Velussi 1997.

Methods	Sample size: no justification. Generation of the allocation sequence: unclear. Allocation concealment: unclear, not described. Blinding: inadequate, not blinded. Follow‐up: adequate, less than 10% of the patients dropped out or were withdrawn. Intention‐to‐treat analysis: used.
Participants	Sixty insulin treated diabetic patients with alcoholic liver cirrhosis from the 7050 diabetic outpatients registered at the author's anti‐diabetes centre. Chronic liver disease. Inclusion criteria: 1) age 45 to 70 years; 2) non‐insulin‐dependent diabetes mellitus with alcoholic liver cirrhosis; 3) body mass index < 29 kg/m2; 4) ascertained diabetes for a period of at least 5 years and treated with insulin only; 5) undergoing stable insulin therapy for a period of at least two years; 6) presenting raised endogenous insulin secretion; 7) fasting insulin levels and basal and stimulated C‐peptide levels above normal range (above 15 mU/ml for insulin; above 1 ng/ml for basal C‐peptide levels); 8) negative for markers of hepatitis A, B, C; 9) not addicted to alcohol for a period of at least two years prior to the start of the study; 10) no bleeding from variceal oesophagus; 11) liver biopsy, performed no more than four years prior to enrolment, demonstrating liver cirrhosis.
Interventions	MT group: silymarin tablets (Legalon®) 200 mg tablets, three times daily (600 mg per day). Control group: standard treatment. Duration of treatment and of follow‐up: 12 months.
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