Efficacy of a combination of FCHG49 (TM) glucosamine hydrochloride, TRH122(TM) low molecular weight sodium chondroitin sulfate and manganese ascorbate in the management of knee osteoarthritis

Objectives: The objective of this study was to evaluate the oral combinatio n of glucosamine HCl, sodium chondroitin sulfate and manganese ascorbate fo r the treatment of osteoarthritis (OA) of the knee. Design: A randomized placebo-controlled study design was implemented. We re cruited 93 patients with OA of the knee from a single center. The intervent ion group received 1000 mg FCHG49(TM) glucosamine HCl, 800 mg TRH122(TM) lo w molecular weight sodium chondroitin sulfate and 152 mg manganese ascorbat e twice daily (Cosamin(R)DS). Patients were evaluated initially and then ev ery 2 months for 6 months. The primary outcome was the Lesquene Index of se verity of osteoarthritis of the knee (ISK). Results: Patients with radiographically mild or moderate OA (N=72) in the i ntervention group showed significant improvement in the ISK at 4 and 6 mont hs (P=0.003 and P=0.04, respectively). The response rate to the medication was 52% vs a 28% response rate to placebo. Patients with radiographically s evere osteoarthritis (N=21) did not show significant improvements in the IS K. There was a 17% incidence of adverse events in the intervention group an d 19% in the placebo group. Conclusions: The studied combination of glucosamine HCl, sodium chondroitin sulfate and manganese ascorbate was found to be effective for the treatmen t of radiographically mild to moderate OA of the knee as measured by the IS K. This is the first U.S. study of these agents. (C) 2000 OsteoArthritis Re search Society International.