Lactulose with or without TeleTai-Chi for the prevention of falls: A sequential multiple assignment randomized controlled trial (LiveSMART).

BACKGROUND AND AIMS: Falls are common and morbid for patients with cirrhosis, and patients have identified reducing fall risk as an unmet need and care priority.

APPROACH AND

RESULTS

This is a 24-week two-stage Sequential, Multiple Assignment Randomized Trial (SMART) at 4 centers in Michigan, Pennsylvania, and Texas enrolling 230 adults with cirrhosis and portal hypertension without prior overt hepatic encephalopathy (HE). There were 2 stages. In stage 1 (weeks 1-12), participants were randomized to lactulose or enhanced usual care (education on nutrition and fall prevention). In stage 2 (weeks 13-24), participants were randomized to TeleTai-Chi or enhanced usual care (exercise education). We evaluated the effectiveness of lactulose with or without TeleTai-Chi. The primary outcome was a hierarchical composite of death or transplantation, injurious falls, incident HE, and non-injurious falls. We used an intention-to-treat (ITT) win ratio (WR). Lactulose followed by TeleTai-Chi, compared with enhanced usual care, reduced injurious falls (4% vs. 12%) and non-injurious falls (19% vs. 32%), with no differences in overt HE (2% vs. 0%) or death/transplantation (0% vs. 0%). Compared with non-users, lactulose users experienced fewer injurious falls (3.5% vs. 8.5%), non-injurious falls (15.0% vs. 26.5%), and overt HE (1.8% vs. 2.6%), with no difference in death/transplantation or adverse events, resulting in a WR 2.3, 95% CI (1.3-4.0). Sequential lactulose/TeleTai-Chi reduced the risk of the primary outcome compared with usual care (WR 2.7, 95% CI (1.3-5.5).

CONCLUSION

In patients with cirrhosis and portal hypertension without prior overt HE, lactulose reduced falls and fall-related harms. Sequential lactulose followed by TeleTai-Chi was also superior to enhanced usual care.