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Rifaximin vs. lactulose in treatment of minimal hepatic encephalopathy.

Abstract

BACKGROUND & AIMS

Lactulose and rifaximin have already been shown to improve both cognitive functions and health related quality of life (HRQOL) in MHE patients. We aimed to compare the efficacy of rifaximin with lactulose in reversal of MHE and improvement in HRQOL in cirrhotic patients with MHE.

METHOD

This prospective, randomized, open label, non-inferiority trial, was conducted at the Gastroenterology department of a tertiary care institute in Northern India. MHE was diagnosed if any two of the five neuro-psychometric (NP) tests were positive. HRQOL was assessed using the sickness impact profile (SIP) questionnaire (John Hopkins University, USA).

RESULTS

Of 527 cirrhotics screened, 351 were found eligible and tested for MHE. A total of 112 (31.9%) patients were found to have MHE and then randomized into two groups group A (lactulose; 30-120 ml/day) and B (Tablet. rifaximin; 400 mg thrice a day). Based on the intention-to-treat population, the proportion of patients with MHE reversal at 3 months was 73.7% (42/57) in the rifaximin arm and 69.1% (38/55) in the lactulose arm [4.6% difference (90% CI -9.3% to 18.4%)]. However, non-inferiority of rifaximin over lactulose could not be established as the pre-specified non-inferiority margin (-5%) lies within the two-sided 90% confidence interval of the difference. HRQOL was significantly improved in both groups (P = 0.20). However, the proportion of patients with flatulence (P = 0.004) and diarrhoea (P = 0.0002) was significantly higher in patients who took lactulose.

CONCLUSION

Non-inferiority of rifaximin over lactulose for MHE reversal was not established.

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  • Authors+Show Affiliations

    ,

    Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.

    ,

    Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.

    ,

    Edinburgh Health Services Research Unit, University of Edinburgh, Edinburgh, UK.

    ,

    Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.

    Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.

    Source

    MeSH

    Adult
    Aged
    Cognition
    Female
    Hepatic Encephalopathy
    Humans
    India
    Lactulose
    Liver Cirrhosis
    Male
    Middle Aged
    Neuropsychological Tests
    Prospective Studies
    Psychometrics
    Quality of Life
    Rifamycins
    Rifaximin
    Sickness Impact Profile
    Time Factors
    Treatment Outcome

    Pub Type(s)

    Comparative Study
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    26201713

    Citation

    Sidhu, Sandeep S., et al. "Rifaximin Vs. Lactulose in Treatment of Minimal Hepatic Encephalopathy." Liver International : Official Journal of the International Association for the Study of the Liver, vol. 36, no. 3, 2016, pp. 378-85.
    Sidhu SS, Goyal O, Parker RA, et al. Rifaximin vs. lactulose in treatment of minimal hepatic encephalopathy. Liver Int. 2016;36(3):378-85.
    Sidhu, S. S., Goyal, O., Parker, R. A., Kishore, H., & Sood, A. (2016). Rifaximin vs. lactulose in treatment of minimal hepatic encephalopathy. Liver International : Official Journal of the International Association for the Study of the Liver, 36(3), pp. 378-85. doi:10.1111/liv.12921.
    Sidhu SS, et al. Rifaximin Vs. Lactulose in Treatment of Minimal Hepatic Encephalopathy. Liver Int. 2016;36(3):378-85. PubMed PMID: 26201713.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Rifaximin vs. lactulose in treatment of minimal hepatic encephalopathy. AU - Sidhu,Sandeep S, AU - Goyal,Omesh, AU - Parker,Richard A, AU - Kishore,Harsh, AU - Sood,Ajit, Y1 - 2015/08/17/ PY - 2015/05/07/received PY - 2015/07/15/accepted PY - 2015/7/24/entrez PY - 2015/7/24/pubmed PY - 2016/12/15/medline KW - lactulose KW - minimal hepatic encephalopathy KW - rifaximin SP - 378 EP - 85 JF - Liver international : official journal of the International Association for the Study of the Liver JO - Liver Int. VL - 36 IS - 3 N2 - BACKGROUND & AIMS: Lactulose and rifaximin have already been shown to improve both cognitive functions and health related quality of life (HRQOL) in MHE patients. We aimed to compare the efficacy of rifaximin with lactulose in reversal of MHE and improvement in HRQOL in cirrhotic patients with MHE. METHOD: This prospective, randomized, open label, non-inferiority trial, was conducted at the Gastroenterology department of a tertiary care institute in Northern India. MHE was diagnosed if any two of the five neuro-psychometric (NP) tests were positive. HRQOL was assessed using the sickness impact profile (SIP) questionnaire (John Hopkins University, USA). RESULTS: Of 527 cirrhotics screened, 351 were found eligible and tested for MHE. A total of 112 (31.9%) patients were found to have MHE and then randomized into two groups group A (lactulose; 30-120 ml/day) and B (Tablet. rifaximin; 400 mg thrice a day). Based on the intention-to-treat population, the proportion of patients with MHE reversal at 3 months was 73.7% (42/57) in the rifaximin arm and 69.1% (38/55) in the lactulose arm [4.6% difference (90% CI -9.3% to 18.4%)]. However, non-inferiority of rifaximin over lactulose could not be established as the pre-specified non-inferiority margin (-5%) lies within the two-sided 90% confidence interval of the difference. HRQOL was significantly improved in both groups (P = 0.20). However, the proportion of patients with flatulence (P = 0.004) and diarrhoea (P = 0.0002) was significantly higher in patients who took lactulose. CONCLUSION: Non-inferiority of rifaximin over lactulose for MHE reversal was not established. SN - 1478-3231 UR - https://www.unboundmedicine.com/medline/citation/26201713/Rifaximin_vs__lactulose_in_treatment_of_minimal_hepatic_encephalopathy_ L2 - https://doi.org/10.1111/liv.12921 DB - PRIME DP - Unbound Medicine ER -