Norman 2008

Methods	Randomised trial comparing enteral nutrition to no enteral nutrition in patients hospitalised with decompensated cirrhosis. Geographical location: Germany. Paper published 2008.
Participants	Inclusion criteria: Clinical diagnosis of alcoholic liver disease, bilirubin > 51 micromol/l, one of the following: albumin < 3gm%, PT > 4secs above control, ascites on examination. Exclusion criteria: None cited. 63 hospitalized patients (40 male/23 female, age not provided).
Interventions	Intervention group received enteral nutrition through nasogastric tube (only detail was "high protein formulation"); Control group given standard diet. Duration of therapy 14 days.
Outcomes	Mortality, gastrointestinal bleeding, infections, bilirubin.
Category of study	Enteral nutrition/Medical.
Sample size calculation	Not performed (information obtained from author at poster).
Full paper or abstract only	Abstract.
Notes	Much of the information obtained via discussion with author who was present at poster where study presented (Digestive Disease Week, 2008) Trial from same group as Schuetz 2006, but appears to be different trial. On September 17, 2011, emails sent to Drs Norman and Pirlich (kristina.norman@charite.de and Matthias.pirlich@charite.de) requesting information about both Norman and Schuetz trials. (Email for Dr Pirlich failed.) No response has been received as of March 20, 2012.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer generated (information obtained at poster from author).
Allocation concealment (selection bias)	Low risk	Central phone (information obtained at poster from author).
Blinding (performance bias and detection bias) All outcomes	High risk	Information obtained at poster.
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropouts had to have occurred, as percentages at poster did not produce whole numbers.
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported.
Other bias	Unclear risk	Funding source not reported; trial stopped because primary investigator left institution (information obtained at poster).
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	Low risk	Although no numerical data, abstract stated that there were no differences.
Early stopping?	High risk	Trial stopped early because principal investigator left institution. (Information obtained at poster.)