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. |