Though discovered in 1952, the past six years have crowned SAMe as one of the most widely used supplements in today’s marketplace. As a natural line of support to the nervous system functions, it increases the synthesis and breakdown of certain neurotransmitters, thus enhancing the sensitivity of nerve receptors. It may also aid in the repair of myelin, the sheath of fatty material that surrounds the nerve cells. SAMe may support joint health through transulfuration, a process that takes a certain amount of sulfur from SAMe to create glucosamine and chondroitin sulfates. This enhances proteoglycan synthesis, the molecule responsible for keeping articular joint cartilage lubricated. Important for the production of glutathione, this powerful free radical scavenger defends the body from toxic agents and is necessary for liver detoxification.
Frequently Asked Questions
Q: What is SAMe?
A: SAMe (S-adenosylmethionine) is a naturally occurring compound found in all human tissue and organs. It is a “building block” necessary for the production of many compounds produced by your body, and is used in over 35 different biochemical reactions. SAMe actually donates a part of itself to form these new compounds through a process called methylation or transmethylation. SAME is one of the few dietary supplements on the market today that combines the benefits of several nutrients into one, because the body uses the substances produced from SAMe for numerous bodily reactions and processes.
Q: Are there any side effects associated with SAMe supplementation?
A: SAMe is a very safe dietary supplement. Minor side effects include nausea and gastrointestinal irritation, due to its sulfur content. These were only noted at very high doses (1200-1600mg) and symptoms diminished with continued use. Persons suffering from manic depression (bipolar disorder) should not take SAMe without prior consultation with their physician. If you experience any of the symptoms above for an extended period of time, you may be allergic to SAMe, or it may not be the right supplement for you.
Q: Why is the dosage information with SAMe supplements so confusing?
A: SAMe in its ion form as found in human cells has a very short life span and is rapidly metabolized into other necessary compounds as needed, which is good! However, this natural form does not lend itself to the production of a stable and effective dietary supplement. It took scientists years to come up with a way to stabilize SAMe so it could be manufactured as a dietary supplement. It was finally discovered that SAMe must be manufactured in a salt form to prevent rapid degradation. In its salt form, you will actually get 200mg of SAMe in its stable salt form. However, only half of this 200mg is actually raw SAMe ions, hence its yield of 100mg.
Q: Are there size or color variations with your SAMe products, and should SAMe be refrigerated?
A: Because of the nature of SAMe, NOW takes special precautions when packaging this product. We bottle SAMe in amber glass bottles to keep light exposure to a minimum, and keep SAMe products refrigerated in our plant until shipping. It is not necessary to keep SAMe refrigerated after purchase, but it can extend the shelf life of the product.
Because SAMe is a natural product, there can be variations in color, usually ranging from white to pale yellow or tan. This is normal and does not mean the product is expired. You may also notice a difference in tablet size. We recently reformulated our SAMe to include less excipients, so there are two different tablet sizes on the market at this time.
Clinical Trial Supports Efficacy of NOW® SAMe for OA of the Knee
At NOW Foods we take an active role in reassuring the public that dietary supplements are safe and effective when used as recommended. We pursue this ongoing goal through several different avenues, one of which is supplying researchers with top quality dietary supplements for use in clinical trials. NOW Foods is proud to support clinical research into the efficacy of dietary supplements and we are confident that science will continue to prove the safety and effectiveness of natural dietary supplements as viable alternatives to synthetic prescription medications and their side effects.
NOW Foods recently supplied researchers at the University of California–Irvine with our high grade SAMe (S-adenosylmethionine) product for a study into the effectiveness of this natural nutritional supplement for pain associated with osteoarthritis (OA). The study, entitled “Effectiveness of SAMe for Pain Relief in Osteoarthritis of the Knee”, compared the therapeutic efficacy of SAMe to the pharmaceutical Celebrex (a COX2 inhibitor) in adults with OA of the knee.
Osteoarthritis of the knee is a major disability among the aging American population and is more common than OA in other peripheral joints. Patients report that control of the pain and improved mobility is of greatest importance to them. Many of the prescription pharmaceuticals available today for the treatment of OA are non-steroidal anti-inflammatory drugs (NSAIDS) that can have serious side effects, especially if used long term. As more people are afflicted with OA of the knee, demand will increase for new ways to relieve the pain and stiffness of OA with as few negative side effects as possible. SAMe is one of the more promising natural alternatives available.
SAMe is a naturally occurring compound found in all human tissue and organs. It is produced when methionine, an essential amino acid derived from food sources, and ATP (adenosine triphosphate), the body’s primary energy molecule, are combined. Once created, SAMe is available for use by your body in over 35 different biochemical reactions necessary for optimal health. SAMe is considered a methyl donor. Its purpose is to attach a methyl group (a unit of organic chemical compounds) to other key elements in your body, such as DNA, to create more complex compounds. Your body then uses these new compounds for numerous purposes, including detoxification. This process, known as methylation or transmethylation, is vital to your body’s maintenance. SAMe may be the most effective of all methyl donors.
The study was a randomized, double-blind cross over trial with 61 participants (5 withdrew for various reasons) and was conducted at the Clinical Research Center at the University of California Irvine Medical Center. There was a one-week washout period to clear any anti-inflammatory medicine from the participant’s systems before they were given 600 milligrams of SAMe twice daily for eight weeks. After another one-week washout of SAMe, participants were then given 100 milligrams of Celebrex twice daily for eight weeks.
Researchers concluded that, over the two-month testing period, SAMe was as effective in reducing pain as Celebrex. It was noted that at the beginning of Celebrex treatment pain was immediately reduced but gradually began to increase, whereas SAMe did not reduce pain as quickly as Celebrex but continued to show pain reduction over the two-month treatment period. Functional health, defined as improved mobility and the ability to function without pain, was observed to improve equally with both SAMe and Celebrex.
Due to the success of this study, researchers are planning to conduct a larger-scale, multi-year study on SAMe funded by the National Institutes of Health (NIH). This new study would enlist a greater number of participants and would evaluate at which dosage range SAMe is most effective, among other goals.
NOW has supplied high quality nutritional supplements for other clinical trials, and we hope to have results from these studies later in 2003. Our Cranberry Concentrate is currently being used by researchers at the University of Calgary in an important study looking into concentrated cranberry’s effects on bacteriuria in persons with multiple sclerosis. L-Glutamine is being studied as a possible treatment for cocaine and alcohol abuse, and NOW was happy to provide our 100% pure, high quality L-Glutamine for this important research.
10/01/04-IMMEDIATE RELEASE: Arthritis Drug Withdrawn, People are Looking for Alternative
Merck has withdrawn Vioxx from the market after a study was halted because users of the drug had 200% as much risk of getting heart attacks than participants taking a placebo. Medical experts are advising patients taking Vioxx to consult with their physicians about a substitute.
By Neil E. Levin, CCN, DANLA
A major pharmaceutical company has announced a worldwide recall of its top arthritis drug due to cardiovascular problems seen in long-term users.
Merck has withdrawn Vioxx from the market after a study was halted because users of the drug had 200% as much risk of getting heart attacks than participants taking a placebo. Medical experts are advising patients taking Vioxx to consult with their physicians about a substitute.
European regulators are launching a safety investigation into the entire class of drugs that includes Vioxx, Celebrex and Bextra.
A recent editorial in the New England Journal of Medicine questions whether any COX-2 inhibitor drug is safe, recommending that these drugs not be given to patients with any risk of cardiovascular disease.
Vioxx was the only one of these drugs allowed to use a label claim of being gentler on the stomach than traditional anti-inflammatory drugs known as NSAIDS (non-steroidal anti-inflammatory drugs), but that is the main reason a physician would recommend any of these COX-2 inhibitor drugs over NSAIDS.
If you are one of these people using any of these drugs, there is no better time than now to discuss the use of natural alternatives to drugs with your doctor. If you can get temporary relief of aches and pains by using natural herbs and foods with minimal side effects rather than with more dangerous prescription drugs, why not? After all, dangerous side effects are the main reason why drugs have restrictions on their sale in the first place.
You have three basic choices to inhibit inflammation. Here they are, one at a time:
PRESCRIPTION COX-2 INHIBITORS
COX-2 Inhibitors help to prevent inflammation from developing by blocking the action of a certain chemical called COX-2. These drugs are noted for reducing "risk of clinically important GI (gastrointestinal) events" by some 50-60% versus non-steroidal anti-inflammatory drugs like aspirin and ibuprofen. However, most of the COX-2 Inhibitor drugs are also associated with an increased risk of cardiovascular problems, including elevated blood pressure. And there are still a goodly number of GI complaints in the COX-2 groups. Now one of the most prominent COX-2 inhibitor drugs has been pulled off the market for doubling the rate of heart attacks. And it was the only one recognized as removing most of the risks of stomach and GI tract damage versus the NSAIDS.
Over-The-Counter NSAIDs (non-steroidal anti-inflammatory drugs)
Doctors reportedly recommend NSAIDs, which are COX inhibitor drugs like aspirin and ibuprofen, more than they prescribe COX-2 inhibitor drugs like Celebrex and Vioxx. But there are also problems with NSAIDs.
Gideon Bosker, MD, Assistant Clinical Professor at Yale University School of Medicine, reports on the use of NSAIDs for Osteoarthritis (OA) and Rheumatoid Arthritis (RA): "As every primary care practitioner knows, NSAID-associated GI toxicity has become a public health problem, especially among older patients with OA and RA. Gastrointestinal intolerance has been reported in up to 50% of patients on long-term NSAIDs."
NSAIDs cause irritations in the gastrointestinal tract, leading to bleeding and iron loss. (Bjarnason I, Macpherson AJ. Intestinal toxicity of non-steroidal anti-inflammatory drugs. Pharmacol Ther 1994;62:145–57)
Going off drugs like aspirin and ibuprofen often causes a rebound effect that creates a cascade of inflammation in the Cox and Lox enzyme pathways. In one report the levels of these inflammatory markers was over 500% higher even two weeks after going off aspirin and ibuprofen!
(Endres S. Oral aspirin and ibuprofen increase cytokin-induced synthesis of IL-1 beta and of tumour necrosis factor-alpha ex vivo. Immunology 1996; 87(2): 264-270)
Ibuprofen has caused kidney dysfunction and water retention.
(Threlkeld DS, ed. Central Nervous System Drugs, Nonsteroidal Anti-Inflammatory Agents, Facts and Comparisons Drug Information. St. Louis, MO: Mar 1993, 251j–1l)
There are about 16,000 deaths a year from NSAIDs, and 100,000 people hospitalized with serious complications. NSAIDs are blamed for over half of all liver failures in this country. These serious side effects have caused a demand for the COX-2 inhibitor drugs, which do not inhibit the COX-1 enzyme like some NSAIDs do.
Two recent large studies (called CLASS and VIGOR) looked at the relative safety of NSAIDs versus COX-2 drugs. NSAIDs were shown to be associated with significantly more upper G.I. tract complications, including ulcers and bleeding. Partly because of such studies, COX-2 drugs have become a major success story for pharmaceutical companies over the past few years, becoming a multi-billion dollar a year business.
Research published in the British Medical Journal found that 21% of adults with asthma are sensitive to aspirin. Aspirin may trigger a deadly reaction, as may ibuprofen, diclofenac and naproxen. The doctors recommend new warning labels on all products containing these drugs. Some experts have also warned about possible dangers of taking Celebrex if you have asthma.
People using non-selective NSAIDS had a 40% increased risk of admission for congestive heart failure, versus an 80% increase for those using Vioxx. (The Lancet; 2004;363:1751-56)
DIETARY SUPPLEMENTS
There are dietary supplements that may help control the inflammatory COX-2 enzyme while not blocking the beneficial COX-1 enzyme. Some of these supplements will also block the 5-LOX inflammatory enzyme that is not blocked by many of the arthritis symptom relief drugs.
Methyl donors are natural substances that have been studied for their effects on methylation. Methylation is a key factor in detoxification of chemicals, protection of DNA and conversion of the inflammatory chemical homocysteine - which is a risk factor for cardiovascular health - into the safe amino acid methionine. One methyl donor was deemed effective enough to be studied in comparison to the leading COX-2 inhibitor, and provided the same level of functional knee health in a randomized, double-blind crossover trial with 61 participants that was conducted at the Clinical Research Center at the University of California Irvine Medical Center.
The anti-inflammatory effects of aspirin and other drugs can also be achieved more safely with concentrated blends of spices and herbs that have a wide range of benefits. These formulas will block the COX-2 enzyme, which triggers inflammation in tissues as a response to chemical signals. NSAIDs block not only the inflammatory enzyme COX-2, but also the beneficial enzyme COX-1, whose beneficial uses include protecting the stomach lining. The natural ingredients do not have this problem, because they block only the inflammatory enzymes. These natural ingredients will prevent the actions of not only the COX-2 inflammatory enzyme, but also block the 5-LOX inflammatory enzyme that the drugs do not affect.
Look for an herbal formula that uses ingredients that have been shown to be helpful for inflammation and joint health, and also promoting normal cell growth (preventing abnormal growth). It should contain highly concentrated common spices like ginger and turmeric, which have been naturally extracted to contain the therapeutic chemicals in the plants. Other ingredients that will enhance an herbal formula are holy basil, EGCg-rich green tea extract, Boswellia, the antioxidant resveratrol and the enzyme bromelain (which helps “digest” damaged tissues so your body can rebuild). The herbs also serve as antioxidants and mild anticoagulants (blood thinners).
RELATIVE SAFETY
The tremendous safety difference between dietary supplements and drugs is staggering. There are over 100,000 deaths a year from drugs versus a handful from all dietary supplements, which are far safer than any other category of food. Our risk of dying from eating dinner is far greater than from taking a dietary supplement.
| NUTRITION INFO |
| Serving Size: 1 Tablet |
| Servings Per Container: 60 |
| Amount Per Serving | % Daily Value |
| Vitamin B-6 (as Piridoxine HCl) | 2mg | 100% |
| Folic Acid | 200mcg | 50% |
| Vitamin B-12 (as Cyanocobalamin) | 50mcg | 833% |
| SAMe (S-Adenosyl-L-Methionine) | 200mg | † |
(from 400mg of S-Adenosyl-L-Methionine
Disulfate Tosylate) | | |
|
|
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| * Percent Daily Values are based on 2,000 calorie diet. |
| † Daily Value not established. |
Serving Size: 1 Tablet.
Suggested Use: As a dietary supplement, take 1 tablet 1 - 2 times daily, preferably on an empty stomach. Refrigeration is recommended after opening.
Free of: sugar, salt, starch, yeast, wheat, gluten, soy, milk egg or preservatives.
Other Ingredients: Cellulose, Croscarmellose Sodium, Methacrylic Acid, Magnesium Stearate (vegetable source), Silica, Triethyl Citrate, Stearic Acid (vegetable source), Citric Acid and Ascorbic Acid. Vegetarian Formula.
Warnings: Individuals with bipolar (manic) depression should not take SAMe unless under professional supervision.
Brand: Now Foods
SAMe with B Vitamin Cofactors, Vegetarian, Enteric Coated, 200mg each Tablet - 60 Tabs
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