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Efficacy and safety of oral betaine glucuronate in non-alcoholic steatohepatitis. A double-blind, randomized, parallel-group, placebo-controlled prospective clinical study

F Miglio, L C Rovati, A Santoro, I Setnikar
Arzneimittel-Forschung 2000 50(8):722-727

Bibliography

PubMed
PMID 10994156
Funding
Funding was not specified in the indexed record or accessible funding metadata.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignRandomized controlled trial
ModelHuman participants
Sample191 patients with nonalcoholic steatohepatitis
InterventionBetaine glucuronate plus diethanolamine glucuronate and nicotinamide ascorbate versus placebo
Duration8 weeks
EndpointsLiver measures; Symptoms; Adverse events

What the study showed, in plain terms

Published in 2000, this source examined metabolic health and liver trials. Design: Randomized controlled trial. Sample/model: 191 patients with nonalcoholic steatohepatitis. The exposure or intervention was Betaine glucuronate plus diethanolamine glucuronate and nicotinamide ascorbate versus placebo. Follow-up or treatment period: 8 weeks.

The combination improved reported steatosis, liver-enzyme and symptom measures more than placebo, with similar mild adverse-event rates.

A different betaine formulation with multiple active components. The result cannot be attributed to ordinary anhydrous TMG alone.

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Key findings

  • The combination improved reported steatosis, liver-enzyme and symptom measures more than placebo, with similar mild adverse-event rates.
  • The recorded outcome domains were Liver measures; Symptoms; Adverse events.
  • The result applies to the tested exposure: Betaine glucuronate plus diethanolamine glucuronate and nicotinamide ascorbate versus placebo; 8 weeks.

What this study can and cannot tell us

  • A different betaine formulation with multiple active components. The result cannot be attributed to ordinary anhydrous TMG alone.
  • 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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