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    Milk Thistle (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI] - Human / Clinical Studies

    Clinical Studies Investigating Silymarin in the Treatment or Prevention of Liver Disease

    Reference Citation Type of Study Type of Disease No. of Patients: Enrolled; Treated; Controla Strongest Benefit Reported
    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 studiedAND 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 wererandomlyassigned 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).
    [5] Double-blind, placebo-controlled, randomized clinical trial Acute and subacute liver disease 106b; 47; 50 Decreased LFTs; improved histology
    [9] Double-blind, placebo-controlled, randomized clinical trial Cirrhosis 170; 87; 83 Increased survival
    [4] Phase IIrandomizedopen trial Viral or alcoholic hepatitis 60c; 60; 0 Reduction in ALT and gamma-glutamyl transpeptidase
    [7] Controlled, randomized trial Viral hepatitis B 52d; 20-silymarin, 20-misoprostol; 12 No significant findings
    [6] Double-blind, placebo-controlled, randomized clinical trial Alcohol-induced cirrhosis 200e; 58; 67 No significant findings
    [10] Double-blind, placebo-controlled, randomized clinical trial Alcohol-induced cirrhosis 60f; 24; 25 Significant increases inerythrocyte glutathioneand decreased platelet MDA values; no significant differences in liver function tests
    [8] Nonrandomized pilot study Primary biliary cirrhosis 27; 27; 0 No significant findings
    [17] Nonrandomized, controlled trial HCV nonresponder patients 16; 16; 0 and 20; 20; 0 Increased antiviral effect
    [11] Controlled, randomized trial Diabetic patients with cirrhosis 60; 30; 30 Decrease in lipid peroxidation andinsulinresistance
    [12] Randomized, controlled trial Chronic hepatitis C 1,145; 195; 772 Decreased fatigue, nausea, liver pain, anorexia, and muscle and joint pain
    [13] 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
    [3] 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
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