Comparison of rifaximin and lactulose for the treatment of hepatic encephalopathy: a prospective randomized study.
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.
Department of Internal Medicine, Division of Gastroenterology, Yonsei University College of Medicine, Yongdong Severance Hospital, 146-92 Dogok- dong, Gangnam-gu, Seoul 135-720, Korea.
Yong Han
YH
Paik
Kwan Sik
KS
Lee
Kwang Hyub
KH
Han
Kun Hoon
KH
Song
Myoung Hwan
MH
Kim
Byung Soo
BS
Moon
Sang Hoon
SH
Ahn
Se Joon
SJ
Lee
Hyo Jin
HJ
Park
Dong Ki
DK
Lee
Chae Yoon
CY
Chon
Sang In
SI
Lee
Young Myoung
YM
Moon
D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006501:Hepatic Encephalopathy / Q000188:drug therapy*; D006801:Humans; D007792:Lactulose / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012294:Rifamycins / Q000008:administration & dosage* / Q000009:adverse effects; D000078262:Rifaximin; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D012294:Rifamycins; D007792:Lactulose; D000078262:Rifaximin