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Limbrel - Arthritis Patients Confused By Medical Food for Osteoarthritis
Is there real benefit?

By Carol & Richard Eustice, About.com

Updated January 15, 2008

About.com Health's Disease and Condition content is reviewed by the Medical Review Board

Limbrel - Treatment Option for Osteoarthritis

Limbrel (flavocoxid) is a prescription medical food for the treatment of osteoarthritis. Some arthritis patients have been confused by the name and terminology associated with Limbrel.

The brand name "Limbrel" is very close to the brand name "Enbrel" (one of the TNF blocker drugs used to treat rheumatoid arthritis). The generic name for Limbrel is flavocoxid, which may be easily confused with COX-2 selective inhibitors, such as celecoxib (Celebrex). The differences are vast, and the confusion is a concern.

Limbrel Confusion Expressed On Our Forum

On our forum:
"In another forum somebody suggested taking Limbrel. I'm not sure if I can even get it in the UK. Has anyone in here tried it and what's it like?"

Another forum member responded, "Could the person have meant Enbrel?"

Limbrel - What is a Medical Food?

Limbrel is classified as a medical food, not as a drug or nutritional supplement. Medical foods have their own regulatory requirements and are regulated by the Center for Food Safety and Applied Nutrition, a Food Division of the FDA.

Medical foods are available by prescription only. According to the FDA, "a medical food is prescribed by a physician when a patient has special nutrient needs in order to manage a disease or health condition, and the patient is under the physician's ongoing care. The label must clearly state that the product is intended to be used to manage a specific medical disorder or condition."

"Medical foods are not meant to be used by the general public and may not be available in stores or supermarkets. Medical foods are not those foods included within a healthy diet intended to decrease the risk of disease, such as reduced-fat foods or low-sodium foods, nor are they weight loss products", according to the FDA.

  • Frequently Asked Questions About Medical Foods, from FDA/Center for Food Safety & Applied Nutrition
  • What's in Limbrel?

    Limbrel contains flavocoxid, a blend of concentrated flavonoids, primarily baicalin and catechin. Primus Pharmaceuticals, Inc., the company which markets Limbrel in the U.S., claims that the ingredients in Limbrel have both anti-inflammatory and antioxidant properties in a concentrated form which cannot be obtained through normal diet.

    The Mechanism of Limbrel

    According to Primus, Limbrel restores the body's normal metabolic inflammatory processes through dual inhibition of excess arachidonic acid metabolization and antioxidant action. Limbrel manages production of arachidonic acid metabolites, while inhibiting COX-1, COX-2, and 5-LOX (5-lipoxygenase), all of which contribute to osteoarthritis.

    Safety and Efficacy of Limbrel

    More than 20 million Americans have osteoarthritis. A new approach to managing the pain and disability associated with osteoarthritis which would help even a subset of patients would be welcome - as long as it was proven to be safe and effective. Because of it mechanism of action, Limbrel is thought to be potentially safer than NSAIDs or COX-2 inhibitors.

    Two safety studies were conducted by the manufacturer of Limbrel:

  • An 80 patient safety trial with a treatment dose of 250 mg. Limbrel twice daily revealed adverse effects comparable to placebo.
  • A second study, randomized and placebo-controlled in which one group received Celebrex and the other Limbrel, demostrated better WOMAC scores at 90 days for the Limbrel group. WOMAC (The Western Ontario MacMaster) is a validated instrument designed specifically for the assessment of lower extremity pain and function in osteoarthritis of the knee or hip.
  • More Limbrel Studies Are Underway

    600 more patients are involved in three clinical trials which are ongoing. Over 25,000 patients are being monitored in postmarketing surveillance associated with Limbrel.

    "Studies are limited but there is a doctor I spoke to who has treated over 500 patients with Limbrel. He has noted some benefit and finds it useful in patients who cannot or do not want to take NSAIDs", according to rheumatologist Scott J. Zashin, M.D.

    Related Resources

  • Limbrel (Flavocoxid)
  • Osteoarthritis Screening Quiz
  • Osteoarthritis - Test Your Knowledge
  • Guide To Osteoarthritis
  • Inflammation - Test Your Knowledge
  • Sources: What Is A Medical Food?, FDA; Medical Food Available For Management Of Osteoarthritis, Medscape; Flavocoxid (Systemic), MayoClinic.com; Safe Prescription Osteoarthritis Product Introduced Nationally, Press Release; Limbrel, limbrel.com

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