HR : Antiviral+Milk Thistle - Any Issue?

[Ann8]

To: HR

Bump......really need your expert opinions on this. We are blessed to have you in this forum.

I will talk to my GI on combo treatment in my next visit since TDF is approved now. I suspect I will get the usual response......not proven yet. I wanted to take Milk Thistle to protect my liver but my GI strongly against it.Milk Thistle has been proven to be effective to protect the liver (Taiwan Research). Is there any synergy between antiviral + milk thistle medication? I alway believe that killing the virus w/ antiviral medication and taking the milk thistle same time as liver protection will be the best combination but not too sure on the contradict between these two drugs. Does milk thistle disturb the virus or interfere with antiviral drug? Can I take them together ?

Cluvedine & Alinia - what is your take on drug potency looking at the off-treatment effects? Lastly, any news on RNAi clinical trial? Is it still going on or been cancelled? Thanks in adance....      

[cajim]

Notes on “Milk Thistle,” Francine Rainone, D.O., Ph.D., M.S. AMERICAN FAMILY PHYSICIAN

Milk thistle has been used as a cytoprotectant for the treatment of liver disease, for the treatment and prevention of cancer, and as a supportive treatment of Amanita phalloides poisoning. Clinical studies are largely heterogeneous and contradictory. Aside from mild gastrointestinal distress and allergic reactions, side effects are rare, and serious toxicity rarely has been reported. In an oral form standardized to contain 70 to 80 percent silymarin, milk thistle appears to be safe for up to 41 months of use. Significant drug reactions have not been reported. Clinical studies in oncology and infectious disease that are under way will help determine the efficacy and effectiveness of milk thistle. (Am Fam Physician 2005;72:1285-8. Copyright © 2005 American Academy of Family Physicians.)

Milk thistle (Silybum marianum) was used in classical Greece to treat liver and gallbladder diseases and to protect the liver against toxins. It recently has been investigated for use as a cytoprotectant, an anticarcinogen, and a supportive treatment for liver damage from Amanita phalloides poisoning. Its active ingredient is silymarin, found primarily in the seeds. Silymarin undergoes enterohepatic recirculation, which results in higher concentrations in liver cells than in serum.1 It is made up of components called flavonolignans, the most common being silybin.2

...

liver disease

In the United States, milk thistle is most commonly used to treat viral infections and cirrhosis of the liver. Clinical trials have produced conflicting results. In a study25 of patients with cirrhosis, 170 patients (46 with alcoholism) were randomized to Legalon, a proprietary product standardized to contain 70 to 80 percent silymarin, or placebo. In the 146 patients who completed 24 to 41 months of therapy, there was a lower mortality rate among the patients treated with Legalon. The greatest benefit occurred in those whose cirrhosis was caused by alcoholism and in those who had less severe cirrhosis on entry.25

In a six-month double-blind study26 of 36 patients with chronic alcoholic liver disease, the group given Legalon showed normalization of their bilirubin, aspartate transaminase and alanine transaminase serum levels, and also showed improvement in histology. These effects did not occur in the placebo group. In another study,27 106 patients with mild acute and subacute liver disease characterized by elevated serum transaminase levels were randomized to receive silymarin or placebo. Of the 97 patients who completed the four-week study, there was a statistically significant greater decrease in transaminase levels in the silymarin group. In addition, results of a smaller study28 of 20 patients with chronic active hepatitis randomized to placebo or silybin showed that the milk thistle group had significantly lower transaminase, bilirubin, and gamma-glutamyltranspeptidase levels than the placebo group. This study used a complex of silybin with phosphatidylcholine, which appears to increase bioavailability.

...

Adverse Effects and Interactions

The Agency for Healthcare Research and Quality reviewed the effects of milk thistle on liver disease and cirrhosis,32 noting that serious adverse reactions are virtually unheard of. The most common reported complaints were gastrointestinal disturbances, but the overall incidence was no different from placebo. Allergic reactions, ranging from pruritus and rash to eczema and anaphylaxis, are rare.

Drug interactions do not appear to be problematic. Silybin inhibits the activities of CYP2D6, CYP2E1, and CYP3A4, but at physiologic concentrations far higher than those given clinically.38 In a study39 of 10 healthy volunteers, administration of 175 mg of milk thistle three times daily for three weeks had no significant effect on concomitantly administered indinavir (Crixivan).
Table 1Key Points About Milk Thistle
Efficacy Acute and chronic viral hepatitis, alcoholic liver disease: conflicting evidenceCytoprotection: rigorous randomized controlled trials ongoing; limited evidence suggests benefit.Anticarcinogen: clinical trials ongoingAmanita phalloides poisoning: insufficient data
Adverse effects Generally well tolerated; infrequent reports of gastrointestinal disturbances; rare reports of pruritus, eczema, rash, and anaphylaxis*CAUTION: do not use in patients with allergies to members of the aster family.
Interactions No significant drug interactions
Dosage Milk thistle seed extract, 150- to 175-mg capsule, standardized to 80 percent silymarin, three times dailyUltrathistle (seed extract bound to phosphatidylcholine), 360-mg capsule, three times daily
Cost $15 to $30 per month at 150 to 175 mg three times daily$42 per month at 360 mg three times daily
Bottom line Safe, no known drug interactions; insufficient data to recommend for treatment of liver disease; under investigation for anticarcinogenic and chemoprotective effects
*-Three nonfatal case reports, only one of which is sufficiently attributed to the herb.
Dosage

Most clinical trials have used daily dosages of 420 to 480 mg silymarin, divided into two or three doses daily. Until the specific effects of each of the flavonolignans is known and products are available that contain standardized ratios of these components, the optimal dosage will remain unknown. Table 1 outlines the efficacy, safety, tolerability, dosage, and cost of milk thistle.