Comparison of Efficacy and Tolerability of Immediate Release Glucosamine HCL And Glucosamine HCL Sustained Release Formulation in the Treatment of Knee Osteoarthritis; A Randomised Clinical Trial

ABSTRACT

Background: Osteoarthritis (OA) is the most common form of and a leading cause of chronic disability between fourth and fifth decade of life, with a prevalence ranging between 17-60.6% in India. Objective: To compare the efficacy and safety profile of glucosamine HCl- sustained release (GLU-SR) with that of Glucosamine HCl- immediate release (GLU-IR) in patients with knee osteoarthritis (OA). Methods: This was an open labelled, randomised, controlled trial conducted in a tertiary care hospital at Kanpur. The study involved 60 patients with knee OA, randomised to receive single oral dose of 1,500 mg GLU-SR and GLU-IR for 60 days with 30 patients in each group. The primary efficacy being reduction in pain and improvement in 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 for statistical analysis. The history of adverse reactions experienced was collected throughout the study period. Results: There was a significant reduction in algo functional indices as primary outcome measure in both the groups (P < 0.001). A significant difference (P < 0.05) in the number of patients reporting ADR in the GLU-SR arm (38% lesser) was noted as compared to GLU-IR arm, with no difference in the use of rescue medications in both arms. Conclusions: From the observations made in this study it is concluded that GLU-SR is as effective as GLU-IR in the management of knee OA; with an advantage of having a better safety profile.