Lactulose reduced falls in cirrhosis without prior overt encephalopathy; adding tele-tai chi helped further

Design

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

Population

230 adults with cirrhosis and portal hypertension without prior overt HE, 4 US centres

Primary outcome

Hierarchical composite: death/transplant, injurious falls, overt HE, non-injurious falls (win ratio)

Effect

Lactulose WR 2.3 (95% CI 1.3–4.0); injurious falls 3.5% vs 8.5%; lactulose then tai chi WR 2.7 (1.3–5.5)

LiveSMART was a 24-week sequential multiple-assignment randomised trial at four US centres in 230 adults with cirrhosis and portal hypertension who had never had overt hepatic encephalopathy. In weeks 1–12, participants were randomised to lactulose or enhanced usual care (nutrition and fall-prevention education); in weeks 13–24, to tele-delivered tai chi or exercise education. The primary outcome was a hierarchical composite of death or transplant, injurious falls, overt encephalopathy and non-injurious falls, analysed by win ratio.

Compared with non-users, lactulose users had fewer injurious falls (3.5% vs 8.5%) and non-injurious falls (15.0% vs 26.5%), with no difference in death, transplant or adverse events (win ratio 2.3, 95% CI 1.3–4.0). Lactulose followed by tai chi beat enhanced usual care (win ratio 2.7, 1.3–5.5), with injurious falls 4% versus 12%.

Falls in cirrhosis are common, injurious and partly driven by covert hepatic encephalopathy. Lactulose is cheap and widely available, including in India. This trial supports offering it to patients with portal hypertension who fall or are at high fall risk, even without a history of overt encephalopathy. The trial was modest in size and short, and diarrhoea and adherence will limit use in some.

• Offer lactulose to patients with cirrhosis and portal hypertension who are falling or at high fall risk, even without prior overt encephalopathy.
• Titrate to two to three soft stools a day and warn about dehydration and electrolyte loss.
• Add structured balance exercise — tai chi, delivered remotely, reduced falls further.
• Combine with a fall-risk review: medications, vision, footwear, home hazards.
• Lactulose is inexpensive and widely available, so cost is rarely a barrier.

Why it matters

It extends lactulose from treating overt encephalopathy to preventing falls, a patient-prioritised harm with no prior proven intervention.

Don't overread it

A 230-patient, 24-week trial with a composite outcome; mortality and long-term effects were not tested.

The statistics, in plain English

A win ratio of 2.3 means that, comparing patients pairwise and ranking outcomes from most to least serious, lactulose users came out better about 2.3 times as often as worse. The wins here came mainly from fewer falls, since there were almost no deaths or transplants.

Read the rest in the app

You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.

Get Daily Doctor — free

Scan to keep reading on your phone. No account needed to start.