ACECLOFENAC - A NEW NSAID IN THE TREATMENT OF ACUTE LUMBAGO - MULTICENTER SINGLE-BLIND STUDY VS DICLOFENAC

One hundred patients with a diagnosis of acute lumbago entered this mu lticentre, comparative, single blind (observer blind), randomized para llel group study to evaluate the efficacy and tolerability of aceclofe nac (AC) given first by intramuscular injection (150 mg vials) b.i.d. for two days and then as tablets, 100 mg b.i.d., for 5 days versus int ramuscular diclofenac (DI) (75 mg vials) b.i.d. for two days and 50 mg tablets t.i.d. for 5 days. The protocol included patients of both sex es, aged between 18 and 70 years, with acute lumbago which began less than 48 hours before study entry, with a pain intensity>50 mm on a 100 mm Visual Analog Scale (VAS). Patients were examined prior to treatme nt and were visited after 3 days (end of vial period) and after 8 days (end of study). All efficacy parameters evaluated showed progressive improvement during the study. For both treatment groups a statisticall y significant difference (p<0.01) was found both at the end of the via l period and at the end of the study for all efficacy parameters evalu ated (pain on VAS; pain on movement, degree of muscle contraction, deg ree of functional impairment, pain on pressure, lateral mobility and s agittal mobility Schober test on a 4-point scale). Eight hours after t he first injection, pain intensity was significantly less (p<0.05) in AC than in the DI group. A statistically significant difference betwee n groups (p<0.01) in favour of AC was found for pain relief 8 hours af ter the first injection and for functional impairment at the final eva luation. A statistically significant difference between groups (p<0.01 ) in favour of AC, was also found for patient's judgment of efficacy f or both vials and tablet periods. In addition, investigator's judgemen t of tablet efficacy was significantly (p<0.05) in favour of AC. One p atient in AC group and 6 in DI group did not complete the study becaus e of adverse events. There were no changes in vital signs or haematolo gical or biochemical tests for safety. There was a statistically signi ficant difference between groups (p<0.01), in favour of AC in both pat ients' and investigators' judgements of tolerability at the end of bot h vial and tablet periods. In conclusion, AC demonstrated an antiinfla mmatory and analgesic efficacy similar to DI in the treatment of low b ack pain, but was better tolerated.