Supplement Quality

This information will forever change your views about nutritional supplements – read the following carefully!

With the exception of a few supplement companies, DaVinci Labs like Anabolic Laboratories (the company recommended by deflame.com), we as consumers have absolutely no idea if our nutritional supplement pills contain what is written on the label, and here is why:

•There are no laws and regulations for manufacturing supplements…it is an unregulated industry at present.
 

•Did you know that most companies selling supplements are marketing companies? In other words, the supplement stores/shops do not make supplements; they only sell them.

Look on your supplements labels: you will likely read: “distributed by” or “manufactured for” the company that sells the supplements to the public.

This means that most companies selling supplements to us have no idea if the product contains the nutrients listed on the label, because in most cases the “selling” company has nothing to do with supplement manufacturing.

•Drug manufacturing is very different. In the United States, there are about 100 companies that are licensed to manufacture pharmaceuticals. The FDA visits these facilities on a regular basis to insure that manufacturing procedures are proper. Failure to comply with regulations means closure of the company and potential criminal prosecution. Supplement manufacturing is very different from pharmaceutical manufacturing.
 

•There are approximately 1000 manufacturers of supplements currently in the United States, and unlike drug manufacturers, they are NOT required by law to adhere to consistent manufacturing standards, and NO agency inspects nutrition supplement manufacturers.

• As of January 1, 2004, supplement manufacturers are only required to register with the FDA as a Food Manufacturing Facility. This is a new requirement, which went into effect as part of the BioTerrorism Act. Consider what this means in terms of the supplements you may be taking.
 

• Approximately 1000 of the companies that manufacture supplements have never been visited or inspected by any outside agency to insure appropriate manufacturing.

- This means that no one has any idea what these companies are doing in terms of manufacturing and quality control; we must rely solely on company literature…and which company will admit to less than adequate manufacturing practices? None. All will claim great prowess.

1. •Approximately 50 supplement manufacturers are GMP-certified (Good Manufacturing Practices) by the Natural Products Association (NPA). The NPA is a 70 year-old organization and about 15 years ago it created a GMP certification program for nutritional supplement manufacturers.
   
   Only 50 of the more than 1000 manufacturers have endeavored to get GMP-certified by the NPA, and several of them are suppliers of raw materials to the GMP manufacturers.
   
   You can visit the NPA website to see if your supplement company has met the minimal standards set forth by the npa. Here is a list of GMP certified companies updated Feb. 2013http://www.npainfo.org/NPA/EducationCertification/GMPCertifiedCompanies.aspx
   

2. •
   

3. • Here is a Link! Go to the bottom of the consumers page for the link to a updated list.  http://www.npainfo.org/NPA/Consumers/NPA/For_Consumers.aspx?consumers=1
   
   

4. •The NPA-GMP companies are listed in alphabetical order. Notice that FoodScience Corporation
   Essex Junction, VT  the parent company for DaVinci Labs. is on the list. 
   

This is why I only buy from manufactures, that are NPA  members, they agree to outside product testing. 

Natural Products Association.  They can prove what is on the label is in the product. GMP Certified Companies

Updated March 2014

Aloha Medicinals
Carson City, CA

Anabolic Labs
Colorado Springs, CO

Archon Vitamin Corporation
Irvington, NJ

Bactolac Pharmaceutical, Inc.
Hauppauge, NY

Baxco Pharmaceuticals Inc
Walnut, CA

Beenefits, Inc.
Miami, FL

Best Formulations
City of Industry, CA

BF Suma Pharmaceuticals
San Gabriel, CA

Biholon Inc.
Toyama City, Toyama Pref., Japan

CC Pollen Company
Phoenix, AZ

Command Nutritionals LLC
Fairfield, NJ

Cyanotech Corporation
Kailua-Kona, HI

Earthrise Nutritionals

Calipatria, CA

Flora, Inc.
Lynden, WA

FoodScience Corporation
Essex Junction, VT

Highland Laboratories, Inc.

Mt. Angel, OR

K-Max Health Products Corp
Pomona, CA

Metagenics, Inc.
San Clemente, CA

National Vitamin Company
Casa Grande, AZ

Natrol, Inc.
Chatsworth, CA

Nature's Products
Sunrise, FL

Nexgen Pharma
Colorado Springs, CO

NHK Laboratories
Santa Fe Springs, CA

NOW Foods
Bloomingdale, IL

NuScience Corporation

Lancaster, CA

NutraMed Inc.
Chino, CA

Organic By Nature Inc.
Long Beach, CA

Pacific Nutritionals Inc.
Vancouver, WA

Paragon Laboratories
Torrance, CA

ProStar Manufacturing, Inc.

Farmington, CT

Reliance Vitamin Company Inc.
Somerset, NJ

Robinson Pharma
Santa Ana, CA

Shandong Yibao Biologics Co.,Ltd.
Yanzhou, China

Shandong Zhongyuan Greentech Co., Ltd.
Bejing, China

SIRIO Pharma Co., Ltd.
Shantou, China

Soft Gel Technology/Optipure
Los Angeles, CA

Solgar, Inc.
Bohemia, NY

STPCA dba Sun Ten Laboratories

Irvine, CA

Tishcon Corporation
Westbury, NY

Trace Minerals Research
Ogden, UT

Triarco Industries, LLC, an Innophos Company
Wayne, NJ

Ultimate Nutrition, Inc.

Farmington, CT

Vesta Pharmaceuticals, Inc.
Indianapolis, IN

VitaCeutical Labs
Colorado Springs, CO

Vitamer Labs
Colorado Springs, CO

VitaTech Nutritional Sciences, Inc.
Tustin, CA

Wellington Foods, Inc.
Long Beach, CA

WTSmed, Inc
Montpelier, VT

ZyCal Bioceuticals, Inc.
Toms River, NJ

This is current article about the problem of Non-NPA unregulated manufacturers!!

NEW YORK TIMES

ALTERNATIVE MEDICINE  FEB 3 12:00 AM

New York Attorney General Targets Supplements at Major Retailers

Three out of six herbal products at Target,Walmart, Walgreens— ginkgo biloba, St. John’s wort and valerian root, a sleep aid — tested negative for the herbs on their labels. But they did contain powdered rice, beans, peas and wild carrots. And at GNC, the agency said, it found pills with unlisted ingredients used as fillers, like powdered legumes, the class of plants that includes peanuts and soybeans, a hazard for people with allergies.

The article referred to research at the University of Guelph in Canada that found that as many as a third of herbal supplements tested did not contain the plants listed on their labels — only cheap fillers instead.

http://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html?ref=health

Herbal Supplements Are Often Not What They Seem

Americans spend an estimated $5 billion a year on unproven herbal supplements that promise everything from fighting off colds to curbing hot flashes and boosting memory. But now there is a new reason for supplement buyers to beware: DNA tests show that many pills labeled as healing herbs are little more than powdered rice and weeds.

Using a test called DNA barcoding, a kind of genetic fingerprinting that has also been used to help uncover labeling fraud in the commercial seafood industry, Canadian researchers tested 44 bottles of popular supplements sold by 12 companies. They found that many were not what they claimed to be, and that pills labeled as popular herbs were often diluted — or replaced entirely — by cheap fillers like soybean, wheat and rice.

Consumer advocates and scientists say the research provides more evidence that the herbal supplement industry is riddled with questionable practices. Industry representatives argue that any problems are not widespread.

For the study, the researchers selected popular medicinal herbs, and then randomly bought different brands of those products from stores and outlets in Canada and the United States. To avoid singling out any company, they did not disclose any product names.

Among their findings were bottles of echinacea supplements, used by millions of Americans to prevent and treat colds, that contained ground up bitter weed, Parthenium hysterophorus, an invasive plant found in India and Australia that has been linked to rashes, nausea and flatulence.

Two bottles labeled as St. John’s wort, which studies have shown may treat mild depression, contained none of the medicinal herb. Instead, the pills in one bottle were made of nothing but rice, and another bottle contained only Alexandrian senna, an Egyptian yellow shrub that is a powerful laxative. Gingko biloba supplements, promoted as memory enhancers, were mixed with fillers and black walnut, a potentially deadly hazard for people with nut allergies.

Of 44 herbal supplements tested, one-third showed outright substitution, meaning there was no trace of the plant advertised on the bottle — only another plant in its place.

Many were adulterated with ingredients not listed on the label, like rice, soybean and wheat, which are used as fillers.

In some cases, these fillers were the only plant detected in the bottle — a health concern for people with allergies or those seeking gluten-free products, said the study’s lead author, Steven G. Newmaster, a biology professor and botanical director of the Biodiversity Institute of Ontario at the University of Guelph.

The findings, published in the journal BMC Medicine, follow a number of smaller studies conducted in recent years that have suggested a sizable percentage of herbal products are not what they purport to be. But because the latest findings are backed by DNA testing, they offer perhaps the most credible evidence to date of adulteration, contamination and mislabeling in the medicinal supplement industry, a rapidly growing area of alternative medicine that includes an estimated 29,000 herbal products and substances sold throughout North America.

“This suggests that the problems are widespread and that quality control for many companies, whether through ignorance, incompetence or dishonesty, is unacceptable,” said David Schardt, a senior nutritionist at the Center for Science in the Public Interest, an advocacy group. “Given these results, it’s hard to recommend any herbal supplements to consumers.”

Representatives of the supplement industry said that while mislabeling of supplements was a legitimate concern, they did not believe it reached the extent suggested by the new research.

Stefan Gafner, the chief science officer at the American Botanical Council, a nonprofit group that promotes the use of herbal supplements, said the study was flawed, in part because the bar-coding technology it used could not always identify herbs that have been purified and highly processed.

“Over all, I would agree that quality control is an issue in the herbal industry,” Dr. Gafner said. “But I think that what’s represented here is overblown. I don’t think it’s as bad as it looks according to this study.”

The Food and Drug Administration has used bar-coding technology to warn and in some cases prosecute sellers of seafood found to be “misbranded.” The DNA technique has also been used in studies of herbal teas, which showed that a significant percentage contain herbs and ingredients that are not listed on their labels.

But policing the supplement industry is a special challenge. The F.D.A. requires that companies test the products they sell to make sure that they are safe. But the system essentially operates on the honor code. Unlike prescription drugs, supplements are generally considered safe until proved otherwise.

Under a 1994 federal law, they can be sold and marketed with little regulatory oversight, and they are pulled from shelves generally only after complaints of serious injury. The F.D.A. audits a small number of companies, but even industry representatives say more oversight is needed.

“The regulations are very appropriate and rigorous,” said Duffy MacKay of the Council for Responsible Nutrition, a supplement industry trade group. “But we need a strong regulator enforcing the full force of the law. F.D.A. resources are limited, and therefore enforcement has not historically been as rigorous as it could be.”

An F.D.A. spokeswoman did not respond to a request for comment.

DNA bar coding was developed about a decade ago at the University of Guelph. Instead of sequencing entire genomes, scientists realized that they could examine genes from a standardized region of every genome to identify species of plants and animals. These short sequences can be quickly analyzed — much like the bar codes on the items at a supermarket — and compared with others in an electronic database. An electronic reference library at Guelph called the International Barcode of Life Project, contains over 2.6 million bar code records for almost 200,000 species of plants and animals.

The testing technique is not foolproof. It can identify the substances in a supplement, but it cannot determine their potency. And because the technology relies on the detection of DNA, it may not be able to identify concentrated chemical extracts that do not contain genetic material, or products in which the material has been destroyed by heat and processing.

But Dr. Newmaster emphasized that only powders and pills were used in the new research, not extracts. In addition, the DNA testing nearly always detected some plant material in the samples —just not always the plant or herb named on the label.

Some of the adulteration problems may be inadvertent. Cross-contamination can occur in fields where different plants are grown side by side and picked at the same time, or in factories where the herbs are packaged. Dr. Gafner of the American Botanical Council said that rice, starch and other compounds were sometimes added during processing to keep powdered herbs from clumping, just as kernels of rice are added to salt shakers.

But that does not explain many of the DNA results. For instance, the study found that one product advertised as black cohosh — a North American plant and popular remedy for hot flashes and other menopause symptoms — actually contained a related Asian plant, Actaea asiatica, that can be toxic to humans.

Those findings mirror a similar study of black cohosh supplements conducted at Stony Brook University medical center last year. Dr. David A. Baker, a professor of obstetrics, gynecology and reproductive medicine, bought 36 black cohosh supplements from online and chain stores. Bar coding tests showed that a quarter of them were not black cohosh, but instead contained an ornamental plant from China.

Dr. Baker called the state of supplement regulation “the Wild West,” and said most consumers had no idea how few safeguards were in place. “If you had a child who was sick and 3 out of 10 penicillin pills were fake, everybody would be up in arms,” Dr. Baker said. “But it’s O.K. to buy a supplement where 3 out of 10 pills are fake. I don’t understand it. Why does this industry get away with that?”

Here is a Link to a great article about the discussion on taking a daily Multiple Vitamin.

ihttp://www.anaboliclabs.com/company_main/PDFS/2Q%202006%20Quarterly%20Article.pdf

DaVinci  Labs  can prove their purity on request.  Here is a recent Assay of their popular Multiple Vitamin -Mineral formula  OMNI product.

A Quick Vitamin Guide cut and pasted from Wikipedia

The structure of retinol, the most common dietary form of vitamin A

Vitamin A is an essential human nutrient. Its important part is the retinyl group, which can be found not in a single compound, but in several forms. In foods of animal origin, the major form of vitamin A is an alcohol (retinol), but can also exist as an aldehyde (retinal), or as an acid (retinoic acid). Precursors to the vitamin (provitamins) are present in foods of plant origin as some of the members of the carotenoid family of compounds.[1

Vitamin C or L-ascorbate is an essential nutrient for a large number of higher primate species.In living organisms, ascorbate is an antioxidant, since it protects the body against oxidative stress,[5] and is a cofactor in several vital enzymatic reactions.[6]

The uses and the daily requirement amounts of vitamin C are matters of on-going debate.The human body can store only a certain amount of vitamin C,[31] and so the body soon depletes itself if fresh supplies are not consumed.

Smoking cigarettes has a negative correlation to the amount of vitamin C in the blood stream. The relative amounts of vitamin C drop with the increased amount of cigarettes smoked. [32]

The North American Dietary Reference Intake recommends 90 milligrams per day and no more than 2 grams per day (2000 milligrams per day).[40]High doses (thousands of milligrams) may result in diarrhea in healthy adults. Proponents of alternative medicine (specifically orthomolecular medicine)[44] claim the onset of diarrhea to be an indication of where the body’s true vitamin C requirement lies, though this has yet to be clinically verified.

Stone[58] and Pauling[42] calculated, based on the diet of our primate cousins[41] (similar to what our common descendants are likely to have consumed when the gene mutated), that the optimum daily requirement of vitamin C is around 2,300 milligrams for a human requiring 2,500 kcal a day.

The established RDA has been criticized by Pauling to be one that will prevent acute scurvy, and is not necessarily the dosage for optimal health.[50]

Vitamin D is a group of fat-soluble prohormones, the two major forms of which are vitamin D2 (or ergocalciferol) and vitamin D3 (or cholecalciferol).[1] The term vitamin D also refers to metabolites and other analogues of these substances. Vitamin D3 is produced in skin exposed to sunlight, specifically ultraviolet B radiation.

Vitamin D plays an important role in the maintenance of organ systems.[2]

▪Vitamin D regulates the calcium and phosphorus levels in the blood by promoting their absorption from food in the intestines, and by promoting re-absorption of calcium in the kidneys.

▪It promotes bone formation and mineralization and is essential in the development of an intact and strong skeleton. However, at very high levels it will promote the resorption of bone.

▪It inhibits parathyroid hormone secretion from the parathyroid gland.

▪Vitamin D affects the immune system by promoting phagocytosis, anti-tumor activity, and immunomodulatory functions.Vitamin D deficiency can result from inadequate intake coupled with inadequate sunlight exposure, disorders that limit its absorption, conditions that impair conversion of vitamin D into active metabolites, such as liver or kidney disorders, or, rarely, by a number of hereditary disorders.[2] Deficiency results in impaired bone mineralization, and leads to bone softening diseases, rickets in children and osteomalacia in adults, and possibly contributes to osteoporosis. Research has indicated that vitamin D deficiency is linked to colon cancer; conflicting evidence links vitamin D deficiency to other forms of cancer.

A critical determinant of vitamin D3 production in the skin is the presence and concentration of melanin. Melanin functions as a light filter in the skin, and therefore the concentration of melanin in the skin is related to the ability of UVB light to penetrate the epidermal strata and reach the 7-dehydrocholesterol-containing stratum basale and stratum spinosum.

The Vitamin D receptor belongs to the nuclear receptor superfamily of steroid/thyroid hormone receptors, and VDR are expressed by cells in most organs, including the brain, heart, skin, gonads, prostate, and breast. VDR activation in the intestine, bone, kidney, and parathyroid gland cells leads to the maintenance of calcium and phosphorus levels in the blood (with the assistance of parathyroid hormone and calcitonin) and to the maintenance of bone content.[12]

The VDR is known to be involved in cell proliferation, differentiation. Vitamin D also affects the immune system, and VDR are expressed in several white blood cells including monocytes and activated T and B cells.[9]

The U.S. Dietary Reference Intake for adequate intake (AI) of vitamin D for infants, children and men and women aged 19–50 is 5 micrograms/day (200 IU/day).[13] Adequate intake increases to 10 micrograms/day (400 IU/day) for men and women aged 51–70 and up to 15 micrograms/day (600 IU/day) past the age of 70. These dose rates will be too low during winter months above 30° latitude. In the absence of sun exposure, 1000 IU of cholecalciferol is required daily for children. 2000-4000 IU of vitamin D may be required for adults absent summer UVB. [1]

Vitamin D deficiency is known to cause several bone diseases[18] including:

▪Rickets, a childhood disease characterized by impeded growth, and deformity, of the long bones.

▪Osteomalacia, a bone-thinning disorder that occurs exclusively in adults and is characterized by proximal muscle weakness and bone fragility.

▪Osteoporosis, a condition characterized by reduced bone mineral density and increased bone fragility.

The use of sunscreen with a sun protection factor (SPF) of 8 inhibits more than 95% of vitamin D production in the skin.[12][27] Recent studies showed that, following the successful "Slip-Slop-Slap" health campaign encouraging Australians to cover up when exposed to sunlight to prevent skin cancer, an increased number of Australians and New Zealanders became vitamin D deficient.[15] Ironically, there are indications that vitamin D deficiency may lead to skin cancer.[28] To avoid vitamin D deficiency dermatologists recommend supplementation along with sunscreen use.

A 2006 study published in the Journal of the American Medical Association, reported evidence of a link between Vitamin D deficiency and the onset of Multiple Sclerosis; the authors posit that this is due to the immune-response suppression properties of Vitamin D.[55]

A search of primary and review medical literature published between 1970 and 2007 found an increasing body of research supporting the hypothesis that the active form of vitamin D has significant, protective effects against the development of cancer.

Drawing from a meta-analysis of 63 published reports, the authors showed that intake of an additional 1,000 international units (IU) (or 25 micrograms) of vitamin D daily reduced an individual's colon cancer risk by 50%, and breast and ovarian cancer risks by 30%.[57] Research has also shown a beneficial effect of high levels of calcitriol on patients with advanced prostate cancer.[58] A randomized intervention study involving 1,200 women, published in June 2007, reports that vitamin D supplementation (1,100 international units (IU)/day) resulted in a 60% reduction in cancer incidence, during a four-year clinical trial, rising to a 77% reduction for cancers diagnosed after the first year (and therefore excluding those cancers more likely to have originated prior to the vitamin D intervention).[59][60] In 2006, a study at Northwestern University found that taking the U.S. RDA of vitamin D (400 IU per day) cut the risk of pancreatic cancer by 43% in a sample of more than 120,000 people from two long-term health surveys.[61][62]

Research indicates that vitamin D may play a role in preventing or reversing coronary disease.The issue of vitamin D in heart health may not yet be finally settled. Exercise may account for some of the benefit attributed to vitamin D, since Vitamin D levels are higher in physically active persons.[70] Moreover, there may be an upper limit after which cardiac benefits decline.

Researchers at the Harvard Medical School in Boston reported in Circulation, the Journal of the American Heart Association, January 2008 that Vitamin D deficiency is associated with an increase in high blood pressure and cardiovascular risk.They found that those people with low levels of Vitamin D had a 62% higher risk of a cardiovascular event than those with normal Vitamin D levels.[78]

Vitamin E

Tocopherol, a class of chemical compounds of which many have vitamin E activity, describes a series of organic compounds consisting of various methylated phenols. Because the vitamin activity was first identified in 1936 from a dietary fertility factor in rats, it was given the name "tocopherol"

Ideally, vitamin E should be consumed in the broader family of mixed natural tocopherols and tocotrienols, (also referred to as full-spectrum vitamin E) to get the maximum benefits.

And there’s the main problem: the vitamin E most often referred to and sold in most stores is a synthetic form of the vitamin, which really should NOT be used if you want to reap any of its health benefits.

You can tell what you’re buying by carefully reading the label.

•Natural vitamin E is always listed as the “d-“ form (d-alpha-tocopherol, d-beta-tocopherol, etc.)

•Synthetic vitamin E is listed as “dl-“ forms

When vitamin E is stabilized by adding either succinic acid or acetic acid, the chemical name changes from tocopherol to tocopheryl (as in d-alpha-tocopheryl succinate, for example).

Your body can easily distinguish between natural and synthetic vitamins, and several studies have shown that natural vitamin E is between two and three times as bioactive as the same amount of synthetic vitamin E.

However, they do caution individuals who consume low fat diets because vegetable oils are such a good dietary source of vitamin E. "Low-fat diets can substantially decrease vitamin E intakes if food choices are not carefully made to enhance alpha-tocopherol intakes". Vitamin E supplements are absorbed best when taken with meals.[7]

Because vitamin E can act as an anticoagulant and may increase the risk of bleeding problems, many agencies have set an upper tolerable intake level (UL) for vitamin E at 1,000 mg (1,500 IU) per day.[8]

Some evidence associates higher intake of vitamin E with a decreased incidence of prostate cancer (see ATBC study) and breast cancer. Some studies correlate additional cofactors, such as specific vitamin E isomers, e.g. gamma-tocopherol, and other nutrients, e.g. selenium, with dramatic risk reductions in prostate cancer.[34] However, an examination of the effect of dietary factors, including vitamin E, on incidence of postmenopausal breast cancer in over 18,000 women from New York State did not associate a greater vitamin E intake with a reduced risk of developing breast cancer. A study of the effect on lung cancer in smokers also showed no benefit.[35]

Benifit has been found with Glaucoma, Alzheimer’s, and Parkinsons’s Disease.

The B vitamins are eight water-soluble vitamins that play important roles in cell metabolism. Historically, the B vitamins were once thought to be a single vitamin, referred to as vitamin B (much like how people refer to vitamin C or vitamin D). Later research showed that they are chemically distinct vitamins that often coexist in the same foods. Supplements containing all eight are generally referred to as a vitamin B complex. Individual B vitamin supplements are referred to by the specific name of each vitamin.

▪Vitamin B1 (thiamine)Deficiency causes beriberi. Symptoms of this disease of the nervous system include weight loss, emotional disturbances, Wernicke's encephalopathy (impaired sensory perception), weakness and pain in the limbs, periods of irregular heartbeat, and edema (swelling of bodily tissues). Heart failure and death may occur in advanced cases. Chronic thiamine deficiency can also cause Korsakoff's syndrome, an irreversible psychosis characterized by amnesia and confabulation

▪Vitamin B2 (riboflavin)Deficiency causes ariboflavinosis. Symptoms may include cheilosis (cracks in the lips), high sensitivity to sunlight, angular cheilitis, glossitis (inflammation of the tongue), seborrheic dermatitis or pseudo-syphilis (particularly affecting the scrotum or labia majora and the mouth), pharyngitis, hyperemia, and edema of the pharyngeal and oral mucosa.

▪Vitamin B3,(niacin, includes nicotinic acid and nicotinamide)Deficiency, along with a deficiency of tryptophan causes pellagra. Symptoms include aggression, dermatitis, insomnia, weakness, mental confusion, and diarrhea. In advanced cases, pellagra may lead to dementia and death.

▪Vitamin B5 (pantothenic acid)Deficiency can result in acne and paresthesia, although it is uncommon.

▪Vitamin B6 (pyridoxine)Deficiency may lead to anemia, depression, dermatitis, high blood pressure (hypertension), water retention, and elevated levels of homocysteine.

▪Vitamin B7, also called vitamin H (biotin)Deficiency does not typically cause symptoms in adults but may lead to impaired growth and neurological disorders in infants.

▪Vitamin B9, also vitamin M and vitamin B-c (folic acid)Deficiency results in a macrocytic anemia, and elevated levels of homocysteine. Deficiency in pregnant women can lead to birth defects. Supplementation is often recommended during pregnancy. Researchers have shown that folic acid might also slow the insidious effects of age on the brain.

▪Vitamin B12 (cobalamin)Deficiency causes macrocytic anemia, elevated homocysteine, peripheral neuropathy, memory loss and other cognitive deficits. It is most likely to occur among elderly people as absorption through the gut declines with age; the autoimmune disease pernicious anemia is another common cause. In rare extreme cases, paralysis can result.

The B vitamins often work together to deliver a number of health benefits to the body. B vitamins have been shown to:

▪Support and increase the rate of metabolism

▪Maintain healthy skin and muscle tone

▪Enhance immune and nervous system function

▪Promote cell growth and division — including that of the red blood cells that help prevent anemia.

▪Reduce the risk of pancreatic cancer, one of the most lethal forms of cancer[3], when consumed in food, but not when ingested in vitamin tablet form.[4][5]

Together, they also help combat the symptoms and causes of stress, depression, and cardiovascular disease.

All B vitamins are water soluble, and are dispersed throughout the body. Most of the B vitamins must be replenished daily, since any excess is excreted in the urine.[6] A six year cobalamin store can be found in the liver, despite its water soluble nature.

One mnemonic to remember the most commonly referenced B vitamins is "The (B1, Thiamine) Rhythm (B2, Riboflavin) Nearly (B3, Niacin) Proved (B6, Pyridoxin) Contagious (B12, Cobalamin)".[10]

Calcium

Calcium is essential for living organisms, particularly in cell physiology, where movement of the calcium ion Ca2+ into and out of the cytoplasm functions as a signal for many cellular processes. As a major material used in mineralization of bones and shells, calcium is the most abundant metal by mass in many animals.

Calcium is the fifth most abundant element by mass in the human body, where it is a common cellular ionic messenger with many functions, and serves also as a structural element in bone. It is the relatively high atomic-numbered calcium in the skeleton which causes bone to be radio-opaque. Of the human body's solid components after drying (as for example, after cremation), about a third of the total mass is the approximately one kilogram of calcium which composes the average skeleton (the remainder being mostly phosphorus and oxygen).

Calcium is an important component of a healthy diet. Calcium is essential for the normal growth and maintenance of bones and teeth, and calcium requirements must be met throughout life. Long-term calcium deficiency can lead to osteoporosis, in which the bone deteriorates and there is an increased risk of fractures

Vitamin D is needed to absorb calcium. Dairy products, such as milk and cheese, are a well-known source of calcium. However, some individuals are allergic to dairy products and even more people, particularly those of non Indo-European descent, are lactose-intolerant, leaving them unable to consume non-fermented dairy products in quantities larger than about half a liter per serving.

Calcium supplements are used to prevent and to treat calcium deficiencies. Most experts recommend that supplements be taken with food and that no more than 600 mg should be taken at a time because the percent of calcium absorbed decreases as the amount of calcium in the supplement increases.[5] It is recommended to spread doses throughout the day. Recommended daily calcium intake for adults ranges from 1000 to 1500 mg. It is recommended to take supplements with food to aid in absorption.

▪The absorption of calcium from most food and commonly-used dietary supplements is very similar.[12] This is contrary to what many calcium supplement manufacturers claim in their promotional materials.

▪Milk is an excellent source of dietary calcium because it has a high concentration of calcium and the calcium in milk is excellently absorbed.[13]

Calcium carbonate is the most common and least expensive calcium supplement. It should be taken with food. The absorption of calcium from calcium carbonate is similar to the absorption of calcium from milk.[14] While most people digest calcium carbonate very well, some might develop gastrointestinal discomfort or gas. Taking magnesium with it can help to avoid constipation. Calcium carbonate is 40% elemental calcium. 1000 mg will provide 400 mg of calcium. However, supplement labels will usually indicate how much calcium is present in each serving, not how much calcium carbonate is present.

Calcium citrate can be taken without food and is the supplement of choice for individuals with achlorhydria or who are taking histamine-2 blockers or protein-pump inhibitors.[15] It is more easily digested and absorbed than calcium carbonate if taken on empty stomach and less likely to cause constipation and gas than calcium carbonate. It also has a lower risk of contributing to the formation of kidney stones. Calcium citrate is about 21% elemental calcium. 1000 mg will provide 210 mg of calcium. It is more expensive than calcium carbonate and more of it must be taken to get the same amount of calcium. Calcium is often taken with Magnesium.

A Calcium/Magnesium/D3 supplement to support bone function.* A hydrolyzed protein chelate form of Calcium and Magnesium in a 2:1 ratio, with additional Vitamin D3, this complex is efficiently assimilated by the body.*

Take 2 tablets with lunch and 2 tablets with dinner.
90 Tablets 0200220.090
180 Tablets 0200220.180

Two tablets contain:
Vitamin D3 . . . . . . . . 50 IU
Calcium . . . . . . . . . 500 mg
Magnesium . . . . . . . . 200 mg

Other ingredients: calcium amino acid chelate, magnesium amino acid chelate, microcrystalline cellulose, stearic acid, vegetable stearate, croscarmellose sodium, silicon dioxide.

Magnesium is an essential element in biological systems. Magnesium occurs typically as the Mg2+ ion. It is an essential mineral nutrient for life[1][2][3] and is present in every cell type in every organism.

The importance of magnesium to proper cellular function cannot be understated. Deficiency of the nutrient results in disease in the affected organism. In single-celled organisms such as bacteria and yeast, low levels of magnesium manifests in greatly reduced growth rates. In magnesium transport knockout strains of bacteria, healthy rates are maintained only with exposure to very high external concentrations of the ion.[13][14] In yeast, mitochondrial magnesium deficiency is also leads to disease.[15]

Magnesium deficiency in humans was first described in the medical literature in 1934. The adult human daily nutritional requirement, which is affected by various factors including gender, weight and size, is 300-400 mg/day. Inadequate magnesium intake frequently causes muscle spasms, and has been associated with cardiovascular disease, diabetes, high blood pressure, anxiety disorders, migraines and osteoporosis.

Too much magnesium may make it difficult for the body to absorb calcium. Not enough magnesium can lead to hypomagnesemia as described above, with irregular heartbeats, high blood pressure (a sign in humans but not some experimental animals such as rodents), insomnia and muscle spasms (fasciculation). However, as noted, symptoms of low magnesium from pure dietary deficiency are thought to be rarely encountered.

Following are some foods and the amount of magnesium in them:

▪spinach (1/2 cup) = 80 milligrams (mg)

▪peanut butter (2 tablespoons) = 50 mg

▪black-eyed peas (1/2 cup) = 45 mg

▪milk: low fat (1 cup) = 40 mg

The U.S. RDA/RDV is 400 mg of magnesium.

Zinc is an essential element, necessary for sustaining all life. It is estimated that 3,000 of the hundreds of thousands of proteins in the human body contain zinc prosthetic groups, one type of which is the so-called zinc finger. In addition, there are over a dozen types of cells in the human body that secrete zinc ions, and the roles of these secreted zinc signals in medicine and health are now being actively studied. Zinc ions are now considered to be neurotransmitters. Cells in the salivary gland, prostate, immune system and intestine use zinc signalling.[7]

Zinc is also involved in olfaction: the olfactory receptors contain zinc binding sites and a deficiency in zinc causes anosmia.

Zinc is an activator of certain enzymes, such as carbonic anhydrase. Carbonic anhydrase is important in the transport of carbon dioxide in vertebrate blood. It is also required in plants for leaf formation, the synthesis of indole acetic acid (auxin) and anaerobic respiration (alcoholic fermentation).

The (US) recommended dietary allowance of zinc from puberty on is 11mg for males and 8mg for females, with higher amounts recommended during pregnancy and lactation.

Selenium (pronounced /səˈliːniəm/) is a chemical element with atomic number 34, with the chemical symbol Se. It is a nonmetal, chemically related to sulfur and tellurium, and rarely occurring in its elemental state in nature. It is toxic in large amounts, but trace amounts of it are necessary for cellular function in most, if not all, animals, forming the active center of the enzymes glutathione peroxidase and thioredoxin reductase (which indirectly reduce certain oxidized molecules in animals and some plants) and three known deiodinase enzymes (which convert one thyroid hormone to another).

In 1996, continuing research showed a positive correlation between selenium supplementation and cancer prevention in humans, but widespread direct application of this important finding would not add significantly to demand owing to the small doses required.

In humans, selenium is a trace element nutrient which functions as cofactor for reduction of antioxidant enzymes such as glutathione peroxidases and certain forms of thioredoxin reductase.  Dietary selenium comes from nuts, cereals, meat, fish, and eggs. Brazil nuts are the richest ordinary dietary source (though this is soil-dependent, since the Brazil nut does not require high levels of the element for its own needs). High levels are found in meats such as kidney, crab and lobster, in that order.[7][8]

Selenium is also necessary for the conversion of the thyroid hormone thyroxine (T4) into its more active counterpart, triiodothyronine, and as such a deficiency can cause symptoms of hypothyroidism, including extreme fatigue, mental slowing, goitre, cretinism and recurrent miscarriage.[10]

Cancer

Several studies have suggested a link between cancer and selenium deficiency.[24][25][26][27][28][29][30] A study conducted on the effect of selenium supplementation on the recurrence of skin cancers did not demonstrate a reduced rate of recurrence of skin cancers, but did show a significantly reduced occurrence of total cancers.[31] Selenium normally acts as an antioxidant, so low levels of it may increase oxidative stress on the immune system leading to more rapid decline of the immune system.

Diabetes

A well-controlled study showed that selenium intake is positively correlated with the risk of developing type II diabetes. Because high serum selenium levels are positively associated with the prevalence of diabetes, and because selenium deficiency is rare, supplementation is not recommended in well-nourished populations such as the U.S.[45]

Most of the remaining nutrients in the Omni Formula have essential properties and can be looked up on Wikipedia.

Glucosamine Sulfate and Arthritis: The Scientific Evidence

Introduction

Osteoarthritis has been reported to affect 40 million Americans, with 80% of individuals over the age of fifty affected to some degree.(1) Essentially, osteoarthritis is considered to be an age-related affliction. As a contributing factor to the development of osteoarthritis, is the apparent age-related decline in glucosamine sulfate synthesis by the body, which appears to become pronounced by 45 to 50 years of age.(2) Glucosamine sulfate is normally synthesized by chondrocytes and serves as the precursor to the production of N-acetyl-glucosmine sulfate and N-acetyl-galactosamine sulfate, which are essential components of the ground substance material (glycosaminoglycans, proteoglycans or mucopolysaccharides), with the latter required for joint cartilage synthesis.(3) Thus, any reduction in glucosamine sulfate synthesis results in a decline in joint cartilage (articular cartilage) ground substance production with subsequent joint space narrowing and arthritic degeneration.(2)

In the body, glucosamine is synthesized by the conversion of fructose-6 phosphate to glucosamine-6 phosphate by the enzyme, fructose-6 phosphate amide transferase, in the hexosamine biosynthetic pathway.(3 ) In the aging process, it appears that the fructose-6 phosphate amide transferase enzyme concentrations decline or this enzyme becomes less active, resulting in the noted reduction in glucosamine synthesis seen with aging.(2) Since the early 1980’s, researchers have conducted a large number of clinical and experimental investigations to determine if oral glucosamine sulfate supplementation can compensate for the age-related decline in glucosamine synthesis and thereby, block the progression of osteoarthritis and/or reverse or repair any existing joint cartilage damage.(4,5 ) In the past twenty years glucosamine sulfate has been the subject of more than 300 scientific investigations and over 20 double-blind clinical studies.(2) In a recent review, which appeared in the journal, Rheumatology Disease Clinics Of North America, (25; 2 379-395,1999),  researchers indicated that glucosamine supplementation has been shown to be highly effective in the treatment of osteoarthritis in all 13 double-blind clinical trials reviewed by these investigators.(6)

Absorption and Metabolism of Oral Glucosamine Sulfate

Glucosamine is a small and simple molecule that is readily absorbed from the gastrointestinal tract. In fact, studies demonstrate that 90-98% of glucosamine sulfate is absorbed intact from the intestinal tract. By contrast, less than 13% of chondroitin sulfate is absorbed from the intestinal tract, making it significantly less effective than glucosamine sulfate as an intervention in the prevention and management of osteoarthritis. (7,8,9,10,11 )  Once absorbed from the gut, glucosamine circulates through the bloodstream, where it can be taken up by cartilage cells (chondrocytes) and used to synthesize N-acetyl- galactosamine sulfate in the production of cartilage ground substance (glycosaminoglycans).( 3, 12) The ground substance in joint cartilage fills in the gaps between the collagen fibers, which run parallel to each other within the cartilage.  As an analogy, the collagen fibers are like the bricks of the cartilage structure and the glycosaminoglycans are like the mortar between the bricks. Not only does glucosamine sulfate supplementation stimulate the synthesis of glycosaminoglycans, but it also stimulates the synthesis of collagen by chondrocytes.(13) As well, glucosamine sulfate is required for the synthesis of hyaluronic acid by the synovial membrane of the joint. Hyaluronic acid increases the viscosity of the synovial fluid and thus, serves to reduce the wear and tear stress on the articular cartilage and related joint structures. Thus, glucosamine may be helpful in preventing, reversing or stabilizing the osteoarthritic process by stimulating the synthesis of glycosaminoglycans, collagen and hyaluronic acid.(13,14)

 Essentially all of the research on glucosamine has employed the use of glucosamine sulfate. Only glucosamine sulfate is approved as a treatment for osteoarthritis in more than 70 countries around the world and has been used by millions of people for this purpose for more than 20 years.(2) Glucosamine sulfate also delivers the mineral sulfur (hence the name glucosamine sulfate) to the joint cartilage. It has been recognized for many years that sulfur is a vital nutrient for the maintenance of joint cartilage. Sulfur is required to stabilize the connective tissue matrix of cartilage, tendons, and ligaments. Sulfur hot springs and the recent popularity and use of MSM (methlyl sulfonyl methane) by arthritis patients have provided strong anecdotal evidence that increasing the delivery of sulfur to the joints can help to alleviate arthritic symptoms to an appreciable degree. Experimental evidence indicates that sulfur has an anti-inflammatory effect and directly helps to maintain the structure and the integrity of joint cartilage. The veterinary use of DMSO (dimethylsulfoxide), a rich source of sulfur, has demonstrated effective anti-inflammatory effects in animals when applied topically. Preliminary trials with oral MSM in humans have revealed significant improvement in the symptoms of osteoarthritis.(15,16,17,18,19) As such, the use of glucosamine sulfate provides the joint structures with the mineral sulfur as well as glucosamine and  thus, this form of glucosamine offers a double benefit in the management of osteoarthritis cases.

Other forms of glucosamine are present in the commercial market place such as N-acetyl-glucosamine and glucosamine hydrochloride. There is presently insufficient evidence to support their use and neither one of these forms provides the addition of the mineral sulfur, which has shown to be of value in osteoarthritis cases.(2)

Clinical Studies With Glucosamine Sulfate

Glucosamine sulfate has been the subject of more than 300 scientific investigations and over 20 double –blind clinical studies.(2) In a recent meta-analysis of glucosamine clinical trials in the treatment of osteoarthritis, McAlindon and colleagues indicated that all 13 studies that met the inclusion criteria (double –blind, placebo-controlled trials of greater than 4 weeks’ duration; using global pain score or the Lequesne index joint as the primary outcome measure and considered the trial positive if improvement in the treatment group was equal to or greater than 25% compared with the placebo group), were classified as positive, demonstrating that glucosamine supplementation is highly effective in the treatment of osteoarthritis. This meta-analysis revealed that glucosamine supplementation reduced the symptoms and signs of osteoarthritis by 40.2% on average, compared with the placebo.(6)

Glucosamine sulfate supplementation has also been investigated in head-to-head studies against non- steroidal anti-inflammatory drugs (NSAIDs) in the treatment of osteoarthritis. In a number of these trials glucosamine supplementation was shown to produce better results than ibuprofen and other NSAIDs in relieving the pain and inflammation of osteoarthiitis. Unlike many NSAIDs, glucosamine has not been shown to  produce any of the adverse side effects that are frequently encountered with the use of NSAIDs (gastritis, peptic ulcer, GI bleeding and erosion of the intestinal lining, liver and kidney toxicity, tinnitis). (20,21,22,23,24,)

In a recent therapeutic investigation involving 178 Chinese patients suffering from osteoarthritis of the knee, the group given a daily dose of 1500mg of glucosamine sulfate demonstrated better results than did the group given ibuprofen at 1200mg per day (NSAID) with respect to reduction in symptoms of osteoarthritis. In this study, glucosamine sulfate was shown to be better tolerated than ibuprofen. Sixteen percent of the ibuprofen group dropped out due to adverse side effects from the drug. A six percent drop out rate occurred in the glucosamine group. The authors of the study conclude that glucosamine sulfate is a selective intervention for osteoarthritis, as effective on the symptoms of the disease as NSAIDs but significantly better tolerated. As such, glucosamine sulfate seems particularly indicated in the long-term treatment needed in osteoarthritis.(25)

In North America, the medical profession has taken a skeptical view of the original research on glucosamine that has largely been performed in Europe and Asia. Acknowledging that oral glucosamine has been shown to be highly bioavailable  (26%  bioavailability after first pass through the liver to enter the bloodstream) and demonstrates impressive results in clinical trials with osteoarthritis patients, some researchers have criticized the research methodology of some of these trials, suggesting that North American trials are required before glucosamine can be recommended as a treatment for arthritis.(26) In 1999 and 2001, this request was answered when Reginster et al published their findings in the journals, Arthritis and Rheumatology (1999;42, suppl) and Lancet (2001;357) . The three-year randomized study by Dr. Reginster was a large randomized controlled analysis that was placebo-controlled, double-blind, and prospective in nature. It involved 212 patients with knee osteoarthritis. Weight-bearing and antero-posterior radiographs of each knee were done at 1 and 3 years. Joint space width was also measured.  Symptom and functional status were scored every 4 months using the Western Ontario and McMaster University Osteoarthritis index (WOMAC). The two groups had comparable baseline status, but after 3 years there was no further joint space narrowing in the glucosamine group. The placebo group had further joint space narrowing and objective evidence of disease progression. As well, subject symptoms worsened in the placebo group, but the group taking glucosamine realized a marked reduction in symptoms of osteoarthritis over the three-year period. The authors concluded that glucosamine sulfate supplementation significantly reduced progression of knee osteoarthritis. Patients in the glucosamine group did not experience any untoward side effects.(27, 28) In the Lancet editorial, medical practitioners were encouraged to begin embracing certain aspects of the alternative movement, including the use of glucosamine as an effective lifelong intervention for osteoarthritis. As stated in the article, “It is time for (medical doctors) to accommodate the possibility that many nutritional products may have valuable therapeutic effects and to regain the credibility of the public at large”.(41)

Other Clinical Uses Of Glucosamine

The clinical use of glucosamine supplementation may extend beyond the treatment of osteoarthritis. Glucosamine sulfate is also required for the synthesis of other glycosaminoglycans that are integral components of the basement membrane below the skin and intestinal tract lining and blood vessels. As reviewed by McCarty, glucosamine supplementation can be used to enhance wound healing (e.g., post-surgical), through its effects on stimulating the synthesis of hyaluronic acid. Experimental studies and human anecdotal evidence supports this application at the present time.(29) Glucosamine sulfate has also been used in a clinical trial involving 50 patients with temperomandibular disorders, stemming from internal derangement and a diagnosis of osteoarthritis. These patients experienced decreased joint noises, pain and swelling, after the administration of therapeutic doses of glucosamine and chondroitin sulfate.(30) However it should be noted that experts in this area conclude that adding chondroitin to glucosamine administration has not been shown to further improve the benefits available from glucosamine alone. Thus, at this time, the addition of chondroitin sulfate is seen to impose additional cost with no added benefit.(13)

There is also evidence to suggest that glucosamine sulfate supplementation may be beneficial as part of a nutritional regime to aid in the management of inflammatory bowel diseases. Experimental studies and human anecdotal evidence suggests that this may be the case. It is proposed that glucosamine supplementation can strengthen the basement membrane of gut blood vessels helping to prevent leakage of blood into the intestinal lumen, which may otherwise trigger an inflammatory immune reaction. Further, glucosamine has been shown to have a healing effect on the mucosal lining of the G-I tract itself. Anecdotal evidence supports the trial of glucosamine in both Crohn’s disease and ulcerative colitis.(31,38)

As a final consideration, the decline in glucosamine sulfate synthesis with age may imply that a prudent anti-aging strategy is to use a low to moderate dose of glucosamine sulfate (500mg per day) as an anti- aging strategy beginning at 45-50 years of age. This intervention may help to prevent or minimize the development of osteoarthritis changes to our joints, helping to preserve quality of life to a significant degree. This practice may also serve to reduce the chances of capillary fragility that is associated with risk of stroke and vein disorders that are also seen with increasing frequency with advancing age. Optimizing the heparan sulfate (a glycosaminoglycan made from glucosamine sulfate) content of ground substance between body cells has also been shown in animal experiments to reduce the ability of cancer cells to metastasize. The metastatic capacity of cancer cells tends to correlate with their ability to produce heparanase enzyme. Heparanase enzyme eats through the heparan sulfate ground substance (mortar) between cells, allowing cancer cells to affect neighboring host cells. As well, many viruses spread from cell to cell by breaking down the heparan sulfate ground substance between cells through the secretion of heparanase enzyme.  Once again, glucosamine sulfate is required for the optimum synthesis of heparan sulfate, thickening the mortar between cells and making it more difficult for heparanase enzyme to break it down. With realization that heparan sulfate production may decline as we age due to reduced glucosamine sulfate synthesis, the prophylactic administration of glucosamine may also be of value in these facets of disease prevention.(32,33,34,35,36,37)

Side Effects, Toxicity and Contra-Indications To The Use Of Glucosamine

Reported short-term adverse side effects from the use of glucosamine are generally mild and infrequent. These include mild gastrointestinal upset, drowsiness, skin reactions, and headache.(26) Glucosamine sulfate has been shown to be non-toxic at prescribed doses. (14) Patients allergic or sensitive to sulfa drugs or sulfate-containing food additives can safely take glucosamine sulfate. The word sulfate in this instance indicates the presence of the mineral sulfur, not the sulfa compounds used in sulfa drugs and sulfate-containing food additives. All cells of the body contain the mineral sulfur and thus, it is not possible to be allergic to this mineral. However, glucosamine sulfate is manufactured from the chitin exoskeleton of shellfish, such as lobster crab and shrimp. Therefore, it is conceivable that a person with a severe allergy to shellfish may be sensitive to the use of glucosamine, although the pharmaceutical grade of glucosamine is generally devoid of shellfish contaminants. Nevertheless, caution should be exercised in these cases.(2,14 ) Some preliminary animal experiments and human trials on healthy individuals reveals that glucosamine supplementation may increase insulin resistance in some individuals by down-regulating the synthesis of insulin receptors by the nuclear DNA(39). In large clinical trials this has not surfaced as a concern and no indication of pronounced glucose intolerance has been demonstrated in the many well-documented glucosamine studies, including the study in Lancet and the glucosamine meta-analysis appearing in The Journal of The American Medical Association.(22, 40) It is advisable for diabetic patients and pre-diabetic patients to have their blood glucose monitored during the first few weeks of glucosamine sulfate supplementation however, at this time these conditions are not an absolute contra-indication to the use of glucosamine

Dosage

In regards to the treatment of osteoarthritis, the usual daily dosage of glucosamine sulfate is 1500mg per day, which can be taken all at one time (28) or in divided doses of 500mg per dose.(2,14) Individuals taking diuretic drugs may require an additional 500mg per day to compensate for the increased excretion rate. Individuals weighing more than 200 pounds may also be advised to up their dosage to 2000mg per day.(2)

Quality Assurance.

In many European countries, glucosamine is available only by prescription from a medical practitioner. In North America, glucosamine is classified as a natural health product and is readily available as an over-the-counter product. As such, glucosamine products are held to much lower standards in regards to purity and potency than are prescription medications. A recent independent study revealed that up to one-third of the glucosamine products tested did not contain the amount of glucosamine stated on the label.(42) For this reason, it is imperative that health practitioners recommend only those glucosamine products whereby the manufacturer can issue a certificate of analysis and/or a third party true-to-label claim document that verifies the purity and potency of the product. This should be a standing policy for practitioners in regards to the recommendation of all herbal or accessory nutrient (e.g. glucosamine, CoQ-10, MSM) supplements. 

References

1. 1.Bland, J.H.,  and Cooper, S.M. Osteoarthritis: A review of the cell biology involved and evidence for reversibility. Management rationally related to known genesis and pathophysiology. Sem Arthr Rheum 14:106-33, 1984.
   

2. 2.Murray, Michael, T. Glucosamine sulfate: nature’s arthritis cure. Excerpt from The Chiropractic Journal – March 1998
   

3. 3.Williams & Wilkins. Basic Medical Biochemistry: A Clinical Approach. 1996: 452-453.
   

4. 4.Glucosamine Sulfate. Altern Med Rev 1999 Jun; 4(3): 193-5 (ISSN: 1089-5159)
   

5. 5.Vidal, Y., and Plana, R.R., et al. Articular cartilage pharmacology. In vitro studies on glucosamine and non-steroidal anti-inflammatory drugs. Pharmacol Res Comm 10, 557-569, 1978.
   

6. 6.Deal, C.L., Moskowitz, R.W. Nutraceuticals as therapeutic agents in osteoarthritis. The role of glucosamine, chondroitin sulfate, and collagen hydrolysate. Rheum Dis Clin North Am, 1000 May; 25 (2): 379-95 (ISSN: 0889-857X)
   

7. 7.Setnikar, I., et al: Pharmacokinetics of glucosamine in the dog and man. Arzneim Forsch, 43: (10) 1109-13, 1993.
   

8. 8.Setnikar, I, et al: Pharmacokinetics of glucosamine in the dog and man. Arzneim Forsch, 36 (4) 729-35, 1986.
   

9. 9.Baici, A., et al. Analysis of glycosaminoglycans in human sera after oral administration of chondroitin sulfate. Rheumatol Int 12:81-8, 1992.
   

10. 10.Conte, A., et al. Biochemical and pharmacokinetic aspects of oral treatment with chondroitin sulfate. Arzneim Forsch 45:918-25, 1995.
    

11. 11.Baici, A. and Wagenhauser, F.J.: Bioavailability of oral chondroitin sulfate. Rheumatology Int. 13:41-43, 1993.
    

12. 12.Peperno, M., Reboul, P., Hellio Le Graverand, M.P., Peschard, J.J., Annefeld, M., Richard, M., Vignon, E. Glucosamine sulfate modulates dysregulated activities of human osteoarthritic chondrocytes in vitro. Osteoarthritis Cartilage, 2000 May; 8 (3): 207-12 (ISSN: 1063-4584)
    

13. 13.Kelly, G.S. The role of glucosamine sulfate and chondroitin sulfates in the treatment of degfenerative joint disease. Altern Med Rev 1998 Feb.; 3 (1): 27-29 (ISSN: 1089-5159)
    

14. 14.Gottlieb, Marc S. Conservative Management of Spinal Osteoarthritis with Glucosamine Sulfateand Chiroprctic Treatment. Journal of Manipulative and Physiological Therapeutics, Volume 20, (6) July/August, 1997.
    

15. 15.Sullivan, M.S. and hess, W.C. Cystine content of fingernails in arthritis. J Bone Joint Surg 16: 185-8, 1935.
    

16. 16.Senturia, B.D., “Results of treatment of chronic arthritis and rheymatoid conditions with colloidal sulphur.” J Bone Joint Surg 16: 119-25, 1934.
    

17. 17.Lawrence, R.M. Methylsulfonylmethane (MSM): A double-blind study of its use in Degenerative Arthritis. Int J Anti-Aging Med., 1998; 1, 1:50
    

18. 18.Challem, J., Sulfur Power. Natural Way For Better Health (magazine). 1999 (02/28): 34-35
    

19. 19.Methylsulfonylmethane (MSM). Herbal Advisor. www.herbaladvisor.com, Samtech Research, 2001
    

20. 20.Noack, W., et al. Glucosamine sulfate in osteoarthritis of the knee. Osteoarthritis Cartilage 2: 51-9, 1994.
    

21. 21.Vaz, A.L. Double-blind clinical evaluation of the relative efficacy of ibuprofen and glucosamine sulfate in the management of osteoarthrosis of the knee in out-patients. Curr Med Res Opn 8. 145-9, 1982.
    

22. 22.Muller-Fassbender, H. et al. Glucosamine sulfate compared to ibuprofen in osteoarthritis of the know. Osteoarthritis Cartilage 2: 61-9, 1994.
    

23. 23.Rovati, L.C., et al. A large randomized placebo-controlled, double-blind study of glucosamine sulfate vs. piroxicam and vs. their association on the kinetics of the symptomatic effect in knee osteoarthritis. Osteoarthritis Cartilage 2 (suppl 1): 56, 1994.
    

24. 24.Tapadinhas, M.J., et al. Oral glucosamine sulfate in the management of arthrosis: report on a multi-centre open investigation in Portugal. Pharmatherapeutica 3: 157-68, 1982.
    

25. 25.Qiu, G.X., Gao, S.N., Giacovelli, G., Rovati, L., Setnikar, I. Efficacy and safety of glucosamine sulfate versus ibuprofen in patient with knee osteoarthritis. Arzneimittelforschung. 1998 May; 48 (5): 469-74 (ISSN: 0004-4172)
    

26. 26.Barclay, T.S., Tsourounis, C., McCart, G.M. Glucosamine. Ann Pharmacother 1998 May; 32 (5): 574-9 (ISSN: 1060-0280)
    

27. 27.Reginster, Y.J., Deroisy, R., Paul, I., et al. Glucosamine sulfate significantly reduces progession of knee OA over 3 years: a large randomized, placebo-controlled, double-blind prospective trial. Arthritis Rheum. 1999; 42 (suppl).
    

28. 28.Reginster, J.Y., Deroisy, R., Rovati, L.C., Lee, R.L. , Lejeune, E., Bruyere, O., Giacovelli, G., Henrotin, Y., Dacre, J.E., Gossett, C. Long-term effects of glucosamine sulphate on osteoarthritis progression: a randomized, placebo-controlled clinical trial. Lancet 2001, Jan. 27; 357 (9252): 251-6 (ISSN: 0140-6736)
    

29. 29.McCarty, M.F. Glucosamine for Wound Healing. Medical Hypotheses, 1996. 47; 273-275.
    

30. 30.Shankland, W.E. The effects of glucosamine and chondroitin sulfate on osteoarthritis of the TMJ: a preliminary report of 50 patients. Cranio 1998 Oct.; 16 (4): 230-5 (ISSN: 0886-9634)
    

31. 31.McCarty, Mark F. Vascular Heparan Sulfates May limit the Ability of Leukocytes to Penetrate the Endothelial Barrier – Implicatoins for Use of Glucosamine in Inflammatory Disorders.
    

32. 32.Vlodavsky, I., Fuks, Z., Bar-Ner, M., et al. Lymphoma-cell-mediated degradation of sulfated proteoglycans in the subendothelial extracellular matrix: Relationship to tumor cell metastasis. Cancer Res 1983; 43: 2704-2711.
    

33. 33.Nakajima, M., irimura, T., Di Ferrante, D., et al. Heapran sulfate degradation: Relation to tumor invasion and metastatic properties of mouse B16 melanoma sublines. Science 983; 220: 611-612
    

34. 34.Ricoveri, W., Cappelletti, R. Heparan sulfate endoglycosidase and metastatic potential in murine fibrosarcoma and melanoma. Cancer Res 1986; 45: 3855-3861.
    

35. 35.Nakajima, M., Irimura, T., Nicolson, G.L. Heparanase and tumor metastasis. J Cell Biochem 1988; 36: 157-167.
    

36. 36.Vlodavsky, I., Eldor, A., Bar-Ner, M., et al. Heparan sulfate degradation in tumor cell invasion and angiogenesis. Adv Exp Med Biol 1988; 233: 201-210.
    

37. 37.Vlodavsky, I., Korner, G., Ishai-Michaeli, R., et al. Extracellular-matrix-resident growth factors and enzymes: Possible involvement in tumor metastasis and angiogenesis. Cancer Metastasis Rev 1990; 9: 203-226.
    

38. 38.Russell, A.L. Glucosamine in osteoarthritis and gastrointestinal disorders: an example of the need for a paradigm shift. Med Hypotheses 1998 Oct.; 51 (4): 347-9 (ISSN: 0306-9877)
    

39. 39.Monauni, T., Zenti, M.G., Cretti, A., et al. Effects of glucosamine infusion on insulin secretion and insulin action in humans. Diabetes 2000 Jun.; 49 (6): 926-35 (ISSN: 0012-1797)
    

40. 40.McAlindon, T.E., La Valley, M.P., Gulin, J.P., Felson, D.T. Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and meta-analysis. JAMA 2000 Mar. 15; 283 (11): 1469-75 (ISSN: 0098-7484)
    

41. 41.McAlindon, T., Glucosamine for osteoarthritis: dawn of a new era? Lancet, 2001; 357, 9252: 247-248.
    

42. 42.Nutrition News Focus, February 13, 2001.
    

Glucosamine Sulphate

 

Glucosamine Hydrochloride vs. Sulfate /Chondroitin

This section is compiled by Frank M. Painter, D.C.

Send all comments or additions to:   Frankp@chiro.org

Glucosamine hydrochloride was chosen instead of glucosamine sulfate for a number of reasons. The hydrochloride form is more concentrated than the sulfate form, and the hydrochloride form contains substantially less sodium per effective dose than the sulfate form. Glucosamine sulfate is stabilized with sodium chloride (table salt) and can contain as much as 30% sodium. This is a consideration for individuals who want to reduce their dietary intake of sodium.

Glucosamine hydrochloride offers the promise of the same efficacy as glucosamine sulfate, since glucosamine is not absorbed intact with its carrier. The body doesn’t care how it gets glucosamine as long as it is bioavailable. Nonetheless, we embarked on clinical research to prove the efficacy of the hydrochloride form.

We first conducted pilot testing, which indicated benefit for those with osteoarthritis. We then went forward with a full-scale, double-blind, placebo-controlled intervention trial with glucosamine hydrochloride, the results, of which, are published in the Journal of Rheumatology listed in the references on the next page. Results showed a strong, beneficial effect for between 60 and 70% of the subjects, compared to their baseline symptoms.

Chondroitin

A number of glucosamine products tout the inclusion of chondroitin, a cattle-sourced compound, as a necessary and beneficial addition to glucosamine products. Such contentions are misleading. Tests showing the benefits of chondroitin involved direct injection by syringe to the affected part of the body. In an orally-taken compound, chondroitin doesn’t make sense because it is essentially destroyed during the digestive process. Scientific evidence does not show that a glucosamine-chondroitin combination is any more effective than glucosamine by itself.

Other clinical studies

Dr. Michael T. Murray, a proponent of glucosamine sulfate, has pointed to a clinical study in Canada that involved glucosamine hydrochloride to make claims about the superiority of glucosamine sulfate. A close look at the study shows that, in actual fact, half the subjects were shown to benefit from glucosamine hydrochloride with the placebo response almost as positive.

“Pharmacokinetics of glucosamine in man” (Setnikar et.al.), a study referencing the bioavailability of glucosamine, states that after oral administration, glucosamine sulfate is rapidly split into glucosamine and sulfate ions and absorbed. After absorption, the sulfate ions enter the blood stream where a steady level already exists. None of the clinical studies performed with glucosamine sulfate indicate that sulfate contributed to the benefits shown in the study. As a matter of clarification, while this study references glucosamine sulfate, it was actually glucosamine hydrochloride that was radiolabeled and used to prove the bioavailability of glucosamine. We can conclude that since sulfate and hydrochloride are not the key building blocks for the production of joint cartilage, it makes no difference whether glucosamine has a sulfate or hydrochloride carrier, in terms of bioavailability.

In summary, chondroitin has no scientific rationale for an orally-taken glucosamine product. There is no evidence to suggest that glucosamine sulfate offers advantages over glucosamine hydrochloride. There is no need for glucosamine hydrochloride to be stabilized with salt. Hydrochloride offers a more concentrated form of glucosamine. Given these facts, the glucosamine product of choice for consumers should be Glucosamine hydrochloride.

References:

1. Houpt JB, McMillan R, Paget-Dellio D, Russel A, Gahunia HK Effect of treatment of glucosamine hydrochloride in the treatment of pain in osteoarthritic of the knee. J Rheumatology 1998; 25 (supplemement 52): 8

2. Noack W, Fischer M, Forster KK, Rovati LC, Setnikar I. Glucosamine sulfate in osteoarthritis of the knee. Osteoarthritis Cart 1994; 2:51-9

3. Muller-Fabbender H, Bach GL, Haase W, Rovati LC, Setnikar I. Glucosamine sulfate compared to ibuprofen in osteoarthritis of the knee. Osteoarthritis Cart 1994; 2:61-9

4. Setnikar L, Palumbo R, Canali S, Zanolo G. Pharmacokinetics of glucosmine in man. Arzneimittelforschung 1993;43:1109-13

5. Vaz AL. Double-blind clinical evaluation of the relative efficacy of ibuprofen and glucosamine sulphate in the management of osteoarthrosis of the knee in out patients. Curr Med Res Opin 1982;8:145-9

6. Drovanti A, Bignamini AA, Rovati AL. Therapeutic activity of oral glucosamine sulfate in osteoarthritis: A placebo-controlled, double-blind investigation. Clin Ther 1980;3:260-72

7. Pujalte JM, Llavore EP, Ylescupidez FR. Double-blind clinical evaluation of oral glucosamine sulphate in the basic treatment of osteoarthritis. Curr Med Res Opin 1980;7:110-14

Glucosamine Sulfate Monograph

Alternative Medicine Review 1999 (Jun);   4 (3):   193–195

Summary

Glucosamine sulfate's role in halting or reversing joint degeneration appears to be directly due to its ability to act as an essential substrate for, and to stimulate the biosynthesis of, the glycosaminoglycans and the hyaluronic acid backbone needed for the formation of the proteoglycans found in the structural matrix of joints. Successful treatment of osteoarthritis must effectively control pain and should slow down or reverse the progression of the degeneration. Biochemical and pharmacological data combined with animal and human studies demonstrate that glucosamine sulfate is capable of satisfying both of these criteria.


Introduction

Glucosamine is the most fundamental building block required for biosynthesis of the classes of compounds including glycolipids, glycoproteins, glycosaminoglycans (formerly called mucopolysaccharides), hyaluronate, and proteoglycans. As a component of these macromolecules, glucosamine has a role in the synthesis of cell membrane lining, collagen, osteoid, and bone matrix. Glucosamine is also required for the formation of lubricants and protective agents such as mucin and mucous secretions.


Pharmacokinetics

In humans, about 90 percent of glucosamine, administered as an oral dose of glucosamine sulfate, is absorbed from the digestive tract.1 After an oral dose, glucosamine concentrates in the liver, where it is either incorporated into plasma proteins, degraded into smaller molecules, or utilized for other biosynthetic processes.1 Elimination of glucosamine is primarily through the urine, with a small amount of glucosamine or its derivatives eliminated in the feces.2,3


Mechanism of Action

Glucosamine sulfate is capable of stimulating proteoglycan synthesis, inhibiting the degradation of proteoglycans, and stimulating the regeneration of experimentally-induced cartilage damage.4,5 Some experts also believe glucosamine sulfate might promote the incorporation of sulfur into cartilage.6


Clinical Research on Osteoarthritis

The primary therapeutic use of glucosamine sulfate has been in the treatment of degenerative diseases of the joints. Although many of the available studies have compared glucosamine sulfate to placebo, in the trials where glucosamine sulfate has been compared to NSAIDs, long-term reductions in pain are greater in patients receiving glucosamine sulfate.7-11

Symptoms such as articular pain, joint tenderness, and swelling often improve following a 6-8 week period of oral administration of glucosamine sulfate.7-13For most individuals, an expectation of a reduction in symptoms of from 50-70 percent is reasonable.7 Improvements secondary to glucosamine sulfate therapy generally are sustained six to 12 weeks following cessation of the treatment regimen.12

For arthritis of the knee, evidence suggests that about 60 percent of patients will have a good to excellent response to this intervention, while an additional 35 percent will have a more moderate benefit. Preliminary evidence suggests patients with arthritis of the shoulder or elbow respond the best to glucosamine sulfate (about 75 percent judged as good and only one percent judged as insufficient), while polyarticular arthritis and arthritis of the hip had the poorest response rate (only 43 percent and 49 percent, respectively).12

DMG Improves Immune system.

The difference of foods/nutrients vrs. Drugs

STATEMENT OF ROGER J. WILLIAMS, Ph.D., D.Sc.

Dr. WILLIAMS. First, I would like to say that I am fully in favor of the Food and Drug Administration and their responsible activities. I am not in favor of mistakes they make but am in favor of the general objectives and any legitimate regulations which they feel they should make.

I am going to limit my remarks largely to the one question of the difference between drugs and nutrients.

Our bodies are made up of cells. A cell under an [electron microscope] may be about so big [indicates.] And this cell is filled with machinery like a chemical factory; all kinds of operations are going on in this. These cells and these operations are what we call metabolism. Now, both drugs and nutrients affect metabolism but they do it in very different ways. The nutrients furnish the building materials for constructing this metabolic machinery and that is the only source of material that the cells get; that is, anything that is a nutrient is furnished them and if it is furnished them it is a nutrient. And they are absolutely essential.

Drugs, on the other hand, work by interfering with this metabolic machinery in some particular way. There are many, many steps. There are thousands of catalysts in this machinery and these drugs interfere in some way with the operation of this machinery. But they do not act constructively. They furnish no constructive material at all, whereas nutrients furnish all the constructive material for the cells.

If an agent furnishes something that is constructive it is a nutrient. It cannot be a drug. Life can exist without any drugs but life cannot possibly exist without nutrients. Therefore there is a definitely scientific distinction between drugs and nutrients and I would like to bring this out.

As I say, they operate in entirely different ways and they do not belong together. Let me use a homely illustration. One of the important functions of the shoe is to keep our feet warm. One of the important functions of electric heaters is to keep our feet warm. But they do it in very, very different ways. I don’t think anybody would want to confuse shoes with electric heaters and say, “Well, we have made regulations for shoes and regulations for electric heaters should correspond.” I don’t see where you can say there are sometimes shoes which are electric heaters and sometimes electric heaters which are shoes. They do perform several similar functions but in an entirely different way.

Drugs and nutrients are likewise different in the same sense.

The Food and Drug Administration sometimes is incorrectly referred to as Food-Drug Administration. I would like to emphasize that word “and” in the correct name, the Food and Drug Administration. The administration of food is one thing and administration of drugs is another. They need to be handled separately and not together. You can’t make regulations that are appropriate for both.

Well, calling a nutrient a drug doesn’t make it a drug. They are not the same. They function entirely differently and should be treated separately and regulations suitable for one are not suitable for the other. And I can amplify that, if you wish. But that is my statement—the drugs are not the same as nutrients; nutrients are not the same as drugs and no amount of legal pronouncements, no matter if they are made a thousand times would make nutrients into drugs because they are not. They don’t belong in the same category.

Senator KENNEDY. Thank you very much, doctor.

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