Buzzelli 1993.

Methods	Sample size: no justification. Generation of the allocation sequence: unclear, not described. Allocation concealment: unclear, not described. Blinding: adequate, double blind with identical placebo. Follow‐up: adequate, less than 10% of the patients dropped out or were withdrawn. Intention‐to‐treat analysis: used.
Participants	Twenty patients (6 males, 14 females, mean age 53± 3.0 years, range 31‐70) with HBV and/or HCV chronic active hepatitis. Chronic liver disease. Inclusion criteria: 1) histologically chronic active hepatitis; 2) increased AST and/or ALT serum activities (twice to sixfold the upper limit of the reference range) for more than 12 months; 3) age range: 30 to 70 years. Exclusion criteria: 1) portal hypertension; 2) hepatic encephalopathy; 3) ascites; 4) hepatocellular carcinoma; 5) clinical signs and biochemical parameters of cholestasis; 6) drug addiction; 7) positive antinuclear, antimitochondrial, and antismooth muscle antibodies; 8) ethanol intake more than 30 gr per day; 9) malabsorption syndromes; 10) cardiovascular, renal or endocrine disorders; 11) pregnancy; 12) any pharmacological treatment three months before the beginning of the trial.
Interventions	MT group: IdB1016 two capsules, twice a day (equivalent to 120 mg of silybin in each capsule) (480 mg per day). IdB1016 is a lipophilic complex with phosphatidylcholine and silybin in a molar ratio of 1:1. Control group: placebo, 2 capsules twice a day. Duration of treatment and of follow‐up: seven days. Eight patients were also treated for two months in total. No adverse events occurred in these patients.
Outcomes	Mortality. Liver biochemistry. Adverse events.
Notes	Letter to the trialist: sent (August 2002).
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear