Velussi 1997.
| Methods | Randomised clinical trial | |
| Participants | Country: Italy. Number randomised: 60. Post‐randomisation dropouts: 0 (0%). Revised sample size: 60. Average age: 63 years. Females: not stated Inclusion criteria: 1. Age 45 to 70 years. 2. Non‐insulin dependent diabetes mellitus with alcoholic liver cirrhosis. 3. Body mass index less than 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 2 years. 6. Presenting raised endogenous insulin secretion. 7. Fasting insulin levels and basal and stimulated Cpeptide levels above normal range (above 15 mU/ml for insulin; above 1 ng/mL for basal C‐peptide levels and 3 ng/mL stimulated C‐peptide levels). 8. Liver biopsy, performed no more than 4 years prior to enrolment, demonstrating liver cirrhosis. Exclusion criteria: 1. Negative for markers of hepatitis A, B and C. 2. No bleeding from oesophageal varices. 3. Not addicted to alcohol for a period of at least 2 years prior to the start of the study | |
| Interventions | Participants were randomly assigned to two groups. Group 1 (n = 30): silymarin 600 mg thrice daily. Group 2 (n = 30): no intervention. Duration: 12 months | |
| Outcomes | adverse events. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "On inclusion into the study, the patients were randomly assigned to one of two groups". Comment: Further details were not available. |
| Allocation concealment (selection bias) | Unclear risk | Comment: this information was not available. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The control group (30 patients), were not treated with silymarin". |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: this information was not available. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: there were no post‐randomisation dropouts. |
| Selective reporting (reporting bias) | High risk | Comment: mortality was not reported. |
| For‐profit bias | Unclear risk | Comment: this information was not available. |
| Other bias | Low risk | Comment: there was no other bias. |
ALD = alcoholic liver disease ALT = alanine transaminase AST = aspartate transaminase G‐CSF = granulocyte‐colony stimulating factor HCC = hepatocellular carcinoma ITT = intention‐to‐treat IU = international unit LT = liver transplant MELD = model for end‐stage liver disease NAFLD = non‐alcoholic fatty liver disease PTX = pentoxifylline SAMe = s‐adenosyl‐L‐methionine SC = subcutaneous SGOT = serum glutamic oxaloacetic transaminase (currently called aspartate transaminase) SGPT = serum glutamic pyruvic transaminase (currently called alanine transaminase) TNF = tumour necrosis factor UDCA = ursodeoxycholic acid