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Meta-Analysis
. 2017 Feb 23;2(2):CD008716.
doi: 10.1002/14651858.CD008716.pub3.

Probiotics for people with hepatic encephalopathy

Rohan Dalal  1 , Richard G McGee  2 , Stephen M Riordan  3 , Angela C Webster  4
Affiliations
Meta-Analysis

Probiotics for people with hepatic encephalopathy

Rohan Dalal et al. Cochrane Database Syst Rev. .

Abstract

Background: Hepatic encephalopathy is a disorder of brain function as a result of liver failure or portosystemic shunt or both. Both hepatic encephalopathy (clinically overt) and minimal hepatic encephalopathy (not clinically overt) significantly impair patient's quality of life and daily functioning, and represent a significant burden on healthcare resources. Probiotics are live micro-organisms, which when administered in adequate amounts, may confer a health benefit on the host.

Objectives: To determine the beneficial and harmful effects of probiotics in any dosage, compared with placebo or no intervention, or with any other treatment for people with any grade of acute or chronic hepatic encephalopathy. This review did not consider the primary prophylaxis of hepatic encephalopathy.

Search methods: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, Science Citation Index Expanded, conference proceedings, reference lists of included trials, and the World Health Organization International Clinical Trials Registry Platform until June 2016.

Selection criteria: We included randomised clinical trials that compared probiotics in any dosage with placebo or no intervention, or with any other treatment in people with hepatic encephalopathy.

Data collection and analysis: We used standard methodological procedures expected by The Cochrane Collaboration. We conducted random-effects model meta-analysis due to obvious heterogeneity of participants and interventions. We defined a P value of 0.05 or less as significant. We expressed dichotomous outcomes as risk ratio (RR) and continuous outcomes as mean difference (MD) with 95% confidence intervals (CI).

Main results: We included 21 trials with 1420 participants, of these, 14 were new trials. Fourteen trials compared a probiotic with placebo or no treatment, and seven trials compared a probiotic with lactulose. The trials used a variety of probiotics; the most commonly used group of probiotic was VSL#3, a proprietary name for a group of eight probiotics. Duration of administration ranged from 10 days to 180 days. Eight trials declared their funding source, of which six were independently funded and two were industry funded. The remaining 13 trials did not disclose their funding source. We classified 19 of the 21 trials at high risk of bias.We found no effect on all-cause mortality when probiotics were compared with placebo or no treatment (7 trials; 404 participants; RR 0.58, 95% CI 0.23 to 1.44; low-quality evidence). No-recovery (as measured by incomplete resolution of symptoms) was lower for participants treated with probiotic (10 trials; 574 participants; RR 0.67, 95% CI 0.56 to 0.79; moderate-quality evidence). Adverse events were lower for participants treated with probiotic than with no intervention when considering the development of overt hepatic encephalopathy (10 trials; 585 participants; RR 0.29, 95% CI 0.16 to 0.51; low-quality evidence), but effects on hospitalisation and change of/or withdrawal from treatment were uncertain (hospitalisation: 3 trials, 163 participants; RR 0.67, 95% CI 0.11 to 4.00; very low-quality evidence; change of/or withdrawal from treatment: 9 trials, 551 participants; RR 0.70, 95% CI 0.46 to 1.07; very low-quality evidence). Probiotics may slightly improve quality of life compared with no intervention (3 trials; 115 participants; results not meta-analysed; low-quality evidence). Plasma ammonia concentration was lower for participants treated with probiotic (10 trials; 705 participants; MD -8.29 μmol/L, 95% CI -13.17 to -3.41; low-quality evidence). There were no reports of septicaemia attributable to probiotic in any trial.When probiotics were compared with lactulose, the effects on all-cause mortality were uncertain (2 trials; 200 participants; RR 5.00, 95% CI 0.25 to 102.00; very low-quality evidence); lack of recovery (7 trials; 430 participants; RR 1.01, 95% CI 0.85 to 1.21; very low-quality evidence); adverse events considering the development of overt hepatic encephalopathy (6 trials; 420 participants; RR 1.17, 95% CI 0.63 to 2.17; very low-quality evidence); hospitalisation (1 trial; 80 participants; RR 0.33, 95% CI 0.04 to 3.07; very low-quality evidence); intolerance leading to discontinuation (3 trials; 220 participants; RR 0.35, 95% CI 0.08 to 1.43; very low-quality evidence); change of/or withdrawal from treatment (7 trials; 490 participants; RR 1.27, 95% CI 0.88 to 1.82; very low-quality evidence); quality of life (results not meta-analysed; 1 trial; 69 participants); and plasma ammonia concentration overall (6 trials; 325 participants; MD -2.93 μmol/L, 95% CI -9.36 to 3.50; very low-quality evidence). There were no reports of septicaemia attributable to probiotic in any trial.

Authors' conclusions: The majority of included trials suffered from a high risk of systematic error ('bias') and a high risk of random error ('play of chance'). Accordingly, we consider the evidence to be of low quality. Compared with placebo or no intervention, probiotics probably improve recovery and may lead to improvements in the development of overt hepatic encephalopathy, quality of life, and plasma ammonia concentrations, but probiotics may lead to little or no difference in mortality. Whether probiotics are better than lactulose for hepatic encephalopathy is uncertain because the quality of the available evidence is very low. High-quality randomised clinical trials with standardised outcome collection and data reporting are needed to further clarify the true efficacy of probiotics.

PubMed Disclaimer

Conflict of interest statement

RD: is a recipient of a scholarship from The University of Sydney. This scholarship had no influence on the conduct of this review. RMG: none to declare. SMR: is an author of a trial included in the review. SMR had no influence on its inclusion or data extraction and analysis. ACW: none to declare.

Figures

1
1
Study flow diagram.
2
2
Figure 2. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials.
3
3
Figure 3. Risk of bias summary: review authors' judgements about each risk of bias item for each included trial.
1.1
1.1. Analysis
Comparison 1: Probiotic versus placebo or no intervention, Outcome 1: All‐cause mortality
1.2
1.2. Analysis
Comparison 1: Probiotic versus placebo or no intervention, Outcome 2: No recovery (incomplete resolution of clinical symptoms)
1.3
1.3. Analysis
Comparison 1: Probiotic versus placebo or no intervention, Outcome 3: Adverse events
1.4
1.4. Analysis
Comparison 1: Probiotic versus placebo or no intervention, Outcome 4: Quality of life
1.5
1.5. Analysis
Comparison 1: Probiotic versus placebo or no intervention, Outcome 5: Plasma ammonia concentration (final and change scores) (μmol/L)
2.1
2.1. Analysis
Comparison 2: Probiotic versus lactulose, Outcome 1: All‐cause mortality
2.2
2.2. Analysis
Comparison 2: Probiotic versus lactulose, Outcome 2: No recovery (incomplete resolution of clinical symptoms)
2.3
2.3. Analysis
Comparison 2: Probiotic versus lactulose, Outcome 3: Adverse events
2.4
2.4. Analysis
Comparison 2: Probiotic versus lactulose, Outcome 4: Health‐related quality of life
2.5
2.5. Analysis
Comparison 2: Probiotic versus lactulose, Outcome 5: Plasma ammonia concentration (final and change scores) (μmol/L)
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Druart 2014 {published data only}
    1. Druart C, Alligier M, Salazar N, Neyrinck AM, Delzenne NM. Modulation of the gut microbiota by nutrients with prebiotic and probiotic properties. Advances in Nutrition 2014;5(5):624S-33S. [2161-8313] - PMC - PubMed
Dylag 2014 {published data only}
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EASL 2012 {published data only}
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Eguchi 2011 {published data only}
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El‐Nezami 2006 {published data only}
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Eslamparast 2014 {published data only}
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Fan 2009 {published data only}
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Fan 2013 {published data only}
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Fehervari 2012 {published data only}
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Ferreira 2010 {published data only}
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Festi 2014 {published data only}
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Finney 2007 {published data only}
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Floch 2015 {published data only}
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Fontana 2013 {published data only}
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Foster 2010 {published data only}
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Fujita 2008 {published data only}
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Fuster 2007 {published data only}
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Ganguli 2013 {published data only}
    1. Ganguli K, Meng D, Rautava S, Lu L, Walker WA, Nanthakumar N. Probiotics prevent necrotizing enterocolitis by modulating enterocyte genes that regulate innate immune-mediated inflammation. American Journal of Physiology. Gastrointestinal and Liver Physiology 2013;304(2):G132-41. [0193-1857] - PMC - PubMed
Garcia 2012 {published data only}
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Gareau 2014 {published data only}
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Gluud 2013 {published data only}
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Gomez‐Hurtado 2014 {published data only}
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Grat 2014 {published data only}
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Gratz 2010 {published data only}
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Greco 2007 {published data only}
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Gu 2014 {published data only}
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Guarner 2009 {published data only}
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Guerrero 2008 {published data only}
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Gupta 2010 {published data only}
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Gupta 2010a {published data only}
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Gupta 2013 {published data only}
    1. Gupta N, Kumar A, Sharma P, Garg V, Sharma BC, Sarin SK. Effects of the adjunctive probiotic VSL#3 on portal haemodynamics in patients with cirrhosis and large varices: a randomized trial. Liver International 2013;33(8):1148-57. [1478-3223] - PubMed
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Higashikawa 2010 {published data only}
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Holte 2012 {published data only}
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Hutt 2011 {published data only}
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Ianiro 2014 {published data only}
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Iannitti 2010 {published data only}
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Ivanovic 2015 {published data only}
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Jayakumar 2012 {published data only}
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Jayakumar 2013 {published data only}
    1. Jayakumar S, Carbonneau M, Hotte N, Befus AD, St Laurent C, Owen R, et al. VSL#3 probiotic therapy does not reduce portal pressures in patients with decompensated cirrhosis. Liver International 2013;33(10):1470-7. [1478-3223] - PubMed
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Jiang 2008 {published data only}
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Jones 2013 {published data only}
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Jover‐Cobos 2014 {published data only}
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Koga 2013 {published data only}
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Kumashiro 2008 {published data only}
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Lata 2011 {published data only}
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Liu 2006 {published data only}
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Liu 2009 {published data only}
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Liu 2010 {published data only}
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Lunia 2012 {published data only}
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Lunia 2014a {published data only}
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Schiano 2010 {published data only}
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Shukla 2011 {published data only}
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Stadlbauer 2008 {published data only}
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Stewart 2007 {published data only}
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References to studies awaiting assessment

ACTRN12610001021066 {published data only}
    1. ACTRN12610001021066. The effects of synbiotics, branched chain amino acids on hepatic encephalopathy. apps.who.int/trialsearch/Trial2.aspx?TrialID=ACTRN12610001021066 (irst recieved 22 November 2010).
IRCT201211012417N9 {published data only}
    1. IRCT201211012417N9. Effects of probiotics on the level of consciousness in patients with hepatic encephalopathy. apps.who.int/trialsearch/Trial2.aspx?TrialID=IRCT201211012417N9 (first received 24 November 2012).
NCT01798329 {published data only}
    1. NCT01798329. Minimal hepatic encephalopathy in childhood and young adult: epidemiological study and pilot interventional study. clinicaltrials.gov/ct2/show/NCT01798329 (first recieved 19 February 2013).

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References to other published versions of this review

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