International Journal of Phytomedicine and Phytotherapy
Table 4 Clinical trials with silymarin vs. placebo or other drugs in NAFLD/NASH
From: The potential of silymarin for the treatment of hepatic disorders
Author | Hajiani et al. 2009 [98] | Hashemi et al. 2009 [100] | Hajiaghamo-hammadi et al. 2012 [102] | Masoodi, et al. 2013 [99] | Solhi et al. 2014 [101] |
|---|---|---|---|---|---|
Diagnosis | abdominal sonography at entry & at the end (NAFLD) | abdominal sonography or liver biopsy (NAFLD or NASH) | abdominal sonography + increased AST/ALT serum levels | abdominal sonography + increased AST/ALT serum levels (NASH) | abdominal sonography + increased AST/ALT serum levels |
Type of Trial | Open label, Comparative | Comparative randomized | Comparative randomized | Comparative, double blind | Comparative randomized |
Duration of silymarin application | 12Â weeks | 24Â weeks | 8Â weeks | 12Â weeks | 8Â weeks |
Silymarin dose | 70Â mg tid | 140Â mg bid | 140Â mg/d [S] | 140Â mg bid | 70Â mg tid |
Comparator | vitamin E 400Â IU d/12 w. | Placebo | pioglitazone 15Â mg/d [P], metformin 500Â mg/d [M] | Placebo | Placebo |
N pts./Group | 71 / 71 | 50 / 50 | S 22 / P 22 / M 22 | 50 / 50 | 33 / 31 |
Outcomes (Significances End of TT) | AST Normal. 74.6 % vs. 56.3 % pts (P = 0.025) | AST < 40 in 62 % of cases Silymarin vs 20 % placebo (P < 0.001). | AST Normal. S 62 %, P 68 %, M 54 % (P < 0.1) | Mean AST 54.7 UI vs. 61.6; (P < 0.2; CAVE diff. At admission) | Mean AST 30 UI vs. 36 UI; (P = 0.04) |
ALT Normal. 41 % vs. 45 % pts (N.S.) | ALT < 56 in 52 % of cases Silymarin vs 18 % placebo (P < 0.001) | ALT Normal. S 18 %, P 27 %, M 9 % (P > 0.1) | Mean ALT 68.54 UI vs. 73.3; (P < 0.5., CAVE diff. at admission) | Mean ALT 38 UI vs. 52 UI (P = 0.03) | |
End-Pointsa | Not Reported | Not Reported b | Not Reported c | Not Reported | Not Reported |
Quality (Simplified Consort Checklist) | 5 / 10 | 4 / 10 | 4 / 10 | 4 / 10 | 5 / 10 |