title: Randomized controlled trial comparing lactulose plus albumin versus lactulose alone for treatment of hepatic encephalopathy.
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. 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.
authors.affiliation: Department of Gastroenterology, G. B. Pant Institute of Postgraduate Medical Education and Research, JLN Marg, New Delhi, India.
authors.forename: Barjesh Chander
authors.initials: BC
authors.lastname: Sharma
authors.affiliation: Department of Gastroenterology, G. B. Pant Institute of Postgraduate Medical Education and Research, JLN Marg, New Delhi, India.
authors.forename: Jatinderpal
authors.initials: J
authors.lastname: Singh
authors.affiliation: Department of Gastroenterology, G. B. Pant Institute of Postgraduate Medical Education and Research, JLN Marg, New Delhi, India.
authors.forename: Siddharth
authors.initials: S
authors.lastname: Srivastava
authors.affiliation: Department of Gastroenterology, G. B. Pant Institute of Postgraduate Medical Education and Research, JLN Marg, New Delhi, India.
authors.forename: Alok
authors.initials: A
authors.lastname: Sangam
authors.affiliation: Department of Gastroenterology, G. B. Pant Institute of Postgraduate Medical Education and Research, JLN Marg, New Delhi, India.
authors.forename: Alok Kumar
authors.initials: AK
authors.lastname: Mantri
authors.affiliation: Department of Molecular and Cellular Medicine, ILBS, New Delhi, India.
authors.forename: Nirupma
authors.initials: N
authors.lastname: Trehanpati
authors.affiliation: Department of Hepatology, ILBS, New Delhi, India.
authors.forename: Shiv Kumar
authors.initials: SK
authors.lastname: Sarin
mesh_terms: D000328:Adult; D000418:Albumins / Q000008:administration & dosage*; D000641:Ammonia / Q000097:blood; D015415:Biomarkers / Q000097:blood; D004359:Drug Therapy, Combination; D004731:Endotoxins / Q000097:blood; D005260:Female; D006501:Hepatic Encephalopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D020382:Interleukin-18 / Q000097:blood; D015850:Interleukin-6 / Q000097:blood; D007792:Lactulose / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000097:blood
chemical_list: D000418:Albumins; D015415:Biomarkers; D004731:Endotoxins; D020382:Interleukin-18; D015850:Interleukin-6; D014409:Tumor Necrosis Factor-alpha; D007792:Lactulose; D000641:Ammonia
keywords: albumin; hepatic encephalopathy; lactulose