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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 CitationType of StudyType of DiseaseNo. of Patients: Enrolled; Treated; ControlaStrongest 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 trialAcute and subacute liver disease106b; 47; 50Decreased LFTs; improved histology
[9]Double-blind, placebo-controlled, randomized clinical trialCirrhosis170; 87; 83Increased survival
[4]Phase IIrandomizedopen trialViral or alcoholic hepatitis60c; 60; 0Reduction in ALT and gamma-glutamyl transpeptidase
[7]Controlled, randomized trialViral hepatitis B52d; 20-silymarin, 20-misoprostol; 12No significant findings
[6]Double-blind, placebo-controlled, randomized clinical trialAlcohol-induced cirrhosis200e; 58; 67No significant findings
[10]Double-blind, placebo-controlled, randomized clinical trialAlcohol-induced cirrhosis60f; 24; 25Significant increases inerythrocyte glutathioneand decreased platelet MDA values; no significant differences in liver function tests
[8]Nonrandomized pilot studyPrimary biliary cirrhosis27; 27; 0No significant findings
[17]Nonrandomized, controlled trialHCV nonresponder patients16; 16; 0 and 20; 20; 0Increased antiviral effect
[11]Controlled, randomized trialDiabetic patients with cirrhosis60; 30; 30Decrease in lipid peroxidation andinsulinresistance
[12]Randomized, controlled trialChronic hepatitis C1,145; 195; 772Decreased fatigue, nausea, liver pain, anorexia, and muscle and joint pain
[13]Double-blind, placebo-controlled, randomized clinical trialPatients treated with silymarin as a prophylaxis to psychotropic drug-induced hepatic damage60; 15-psychotropic drug+silymarin; 15-silymarin alone; 15-psychotropic drug+placebo; 15-placebo aloneSilymarin effective at reducing hepatotoxicity associated with psychotropic drug use
[3]Double-blind, placebo-controlled, randomized clinical trialChildren with ALL experiencing elevated LFTs50; 24; 26Significant decrease in AST; trend towards reduction in ALT
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