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Efficacy of naproxen in patients with sciatica: multicenter, randomized, double-blind, placebo-controlled trial

2024; Lippincott Williams & Wilkins; Volume: 165; Issue: 11 Linguagem: Inglês

10.1097/j.pain.0000000000003280

1872-6623

Lars Grøvle, Eivind Hasvik, René Holst, Anders Sætre, Jens Ivar Brox, Ståle Mathiassen, Kjersti Myhre, Thor Einar Holmgard, Anne Julsrud Haugen,

Orthopaedic implants and arthroplasty

Abstract This trial assessed the efficacy of naproxen in patients with sciatica in outpatient clinics across 4 Norwegian hospitals. A total of 123 adults with radiating pain below the knee (≥4 on a 0-10 numeric rating scale) and signs consistent with nerve root involvement were included. Participants were randomized to receive either naproxen 500 mg or a placebo twice daily for 10 days. The primary outcome, daily leg pain intensity measured on a 0 to 10 numeric rating scale throughout the treatment period, revealed a statistically significant difference in favor of naproxen, with an adjusted mean difference of −0.5 (95% CI −0.8 to −0.1, P = 0.015). In the naproxen group, the treatment effect was significantly related to time, and over the whole 10-day period, the average adjusted difference was −0.6 (95% CI −0.8 to −0.5). Mean numbers needed to treat for 30% and 50% improvement were 9.9 (95% CI 4.7-15.0) and 20.7 (8.7-32.7), respectively. The adjusted mean difference for back pain was −0.4 (95% CI −0.8 to 0.0), and for Roland Morris Disability Questionnaire for Sciatica, it was −1.5 (95% CI −3.0 to 0.0). No differences were found for sciatica bothersomeness or consumption of rescue medication or opioids. Participants in the naproxen group exhibited an adjusted odds ratio of 4.7 (95% CI 1.3-16.2) for improvement by 1 level on the global perceived change scale. In conclusion, naproxen treatment showed small, likely clinically unimportant benefits compared with placebo in patients with moderate-to-severe sciatica.