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. 2017 May 19;2017(5):CD011598. doi: 10.1002/14651858.CD011598.pub2

Itou 2011.

Methods Randomised clinical trial, Japan
Participants 36 hospitalised adults with chronic liver disease and oesophageal and gastric varices, at nutritional risk defined by trialist
Male:Female = 29:7
Mean age: 65.9 years
Exclusion criteria: Ascites and renal failure
Interventions Experimental group: Oral supplement consisting of a 200 kcal CalorieMate Jelly(n = 18)
 Control group: No intervention (no meal)(n = 18)
Outcomes Physical symptoms (thirst, light‐headedness, nausea, headache, palpitation and cold sweat) and mental symptoms(hunger, hypodynamia, fatigue, poor thinking, poor concentration, irritability)
Study dates Not stated
Notes The authors were contacted on 9.12.15 by email: Itou74m@med.kurume‐u.ac.jp. 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 Not described
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants were not blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Endoscopists were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts
Selective reporting (reporting bias) Unclear risk No protocol could be obtained and the trial did not report on all‐cause mortality or serious adverse event.
For‐profit bias Low risk The study was supported, in part, by a Grant‐in‐Aid for Young Scientists (B) (No.22790874 to T.K.) and a Grant‐in‐Aid for Scientific Research (C)(No. 21590865 to M.S.) from the Ministry of Education, Culture, Sports, Science and Technology of Japan, and by Health and Labour Sciences Research Grants for Research on Hepatis from the Ministry of Health, Labour and Welfare of Japan.
Other bias Low risk The trial appeared to be free of other components that could put it at risk of bias.