The HELP Trial, 2014

Rahimi RS, Singal AG, Cuthbert JA, Rockey DC. Lactulose vs polyethylene glycol 3350 – electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial. JAMA Intern Med. 2014 Nov;174(11):1727-33. doi: 10.1001/jamainternmed.2014.4746. PubMed PMID: 25243839.

• Does catharsis of the gut using polyethylene glycol (PEG) resolve hepatic encephalopathy more effectively than standard therapy with lactulose?

TYPE OF STUDY

• Single Center Randomised Control Trial
• Parkland Memorial Hospital, Texas, USA (a tertiary academic center)

POPULATION

• All patients attending the ED with cirrhosis and altered mental status with typical symptoms of hepatic encephalopathy without another clear cause
• n =50 (out of 186 screened)

INTERVENTIONS/ COMPARISONS

• Control arm (n = 25)
  • standard therapy lactulose 20-30g at least 3x in 24h (oral/NG/PR)
• Study arm (n = 25)
  • 4L polyethylene glycol 3350-electrolyte solution (PEG) (oral/NG); 19 (76%) had the full 4L therapy

OUTCOMES

• Primary outcome
  • Improvement of ≥1 grade in the hepatic encephalopathy scoring algorithm (HESA) at 24h post admission
• Secondary outcomes
  • Time to resolution of HE
  • Overall LOS

*2 patients were not evaluated

• Single centre only
• Small population
• Non-blinded
• Intention to treat analysis with a patient in PEG group being treated with lactulose
• Not all PEG patients received the same treatment
• Only short-term outcomes studied
• 2 patients were not evaluated as 1 patient was discharged before final analysis and 1 refused participation
• Possible patient preference for the taste of PEG!

• Polyethylene glycol, as a one off treatment was superior to regular lactulose for the treatment of hepatic encephalopathy, but a larger multi-center study conducted with longer follow up is required