Another published report describes the use of silybinin as the only effective antidote in patients with liver damage from Amanita phalloides (Fr.) Link poisoning. Patients were administered doses of 35 to 55 mg/kg body weight, with no reports of adverse events. A recent retrospective review of the treatment for Amanita phalloides poisoning suggests that silymarin continues to be a promising drug in the treatment of this rare mushroom poisoning. The beneficial effect of silymarin on liver histology suggests it has a role in the prevention of hepatitis and/or hepatocellular carcinoma; however, no clinical trials in humans have investigated these uses of silymarin.
Clinical Studies Investigating Silymarin in the Treatment or Prevention of Liver Disease
ALL = acute lymphoblastic leukemia; ALT = alanine aminotransferase; HCV = hepatitis C virus; LFT = liver function test; No. = number.
a Number 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.
b Nine patients were excluded from the final analysis (seven patients missed appointments, and two patients were missing data requirements).
c Study 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.
d Patients were randomly assigned to the misoprostol and silymarin groups. Twelve nonrandomized patients served as controls.
e Fifteen patients were lost to follow-up, 18 patients were deceased, and 42 patients withdrew from the study (adverse events, noncompliance, and voluntary withdrawal).
f Eleven patients did not complete the trial (voluntary withdrawal, disease progression, and one adverse event).
|Reference Citation||Type of Study||Type of Disease||No. of Patients: Enrolled; Treated; Controla||Strongest Benefit Reported|
|||Double-blind, placebo-controlled, randomized clinical trial||Acute and subacute liver disease||106b; 47; 50||Decreased LFTs; improved histology|
|||Double-blind, placebo-controlled, randomized clinical trial||Cirrhosis||170; 87; 83||Increased survival|
|||Phase II randomized open trial||Viral or alcoholic hepatitis||60c; 60; 0||Reduction in ALT and gamma-glutamyl transpeptidase|
|||Controlled, randomized trial||Viral hepatitis B||52d; 20-silymarin, 20-misoprostol; 12||No significant findings |
|||Double-blind, placebo-controlled, randomized clinical trial||Alcohol-induced cirrhosis||200e; 58; 67||No significant findings|
|||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|
|||Nonrandomizedpilot study||Primary biliary cirrhosis||27; 27; 0||No significant findings|
|||Nonrandomized, controlled trial||HCV nonresponder patients||16; 16; 0 and 20; 20; 0||Increased antiviral effect|
|||Controlled, randomized trial||Diabetic patients with cirrhosis||60; 30; 30||Decrease in lipid peroxidation and insulin resistance|
|||Randomized, controlled trial||Chronic hepatitis C||1,145; 195; 772||Decreased fatigue, nausea, liver pain, anorexia, and muscle and joint pain|
|||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|
|||Double-blind, placebo-controlled, randomized clinical trial||Children with ALL experiencing elevated LFTs||50; 24; 26||Significant decrease in AST; trend towards reduction in ALT|