Effect of long-term aggressive nutrition therapy on survival in patients with alcohol-related cirrhosis: A randomized controlled trial.

Abstract

The aim of this study was to assess the effect of long-term aggressive nutritional therapy on clinical outcomes and survival in patients with alcoholic liver cirrhosis (ALC). Malnourished patients assessed by Royal Free Hospital-Subjective Global Assessment (RFH-SGA) were randomized to control group (CG) (35-40 kcal and 1.2 g protein/kg/day; diet alone) or intervention group (IG) (40-45 kcal and 1.5 g protein/kg/day; diet plus polymeric formula) for 3 months. Patients were followed up at 3 and 12 months. Malnourished patients (age 44.0 ± 9 years; M [100%]; Child A:B:C [%] = 11:39:50) were randomized to the CG (n = 50) or IG (n = 54); 21 patients in CG and 27 in IG completed 3 months of follow-up. The RFH-SGA improved in 7 (33.3%; p = 0.016) in IG vs. 3 (14.2%; p = 0.625) in CG. Over 3 months, increments (CG vs. IG) were seen in calories (1554 ± 972 to 1823 ± 398; p = 0.001 vs.1542 ± 603 to 2254 ± 372; p=0.001), protein (53.1 ± 18.4 to 72.5 ± 19.6; p = 0.001 vs. 53 ± 21 to 86.9 ± 18.8; p = 0.00), dry body weight (64 ± 10 to 66 ± 11; p = 0.04 vs. 60.8 ± 9.2 to 63.2 ± 10.7; p = 0.009), and mid-upper arm circumference (MUAC) (24.7 ± 3.3 to 25.5 ± 3.3; p = 0.116 vs. 23.5 ± 2.7 to 24.1 ± 2.9; p = 0.015), with better ascites resolution in IG (53.3%; p = 0.008) vs. CG (44.4%; p = 0.227). Median 12-month survival was comparable in both the groups (p = 0.864). Irrespective of the intervention group, energy intake > 25 kcal and protein > 0.8 g/kg/day significantly improved 12-month survival. Aggressive nutritional therapy improves nutritional status and resolves ascites, however fails to show long-term survival benefit, though higher calorie and protein intake has the potential to impact survival. NCT02140294.