Evidence map›Paper›PMID 21079746›Full record

Trial reportPloS one2010

S-adenosyl-methionine and betaine improve early virological response in chronic hepatitis C patients with previous nonresponse.

Magdalena Filipowicz, Christine Bernsmeier, Luigi Terracciano, Francois H T Duong, Markus H Heim

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00310336 (Chronic Hepatitis C), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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.

NCT00310336 phase2 / phase3completednot on this map

Chronic Hepatitis C: Treatment of (Peg)Interferon Alpha - Ribavirin Non-Responders With Pegylated Interferon alpha2b, Ribavirin, AdoMet and Betaine

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2006 to 2009Enrolled30ConditionsHepatitis CArmsS-adenosyl-L-methionine, betaine, pegylated interferon alpha2b, ribavirin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Review
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  4. Review
  5. Article
  6. Article
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4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Magdalena FilipowiczHepatology Laboratory, Department of Biomedicine, University Hospital Basel, Basel, Switzerland.
Christine Bernsmeier
Luigi Terracciano
Francois H T Duong
Markus H Heim
University Hospital of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsTreatment of chronic hepatitis C (CHC) with pegylated interferon α (pegIFNα) and ribavirin results in a sustained response in approximately half of patients. Viral interference with IFNα signal transduction through the Jak-STAT pathway might be an important factor underlying treatment failure. S-adenosyl-L-methionine (SAMe) and betaine potentiate IFNα signaling in cultured cells that express hepatitis C virus (HCV) proteins, and enhance the inhibitory effect of IFNα on HCV replicons. We have performed a clinical study with the aim to evaluate efficacy and safety of the addition of SAMe and betaine to treatment of CHC with pegIFNα/ribavirin.

methodsIn this open-label pilot study, 29 patients with CHC who failed previous therapy with (peg)IFNα/ribavirin were treated with SAMe, betaine, pegIFNα2b and ribavirin. Treatment duration was 6 or 12 months, depending on genotype, and the protocol comprised a stopping rule at week 12 if early virological response (EVR) was not achieved. Virological and biochemical response and safety were assessed throughout the treatment.

results29 patients were enrolled and treated according to the study protocol. 79% of the patients were infected with genotype 1, 72% had advanced fibrosis, 76% had previously received pegIFNα/ribavirin, and only 14% achieved EVR to the previous treatment. When treated with the study medications, 17 patients (59%) showed an EVR, only 3 (10%) however achieved a sustained virological response (SVR). SAMe and betaine were found to be safe when used with pegIFNα/ribavirin.

conclusionThe addition of SAMe and betaine to pegIFNα/ribavirin improves early virological response in CHC.

trial registrationClinicalTrials.gov NCT00310336.

Indexed as

AdultAntiviral AgentsArthralgiaBetaineDiarrheaDrug Therapy, CombinationFatigueFemaleGastrointestinal AgentsHeadacheHepacivirusHepatitis C, ChronicHumansInterferon-alphaInterferon alpha-2MaleAntiviral AgentsBetaineGastrointestinal AgentsInterferon-alphaInterferon alpha-2peginterferon alfa-2aPolyethylene GlycolsRecombinant ProteinsRibavirinS-Adenosylmethionine

Identifiers

PMID21079746
PMCPMC2975710
OpenAlexW2147651204

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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.