Reference Citation	Type of Study	Type of Disease	No. of Patients: Enrolled; Treated; Controla	Strongest Benefit Reported
[4]	Double-blind, placebo-controlled, randomized clinical trial	Acute and subacute liver disease	106b; 47; 50	Decreased LFTs; improved histology
[8]	Double-blind, placebo-controlled, randomized clinical trial	Cirrhosis	170; 87; 83	Increased survival
[3]	Phase II randomized open trial	Viral or alcoholic hepatitis	60c; 60; 0	Reduction in ALT and gamma-glutamyl transpeptidase
[6]	Controlled, randomized trial	Viral hepatitis B	52d; 20-silymarin, 20-misoprostol; 12	No significant findings
[5]	Double-blind, placebo-controlled, randomized clinical trial	Alcohol-induced cirrhosis	200e; 58; 67	No significant findings
[9]	Double-blind, placebo-controlled, randomized clinical trial	Alcohol-induced cirrhosis	60f; 24; 25	Significant increases in erythrocyteglutathione and decreased platelet MDA values; no significant differences in liver function tests
[7]	Nonrandomized pilot study	Primary biliary cirrhosis	27; 27; 0	No significant findings
[10]	Controlled, randomized trial	Diabetic patients with cirrhosis	60; 30; 30	Decrease in lipid peroxidation and insulin resistance
[11]	Double-blind, placebo-controlled, randomized clinical trial	Patients treated with silymarin as a prophylaxis to psychotropic drug-induced hepatic damage	60; 15-psychotropic drug+silymarin; 15-silymarin alone; 15-psychotropic drug+placebo; 15-placebo alone	Silymarin effective at reducing hepatotoxicity associated with psychotropic drug use

ALT = alanine aminotransferase; LFT = liver function test ; No. = number.

aNumber of patients treated plus number of patients controlled may not equal number of patients enrolled; number of patients enrolled = number of patients initially recruited/considered by the researchers who conducted a study; number of patients treated = number of enrolled patients who were administered the treatment being studied AND for whom results were reported; historical control subjects are not included in number of patients enrolled.

bNine patients were excluded from the final analysis (seven patients missed appointments, and two patients were missing data requirements).

cStudy investigated dose-response relationships. Patients were randomly assigned to receive 80 mg 2 times a day (n = 20), 120 mg 2 times a day (n = 20), or 120 mg 3 times a day (n = 20). The effective dose was 120 mg 2 times a day and 120 mg 3 times a day.

dPatients were randomly assigned to the misoprostol and silymarin groups. Twelve nonrandomized patients served as controls.

eFifteen patients were lost to follow-up, 18 patients were deceased, and 42 patients withdrew from the study (adverse events, noncompliance, and voluntary withdrawal).

fEleven patients did not complete the trial (voluntary withdrawal, disease progression, and one adverse event).

References

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4. Salmi HA, Sarna S: Effect of silymarin on chemical, functional, and morphological alterations of the liver. A double-blind controlled study. Scand J Gastroenterol 17 (4): 517-21, 1982.  [PUBMED Abstract]
   
   
5. Parés A, Planas R, Torres M, et al.: Effects of silymarin in alcoholic patients with cirrhosis of the liver: results of a controlled, double-blind, randomized and multicenter trial. J Hepatol 28 (4): 615-21, 1998.  [PUBMED Abstract]
   
   
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9. Lucena MI, Andrade RJ, de la Cruz JP, et al.: Effects of silymarin MZ-80 on oxidative stress in patients with alcoholic cirrhosis. Results of a randomized, double-blind, placebo-controlled clinical study. Int J Clin Pharmacol Ther 40 (1): 2-8, 2002.  [PUBMED Abstract]
   
   
10. Velussi M, Cernigoi AM, De Monte A, et al.: Long-term (12 months) treatment with an anti-oxidant drug (silymarin) is effective on hyperinsulinemia, exogenous insulin need and malondialdehyde levels in cirrhotic diabetic patients. J Hepatol 26 (4): 871-9, 1997.  [PUBMED Abstract]
    
    
11. Palasciano G, Portincasa P, Palmieri V, et al.: The effect of silymarin on plasma levels of malon-dialdehyde in patients receiving long-term treatment with psychotropic drugs. Current Therapeutic Research 55 (5): 537-45.