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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 12 weeks 24 weeks 8 weeks 12 weeks 8 weeks
Silymarin dose 70 mg tid 140 mg bid 140 mg/d [S] 140 mg bid 70 mg tid
Comparator vitamin E 400 IU d/12 w. Placebo pioglitazone 15 mg/d [P], metformin 500 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
  1. a Hard End-Points: Death, Major Clinical Event, Biopsy or sonography
  2. b No changes in Fasting plasma glucose, 2Hpp (2-Hour Post Prandial), Triglycerides, Total Cholesterol, HDL, LDL
  3. c In all a decrease of Cholesterol. With pioglitazone and metformin decreased glycaemia