Rebecca Wright02.27.06
The long-awaited results from the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) were published in the New England Journal of Medicine (NEJM) in late February. Following publication, the news was picked up by major media. One headline read “Supplements Fail to Ease Arthritis,” while another touted “No Overall Benefit for Mild Arthritis from Supplements.” The latter headline graced the pages of USA Today for a story that started out by saying, “For many arthritis sufferers, there has been a long and frustrating search for the best and safest pain relief. For some, the quest seemed to lead to a health store for unregulated supplements.”
The reality, according to the Council for Responsible Nutrition (CRN), Washington, D.C., is that the combination of glucosamine and chondroitin significantly reduced pain in those suffering the most. “The clinical trial, sponsored by the National Institutes of Health (NIH), Bethesda, MD, found that using a combination of the two supplements ‘significantly decreased’ knee pain in osteoarthritis (OA) patients experiencing moderate-to-severe pain,” the organization said. OA is the most common form of arthritis.
Indeed, the official release from NIH said that while glucosamine and chondroitin did not provide relief among all patients suffering from mild OA of the knee, the combination of the two did provide significant relief in a small subgroup of patients suffering from moderate-to-severe OA of the knee. However, according to Daniel Clegg, MD, principal author of the study, “Because of the small size of the moderate-to-severe pain subgroup, the findings in this group for glucosamine plus chondroitin sulfate should be considered preliminary and need to be confirmed in a study designed for this purpose.” The USA Today article discussing the GAIT results also claims that Dr. Clegg received fees or grant support from Pfizer, maker of Celebrex, or McNeil Consumer & Specialty Pharmaceuticals, which produces Tylenol.
The six-month GAIT study was funded by the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which are both part of the NIH. It involved nearly 1600 OA patients, who were given a placebo or daily doses of 1500 mg of glucosamine hydrochloride and/or 1200 mg of chondroitin sulfate or 200 mg of the common prescription pain medication celecoxib (Celebrex).
On entering the study, a participant’s level of pain was assessed as either mild or moderate-to-severe using standard pain assessment tools and scales, such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Of the 1583 study participants, 78% fell into the mild pain subgroup, while the other 22% were considered part of the moderate-to-severe pain subgroup. Level of pain was evaluated at weeks four, eight 16, and 24 using the WOMAC scale and other tools. In addition to taking their daily study treatment, participants could take up to 4000 mg of acetaminophen daily for pain, except for the 24 hours before they were assessed by study staff. The use of acetaminophen, however, was low, overall averaging fewer than two 500 mg tablets per day. Participants could not take other non-steroidal anti-inflammatory (NSAID) medicines or narcotic (opioid-based) pain relievers during the study.
Due to the positive results in the small subgroup of moderate-to-severe patients, more analysis is planned. The GAIT team will also continue its research with a smaller study to see whether glucosamine and chondroitin sulfate can alter the progression of OA, such as delaying the narrowing of the joint spaces. About one-half of the participants in the larger GAIT study were eligible to enroll in this ancillary study. The results are expected in about a year.
The reality, according to the Council for Responsible Nutrition (CRN), Washington, D.C., is that the combination of glucosamine and chondroitin significantly reduced pain in those suffering the most. “The clinical trial, sponsored by the National Institutes of Health (NIH), Bethesda, MD, found that using a combination of the two supplements ‘significantly decreased’ knee pain in osteoarthritis (OA) patients experiencing moderate-to-severe pain,” the organization said. OA is the most common form of arthritis.
Indeed, the official release from NIH said that while glucosamine and chondroitin did not provide relief among all patients suffering from mild OA of the knee, the combination of the two did provide significant relief in a small subgroup of patients suffering from moderate-to-severe OA of the knee. However, according to Daniel Clegg, MD, principal author of the study, “Because of the small size of the moderate-to-severe pain subgroup, the findings in this group for glucosamine plus chondroitin sulfate should be considered preliminary and need to be confirmed in a study designed for this purpose.” The USA Today article discussing the GAIT results also claims that Dr. Clegg received fees or grant support from Pfizer, maker of Celebrex, or McNeil Consumer & Specialty Pharmaceuticals, which produces Tylenol.
The six-month GAIT study was funded by the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which are both part of the NIH. It involved nearly 1600 OA patients, who were given a placebo or daily doses of 1500 mg of glucosamine hydrochloride and/or 1200 mg of chondroitin sulfate or 200 mg of the common prescription pain medication celecoxib (Celebrex).
On entering the study, a participant’s level of pain was assessed as either mild or moderate-to-severe using standard pain assessment tools and scales, such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Of the 1583 study participants, 78% fell into the mild pain subgroup, while the other 22% were considered part of the moderate-to-severe pain subgroup. Level of pain was evaluated at weeks four, eight 16, and 24 using the WOMAC scale and other tools. In addition to taking their daily study treatment, participants could take up to 4000 mg of acetaminophen daily for pain, except for the 24 hours before they were assessed by study staff. The use of acetaminophen, however, was low, overall averaging fewer than two 500 mg tablets per day. Participants could not take other non-steroidal anti-inflammatory (NSAID) medicines or narcotic (opioid-based) pain relievers during the study.
Due to the positive results in the small subgroup of moderate-to-severe patients, more analysis is planned. The GAIT team will also continue its research with a smaller study to see whether glucosamine and chondroitin sulfate can alter the progression of OA, such as delaying the narrowing of the joint spaces. About one-half of the participants in the larger GAIT study were eligible to enroll in this ancillary study. The results are expected in about a year.
