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Professional Review: Herb & Supplements
Milk Thistle
Uses: For a definition of the categories listed below, please visit the HYPERLINK "http://www.camline.ca/dictionary/dictionary_listing.php"dictionary and scroll down to Uses (professional review) HYPERLINK "http://www.camline.ca/professionalreview/pr_uses.php?NHPID=51&Section=1&SubSection=1"1.Likely Effective | HYPERLINK "http://www.camline.ca/professionalreview/pr_uses.php?NHPID=51&Section=1&SubSection=2"2.Possibly Effective | HYPERLINK "http://www.camline.ca/professionalreview/pr_uses.php?NHPID=51&Section=1&SubSection=3"3.Further Research Required | HYPERLINK "http://www.camline.ca/professionalreview/pr_uses.php?NHPID=51&Section=1&SubSection=4"4.Possibly Ineffective | HYPERLINK "http://www.camline.ca/professionalreview/pr_uses.php?NHPID=51&Section=1&SubSection=5"5.Likely Ineffective | HYPERLINK "http://www.camline.ca/professionalreview/pr_uses.php?NHPID=51&Section=1&SubSection=6"6.Traditional Uses 4.Possibly Ineffective: Hepatitis - Alcoholic, Hepatitis - Viral (Including Hepatitis B and C)
Hepatitis - Alcoholic
In a negative high quality double-blind randomized controlled trial (RCT) by Trinchet et al., patients with alcoholic hepatitis (n=57) or placebo (n=59) were given 420 mg silymarin (a component of milk thistle) daily for 3 months [10]. Outcome measures included quantitative liver biopsy analyses for alcoholic hepatitis and serum aminotransferase levels. There were no significant differences between placebo and silymarin groups, although outcome measures in both groups improved since patients consumed less/no alcohol during the study.
In a systemic review by Rambaldi et al., it was found that milk thistle did not significantly influence patients with alcoholic liver diseases [66] in a meta-analysis pooling 9 studies [7, 8, 10, 29, 55, 56, 67-69].
Hepatitis - Viral
General:
Mayer et al. conducted a systematic review of 6 clinical trials investigating the efficacy of silymarin (a component of milk thistle) in patients with viral hepatitis [9, 36, 39, 41, 70, 71]. They concluded that treatment with silymarin does not affect viral load or improve liver histology, but it likely decreases serum transaminases in patients with chronic viral hepatitis [43]. However, it is unknown whether transaminase levels have any clinical significance.
In a open-label, controlled study (randomization unknown) 87 patients with acute viral hepatitis were given a combination therapy of silymarin, Vitamin B and C or thiamine diphosphate, Vitamin B and C [72]. After three weeks, no significant decreases in transaminase levels or lengths of hospital stays were identified in the group taking the silymarin combination product. It is unknown whether the analysis was compared to baseline or controls.
Hepatitis B:
There have been two human clinical studies looking at silymarin (a component of milk thistle) use in patients with hepatitis B. [73, 74]. There were several studies that included patients with hepatitis B among many other conditions. The current evidence is generally negative, but more RCTs with hepatitis B patients only are needed to draw conclusions about the efficacy of silymarin in treating this indication.
RCTs in Hepatitis B Patients
Flisiak et al. conducted a mostly negative RCT where three groups of patients with hepatitis B (n=52) were treated with silymarin 210 mg daily, misoprostol, or no treatment [73]. It is unknown how many patients were in each group. There were no significant differences in hepatomegaly, bilirubin, ALT, AST, and GGT between groups, however, there was a significant decrease in ALP levels after 5 weeks of treatment in one unknown group. Researchers noticed 15% of those in the silymarin and 17% in the controls did not clear the HBsAg, becoming patients with the chronic form of the virus. The expected rate of chronicity is only 1-5% after an acute hepatitis infection. It was thought that occurred because some acute episodes were actually flare-ups of the infection in chronic hepatitis patients.
In an open-label study (unknown randomization), HBs-antigen-positive acute hepatitis patients (n=151) were given either 420mg silymarin (Legalon ) daily or no silymarin (not clear if placebo was provided) for 5-35 days [74]. It is unknown how many patients were in each group. Patient levels of total serum bilirubin, activity of GOT, GPT and alkaline phosphatase and prothrombin time were determined every 5-7 days. The study began from the onset of jaundice in patients to 5 weeks later. There were no statistical differences between groups in any outcomes.
Combination Diagnoses Including Hepatitis B:
Reviews:
In a systematic review of 6 clinical trials [9, 36, 39, 41, 70, 71] investigating the efficacy of silymarin in patients with viral hepatitis, there was no evidence silymarin use affects viral load or improves liver histology in patients with hepatitis B or C, although it may decrease serum transaminase levels [43]. None of the trials included hepatitis B patients only.
RCTs:
In a RCT conducted by Buzzelli et al. (n=20), 5 patients had hepatitis B, 7 patients had hepatitis B and C, and 8 patients had hepatitis C [71]. The treatment group received the silybin complex Silipide 480 mg daily for one week. There was a significant decrease in AST, ALT, and ~{&C~}-glutamyltransferase (GGT) compared to placebo and significant decrease in AST, ALT, GGT, and total bilirubin compared to baseline in the silymarin group but not in placebo. Baseline measures of the MDA levels (i.e. lipid peroxidation) did not significantly decrease. This could have been due to the short duration of the treatment.
In a randomized crossover study, silymarin was found to decrease ALT and AST levels in patients with chronic liver disease and compensated cirrhosis of the liver who were hepatitis B surface antigen (HBsAg) positive and hepatitis B e antigen (HBeAg) negative [68] cited in [43]. Patients (n=21) received either silymarin 420 mg daily or ursodeoxycholic acid for 6 months. Silymarin had no effects on liver enzyme levels and it is unknown whether there were any significant clinical effects.
In one poor-quality double-blind RCT, patients with acute hepatitis A and B were either given silymarin 140 mg (n=28) or a placebo (n=29) three times daily for 3 weeks [45]. Bilirubin and AST levels were normalized in significantly more patients in the silymarin group, but no significant differences were seen in ALT and AP levels. The loss of hepatitis B e antigen (HBeAg) was not significant between groups.
Hepatitis C:
There have been 4 clinical studies looking at silymarin (a component of milk thistle) use in patients with hepatitis C. In 1 positive randomized controlled trial (RCT), there was an improvement in an aminotranferase level [70]. However, in 3 negative clinical trials (among them 2 high quality RCTs), there were no significant differences in aminotransferase levels and silymarin was not as effective as traditional therapy for hepatitis C [75-77]. There were several additional studies that included patients with hepatitis C among many other conditions. Since no subgroup analysis was done with only the hepatitis C patients in these studies, no conclusions could be made from those studies regarding the efficacy of silymarin for this indication. Silymarin is possibly ineffective in treating hepatitis C patients, although more high quality RCTs with only hepatitis C patients are needed to confirm this findings.
Positive RCTs with Hepatitis C Patients
In a crossover double-blind RCT, there was a significant decrease in aspartate aminotransferase (AST) levels in patients with chronic hepatitis C who were not responsive to interferon ~{&A~}2b therapy (n=10) taking silymarin, but not in the placebo group [70]. Patients received Silipide first had higher baseline levels of AST and ALT to begin with and the study design may not have been appropriate to see the effects of silymarin.
Negative RCTs with Hepatitis C Patients
In a quality RCT by El-Zayadi et al., chronic hepatitis C patients were either given silymarin 450 mg daily (n=72) or a combination of ribavirin 600-800 mg plus amantidine 200 mg and ursodeoxycholic acid (n=82) for 24 weeks [75]. Researchers wanted to evaluate whether silymarin could improve hepatic necro-inflammatory activity as well as the expensive combination therapy. The study found that normalization of the alanine aminotrasferase (ALT) was apparent in 58% of the combination therapy group and 15% in the silymarin group (p < 0.001). The normalization of the virologic response occurred in 2.4% and 0% of the combination and silymarin therapy groups respectively. After another 24 weeks after the cessation of therapy, patients were reassessed. Normalization of ALT levels was sustained in 28% and 2.8% of combination therapy and silymarin groups respectively, while virologic responses stayed the same in both groups. Silymarin is 4 times less effective in normalizing ALT levels and 10 times less effective in sustaining biochemical responses compared to the combination therapy.
Huber et al. conducted a retrospective study to examine the efficacy of silymarin in chronic hepatitis C patients using different strengths of silymarin [76]. Patients were given 3 different silymarin dose regimens: 420 mg (n=13), 840 mg (n=20), or 1260 mg (n=7) silymarin daily. Aminotransferase levels were measured before, at 3-4 weeks intervals, and after treatment. Treatment lasted 125 days on average for patients. There were no significant differences in ALT, AST and GGT levels compared to baseline levels and between the groups of different strengths of silymarin. A limitation of this study was the lack of control group.
In a high quality double-blind RCT by Tanamly et al., residents of Sallam, Egypt who had tested positive for anti-HCV (66% of these patients also had HCV RNA in their sera) were given silymarin (n=69) or a multi-vitamin placebo (n=72) [77]. Legalon 140 mg (Madaus AG, Cologne, Germany), containing 124.5 mg silymarin per capsule, was given three times daily for 1 year. The purpose was to assess whether silymarin could prevent complications of chronic hepatitis C virus infections by looking at several biochemical measures in patients showing no or little symptoms associated with the condition. There were no significant differences between groups for symptoms and general well-being, virology of the hepatitis C virus, serum ALT, or serum and ultrasound markers for hepatic fibrosis. There were no significant differences in serum alanine aminotransferase, serum heptatic fibrosis marker, hyaluronic acid, YKL-40, abdominal ultrasound results between groups. After an additional year of treatment, there continued to be no significant changes between the groups [78]. No progression of liver disease was found at the two-year mark. Limitations of the study include the low dose of the silymarin tested and the short duration of the study compared to the length of time it takes for hepatitis C to become symptomatic.
Combination Diagnoses Including Hepatitis C:
Reviews:
Mayer et al. conducted a systematic review of 6 clinical trials investigating the efficacy of silymarin in patients with viral hepatitis [9, 36, 39, 41, 70, 71]. They concluded that there is no evidence that treatment with silymarin affects viral load or improves liver histology in patients with viral hepatitis C or B [43]. However, it is unknown whether transaminase levels have any clinical significance.
In a systemic review by Rambaldi et al., it was found that milk thistle did not significantly influence patients with hepatitis B or C liver diseases [66]. The authors acknowledged that milk thistle could affect liver injury however, more randomized clinical trials of milk thistle and placebo groups with higher quality methodologies and sample sizes are needed.
RCTs:
In another uncontrolled open-labeled study, patients with chronic hepatitis C and alcoholic liver disease were treated with silymarin 300 mg daily for 1 week, which was then decreased to 200 mg daily for 1 month [36]. There were significant decreases in AST, ALT, lactate dehydrogenase and bilirubin compared to baseline in the silymarin group. Limitations included: absence of control group and no information regarding alcohol use during the study.
In a quality double-blind RCT by Pares et al., there was no effect in treating alcoholic patients with cirrhosis using silymarin, where 39% of patients whose antibodies were measured were positive for hepatitis-C (exact number was not given) [9]. The primary outcome was time to death and the secondary outcome was course of liver failure. Patients received 150 mg silymarin three times daily (n=57) or placebo (n=68). There was no difference in the 5-year survival rate of the two groups. The authors suggest the lack of effect could have been attributed to patients consuming little to no alcohol, which was verified by a quick urine test before their visits. Alcohol removal could have been the root cause of both groups experiencing fewer complications when compared to baseline measures [17]. There were also many dropouts that could have reduced the power of the study and resulted in possibly masking a significant effect of silymarin in treating patients with liver cirrhosis and hepatitis C [17].
In a RCT conducted by Buzzelli et al. (n=20), 8 patients had hepatitis C, 7 patients had hepatitis B and C, and 5 patients had hepatitis B [71]. The treatment group received the silybin complex Silipide 480 mg daily for one week. There was a significant decrease in AST, ALT, and ~{&C~}-glutamyltransferase (GGT) compared to placebo and significant decrease in AST, ALT, GGT, and total bilirubin compared to baseline in the silymarin group but not in placebo. Baseline measures of the MDA levels did not significantly decrease, perhaps indicating that silymarin does not decrease lipid peroxidation. This could have been due to the short duration of the treatment.
Pharmacology
Although the complete mechanism of action is unknown, there have been many studies that have investigated the antioxidant and free-radical-antagonizing actions of milk thistle. This is thought to be the key mechanism of action when used to treat liver disease. Other suggested actions include increased protein synthesis, stabilized immunologic response, and alteration and increased stability of cellular membranes. In the review by Mayer et al., regeneration-promoting [46] and iron-binding properties [47] may specifically be helpful in hepatitis B and C patients.
Anti-oxidant:
The antioxidant activity appears to be an important factor in the hepatoprotective action of silymarin. In vitro and in vivo studies show that silymarin influences the expression and activity of superoxide dismutase (SOD) enzyme in erythrocytes and lymphocytes of alcoholic cirrhosis patients [18] and may also be applicable to hepatitis patients.
Protein Synthesis:
In vitro studies with isolated hepatocytes demonstrate that silymarin has liver protective properties [19]. Cells preincubated with the drug were found to be entirely or almost resistant when exposed to solutions which had a lethal effect on a considerable proportion of the controlled liver cells [19, 20]. Protein synthesizing capacity remained intact and protection was reduced but not abolished upon removal of the drug and cell washing.
Lipid peroxidation:
Silymarin can increase glutathione (GSH) peroxidase and GSH transferase activities as seen in extrahepatic biliary obstruction rats [21]. Silymarin can reduce lipid peroxidation in the liver and enhance the glutathione antioxidant system. Silymarin inhibited peroxidative processes in rat liver microsomes and isolated hepatocytes [22].
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