Abstracts of clinical trials with silymarin

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Immunomodulatory and hepatoprotective effects of in vivo treatment with free radical scavengers from:http://www.thorne.com/silymarin.html

The hepatoprotective and immunomodulatory effects of silymarin and amino-imidazol-carboxamid-phosphate were studied in 60 patients with compensated alcoholic cirrhosis of the liver in a one month double blind clinical trial. Treatment with both drugs normalized the elevated levels of aspartate aminotransferase, alanine aminotransferase and serum bilirubin, markedly reduced the high level of gamma-glutamyl transferase, increased lectin-induced lymphoblasttransformation, decreased the percentage of CD8+ cells and suppressed lymphocytotoxicity. None of these changes occurred in the placebo-treated group. Thus the hepato-protective effects of silymarin and amino-imidazol-carboxamid-phosphate are accompanied by changes in parameters of cellular immunoreactivity of the treated patients.Lang I, Nekam K, Deak G, et al. Immunomodulatory and hepatoprotective effects of in vivo treatment with free radical scavengers. Ital J Gastroenterol 22:283-7; 1990.


Liver-protective action of silymarin therapy in chronic alcoholic liver diseases from:http://www.thorne.com/silymarin.html

The effects of silymarin (Legalon) therapy on liver function tests, serum procollagen III peptide level and liver histology were studied in 36 patients with chronic alcoholic liver disease in a six month double blind clinical trial. During silymarin treatment serum bilirubin, aspartate aminotransferase and alanin-aminotransferase values have been normalized, while gamma-glutamyl transferase activity and procollagen III peptid level decreased. The changes were significant, and there was a significant difference between post-treatment values of the two groups, as well. In the placebo group only gamma-glutamyl transferase values decreased significantly but to a lesser extent than that in the silymarin group. The histological alterations showed an improvement in the silymarin group, while remained unchanged in the placebo group. These results indicate that silymarin exerts hepatoprotective activity and is able to improve liver functions in alcoholic patients.Feher J, Deak G, Muzes G, et al. Liver-protective action of silymarin therapy in chronic alcoholic liver diseases. Orv Hetil (HUNGARY) 130:2723-2727; 1989.


Effect of silymarin on chemical, functional, and morphological alterations of the liver. A double-blind controlled study from:http://www.thorne.com/silymarin.html

One hundred and six consecutive patients with liver disease were selected on the basis of elevated serum transaminase levels. The patients were randomly allocated into a group treated with silymarin (treated) and a group receiving placebo (controls). Ninety-seven patients complete the 4-week trial-47 treated and 50 controls. In general, the series represented a relatively slight acute and subacute liver disease, mostly induced by alcohol abuse. There was a statistically highly significantly greater decrease of S-SGPT (S-ALAT) and S-SGOT (S-ASAT) in the treated group than in controls. Serum total and conjugated bilirubin decreased more in the treated than in controls, but the differences were not statistically significant. BSP retention returned to normal significantly more often in the treated group. The mean percentage decrease of BSP was also markedly higher in the treated. Normalization of histological changes occurred significantly more often in the treated than in controls.Salmi HA, Sarna S. Effect of silymarin on chemical, functional, and morphological alterations of the liver. A double-blind controlled study. Scand J Gastroenterol 17:517-521; 1982.


Results of a double blind study on the effect of silymarin in the treatment of acute viral hepatitis, carried out at two medical centres from:http://www.thorne.com/silymarin.html

In a double blind study carried out under standard conditions at two treatment centers silymarin, 2 sugar-coated tablets 70 mg three times daily, showed a definite therapeutic influence on the characteristic increased serum levels of bilirubin, GOT and GPT associated with acute viral hepatitis. The above mentioned values in 28 patients treated with silymarin were compared with those in 29 patients treated with placebo. The laboratory parameters in the silymarin group regressed more than in the placebo group after the 5th day of treatment. The number of patients having attained normal values after 3 weeksÕ treatment was higher in the silymarin group than in the placebo group. A statistical comparison revealed a difference between bilirubin and GOT values in the placebo and silymarin groups and a definite trend in the regression of GPT values in favour of silymarin. The course of the immune reaction in HBS Ag patients was not influenced by silymarin. As already proved by other investigators, the use of silymarin in acute viral hepatitis can lead to an accelerated regression in pathological values, thus indicating its use in the treatment of this liver disease.Magliulo E, Gagliardi B, Fiori GP. Results of a double blind study on the effect of silymarin in the treatment of acute viral hepatitis, carried out at two medical centres. Med Klin (GERMANY) 73:1060-1065; 1978.


Immunomodulator effect of silymarin therapy in chronic alcoholic liver diseases from:http://www.thorne.com/silymarin.html

The effects of the hepatoprotective, antioxidant drug silymarin (Legalon) on some cellular immune parameters of patients with histologically proven chronic alcoholic liver disease were studied in a six month double blind study. The lectin induced proliferative activity of the lymphocytes got enhanced, the originally low T cell percentage and the originally high CD8+ cell percentage have been normalized, the antibody-dependent and natural cytotoxicity of the lymphocytes decreased during silymarin therapy. All these changes were significant, while in the placebo group no significant changes occurred, except for a moderate elevation of the T cell percentage. Thus, the immunomodulatory activity of silymarin might be involved in the hepatoprotective action of the drug and improves the depressed immunoreactivity of the patients.Deak G, Muzes G, Lang I, et al. Immunomodulator effect of silymarin therapy in chronic alcoholic liver diseases. Orv Hetil (HUNGARY) 131:1291-1292;1990.


Effect of silimarin (Legalon) therapy on the antioxidant defense mechanism and lipid peroxidation in alcoholic liver disease (double blind protocol) from:http://www.thorne.com/silymarin.html

Antioxidant and antiperoxidative effects of the free radical scavenger agent silymarin (Legalon) were investigated in patients with chronic alcoholic liver disease in a double blind clinical trial. Six month treatment (at a daily dose of 420 mg) with silymarin significantly enhanced the originally low superoxide dismutase activity of erythrocytes and lymphocytes and also restored the diminished superoxide dismutase expression on lymphocytes as measured by flow-cytofluorimetry. In addition, silymarin therapy markedly increased the serum level of freeÑSH groups and the activity of glutathione peroxidase. In contrast, a considerable fall in serum malondialdehyde concentration was detected in patients having received silymarin. However, in case of placebo-treated patients the above mentioned parameters of antioxidant defense system and lipid peroxidation failed to change significantly. These data indirectly suggest that antioxidant, antiperoxidative effects might be important factors in the mechanism of hepatoprotective action of silymarin. Muzes G, Deak G, Lang I, et al. Effect of silimarin (Legalon) therapy on the antioxidant defense mechanism and lipid peroxidation in alcoholic liver disease (double blind protocol). Orv Hetil (HUNGARY) 131:863-866; 1990.


Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver from:http://www.thorne.com/silymarin.html

Silymarin, the active principle of the milk thistle Silybum marianum, protects experimental animals against various hepatotoxic substances. To determine the effect of silymarin on the outcome of patients with cirrhosis, a double blind, prospective, randomized study was performed in 170 patients with cirrhosis. 87 patients (alcoholic 46, non-alcoholic 41; 61 male, 26 female; Child A, 47; B, 37; C, 3; mean age 57) received 140 mg Silymarin three times daily. 83 patients (alcoholic 45, non-alcoholic 38; 62 male, 21 female; Child A, 42; B, 32; C, 9: mean age 58) received a placebo. Non-compliant patients and patients who failed to come to a control were considered as Ôdrop outsÕ and were withdrawn from the study. All patients received the same treatment until the last patient entered had finished 2-years of treatment. The mean observation period was 41 months. There were 10 drop outs in the placebo group and 14 in the treatment group. In the placebo group, 37 (+ 2 drop outs) patients had died, and in 31 of these, death was related to liver disease. In the treatment group, 24 (+ 4 drop outs) had died, and in 18 of these, death was related to liver disease. The 4-year survival rate was 58 plus or minus 9% (S.E.) in silymarin-treated patients and 39 plus or minus 9% in the placebo group (P = 0.036). Analysis of subgroups indicated that treatment was effective in patients with alcoholic cirrhosis (P = 0.01) and in patients initially rated ÔChild AÕ (P = 0.03). No side effects of drug treatment were observed. The results of this study suggest that mortality of patients with cirrhosis was reduced by treatment with silymarin. However, as this effect was more pronounced in alcoholic cirrhosis, the interrelation of patterns of alcohol consumption and of drug treatment affecting survival must be addressed by future studies.Ferenci P, Dragosics B, Dittrich H, Frank H, et al. Randomized controlled trial of silymarin treatment in patients with cirrhosis of the liver. J Hepatol (Netherlands) 9:105-113; 1989.


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