A randomized, single-blind comparison of the efficacy and tolerability of hyaluronate acid and meloxicam in adult patients with Kashin–Beck disease of the knee

Abstract

The aim of this study was to prospectively evaluate the efficacy and tolerability of hyaluronic acid (HA) and meloxicam for the treatment of knee pain due to Kashin-Beck disease (KBD). A total of 162 patients with KBD-based knee pain were randomly assigned to treatment with a 3-week course of HA (n = 80) and a 12-week course of meloxicam (n = 82). Clinical assessments for each patient were made at 0 (baseline), 1, 2, 4, 8, and 12 weeks. The primary efficacy measure was visual analog scale (VAS) pain score. Second efficacy measures comprised the Western Ontario and McMaster Universities (WOMAC) A (pain), B (stiffness), and C (function) scores as well as patients' and physicians' global assessments. Tolerability was evaluated based on adverse events (AEs) and physician reporting. The VAS rapidly decreased in both groups over 12 weeks. The VAS improvement observed in HA group was lower at week 1 (p = 0.001) but better at weeks 8 and 12 (p < 0.001) than the meloxicam group, which were supported by the secondary variables of WOMAC A (p = 0.001) and WOMAC C (p < 0.001) scores and the global assessments of the patients and their physicians (p = 0.020 and 0.003, respectively). No serious AEs were reported, and the overall incidence of AEs among patients treated with meloxicam was higher than in patients treated with HA (p = 0.012). This study suggests that intra-articular injection of HA and administration of oral meloxicam should be efficacious and well tolerated in the treatment of knee pain due to KBD; the onset of action of meloxicam was faster than that of HA, whereas HA therapy resulted in a more prolonged increasing improvement of symptoms than meloxicam. In addition, HA treatment was likely superior to meloxicam with respect to tolerability. Other randomized double-blind studies are needed to confirm the findings of our open-label study.