Zhang 2013.
Methods | Randomised clinical trial, China | |
Participants | 100 hospitalised adults with viral hepatitis, and alcoholic liver disease, at nutritional risk according to the trialist. Male:Female = 80:20 Mean age = 49 years Exclusion criteria: Upper gastro‐intestinal haemorrhage within 2 weeks before admission, uncontrolled diabetes, malignant tumour, clinical manifestations of hepatic encephalopathy, clear infection, antiviral indications of hepatitis B cirrhosis in the prevention and treatment guidelines of chronic hepatitis (2010 version), but did not want to or could not receive nucleoside analogue antiviral treatment |
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Interventions | Experimental group: Enteral nutrition: Weekly recipes were prepared with 35 ˜ 40 kcal/(kg/day) , 1.2 ˜ 1.5 g/(kg/day) protein, 0.8 ˜ 1.2 g/(kg/day) amino acid and 350 ˜ 500 g/day carbohydrate. Additionally supplemented vitamins A, D, e, K, B and Se, were included on the 4th day in the daily meals. They were given yoghurt (or hot milk) of 100 ml and 15 g Noveliver compound protein granule (purchased from the Global Partner of Institute for Liver Cell Media, Myer Otec Co. California USA, which contained 18 kinds of amino acids including all essential amino acids, and folic acid, selenium, etc.) at bedtime. Nutrition intervention lasted for 4 weeks.(n = 50) Control group: Conventional diet(n = 50) Co‐interventions: Protecting liver therapy and antiviral therapy |
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Outcomes | Triceps skin fold, BMI, mid‐arm circumference, mid‐arm muscle circumference, self‐conscious symptoms, growth and decline of ascites, Albumin, pre‐albumin, cholinesterase, transaminase and bilirubin, blood coagulation index, HBV DNA and complications | |
Study dates | Not stated | |
Notes | We contacted the author by phone and received information on mortality, follow‐up length, and funding. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The author told us that he could not remember the specific method of randomisation. |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
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 all‐cause mortality or serious adverse events. |
For‐profit bias | Low risk | The trial was funded by Major special projects of science and technology bureau of Changchun (10SF05). |
Other bias | Low risk | The trial appeared to be free of other components that could put it at risk of bias. |