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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 
[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 II randomized open 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 in erythrocyteglutathione and decreased platelet MDA values; no significant differences in liver function tests
[8]Nonrandomized pilot study Primary biliary cirrhosis27; 27; 0No significant findings
[18]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 and insulin resistance
[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

ALL = acute lymphoblastic leukemia; ALT = alanine aminotransferase; HCV = hepatitis C virus; 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

  1. Ladas EJ, Kroll DJ, Oberlies NH, et al.: A randomized, controlled, double-blind, pilot study of milk thistle for the treatment of hepatotoxicity in childhood acute lymphoblastic leukemia (ALL). Cancer 116 (2): 506-13, 2010.  [PUBMED Abstract]

  2. Vailati A, Aristia L, Sozzé E, et al.: Randomized open study of the dose-effect relationship of a short course of IdB 1016 in patients with viral or alcoholic hepatitis. Fitoterapia 64 (3), 219-28, 1993. 

  3. 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]

  4. 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]

  5. Flisiak R, Prokopowicz D: Effect of misoprostol on the course of viral hepatitis B. Hepatogastroenterology 44 (17): 1419-25, 1997 Sep-Oct.  [PUBMED Abstract]

  6. Angulo P, Patel T, Jorgensen RA, et al.: Silymarin in the treatment of patients with primary biliary cirrhosis with a suboptimal response to ursodeoxycholic acid. Hepatology 32 (5): 897-900, 2000.  [PUBMED Abstract]

  7. Ferenci P, Dragosics B, Dittrich H, et al.: Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver. J Hepatol 9 (1): 105-13, 1989.  [PUBMED Abstract]

  8. 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]

  9. 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]

  10. Seeff LB, Curto TM, Szabo G, et al.: Herbal product use by persons enrolled in the hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) Trial. Hepatology 47 (2): 605-12, 2008.  [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. 

  12. Ferenci P, Scherzer TM, Kerschner H, et al.: Silibinin is a potent antiviral agent in patients with chronic hepatitis C not responding to pegylated interferon/ribavirin therapy. Gastroenterology 135 (5): 1561-7, 2008.  [PUBMED Abstract]