AIM: The efficacy and safety of oral lornoxicam (LNX) as early treatment of acute sciatica/lumbo-sciatica was compared with placebo and diclofenac in a 5-day double-blind, randomised study. METHODS:Male or female patients (n = 171) aged 18-70 years with acute sciatica or lumbo-sciatica [acute sciatica defined as typical radiation of pain along the sciatic nerve (including radiating pain below the knee) and worsening of pain as defined by Lasegue's leg-raising test (< 60 degrees ) within 72 h and previous attack ceased > 3 months previously; lumbo-sciatica defined as symptoms of sciatica with concurrent lumbar pain and a predefined minimum pain score]. The dosage of study treatment was 8-24 mg/day LNX, 100-150 mg/day diclofenac or placebo. The primary end-point was the difference in pain intensity difference from baseline to 6 h (PID(0-6 h)) after the first dose of study treatment. Secondary end-points were pain relief, the cumulative sums of pain intensity difference and total pain relief on day 1 and on days 2-4. RESULTS: In total, 164 patients completed the study. Significant differences in PID between LNX and placebo were seen in the time interval 3-8 h after the first dose including PID(0-6 h) (p = 0.015). Secondary end-points favoured LNX vs. placebo, but in general were not significantly different. LNX and diclofenac had similar analgesic effect. Incidence and severity of adverse events were comparable for the three treatments; overall tolerability was rated as very good/good by 93% of the patients. CONCLUSION: These data indicate that the analgesic efficacy of LNX is superior to placebo and similar to diclofenac in acute sciatica/lumbo-sciatica.
RCT Entities:
AIM: The efficacy and safety of oral lornoxicam (LNX) as early treatment of acute sciatica/lumbo-sciatica was compared with placebo and diclofenac in a 5-day double-blind, randomised study. METHODS: Male or female patients (n = 171) aged 18-70 years with acute sciatica or lumbo-sciatica [acute sciatica defined as typical radiation of pain along the sciatic nerve (including radiating pain below the knee) and worsening of pain as defined by Lasegue's leg-raising test (< 60 degrees ) within 72 h and previous attack ceased > 3 months previously; lumbo-sciatica defined as symptoms of sciatica with concurrent lumbar pain and a predefined minimum pain score]. The dosage of study treatment was 8-24 mg/day LNX, 100-150 mg/day diclofenac or placebo. The primary end-point was the difference in pain intensity difference from baseline to 6 h (PID(0-6 h)) after the first dose of study treatment. Secondary end-points were pain relief, the cumulative sums of pain intensity difference and total pain relief on day 1 and on days 2-4. RESULTS: In total, 164 patients completed the study. Significant differences in PID between LNX and placebo were seen in the time interval 3-8 h after the first dose including PID(0-6 h) (p = 0.015). Secondary end-points favoured LNX vs. placebo, but in general were not significantly different. LNX and diclofenac had similar analgesic effect. Incidence and severity of adverse events were comparable for the three treatments; overall tolerability was rated as very good/good by 93% of the patients. CONCLUSION: These data indicate that the analgesic efficacy of LNX is superior to placebo and similar to diclofenac in acute sciatica/lumbo-sciatica.
Authors: Rafael Zambelli Pinto; Chris G Maher; Manuela L Ferreira; Paulo H Ferreira; Mark Hancock; Vinicius C Oliveira; Andrew J McLachlan; Bart Koes Journal: BMJ Date: 2012-02-13