Table 1.
Clinical trials with silymarin in patients with liver cirrhosis and/or alcoholic liver disease
| References | Condition | n | Treatment (n) | Duration | Outcome with silymarin |
|---|---|---|---|---|---|
| Salmi et al. [61] | Liver disease (78% with daily alcohol use) | 97 |
Silymarin 420 mg/day (47) Placebo (50) |
4 weeks | Improvement in ALT, AST, liver function parameters and liver histology |
| Trinchet et al. [58] | ALD (50% with cirrhosis) | 116 |
Silymarin 420 mg/day (57) Placebo (59) |
3 months | No significant effect |
| Ferenci et al. [55] | ALD or NAFLD (70% with cirrhosis) | 170 |
Silymarina 420 mg/day (87) Placebo (59) |
Median 41 months | Improvement in 4-year survival; survival differences most marked in patients with ALD and cirrhosis, and those with low severity disease (Child class A) |
| Feher et al. [62] | ALD | 36 |
Silymarina (17) Placebo (19) |
6 months | ↓ in ALT, AST, bilirubin and procollagen synthesis |
| Muzes et al. [63] | ALD | NA |
Silymarina 420 mg/day Placebo |
6 months | Improvement of anti-oxidative systems (↓ in MDA, ↑ in GSH) |
| Bunout et al. [60] | ALD (72% with cirrhosis) | 59 |
Silymarina 280 mg/day (25) Placebo (34) |
15 months | No effect on clinical course or mortality, or liver function |
| Velussi et al. [59] | Insulin-treated T2DM with alcoholic cirrhosis | 60 |
Silymarina 600 mg/day + standard treatment (30) Standard treatment only (30) |
12 months |
Improvement in blood glucose (including fasting), HbA1c and MDA, and ↓ in daily insulin requirement ↓ in ALT and AST |
| Pares et al. [57] | ALD with cirrhosis | 200 |
Silymarina 450 mg/day (103) Placebo (97) |
2 years | No effect on progression of liver disease or survival |
| Lucena et al. [56] | ALD with cirrhosis | 49 |
Silymarina 450 mg/day (24) Placebo (25) |
6 months | ↓ MDA and aminoterminal propeptide of procollagen type III |
ALD alcoholic liver disease, ALP alkaline phosphatase, ALT alanine transaminase, AST aspartate aminotransferase, GGT gamma-glutamyl transferase, GSH glutathione, HbA1c glycosylated hemoglobin, MDA methylenedioxyamphetamine, NA not available, NAFLD non-alcoholic fatty liver disease, T2DM type 2 diabetes mellitus
aSilymarin formulation using the Eurosil 85® process