|NATIONAL INSTITUTES OF HEALTH|
|For Immediate Release
Wednesday, September 15, 1999
Anita Greene, NCCAM (301) 496-1712
NIH Awards Study on Glucosamine/Chondroitin Sulfate for Knee Osteoarthritis
Research Update February 23, 2006: Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) Study Results
Bethesda, MD. The first U.S. multicenter study to investigate the dietary supplements glucosamine and chondroitin sulfate for knee osteoarthritis has been awarded by the National Center for Complementary and Alternative Medicine (NCCAM) in collaboration with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), two components of the National Institutes of Health (NIH).
The University of Utah School of Medicine was awarded a 4-year research contract totaling approximately $6.6 million to coordinate a nine-center effort to study the effectiveness of glucosamine and chondroitin sulfate, two natural substances found in and around the cells of cartilage, in over 1,000 patients with osteoarthritis of the knee. Daniel O. Clegg, M.D., professor of medicine, Division of Rheumatology, University of Utah School of Medicine, will direct the coordinating center, which will oversee the research and patient recruitment efforts of nine study centers across the country.
"Osteoarthritis is a major public health problem affecting the quality of life for a large portion of the older American population," said NIAMS Director Stephen I. Katz, M.D., Ph.D. "We hope to determine the effectiveness of glucosamine and chondroitin sulfate in reducing pain and improving mobility in patients with osteoarthritis of the knee," he added.
The nine study centers include:
|Arthritis Research and Clinical Centers, Wichita, KS||Frederick Wolfe, M.D.|
|Case Western Reserve University, Cleveland, OH||Michele Hooper, M.D.|
|University of California at San Diego, San Diego, CA||Michael H. Weisman, M.D.|
|University of California at San Francisco, San Francisco, CA||Nancy E. Lane, M.D.|
|Indiana University School of Medicine, Indianapolis, IN||John D. Bradley, M.D.|
|University of Nebraska Rheumatology Network, Omaha, NE||James R. O'Dell, M.D.|
|University of Pennsylvania School of Medicine, Philadelphia, PA||H. Ralph Shumacher, Jr., M.D.|
|University of Utah School of Medicine, Salt Lake City, UT||Christopher G. Jackson, M.D.|
|Virginia Mason Medical Center, Seattle, WA||Daniel E. Furst, M.D.|
Researchers at the centers will conduct a randomized, double-blind, placebo-controlled study consisting of four arms: (1) patients taking glucosamine alone, (2) patients taking chondroitin sulfate alone, (3) patients taking glucosamine and chondroitin sulfate together, and (4) patients taking a placebo. Patients will be evaluated at monthly intervals for 16 weeks and closely monitored for improvement of their osteoarthritis as well as for any possible adverse reactions to the agents. Medical evaluations and x rays will be used to document the patients' diagnoses. The primary outcome will be measured as improvement in pain. Improvement in function will be included as a secondary outcome. Patient recruitment is expected to begin in 6 months.
Osteoarthritis (OA), also called degenerative joint disease, is caused by the breakdown of cartilage, which is the connective tissue that cushions the ends of bones within the joint. It is characterized by pain, joint damage, and limited motion. The disease generally occurs later in life, and most commonly affects the hands and large weight-bearing joints. Although the disease can impact several joints, the knees are often affected. An estimated 21 million adults in the United States are affected with OA. Age, female gender, and obesity are risk factors for knee OA, which is associated with progressive reduction in function, including difficulty in changing from the sitting to the standing position, and with a decrease in mobility. In 1994, advanced OA accounted for 85 percent of knee joint replacement surgeries among Medicare recipients.
Alternative approaches to controlling pain and functional impairment in OA have recently received wide attention due to the prevalence of various formulations of glucosamine and chondroitin sulfate currently marketed and sold as nutritional or dietary supplements. Several new books and news publications have recently promoted the use of glucosamine and chondroitin sulfate as effective treatments for arthritis.
On January 27, 1998, the NCCAM convened a group of scientists to discuss the need, rationale, and feasibility of conducting a Phase III study (a human study involving over 1,000 patients to test the efficacy, safety, and side effects of a substance(s)) on glucosamine and chondroitin sulfate for the treatment of knee OA. The group, consisting of experts in OA, alternative medicine, biostatistics, family practice, and staff from the NIH and the U.S. Food and Drug Administration determined that, "...there is a real and urgent public health need to test these agents in a rigorous way." They concluded that current data support short-term testing of glucosamine and chondroitin sulfate in pain control and functional improvement of OA.
"Complementary and alternative treatments are increasingly popular among consumers who are interested in other options to improving pain and achieving optimal health," said William R. Harlan, M.D., acting director of the NCCAM. "Providing solid evidence on the benefits and safety of this treatment may help expand health care options for patients challenged with this condition," Harlan concluded.
The mission of the National Center for Complementary and Alternative Medicine (NCCAM) is to conduct and support basic and applied research and research training and disseminate evidenced-based information on complementary and alternative medical practices to health professionals and the public. For more information, contact the NCCAM's Clearinghouse at 1-888-644-6226 or visit the NCCAM web site at http://nccam.nih.gov
The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. For more information about NIAMS, call their Information Clearinghouse at (301) 495-4484 or visit the NIAMS web site at http://www.niams.nih.gov/ .
Both the NCCAM and NIAMS are components of the National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services.