Lactulose therapy for patients with cirrhosis, portal hypertension, and poor patient-reported outcomes: The Mi-Kristal trial

Background and aims: Poor patient-reported outcomes (PROs) are common in cirrhosis, including poor sleep and health-related quality of life (HRQoL). Hepatic encephalopathy (HE) is a major driver of poor PROs. Many clinicians initiate lactulose therapy to address poor PROs. PRO-triggered therapy, however, has not been studied till date.
Methods: The authors conducted a 28-day randomized trial of crystalline lactulose therapy (20 g b.i.d.) compared with no HE-directed therapy in 52 patients with cirrhosis, portal hypertension, no prior HE, and high Work Productivity and Activity Impairment scores (0–10) attributed to cirrhosis. The primary outcome was change in global HRQoL measured with Short Form-8 Health Survey. Secondary outcomes included change in Animal Naming Test score, Work Productivity and Activity Impairment, and sleep quality (scored “very bad” to “very good”).
Approach and results: Overall, 52 patients underwent randomization; 3 subjects withdrew from the crystalline lactulose arm (1 before medication initiation, 1 due to an unrelated condition, and 1 due to high baseline bowel movements). The average age was 60 years, the average Model for End-stage Liver Disease-Sodium score was 10.5, and 56% of the patients had ascites. Baseline bowel movements were 2.3/day, with 35% of the patients having Bristol Stool Scale > 4. At 28 days, there was no improvement in HRQoL: Patients receiving crystalline lactulose had an 8.1-point (95% confidence interval [CI]: 3.7–12.4) increase compared with 6.6 (95% CI: 2.3–10.8) in the control group (p = 0.6). Lactulose was associated with a significantly (p = 0.002) increased Animal Naming Test score (3.7, 95% CI: 2.1–5.4) versus the control group (0.2, 95% CI: -1.7–1.4). Lactulose users reported more good sleep (92% vs. 52%, p = 0.001) and lower activity impairment (3.0 vs. 4.8, p = 0.02).

Lactulose improves sleep and activity impairment in patients with poor patient-reported outcomes. The authors did not observe any improvement in global health-related quality of life after 28 days using the Short Form-8 Health Survey instrument.

E.B. Tapper, M.D., Associate Professor of Medicine, Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA, E-Mail: etapper@umich.edu

DOI: 10.1097/hep.0000000000000408

Back to overview

this could be of interest:

Liver and Bile

Development, validation, and prognostic evaluation of a risk score for long-term liver-related outcomes in the general population: A multicohort study

Lancet. 2023;402(10406):988–96

Serra-Burriel M, Juanola A, Serra-Burriel F, Thiele M, Graupera I, Pose E, Pera G, Grgurevic I, Caballeria L, Piano S, van Kleef L, Reichert M, Roulot D, Pericàs JM, Schattenberg JM, Tsochatztis EA, Guha IN, Garcia-Retortillo M, Hernández R, Hoyo J, Fuentes M, Expósito C, Martínez A, Such P, Madir A, Detlefsen S, Tonon M, Martini A, Ma AT, Pich J, Bonfill E, Juan M, Soria A, Carol M, Gratacós-Ginès J, Morillas RM, Toran P, Navarrete JM, Torrejón A, Fournier C, Llorca A, Arslanow A, de Koning HJ, Cucchietti F, Manns M, Newsome PN, Hernáez R, Allen A, Angeli P, de Knegt RJ, Karlsen TH, Galle P, Wong VWS, Fabrellas N, Castera L, Krag A, Lammert F, Kamath PS, Ginès P; LiverScreen Consortium Investigators

Go to article

Liver and Bile

Risk of severe infection in patients with biopsy-proven non-alcoholic fatty liver disease – A population-based cohort study

Clin Gastroenterol Hepatol. 2023;21(13):3346–55.e19