A multicentre, double-blind, randomised, parallel group study was undertaken to investigate the efficacy and safety of
aceclofenac (123 patients, 100 mg twice daily) in comparison to
piroxicam (117 patients, 20 mg once daily and placebo once daily) in patients with
osteoarthritis of the knee. The treatment period of two months was preceded by a washout period of one week duration. On completion of the study, patients in both
aceclofenac and
piroxicam-treated groups exhibited significant improvement in
pain intensity and functional capacity of the affected knee, as represented by the
Osteoarthritis Severity Index (OSI) (p < 0.0001 and p < 0.001 respectively). This was further substantiated following the patient's assessment of
pain intensity using the Visual Analogue Scale (VAS), in which significant improvements were demonstrated at all time points for each treatment group (p < 0.001). Although both treatment groups showed a significant improvement in all investigator's clinical assessments (functional exploration of the knee, knee flexion and extension (EXT)), there were no significant differences between the groups. There was, however, a more rapid improvement in knee flexion in the
aceclofenac group after 15 days of treatment. Both
aceclofenac and
piroxicam were well tolerated by patients, the most commonly reported adverse events being gastrointestinal, although their incidence was low. Only 24 patients on
aceclofenac, as opposed to 33 on
piroxicam complained of
dyspepsia, epigastralgia and
pyrosis. While 7 patients in each group were withdrawn because of adverse events, only one patient with
piroxicam was withdrawn because of severe upper gastrointestinal
bleeding. Twice as many reports of fecal blood loss were made in the
piroxicam group in comparison to the
aceclofenac group. In summary, this study confirms the therapeutic efficacy of
aceclofenac and suggests that it is a well-tolerated alternative
NSAID to
piroxicam in the treatment of
osteoarthritis.