Twenty-two patients with cirrhosis and acute encephalopathy who were refractory to medical therapy were entered into a randomized, double-blind prospective trial. This trial consisted of either neomycin or a modified amino acid solution rich in branched chains and low in aromatic amino acids and methionine (F080) in the presence of isocaloric amounts of dextrose. The groups were indistinguishable from each other by clinical or laboratory criteria; they were primarily patients who had undergone operation and they would tolerate only 30 gm of oral protein or intravenous standard amino acids. The group receiving F080 had a faster and more complete improvement in encephalopathy. This improvement correlated with the plasma molar ratio and occurred with a lower mortality rate. In addition, the patients also tolerated twice the amino acid load without encephalopathy and were in positive nitrogen balance. Modified metabolic support is effective in the setting of acute liver failure in chronic cirrhosis, particularly in patients who have undergone operation.
Seventy-five patients with acute hepatic decompensation superimposed on chronic alcoholic cirrhosis were prospectively randomized for a blinded trial of the treatment of hepatic encephalopathy. The control group received 4 g of enteral neomycin daily along with 25% dextrose by a central venous catheter. The experimental group received a placebo resembling neomycin and isocaloric dextrose plus a modified amino acid mixture enriched with branched-chain amino acids to 36% and deficient in aromatic amino acids and methionine. Thirty patients in the F080 group and 29 in the control group completed the trial. The group receiving the modified amino acid mixture demonstrated a statistically significant improvement in encephalopathy as compared to the neomycin group, while maintaining nitrogen equilibrium. Survival and discharge from the hospital were statistically greater in the group treated with the modified amino acid solution and hypertonic dextrose. Treatment of hepatic encephalopathy in the presence of hepatic decompensation with an amino acid solution formulated for its treatment seems to produce faster, more complete recovery with improved capacity for nutritional support. (Journal of Parenteral and Enteral Nutrition9:288-295, 1985)