The safety of silymarin
A double-blind clinical study on humans showed that the incidence of adverse reactions caused by silymarin powder was low (<2.4%), similar to placebo. The most common adverse event was mild diarrhea. Other symptoms included nausea, epigastric discomfort, arthralgia, itching, and urticaria.

Silymarin powder for NAFLD patients
A randomized controlled clinical study involving 64 patients with NASH showed that patients in the experimental group (n = 33) who received 210 mg/d of silymarin for 8 weeks were better than those in the control group (n=31) who received placebo in liver enzymes. Significant improvements have been made in this aspect; the combined treatment plan of milk thistle preparations with metformin, pioglitazone, vitamin E, axilimus, lovastatin and other drugs can improve insulin resistance and liver pathology in patients with non-alcoholic fatty liver disease. In addition, silybin capsules combined with acipimox capsules, lovastatin and other drugs in the treatment of non-alcoholic fatty liver disease have a definite effect and solid safety in improving patients' symptoms, liver function, blood lipids and ultrasound imaging.
Silymarin for alcoholic liver patients
There are 5 published clinical studies on the application of silymarin in the treatment of alcoholic liver disease, involving more than 600 patients with alcoholic liver cirrhosis. The results showed that after a period of 41 months of treatment, the 4-year cumulative survival rate of patients in the milk thistle treatment group was significantly higher than that of the placebo group (P=0.036), and the subgroup analysis suggested that silymarin had an effect on alcoholic liver cirrhosis. The efficacy has nothing to do with the severity of the liver disease. Milk thistle preparation can effectively treat alcoholic liver disease, which is of great significance for improving the quality of life for patients with alcoholic liver cirrhosis and for prolonging survival time.
Silymarin for drug-induced liver injury
A number of studies have confirmed that silymarin can effectively treat liver damage caused by toadstool (amanitaxin) poisoning. A retrospective study that collected 20 years of clinical data and included 2,000 patients with liver injury caused by toadstools found that the case fatality rate of silymarin was 5.8%, compared to 14.1% for those who did not take silymarin.
Some scholars have evaluated the effect of silymarin in preventing drug-induced liver injury (DILI) caused by antituberculosis drugs. The newly published Meta-analysis included 7 RCTs and 1 612 patients. The results showed that the incidence of liver injury in the silibinin preventive liver protection treatment group was significantly lower than that in the conventional anti-tuberculosis treatment group (RR=0.27, 95%CI=0.21~0.35, P<0.01), suggesting that silibinin has a preventive effect on drug-induced liver injury caused by antituberculosis drugs.
Silymarin for chronic viral hepatitis
Application of antiviral drugs in the treatment of patients with chronic hepatitis B, combined with silymarin therapy can improve liver function and the degree of liver fibrosis in patients without affecting the antiviral efficacy of nucleoside (acid) analogs, thereby delaying and preventing disease progression and improving patients Compliance to ensure the continuity of antiviral treatment.
Studies have confirmed that high-dose silybin is well tolerated and safe in patients with chronic hepatitis C. Since then, many researchers have used high-dose silibinin intravenously to prevent recurrence after liver transplantation in patients with HCV infection; these studies have also confirmed that silibinin can rapidly reduce HCV viremia and is safe.
At present, the application of milk thistle preparations is mainly focused on liver protection, especially in the adjuvant treatment of NAFLD, ALD and DILI. With more and more in-depth research being conducted on the pharmacological activity of silibinin, silibinin’s efficacy in reducing blood lipids, anti-platelet aggregation, anti-tumor and treatment of diabetes complications are revealed.






