OBJECTIVE: Two randomised, double-blind, double-dummy trials evaluated the efficacy and tolerability of meloxicam compared with placebo or diclofenac in patients with acute sciatica. SUBJECTS:1021 patients with acute sciatica. TREATMENT AND METHODS: In the first study, 532 patients receivedmeloxicam 7.5 mg, meloxicam 15 mg, or placebo for 7 days. The second study randomised 489 patients tomeloxicam 7.5 mg, meloxicam 15 mg, or diclofenac 150 mg for 14 days. RESULTS:Meloxicam 7.5 mg and 15 mg significantly improved overall pain between baseline and day 7 (p < 0.05) compared with placebo. Furthermore, both meloxicam doses showed similar improvements on all primary and secondary efficacy endpoints compared with diclofenac 150 mg. No significant differences in tolerability were observed between any of the treatment groups in either study. CONCLUSIONS:Meloxicam (7.5 mg or 15 mg) was well tolerated and was more effective than placebo, and as effective as diclofenac, in acute sciatica.
RCT Entities:
OBJECTIVE: Two randomised, double-blind, double-dummy trials evaluated the efficacy and tolerability of meloxicam compared with placebo or diclofenac in patients with acute sciatica. SUBJECTS: 1021 patients with acute sciatica. TREATMENT AND METHODS: In the first study, 532 patients received meloxicam 7.5 mg, meloxicam 15 mg, or placebo for 7 days. The second study randomised 489 patients to meloxicam 7.5 mg, meloxicam 15 mg, or diclofenac 150 mg for 14 days. RESULTS:Meloxicam 7.5 mg and 15 mg significantly improved overall pain between baseline and day 7 (p < 0.05) compared with placebo. Furthermore, both meloxicam doses showed similar improvements on all primary and secondary efficacy endpoints compared with diclofenac 150 mg. No significant differences in tolerability were observed between any of the treatment groups in either study. CONCLUSIONS:Meloxicam (7.5 mg or 15 mg) was well tolerated and was more effective than placebo, and as effective as diclofenac, in acute 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