Simon 1988

Methods	Randomised trial comparing parenteral nutrition to no parenteral nutrition in hospitalized patients with alcoholic hepatitis. Geographical location Atlanta, Georgia. Study published 1988.
Participants	Inclusion criteria: >80 gm alcohol intake for at least 2 years, right hepatic lobe enlargement, severe alcoholic hep (bilirubin >5 mg% and either primary hepatic encephalopathy or prothrombin time at least 5 sec > control) or moderate alcoholic hepatitis (albumin < 2.9gm% and one of the three criteria for severe hepatitis), and either biopsy‐proven alcoholic hepatitis or, if no biopsy possible, AST <350 IU/l, AST/ALT >2, and actively consuming alcohol at time of admission. Exclusion criteria: Acute pancreatitis, insulin‐dependent diabetes mellitus, positive test for hepatitis B surface antigen, malignancy, hypotension, congestive heart failure, sepsis, severe chronic obstructive pulmonary disease, recent severe trauma or surgery. 34 patients in the full paper, but 69 in a subsequent abstract (age and sex only available for 22 patients in the original paper (7 men/15 women, mean age 41).
Interventions	Intervention group received intravenous formulation (35 gm AA, 5% dextrose, minerals, MVI/liter, 2 liters/day, 0.5 liter 10% lipid solution/day) and oral intake offered to control patients; Controls received oral diet (2400 kcal and 100 gm protein) and 1 can Ensure with each meal, 1 mg folic acid/day, multivitamins. Duration therapy 28 days.
Outcomes	Mortality (in abstract with 69 patients), appearance/resolution of ascites or hepatic encephalopathy (only for severe subgroup), bilirubin (only for severe subgroup).
Category of study	Parenteral nutrition/Medical.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full paper.
Notes	A couple of the numbers in the abstract describing the 69 patients were inconsistent with the original paper, and the data from the larger group were accepted. Address and location not identified for Dr Simon; letter sent to Dr Galambos (John T Galambos, MD, 95 Collier Road, Suite 4075, Atlanta, Georgia 30309) on September 12, 2011. No response has been received as of March 20, 2012.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states "randomised".
Allocation concealment (selection bias)	Unclear risk	Sealed envelope noted, but not mentioned if opaque and/or serially numbered.
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Two dropouts in trial reported in full paper; one from each group in those with moderate alcoholic hepatitis, but not stated which reason for which group. No information regarding subsequent report of 69 patients provided as abstract.
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported.
Other bias	Unclear risk	Funding source not reported.
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	Low risk	No differences identified.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.