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.
Background: To study the efficacy of vitamin D supplementation therapy with three different protocols. Methods:In protocols 1 (intensive) and 3 (standard) oral cholecalciferol was given 60,000 IU/week/8 weeks followed bimonthly for 12 weeks. In protocol 2 parenteral-bolus cholecalciferol was given as 600,000 IU loading dose, 8 weeks later followed by cholecalciferol 60,000IU bimonthly for 12 weeks. Elemental calcium (1 g/day) was administered for full duration of study in all three protocols. Serum albumin, calcium, phosphorous, alkaline phosphatase, 25-hydroxy vitamin D (25OHD) and parathyroid hormone were tested at baseline, at 2 nd , and 5 th months. Statistical analysis was performed using random measures analysis of variance. As patients receiving protocol 3 were significantly older compared to the other two groups, age-adjusted analysis was carried out.Results: Intention-to-treat and per-protocol analysis showed that patients receiving protocol 2 had achieved 25OHD sufficiency levels at 8 weeks suggesting that protocol 2 appeared to perform best among the three protocols. However, these differences were not sustained at 5 months suggesting the need for continuing supervision. Conclusions:Despite varied responses of different biochemical markers, all three protocols were effective in bringing up 25OHD levels. However, protocol 2 performed the best among the three protocols. Our observation also highlight the importance of need for ongoing supplementation and continuing supervision of the same.
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