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An open-label randomized controlled trial of lactulose and probiotics in the treatment of minimal hepatic encephalopathy.

Abstract

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 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.

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.

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  • Authors+Show Affiliations

    ,

    Departments of aGastroenterology bNeurology, G.B. Pant Hospital, New Delhi, India.

    , ,

    Source

    MeSH

    Adult
    Ammonia
    Drug Therapy, Combination
    Event-Related Potentials, P300
    Female
    Hepatic Encephalopathy
    Humans
    Lactulose
    Male
    Middle Aged
    Neuropsychological Tests
    Probiotics
    Psychometrics
    Severity of Illness Index
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    18467909

    Citation

    Sharma, Praveen, et al. "An Open-label Randomized Controlled Trial of Lactulose and Probiotics in the Treatment of Minimal Hepatic Encephalopathy." European Journal of Gastroenterology & Hepatology, vol. 20, no. 6, 2008, pp. 506-11.
    Sharma P, Sharma BC, Puri V, et al. An open-label randomized controlled trial of lactulose and probiotics in the treatment of minimal hepatic encephalopathy. Eur J Gastroenterol Hepatol. 2008;20(6):506-11.
    Sharma, P., Sharma, B. C., Puri, V., & Sarin, S. K. (2008). An open-label randomized controlled trial of lactulose and probiotics in the treatment of minimal hepatic encephalopathy. European Journal of Gastroenterology & Hepatology, 20(6), pp. 506-11. doi:10.1097/MEG.0b013e3282f3e6f5.
    Sharma P, et al. An Open-label Randomized Controlled Trial of Lactulose and Probiotics in the Treatment of Minimal Hepatic Encephalopathy. Eur J Gastroenterol Hepatol. 2008;20(6):506-11. PubMed PMID: 18467909.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - An open-label randomized controlled trial of lactulose and probiotics in the treatment of minimal hepatic encephalopathy. AU - Sharma,Praveen, AU - Sharma,Barjesh C, AU - Puri,Vinod, AU - Sarin,Shiv Kumar, PY - 2008/5/10/pubmed PY - 2009/2/10/medline PY - 2008/5/10/entrez SP - 506 EP - 11 JF - European journal of gastroenterology & hepatology JO - Eur J Gastroenterol Hepatol VL - 20 IS - 6 N2 - 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 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. 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. SN - 0954-691X UR - https://www.unboundmedicine.com/medline/citation/18467909/An_open_label_randomized_controlled_trial_of_lactulose_and_probiotics_in_the_treatment_of_minimal_hepatic_encephalopathy_ L2 - http://Insights.ovid.com/pubmed?pmid=18467909 DB - PRIME DP - Unbound Medicine ER -