from joint and bone newsletter

I just discovered the Joint and Bone newsletter from a forwarded post. The Joint and bone newsletter is free and looks absolutely wonderful. Here's their article talking about the results of a glucosamine trial, and talking a bit about the new trend in setting up studies via the internet. IMHO the more studies the better, so kudos to the internet study folks. Glucosamine no better than placebo in knee OA Boston, MA - Glucosamine may not improve knee pain in osteoarthritis (OA) after all, according to an independent, internet-based clinical trial reported in the November 1, 2004 issue of the American Journal of Medicine [1]. The 12-week study was conducted in 205 symptomatic knee OA patients aged 45 or older who were recruited over the internet and compared 1.5-g/day glucosamine with placebo. Patients on glucosamine did no better on measures of pain, stiffness, physical function, overall questionnaire score, and analgesic use compared with those who took placebo. The primary outcome measure was the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (Likert version). In addition, the number and type of adverse events reported was similar between the groups. "Our results suggest that although glucosamine appears to be safe, it is no more effective than placebo in treating the symptoms of knee osteoarthritis," says lead researcher Dr Timothy McAlindon (Tufts New England Medical Center, Boston, MA). The new study was not industry-funded, while many of the positive studies on glucosamine have been. "There is a real possibility of industry bias," he says. But this new study may not be the final word, McAlindon says. Results form the large-scale National Institutes of Health (NIH)-sponsored Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) are now being tallied. "Ours was an internet trial done primarily to test this approach," he tells rheumawire. "We definitely need more data, and the GAIT study will provide [this] and may give a definitive answer on whether or not glucosamine is effective in OA." First, do no harm McAlindon says: "Glucosamine is safe — in fact, it's a lot safer than pills we prescribe without a thought, like ibuprofen, so if individuals try glucosamine instead of rofecoxib [Vioxx, Merck], they may actually encounter fewer adverse effects." He adds that he doesn't discourage people from trying it. "It's a real conundrum, so many people use it and feel it helps, and supposing the conclusion of the GAIT study is that it has no efficacy, what will happen will they take the next Vioxx?" he tells rheumawire. "I wish our study had been positive." Glucosamine guru sounds off A prominent proponent of the use of glucosamine for osteoarthritis is Dr Jason Theodosakis, who works in private practice and also holds the post of assistant clinical professor at the University of Arizona College of Medicine. He is the author of the best-selling book Arthritis Cure [2] and runs a website, Dr Theo online. "A huge confounder is that this trial failed to monitor activity," Theodosakis tells rheumawire. "I have a patient who was an elite runner who ran marathons in 2:20- to 2:30-hour range, and I put him on glucosamine and chondroitin and he started to run again, but after mile 12, he would get a flare-up," he says. According to some trials, he would be a failure, but he went from 0 to 12 miles. "This makes it hard because people with OA increase activity until they feel their symptoms, and unless we start looking at that, negative studies will continue." Another caveat is that this was a 12-week trial, he says. "That is short for a full effect; it usually takes a minimum of six months. These supplements are not meant for short-term use and, certainly by clinical experience, 12 weeks is not sufficient to see an effect," he says. "We need to view supplements less like ibuprofen or acetaminophen and more like calcium for osteoporosis." "This is one of many studies, and just because there is a negative study, does not mean treatment is negative," Theodosakis says. "A large percentage of people respond many months down the road." Internet fertile ground for clinical trials The new trial was conducted solely over the internet, as reported by rheumawire [3]. The cost of conducting this trial online was estimated at $914 per participant. By contrast, a traditional trial costs $1925 per participant. Savings came from doing away with the need for clinical space, nursing services, and travel reimbursement for the participants. Data entry too saved both time and money in this trial. Participants reported their responses in scheduled online sessions every 2 weeks, and these responses went directly into the database. As soon as the last response was recorded, the database was locked. McAlindon et al are now using the internet to test the approach of case-control risk-factor studies in lupus, OA, and gout. Recruitment will take place through the Google search engine. Denise Mann Sources McAlindon T, Formica M, LaValley M, Lehmer M, Kabbara K. Effectiveness of glucosamine for symptoms of knee osteoarthritis: results from an internet-based randomized double-blind controlled trial. Am J Med 2004 Nov 1; 117(9):643-9. Theodosakis J, Adderley B, Fox B. The Arthritis Cure. New York, NY: St Martin's Press, 1997. McAlindon T, Formica M, Kabbara K, LaValley M, Lehmer M. Conducting clinical trials over the Internet: feasibility study. BMJ 2003 Aug 30; 327(7413):484-7.