Randomized controlled trial comparing lactulose plus albumin versus lactulose alone for treatment of hepatic encephalopathy.

Background: Hepatic encephalopathy (HE) is associated with poor prognosis and treatment of HE is primarily directed at the reduction of the blood ammonia levels. The study evaluated the efficacy and safety of albumin plus lactulose versus lactulose alone for treatment of overt HE.

Methods: In prospective randomized controlled trial, 120 patients with overt HE were randomized in two groups: group A lactulose plus albumin (n = 60) and group B lactulose alone (n = 60). Primary end point was complete reversal of HE, and secondary end points were mortality and hospital stay.

Results: A total of 120 patients (mean age 40.4 ± 9.3 years) were included in this study. Thirty-six (30%) patients were in Child-Turcotte-Pugh (CTP) class B, and 84 (70%) were in CTP Class C. Mean CTP score was 9.8 ± 2.1, and model for end-stage liver disease score was 26.1 ± 5.3. Twenty seven (22.5%) had grade 2, 57 (47.5%) had grade 3, and 36 (30%) had grade 4 HE at the time of admission. Forty-five (75%) patients in group A compared with 32 (53.3%) patients in group B had complete reversal of HE (P = 0.03). Mortality was significantly lower in lactulose plus albumin group (11[18.3%]) versus lactulose alone (19 [31.6%], [P < 0.05]). There was significant decrease in levels of arterial ammonia, interleukin-6, interleukin-18, tumor necrosis factor-alpha, and endotoxins after treatment in both groups; however, the delta decrease was significantly higher in group A compared with group B. Hospital stay was shorter in group A.

Conclusions: Combination of lactulose plus albumin is more effective than lactulose alone in treatment of overt HE.