Moreno 2016.
Methods | Randomised clinical trial, Belgium | |
Participants | 136 hospitalised adults with severe alcoholic hepatitis, at nutritional risk by trialists Male:Female = 86:50 Mean age = 50 years Exclusion criteria: Not stated |
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Interventions | Experimental group: Intensive enteral nutrition: Enteral nutrition was given using a feeding tube for 14 days and participants received Fresubin HP Energy (1.5 kcal/ml, 7.5 g prot/100 ml) as follows: 1 L/day if body weight < 60 kgs, 1.5 L if body weight was between 60 and 90 kgs, 2 L if body weight was > 90 kgs. (n = 68) Control group: Treatment as usual ("conventional nutrition")(n = 68) Co‐interventions: Methylprednisolone |
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Outcomes | 6 months survival | |
Study dates | Feburary 2010 to February 2013 | |
Notes | We did not contact the authors since the trial was included late in the writing phase. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was under 5% with missing data |
Selective reporting (reporting bias) | Low risk | A protocol could not be obtain but the trial reported all‐cause mortality and serious adverse events (NCT01801332, published after completion). |
For‐profit bias | High risk | Several of the authors received grants for trials which might have conflict of interest (Abbvie, Novartis). |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |