Tier 2 — strong

Betaine for nonalcoholic fatty liver disease: results of a randomized placebo-controlled trial

Manal F Abdelmalek, Schuyler O Sanderson, Paul Angulo, Consuelo Soldevila-Pico, Chen Liu, Joy Peter, Jill Keach, Matt Cave, Theresa Chen, Craig J McClain, Keith D Lindor
Hepatology (Baltimore, Md.) 2009 50(6):1818-1826

Bibliography

PubMed
PMID 19824078
DOI
10.1002/hep.23239
Funding
Indexed grant support: K23 DK062116 — NIDDK NIH HHS — United States. The indexed list may not contain the complete funding declaration.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignRandomized controlled trial
ModelHuman participants
Sample55 patients with biopsy-confirmed NASH; 35 completed and 34 had a repeat biopsy
InterventionBetaine 20 g/day versus placebo
Duration12 months
EndpointsLiver steatosis; Fibrosis; Metabolic markers

What the study showed, in plain terms

Published in 2009, this source examined metabolic health and liver trials. Design: Randomized controlled trial. Sample/model: 55 patients with biopsy-confirmed NASH; 35 completed and 34 had a repeat biopsy. The exposure or intervention was Betaine 20 g/day versus placebo. Follow-up or treatment period: 12 months.

The corrected conclusion states that betaine did not improve hepatic steatosis compared with placebo, although it might have limited worsening. Fibrosis and overall activity scores did not improve.

High attrition and a high dose. Interpretation follows the publisher's correction, not an unqualified positive reading of within-group changes. The 2010 publisher correction states that betaine did not improve hepatic steatosis relative to placebo, although it might protect against worsening. The summary follows that corrected conclusion. Publication update

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Key findings

  • The corrected conclusion states that betaine did not improve hepatic steatosis compared with placebo, although it might have limited worsening.
  • Fibrosis and overall activity scores did not improve.
  • The recorded outcome domains were Liver steatosis; Fibrosis; Metabolic markers.
  • The result applies to the tested exposure: Betaine 20 g/day versus placebo; 12 months.

What this study can and cannot tell us

  • High attrition and a high dose. Interpretation follows the publisher's correction, not an unqualified positive reading of within-group changes. The 2010 publisher correction states that betaine did not improve hepatic steatosis relative to placebo, although it might protect against worsening. The summary follows that corrected conclusion. Publication update
  • An individual controlled trial must be interpreted alongside its comparator, sample size, endpoint selection and independent replication. It does not validate a different commercial formulation or a general longevity claim.
  • Source basis: Indexed abstract and 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