Last week there it was reported that Milk Thistle No Help in Chronic HCV from an abstract presented at the AASLD conference. This of course peeked my interest and I had to go and read what I could on the report. I love these side-line investigations. So I am going to break down the report into point form and then look at a few other studies using milk thistle. Is milk thistle the best herb choice? And what about the dosage? After looking at the studies I think both are in question.
Fried MW, et al "A randomized, placebo-controlled trial of oral silymarin (milk thistle) for chronic hepatitis C: final results of the SYNCH multicenter study" AASLD 2011; Abstract 228.
- The study involved 154 patents with a history of failed interferon-therapy and Hepatitis C Visus (HCV) and a serum ALT >/= 65 IU
- 2 doses of silymarin were used 420 or 700 mg/day for 6 months
- Symptom scores and QoL were unchanged at study end
- There was little effect on ALT
- 4% of patients in each group met the endpoint decline of ALT to=/> 45 IU or at least a 50% decline from baseline
- Conc: had no detectable effect on hepatitis C virus (HCV) disease activity in comparison with placebo in patients with previously treated chronic disease,
To help put this report in context about milk thistle and hepatitis Let’s take a look at the properties of milk thistle (silymarin) and liver disease, past studies involving hepatitis C, milk thistle and anti oxidants.
Milk Thistle (silybum marianum)
- Has been traditional used for the treatment of liver disorders and as a hepatoprotective
- In experimental models is has shown hepatoprotective and anti carcinogenic activity
- Has been shown to lower liver enzymes in alcohol-related disorders and non-alcoholic fatty liver disease
- Contains flavanolignan mixture (silymarin: mostly silybin, silychristin and silydianin)
Simon Mills MNIMH says "it can be concluded that milk thistle should not be solely relied on for the treatment of hepatitis C, but may have some role as an hepatoprotective agent"
Milk thistle may not be the been the best herb choice in this study for HCV. As as seen in the studies below In combination with other agents it may have faired better. As well the dosage of silybum in this report may have been low or perhaps as they outline not effective given orally.
There are a few studies and case studies showing that antioxidant therapy in Hepatitis C has fairly good results:
Med Klin (Munich). 1999 Oct 15;94 Suppl 3:84-9.
A conservative triple antioxidant approach to the treatment of hepatitis C. Combination of alpha lipoic acid (thioctic acid), silymarin, and selenium: three case histories.
Berkson BM.
World J Gastroenterol. 2007 Oct 28;13(40):5317-23.
Antioxidant therapy for chronic hepatitis C after failure of interferon: results of phase II randomized, double-blind placebo controlled clinical trial.
Gabbay E, Zigmond E, Pappo O, Hemed N, Rowe M, Zabrecky G, Cohen R, Ilan Y.
J Med Virol. 2008 Nov;80(11):1900-6.
Treatment with silybin-vitamin E-phospholipid complex in patients with hepatitis C infection.
Falasca K, Ucciferri C, Mancino P, Vitacolonna E, De Tullio D, Pizzigallo E, Conti P, Vecchiet J.
There was a study in the spring of 2011 on the Effects of silybum marianum on patients with chronic hepatitis C.
- In this study 55 patients with HCV received 620 mg/day of silymarin for 24 weeks.
- Liver fibrosis markers (YKL 40 and HA) results before treatment, patients were divided into three stages: Fibrosis group: YKL 40 > 150 ng/ml and HA > 60 ng/ml or YKL 40 > 150 ng/ml or HA > 100 ng/ml; Non-fibrosis group: YKL 40 < 100 ng/ml and HA < 20 ng/ml
- They found there was improved serum HCV-RNA, ALT and AST, hepatic fibrosis and quality of life. There was a statistical improvement only in the Fibrosis group.
Finally there was a study on the oral availability of milk thistle and the dosages required. This last study found to achieve steady-state concentrations of silybin A and B that silymarin must be dosed tid and at dosages above 2.1g day. And at 2.1g a day silybin A and B concentrations "were still 1 to 2 orders of magnitude below those concentrations associated with antiviral effects in vitro"
- 32 patients with chronic non cirrhotic HCV who previously failed interferon therapy were divided into 4 groups and given 140, 280, 560, or 700 mg silymarin were administered every 8 hours for 7 days.
- They concluded that Oral doses of silymarin up to 2.1 g per day were safe and well tolerated. The nonlinear pharmacokinetics of silybin A and silybin B suggests low bioavailability associated with customary doses of silymarin may be overcome with doses above 700 mg.
- These data suggest that multiple daily oral doses must be administered at least 3 times per day if steady-state concentrations and antiviral effects are to be achieved.
- At the highest dose of 700 mg, which may represent a reasonable pill burden limit for patients, the steady-state peak plasma concentrations of silybin A and silybin B achieved were still 1 to 2 orders of magnitude below those concentrations associated with antiviral effects in vitro, and trough concentrations were approximately 25-fold lower than peak concentrations
