Metadoxine Versus Placebo for the Treatment of Non-alcoholic Steatohepatitis: A Randomized Controlled Trial

Journal of Clinical and Experimental Hepatology
Kotacherry T ShenoyAngelo A Bignamini

Abstract

The study aimed at assessing the therapeutic efficacy and safety of metadoxine versus placebo on the ultrasonographic and histological features of non-alcoholic steatohepatitis (NASH). 134 subjects with biopsy-confirmed NASH were randomized to receive metadoxine 500 mg two times daily (n = 75) or placebo (n = 59) added to the standard of care, over 16 weeks. Originally, the primary efficacy endpoint was the composite of: reduction in the steatosis by ≥1 grade, reduction in hepatic necro-inflammation by ≥1 grade and ALT normalization. Since >50% of patients refused the second biopsy, it was decided to analyze only the individual parameters. There was no significant difference between the treatment and the placebo groups in either liver histology or ALT or AST. Overall, as expected both groups showed reduction in serum ALT and AST compared to baseline. Compared to placebo (9 out 54), patients on metadoxine (34 out of 75) had significantly higher rates of improvement in 1-point in steatosis grade on ultrasound (P-value <0.001). Safety and tolerability did not differ between treatments. Metadoxine is not effective in improvement of liver histology or serum ALT or AST in patients with NASH. However, there was significant improvement...Continue Reading

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Citations

Aug 27, 2016·Expert Opinion on Pharmacotherapy·Gesthimani Mintziori, Stergios A Polyzos
Oct 21, 2018·Postgraduate Medical Journal·Kannan SridharanAbdelaziz Elamin
Mar 31, 2017·The Cochrane Database of Systematic Reviews·Rosa LombardiEmmanuel Tsochatzis
Oct 3, 2018·Journal of Clinical and Translational Hepatology·James J ConnollyJoseph K Lim
Nov 21, 2020·European Journal of Gastroenterology & Hepatology·Anna RoskillyIan A Rowe
Dec 8, 2020·Liver International : Official Journal of the International Association for the Study of the Liver·Anna RoskillyIan A Rowe

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