Concerns over possible gastrointestinal bleeding and heart problems linked to COX-2 inhibitors such as Vioxx and Celebrex have opened the door to a little known product classified as a medical food for people suffering the pain of osteoarthritis.
Limbrel, introduced nationally this year, is a medical food promoted by the manufacturer as a good option for meeting “the distinctive nutritional requirements of patients with osteoarthritis” and reducing painful joint inflammation.
Controlled by the Food and Drug Administration, medical foods are used when certain nutrient needs can’t be met with a conventional diet, and they must include ingredients that are generally recognized as safe, an FDA standard.
Not “food,” “drug” or “supplement,” the FDA explains that medical foods are “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.”
Dr. Steven D. Levin, assistant professor of orthopaedic surgery at the Northwestern University Feinberg School of Medicine and chief orthopaedic surgeon for sports medicine at Evanston Northwestern Healthcare Medical Group, has been prescribing Limbrel for about two years. Limbrel already was available in the Chicago area.
“The patients I have been prescribing it to have done well,” he said. “It has been my experience that in my patient population the positive effect of Limbrel takes about one week.
“Limbrel does seem to ease the discomfort patients experience from arthritic knees and shoulders, especially early in the disease process.”
Produced by Primus Pharmaceuticals of Scottsdale, Ariz., Limbrel, or flavocoxid, comes in capsules and is available by prescription only. It comprises a proprietary blend of flavonoids, or plant pigments, that have antioxidant properties. They are found in everyday foods such as soy, cauliflower, kale, green tea and several types of beans. Flavonoids have been shown in numerous studies to have natural anti-inflammatory effects, but it would be impossible to get a high enough quantity for the desired effect through diet alone.
Dr. Brian Cole, head of the Cartilage Restoration Center at Rush University Medical Center and also head physician for the Chicago Bulls, said he and his colleagues had been looking for alternatives to the anti-inflammatory drugs commonly prescribed for osteoarthritis “because of what was going on with the COX-2s.”
Once he started prescribing Limbrel, the response rate among patients, including some of the Bulls, was “quite good.” Particularly in people with osteoarthritis of the knee, there has been less swelling and thus less pain in 50 to 75 percent of patients, compared with 75 percent to 85 percent with commonly prescribed COX-2 inhibiting medications. The side effects of Limbrel are minimal, he said, not much worse than those seen in studies from a placebo. He since has become a medical consultant for Primus.
John Erdman, a professor of food science and nutrition at the University of Illinois at Urbana-Champaign, said other medical foods eventually found their way to the regular marketplace. For example, he said, liquid nutrition products found in most supermarkets today, such as Ensure and Glucerna, which targets diabetic consumers, originally were sold as medical foods for undernourished patients. “Now those products are sold to [the public when people] just need a boost.”
The defining lines among terms such as nutraceuticals, functional foods, medical foods and dietary supplements can be confusing.
For those suffering the pain, however, it’s simply called a relief.