TREATMENT OF ACUTE LUMBOSACRAL BACK PAIN WITH DICLOFENAC RESINATE - RESULTS OF A DOUBLE-BLIND COMPARATIVE TRIAL VERSUS PIROXICAM

A 2-week multicentre, double-blind, randomised trial was conducted to evaluate the efficacy and tolerability of diclofenac resinate, a new g alenic formulation of diclofenac, versus piroxicam, an established ana lgesic/anti-inflammatory agent, in patients suffering from acute lumbo sacral back pain. Adult male or female patients complaining of moderat e to severe pain at rest/on movement were treated with either diclofen ac resinate 75mg twice daily or piroxicam 20mg once daily for up to 14 days; the latter group received piroxicam 40 mg/day for the first 2 d ays. In the 132 patients eligible for efficacy analyses (66 in each tr eatment group), both drugs led to comparable and clinically significan t reductions in mean pain scores commencing after 3 days of treatment. Tests far spinal flexion also showed considerable improvement, as did functional capability, with no significant differences being observed between diclofenac and piroxicam. Overall evaluations of efficacy by the investigators and the patients revealed a positive response rate i n 78.8 and 81.8%, respectively, in patients treated with diclofenac co mpared with 83.3 and 87.7%, respectively, for piroxicam. The incidence of adverse effects, most frequently gastrointestinal, was 19.7% for d iclofenac resinate and 18.2% for piroxicam. The results of this contro lled study show that diclofenac at a daily dosage of 150mg has efficac y similar to piroxicam 20mg with a loading dose regimen of 40mg for th e symptomatic management of acute lumbosacral back pain.