Comparison of rifaximin and lactulose for the treatment of hepatic encephalopathy: a prospective randomized study

Yong Han Paik, 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, Yong Han Paik, 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

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.

Figures

Fig. 1
Fig. 1
(A) Changes in grade of blood ammonia level with Rifaximin (solid line) or Lactulose (dotted line) treatment. Grade of blood ammonia was significantly decreased at the end of the treatment with respect to pre-treatment values in both groups (p < 0.01). (B) Changes in HE index with Rifaximin (solid line) and Lactulose (dotted line) treatment. Marked improvement in HE index was noted at the end of the treatment (p < 0.01) compared to pre-treatment values in both groups (p < 0.01).

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