Evidence map›Paper›PMID 34684666›Full record

Trial reportNutrients2021

Berberine Phospholipid Is an Effective Insulin Sensitizer and Improves Metabolic and Hormonal Disorders in Women with Polycystic Ovary Syndrome: A One-Group Pretest-Post-Test Explanatory Study.

Mariangela Rondanelli, Antonella Riva, Giovanna Petrangolini, Pietro Allegrini, Attilio Giacosa, Teresa Fazia, Luisa Bernardinelli, Clara Gasparri, Gabriella Peroni, Simone Perna

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Nutrients, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
5.2field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 42 citations in OpenAlex.

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  17. AnFrontiers in molecular biosciences · 2024
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  18. Heliyon · 2023
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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

10 authors at 4 institutions in 2 countries.

Mariangela RondanelliIRCCS Mondino Foundation, 27100 Pavia, Italy.ORCID 0000-0001-8336-4851
Antonella RivaResearch and Development Department, Indena SpA, 20139 Milan, Italy.ORCID 0000-0003-2819-943X
Giovanna PetrangoliniResearch and Development Department, Indena SpA, 20139 Milan, Italy.ORCID 0000-0001-6681-7329
Pietro AllegriniResearch and Development Department, Indena SpA, 20139 Milan, Italy.ORCID 0000-0002-4380-9577
Attilio GiacosaDepartment of Gastroenterology and Clinical Nutrition, Policlinico di Monza, Via Amati 111, 20900 Monza, Italy.
Teresa FaziaDepartment of Brain and Behavioral Science, University of Pavia, 27100 Pavia, Italy.ORCID 0000-0002-9577-8450
Luisa BernardinelliDepartment of Brain and Behavioral Science, University of Pavia, 27100 Pavia, Italy.
Clara GasparriEndocrinology and Nutrition Unit, Azienda di Servizi Alla Persona ''Istituto Santa Margherita'', University of Pavia, 27100 Pavia, Italy.ORCID 0000-0002-1088-6648
Gabriella PeroniEndocrinology and Nutrition Unit, Azienda di Servizi Alla Persona ''Istituto Santa Margherita'', University of Pavia, 27100 Pavia, Italy.ORCID 0000-0002-1632-1787
Simone PernaDepartment of Biology, College of Science, Sakhir Campus, University of Bahrain, Zallaq 32038, Bahrain.ORCID 0000-0002-2720-1473
University of Pavia · ITIndena (Italy) · ITFondazione Lanza · ITUniversity of Bahrain · BH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in females of reproductive age and is characterized by multifactorial unhealthy conditions related to hormonal unbalance and also to dysmetabolism and inflammation. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. The aim of this one-group pretest-post-test explanatory study was to evaluate, in normal-overweight PCOS women with normal menses, the effectiveness of berberine on: Insulin resistance (IR) by Homeostasis Model Assessment (HOMA); Inflammation by C-Reactive Protein (CRP), Tumor Necrosis Factor α (TNF-α); Lipid metabolism; Sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); Body composition by DXA. Finally, adverse effects were assessed by liver and kidney functions and creatine phosphokinase (CPK). All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Twelve females (aged 26.6 ± 4.9, BMI 25.3 ± 3.6) were supplied for 60 days with two tablets/day (550 mg/table) of the bioavailable berberine. Results showed a statistically significant decrease in HOMA, CRP, TNF-α, Triglycerides, testosterone, Body Mass Index (BMI), Visceral Adipose Tissue (VAT), fat mass, GAGS and CADI scores, and a statistically significant increase in sex hormone-binding globulin (SHBG). Liver and kidney functions and CPK are not statistically significantly different. Therefore, berberine can represent a safe novel dietary supplement, helpful in treatment strategy for PCOS.

Indexed as

AdultBerberineBody CompositionEndpoint DeterminationFemaleHormonesHumansInflammationInsulinInsulin ResistanceLinear ModelsLipidsPhospholipidsPolycystic Ovary SyndromeBerberineHormonesInsulinLipidsPhospholipidsacne symptomsberberinehomeostasis model assessmentinflammationphytosomepolycystic ovary syndromevisceral adipose tissue

Identifiers

PMID34684666
PMCPMC8538182
OpenAlexW3207263306

What OpenQuestion holds

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Registered trials

None linked

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.