Comparison of Rifaximin and Lactulose for the Treatment of Hepatic Encephalopathy: A Prospective Randomized Study.
10.3349/ymj.2005.46.3.399
- Author:
Yong Han PAIK
1
;
Kwan Sik LEE
;
Kwang Hyub HAN
;
Kun Hoon SONG
;
Myoung Hwan KIM
;
Byung Soo MOON
;
Sang Hoon AHN
;
Se Joon LEE
;
Hyo Jin PARK
;
Dong Ki LEE
;
Chae Yoon CHON
;
Sang In LEE
;
Young Myoung MOON
Author Information
1. Department of Internal Medicine, Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea. leeks519@yumc.yonsei.ac.kr
- Publication Type:Original Article ; Clinical Trial ; Comparative Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Hepatic encephalopathy;
rifaximin;
lactulose;
liver cirrhosis
- MeSH:
Comparative Study;
Female;
Gastrointestinal Agents/*administration & dosage/adverse effects;
Hepatic Encephalopathy/*drug therapy;
Humans;
Lactulose/*administration & dosage/adverse effects;
Male;
Middle Aged;
Prospective Studies;
Research Support, Non-U.S. Gov't;
Rifamycins/*administration & dosage/adverse effects;
Treatment Outcome
- From:Yonsei Medical Journal
2005;46(3):399-407
- CountryRepublic of Korea
- Language:English
-
Abstract:
Rifaximin has been reported to be effective for the treatment of hepatic encephalopathy (HE) in Europe. However, it is unknown whether Rifaximin is effective for the treatment of HE in Koreans, therefore we conducted a open-label prospective randomized study to evaluate the efficacy of rifaximin versus lactulose in Korean patients. Fifty-four patients with liver cirrhosis and hepatic encephalopathy were enrolled. Thirty-two patients were randomized to receive rifaximin and 22 to receive lactulose both over a 7-day periods. Before and at the end of treatment, gradation of blood ammonia, flapping tremor, mental status, number connection test (NCT) were performed and estimation of HE indexes determined. Both rifaximin and lactulose were effective in the majority of patients (84.4% and 95.4%, respectively, p=0.315). Blood NH3, flapping tremor, mental status, and NCT was significantly improved by rifaximin and lactulose, and the post- treatment levels of these measures were similar for the rifaximin and lactulose-treated groups, as was the HE index (rifaximin group (10.0-->> 4.2, p=0.000) ; lactulose group (11.3-->> 5.0, p=0.000) ). One patient treated with rifaximin complained of abdominal pain, which was easily controlled. There was no episode of renal function impairment in either treatment group. Rifaximin proved to be as safe and as effective as lactulose for the treatment of Korean patients with hepatic encephalopathy.