Pockros 2009

Methods	AST‐120 (spherical carbon absorbant): multicentre, open‐label, clinical trial
Participants	Included participants: cirrhosis (MELD score ≤ 15) and hepatic encephalopathy Grades 1 or 2 using West Haven Criteria (n = 47) Age: not reported Proportion of men: not reported Aetiology of liver disease: not reported MELD score: not reported
Interventions	Intervention comparison: oral AST‐120 vs lactulose AST‐120: 2 g 4 times/day (n = 24) Lactulose: no details reported (n = 23) Duration of treatment: 4 weeks Co‐intervention: some participants were taking lactulose on admission: this was stopped in the participants randomised to AST‐120
Outcomes	Neurocognitive assessment: mental status (West Haven Criteria) HESA venous blood ammonia
Inclusion period	September 2007 ‐ June 2009
Country of origin	USA
Outcomes included in meta‐analyses	Mortality Hepatic encephalopathy Venous blood ammonia
Notes	Publication status: abstract Participants were classified using West Haven Criteria as Grade 1 or 2 hepatic encephalopathy but, based on the HESA score, were predominantly Grade 0. The trial report describes non‐serious adverse events including diarrhoea and flatulence, but does not provide the number or proportion of participants affected. The trial authors provided further information regarding random sequence generation. Funding: Trial sponsored by Ocera Therapeutic Inc
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random numbers
Allocation concealment (selection bias)	Low risk	Central allocation
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label trial without blinding
Blinding of outcome assessment (detection bias) Non‐mortality outcomes	High risk	Open‐label trial without blinding
Incomplete outcome data (attrition bias) All outcomes	High risk	Evaluable data are available for 41 participants: 3 participants randomised to lactulose were excluded because of non‐compliance; 3 participants randomised to AST‐120 were excluded for 'other reasons'
Selective reporting (reporting bias)	Low risk	The outcomes reported in the published abstract correspond to the outcomes listed in the trial protocol.
Other bias	Low risk	None identified
Overall assessment Non‐mortality outcomes	High risk
Overall assessment Mortality outcomes	High risk