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Cited by 343Liver Disease and TransplantationLiver Disease Diagnosis and TreatmentDrug-Induced Hepatotoxicity and Protection

A Randomized, Double-Blind, Controlled Trial Comparing Rifaximin Plus Lactulose With Lactulose Alone in Treatment of Overt Hepatic Encephalopathy

Sharma, Barjesh Chander, Sharma, Praveen, Lunia, Manish Kumar, Srivastava, Siddharth, Goyal, Rohit, Sarin, S K·2013·American Journal of Gastroenterology
DOI 10.1038/ajg.2013.219
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Abstract

OBJECTIVES: Hepatic encephalopathy (HE) is associated with poor prognosis in cirrhosis. Drugs used in the treatment of HE are primarily directed at the reduction of the blood ammonia levels. Rifaximin and lactulose have shown to be effective in HE. We evaluated the efficacy and safety of rifaximin plus lactulose vs. lactulose alone for treatment of overt HE. METHODS: In this prospective double-blind randomized controlled trial, 120 patients with overt HE were randomized into two groups: (group A lactulose plus rifaximin 1,200 mg/day; n=63) and group B (lactulose (n=57) plus placebo). The primary end point was complete reversal of HE and the secondary end points were mortality and hospital stay. RESULTS: A total of 120 patients (mean age 39.4±9.6 years; male/female ratio 89:31) were included in the study. 37 (30.8%) patients were in Child-Turcotte-Pugh (CTP) class B and 83 (69.2%) were in CTP class C. Mean CTP score was 9.7±2.8 and the MELD (model for end-stage liver disease) score was 24.6±4.2. At the time of admission, 22 patients (18.3%) had grade 2, 40 (33.3%) had grade 3, and 58 (48.3%) had grade 4 HE. Of the patients, 48 (76%) in group A compared with 29 (50.8%) in group B had complete reversal of HE (P<0.004). There was a significant decrease in mortality after treatment with lactulose plus rifaximin vs. lactulose and placebo (23.8% vs. 49.1%, P<0.05). There were significantly more deaths in group B because of sepsis (group A vs. group B: 7:17, P=0.01), whereas there were no differences because of gastrointestinal bleed (group A vs. group B: 4:4, P=nonsignificant (NS)) and hepatorenal syndrome (group A vs. group B: 4:7, P=NS). Patients in the lactulose plus rifaximin group had shorter hospital stay (5.8±3.4 vs. 8.2±4.6 days, P=0.001). CONCLUSION: Combination of lactulose plus rifaximin is more effective than lactulose alone in the treatment of overt HE.

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  • Several small clinical studies suggest that norfloxacin and rifaximin increase survival in patients with liver cirrhosis.

    “Moreover, several small-scale clinical studies have suggested that antibiotics such as norfloxacin and rifaximin increase survival in patients with liver cirrhosis92–95.”

    From The gut microbiome and liver cancer: mechanisms and clinical translation (2017) · cites this paper as [95]

  • Rifaximin has been reported to increase survival in advanced liver cirrhosis in several small trials.

    “Similar to norfloxacin, rifaximin has been noted to increased survival in patients with advanced liver cirrhosis in several small-scale trials92–95.”

    From The gut microbiome and liver cancer: mechanisms and clinical translation (2017) · cites this paper as [95]

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Authors
Sharma, B. C., Sharma, P., Lunia, M. K., Srivastava, S., Goyal, R., & Sarin, S. K.
Affiliations
  • Govind Ballabh Pant Hospital (IN)
  • Institute of Liver and Biliary Sciences (IN)
Corresponding author
  • Sharma, Barjesh Chander
  • Sharma, Praveen
ORCID
Venue
American Journal of Gastroenterology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2013-09
Volume
108
Issue
9
Pages
1458-1463
ISSN
0002-9270 (ISSN-L)
DOI
10.1038/ajg.2013.219
OpenAlex
W2091958019
Cited by
343
References
27
Citations by year
2026: 13 · 2025: 23 · 2024: 31 · 2023: 34 · 2022: 26 · 2021: 24 · 2020: 30 · 2019: 25 · 2018: 31 · 2017: 24 · 2016: 23 · 2015: 29 · 2014: 26 · 2013: 3 · 2012: 1
FWCI
16.84
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (unspecified)
Locations
  • The American Journal of Gastroenterology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Hepatology › Liver Disease and Transplantation
  • Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
Keywords
hepatic encephalopathy, rifaximin, lactulose, liver cirrhosis, ammonia reduction, combination therapy, mortality, sepsis, length of hospital stay, Child-Pugh score, MELD score, drug safety, adverse events, gastrointestinal bleeding, hepatorenal syndrome
MeSH terms
Rifaximin, Adult, Double-Blind Method, Drug Therapy, Combination, Female, Gastrointestinal Agents, Hepatic Encephalopathy, Humans, Lactulose, Length of Stay, Male, Middle Aged, Rifamycins, Severity of Illness Index, Treatment Outcome

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