Tier 2 — strong

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
PloS one 2010 5(11):e15492

Bibliography

PubMed
PMID 21079746
PubMed Central
PMC2975710
DOI
10.1371/journal.pone.0015492
Funding
Funding was not specified in the indexed record or accessible funding metadata.
Competing interests
Reported disclosure: Competing Interests: The authors have declared that no competing interests exist.

Study snapshot

DesignOpen-label pilot with randomized treatment timing
ModelHuman participants
Sample33 enrolled; 29 analyzed according to the treatment protocol
InterventionBetaine 6 g/day plus SAMe 1.2 g/day with interferon/ribavirin
Duration6-12 months with a week-12 stopping rule
EndpointsEarly and sustained virological response; Safety

What the study showed, in plain terms

Published in 2010, this source examined metabolic health and liver trials. Design: Open-label pilot with randomized treatment timing. Sample/model: 33 enrolled; 29 analyzed according to the treatment protocol. The exposure or intervention was Betaine 6 g/day plus SAMe 1.2 g/day with interferon/ribavirin. Follow-up or treatment period: 6-12 months with a week-12 stopping rule.

Seventeen patients achieved an early virological response, but only three achieved a sustained response.

No concurrent control and multiple active treatments. This historical interferon-based regimen does not establish a role for TMG in modern hepatitis C care. The publisher correction identifies the first two authors as equal contributors. It does not report a change to the clinical outcomes. Publication update

Continue with TMG Data Center

Continue with TMG and Liver Health: Human Trials Behind the Claims

Key findings

  • Seventeen patients achieved an early virological response, but only three achieved a sustained response.
  • The recorded outcome domains were Early and sustained virological response; Safety.
  • The result applies to the tested exposure: Betaine 6 g/day plus SAMe 1.2 g/day with interferon/ribavirin; 6-12 months with a week-12 stopping rule.

What this study can and cannot tell us

  • No concurrent control and multiple active treatments. This historical interferon-based regimen does not establish a role for TMG in modern hepatitis C care. The publisher correction identifies the first two authors as equal contributors. It does not report a change to the clinical outcomes. Publication update
  • Without a sufficiently blinded concurrent control, time effects, expectations, co-interventions and regression toward the mean can explain part of an apparent improvement.
  • Source basis: Accessible full-text extract plus indexed bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology