A multicentre randomised, double-blind, parallel group, general practice study was undertaken to investigate the efficacy and safety of
aceclofenac (200 patients, 100 mg twice daily and placebo once daily) in comparison with
diclofenac (197 patients, 50mg three times daily) in patients with
osteoarthritis of the knee. The treatment period of twelve weeks was preceded by a washout period of two weeks duration. At end point, patients in both
aceclofenac and
diclofenac-treated groups exhibited significant improvement in
pain intensity (p = 0.0001). Although both treatment groups showed significant improvement in all investigators' clinical assessments (joint tenderness, swelling,
pain on movement, functional capacity, overall assessment), there were no significant differences between the groups. There was, however, a trend towards greater improvement in complete knee movement and reduced
pain on movement with
aceclofenac. In patients with initial flexion
deformity,
aceclofenac was significantly more effective than
diclofenac in improving knee flexion after 2-4 weeks treatment. Patients' subjective assessment of
pain relief demonstrated significantly greater efficacy with
aceclofenac. At end point, 71% of patients in the
aceclofenac group reported improvement in
pain intensity as compared to 59% treated with
diclofenac (p = 0.005). Tolerability of
aceclofenac was better than with
diclofenac as fewer patients experienced gastrointestinal adverse events. In particular, the incidence of treatment related diarrhoea was less with
aceclofenac (1%) than the
diclofenac (6.6%). In summary, this study supports a therapeutic role for
aceclofenac in
arthritis and suggests that it is an alternative
NSAID to
diclofenac in the treatment of
osteoarthritis.