NIH GAIT Trial Second Government Study to Affirm Positive Effects of Glucosamine/Chondroitin Sulfate Combination on Knee Pain.EDGEWOOD, Md. -- The February 23rd edition of the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. reported a detailed analysis of the taxpayer funded, National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ), Glucosamine/chondroitin Arthritis Intervention Trial (GAIT). This randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled trial was reported to be the first study of its kind to evaluate the clinical effects of chondroitin sulfate and glucosamine glucosamine /glu·co·sa·mine/ (gloo-ko´sah-men) an amino derivative of glucose, occurring in glycosaminoglycans and a variety of complex polysaccharides such as blood group substances. hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. , individually and in combination on safety and effectiveness. One of the outcomes of this 24-week study was the response rate to the combination of glucosamine hydrochloride and chondroitin sulfate in those study participants with moderate to severe knee pain, which was reported as 79.2%, statistically higher than that of a placebo agent (54.3%) and higher than celecoxib (69.4%). In February, 1999, a study published in the Journal of Military Medicine, Vol. 164, the Medical Department of the Naval Special Warfare Group A permanent Navy echelon III major command to which most naval special warfare forces are assigned for some operational and all administrative purposes. It consists of a group headquarters with command and control, communications, and support staff; sea-air-land teams; and sea-air-land Two, in Norfolk, Virginia reported their own independent, 16-week, randomized, double-blind, placebo controlled trial of the combination glucosamine HCl (1500 mg/day, same as in GAIT), chondroitin sulfate (1200 mg/day, same dose and same source ingredient as used in GAIT). These were used in study participants with chronic pain of the knee or low back. Their conclusion: the combination relieves "symptoms of knee osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. ". The Naval study was looking for an alternative approach for those with chronic knee or back pain to the standard use of non-steroidal anti-inflammatory agents (NSAIDs) which have well-known side effects. This study was in a single center as compared to the large multi-center GAIT study. Study participants received the combination glucosamine HCl/chondroitin sulfate sulfate, chemical compound containing the sulfate (SO4) radical. Sulfates are salts or esters of sulfuric acid, H2SO4, formed by replacing one or both of the hydrogens with a metal (e.g., sodium) or a radical (e.g., ammonium or ethyl). (Cosamin(R)DS); or a look-alike placebo capsule. During the protocol, participants were not permitted to use NSAIDs but were permitted acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. (similar to GAIT study). In addition to a physician's physical examination of the participant (not provided in the GAIT study), the following were also included: the participants own self assessment tool, a running exercise, the Lequesne index of severity (GAIT used WOMAC WOMAC Western Ontario McMaster University Osteoarthritis Index Rheumatology An arthritic pain scoring system ranging from 0–no pain/disability to 100–most severe pain/disability and Omeract OARSI pain assessment tools), and knee range of motion were also evaluated. The Naval study was sponsored and supported by the Bureau of Medicine and Surgery Clinical Investigation Program. Nutramax Laboratories, Inc. supplied the CosaminDS and matching placebo capsule but had no influence or participation in the study implementation, conduct and reporting, all of which were performed independent of the company. For the GAIT study, Nutramax Laboratories, Inc. was the only commercial products company providing testing services. It also provided NIH a portion of the chondroitin sulfate during the GAIT trial so that the study could move forward without interruption. Nutramax Laboratories, Inc. had no influence or participation in the study design, conduct and reporting. About Nutramax Laboratories, Inc.: Nutramax Laboratories, Inc. researches, develops, and markets products to support the active lifestyles of people. Nutramax Laboratories, Inc. Consumer Products Division markets Cosamin(R)DS joint health supplement that contains the exclusive chondroitin sulfate selected for inclusion by the National Institutes of Health (NIH) GAIT study and supplied to NIH by Bioiberica S. Nutramax Laboratories, Inc. supplied NIH GAIT Study a portion of the chondroitin sulfate. For more information, please contact Nancy Belle at 410-776-4035 to arrange for physician or company spokesperson interview, or visit us online at www.nutramaxlabs.com |
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