Lactulose Therapy and Patient-Reported Outcomes in Cirrhosis Patients

A recent 28-day randomized trial assessed the impact of crystalline lactulose therapy on patient-reported outcomes (PROs) in cirrhosis patients with high Work Productivity and Activity Impairment scores attributed to cirrhosis. The study found that lactulose therapy improved sleep quality and reduced activity impairment, as well as increasing performance on the Animal Naming Test.

This study was published in the Hepatology journal by Tapper and colleagues. Patients with cirrhosis often experience poor patient-reported outcomes (PROs), including sleep disturbances and reduced health-related quality of life (HRQOL), which can be attributed to hepatic encephalopathy (HE). Many clinicians initiate lactulose therapy to address these PROs, but the impact of PRO-triggered therapy with lactulose has not been studied extensively.

Study Design

The study involved a 28-day randomized trial in which 52 patients with cirrhosis, portal hypertension, no prior history of HE, and high Work Productivity and Activity Impairment scores attributed to cirrhosis were included. The patients were divided into two groups:

• One receiving crystalline lactulose therapy (20 g BID)
• The other receiving no HE-directed therapy

The primary outcome was the change in global HRQOL, assessed using the Short Form-8 Health Survey. Secondary outcomes included changes in the Animal Naming Test score, Work Productivity and Activity Impairment, and sleep quality.

Results

At the end of the 28-day trial, there was no significant improvement in global HRQOL. Patients receiving crystalline lactulose showed an 8.1-point increase in HRQOL (95% CI: 3.7–12.4), while the control group exhibited a 6.6-point increase (95% CI: 2.3–10.8), with no statistically significant difference (p = 0.6).

Lactulose therapy was associated with a significantly increased Animal Naming Test score (3.7, 95% CI: 2.1–5.4) compared to the control group (0.2, 95% CI: -1.7, 1.4).

Lactulose users reported more instances of "good" sleep quality (92% vs. 52%, p = 0.001) and lower activity impairment (3.0 vs. 4.8, p = 0.02).

Conclusion

The study concluded that lactulose therapy significantly improved sleep quality and reduced activity impairment in patients with poor PROs related to cirrhosis. However, the research did not observe any significant improvement in overall global health-related quality of life (HRQOL) after 28 days using the Short Form-8 Health Survey instrument. These findings suggest that lactulose therapy can effectively address specific PROs in cirrhosis patients but may not substantially impact their overall HRQOL.

Reference

Tapper, E. B., Ospina, E., Salim, N., Chen, X., & Nikirk, S. Lactulose therapy for patients with cirrhosis, portal hypertension, and poor patient-reported outcomes: The Mi-Kristal trial. Hepatology, 2023;78(4):1159–1167. https://doi.org/10.1097/hep.0000000000000408