NEJM Releases GAIT Results

BETHESDA, Md. & LISBOA, Portugal--Study results published in the new issue of The New England Journal of Medicine are again raising the profile of glucosamine and chondroitin sulfate for treating osteoarthritis. The Glucosamine/chondroitin Arthritis Intervention Trial (GAIT)--a multi-center, $14 million, National Institutes of Health (NIH)-sponsored study--evaluated the efficacy and safety of the nutritional compounds in more than 1,500 patients with knee osteoarthritis. In the active 24-week intervention portion, researchers from more than a dozen health care facilities across the United States compared the effects of 500 mg/tid glucosamine hydrochloride, 400 mg/tid sodium chondroitin sulfate (supplied by Bioiberica S.A.), both of these treatments administered simultaneously, 200 mg/d celecoxib (a drug used to relieve arthritis symptoms) and placebo, on patients with knee pain.

Initial results from the GAIT study were presented at the American College of Rheumatology in November 2005 with discussion at a special symposium following the event. (For more on those stories, visit /sitecore/content/repository/nutrition/articles/2005/11/nih-european-studies-back-efficacy-of-glucosamine.aspxand www.naturalproductsinsider.com/articles/611study01.html.) The NEJM study results (354:795-808, 2006) mirrored the earlier release, with neither nutrient combination nor the individual compounds reducing pain effectively in the overall group of patients (n=1,583) compared to placebo or celecoxib. The researchers, led by Daniel O. Clegg, M.D., from the University of Utah, Salt Lake City, did find a significantly higher response rate to the nutrient combination in patients with moderate-to-severe pain at baseline, aiding almost 80 percent of study participants; the abstract further noted all treatments were well tolerated. In addition, a smaller, ancillary study is ongoing to investigate whether the nutrient combination may alter the progression of osteoarthritis; results are expected in about a year.

NIH released a statement on the study results, noting while the nutrients did not appear to provide significant pain relief among all participants, the ability of the combination to alleviate severe knee pain is promising. "This rigorous, large-scale study showed that the combination of glucosamine and chondroitin sulfate appear to help people with moderate-to-severe pain from knee osteoarthritis, but not those with mild pain," said Stephen E. Straus, M.D., director of the National Center for Complementary and Alternative Medicine (NCCAM). "It is important to study dietary supplements with well-designed research in order to find out what works and what does not."

The Council for Responsible Nutrition (CRN) further applauded the work, noting the GAIT findings are supported by the vast majority of more than 50 published clinical trials demonstrating the safety and efficacy of glucosamine and chondroitin in treating osteoarthritis and joint discomfort. Andrew Shao, Ph.D., CRN's vice president of scientific and regulatory affairs, noted, "The results from this study not only indicate that more research is needed to determine the full potential of glucosamine and chondroitin, but also to reconfirm that these supplements can help the growing number of Americans with joint problems reduce the pain of osteoarthritis."