Evidence map›Paper›PMID 25732561›Full record

Trial reportDrugs in R&D2015

Efficacy of lifestyle changes in subjects with non-alcoholic liver steatosis and metabolic syndrome may be improved with an antioxidant nutraceutical: a controlled clinical study.

Gianpaolo Sorrentino, Paola Crispino, Daniela Coppola, Giorgio De Stefano

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in Drugs in R&D, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 5 pooled it
4.4field-weighted citation impact, top 5% 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

22 citing papers in PubMed, 5 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Review
  11. Review
  12. Silymarin Reduced Insulin Resistance in Non-Diabetic Women with Obesity.International journal of molecular sciences · 2024
    Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. Developmental origins of NAFLD: a womb with a clue.Nature reviews. Gastroenterology & hepatology · 2017
    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

4 authors at 1 institution in 1 country.

Gianpaolo SorrentinoClinic Center, Viale Maria Bakunin 171, 80126, Naples, Italy, lucavic@live.it.
Paola Crispino
Daniela Coppola
Giorgio De Stefano
Ave Maria University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe prevalence of liver steatosis is particularly high in subjects with signs of the metabolic syndrome, and current therapeutic guidelines mostly rely on lifestyle changes alone, which rarely achieve significant objective improvements. In the present study, we evaluated the possibility of monitoring objective improvements in these subjects, before and after a dietary regimen.

methodsOverall, 78 subjects with metabolic syndrome and ultrasound confirmation of liver steatosis were included in an open, controlled study; all of these subjects were treated for 90 days with the standard regimen of diet and exercise. One group of 43 subjects (Group A) also received a Eurosil 85(®)-based nutraceutical (silymarin + vitamin E) as a dietary adjunct, whereas the remaining 35 subjects (Group B) represented the control group. Changes from baseline values were recorded in biometric, biochemical, and ultrasound data. For assessments and monitoring of liver steatosis, two indexes were utilised-Hepatic Steatosis Index (HSI) and Lipid Accumulation Product (LAP) index.

resultsThe absolute changes from baseline were significantly higher in Group A in biometric parameters (reduction of abdominal circumference, Body Mass Index, ultrasound measurement of right liver lobe) and in both the HSI and LAP indexes. Both treatments were well tolerated.

conclusionThe results observed suggest that the use of a Eurosil 85(®)-based nutraceutical as a dietary adjunct with antioxidant properties potentially favours the efficacy of the dietary regimen alone and may possibly improve the subjects' motivation to sustain such lifestyle changes over time.

Indexed as

Life StyleAdultAgedAntioxidantsCombined Modality TherapyDietary SupplementsDrug CombinationsFemaleHumansMaleMetabolic SyndromeMiddle AgedNon-alcoholic Fatty Liver DiseaseSilymarinTreatment OutcomeVitamin EAntioxidantsDrug CombinationsSilymarinVitamin E

Identifiers

PMID25732561
PMCPMC4359182
OpenAlexW1992103312

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.