A randomized comparative study of safety and efficacy of immediate release glucosamine HCL and glucosamine HCL sustained release formulation in the treatment of knee osteoarthritis: A proof of concept study

摘要

Objectives:To compare the safety and efficacy of glucosamine HCl- sustained release (GLU-SR) with that of Glucosamine HCl- immediate release (GLU-IR) in patients with knee osteoarthritis (OA).Materials and Methods:This study involved 59 patients with knee OA, randomised to receive single oral dose of 1,500 mg, GLU-SR and GLU-IR for 60 days with 31 and 28 patients, respectively. The primary efficacy (pain and function) was assessed using visual analogue scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Intention-to-treat principle, repeated measure of ANOVA and mixed model analysis were used.Results:The patients baseline, demographic and clinical characteristics were comparable between groups with female preponderance (71.20%). There was a significant reduction in algofunctional indices as primary outcome measure in both the groups across time (P < 0.001) and 29% lesser adverse events (AEs) in GLU-SR group, with no difference in the use of rescue medications.Conclusions:The study showed equal efficacy of the glucosamine formulations on algofunctional indices in reducing pain in patients with knee OA with less number of AEs in GLU-SR.