Effect of probiotic VSL#3 in the treatment of minimal hepatic encephalopathy: A non-inferiority randomized controlled trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 25266207 · doi:10.1111/hepr.12429
What was done
Patients with chronic liver disease (n = 227) were screened for minimal hepatic encephalopathy (MHE) using neuropsychometric tests (number/figure connection tests A and B) and/or a neurophysiological test (P-300 auditory event-related potential). The 120 diagnosed patients (53%) were randomized to either lactulose (30–60 mL/day) or the probiotic VSL#3 (4 capsules/day; 450 billion CFU/day) for 2 months in a non-inferiority randomized controlled trial. Response was defined as normalization of tests, with serum ammonia also monitored.
What was found
Of 120 randomized patients, 73 completed the 2-month intervention (40 in the lactulose arm, 33 in the probiotic arm). MHE improved in 62.5% (25/40) of the lactulose group and 69.7% (23/33) of the probiotic group. The effect size difference in MHE improvement between groups was 0.072 in per-protocol analysis and 0.040 in intention-to-treat analysis (within the -20% non-inferiority margin). Serum ammonia levels were comparable between groups at baseline and 2 months; ammonia decreased in responders and increased in non-responders.
Why it matters
This trial suggests that high-dose probiotic therapy (VSL#3) achieves rates of minimal hepatic encephalopathy resolution non-inferior to standard lactulose, presenting an alternative option for patients intolerant to lactulose side effects.
Limits
Attrition was high, with 39.2% of randomized patients (47/120) dropping out before the 2-month endpoint. Blinding, specific adverse event rates, and long-term progression to overt hepatic encephalopathy were not detailed in the abstract.
Cited by
- supports VSL#3 probiotic sachets contain 450 billion CFU, which is approximately 10 times higher than what most probiotic supplements contain.