The New England Journal of Medicine
Barcelona, Spain (PRWEB) February 22, 2006
While “The New England Journal of Medicine” concludes that there is still no resolution for the use of supplements in treating knee osteoarthritis (OA), much of the data coming out of the GAIT study suggests otherwise.
Out of the 1,583 patients that were randomized, 1,258 (80%) completed the study.
In the overall population of all patients with mild to moderate pain (WOMAC Pain 125-300mm), the results, for supplement use, while positive, were not statistically significant.
Even the researchers themselves commented that the study had a number of limitations. The high rate of response to placebo (60.1%) and the relatively mild degree of pain from OA among participants, may have limited the ability to detect the benefits of the treatments.
However, in the severe pain group (WOMAC 301-400mm) the G+CS combination (79.2%) scored higher than both P (placebo) 54.3% and CE (celecoxib) 69.4%, concluding that the combination of glucosamine and chondroitin sulfate is effective in treating moderate to severe pain in patients with knee OA. Researchers also concluded that in this subgroup of patients with moderate to severe pain the combination therapy significantly decreased knee pain as measured by the OMERACT-OARSI response.
Also reported in “The New England Journal of Medicine” was that treatment with chondroitin sulfate alone was associated with a significant decrease in the incidence of joint swelling and effusion. There was a statistical improvement of joint swelling for the overall population, 28.3% to 12.4% (p=0.01) and celecoxib was from 26.1% to 13.4% (p=0.03).
Doctors treating patients are always concerned about addressing a number of issues. Getting the pain under control is the first step, however, dealing with all the other symptoms such as joint swelling, stiffness and function is just as important. It is a vicious cycle; joint swelling in 90% of patients is caused by joint effusion. Joint effusion is an increase of liquid inside the articular space, which produces pain and functional incapacity. According to Nicholas DiNubile, MD and orthopaedic surgeon, “It’s crucial when treating osteoarthritis to break that cycle and treat the disease. I find that joint supplements are a very effective and risk-free way of doing that and it’s good to have data that supports what I see in my clinical practice everyday.”
While this major clinical trial is not offering conclusive results, it suggests that there is a need for more research. Physicians, however, are more pragmatic. They see the supplements work every day for their patients who are suffering with OA. Jason Theodosakis M.D. has a decade of practical use and two best selling books on the subject. According to Theodosakis, “With any medical intervention, the risk/benefit/cost considerations must also be addressed. Glucosamine/chondroitin have the best safety record of any prescription or over-the-counter oral treatment for OA. The results of the GAIT study exulted the benefits in those who actually needed the most relief and the cost of good quality (pharmaceutical grade) supplements is approximately one dollar a day, a third of the price of the most popular drug prescribed.”
The selection process for the chondroitin sulfate and glucosamine used in the GAIT study was exhaustive. The study was conducted under pharmaceutical rather than dietary supplement regulations and, as such, the supplements were held to stringent standards of pharmaceutical manufacturing practices. Bioiberica is the leading manufacturer of pharmaceutical-grade chondroitin sulfate and was selected by the NIH as the exclusive supplier of chondroitin sulfate for the GAIT study. Its CSb™Bio-Active brand of chondroitin sulfate used in the study is commercially available in the US in Cosamin®DS.
For more information, or to arrange an interview with a company spokesperson or Dr. Theodosakis or Dr.DiNubile, please contact Tamara York at ADinfinitum, 212 693 2150 Ext 314, or Leesa Raab @ 212 693 2150 Ext. 309.
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