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Effect of rifaximin, probiotics, and l-ornithine l-aspartate on minimal hepatic encephalopathy: a randomized
Kapil Sharma1, Sanjay Pant, Sriprakash Misra
1Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.
Background/Aims:
Minimal hepatic encephalopathy (MHE) implies subtle impairment of cognitive functions in the absence of features of overt encephalopathy. We aimed to determine the prevalence of MHE in patients with liver cirrhosis and to find out the effect of rifaximin, probiotics, and l-ornithine l-aspartate (LOLA) individually in reversal of MHE by comparing it with placebo group.
Patients And Methods:
This study was carried out in two phases. Phase I included the recruitment of 250 apparently healthy controls and extraction of normative data utilizing three neuropsychometric tests (NPTs) and critical flicker frequency (CFF) test. Phase II consisted of screening and recruitment of patients of MHE followed by drugs trial. A total of 317 cirrhotics were screened; 111 were excluded and the remaining 206 cirrhotics were screened for MHE using NPTs and/or CFF test. Of these, 124 patients with MHE were randomized to receive LOLA (n = 31), rifaximin (n = 31), probiotics (n = 32), for 2 months and were compared with patients who were given placebo (n = 30).
Results:
Out of 206 cirrhotics, 124 (60.19%) had MHE. Among these 124 MHE patients, 87 (70.16%) patients had CFF <39Hz, 112 (90.32%) patients with MHE had two or more abnormal NPTs, and 75 (60.48%) patients had abnormality on both the CFF values and more than two abnormal NPTs. Intention-to-treat analysis showed the number of patients who improved after giving treatment were 67.7% (21/31), 70.9% (22/31), 50% (16/32), and 30% (9/30) for LOLA, rifaximin, probiotics, and placebo, respectively. CFF scores and improvement in psychometric tests after treatment were significantly higher (P < 0.05) for LOLA, rifaximin, and probiotics as compared with placebo group.
Conclusions:
Prevalence of MHE is high in patients with cirrhosis of liver. Rifaximin, LOLA, and probiotics are better than giving placebo in patients with MHE.
Insights
Minimal hepatic encephalopathy (MHE) affects over 60% of liver cirrhosis patients. Rifaximin, L-ornithine L-aspartate (LOLA), and probiotics significantly improve MHE symptoms compared to placebo.
Area of Science:
- Hepatology
- Gastroenterology
- Neurology
Background:
- Minimal hepatic encephalopathy (MHE) is a subtle cognitive impairment in liver cirrhosis patients.
- The prevalence and effective treatments for MHE require further investigation.
Purpose of the Study:
- To determine the prevalence of MHE in liver cirrhosis patients.
- To evaluate the efficacy of rifaximin, probiotics, and L-ornithine L-aspartate (LOLA) in reversing MHE compared to placebo.
Main Methods:
- Two-phase study: Phase I established normative data using neuropsychometric tests (NPTs) and critical flicker frequency (CFF). Phase II screened 317 cirrhotics for MHE.
- 124 MHE patients were randomized into four groups: LOLA (n=31), rifaximin (n=31), probiotics (n=32), and placebo (n=30) for 2 months.
Main Results:
- The prevalence of MHE was 60.19% (124/206) among screened cirrhotic patients.
- Treatment success rates were 67.7% for LOLA, 70.9% for rifaximin, 50% for probiotics, and 30% for placebo.
- Improvements in CFF scores and NPTs were significantly greater (P < 0.05) for LOLA, rifaximin, and probiotics versus placebo.
Conclusions:
- MHE is highly prevalent in liver cirrhosis patients.
- Rifaximin, LOLA, and probiotics demonstrate superior efficacy over placebo in managing MHE.
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