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A new "medical food" recently hit the market as a treatment for osteoarthritis. It's Limbrel, manufactured by Primus Pharmaceuticals, and it allegedly offers pain relief in a different and safer way than standard arthritis drugs.
"Medical foods" like Limbrel are regulated by the Food and Drug Administration and are available only by prescription. They differ from standard drugs in that they are made up of ingredients "generally recognized as safe" according to FDA terminology. Because of this, they don't have to go through the long process of testing and approval required of other prescriptions. The makers of medical foods do have to show that they are an effective treatment for a specific condition.
So just what type of foods ingredients are in Limbrel? According to the maker, Limbrel contains highly concentrated and refined natural flavonoids similar to those found in green tea, cocoa, cauliflower, kale, red wine, soy and peanuts. It would be impossible to simply eat enough of the foods containing the beneficial flavonoids to get the concentration found in Limbrel. The patented blend of flavonoids that goes into Limbrel is called flavocoxid. Root and bark extracts are the source of these natural compounds.
Dr. Jonathan Cluett, About.com's orthopedics guide states, "The flavonoid extracts found in Limbrel appear to have anti-inflammatory properties by inhibiting enzymes that cause inflammation. These enzymes, called COX (cyclooxygenase) and LOX (lipooxygenase) create molecules that cause inflammation and pain."1 Limbrel affects the metabolic processes that cause arthritic damage.
If Limbrel does indeed offer the hoped-for relief from arthritis, it would be a welcome new weapon. Many other prescriptions and over the counter medicines recommended for arthritis are non-steroidal anti-inflammatory drugs (NSAIDs). These drugs such as asprin, Motrin, and Aleve work by blocking 2 forms of the COX enzymes, COX-1 and COX-2. COX-2 is produced as a result of inflammation, but COX-1 works to protect the stomach from damage from strong digestive fluids. Blocking both enzymes eased arthritis symptoms, but caused nausea and even ulcers as a side effect.
Eventually drug companies came out with what was seen as a refinement, COX-2 inhibitors, which functioned by blocking just one of the enzymes, and was touted as free of some of the undesirable digestive problems. After several years of use, the COX-2 inhibitors didn't live up to expectations. According to the American Academy of Orthopedic Surgeons website, "some studies have not shown any difference between the incidence of gastrointestinal side effects from traditional NSAIDs and COX-2 inhibitors." 2
Vioxx and Bextra were two of the COX-2 inhibitors, but both eventually were taken off the market by their manufacturers due to worries about cardiovascular complications. Limbrel offers arthritis relief without major side effects. A few patients have reported rash and itching or slight indigestion after taking it.
Limbrel is dispensed in 250 mg capsules and is taken twice a day about an hour before or after a meal for best absorption. The Walgreen's Pharmacy site lists a 30 day supply of 60 tablets at $105.99. Because this is a fairly new medical food, insurance coverage is problematic.
1 http://orthopedics.about.com/o d/paintreatment/p/limbrel.htm
2 http://orthoinfo.aaos.org/fact /thr_report.cfm?Thread_ID=398& topcategory
http://www.walgreens.com/libra ry/finddrug/druginfo.jsp?parti cularDrug=Limbrel
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