Evidence map›Paper›PMID 23730838›Full record

Trial reportJournal of viral hepatitis2013

Impact of oral silymarin on virus- and non-virus-specific T-cell responses in chronic hepatitis C infection.

O Adeyemo, H Doi, K Rajender Reddy, D E Kaplan

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of viral hepatitis, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 4 pooled it
1.2field-weighted citation impact, top 19% 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

11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Differential regulation of CD4Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2018
    Article
  11. 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.

O AdeyemoDivision of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
H Doi
K Rajender Reddy
D E Kaplan
University of Pennsylvania · US

Funding

INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR024134 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2006 to 2011
$70.4M
TRANSGENIC AND CHIMERIC MOUSE COREP30DK050306 · NIDDK · UNIVERSITY OF PENNSYLVANIA · PI REBECCA G WELLS · 1997 to 2026
$32.5M
Phase I/II Trials of Silymarin for Chronic Liver Diseases Data Coordinating CenteU01AT003566 · NCCIH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BELLE, STEVEN H. · 2006 to 2011
$1.9M
Mentoring Junior Faculty: Viral hepatitis Clinical ResearchK24DK066144 · NIDDK · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRIED, MICHAEL W · 2004 to 2014
$1.5M
Clinical Center for Phase I/II trials of Silymarin in Chronic Liver DiseaseU01AT003571 · NCCIH · BETH ISRAEL DEACONESS MEDICAL CENTER · PI AFDAHL, NEZAM HASSAN · 2006 to 2010
$1.1M
A phase I/II trial of silymarin for chronic liver diseasesU01AT003573 · NCCIH · UNIVERSITY OF PENNSYLVANIA · PI REDDY, RAJENDER KUCHIKULLA · 2006 to 2010
$1.0M
Silymarin for the Treatment of Nonalcoholic SteatohepatitisU01AT003574 · NCCIH · THOMAS JEFFERSON UNIVERSITY · PI NAVARRO, VICTOR J · 2006 to 2010
$937k
A phase I/II randomized, placebo controlled trial of silymarin for hepatitis CU01AT003560 · NCCIH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI FRIED, MICHAEL W · 2006 to 2008
$824k
NCCIH NIH HHS AT003560NCCIH NIH HHS AT003566NCCIH NIH HHS AT003571NCCIH NIH HHS AT003573NCCIH NIH HHS AT003574NCCIH NIH HHS U01 AT003560NCCIH NIH HHS U01 AT003566NCCIH NIH HHS U01 AT003571NCCIH NIH HHS U01 AT003573NCCIH NIH HHS U01 AT003574NCRR NIH HHS UL1 RR024134NIDDK NIH HHS K24 DK066144NIDDK NIH HHS P30 DK050306NIDDK NIH HHS P30-DK050306
6 · The paper itself

Abstract

Silymarin displays anti-inflammatory effects on T lymphocytes in vitro. The immunomodulatory properties of oral silymarin in vivo in humans with chronic hepatitis C have not previously been characterized. We hypothesized that silymarin would suppress T-cell proliferation and pro-inflammatory cytokine production of virus- and non-virus-specific T cells while increasing anti-inflammatory IL-10 production in vivo. Patients from one site of the SyNCH-HCV double-masked, placebo-controlled study of oral silymarin in prior interferon nonresponders with chronic hepatitis C provided blood samples at baseline and treatment week 20. Mononuclear cells were stimulated with recombinant HCV proteins and controls in (3) H-thymidine proliferation assays, IFNγ ELISPOT and IL-10 ELISPOT. The frequency of CD4(+) CD25(hi) and CD4(+) foxp3(+) regulatory T cells, serum cytokine levels, serum IP-10 and lymphocyte interferon-stimulated gene expression were also quantified at baseline and week 20. Thirty-two patients were recruited (10; placebo, 11; 420 mg three times a day, 11; 700 mg three times a day). Serum ALT and HCV RNA titres did not change in any group. HCV-specific CD4(+) T-cell proliferation and the frequency of IFNγ- and IL-10-producing T cells were not significantly changed in silymarin-treated subjects. However, C. albicans-induced T-cell IFNγ and phytohaemagglutinin-induced T-cell proliferation were suppressed by silymarin therapy. A trend towards augmentation of interferon-induced ISG15 expression was present in the high-dose silymarin group. While no effect on HCV-specific T cells was identified, these data confirm that high-dose oral silymarin exerts modest nonspecific immunomodulatory effects in vivo. The impact of this anti-inflammatory effect on long-term liver health in chronic hepatitis C merits future clinical investigation.

Indexed as

Administration, OralCell ProliferationCytokinesDouble-Blind MethodFemaleHepatitis C, ChronicHumansImmunologic FactorsMaleMiddle AgedPlacebosSilymarinT-Lymphocyte SubsetsTreatment OutcomeCytokinesImmunologic FactorsPlacebosSilymarin

Identifiers

PMID23730838
PMCPMC3675799
OpenAlexW2059065322

What OpenQuestion holds

Textmetadata
LicenceTDM
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.