Supportive Treatment In Chronic Liver Diseases

Numerous clinical trials have been conducted with St Mary's thistle preparations in _ _

various chronic liver diseases. The most studied treatments are Legalon (Madaus St Mal7's thlstle

Corporation, Cologne, Germany) and Silipide (Inverni Delia Beffa Research and > 2007 Elsevier Australia

Development Laboratories, Milan, Italy) designed to improve oral absorption of silymarin.

Clinical note — Hepatic fibrosis

Hepatic fibrosis is a pathological wound-healing process that occurs when the liver is injured chronically, such as in chronic alcohol abuse. The oxidative metabolite of ethanol, acetaldehyde, often in conjunction with viral or metabolic liver disease, is implicated as the major cause for liver fibrogenesis, which ultimately leads to cirrhosis (Schuppan et al 1995). Antifibrotic agents, which interrupt the continuous process of wound healing in the liver, are being investigated as strategies to prevent or reverse liver cirrhosis.

A 1998 clinical review of St Mary's thistle concluded that it may be effective in improving the clinical courses of both acute and chronic viral, drug-induced, toxin-induced and alcoholic hepatitis (Flora et al 1998). A more recent systematic review of efficacy for St Mary's thistle in chronic liver diseases stated that data are still too limited to detect a substantial benefit on mortality or recommend the herb in liver disease (Jacobs etal 2002).

Eleven clinical studies were located in which researchers have attempted to clarify the role of St Mary's thistle in the treatment of various liver diseases (Angulo et al 2000, Benda et al 1980, Buzzelli et al 1993, Ferenci et al 1989, Lucena et al 2002, Magliulo et al 1978, Par et al 2000, Pares et al 1998, Salmi and Sarna 1982, Trinchet et al 1989, Velussi et al 1997). Much of the research focuses on the different forms of hepatitis and alcoholic liver cirrhosis with doses ranging from 100-300 mg three times daily, usually given in a standardised extract of 70-80% silymarin. Overall, results have been mixed, with eight trials showing generally positive results and three negative, suggesting more research is still required.

A 2005 Cochrane review of 13 randomised clinical trials assessed milk thistle in 91 5 patients with alcoholic and/or hepatitis B or C virus liver diseases (Rambaldi et al 2005). The authors stated that the methodological quality of the trials was low and although liver-related mortality was significantly reduced by milk thistle in patients with alcoholic liver disease, milk thistle versus placebo or no intervention had no significant effect on complications of liver disease, or liver histology. Milk thistle was not associated with a significantly increased risk of adverse events. Acute viral hepatitis Several studies have investigated the use of milk thistle in this disease, reporting beneficial effects on serological outcomes (Bode et al 1977,

Magliulo et al 1978, Tkacz & Dworniak 1983). However, several studies were not st Mary's thistle 1045

clearly blinded and further research Is required to determine whether St Mary's thistle can provide significant benefits in this population.

Hepatitis C infection A 2003 systematic review of medicinal herbs for hepatitis C virus (HO/) infection concluded that compared with placebo, none of the herbs showed effects on HCV RNA or liver enzyme, except for silybin, which showed a significant reduction of serum AST and gamma-glutamyltranspeptidase levels in one trial (Liu et al 2003). Overall, the review concluded that further randomised trials are justified.

Commission E approves the use of standardised St Mary's thistle extracts (70-80% silymarin content) as supportive treatment in chronic inflammatory liver disease and hepatic cirrhosis (Blumenthal et al 2000).

Diabetes Silymarin has also been investigated in diabetic patients with cirrhosis. Velussi et al (1997) investigated whether long-term treatment with silymarin is effective in reducing lipoperoxidation and insulin resistance in diabetic patients with cirrhosis. The 6-month open trial found that silymarin treatment had several benefits. After the first month's treatment, fasting glucose levels showed a progressive and significant decline that, interestingly, did not lead to an increase in the frequency of hypoglycaemic episodes. Other observations revealed decreased glucosuria and levels of glycosylated haemoglobin also decreased significantly, indicating an overall improvement in glucose control. The dose used was 600 mg/day silymarin.

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