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.