Abstract
Background. A phase II randomized controlled trial was conducted in patients with compensated liver cirrhosis to investigate the inhibitory effect of branchedchain amino acid (BCAA) granules for oral use (TK-98) on disease progression. Methods. Patients who had compensated liver cirrhosis due to hepatitis C virus with baseline serum albumin levels between 3.6 and 4.5 g/dl were assigned to the TK-98 group, which was treated with BCAA granules (TK-98) for 168 weeks, or to a control group (no treatment). Results. No symptoms indicating decompensated cirrhosis, including ascites, edema, and hepatic encephalopathy were reported in either the TK-98 or control group during the study observation period. Hepatocellular carcinoma (HCC) was noted in eight of the 39 patients studied, and of these three received TK-98 (15.8%) and five were untreated (25.0%). A time-to-event analysis for the effect of BCAA therapy on development of HCC revealed no statistically significant differences between the two groups. However, an additional analysis of data from a subgroup with a baseline serum albumin level of <4.0 g/dl showed that the incidence of HCC was likely to be lower in BCAA-treated patients. Conclusions. BCAA may inhibit hepatic carcinogenesis in patients with compensated cirrhosis with a serum albumin level of <4.0 g/dl.
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Kobayashi, M., Ikeda, K., Arase, Y. et al. Inhibitory effect of branched-chain amino acid granules on progression of compensated liver cirrhosis due to hepatitis C virus. J Gastroenterol 43, 63–70 (2008). https://doi.org/10.1007/s00535-007-2122-0
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DOI: https://doi.org/10.1007/s00535-007-2122-0