Simon 1988.
Methods | Randomised clinical trial, USA | |
Participants | 34 hospitalised adults with moderate or severe alcoholic hepatitis (chronic ethanol ingestion > 80 g/day for at least 2 years and right lobe hepatomegaly), at nutritional risk according to the trialist Male:Female = 7:15(gender not reported for 12 participants) Mean age = 41.5 years (only for the severe malnourished) Exclusion criteria: acute pancreatitis, insulin‐dependent diabetes mellitus, positive HBsAg, malignancy, hypotension, congestive heart failure, sepsis, severe COPD, and recent severe trauma, surgery, mild disease or rapidly became moribund |
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Interventions | Experimental group: 28 days of peripheral parenteral nutrition (2 litres a day). Each litre consisted of 35 g Aminosyn, 50 g dextrose, 500 ml of 10% Intralipid a day for a total of 1070 intravenous calories a day.(n = 16)
Control group: no intervention(n = 18) Co‐interventions: diet consisting of 2400 calories and 100 g protein + can of Ensure |
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Outcomes | Biochemistry, grade of encephalopathy, mortality, ascites, function tests | |
Study dates | Not stated | |
Notes | We contacted the authors on 19th August 2015 by email: jgalamb@emory.edu. We received no reply. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | The trial used sealed envelopes, but they were not described as being opaque. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The trial was described as "lack of blinding". |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The trial was described as "lack of blinding". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | The number of participants with incomplete data was not reported. |
Selective reporting (reporting bias) | Unclear risk | No protocol could be obtained, and the trial did not report on serious adverse events. |
For‐profit bias | Unclear risk | It was unclear how the trial was funded. |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |