The HELP Trial, 2014

Author: Ged Dalgleish
Reviewer: Chris Nickson

Journal Club 017

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.

THE QUESTION

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

STUDY DESIGN

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
Result Lactulose PEG P value
Achieved primary outcome 13 (52%) 21 (91%)* <0.01
Mean change in score 2.3 -> 1.6 2.3 -> 0.9 0.002
Time to resolution 2 days 1 day 0.01
LOS 8 days 4 days 0.07

*2 patients were not evaluated

CRITICISMS AND COMMENTARY

  • 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!

FINAL WORDS

  • 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

 

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