SAN FRANCISCO, CA—In patients with minimal hepatic encephalopathy, prophylactic lactulose treatment improved cognition, quality of life, and intestinal microbiota, results of a multicenter, randomized, controlled trial presented at The Liver Meeting® 2015 have shown.
Minimal hepatic encephalopathy is highly prevalent in China—39.8 %—and patients have a low quality of life. Based on previous findings, Jiyao Wang, MD, MSc, AGAF, Zhongshan Hospital, Fudan University, Shanghai, China, and colleagues assessed the efficacy and safety of lactulose in patients with cirrhosis.
Study subjects were screened by the psychometric number connection test A (NCT-A) and digit symbol test (DST), both of which were required to be positive to confirm a diagnosis of minimal hepatic encephalopathy. A total of 98 patients were then randomly assigned 2:1 to receive lactulose 30–60mL twice daily (n=67) or no therapy (n=31).
The primary endpoint was recovery rate, defined as the normalization of at least 1 of the psychometric tests. Secondary endpoints included comparisons of quality of life (QoL) questionnaire, Child-Turcotte Pugh (CTP) score, ammonia, and microbiota from baseline to Month 2.
Eleven patients were lost to follow-up, eight in the lactulose group and 3 in the no therapy group.
At Month 2, the minimal hepatic encephalopathy recovery rate in the lactulose group, 69.49% (41 of 59 patients) was significantly higher than in the untreated group, 21.43% (6 of 28 patients).
Compared with the no therapy group, QoL in the lactulose group was significantly improved from baseline in all five aspects of physical function (4.62 vs. 1.5), psychological well-being (3.03 vs. 1.43), relief of symptoms (2.12 vs. 0.86), social function (1.07 vs. 0.57). On the QoL questionnaire, the lactulose group scored 12.63 ± 15.10, which was higher than the no therapy group, 6.36 ± 12.16 (P=0.0523).
Intestinal microbiota changed in both autochthonous taxa and non-autochthonous taxa in the lactulose group. Researchers also observed a decrease of certain microbiota families in patients with lactulose treatment compared to the no therapy group (P<0.05).
All patients tolerated lactulose and no severe side effects were reported, the investigators reported.