Does anybody know If glucosamine has been approved by the FDA?!

Does anybody know If glucosamine has been approved by the FDA?

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A long-awaited study of the popular arthritis supplements glucosamine and chondroitin was supposed to be the final word on the popular treatments. Instead, it has just reignited the debate over them.

Although the study didn't find any overall benefit to the supplements, many doctors don't think patients should give up on the treatments just yet. Some doctors reason that traditional arthritis pain remedies carry so many risks, the unproven treatments still might be worth a try. Many medical researchers, however, remain skeptical, saying it's unlikely the treatments have any effect at all.

Glucosamine, derived from shellfish, and chondroitin, made from cow cartilage, are among the most popular supplements on the market today, with combined sales in excess of $700 million. Many arthritis sufferers swear by the treatments, and a handful of studies, most of which have been sponsored by the supplement industry, have suggested the supplements really do help relieve arthritis pain.

The Glucosamine/chondroitin Arthritis Intervention Trial, or GAIT, was hailed as the largest-ever study of the supplements. The $12.5 million study was paid for by the National Center for Complementary and Alternative Medicine, part of the National Institutes of Health. At first look, the results of the GAIT study, released in the New England Journal of Medicine last week, appear to debunk the notion that the treatments really work. In the six-month study of more than 1,580 arthritis sufferers, most of whom had mild to moderate arthritis pain, glucosamine and chondroitin didn't offer any more pain relief than a placebo pill.

But the study researchers and other experts say it's not time to write off the supplements. In a group of sufferers with moderate to severe pain, the glucosamine/chondroitin combination appeared to work. In that group, 79% of glucosamine/chondroitin users reported their pain had dropped by at least 20% after treatment. By comparison, only 69% of patients taking the popular drug Celebrex reported similar benefits. About 66% of patients taking glucosamine alone felt better, while 61% of taking just chondroitin felt better. That compares with about 54% of the placebo group who experienced some pain relief.

However, the study had only about 350 patients with moderate to severe arthritis pain. And then those patients were divided up into five separate groups taking various combinations of the supplements, Celebrex or a placebo. In the end, the part of the study with the most promising data was really only a study of 142 patients -- 72 taking glucosamine and chondroitin and 70 taking a placebo.

"I think the subgroup finding is a clinically important finding," says Daniel Clegg, the study's lead author and chief of rheumatology at the University of Utah School of Medicine. "But it should be interpreted cautiously."

Even so, Dr. Clegg says the results were promising enough that he plans to seek funding for another study looking directly at the effect of glucosamine and chondroitin on moderate to severe arthritis sufferers.

While it might seem like grasping at straws to focus on the results of such a small study group, the truth is, arthritis sufferers don't have many other options. In recent years, new health worries have emerged about popular prescription pain relievers, and one of them, Vioxx, was withdrawn from the market because it was linked with a higher rate of heart problems.

Long-term use of nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen, found in Advil, or naproxen, found in Aleve, is also highly risky. Each year, side effects from NSAIDs cause nearly 103,000 hospitalizations and 16,500 deaths. The drugs can lead to indigestion, peptic ulcer disease and damage to the small intestine and colon, resulting in internal bleeding, bowel perforation and other life-threatening problems. In one recent study comparing arthritis patients who used NSAIDs to those who used Tylenol or took nothing for pain relief, nearly 60% of NSAID users developed ulcers or erosions in the small intestine compared with 17% of nonusers.

Vijay Vad, sports-medicine specialist at the Hospital for Special Surgery in New York, says he is concerned the study results will prompt people to start using traditional pain relievers. "We have fewer options for treating arthritis today than we did five years ago," Dr. Vad says. "What I don't want happening is for people to switch over to anti-inflammatory drugs in giant numbers. I think there are positives in this trial that show these supplements are potentially valuable for a certain subset of arthritis patients."

Another reason researchers don't want to give up on glucosamine and chondroitin is that most arthritis treatments simply don't work that well for a lot of people. Notably, in one part of the GAIT study, Celebrex, a proven pain reliever, didn't offer significant pain relief for half the people who used it.

The supplements, which cost about $30 a month, are considered safe -- the main risk is for people who have shellfish allergy. As a result, doctors typically advise patients to use them for three months to see if they notice a difference. And if the subgroup finding from the study is to be believed, the biggest effect comes from taking both glucosamine and chondroitin, not just one.

In addition, the first GAIT trial isn't over yet. About half of the GAIT participants will be treated for an additional 18 months. Researchers will compare X-rays taken at the beginning of the study and after one and two years to determine if the treatments result in any noticeable changes in the knee joint. (No one knows exactly how the supplements work but they might have a mild anti-inflammatory effect or slow the erosion of joint cartilage.) Results are expected in about a year.
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GAIT was conducted under an Investigational New Drug application filed with the U.S. Food and Drug Administration (FDA). All of the products used in the study were developed for the study and subject to the FDA's pharmaceutical regulations. The products were evaluated and manufactured by the VA Cooperative Studies Program Clinical Research Pharmacy, an FDA-licensed clinical research pharmacy center. The glucosamine and chondroitin sulfate used were tested for purity, potency, quality, and consistency among batches. Products were retested for stability throughout the study.
http://nccam.nih.gov/research/results/ga...