Simko 1983

Methods	Randomised trial comparing supplements to "placebo" in outpatients who had chronic (alcoholic) liver disease with past history of encephalopathy but were currently no worse that Grade I. Geographical location: Cincinatti, Ohio, USA. Paper published 1983.
Participants	Inclusion criteria: Biopsy‐proven chronic liver disease (all alcoholic, either cirrhosis or alcoholic hepatitis) with past history of hepatic encephalopathy but currently no worse than Grade 1. Exclusion criteria: None cited. 15 patients (5 male/5 female [5 additional dropouts], median age of per protocol population 51).
Interventions	Intervention group received branched‐chain amino acid supplement (Hepatic‐Aid®) containing increased amounts branched‐chain amino acids/decreased amounts aromatic amino acids, sucrose, maltodextrins (69.9%) and fat (19/7%) to tolerance or total supplement intake of 60 gm protein; Control group received placebo. Duration of therapy 3 months.
Outcomes	Appearance hepatic encephalopathy, bilirubin, body weight, triceps skinfold thickness, midarm muscle circumference.
Category of study	Supplements/Medical.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full paper.
Notes	Disproportionate number randomised to treatment group with no explanation. We assumed no hepatic encephalopathy since serum ammonia and trailmaking did not deteriorate in either group. On Google, found address for Vlado Simko (VA NY Harbor Healthcare System, 800 Poly Place, Brooklyn, NY 11209) and report of paper published by a Dr Vlado Simko from the GI unit at the University of Cincinnati in same time period when paper written; letter sent to him on September 19, 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 "all patients were randomly assigned".
Allocation concealment (selection bias)	Unclear risk	No details.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	No description of placebo.
Incomplete outcome data (attrition bias) All outcomes	Low risk	5 dropouts accounted for; 4 were in treatment group and one in control group (unknown which reason caused dropout in the control group, however).
Selective reporting (reporting bias)	High risk	No mortality data.
Other bias	High risk	Five control patients older than 5 treatment patients; partial funding by industry.
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	High risk	Controls older than treated patients (at least in those that completed the trial).
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.