Aceclofenac versus naproxen in the treatment of ankylosing spondylitis: A double-blind, controlled study

The efficacy and tolerability of aceclofenac and naproxen sodium in the treatment of ankylosing spondylitis (AS) were evaluated and compared in this double-blind, multicenter, controlled study. Of the 130 patients who entered the study, 126 patients met the inclusion criteria. Efficacy was evaluated at baseline, 15 days, and 1, 2, and 3 months using a visual analog scale for spontaneous pain, a zero to three-point scale for pain on movement and pain at rest, and measurements of chest expansion, hand-to-floor distance, Schober's test, and normal daily activities. No significant between-group differences were seen for any of the variables at baseline, except hand-to-floor distance. Both drugs provided effective analgesia and a corresponding improvement in functional activity. Overall efficacy assessment made by the physician and patients was not statistically significant between the two treatment groups. The overall incidence of adverse effects was higher in the naproxen group than the aceclofenac group, 22 versus 15 patients, respectively. All adverse effects resolved. However, the overall assessment of tolerability given by the physician and patients was significantly (P < 0.05) higher for the aceclofenac group than for the naproxen group. The anti-inflammatory drug aceclofenac was shown to have satisfactory efficacy and tolerability when used in the treatment of AS.