Where was the study conducted?
The University of Utah, School of Medicine, Salt Lake City, UT, served as the coordinating study center and oversaw the research and recruitment efforts of the 16 study centers. The study was led by Daniel O. Clegg, M.D., a Professor of Medicine and Chief of Rheumatology, Division of Rheumatology, University of Utah, School of Medicine. The GAIT biostatistician was Domenic J. Reda, Ph.D., from the Hines VA Cooperative Studies Program, which served as the study data management and analysis center. The GAIT Clinical Research Pharmacist was Crystal L. Harris, Pharm.D., at the Albuquerque VA Cooperative Studies Program Clinical Research Pharmacy, which manufactured, packaged, distributed, and provided analytical testing of the study agents along with regulatory support for GAIT. The 16 study centers and their lead investigators were:
- University of Alabama at Birmingham, Birmingham, AL; Larry W. Moreland, M.D.
- University of Arizona, Tucson, AZ; David Yocum, M.D.
- Cedars-Sinai Medical Center, Los Angeles, CA; Michael Weisman, M.D.
- University of California Los Angeles, Los Angeles, CA; Daniel Furst, M.D.
- University of California San Francisco, San Francisco, CA; Nancy Lane, M.D.
- Northwestern University, Chicago, IL; Thomas J. Schnitzer, M.D.
- Indiana University, Indianapolis, IN; John Bradley, M.D.
- The Arthritis Research and Clinical Centers, Wichita, KS; Frederick Wolfe, M.D.
- University of Nebraska Medical Center, Omaha, NE; James O'Dell, M.D.
- Hospital for Joint Diseases, New York, NY; Clifton Bingham, III, M.D.
- Case Western Reserve University, Cleveland, OH; Michele Hooper, M.D.
- University of Pennsylvania, Philadelphia, PA; H. Ralph Schumacher, Jr., M.D.
- University of Pittsburgh, Pittsburgh, PA; Chester Oddis, M.D.
- Presbyterian Hospital of Dallas, Dallas, TX; John J. Cush, M.D.
- University of Utah, Salt Lake City, UT; Christopher G. Jackson, M.D.
- Virginia Mason Medical Center, Seattle, WA; Jerry Molitor, M.D.
How many people participated in the study and who were they?
A total of 1,583 people participated in the study. People age 40 or older with knee pain and documented x-ray evidence of osteoarthritis were eligible to participate. Participants could not have used glucosamine for 3 months and chondroitin sulfate for 6 months prior to entering the study. Participants were about 59 years of age, on average, and nearly two-thirds of participants were women. Of the 1,583 study participants, 78 percent (1,229) were in the mild pain subgroup and 22 percent (354) were in the moderate-to-severe pain subgroup.
Were there any side effects from the treatments?
There were 77 reports of serious adverse effects during the study. Of those 77, only 3 were attributed to study treatments. Most side effects were mild, such as upset stomach, and were spread evenly across the different treatment groups. In addition, although GAIT was not designed to evaluate these risks, no change in glucose tolerance was seen for glucosamine nor was an increased incidence of cardiovascular events seen with celecoxib.
NCCAM Clearinghouse
The NCCAM Clearinghouse provides information on CAM and NCCAM, including publications and searches of Federal databases of scientific and medical literature. The Clearinghouse does not provide medical advice, treatment recommendations, or referrals to practitioners.
Toll-free in the U.S.: 1-888-644-6226, International: 301-519-3153
Web site: nccam.nih.gov, E-mail: info@nccam.nih.gov
For More Information
National Institute of Arthritis and Musculoskeletal and Skin Diseases
For information on rheumatic diseases such as osteoarthritis and diseases of the musculoskeletal and skin systems, contact the NIAMS Information Clearinghouse. Toll-free in the U.S.: 1-877-22-NIAMS
Web site: www.niams.nih.gov/hi/index.htm
NIH Office of Dietary Supplements
For scientific citations and abstracts on dietary supplements, visit the ODS Web site for access to the International Bibliographic Information on Dietary Supplements database. Web site: ods.od.nih.gov
U.S. Food and Drug Administration
For information on dietary supplement labeling requirements and safety monitoring, order the FDA Guide to Dietary Supplements from the U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition. Toll-free in the U.S.: 1-800-FDA-4010, Web site: www.cfsan.fda.gov
