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Effect of probiotic VSL#3 in the treatment of minimal hepatic encephalopathy: A non-inferiority randomized controlled trial.

Abstract

AIM

Minimal hepatic encephalopathy (MHE) impairs daily functioning and health-related quality of life in chronic liver disease (CLD). Lactulose is the standard treatment but has side-effects. Probiotics have an encouraging role in MHE. The aim of the present study was to test whether probiotics are non-inferior to lactulose in improving MHE.

METHODS

Patients with CLD (n = 227) were screened for MHE using neuropsychometric tests (number connection tests A and B [or figure connection tests A and B]) and/or neurophysiological test (P-300 auditory event-related potential), and 120 (53%) were diagnosed with MHE by abnormal tests. MHE patients were randomized to lactulose (30-60 mL/day) or probiotic (four capsules of VSL#3; total of 450 billion CFU/day) for 2 months. Response was defined as normalization of tests. Serum ammonia was measured by commercial kit.

RESULTS

Of 120 patients randomized, 40 in the lactulose arm and 33 in the probiotic arm completed 2 months of intervention. MHE improved in 25 (62.5%) patients taking lactulose and 23 (69.7%) taking probiotics. The effect size of difference of improvement in MHE between lactulose and probiotic was 0.072 per per-protocol analysis and 0.040 as per intention to treat analysis (within -20% of non-inferiority margin). Serum ammonia was comparable between groups at baseline and 2 months; it decreased in patients in whom MHE improved, while increased in patients with no improvement in MHE.

CONCLUSION

The probiotic VSL#3 was non-inferior to the standard therapy, lactulose in the treatment of MHE. Improvement in MHE correlated with reduction of ammonia levels.

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  • Authors+Show Affiliations

    ,

    Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.

    ,

    Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.

    ,

    Department of Neurology, All India Institute of Medical Sciences, New Delhi, India.

    ,

    Biostatistics, All India Institute of Medical Sciences, New Delhi, India.

    ,

    Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.

    ,

    Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.

    Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, India.

    Source

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    25266207

    Citation

    Pratap Mouli, Venigalla, et al. "Effect of Probiotic VSL#3 in the Treatment of Minimal Hepatic Encephalopathy: a Non-inferiority Randomized Controlled Trial." Hepatology Research : the Official Journal of the Japan Society of Hepatology, vol. 45, no. 8, 2015, pp. 880-9.
    Pratap Mouli V, Benjamin J, Bhushan Singh M, et al. Effect of probiotic VSL#3 in the treatment of minimal hepatic encephalopathy: A non-inferiority randomized controlled trial. Hepatol Res. 2015;45(8):880-9.
    Pratap Mouli, V., Benjamin, J., Bhushan Singh, M., Mani, K., Garg, S. K., Saraya, A., & Joshi, Y. K. (2015). Effect of probiotic VSL#3 in the treatment of minimal hepatic encephalopathy: A non-inferiority randomized controlled trial. Hepatology Research : the Official Journal of the Japan Society of Hepatology, 45(8), pp. 880-9. doi:10.1111/hepr.12429.
    Pratap Mouli V, et al. Effect of Probiotic VSL#3 in the Treatment of Minimal Hepatic Encephalopathy: a Non-inferiority Randomized Controlled Trial. Hepatol Res. 2015;45(8):880-9. PubMed PMID: 25266207.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effect of probiotic VSL#3 in the treatment of minimal hepatic encephalopathy: A non-inferiority randomized controlled trial. AU - Pratap Mouli,Venigalla, AU - Benjamin,Jaya, AU - Bhushan Singh,Mamta, AU - Mani,Kalaivani, AU - Garg,Sushil Kumar, AU - Saraya,Anoop, AU - Joshi,Yogendra Kumar, Y1 - 2014/10/31/ PY - 2014/08/02/received PY - 2014/09/13/revised PY - 2014/09/25/accepted PY - 2014/10/1/entrez PY - 2014/10/1/pubmed PY - 2014/10/1/medline KW - chronic liver disease KW - cirrhosis KW - lactulose KW - non-inferiority trial KW - probiotics SP - 880 EP - 9 JF - Hepatology research : the official journal of the Japan Society of Hepatology JO - Hepatol. Res. VL - 45 IS - 8 N2 - AIM: Minimal hepatic encephalopathy (MHE) impairs daily functioning and health-related quality of life in chronic liver disease (CLD). Lactulose is the standard treatment but has side-effects. Probiotics have an encouraging role in MHE. The aim of the present study was to test whether probiotics are non-inferior to lactulose in improving MHE. METHODS: Patients with CLD (n = 227) were screened for MHE using neuropsychometric tests (number connection tests A and B [or figure connection tests A and B]) and/or neurophysiological test (P-300 auditory event-related potential), and 120 (53%) were diagnosed with MHE by abnormal tests. MHE patients were randomized to lactulose (30-60 mL/day) or probiotic (four capsules of VSL#3; total of 450 billion CFU/day) for 2 months. Response was defined as normalization of tests. Serum ammonia was measured by commercial kit. RESULTS: Of 120 patients randomized, 40 in the lactulose arm and 33 in the probiotic arm completed 2 months of intervention. MHE improved in 25 (62.5%) patients taking lactulose and 23 (69.7%) taking probiotics. The effect size of difference of improvement in MHE between lactulose and probiotic was 0.072 per per-protocol analysis and 0.040 as per intention to treat analysis (within -20% of non-inferiority margin). Serum ammonia was comparable between groups at baseline and 2 months; it decreased in patients in whom MHE improved, while increased in patients with no improvement in MHE. CONCLUSION: The probiotic VSL#3 was non-inferior to the standard therapy, lactulose in the treatment of MHE. Improvement in MHE correlated with reduction of ammonia levels. SN - 1386-6346 UR - https://www.unboundmedicine.com/medline/citation/25266207/Effect_of_probiotic_VSL L2 - https://doi.org/10.1111/hepr.12429 DB - PRIME DP - Unbound Medicine ER -