Evidence map›Paper›PMID 26130251›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2015

A Phase II Randomized, Controlled Trial of S-Adenosylmethionine in Reducing Serum α-Fetoprotein in Patients with Hepatitis C Cirrhosis and Elevated AFP.

Timothy R Morgan, Kathryn Osann, Teodoro Bottiglieri, Neville Pimstone, John C Hoefs, Ke-Qin Hu, Tarek Hassanein, Thomas D Boyer, Lorene Kong, Wen-Pin Chen and 4 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00513461 (A Phase II, Randomized, Controlled Trial of The Safety and Efficacy of S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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.

NCT00513461 phase2completednot on this map

A Phase II, Randomized, Controlled Trial of The Safety and Efficacy of S-Adenosyl-L-Methionine Disulphate P-Toluene-Sulfonate (SAMe) in Reducing Serum Alpha-Fetoprotein (AFP) in Patients With Hepatitis C and Moderately Elevated AFP

TypeinterventionalSponsorChao Family Comprehensive Cancer CenterRan2007 to 2013Enrolled110ConditionsAdult Primary Liver Cancer, Hepatitis C InfectionArmsS-adenosyl-L-methionine disulfate p-toluene-sulfonate, placebo, laboratory biomarker analysis, immunoenzyme technique, high performance liquid chromatography
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Generic chemoprevention of hepatocellular carcinoma.Annals of the New York Academy of Sciences · 2019
    Review
  10. Review
  11. Article
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

14 authors at 9 institutions in 1 country.

Timothy R MorganMedical Healthcare Group, VA Long Beach Healthcare System, Long Beach, California. Department of Medicine, Division of Gastroenterology, University of California, Irvine, California. timothy.morgan@va.gov.
Kathryn OsannDepartment of Medicine, Division of Hematology/Oncology, University of California, Irvine, California.
Teodoro BottiglieriInstitute of Metabolic Disease, Baylor Research Institute, Dallas, Texas.
Neville PimstoneMedical Healthcare Group, VA Greater Los Angeles Healthcare System, Los Angeles, California.
John C HoefsDepartment of Medicine, Department of Medicine, University of California, Irvine, California.
Ke-Qin HuDepartment of Medicine, Division of Gastroenterology, University of California, Irvine, California.
Tarek HassaneinDepartment of Medicine, Division of Hepatology, University of California, San Diego, California.
Thomas D BoyerLiver Research Institute and Department of Medicine, University of Arizona, Tucson, Arizona.
Lorene KongResearch Pharmacy, University of California, Irvine, California.
Wen-Pin ChenChao Family Comprehensive Cancer Center, University of California, Irvine, California.
Ellen RichmondDivision of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.
Rachel GonzalezResearch Healthcare Group, VA Long Beach Healthcare System, Long Beach, California.
Luz M RodriguezDivision of Cancer Prevention, National Cancer Institute, Bethesda, Maryland. Department of Surgery, Walter Reed National Military Medical Center, Bethesda, Maryland.
Frank L MeyskensDepartments of Medicine, Biological Chemistry, Public Health and Epidemiology and Chao Family Comprehensive Cancer Center, University of California, Irvine, California.
University of California, Irvine · USBaylor Institute for Rehabilitation · USComprehensive Blood & Cancer Center · USNational Cancer Institute · USUniversity of Arizona · USUniversity of California San Diego · USVA Greater Los Angeles Healthcare System · USVA Long Beach Healthcare System · USWalter Reed National Military Medical Center · US

Funding

Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Christine Hui · 1994 to 2026
$57.9M
University of California Health Participation in the National COVID Cohort Collaborative (N3C)UL1TR001414 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M, VILAIN, ERIC J. · 2015 to 2023
$35.1M
Institute for Clinical and Translational ScienceUL1TR000153 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M · 2012 to 2015
$12.1M
PHASE I and II CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS-261035-261035160N01CN035160 · CN · REGENTS OF THE UNIVERSITY OF · PI MEYSKENS, FRANK L. · 2004 to 2006
–
NCATS NIH HHS UL1 TR000153NCATS NIH HHS UL1 TR001414NCI NIH HHS N01 CN035160NCI NIH HHS N01-CN-35160NCI NIH HHS P30 CA062203
6 · The paper itself

Abstract

In animal models of hepatocellular carcinoma (HCC), deficiency of S-adenosylmethionine (SAMe) increased the risk of HCC whereas administration of SAMe reduced HCC. The aim of this trial was to determine whether oral SAMe administration to patients with hepatitis C cirrhosis would decrease serum α-fetoprotein (AFP) level, a biomarker of HCC risk in hepatitis C. This was a prospective, randomized, placebo-controlled, double-blind trial of SAMe, up to 2.4 g/d, for 24 weeks as compared with placebo among subjects with hepatitis C cirrhosis and a mildly elevated serum AFP. Primary outcome was change in AFP between baseline and week 24. Secondary outcomes included changes in routine tests of liver function and injury, other biomarkers of HCC risk, SAMe metabolites, markers of oxidative stress, and quality of life. One hundred ten subjects were randomized and 87 (44 SAMe and 43 placebo) completed treatment. There was no difference in the change in AFP during 24 weeks among subjects receiving SAMe as compared with placebo. Changes in markers of liver function, liver injury, and hepatitis C viral level were not significantly different between groups. Similarly, SAMe did not change markers of oxidative stress or serum glutathione level. SAMe blood level increased significantly among subjects receiving SAMe. Changes in quality of life did not differ between groups. Overall, this trial did not find that SAMe treatment improved serum AFP in subjects with advanced hepatitis C cirrhosis and a mildly elevated AFP. SAMe did not improve tests of liver function or injury or markers of oxidative stress or antioxidant potential.

Indexed as

alpha-FetoproteinsAntioxidantsBiomarkersDouble-Blind MethodFemaleHepatitis CHumansLiver CirrhosisLiver Function TestsMaleMiddle AgedOxidative StressProspective StudiesQuality of LifeS-AdenosylmethionineAFP protein, humanalpha-FetoproteinsAntioxidantsBiomarkersS-Adenosylmethionine

Identifiers

PMID26130251
PMCPMC4560676
OpenAlexW2137449120

What OpenQuestion holds

Textmetadata
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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 OpenQuestion graph.