Abstract

A multicenter prospective intervention study was conducted in 204 patients with uncompensated liver cirrhosis to explore the influence of dietary intake and patient clinical characteristics on improvement of hypoalbuminemia at weeks 12 and 24 of treatment with branched-chain amino acid (BCAA) granules. The primary endpoint set in this study was improvement of hypoalbuminemia in patients with liver cirrhosis. The dietary energy and protein intake per day were estimated based on the results of a survey on diet during a 3-day period preceding the start of the study. As for the primary endpoint, the mean serum albumin level increased significantly at weeks 12 and 24 of BCAA treatment, compared with the baseline level. The mean Child-Pugh score decreased significantly at weeks 12 and 24 of treatment as compared to the mean baseline score. There was a significant increase in the serum albumin level following treatment with BCAA granules regardless of energy intake and of protein intake. The incidence of ascites and edema significantly decreased in the overall patient population both at weeks 12 and 24 of treatment, compared with the baseline incidence. A subgroup analysis conducted in patients stratified according to changes in the serum albumin level at week 12 of treatment as against baseline showed that the incidence of ascites/edema was significantly reduced not only in the increased albumin group but in the unchanged albumin group. The present data suggest that the anti-hypoalbuminemic effect of BCAA treatment in patients with liver cirrhosis is independent of dietary intake.

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