A randomized, double-blind, controlled trial comparing rifaximin plus lactulose with lactulose alone in treatment of overt hepatic encephalopathy - PubMed (original) (raw)
Randomized Controlled Trial
. 2013 Sep;108(9):1458-63.
doi: 10.1038/ajg.2013.219. Epub 2013 Jul 23.
Affiliations
- PMID: 23877348
- DOI: 10.1038/ajg.2013.219
Randomized Controlled Trial
A randomized, double-blind, controlled trial comparing rifaximin plus lactulose with lactulose alone in treatment of overt hepatic encephalopathy
Barjesh Chander Sharma et al. Am J Gastroenterol. 2013 Sep.
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.
Comment in
- ACP Journal Club. Adding rifaximin to lactulose increased reversal and decreased mortality in hepatic encephalopathy.
Kowdley KV, Burman BE. Kowdley KV, et al. Ann Intern Med. 2013 Oct 15;159(8):JC8. doi: 10.7326/0003-4819-159-8-201310150-02008. Ann Intern Med. 2013. PMID: 24126669 No abstract available. - Rifaximin for episodic, overt hepatic encephalopathy: the data are catching up to clinical practice, but questions remain.
Congly SE, Leise MD. Congly SE, et al. Am J Gastroenterol. 2014 Apr;109(4):598. doi: 10.1038/ajg.2013.480. Am J Gastroenterol. 2014. PMID: 24698864 No abstract available. - Response to Congly and Leise.
Praveen S, Chander SB. Praveen S, et al. Am J Gastroenterol. 2014 Apr;109(4):598-9. doi: 10.1038/ajg.2013.482. Am J Gastroenterol. 2014. PMID: 24698865 No abstract available.
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