Double-blind, randomized and parallel comparison between droxicam and diclofenac sodium in patients with coxarthrosis and gonarthrosis.

Abstract

This double-blind clinical trial compares droxicam, a new non-steroidal anti-inflammatory agent and the reference compound diclofenac sodium. After a 7 day placebo run-in period, 80 patients with gonarthrosis and coxarthrosis were randomized to receive 20mg/day of droxicam and 150mg/day of diclofenac for 6 weeks. Evaluations were carried out at weeks 0 (placebo run-in), 2,3, and 6. Both drugs showed statistically significant improvements in all clinical measurements (index of severity, pain intensity, morning stiffness, maximal forced flexion and extension of the knee) after 6 weeks of treatment. Investigator's and patient's opinions were consistent with these results. The consumption of paracetamol was significantly lower amongst patients treated with droxicam. Withdrawals due to lack of therapeutic efficacy did not occur. A lower incidence of side effects, mostly upper gastrointestinal symptoms, was noticed amongst droxicam-treated patients. However, two patients in the droxicam group were withdrawn at week 3 and two days after week 6 because of epigastric pain and nausea, and cutaneous rash, respectively. Both study drugs are of benefit in reducing pain and improving joint motion and function in patients with coxarthrosis and gonarthrosis.