Lactulose lowered falls in compensated cirrhosis, and tai chi added a further signal

Design

Two-stage sequential multiple assignment randomised trial (LiveSMART), 24 weeks, four US centres

Population

230 adults with cirrhosis and portal hypertension without prior overt hepatic encephalopathy

Primary outcome

Hierarchical composite of death or transplant, injurious falls, incident overt encephalopathy and non-injurious falls (win ratio)

Effect

Lactulose users vs non-users: win ratio 2.3 (95% CI 1.3 to 4.0); lactulose then tai chi vs usual care: 2.7 (95% CI 1.3 to 5.5)

LiveSMART was a 24-week two-stage sequential randomised trial in 230 adults with cirrhosis and portal hypertension and no prior overt hepatic encephalopathy, at four US centres. In weeks 1 to 12, participants were randomised to lactulose or enhanced usual care, which included education on nutrition and fall prevention. In weeks 13 to 24 they were randomised to tele-delivered tai chi or enhanced usual care. The primary outcome was a hierarchical composite of death or transplantation, injurious falls, incident overt encephalopathy and non-injurious falls, analysed with a win ratio.

Lactulose users had fewer injurious falls (3.5% vs 8.5%), fewer non-injurious falls (15.0% vs 26.5%) and fewer episodes of overt encephalopathy (1.8% vs 2.6%), with no difference in death or transplant or in adverse events (win ratio 2.3, 95% CI 1.3 to 4.0). Lactulose followed by tai chi was better than enhanced usual care on the composite (win ratio 2.7, 95% CI 1.3 to 5.5), mainly through fewer falls.

Events were few. Death and transplant were nearly absent, and the composite was driven by falls. The trial excluded people with prior overt encephalopathy, and results were in a US setting with a tele-delivered programme. It addresses a patient-identified priority, but a longer, larger trial is needed.

• Ask patients with cirrhosis about falls and gait, not only encephalopathy and variceal risk.
• Consider lactulose discussions in compensated cirrhosis with falls, with a specialist, as the trial found fewer falls.
• Watch for diarrhoea and dehydration, which lactulose can cause.
• Add balance and exercise advice, adapted to what the patient can do.

Why it matters

It treats falls as a treatable harm in cirrhosis rather than a side issue.

Don't overread it

A 24-week trial with few events and a composite driven by falls; it does not show effects on survival or on subtle encephalopathy.

The statistics, in plain English

A win ratio of 2.3 means that, when patients were compared pair by pair across the ranked outcomes, the lactulose patient 'won' about 2.3 times for each time the comparison patient did. It combines outcomes of different severity, which is why a few fall events decided it. Intervals starting at 1.3 show the benefit is not certain.

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