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Evidence based medicine researchers evaluate a broad spectrum of research material—such as meta-analyses, systematic reviews of existing research, randomized controlled trials, cohort studies, and other methods of inquiry—to make decisions about patient care and treatment. |
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Below is a cross section of the extensive scientific evidence used in formulating patent-pending Arthroleve™: |
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S-adenosyl methionine |
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In a double-blind crossover trial, the authors concluded that S-adenosyl methionine is as effective as celecoxib (Celebrex®) in the management of symptoms of knee osteoarthritis (Najm WI et al, 2004). |
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A meta-analysis concluded that S-adenosyl methionine appears to be as effective as NSAIDS in reducing the pain and improving the functional limitation in patients with osteoarthritis without the adverse effects often associated with NSAID therapies (Soeken et al, 2003). |
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S-adenosyl methionine plays an important role in the liver, acting as a protective agent for oxidative stress. Patients with liver disease often become deficient and may benefit from the administration of this supernutrient (Liber, 2002). |
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A meta-analysis concluded that the efficacy of S-adenosyl methionine was equivalent to tricyclic antidepressants with fewer side effects (Bressa, 1994). Another meta-analysis concluded that there appears to be a role for this compound in the treatment of major depression in adULTs (Williams et al, 2005). |
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A double-blind, placebo controlled study found that S-adenosyl methionine was effective in treating the pain, stiffness, fatigue, and mood of people suffering from fibromyalgia (Jacobsen et al, 1991). |
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Harpagophytum procumbens: |
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A recent double-blind pilot study comparing Harpagophytum procumbens to rofecoxib (Vioxx®) found both treatment groups responded equally well in the treatment of lower back pain. The authors also found that 20 percent of the patients treated for low back pain with Harpagophytum procumbens were completely pain free after six weeks of treatment (Chrubasik et al, 2003). |
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In a recent review of the literature on Harpagophytum procumbens, the study authors concluded that there is strong evidence for its effectiveness in treating NSLBP and moderate evidence for its effectiveness in treating osteoarthritis pain (Gagnier et al, 2004). |
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Glucosamine Sulfate: |
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In Drug Discovery Today, a 2004 review article concluded that glucosamine sulfate was effective in narrowing joint space, as a structure-modifying agent to protect joints, and in symptomatic relief of arthritic pain (Curtis et al, 2004). |
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A recent review of the scientific literature published in the Annals of Pharmacotherapy concluded that available evidence suggests glucosamine sulfate may be effective and safe in improving symptoms and delaying the progression of knee OA (Poolsup et al, 2005). |
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Mechanism of Action |
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S-adenosyl methionine: |
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S-adenosyl methionine is a natural metabolite present in all living cells. It is formed from methionine (an essential amino acid) and adenosine triphosphate. Evidence on SAMe suggests that it may play a role in reducing inflammation, increasing proteoglycan synthesis, and/or creating an analgesic effect (Najm et al, 2004). |
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Harpagophytum procumbens (Hp): |
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For more than half a century, various preparations of Hp have continuously been used in Europe and are established traditional treatments for rheumatic complaints. Recent in-vitro studies indicate that preparations from Hp may interact with the inflammatory cascades, including the cytokines (Fiebich et al, 2001). In addition, a recent study demonstrated a significant decrease in matrix-degrading enzymes found in isolated mature cartilage cells (ShULTz-tanzil, 2004). |
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Glucosamine sulfate: |
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Harpagophytum procumbens (Hp): |
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Glucosamine is found naturally in the body and is one of the building blocks of cartilage. It is thought that taking glucosamine supplements may help stop cartilage breakdown, build cartilage, and decrease swelling. |
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Glucosamine Sulfate: |
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Arthroleve Safety and Side Effects |
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Safety: |
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Use this product in consULTation with a physician if you have a history of depression, bipolar disorder, or other psychiatric illnesses. |
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ConsULT a physician if you experience any troublesome side effects. |
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Discontinue use if an allergic reaction occurs. |
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ConsULT a physician if you use this product longer than six months. |
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Side Effects: |
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S-adenosyl methionine: |
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S-adenosyl methionine has fewer reported side effects than NSAIDs. Side effects include
occasional gastrointestinal disturbances, mainly diarrhea (Morelli, 2003).
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Harpagophytum procumbens (Hp): |
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Reported side effects due to Harpagophytum extracts include mild gastrointestinal disturbance (Setty et al, 2005).
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Glucosamine sulfate: |
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In a review of trials comparing glucosamine versus placebo, the researchers found that side effects from
glucosamine were 24% less common than with placebo (Anderson, 2005). In the same review article, the
authors concluded that glucosamine had no effects on plasma glucose values in three months of oral intake.
(Anderson, 2005).
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Contraindications: |
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Arthroleve™ should not be used in people with ulcers, gallstones, or diabetes (Setty et al, 2005).
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Drug interactions: |
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No drug interactions have been reported for glucosamine sulfate, Harpagophytum extracts, or S-adenosyl
methionine (Anderson , 2005; Setty et al, 2005). |
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† These statements have not been evaluated by the Food and Drug Administration. This product is not intended
to diagnose, treat, cure, or prevent any disease.
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| References: |
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Chrubasik S, Model A, Black A, Pollak S. A randomized double-blind study comparing Doloteffin®
and Vioxx® in the treatment of low back pain. Rheumatology. 2003:32;141-8.
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Gagnier JJ, Chrubasik S, Manheimer E. Harpophytum procumbens for osteoarthritis and low back
pain: a systematic review. BMC Complement Altern Med. 2004 Sep 15;4:13. |
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Poolsup N, Suthisisang C, Channark P, Kittikulsuth W. Glucosamine long-term treatment and the progression of knee osteoarthritis: Systematic review of randomized controlled trials. The Annals of Pharmacotherapy. 2005 June;39:1080-87. |
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Curtis CL, Harwood JL, Dent CD, Caterson B. Biological basis for benefit of nutraceutical supplementation in arthritis. Drug Discovery Today.2004;9:16572. |
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Bressa GM. S-adenosyl-l-methionine (SAMe) as antidepressants: meta-analysis of clinical studies. Acta Neurol Scand Suppl. 1994;154:7-14.
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Najm WI, Reinsch S, Hoehler F, Tobis JS, Harvery PW. S-adenosyl methionine (SAMe) versus celecoxib for the treatment of osteoarthritis symptoms: a double-blind cross-over trial. BMC Musculoskelet Disord. 2004 Feb 26;5(1):6.. |
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Liber CS, S-adenosyl-L-methionine: its role in the treatment of liver disorders. AM J Clin Nutr. 2002;76(5):1183s-7s |
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Setty AR, Sigal LH. Herbal Medications Commonly Used in the Practice of Rheumatology: Mechanisms of Action, Efficacy, and Side Effects. Semin Arthritis Rheum. 2005 Jun;34(6):773-84. |
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Jacobsen S., Dannekiold-Samsoe B, Andersen RB. Oral S-adenosylmethionine in primary fibromyalgia. Double-blind clinical evaluation. Scandinavian Journal of Rheumatology. 1991;20(4):294-302. |
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Williams Al, Girard C, Jui D, Sabrina A, Katz DL. S-adenosylmethionine (SAMe) as treatment for depression: a systematic review. Clinical & Investigative Medicine – Medecine Clinique et Experimentale. 2005 June;28(3):132-9. |
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Soeken KL, Lee W, Bausell R, Anelli M, Berman BM. Safety and efficacy of S-adenosylmethionine (SAMe) for osteoarthritis. ACP J Club. 2003 Jan-Feb;138(1):21. |
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For a more extensive list of research or information about evidence-based medicine, please
visit the Cochrane Collaboration Web site
or contact us. |
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