NIH, European Studies Back Efficacy of Glucosamine, Chondroitin

BETHESDA, Md. & LISBOA, Portugal--Glucosamine and chondroitin are effective and well-tolerated treatments for osteoarthritis pain, according to results of two new clinical trials slated for presentation at the Annual Scientific Meeting of the American College of Rheumatology (ACR) in San Diego in November.

The first trial, called the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT), has been anticipated by the nutraceutical industry, as the multi-centered study was sponsored by the National Institutes of Health (NIH) through a $14 million Congressional appropriation and announced in 2000. 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. All study participants were allowed up to 4,000 mg/d acetaminophen as a rescue analgesia, except within 24 hours of patient evaluations. Of 1,583 participants, 1,258 individuals with a mean age of 58.6 years, a body mass index of 31.7 kg/m2, and a 10-year history of osteoarthritis symptoms completed the study. The researchers found the combination of glucosamine and chondroitin sulfate was most effective in relieving severe knee pain, aiding almost 80 percent of study participants; the abstract further noted all treatments were well tolerated.

"Our branded ingredient CS^bTM Bio-Active is again being supported by scientific evidence," said Patricia Estepa Clemente, project manager joint care for Bioiberica S. A. "Bioiberica S.A. is very pleased with this new outcome and as Joint Health experts we aim to continue bringing more research and knowledge to help in the growth of this promising market category."  

Similar results were reported in the second study, the European-sponsored Glucosamine Unum In Die Efficacy (GUIDE) trial. Researchers compared the effect of 1,500 mg/d glucosamine sulfate, 3,000 mg/d acetaminophen and placebo on various osteoarthritis pain and mobility indices in 318 osteoarthritis patients (88 percent women) over 24 weeks. Ibuprofen (400 mg/d) was permitted as a rescue medication. Glucosamine sulfate was efficacious in reducing scores on various osteoarthritis symptom indices. There were no differences in safety among treatments. The researchers concluded 1,500 mg/d glucosamine sulfate might be the preferred symptomatic medication in knee osteoarthritis.

"We are extremely pleased with the outcome of both trials, and look forward to their presentation at ACR and subsequent publication," said Andrew Shao, Ph.D., vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN). "These are two well-designed, well-conducted, gold-standard studies that we believe will offer further support to the already long list of studies demonstrating the safety and benefits of glucosamine and chondroitin for joints."