Barjesh Chander Sharma, MD, DM 1, Praveen Sharma, MD, DM 2, Manish Kumar Lunia, MD 1, Siddharth Srivastava, MD, DM 1, Rohit Goyal, MD, DM 1 and S.K. Sarin, MD A Randomized, Double-Blind, Controlled Trial Comparing Rifaximin Plus Lactulose With Lactulose Alone in Treatment of Overt Hepatic Encephalopathy R1. 박은지 / Pf. 심재준 THE AMERICAN JOURNAL OF GASTROENTEROLOGY Vol. 108, 23 July 2013

Introduction Hepatic encephalopathy (HE) ; complication of advanced liver disease → 30 to 45 % of LC ; reversible disorder The primary treatment of HE ; elimination of the increased neurotoxic ammonia levels 1) Lactulose BUT) evidence supporting its efficacy limited !! 2) Rifaximin In randomized studies, more effective than lactulose Equivalent ~ greater than other antibiotics used in acute HE → Evaluation of a combination of rifaximin + lactulose ??

Objective - prospective double-blind randomized controlled trial - Enrolled duration; ~ Age; 18~ 80 years - LC c over HE Exclusion - sCr > 1.5 mg / dl on admission - Active alcohol intake < 4 weeks before present episode - HCC - Other metabolic encephalopathies - Degenerative CNS disease - Major psychiatric illness Methods (1)

Methods (2) Study design - Severity of HE was graded according to West Haven criteria - Utill complete recovery of HE (max; 10 days) - Cured → continued on same medications - Failed → Group A ; L-ornithine and L -aspartate Group B; Rifaximin GroupAGroupB Rifaximin 400mg tid Lactulose 30~60cc tid → Semisoft stool 2~3/day Placebo(sugar) tid Lactulose 30~60cc tid → Semisoft stool 2~3/day

Results (1) Figure 1. Total 172

Results (2)

Results (3)

Adm day A ; 5.8 ± 3.4 days B ; 8.2 ± 4.6 days → P = Decrease in mortality A ; 15 (24 % ) B ; 28 (49.1 %) → P < 0.05 Deaths d/t sepsis A ; 7 B ; 17 → P = 0.01 d/t GI bleeding A ; 4 B ; 4 → P = NS d/t Hepatorenal sdr A ; 4 B ; 7 → P = NS

Conclusion Combination of lactulose plus rifaximin is more effective than lactulose alone in the treatment of overt HE

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