Hayashi 1991

Methods	Randomised trial comparing supplements (standard or branched chain amino acids) to no supplements in patients hospitalized with cirrhosis and hepatic encephalopathy. Geographical location Tokyo, Japan. Paper published 1991.
Participants	Inclusion criteria: Hospitalized patient with cirrhosis (documented clinically and histologically) and Grade I or II encephalopathy or abnormal psychometric testing or abnormal sleeping pattern. Exclusion criteria: <15 years of age, gastrointestinalI bleeding, hepato‐renal syndrome, recent/current cancer treatment, recent/current sclerotherapy for varices, women who were pregnant or thought to be. 67 patients (44 men/21 women [2 other dropouts], age in both groups < 39 to >70).
Interventions	Intervention group received nutritional supplement (elemental diet [300 kcal, 11.2 gm amino acid {5.45 grams BCAA]/80} gm pack]), 2 packs/day orally or via tube + oral diet (1400 kcal/40 gm protein per day); Controls received oral diet (2000 kcal, 60 gm protein). Aminoleban EN®, and intravenous amino acids prohibited in general, but Aminoleban® PO/intravenous albumin prn; lactulose, antibiotics, other concomitant drugs used in fixed doses. Duration therapy 21 days.
Outcomes	Resolution ascites, appearance/resolution hepatic encephalopathy, Karnofsky score, serious/non‐serious adverse events, bilirubin, body weight (only in patients without ascites).
Category of study	Supplements/Medical.
Sample size calculation	Not reported if done.
Full paper or abstract only	Full report (manuscript of PhD thesis or submitted paper).
Notes	Information from trial came from a thesis that RLK received years ago as well as abstract; no address found for Dr Hayashi, so no information request could be sent.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states "envelope method".
Allocation concealment (selection bias)	Unclear risk	"envelop method" (no other details).
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	2 patients dropped out for being "in appropriate" but unknown from which group.
Selective reporting (reporting bias)	Unclear risk	No mortality data.
Other bias	Unclear risk	Funder of trial not reported.
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	Low risk	No differences identified.
Early stopping?	Unclear risk	No sample size calculation and unknown why stopped.