021. 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.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT04381026 nacompletednot on this map

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, 14 citations in OpenAlex.

  1. Trial
  2. Dermocosmetic Potential ofAntioxidants (Basel, Switzerland) · 2026
    Review
  3. Beneficial Effects of Pomegranate Extracts for Benign Gynecologic Disorders.Reproductive sciences (Thousand Oaks, Calif.) · 2025
    Review
  4. Pharmaceuticals (Basel, Switzerland) · 2025
    Article
  5. Review
  6. Article
  7. Review
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 1 institution in 1 country.

Laura López-RíosDepartment of Research, Development and Innovation, Nektium Pharma SL, Agüimes, Las Palmas, Spain.
Miguel A BarberGynecological Division, Baren Clinic, Las Palmas de Gran Canaria, Las Palmas, Spain.
Julia WiebeDepartment of Research, Development and Innovation, Nektium Pharma SL, Agüimes, Las Palmas, Spain.
Rubén P MachínDepartment of Research, Development and Innovation, Nektium Pharma SL, Agüimes, Las Palmas, Spain.
Tanausú Vega-MoralesDepartment of Research, Development and Innovation, Nektium Pharma SL, Agüimes, Las Palmas, Spain.
Ricardo ChirinoDepartment of Biochemistry, Molecular Biology, Physiology, Genetics and Immunology, Universidad de las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Las Palmas, Spain.
Universidad de Las Palmas de Gran Canaria · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study was designed to evaluate the beneficial effects of a botanical extract combination containing soy isoflavone extract (100mg), Aframomum melegueta seed dry extract (50 mg), and Punica granatum skin dry extract (100mg) on health-related Quality of Life in healthy Spanish menopausal women with hot flashes, anxiety, and depressive symptoms using the validated Cervantes Scale. METHODS AND

resultsFifty-seven outpatient women (45-65 years) with menstrual problems associated with climacteric syndrome were enrolled from April 2018 to April 2019 in the context of a prospective, placebo-controlled, double-blind study. Women were randomized to receive treatment with either the botanical combination (250 mg daily divided into two doses) or placebo for eight weeks. At the beginning and end of the study, health-related Quality of Life was assessed using the Cervantes Scale. Subjects treated with the botanical extract, compared to subjects in the placebo group, showed a significant improvement in the Global health-related Quality of Life score (38% [11.3-50.0]% vs. 18.8% [0-37.7]%; P = 0.04) on the Cervantes Scale and, specifically, in the menopause and health domain (13.6% [0-45.4]% vs. 40.7% [20.6-61.0]%; P = 0.05). By contrast, there were no significant changes in the psychic, sexuality, and couple relationship related domains of the Cervantes Scale. Patients who concluded the study did not report substantial side effects.

conclusionShort-term intake of the botanical combination improved the Global Quality of Life of climateric women, according to the Cervantes Scale. Since this is a pilot trial, results should be analysed with caution.

trial registrationNCT04381026; ClinicalTrial.gov (retrospectively registered).

Indexed as

Health StatusMenopausePlant ExtractsQuality of LifeAnimalsDouble-Blind MethodFemaleGlycine maxHumansMiddle AgedPilot ProjectsPomegranateRatsRats, Inbred F344ZingiberaceaePlant Extracts

Identifiers

PMID34288973
PMCPMC8294509
OpenAlexW3186343692

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.