11.19.09
Probiotics, yogurt and gut health in people with HIV
The online information resource for people with HIV, The Body, recently published an article on probiotics, yogurt and gastrointesinal health in people with HIV: A “Cultured” Response to HIV:
Probiotics in Yogurt Could Hold Keys to Optimal Gut Health in HIVers. Here’s an excerpt:
HIV researchers have known since the early days of the pandemic that HIV can wreak havoc on the gut, which is home to an abundance of CD4 cells. This apparently occurs quite soon after someone is infected with HIV. “It’s almost like the gut is a magnet for the virus early on,” says Bill Critchfield of the University of California at Davis. “[It] becomes compromised in weeks.”
The gut also harbors roughly 100 trillion microorganisms that help with immunity and digestion. HIV infection can upset the balance of healthy bacteria in the gut, allowing “bad” bacteria and fungi to flourish there. Several recent studies have suggested that probiotics — the “friendly bacteria” that turn milk into yogurt and also provide health benefits when eaten — can help restore that balance by repopulating the gut with healthy bacteria or by tuckering out the bad bacteria by competing with them for nutrients.
As Nature Medicine reports, microbiologist Gregor Reid of Lawson Health Research Institute in Ontario, Canada, has been studying the health benefits of probiotics for over 25 years. He’s created his own probiotic, called Lactobacillus rhamnosus GR-1, which he has put into a yogurt that is being used in research involving people with HIV. Reid and others around the world have conducted small studies that show probiotics have a positive effect on CD4 counts, though larger studies are certainly needed to confirm those findings.
The article in the journal Nature Medicine is found at
http://www.lhrionhealth.ca/crdcp/pdf/Nature%20Medicine%20feature.pdf. It looks especially at a pilot study in Tanzania on yogurt, gut health and HIV.
NYBC, like its predecessor supplements buyers’ club DAAIR, has long been interested in probiotics for gut health in people with HIV. See the NYBC entries at Probiotics for detailed recommendations for use.
11.17.09
Vitamin D for heart health
Our hometown newspaper, The New York Times, carried an article
on 11/16/2009 entitled “Vitamin D Shows Heart Benefits in Study.” The piece will not come as any terrific surprise to readers of this blog, since we’ve already cited under “Vitamin D” a recent article in the American Journal of Cardiology that suggested supplementing with Vitamin D as an important and economical option for preventing cardiovascular disease.
Quite a few NYT readers sent in comments on the article, mentioning a variety of other recent findings about the “sunshine Vitamin” (many of which we’ve already cited on this blog). We do know that a federal panel is reviewing recommendations on daily intake of Vitamin D, and is expected to issue new guidelines in the next year or so. But we hadn’t heard, as one NYT reader pointed out, that, as of recent years, the general practice in Canada is to recommend up to 2000IU of Vitamin D3/day for children to support and promote good health. Here’s an extract from the Canadian Paediatric Society’s 2007 position statement on Vitamin D supplementation (yes, all of those numbers in parenthese refer to scientific journal articles):
The emphasis is no longer solely on preventing rickets,
which requires only a relatively small amount of vitamin D
supplementation. The focus is now also on the prevention
of associated childhood and adult diseases. New findings
suggest that adequate vitamin D status in mothers during
pregnancy and in their infants may have lifetime implications.
These findings modify our knowledge and understanding of
vitamin D metabolism, our basis for diagnosis of vitamin D
deficiency and our recommendations for supplementation.It is now clear that vitamin D is involved in the regulation
of cell growth, immunity and cell metabolism. Vitamin D
receptors are found in most tissues and cells in the body (7).
The interaction of 1,25(OH)2D with these receptors may
result in a variety of biological responses influencing disease
processes (8). Vitamin D deficiency has been linked to
osteoporosis (9); asthma (10); autoimmune diseases such as
rheumatoid arthritis, multiple sclerosis (11) and inflammatory
bowel diseases (12); diabetes (13); disturbed muscle function
(14); resistance to tuberculosis (15); and the pathogenesis of
specific types of cancer (16,17) (evidence level III).Maternal vitamin D status during gestation and lactation
may influence the health status of the child later in life.
Bone density in nine-year-old children (evidence level II-3)
(9), the severity of asthma in three-year-old children (10)
(evidence level II-2) and the susceptibility to type 1 diabetes
(11) (evidence level II-2) have been linked to low
vitamin D status during fetal life. Intervention trials have
demonstrated that supplementation with vitamin D or its
metabolites may improve blood glucose levels in diabetics
and decrease symptoms of rheumatoid arthritis and multiple
sclerosis (11,13) (evidence level III).
Read the full text at:
http://www.cps.ca/ENGLISH/statements/II/VitaminD.pdf
See also the NYBC entries:
11.16.09
Grape Seed Extract for Colon Cancer Prevention
NCCAM (NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE) is sponsoring a 5-year study of grape seed extract for prevention of colon cancer. The study, being conducted at the University of Colorado – Denver, is based on a number of promising lab studies of this botanical substance.
Here’s an excerpt from the abstract of this study:
Colon Cancer Prevention by Grape Seed Extract
Colorectal cancer (CRC) is the second most common cause of cancer deaths in humans, and about 5% of the US population will develop CRC in their life times. Overall, CRC growth, progression and metastasis involve a gradual accumulation of genetic and epigenetic changes over a period of years. One approach to control CRC growth and metastasis could be its prevention by phytochemicals present in diet and those consumed as dietary supplement, which inhibit one or more events of neoplastic stages and reduce overall cancer risk. Grape seed extract (GSE) is a widely consumed dietary supplement in the United States for its several health benefits, and is a rich source of standardized phytochemicals known as proanthocyanidins. [...] We anticipate that proposed studies will identify GSE as a mechanism-based dietary supplement agent for the prevention of CRC, and will establish its in vivo efficacy in pre-clinical CRC models. As a practical and translational approach, the long- range goal of these studies would be to define and establish the usefulness of GSE for the prevention and intervention of human CRC.
See the NYBC product:
Related References:
Kundu JK, Surh YJ (Oct 2008). “Cancer chemopreventive and therapeutic potential of resveratrol: mechanistic perspectives”. Cancer Lett. 269 (2): 243–61.
Katiyar SK (Jun 2008). “Grape seed proanthocyanidines and skin cancer prevention: inhibition of oxidative stress and protection of immune system”. Mol Nutr Food Res. 52 Suppl 1: S71–6.
11.10.09
Vitamin D3 and Flu Prevention
There has been rising interest in the past few years about Vitamin D’s potential for preventing/controlling flu and other respiratory illnesses.
One notable advocate for Vitamin D as a preventative against flu is Dr. John Cannell, lead author of a 2008 review article in the journal Virology. Cannell and his co-authors build on a decades-old insight from a British researcher, Hope-Simpson, who speculated that influenza was seasonal because of a co-factor related to sun exposure. The co-factor, this article asserts, is Vitamin D and its positive effects on immunity.
The second paragraph quoted below (from the same 2008 article in Virology) reports rather dramatic evidence that African-Americans, who are especially prone to Vitamin D deficiency, might very substantially decrease their susceptibility to colds and flu by supplementing with 2000IU daily during winter months.
Vitamin D, innate immunity, and influenza
Hope-Simpson’s model theorized that an unidentified “seasonal stimulus,” inextricably bound to solar radiation, substantially controlled the seasonality of influenza. Recent evidence suggests the “seasonal stimulus” may be seasonal impairments of the antimicrobial peptide (AMPs) systems crucial to innate immunity, impairments caused by dramatic seasonal fluctuations in 25-hydroxy-vitamin D [25(OH)D] levels. The evidence that vitamin D has profound effects on innate immunity is rapidly growing.
…
In fact, Aloia and Li-Ng presented evidence of a dramatic vitamin D preventative effect from a randomized controlled trial (RCT). In a post-hoc analysis of the side effect questions of their original three-year RCT, they discovered 104 post-menopausal African American women given vitamin D were three times less likely to report cold and flu symptoms than 104 placebo controls. A low dose (800 IU/day) not only reduced reported incidence, it abolished the seasonality of reported colds and flu. A higher dose (2000 IU/day), given during the last year of their trial, virtually eradicated all reports of colds or flu. Recent discoveries about vitamin D’s mechanism of action in combating infections led Science News to suggest that vitamin D is the “antibiotic vitamin” due primarily to its robust effects on innate immunity.References:
Cannell, John J, Michael Zasloff, Cedric F Garland, Robert Scragg and Edward Giovannucci. On the epidemiology of influenza. Virology Journal 2008, 5:29. We accessed this 11/10/2009 at http://www.virologyj.com/content/5/1/29.
Aloia J F, Li-Ng M: Epidemic influenza and vitamin D. Epidemiol Infect 2007; 135: 1095–1096.
See the NYBC entry Vitamin D3 2500IU for additional information. This format of D3 is a convenient way to supplement at approximately the levels discussed by Cannell and others. (NYBC also stocks D3 1000IU and D3 400IU formats.)
11.09.09
Saccharomyces boulardii: new research confirms effectiveness
Saccharomyces boulardii is a very well-researched probiotic, with several hundred peer-reviewed studies to its credit, many from the past two decades. It’s now the first choice for antibiotic-associated diarrhea, C. difficile colitis, and “traveler’s diarrhea.” It can also help in addressing irritable bowel syndrome, ulcerative colitis and Crohn’s disease. Here are some recent research highlights:
–Harvard Medical School researchers located specific pathways by which Saccharomyces boulardii decreases intestinal inflammatory responses; their 2006 report helps explain the broad range of protective effects that the probiotic exerts in a variety of gastrointestinal disorders.
–A 2006 meta-analysis (combined study of multiple individual studies) found that Saccharomyces boulardii was the only probiotic effective against Clostridium difficile disease, a common form of antibiotic-associated diarrhea.
–A 2008 study, meanwhile, found that Crohn’s patients receiving Saccharomyces boulardii treatment showed significant improvements in intestinal function compared with those given a placebo (dummy pill).
–Most recently, an investigation published in 2009 found that, of a variety of probiotics, Saccharomyces boulardii was uniquely able to stimulate production of secretory IgA, the main immunoglobin found in mucus, saliva, and secretions from the intestine and lining of the lungs, and a main component of the body’s protective mechanism against pathogens. (Thus Saccharomyces boulardii may now be credited with a general immune-modulating/strengthening ability.)
References:
Sougioultzis S, Simeonidis S, Bhaskar KR, Chen X, Anton PM, Keates S, Pothoulakis C, Kelly CP. Saccharomyces boulardii produces a soluble anti-inflammatory factor that inhibits NF-kappaB-mediated IL-8 gene expression. Biochem Biophys Res Commun. 2006 Apr 28;343(1):69-76.
McFarland LV. Meta-analysis of probiotics for the prevention of antibiotic associated diarrhea and the treatment of Clostridium difficile disease. Am J Gastroenterol. 2006 Apr;101(4):812-22.
Garcia Vilela E, De Lourdes De Abreu Ferrari M, Oswaldo Da Gama Torres H, Guerra Pinto A, Carolina Carneiro Aguirre A, Paiva Martins F, Marcos Andrade Goulart E, Sales Da Cunha A. Influence of Saccharomyces boulardii on the intestinal permeability of patients with Crohn’s disease in remission. Scand J Gastroenterol. 2008;43(7):842-8.
Flaviano S. Martins, Aparecida A. Silva, Angélica T. Vieira, Flávio H. F. Barbosa, Rosa M. E. Arantes, Mauro M. Teixeira and Jacques Robert Nicoli. Comparative study of Bifidobacterium animalis, Escherichia coli, Lactobacillus casei and Saccharomyces boulardii probiotic properties.
Archives of Microbiology, Volume 191, Number 8 / August, 2009.
Saccharomyces boulardii is available from NYBC as Florastor, recognized as the most reliable commercially available form of the probiotic.
11.06.09
NAC for Systemic Lupus Erythematosus
The National Center for Complementary and Alternative Medicine at the NIH is funding a study at Upstate Medical University (Syracuse, NY) on the use of N-acetylcysteine (NAC) for Systemic lupus erythematosus (SLE). This study was motivated by some promising related research in Europe, where NAC is much more widely used and investigated than in the US. Here’s an excerpt from the study description:
Systemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has debilitating and potentially life-threatening consequences. The cause of SLE is unknown and current therapies lack specificity and carry significant side effects. Existing data in the literature provide evidence that a natural antioxidant, glutathione, is depleted in T cells of patients with SLE which may be a key factor underlying abnormal activation and predisposition of T lymphocytes to pro-inflammatory cell death via necrosis. Administration of N-acetylcysteine (NAC), that serves as a precursor of GSH, improves the clinical outcome of murine lupus, and limits the toxicity of pro-oxidant/immunosuppressant medications commonly used in patients with SLE. NAC is widely available in health food stores and large doses (up to 8 g/day) can be safely administered to humans. In a one-year study of patients with inflammatory lung disease treated with prednisone and azathioprine, addition of NAC (1.8g/day) diminished disease severity and reduced drug toxicity in comparison to placebo. Moreover, oral NAC has been found to improve muscle fatigue which is reported to be the most disabling symptom in 53% of patients with SLE. Thus, establishing a dose ranging between 1.8-7.2 g/day that is well-tolerated and capable of raising intracellular GSH in lupus patients and determining its immunological and therapeutic impact in SLE appear to be well justified.
The project is reported on the NCCAM website: Abstracts of 2008 Funded Projects.
For more on NAC, see the NYBC entry for PharmaNAC. This form of NAC is manufactured to the quality standards of the European Pharmacopoeia, and provides a good way to get the dosages under study in this research on SLE.
11.05.09
Alzheimer’s and Curcumin
Curcumin is the yellow pigment in turmeric, a spice well-known in Indian cuisine. It contains antioxidants that endow it with anti-inflammatory activity, which has been recognized for centuries by the Ayurvedic medicine tradition of India. Curcumin has been the subject of hundreds of scientific studies in recent decades, most dealing with cancer, but some also addressing Alzheimer’s Disease.
One of the leading research groups on curcumin and Alzheimer’s is based at the University of California at Los Angeles, so we were interested to check in and see their current posting about this research:
Many spices as well as fruits and vegetables have polyphenolic antioxidants that also have antiinflammatory acitivity. These compounds can give these food their color. We have found that the yellow pigment in turmeric, curcumin, can act at multiple steps in Alzheimer pathogenesis to stop and even reverse damage.
…
Curcumin is the Asian version of aspirin. Our wonder drug aspirin was originally purified from willow bark extracts that were used in European and American Indian traditional medicines to control inflammation. Eventually aspirin was synthesized by German chemists and developed by Bayer as one of the most successful drugs in the Western medicine cabinet. Today aspirin is used not only in pain remedies and other analgesic applications, but to control minor fever and inflammation and, at low doses, to prevent heart attack and stroke. Curcumin has been used in traditional Indian (Ayruvedic) and Chinese medicine for thousands of years largely because of its proven efficacy in treating conditions with inflammation. They also used it in foods as an effective food preservative, just as we use synthetic additives like BHA. These ancient civilizations have vast trial and error experience with many different herbal remedies and food preparations and they selected curcumin as a food additive and major tool for medicinal use based on efficacy–not superstition.
…
Curcumin and Alzheimer’s Disease. Our group has tested curcumin in several models for Alzheimer’s and found that it not only reduces oxidative damage and inflammation (as expected), but also reduces amyloid accumulation and synaptic marker loss and promotes amyloid phagocytosis and clearance. Curcumin worked to prevent synaptic marker and cognitive deficits caused by amyloid peptide infusion and a beta oligomer toxicity in vitro.
Read more, including references and information on clinical trials, on the UCLA research group’s website:
http://alzheimer.neurology.ucla.edu/Curcumin.html
For additional information, see the NYBC entry
11.03.09
Can carnitine reduce diabetes risk and improve body shape?
We were interested to read about a recent study on carnitine, diabetes risk and body shape in people with HIV, as reported on the CATIE (Canadian AIDS Treatment Information Exchange) website:
Some studies have found less-than-normal levels of carnitine in the blood of HIV positive people. Other studies have found that regular supplementation with carnitine can help to reduce abnormal levels of triglycerides, a fatty substance in the blood. Most of the studies focused on a formulation of carnitine called L-carnitine.
Long-term studies of a different formulation of carnitine—acetyl-L-carnitine—suggest that this substance can help damaged nerves recover from the toxicity of certain anti-HIV drugs such as d4T (Zerit, stavudine) and ddI (Videx EC, didanosine).
Now researchers in Milan, Italy, have conducted a small study with HIV positive volunteers and carnitine, to assess its effects on body composition and other related metabolic parameters. The results from this study suggest the possibility of a decreased risk for diabetes. Furthermore, the research team claims that carnitine supplements increased the fat content in the legs of volunteers. We urge readers to exercise caution when interpreting the results of this small study and we provide critical details later in this CATIE News bulletin.
Read more information on the study at:
http://www.catie.ca/catienews.nsf/00a48c8905294f0b8525717f00661eb8/4c5c394577db43018525763f00731b34!OpenDocument
Read more background information at the NYBC entries:
and
11.02.09
Micronutrients for people with HIV: a low-cost equivalent to K-Pax
K-PAX®, the popular multi-supplement pack, was developed following Dr. Jon Kaiser’s micronutrient study that found an increase in CD4 count among HIV+ individuals using a mix of a potent multivitamin and antioxidants.* At this point, the Medicaid or ADAP formularies of many states include K-PAX®–a validation by the healthcare system welcomed by those of us who have long maintained that supplements can help to address chronic illness. Unfortunately, many people do not have access to these programs and for them, cost can be an issue. (The retail price of the “Double-Strength” K-PAX® formula is about $130/month, quite a sum for those on a budget who face extra healthcare costs.)
That’s why NYBC designed MAC Pack (for Multivitamin Antioxidant Combination), an alternative to the “Double-Strength” K-PAX® formula, based on products already available through our nonprofit co-op. Unlike K-PAX®, the parts of the MAC Pack are delivered in their original bottles, so “some assembly is required” (one reason we also stock small ziplock baggies–great for travel, too!) While NYBC’s MAC Pack is not a precise, 100% match of the K-PAX® formula, it provides a similarly comprehensive vitamin, mineral and antioxidant regimen—and at a much lower cost (about $62/month).
A few small differences between NYBC’s MAC Pack and K-PAX® should be noted:
1) Acetyl L-Carnitine: The MAC Pack actually contains more acetylcarnitine than the double-strength K-PAX®—not a bad idea, especially if you believe, as we do, that acetylcarnitine may be one of the key elements in the multivitamin-antioxidant combination. (Two a day is sufficient if you want to match the K-PAX® formula, but three or more can help if you’re dealing with neuropathy.)
2) Vitamins: The multivitamins contained in the MAC Pack have somewhat different formulas than those in K-PAX®. Taking an extra Vitamin C tab along with the regular multi would make up for one difference. And some might wish to take a bit more calcium and vitamin D3, since bone health remains a concern for people with HIV, and there is also growing recognition of the need for higher doses of D3.
3) Iron: K-PAX® only comes with iron, but for those with liver trouble, this might NOT be a good idea. With the multivitamin Added Protection, you can choose whether to take iron or not (it is available both with iron and without). Also: Ultra Preventive Beta, another Douglas Labs multi, offers a variety of food-based nutrients in addition to a standard multivitamin formula, for $3 more per month.
Note: In 2009, NYBC added to its MAC Pack offerings by introducing the Opti-MAC Pack. This version of the MAC-Pack relies on SuperNutrition’s OptiPack (iron free), which has higher amounts of B vitamins than Added Protection or Ultra Preventive Beta, and so represents a further economy in number of bottles and in cost (about $56/month). Even with these savings, it’s still a close equivalent of the K-PAX®!
For more information on NYBC’s MAC Pack or Opti-MAC Pack, or to place an order, please visit www.newyorkbuyersclub.org, or call 1-800-650-4983. (You can also order the components of the MAC-Pack or Opti-MAC Pack individually.)
REFERENCE:
* Micronutrient Supplementation Increases CD4 Count in HIV-infected Individuals on Highly Active Antiretroviral Therapy: A Prospective, Double-Blinded, Placebo-Controlled Trial. Kaiser JK, Campa AM, Ondercin JP, et al. JAIDS 2006;42[5]: 523-528.
10.28.09
The Probiotic Saccharomyces boulardii
This 2007 article reviewed several well-designed clinical studies of Saccharomyces boulardii and found good evidence for this non-pathogenic yeast’s ability to prevent and treat several forms of diarrhea. Antibiotic-associated diarrhea, recurrent Clostridium difficile (C.difficile) infection, “traveler’s diarrhea,” and inflammatory bowel disease were the conditions investigated in these studies.
Review article: yeast as probiotics — Saccharomyces boulardii.
Czerucka D, Piche T, Rampal P.
ABSTRACT
BACKGROUND: Probiotics are defined as live micro-organisms which confer a health benefit on the host. Although most probiotics are bacteria, one strain of yeast, Saccharomyces boulardii, has been found to be an effective probiotic in double-blind clinical studies. AIMS: To compare the main properties that differentiate yeast from bacteria and to review the properties of S. boulardii explaining its potential benefits as a probiotic. METHODS: The PubMed and Medline databases were searched using the keywords ‘probiotics’, ‘yeast’, ‘antibiotic associated diarrhea’, ‘Saccharomyces boulardii’,'bacterial diarrhea’ and ‘inflammatory bowel disease’ in various combinations. RESULTS: Several clinical studies have been conducted with S. boulardii in the treatment and prevention of various forms of diarrhoea. Promising research perspectives have been opened in terms of maintenance treatment of inflammatory bowel diseases. The mechanism of S. boulardii’s action has been partially elucidated. CONCLUSION: Saccharomyces boulardii is a strain of yeast which has been extensively studied for its probiotic effects. The clinical activity of S. boulardii is especially relevant to antibiotic-associated diarrhoea and recurrent Clostridium difficile intestinal infections. Experimental studies clearly demonstrate that S. boulardii has specific probiotic properties, and recent data has opened the door for new therapeutic uses of this yeast as an ‘immunobiotic’.
Reference: Aliment Pharmacol Ther. 2007 Sep 15;26(6):767-78.
See also the NYBC entry:
10.22.09
Recommendations from the Vitamin D Council
The Vitamin D Council is a California non-profit that promotes education about the health benefits of Vitamin D, and advocates for wider use of supplementation, at a much higher dose than the current RDA, to ward off a variety of diseases, including several types of cancer, diabetes, and cardiovascular disease.
Here are some highlights from the Council’s home page, as accessed by us 10/22/2009:
Current research has implicated vitamin D deficiency as a major factor in the pathology of at least 17 varieties of cancer as well as heart disease, stroke, hypertension, autoimmune diseases, diabetes, depression, chronic pain, osteoarthritis, osteoporosis, muscle weakness, muscle wasting, birth defects, periodontal disease, and more.
Vitamin D’s influence on key biological functions vital to one’s health and well-being mandates that vitamin D no longer be ignored by the health care industry nor by individuals striving to achieve and maintain a greater state of health.
…
Sunshine and Your HealthIf well adults and adolescents regularly avoid sunlight exposure, research indicates a necessity to supplement with at least 5,000 units (IU) of vitamin D daily. To obtain this amount from milk one would need to consume 50 glasses. With a multivitamin more than 10 tablets would be necessary. Neither is advisable.
The skin produces approximately 10,000 IU vitamin D in response 20–30 minutes summer sun exposure—50 times more than the US government’s recommendation of 200 IU per day!
On this website, we also noted with interest a letter from a Wisconsin doctor/long-term care facility manager on the apparent protective value of Vitamin D during a spike in the state’s swine flu rate in June 2009. The doctor had mandated Vitamin D supplementation for the long-term care facility’s residents, whereas staff at the facility were under no such requirement. During the June swine flu peak, less than 1% of the facility residents developed swine flu, while at least 7% of the staff did–a significant variation in outcomes.
We’ll stay tuned to the Vitamin D Council’s website, which seems to us a useful clearinghouse of information on a supplement that holds a great deal of promise, if we’re to judge by the flood of positive new research results coming out in just the past few years. On the practical side, we also note that Vitamin D supplementation is inexpensive; that blood levels of the vitamin are easily monitored; and that overdose is rare (though we certainly recommend checking with your doctor if you plan to supplement at the levels advocated by the Vitamin D Council).
SEE ALSO THE NYBC ENTRY:
D3 – 2500IU (This format provides a convenient way to supplement for those wishing to follow the recommendations of the Vitamin D Council; other strengths are also available at NYBC.)
10.15.09
Milk Thistle Component: CURE FOR HEP C??
A paper out of Austria has some of us at NYBC VERY excited. Researchers looked at varying doses of a component of milk thistle known as silbinin, from 5 to 20 mg/kg/day over a period of 14 days. During the first 7 days, only the silbinin, which was injected, was administered. Subsequently, on day 8, pegylated interferon and ribavirin were given.
Most astonishingly, by the end of the 7 days, those receiving the 15 mg/kg dose saw a 2.11 log drop in their hepatitis C viral load. Those in the 20 mg/kg arm saw a whopping 3.02 log drop!! This in just 7 days? STUNNING!!
Unfortunately, adding the medication to these participants, who had already failed on IFN/riba therapy! resulted in the numbers deteriorating significantly. The silibinin treatment was very well tolerated.
Which raises a host of questions…would a higher dose work better? 25 or 30 mg/kg? What happens if the therapy is provided over a longer period?
This review wants to try it!
Ferenci P, Scherzer TM, Kerschner H, Rutter K, Beinhardt S, Hofer H, Schöniger-Hekele M, Holzmann H, Steindl-Munda P. Silibinin is a potent antiviral agent in patients with chronic hepatitis C not responding to pegylated interferon/ribavirin therapy. Gastroenterology. 2008 Nov;135(5):1561-7. Epub 2008 Aug 3.
Comment in: Gastroenterology. 2009 Jul;137(1):390-1.
Internal Medicine 3, Department of Gastroenterology and Hepatology, Medical University of Vienna, Vienna, Austria. peter.ferenci@meduniwien.ac.at
BACKGROUND & AIMS: Oral Silibinin (SIL) is widely used for treatment of hepatitis C, but its efficacy is unclear. Substantially higher doses can be administered intravenously (IV). METHODS: Pedigreed nonresponders to full-dose pegylated (Peg)-interferon/ribavirin (PegIFN/RBV) were studied. First, 16 patients received 10 mg/kg/day SIL IV (Legalon Sil; Madaus, Köln, Germany) for 7 days. In a subsequent dose-finding study, 20 patients received 5, 10, 15, or 20 mg/kg/day SIL for 14 days. In both protocols, PegIFN alpha-2a/RBV were started on day 8. Viral load was determined daily. RESULTS: Unexpectedly, in the first study, HCV-RNA declined on IV SIL by 1.32 +/- 0.55 log (mean +/- SD), P < .001 but increased again in spite of PegIFN/RBV after the infusion period. The viral load decrease was dose dependent (log drop after 7 days SIL: 0.55 +/- 0.5 [5 mg/kg, n = 3], 1.41 +/- 0.59 [10 mg/kg, n = 19], 2.11 +/- 1.34 [15 mg/kg, n = 5], and 3.02 +/- 1.01 [20 mg/kg, n = 9]; P < .001), decreased further after 7 days combined SIL/PegIFN/RBV (1.63 +/- 0.78 [5 mg/kg, n = 3], 4.16 +/- 1.28 [10 mg/kg, n = 3], 3.69 +/- 1.29 [15 mg/kg, n = 5], and 4.85 +/- 0.89 [20 mg/kg, n = 9]; P < .001), and became undetectable in 7 patients on 15 or 20 mg/kg SIL, at week 12. Beside mild gastrointestinal symptoms, IV SIL monotherapy was well tolerated. CONCLUSIONS: IV SIL is well tolerated and shows a substantial antiviral effect against HCV in nonresponders.