Bonkovsky 1991

Methods	Randomised trial comparing parenteral nutrition to no parenteral nutrition in hospitalized patients with alcoholic hepatitis. Geographical location Atlanta, Georgia, USA. Paper published 1991.
Participants	Inclusion criteria: 1) Prolonged alcohol intake (100 g/d for at least 5 days/week for at least 1 year); 2) AST < 500, AST/ALT >1.5, albumin < 3.0 gm%, bilirubin > 5 mg%, PT > 6 sec over control; 3) Alcohol cessation within last 5‐14 days). Exclusion criteria: Recent bleeding (within 2 days), severe ascites, severe hepatic encephalopathy, creatinine > 2 mg%, sepsis, acute pancreatitis, hemodynamic instability (systolic blood pressure < 80 mm Hg or fluctuating > 20 mm Hg), advanced pulmonary disease (pO2 < 50/pCO2 > 50 mm Hg), diabetes mellitus, active cancer. 21 patients (11 male/10 female, mean age 43).
Interventions	Intervention group received intravenous formulation (35 gm amino acids (Aminosyn II, Abbott), 5% dextrose, minerals, 500 units heparin, 5 mg hydrocortisone/liter), 2 liters/day + daily diet; Controls received daily diet (30 kcal/kg/d, 1 g protein/kg/d). Duration therapy 21 days.
Outcomes	Mortality, serum bilirubin body weight and nitrogen balance (estimated from figures); triceps skinfold thickness and midarm circumference assessed but not reported numerically. One case each of thrombophlebitis and hyponatraemia reported in parenteral nutrition group, but data regarding adverse events did not appear to have been systematically obtained.
Category of study	Parenteral nutrition/Medical.
Sample size calculation	None reported if done.
Full paper or abstract only	Full paper.
Notes	Treatment group got 1000 units heparin and 10 mg hydrocortisone per day for thrombophlebitis prophylaxis; it was decided that these agents were not likely to impact on any outcomes. There were two other trial groups that received oxandrolone with or without parenteral nutrition, but, because of the use of this agent, these groups not considered in the analysis. Request for further information made by e‐mail on September 11, 2011 that failed (address = bonkovsh@ummhc.org) and then by US mail on September 12, 2011 (Address = Herbert L Bonkovsky, MD, Division of Digestive Disease & Nutrition, The Liver‐Biliary‐Pancreatic Center, University of Massachusetts Medical School, 55 Lake Ave., North Worcester, MA 01655). The letter was returned with a note on envelope that Dr Bonkovsky was no longer there.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number table, no blocks.
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	No dropouts.
Selective reporting (reporting bias)	Low risk	Bilirubin reported and this accepted as hepatic morbidity.
Other bias	High risk	Partial funding by Miles Laboratory.
Intent to treat analysis	Low risk	Performed.
Baseline imbalance?	Low risk	No imbalance identified.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.