Evidence map›Paper›PMID 20014183›Full record

Trial reportCancer2010

A randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute lymphoblastic leukemia (ALL).

Elena J Ladas, David J Kroll, Nicholas H Oberlies, Bin Cheng, Deborah H Ndao, Susan R Rheingold, Kara M Kelly

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00055718 (A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia), which is not on this map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
3.8field-weighted citation impact, top 7% 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.

NCT00055718 phase2completednot on this map

A Pilot Study of Silymarin During Maintenance Therapy in Children With Acute Lymphoblastic Leukemia (ALL)

TypeinterventionalSponsorHerbert Irving Comprehensive Cancer CenterRan2001 to 2010Enrolled50ConditionsDrug/Agent Toxicity by Tissue/Organ, LeukemiaArmssilymarin
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it, 107 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. Pooled it
  5. Trial
  6. International journal of molecular sciences · 2026
    Review
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  11. Review
  12. Article
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  14. Article
  15. Silymarin (milk thistle extract) as a therapeutic agent in gastrointestinal cancer.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2021
    Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. 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

7 authors at 4 institutions in 1 country.

Elena J LadasDivision of Pediatric Oncology, Columbia University Medical Center, New York, New York 10032, USA.
David J Kroll
Nicholas H Oberlies
Bin Cheng
Deborah H Ndao
Susan R Rheingold
Kara M Kelly
Columbia University Irving Medical Center · USChildren's Hospital of Philadelphia · USNorth Carolina Central University · USResearch Triangle Park Foundation · US

Funding

Pure Flavonolignans from S. marianum in Prostate CancerR01CA104286 · NCI · RESEARCH TRIANGLE INSTITUTE · PI OBERLIES, NICHOLAS H. · 2004 to 2008
$1.9M
NCI NIH HHS R01 CA104286
6 · The paper itself

Abstract

backgroundDespite limited preclinical and clinical investigations, milk thistle (MT) is often used for the treatment of chemotherapy-associated hepatotoxicity. Limited treatment options exist for chemotherapy-related hepatoxicity. Given the wide use of MT, the authors investigated MT in both the laboratory and a clinical setting.

methodsIn a double-blind study, children with acute lymphoblastic leukemia (ALL) and hepatic toxicity were randomized to MT or placebo orally for 28 days. Liver function tests were evaluated during the study period. To assess MT in vitro, the authors evaluated supratherapeutic concentrations in an ALL cell line.

resultsFifty children were enrolled. No significant differences in frequency of side effects, incidence and severity of toxicities, or infections were observed between groups. There were no significant changes in mean amino alanine transferase (ALT), aspartate amino transferase (AST), or total bilirubin (TB) at Day 28. At Day 56, the MT group had a significantly lower AST (P = .05) and a trend toward a significantly lower ALT (P = .07). Although not significantly different, chemotherapy doses were reduced in 61% of the MT group compared with 72% of the placebo group. In vitro experiments revealed no antagonistic interactions between MT and vincristine or L-asparaginase in CCRF-CEM cells. A modest synergistic effect with vincristine was observed.

conclusionsIn children with ALL and liver toxicity, MT was associated with a trend toward significant reductions in liver toxicity. MT did not antagonize the effects of chemotherapy agents used for the treatment of ALL. Future study is needed to determine the most effective dose and duration of MT and its effect on hepatotoxicity and leukemia-free survival.

Indexed as

PhytotherapySilybum marianumAdolescentAntineoplastic AgentsChemical and Drug Induced Liver InjuryChildChild, PreschoolDouble-Blind MethodDrug Evaluation, PreclinicalDrug InteractionsFemaleHumansInfantLiver Function TestsMalePilot ProjectsAntineoplastic AgentsPlacebos

Identifiers

PMID20014183
PMCPMC3542639
OpenAlexW2073255871

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.