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. 2012 May 16;2012(5):CD008344. doi: 10.1002/14651858.CD008344.pub2
Methods Randomised trial comparing enteral nutrition to no enteral nutrition in patients hospitalized with cirrhosis and encephalopathy. Geographical location: Germany. Paper published 2006.
Participants Inclusion criteria: Hospitalized patients with cirrhosis and hepatic encephalopathy. Exclusion criteria: None cited. 22 hospitalised patients (16 male/6 female, mean age 60).
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 Appearance of hepatic encephalopathy.
Category of study Enteral nutrition/Medical.
Sample size calculation Not reported if performed.
Full paper or abstract only Abstract.
Notes Trial from same group as Norman 2008, but appears to be different trial. Abstract states no change in encephalopathy and all patients appeared to have subclinical encephalopathy at beginning, so assumed no frank encephalopathy developed. On September 17, 2011, e‐mails sent to Drs Norman and Pirlich (kristina.norman@charite.de and Matthias.pirlich@charite.de) requesting information about both Norman and Schuetz trials. (E‐mail 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) Unclear risk Only states "patients were randomly assigned".
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 Unclear risk 22 patients presented, but unclear if they were the only ones randomised.
Selective reporting (reporting bias) High risk No mortality data.
Other bias Unclear risk Funding source not reported.
Intent to treat analysis Unclear risk 22 patients reported but unknown if other patients enrolled in trial.
Baseline imbalance? Unclear risk Only Childs‐Pugh scores at baseline presented.
Early stopping? Unclear risk No sample size calculation and unknown why stopped.