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 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 II randomized open 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 in erythrocyteglutathione and 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 and insulin resistance |
| [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 |
| 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
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- 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]
- 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]
- Flisiak R, Prokopowicz D: Effect of misoprostol on the course of viral hepatitis B. Hepatogastroenterology 44 (17): 1419-25, 1997 Sep-Oct. [PUBMED Abstract]
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- 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]
- 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]
- 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]
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