An open-label randomized controlled trial of lactulose and probiotics in the treatment of minimal hepatic encephalopathy.
Sharma, Praveen a; Sharma, Barjesh C. a; Puri, Vinod b; Sarin, Shiv Kumar a
European Journal of Gastroenterology & Hepatology.
20(6):506-511, June 2008.
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Background and aim: 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.
Patients and 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 [mu]mol/l, group B: 108.2 /-37.5 vs. 75.7 /-33.0 [mu]mol/l, group C: 96.3 /-27.7 vs. 68.7 /-28.4 [mu]mol/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.
Conclusion: 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.
(C) 2008 Lippincott Williams & Wilkins, Inc.