Ichikawa 2010

Methods	Randomised trial comparing the use of a late‐evening snack of a branched‐chain amino acid‐enriched supplement to no supplement in cirrhotic patients.
Participants	21 patients (12 treatment, 9 controls) with compensated cirrhosis (documented by laboratory data and imaging). Exclusion criteria ‐ hepatocellular carcinoma, overt encephalopathy, chronic renal failure, use of BCAA supplements, alcohol use, or albumin infusions.
Interventions	Experimental group received a commercial supplement (Aminoleban EN ‐ 13.5 gm protein [enriched with BCAAs] and 210 kcal energy in 50 gm pack) ingested at night for 8 weeks. The control group did not receive any nutrition therapy but consumed food (rice ball containing 210 kcal energy and 9 gm protein) as nocturnal snack.
Outcomes	Sleepiness (assessed by Epworth Sleepiness Scale), symptoms (assessed by cirrhosis symptom score), development encephalopathy, mortality (inferred), need for hospitalization, serum bilirubin, BMI.
Category of study	Supplements/Medical.
Sample size calculation	None reported.
Full paper or abstract only	Full paper.
Notes	Request for further information sent via e‐mail on September 18, 2011 (ichikawa@net.nagasaki‐u.ac.jp and Shige‐ygc@umin.ac.jp). No response has been received as of March 20, 2012.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"After balancing both groups for sex, age, Child‐{ugh score (CPS), cirrhotic symptom score (CSS) and albumin level, patients were randomised…"
Allocation concealment (selection bias)	Unclear risk	No information provided indicating if or how allocation was concealed.
Blinding (performance bias and detection bias) All outcomes	High risk	No blinding performed.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No dropouts.
Selective reporting (reporting bias)	Low risk	Mortality and onset encephalopathy (morbidity) reported or inferred (data presented for 8 week evaluation on 21 patients, suggesting that there were no deaths).
Other bias	Unclear risk	Unclear funding; authors had published other paper employing this preparation (Takeshita 2009 below).
Intent to treat analysis	Low risk	No dropouts.
Baseline imbalance?	Low risk	No difference in variety of baseline characteristics.
Early stopping?	Unclear risk	No sample size calculation provided and not clear why trial included 21 patients.