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.
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.
Source: The National Institute of Arthritis and Musculoskeletal and Skin Diseases