Instead of Overly Restrictive Rules, Can We Please Have More Useful Research and Education on Supplements from our Federal Agencies?

The New York Buyers’ Club Co-Op’s Treatment Director advocates for more useful research on supplements from the federal government, and shares his long expertise and personal experience in managing liver health with supplements:

Instead of Overly Restrictive Rules, Can We Please Have More Useful Research and Education on Supplements from our Federal Agencies?

The Food and Drug Administration (FDA) recently released a proposed new rule, which many believe could unnecessarily restrict consumer access to supplements introduced after 1994. (Access to supplements on the market before 1994 is generally protected by the Dietary Supplements Health and Education Act, passed that year.)

Perhaps the greatest concern is the form of vitamin B6 known as pyridoxal- 5′-phosphate or P5P. (Used for example, in the MAC-Pack, NYBC’s low-cost alternative to the K-PAX multivitamin/antioxidant combination for people with HIV.) There has been a concerted effort by pharmaceutical companies over the years to turn this vitamin into a drug, thus restricting access to it, and likely raising the price.

Overall, it is unclear what benefit the proposed new FDA rule would have for supplement users—if any. Certainly we believe there is much the FDA can do for consumers, including a robust program to test supplements for identity, potency and purity and broadcast the results quickly and widely. And, turning to the major health research agency of the federal government, we would welcome the National Institutes of Health (NIH) conducting more clinical trials to assess benefits and limitations of supplements. This type of research can answer important clinical questions and truly help consumers.

I am living with hepatitis C and without health insurance, and have relied on diet, lifestyle changes and supplements—identified through years of personal research–to normalize my liver enzymes, slow disease progression and keep my viral load fairly low while I try to enroll in a clinical trial. * Why can’t our federal agencies promote more research on supplement combinations like the ones I have used and circulate useful knowledge about the results, rather than wasting resources on restricting access to widely used supplements like the form of vitamin B6 mentioned above?

George Carter

*You can find a pocket guide to my recommendations for using supplements for liver health in NYBC’s Summer 2010 Supplement Special Issue, 50+ Ways to Love Your Liver.

You can also find a library of other useful guides to using supplements to maintainn and improve your health at NYBC’s SUPPLEMENT Archive Page:

http://newyorkbuyersclub.org/supplement/index.html

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Chlorella: a green food with benefits

Chlorella, a green food supplement derived from algae, has grown in popularity in recent years due to some striking new research on its potential benefits, especially for people susceptible to insulin resistance/diabetes or hypertension (high blood pressure). It’s also been studied recently for its potential use in eliminating toxins such as mercury from the body, and for its potential as a chemopreventive agent against liver cancer.

See the NYBC entry for more details:

Chlorella

A 2011 lab study found that chlorella had the ability to significantly improve insulin sensitivity, improving the digestion of sugars. The study authors suggest that chlorella may therefore be useful as an additional therapy for people with insulin resistance or pre-diabetes.

In a 2009 report on a study involving 80 patients, researchers found that “Chlorella significantly decreased high-normal blood pressure and borderline hypertension, and is a beneficial dietary supplement for prevention of the development of hypertension.”

References:
Y. J. Chiu, et al. Improvement of Insulin Resistance by Chlorella in Fructose-rich Chow-fed Rats. Phytother Res. 2011 Feb 10. doi: 10.1002/ptr.3379.

M. Shimada et al. Anti-hypertensive effect of gamma-aminobutyric acid (GABA)-rich Chlorella on high-normal blood pressure and borderline hypertension in placebo-controlled double blind study. Clin Exp Hypertens. 2009 Jun;31(4):342-54.

See also Journal of Toxicological Sciences 2010; 35(1): 101-105 (for chlorella’s ability to eliminate mercury from the body; and J Zhejiang Univ Sci B. 2009 Jan;10(1):14-21 (for chlorella’s chemopreventive effect against liver cancer cells).

Supplements for Liver Health

NYBC has published an online guide to Liver Health, which you can access at

SUPPLEMENT No. 17 Summer 2010

Liver Health

And, yes! You’ll find liver healthy supplements like silymarin, alpha lipoic acid and Chinese herbal formulas, all described in detail with usage recommendations in a special section of the NYBC catalog pages:

http://nybcsecure.org/index.php?cPath=57

Which silymarin/milk thistle?

NYBC has expanded its offerings of the key liver supportive supplement MilkThistle (Silymarin). The Jarrow product, which has good quality control, continues as the standard silymarin offering:

http://nybcsecure.org/product_info.php?cPath=57&products_id=92

We are also stocking Milk Thistle/Silybin Advanced, which is designed for enhanced absorption:

http://nybcsecure.org/product_info.php?cPath=57&products_id=392

And we are stocking the Milk Thistle/Thisilyn Pro product from MMS, which, while more expensive than the others, is produced according to the proverbially exacting standards of the German pharmaceutical industry. Milk thistle being one of the classic items in the German herbal pharmacopoeia, we feel assured that there is extra careful quality control behind this item:

http://nybcsecure.org/product_info.php?cPath=57&products_id=408

As background, we provide NYBC’s capsule summary of how to use silymarin/milk thistle, what cautions should be observed, and what other supplements might be useful along with it:

A potent liver-strengthening herb, it stimulates the liver to regenerate itself by producing new liver cells as well as having strong antioxidant action to help prevent lipid-peroxidation of cell membranes. Given to seven patients receiving tuberculosis drugs (INH and ethambutol), a standardized silymarin extract normalized elevated liver enzymes after three months treatment. Many people with hepatitis C use milk thistle. It is extremely safe. Some studies suggest it may help to reverse the scarring known as fibrosis. Chilean researchers have discovered that silymarin increases glutathione in the liver, stomach and intestines by over 50% although it was not shown to increase GSH levels in other organs. Milk thistle may interact with cytochrome P450–specifically the 3A4 enzyme. This is important since it is used by many AIDS drugs. A study by Piscitelli, et al., happily, found no effect on the plasma level of indinavir (Crixivan). Now we needa study evaluating the potential benefit against the liver toxicities of drugs like nevirapine and ritonavir (Norvir). Anecdotal reports suggest that it may delay CD4 increases with ARV. See also entries on Dandelion Root as well as Hepato-C, Hepato-Detox and Ecliptex (Chinese Herbal Formulae).

Bioperine for nutrient absorption

Bioperine, an extract of the fruit of the plant that yields black pepper, has connections to the Ayurvedic medicine tradition of India. It is frequently recommended for its ability to increase absorption of difficult-to-absorb nutrients like CoQ10, and may enhance absorption of other supplements as well. Here is a brief account of the whys and hows of its use:

Bioperine (Allergy Research Group). Each bottle, 60 vegetarian capsules. Each tablet, 25 mg black pepper fruit extract (bioperine). Suggested use it to take 1 tablet, with a multi, coQ10, etc., once or twice per day (not more than that). If possible, about an hour or so before you eat to enhance absorption.

Bioperine is the brand name for an extract from the fruit of the plant that produces black pepper (Piper nigrum). It is known generically as piperine. According to research conducted by the manufacturer, bioperine substantially increases the absorption of selenium (30%), beta carotene (60%), vitamin B6 (140-250%) as well as coenzyme Q10. These studies measure the amount found in plasma of these nutrients, comparing the amount found with or without the use of Bioperine.

One theoretical concern is that using this may increase blood levels of some drugs as well. On the good side, could this be a replacement for help reduce the dose of a ritonavir boost for example?

Sabinsa (the supplier) researchers claim it has no effect on the absorption of drugs, stating that research in India found that, Bioperine taken for enhancing nutrient absorption does not significantly affect the level of prescription drugs. Why this would be so is not clear. They also indicate that it is important that the bioperine be taken at the same time as the nutrient supplements, emphasizing that with bioperine, TIMING IS EVERYTHING.

What its mechanism of action is is not clear to us (except they call it a thermonutrient). However, it is an inexpensive addition and may permit lowering dosages of various nutrients. This also conforms with the traditional use of black pepper in many different Ayurvedic recipes. In a study in India, it was shown to be protective of the liver through antioxidant activity but not as powerful as silymarin. It may be best to err on the side of safety and NOT use this with pharmaceutical drugs; however, by contrast, it may help with protease inhibitors which do not get into the plasma well.

For further information, please see the NYBC entry:

Bioperine

Chinese licorice root (glycyrrhizin extract)

This is a formulation of Chinese licorice root (also known as glycyrrhizin extract). It’s widely used in Japan and it has been the subject of clinical studies there–read some details below. Please note that this supplement should not be used if you have high blood pressure or a heart condition.

See also the NYBC entry at GL-2

GL-2 Capsules (Zhang) Each bottle, 60 capsules, each capsule, 500 mg of a proprietary blend of Chinese licorice root (gan-cao) and Paeonia lactiflora PALL. root (chi-shao).

Suggested use is to take 1 capsule twice per day.

Glycyrrhizin is an extract of licorice and has been used extensively in Japan for years. It is used there to treat ulcers and other inflammatory disorders and is a therapy with a variety of effects. Several clinical studies in HIV+ people with hemophilia and others have been conducted indicating clinical stabilization of disease in recipients over 7 or more years of use. While T-cells don’t increase, progression to AIDS is significantly slowed for some. Glycyrrhizin is also an excellent liver tonic and is used to treat not only viral hepatitis but other liver disorders. It also seems to help those with impaired kidney function (particularly the IV formulation). It operates directly against lipid-enveloped viruses (likes herpes viruses) as well as several other pathogens such as TB, staph infections, MAI and others. It affects different pathways of cellular function (different mechanisms of action), including anenzyme called protein kinase C (PKC) which HIV uses for its growth. (PKC is affected by vitamin E as well). In its HIV fighting capacity, there is evidence to show that it inhibits chronically HIV-infected cells (like macrophages), stops clumping of cells (syncytia formation) and interferes with cell-to-cell and virus-to-cell binding. It acts as an antioxidant, reducing damaging inflammatory chemicals like prostaglandin E2 (PGE2), leukotriene C, excess cortisol and other reactive oxygen species. In terms of cytokines, it helps reduce pathologically-elevated levels of TNF and acid-labile interferon while encouraging IL-2 and interferon-gamma production, as well as MHC-I expression.

WARNINGS: Please remember that persons with a history of high blood pressure or a heart condition should not take licorice extracts. It is also important while using these extracts to monitor your potassium level as well as blood pressure. Eat bananas, peaches, dates, raisins, apricots. Potatoes also have a lot of potassium. Please let your health care provider know if you are using these products.

Licorice products can be effective in controlling the dry, hacking coughs due to colds and generating the “productive” cough that helps promote the healing process.

Licorice products have been known to deplete Potassium, an essential mineral, from the human body. A diet containing fruits and vegetables should be eaten when taking this supplement.

Warning: Do not take if you have or suspect you have high blood pressure. Do not use if you have a heart condition.