Trinchet 1989.

Methods	Sample size: based on liver histology response. Randomisation: patients were stratified for presence or absence of liver cirrhosis in initial liver biopsy. Generation of the allocation sequence: adequate, by random tables. Allocation concealment: adequate, with sealed envelopes. Blinding: adequate, double blind with placebo of identical presentation. Follow‐up: adequate, more than 10% dropped‐out or were withdrawn. Intention‐to‐treat: used.
Participants	Multicentre clinical trial including patients from three medical departments. Chronic liver disease. Inclusion criteria: 116 patients with histologically proven alcoholic hepatitis, 58 of them with alcoholic cirrhosis. 78 were males and 38 females with a mean age of 50± 18 years in the silymarin and of 51± 11 years in the placebo group. Exclusion criteria: 1) hepatic encephalopathy; 2) resistant ascites; 3) prothrombin activity< 50%; 4) platelet count< 100 billion/L; 5) hepatocellular carcinoma; other important diseases or refusal to participate.
Interventions	MT group: silymarin tablets 140 mg, three times daily (420 mg per day). Control group: placebo tablets, three times per day. Duration of treatment and of follow‐up: three months.
Outcomes	Mortality. Liver biochemistry. Histology. Adverse events.
Notes	Letter to the trialist: sent (August 2002).
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate