title: An open-label randomized controlled trial of lactulose and probiotics in the treatment of minimal hepatic encephalopathy.
abstract: OBJECTIVE
  Minimal hepatic encephalopathy (MHE) is associated with poor quality of life and increased work disability. Treatment with lactulose and probiotics has shown some benefit. We compared lactulose with probiotics and a combination of lactulose plus probiotics in the treatment of MHE.
  
  
  METHODS
  One hundred and ninety cirrhotic patients without overt encephalopathy [Child's A grade 71 patients (37.4%), Child's B grade 72 patients (37.9%), Child's C grade 47 patients (24.7%)] were evaluated by psychometry (number connection tests A and B or figure connection tests A and B) and P300 auditory event-related potential (P300ERP). MHE was diagnosed by abnormal psychometry and/or P300ERP. Patients were randomized to receive lactulose [group A (n=35): dose 30-60 ml/day], probiotics [group B (n=35): dose 1 capsule three times/day, each capsule contained Streptococcus faecalis 60 million, Clostridium butyricum 4 million, Bacillus mesentricus 2 million, lactic acid bacillus 100 million] and lactulose plus probiotics [group C (n=35)] for 1 month. Response was defined by normalization of the abnormal test parameters.
  
  
  RESULTS
  MHE was diagnosed in 105 (55.2%) patients. Of the 105 patients, 75 (71%) had both abnormal psychometry and P300ERP, whereas 90 (86%) had abnormal psychometry alone, and 89 patients (85%) had abnormal P300ERP alone. Significant improvement was seen in abnormal psychometry tests (group A: n=31 vs. n=12, group B: n=29 vs. n=14, group C: n=30 vs. n=10), P300ERP (group A: 376.8+/-22.3 vs. 344.3+/-30.6 ms, group B: 385.4+/-28.5 vs. 355.5+/-27.9 ms, group C: 387.7+/-27.5 vs. 347.7+/-31.5 ms) and venous ammonia levels (group A: 102.3+/-63.1 vs. 69.3+/-33.3 micromol/l, group B: 108.2+/-37.5 vs. 75.7+/-33.0 micromol/l, group C: 96.3+/-27.7 vs. 68.7+/-28.4 micromol/l) in lactulose, probiotics and a combination of lactulose plus probiotics groups after treatment. Normalization of abnormal psychometry and P300ERP was seen in 54.8, 51.6 and 56.6% of patients treated with lactulose, probiotics and lactulose plus probiotics groups, respectively.
  
  
  CONCLUSIONS
  A total of 55% of the patients with cirrhosis had MHE. Lactulose or probiotics or combinations of both are equally effective in the treatment of MHE.
authors.affiliation: Departments of aGastroenterology bNeurology, G.B. Pant Hospital, New Delhi, India.
authors.forename: Praveen
authors.initials: P
authors.lastname: Sharma
authors.forename: Barjesh C
authors.initials: BC
authors.lastname: Sharma
authors.forename: Vinod
authors.initials: V
authors.lastname: Puri
authors.forename: Shiv Kumar
authors.initials: SK
authors.lastname: Sarin
mesh_terms: D000328:Adult; D000641:Ammonia / Q000097:blood; D004359:Drug Therapy, Combination; D018913:Event-Related Potentials, P300; D005260:Female; D006501:Hepatic Encephalopathy / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D006801:Humans; D007792:Lactulose / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D019936:Probiotics / Q000627:therapeutic use*; D011594:Psychometrics; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D007792:Lactulose; D000641:Ammonia