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. 2017 May 19;2017(5):CD011598. doi: 10.1002/14651858.CD011598.pub2

Simon 1988.

Methods Randomised clinical trial, USA
Participants 34 hospitalised adults with moderate or severe alcoholic hepatitis (chronic ethanol ingestion > 80 g/day for at least 2 years and right lobe hepatomegaly), at nutritional risk according to the trialist
Male:Female = 7:15(gender not reported for 12 participants)
Mean age = 41.5 years (only for the severe malnourished)
Exclusion criteria: acute pancreatitis, insulin‐dependent diabetes mellitus, positive HBsAg, malignancy, hypotension, congestive heart failure, sepsis, severe COPD, and recent severe trauma, surgery, mild disease or rapidly became moribund
Interventions Experimental group: 28 days of peripheral parenteral nutrition (2 litres a day). Each litre consisted of 35 g Aminosyn, 50 g dextrose, 500 ml of 10% Intralipid a day for a total of 1070 intravenous calories a day.(n = 16)
 Control group: no intervention(n = 18)
Co‐interventions: diet consisting of 2400 calories and 100 g protein + can of Ensure
Outcomes Biochemistry, grade of encephalopathy, mortality, ascites, function tests
Study dates Not stated
Notes We contacted the authors on 19th August 2015 by email: jgalamb@emory.edu. We received no reply.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Unclear risk The trial used sealed envelopes, but they were not described as being opaque.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk The trial was described as "lack of blinding".
Blinding of outcome assessment (detection bias) 
 All outcomes High risk The trial was described as "lack of blinding".
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk The number of participants with incomplete data was not reported.
Selective reporting (reporting bias) Unclear risk No protocol could be obtained, and the trial did not report on serious adverse events.
For‐profit bias Unclear risk It was unclear how the trial was funded.
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.