| Vailati et al[146] | A phase II randomised, open trial on 60 patients with chronic alcoholic or viral hepatitis | Three doses (160, 240, 360 mg) of silybin and phosphatidylcholine (IdB 1016, Indena, Italy) for two weeks. No placebo or no intervention group was used | Liver tests | Improvement of liver enzymes with all used doses | Scarce |
| Buzzelli et al[147] | Double blind with identical placebo. Twenty patients with HBV and/or HCV chronic active hepatitis | IdB1016 (complex with phosphatidylcholine and silybin) two capsules, twice a day (equivalent to 120 mg of silybin in each capsule) (480 mg/d). Duration of treatment and of follow-up: two months in total | Mortality. Liver biochemistry | Improvement of liver enzymes and bilirubin | Scarce |
| Buzzelli et al[148] | Unclear, described as double blind but the method to achieve this was not described. Trial characteristics: cross over design. Patients were assigned to the Silipide group for two months treatment, and one month washout. Ten patients with chronic hepatitis C. (non-responders) to a previous treatment with recombinant interferon α | Silipide (IdB1016) capsules 360 mg/d. Control group: placebo capsules. Duration of treatment and follow-up: two months of treatment and one month of washout | Mortality. Liver biochemistry | Results were not reported separately, only overall results. Improvement of liver tests | Data published only in abstract form |
| Lirussi et al[104] | Blinding: adequate, double blind with placebo of identical appearance. Sixty out-patients with chronic alcoholic liver disease and non-insulin dependent type 2 diabetes | Silybin-β-cyclodextrin (135 mg silybin) sachets t.i.d Duration of treatment: 6 mo | Mortality. Liver biochemistry | Decrease of fasting glucose and lipid peroxidation markers | Good |
| Bares et al[138] | Randomized study to 1 of 3 oral doses. Thirthy seven patients with chronic hepatitis C non responders to a previous IFN treatment | IdB1016 at 314, 628, 942 mg t.i.d.(120,240 and 360 mg t.i.d. silybin equivalents, respectively) for 12 wk | Effects on serum markers of iron status | There was a significant decrease in serum ferritin, that was independently associated with the stage III-IV of liver fibrosi | Good |
| Falasca et al[134] | Observational study on forthy naïve HCV positive patients (30 treated and 10 observed without treatments) | Silybin-Vitamine E-Phospholipid Complex (Realsil®- Ibi-Lorenzini-Italy) in a dose of 4 pills per day (each pill: 47 mg of silybin) for 3 mo | Hepatoprotection and anti-inflammatory effect by determining cytokine pattern and markers of liver disease | Improvement of liver enzymes and of Il2 plasma levels. Improvement of insulin resistance markers in patients with contemporaneous liver steatosis | Medium |
| Federico et al[141] | Observational study on 85 outpatients: 59 with NAFLD and 26 with HCV related chronic hepatitis in combination with NAFLD, non-responders to previous antiviral treatment. 53 (39 NAFLD and 14 HCV) were treated, while the other 32 patients (20 NAFLD and 12 HCV) served as a control group (no treatment) | The complex silybin-vitamin E-phospholipids (Realsil®), 4 pieces/d for six months followed by another six months of follow up | Effects on insulin resistance and liver damage | US steatosis, liver enzymes, hyperinsulinaemia, and indices of liver fibrosis were improved in both treated groups | Suggestive |
| Ferenci et al[139] | Observational study on 36 patients with HCV chronic hepatitis non responders to IFN + ribavirin. Duration of the study: 7 d | Silybin i.v. (Madaus, Germany) at 5, 10, 15 and 20 mg/kg per day for 14 d | Effect on viral load. Safety | Good compliance, no side effects and potent antiviral effect against HCV | High |
