SAMe Ultra (S-Adenosyl-Methionine) Fact Sheet & Scientific Data
Now Available from MedVitamins™

Fibromyalgia Relief!

"Those suffering from Fibromyalgia are known to be hyper-sensitive to certain drugs, chemicals and other substances. SAMe appears to offer side effect-free relief to Fibromyalgia patients, while providing other health-enhancing benefits! "

• Shown to provide benefits equal to or greater than that of conventional drugs
• SAMe aids in the management of Fibromyalgia
• No known harmful, side-effects!

SAMe ULTRATM 400mg 30 Tablets $49.99ea

SAMe STUDIES One of the first studies done on SAM-e and Fibromyalgia took place in Italy, 1987. In that study, 70 people were studied: one group received SAMe, the other, a placebo. At the end of a 21-day period, both groups stopped treatment for 14 days. Then the two groups switched treatments. Researchers found that patients experienced a significant improvement in mood and a decrease in tender points when taking SAMe. When taking placebo, they did not experience such relief. Doctors concluded, "SAMe seems to be an effective and safe therapy in the management of Fibromyalgia." A subsequent six week study in Denmark, 1991, conducted by Dr. Jacobsen, found that those who had taken SAMe experienced improvements. The study involved over 40 patients. Researchers reported, "[SAMe] has some beneficial effects on primary Fibromyalgia and could be an important option in the treatment hereof." A 1991 study in Italy of 47 patients found that SAM-e "proved to be effective in relieving pain and suppressing mood" while improving sleep quality.

FIBROMYALGIA PRODUCTS

Dosage and Administration- Patients take 1 Tablet per day on an empty stomach, or as directed by your physician.

ADDITIONAL HEALTH BENEFITS:

SAM-e (S-adenosylmethionine) is a naturally occurring compound that has been shown to support joint and liver health as well as to aid with the management of milder forms of depression. This high potency 400mg formula uses enterically coated tablets contained in amber glass bottles to ensure product quality and help prevent degradation.

MECHANISM OF ACTION:
Evidence shows SAM-e may benefits joints by stimulating articular cartilage growth and repair by enhancing chondrocyte proteoglycan synthesis and proliferation rate. It also helps protect against cytokine induced cell damage by antagonizing the activity of tumor necrosis factor-alpha on synovial cell proliferation and fibronectin mRNA expression (1).
SAM-e crosses the blood-brain barrier and benefits mood by increasing the synthesis of neurotransmitters such as serotonin, norepinephrine and dopamine, thus increasing the responsiveness of neurotransmitter receptors and increasing the fluidity of cell membranes through the production of phospholipids. SAM-e is also metabolized to s-adenosylhomocysteine, which can be metabolized to homocysteine, which in turn is remethylated to form methionine, which can form more SAM-e, or be converted via transsulfuration to the antioxidant, glutathione, the liver’s natural antioxidant and detoxifier.

SPECIAL DIETARY USEFULNESS:
This product may have special dietary usefulness, under a physician’s supervision, for patients diagnosed with joint pain, depression and liver disease.

PUBLISHED RESEARCH STUDIES:
In a study published in the International Journal of Neuropsychopharmocology (2), a multicenter trial was carried out to confirm both efficacy and safety of SAM-e in the treatment of major depression. SAM-e was given intramuscularly (i.m.) at a dose of 400 mg/d, double-blind, vs. 150 mg/d oral Imipramine (IMI) in patients with a diagnosis of major depressive episode, with a baseline score on the 21-item Hamilton Depression Rating Scale (HAMD) of >/=18. A total of 146 patients received SAM-e whereas 147 received IMI for a period of 4 weeks. The two main efficacy measures were endpoint HAMD score and percentage of responders to Clinical Global Impression (CGI) at week 4. Secondary efficacy measures were the final Montgomery-Asberg Depression Rating Scale (MADRS) scores and the response rate intended as a fall in HAMD scores of at least 50% with respect to baseline. SAM-e and IMI did not differ significantly on any efficacy measure, either main or secondary. Adverse events were significantly less in patients treated with SAM-e compared to those treated with IMI. The data showed 400 mg/d i.m. SAM-e to be comparable to 150 mg/d oral IMI in terms of antidepressive efficacy, but significantly better tolerated.

In a double-blind study published in the American Journal of Medicine (3), researchers from Sacco Hospital in Milan, Italy studied the efficacy and tolerability of SAM-e in comparison with those of placebo and naproxen in the treatment of osteoarthritis of the hip, knee, spine, and hand. Thirty-three centers, 18 rheumatologic and 15 orthopedic, participated in this study. A total of 734 subjects, including 582 with coxarthrosis (hip osteoarthritis) or gonarthrosis (knee osteoarthritis), were enrolled. SAM-e administered orally at a dose of 1,200 mg daily was shown to exert the same analgesic activity as naproxen at a dose of 750 mg daily. Both treatments were more effective than placebo (p less than 0.01). Tolerability of SAM-e was significantly better than that of naproxen, both in terms of physicians' (p less than 0.025) and patients' (p less than 0.01) judgments and in terms of the number of patients with side effects (p less than 0.05). There was no difference between SAM-e and placebo in the number of side effects. Ten patients in the SAM-e group and 13 in the placebo group withdrew from the study because of intolerance to the drug.

A study on SAMe and liver disease was published in the Scandinavian Journal of Gastroenterology (4) and examined the effect of SAM-e administration on the hepatic glutathione content of liver patients. Four groups of subjects were selected: a) 9 patients with alcoholic liver disease treated with SAM-e (1.2 g/day orally for 6 months); b) 7 patients with non-alcoholic liver disease treated as above; c) 8 placebo-treated patients with alcoholic liver disease; and d) 15 normal subjects as a control group. Total and oxidized glutathione were assayed by high-performance liquid chromatography of liver biopsy specimens before and after the treatment period. In all patients pre-treatment hepatic glutathione was significantly decreased as compared with controls. SAM-e therapy resulted in a significant increase of hepatic glutathione levels both in patients with alcoholic and in those with non-alcoholic liver diseases as compared with placebo-treated patients. SAM-e may therefore exert an important role in reversing hepatic glutathione depletion in patients with liver disease.

ADVERSE REACTIONS:
SAM-e has proven to be safe when taken at recommended dosages. The most common side effect is mild digestive distress. SAM-e should not be combined with other standard antidepressants without the supervision of a physician. SAM-e should not be taken by those with bi-polar disorder (manic depression). Parkinson’s disease patients should be cautious about taking SAM-e with the drug levodopa, SAM-e may interfere with the drug’s actions.

RECOMMENDED USE:
Take one tablet per day on an empty stomach.

STORAGE:
Store in a cool dry place.

This product cannot be shipped to Canada.