Evidence mapPaperPMID 31845191Full record

Trial reportJournal of endocrinological investigation2020

Micronutrients in support to the one carbon cycle for the modulation of blood fasting homocysteine in PCOS women.

N Schiuma, A Costantino, T Bartolotti, M Dattilo, V Bini, M C Aglietti, M Renga, A Favilli, A Falorni, S Gerli

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of endocrinological investigation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.1field-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.

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

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Vitamin BJournal of the Turkish German Gynecological Association · 2022
    Article
  11. Article
  12. 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

10 authors at 1 institution in 1 country.

N SchiumaCentro Demetra ARTeBIOS, Via Giardini 11, Lugo, RA, Italy.
A CostantinoCentro Demetra ARTeBIOS, Via Giardini 11, Lugo, RA, Italy.
T BartolottiCentro Demetra ARTeBIOS, Via Giardini 11, Lugo, RA, Italy.
M DattiloParthenogen, Piazza Indipendenza 11, Lugano, Switzerland. maurizio.dattilo@parthenogen.ch.ORCID http://orcid.org/0000-0002-0676-7929
V BiniSection of Internal Medicine and Endocrine and Metabolic Sciences, Department of Medicine, University of Perugia, Perugia, Italy.ORCID http://orcid.org/0000-0001-8404-2918
M C AgliettiSection of Internal Medicine and Endocrine and Metabolic Sciences, Department of Medicine, University of Perugia, Perugia, Italy.
M RengaSection of Internal Medicine and Endocrine and Metabolic Sciences, Department of Medicine, University of Perugia, Perugia, Italy.
A FavilliSection of Obstetrics and Gynecology, Department of Surgical and Biomedical Sciences, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.ORCID http://orcid.org/0000-0002-1556-0962
A FalorniSection of Internal Medicine and Endocrine and Metabolic Sciences, Department of Medicine, University of Perugia, Perugia, Italy.ORCID http://orcid.org/0000-0003-4532-3519
S GerliSection of Obstetrics and Gynecology, Department of Surgical and Biomedical Sciences, S. Maria della Misericordia Hospital, University of Perugia, Perugia, Italy.
University of Perugia · IT

Funding

University of Perugia (IT), Fondo di finanziamento della ricerca di base del Dipartimento di Scienze Chirurgiche e Biomediche Year 2015
6 · The paper itself

Abstract

purposeFasting blood homocysteine is increased in PCOS women and is involved in several of its co-morbidities including cardiovascular disease and infertility. Corrective interventions based on the administration of supra-physiologic doses of folic acid work to a low extent. We aimed to test an alternative approach.

methodsThis was a prospective, randomized, parallel group, open label, controlled versus no treatment clinical study. PCOS women aged > 18, free from systemic diseases and from pharmacological treatments were randomized with a 2:1 ratio for treatment with activated micronutrients in support to the carbon cycle (Impryl, Parthenogen, Switzerland-n = 22) or no treatment (n = 10) and followed-up for 3 months. Fasting blood homocysteine, AMH, testosterone, SHBGs, and the resulting FTI were tested before and at the end of the follow-up.

resultsThe mean baseline fasting blood homocysteine was above the normal limit of 12 μMol/L and inversely correlated with SHBG. AMH was also increased, whereas testosterone, SHBG, and FTI were within the normal limit. The treatment achieved a significant reduction of homocysteine, that did not change in the control group, independently of the starting value. The treatment also caused an increase of AMH and a decrease of SHBGs only in the subgroup with a normal homocysteine at baseline.

conclusionsIn PCOS ladies, blood homocysteine is increased and inversely correlated with the SHBGs. Physiologic amounts of activated micronutrients in support to the carbon cycle achieve a reduction virtually in all exposed patients. Whether this is of clinical benefit remains to be established.

Indexed as

AdultBiomarkersCarbon CycleFastingFemaleFollow-Up StudiesHomocysteineHumansMicronutrientsPolycystic Ovary SyndromeProspective StudiesYoung AdultBiomarkersHomocysteineMicronutrientsHomocysteineMicronutrientsOne carbon cyclePCOS

Identifiers

PMID31845191
PMCPMC7230049
OpenAlexW2994663511

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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 Socratic graph.