Milk Thistle for Alcoholic and/or Hepatitis B or C Liver Diseases-A Systematic Cochrane Hepato-Biliary Group Review with Meta-Analyses of Randomized Clinical Trials

Rambaldi, A.; Jacobs, Bradly; Iaquinto, Gaetano; Gluud, Christian

doi:10.1111/j.1572-0241.2005.00262.x

Cited by 97 publications

(64 citation statements)

References 35 publications

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“…Studies have frequently been small, with a lack of appropriate randomization, insufficient information about the compound used, and wide variations in treatment duration. Additionally, in the case of milk thistle derivatives, silymarin, silybin, and other varying compounds are frequently used synonymously [49,50].…”

Section: Discussionmentioning

confidence: 99%

Silybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: A randomized controlled trial

Loguercio

Andreone

Brisc

et al. 2012

Free Radical Biology and Medicine

219

147

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The only currently recommended treatment for nonalcoholic fatty liver disease (NAFLD) is lifestyle modification. Preliminary studies of silybin showed beneficial effects on liver function. Realsil (RA) comprises the silybin phytosome complex (silybin plus phosphatidylcholine) coformulated with vitamin E. We report on a multicenter, phase III, double-blind clinical trial to assess RA in patients with histologically documented NAFLD. Patients were randomized 1:1 to RA or placebo (P) orally twice daily for 12 months. Prespecified primary outcomes were improvement over time in clinical condition, normalization of liver enzyme plasma levels, and improvement of ultrasonographic liver steatosis, homeostatic model assessment (HOMA), and quality of life. Secondary outcomes were improvement in liver histologic score and/or decrease in NAFLD score without worsening of fibrosis and plasma changes in cytokines, ferritin, and liver fibrosis markers. We treated 179 patients with NAFLD; 36 were also HCV positive. Forty-one patients were prematurely withdrawn and 138 patients analyzed per protocol (69 per group). Baseline patient characteristics were generally well balanced between groups, except for steatosis, portal infiltration, and fibrosis. Adverse events (AEs) were generally transient and included diarrhea, dysgeusia, and pruritus; no serious AEs were recorded. Patients receiving RA but not P showed significant improvements in liver enzyme plasma levels, HOMA, and liver histology. Body mass index normalized in 15% of RA patients (2.1% with P). HCV-positive patients in the RA but not the P group showed improvements in fibrogenesis markers. This is the first study to systematically assess silybin in NAFLD patients. Treatment with RA but not P for 12 months was associated with Free

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Section: Discussionmentioning

confidence: 99%

Silybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: A randomized controlled trial

Loguercio

Andreone

Brisc

et al. 2012

Free Radical Biology and Medicine

219

147

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“…patients with alcoholic hepatitis and hepatitis B or C (Rambaldi et al, 2005). The primary outcome measure was the number of patients dying.…”

Section: Rambaldi Et Al In the Meta-analyses Of Randomized Clinical mentioning

confidence: 99%

Milk thistle in liver diseases: past, present, future

Abenavoli

Capasso²,

Milić

et al. 2010

Phytotherapy Research

503

350

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Silybum marianum or milk thistle (MT) is the most well‐researched plant in the treatment of liver disease. The active complex of MT is a lipophilic extract from the seeds of the plant and is composed of three isomer flavonolignans (silybin, silydianin, and silychristin) collectively known as silymarin. Silybin is a component with the greatest degree of biological activity and makes up 50% to 70% of silymarin. Silymarin is found in the entire plant but it is concentrated in the fruit and seeds. Silymarin acts as an antioxidant by reducing free radical production and lipid peroxidation, has antifibrotic activity and may act as a toxin blockade agent by inhibiting binding of toxins to the hepatocyte cell membrane receptors. In animals, silymarin reduces liver injury caused by acetaminophen, carbon tetrachloride, radiation, iron overload, phenylhydrazine, alcohol, cold ischaemia and Amanita phalloides. Silymarin has been used to treat alcoholic liver disease, acute and chronic viral hepatitis and toxin‐induced liver diseases. Copyright © 2010 John Wiley & Sons, Ltd.

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“…Although milk thistle was not associated with a statistically significantly increased risk for adverse events (RR, 0.83; CI, 0.46 to 1.50), it had no statistically significant effect on mortality (RR, 0.78; CI, 0.53 to 1.15), complications of liver disease (RR, 0.95; CI, 0.83 to 1.09), or liver histology (27).…”

Section: Are Complementary-alternative Therapies Useful In the Treatmmentioning

confidence: 83%

“…In the case of milk thistle, no significant harm has been observed in studies to date (27). However, a number of herbal remedies, such as chaparral, leaf germander, jin bu huan, kava kombucha mushroom, margosa oil, mistletoe, pennyroyal, pyrrolizidine alkaloids, and traditional Chinese herbs, are known to be hepatotoxic (28).…”

Section: Are Complementary-alternative Therapies Useful In the Treatmmentioning

confidence: 99%

Hepatitis C

Jou¹,

Muir²

2008

Ann Intern Med

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Chronic hepatitis C virus (HCV) infection is the most common blood-borne infection in the United States, with an estimated overall prevalence of 3.2 million persons (1.3%) and prevalence peaks between age 40 to 49 years (1). The worldwide prevalence of HCV infection is even higher at 2.0%, corresponding to 140 million persons (2).In terms of complications, cirrhosis due to HCV disease is the most frequent indication for liver transplantation in the United States (3), and the overall incidence of hepatocellular carcinoma, a complication of HCV cirrhosis, continues to increase at alarming rates. In an evaluation of population-based registries of the Surveillance, Epidemiology, and End Results (SEER) program in the United States, the overall age-adjusted incidence rates of hepatocellular carcinoma increased from 1.4 per 100 000 in 1975 to 1977 to 3.0 per 100 000 in 1996 to 1998 (4). Prevention What factors increase the risk for hepatitis C virus (HCV) infection?The predominant risk factor for the transmission of HCV is percutaneous exposure to infected blood, which most commonly takes place through remote or chronic injection drug use. Transmission of HCV historically occurred with transfusion of blood products before screening of the blood supply in the United States before 1992. There seems to be no increased risk for HCV transmission through cosmetic procedures, such as tattooing and piercings, unless infection control measures are not followed (5).Transmission of HCV in health care workers after a needle-stick exposure occurs in up to 10% of cases (6). Additionally, the prevalence of HCV infection in hemodialysis patients isThe content of In the Clinic is drawn from the clinical information and education resources of the American College of Physicians (ACP), including PIER (Physicians' Information and Education Resource) and MKSAP (Medical Knowledge and Self-Assessment Program). Annals of Internal Medicine editors develop In the Clinic from these primary sources in collaboration with the ACP's Medical Education and Publishing Division and with the assistance of science writers and physician writers. Editorial consultants from PIER and MKSAP provide expert review of the content. Readers who are interested in these primary resources for more detail can consult http://pier.acponline.org and other resources referenced in each issue of In the Clinic. The information contained herein should never be used as a substitute for clinical judgment. For More Information Centers for Disease Control and Prevention (CDC)Hepatitis C Prevention www.cdc.gov/ncidod/diseases/hepatitis/c/hepcprev.htm Viral Hepatitis C www.cdc.gov/ncidod/diseases/hepatitis/c/index.htm National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Chronic Hepatitis C: Current Disease Management digestive.niddk.nih.gov/ddiseases/pubs/chronichepc/index.htm What I Need to Know about Hepatitis C digestive.niddk.nih.gov/ddiseases/pubs/hepc_ez/index.htm (English) digestive.niddk.nih.gov/ spanish/pubs/hepc_ez/index.htm (Spanish)

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Milk Thistle for Alcoholic and/or Hepatitis B or C Liver Diseases-A Systematic Cochrane Hepato-Biliary Group Review with Meta-Analyses of Randomized Clinical Trials

Abstract: Based on high-quality trials, MT does not seem to significantly influence the course of patients with alcoholic and/or hepatitis B or C liver diseases. MT could potentially affect liver injury. Adequately conducted randomized clinical trials on MT versus placebo may be needed.

Cited by 97 publications

References 35 publications

Silybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: A randomized controlled trial

Silybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: A randomized controlled trial

Milk thistle in liver diseases: past, present, future

Hepatitis C

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