PARENTERAL DIPYRONE VERSUS DICLOFENAC AND PLACEBO IN PATIENTS WITH ACUTE LUMBAGO OR SCIATIC PAIN - RANDOMIZED OBSERVER-BLIND MULTICENTER STUDY

Two hundred and sixty patients with lumbago or sciatic pain participat ed in a multicenter observer-blind randomized trial to compare the eff icacy and tolerability of dipyrone 2.5 g, diclofenac 75 mg, and placeb o administered as an intramuscular injection once daily for the durati on of one to two days. The effectiveness of the test treatments in rel ieving sciatic pain was measured by a visual analog scale (VAS) before and 30 minutes, 1, 2, 3, 6 and 24 hours after each injection. In addi tion, the patient's general well-being was measured on a 5-point ratin g scale on day 0, 1 and 2. At the end of the trial, the patients evalu ated the overall efficacy of the study drugs on a 5-point rating scale . Minimal finger-toe distance was measured every day of the trial. Pai n intensity on VAS (primary endpoint) showed a significantly greater r eduction with dipyrone than with diclofenac or placebo between 1 and 6 hours after application (p less than or equal to 0.01) and at the end of the trial (after 48 hours). Improvement in general well-being and minimal finger-toe distance was greatest in the dipyrone group. 59% of the patients with dipyrone assessed the overall efficacy as ''excelle nt'' or ''very good'', compared with 30% with diclofenac, and 18% with placebo. Adverse reactions were reported in only 7 patients (3%), 4 ( 5%) in the dipyrone, 1 (1%) in the diclofenac, and 2 (2%) in the place bo group.