A Randomized Controlled Trial Comparing Lactulose Plus Albumin versus Lactulose alone for Treatment of Hepatic Encephalopathy.
J Gastroenterol Hepatol. 2016 Nov 25;:
Authors: Sharma BC, Singh J, Srivastava S, Sangam A, Mantri AK, Trehanpati N, Sarin SK
Abstract
BACKGROUND: Hepatic encephalopathy (HE) is associated with poor prognosis and treatment of HE is primarily directed at the reduction of the blood ammonia levels. We 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 2 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: 120 patients (mean age 40.4 ± 9.3 years) were included in study. 36 (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 MELD score was 26.1 ± 5.3. 27 (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 to thirty two (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, IL-6, IL-18, TNF-alpha and endotoxins after treatment in both groups however the delta decrease was significantly higher in group A compared to 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. This article is protected by copyright. All rights reserved.
PMID: 27885712 [PubMed - as supplied by publisher]