Calvey 1985

Methods	Randomised trial comparing artificial (majority receiving enteral) nutrition (branched chain or standard amino acid formulation) to no enteral nutrition in patients hospitalized with alcoholic hepatitis. Geographical location: London, England. Paper published 1985.
Participants	Inclusion criteria: Patients with alcoholic hepatitis (clinical and biochemical evidence of hepatocellular damage, alcohol intake > 80 gm for several years and up to present, poor uptake tracer on liver scan, no evidence active hepatitis A or B serologically. Exclusion criteria: Hepatocellular carcinoma, hypotensive (usually from current upper gastrointestinal bleeding). 64 hospitalized patients (31 male/33 female, mean age 49).
Interventions	Intervention group received enteral nutrition through nasogastric tube (either branched chain amino acid formulation [described in Calvey 1985 ‐ BCAA] or standard amino acid formulation [described in Calvey 1985 ‐ SAA] + oral diet given to controls); Control group given oral diet (18‐2400 kcal, 70‐100 gm protein daily [decreased to 40‐60 gm for hepatic encephalopathy]) + intravenous dextrose (5‐20%) as needed. Duration therapy planned to be 3 weeks.
Outcomes	Mortality, gastrointestinal bleeding, appearance/resolution of hepatic encephalopathy, infections, nitrogen balance (in subgroup without renal insufficiency. Triceps skinfold thickness and midarm muscle circumference reported only as showing "no difference".
Category of study	Enteral nutrition/Medical.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full paper.
Notes	Enteral nutrition (or supplements) changed to parenteral nutrition if gastrointestinal bleeding or other gastrointestinal problems prevented enteral delivery of nutrients. Days of observation reported, but not clear if this equivalent to duration of hospitalization. E‐mail request for more information sent to Dr Williams (since we were not able to identify address for Dr Calvey) on September 15, 2011 (r.williams@researchinliver.org.uk). Response from Dr Williams received on September 19, 2011; Dr Calvey died several years ago and no data available except what is in paper.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states "randomly allocated".
Allocation concealment (selection bias)	Unclear risk	No details.
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Assumption made that only the reported patients were randomised.
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported.
Other bias	Low risk	Funded by Joint Research Committee of King's College Hospital and Medical School.
Intent to treat analysis	Low risk	No dropouts.
Baseline imbalance?	Low risk	No imbalance identified.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.