Betaine, a promising new agent for patients with nonalcoholic steatohepatitis: results of a pilot study

doi:10.1111/j.1572-0241.2001.04129.x

Paper

Betaine, a promising new agent for patients with nonalcoholic steatohepatitis: results of a pilot study

Published Sep 1, 2001 · M. Abdelmalek, P. Angulo, R. Jorgensen

American Journal of Gastroenterology

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430

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5

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Abstract

OBJECTIVES:No effective therapy currently exists for patients with nonalcoholic steatohepatitis (NASH). Betaine, a naturally occurring metabolite of choline, has been shown to raise S-adenosylmethionine (SAM) levels that may in turn play a role in decreasing hepatic steatosis. Our aim was to determine the safety and effects of betaine on liver biochemistries and histological markers of disease activity in patients with NASH.METHODS:Ten adult patients with NASH were enrolled. Patients received betaine anhydrous for oral solution (Cystadane) in two divided doses daily for 12 months. Seven out of 10 patients completed 1 yr of treatment with betaine.RESULTS:A significant improvement in serum levels of aspartate aminotransferase (p = 0.02) and ALAT (p = 0.007) occurred during treatment. Aminotransferases normalized in three of seven patients, decreased by >50% in three of seven patients, and remained unchanged in one patient when compared to baseline values. A marked improvement in serum levels of aminotransferases (ALT −39%; AST −38%) also occurred during treatment in those patients who did not complete 1 yr of treatment. Similarly, a marked improvement in the degree of steatosis, necroinflammatory grade, and stage of fibrosis was noted at 1 yr of treatment with betaine. Transitory GI adverse events that did not require any dose reduction or discontinuation of betaine occurred in four patients.CONCLUSIONS:Betaine is a safe and well tolerated drug that leads to a significant biochemical and histological improvement in patients with NASH. This novel agent deserves further evaluation in a randomized, placebo-controlled trial.

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Study Snapshot

Betaine is a safe and well-tolerated drug that leads to significant biochemical and histological improvement in patients with nonalcoholic steatohepatitis.

PopulationOlder adults (50-71 years)

Sample size24

MethodsObservational

OutcomesBody Mass Index projections

ResultsSocial networks mitigate obesity in older groups.

Betaine, a promising new agent for patients with nonalcoholic steatohepatitis: results of a pilot study

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