Use of oral prednisolone or naproxen for the treatment of gout arthritis: a double-blind, randomised equivalence trial

Abstract

Background: Non-steroidal anti-inflammatory drugs and colchicine used to treat gout arthritis have gastrointestinal, renal, and cardiovascular adverse effects. Systemic corticosteroids might be a beneficial alternative. We investigated equivalence of naproxen and prednisolone in primary care. Methods: We did a randomised clinical trial to test equivalence of prednisolone and naproxen for the treatment of monoarticular gout. Primary-care patients with gout confirmed by presence of monosodium urate crystals were eligible. 120 patients were randomly assigned with computer-generated randomisation to receive either prednisolone (35 mg once a day; n=60) or naproxen (500 mg twice a day; n=60), for 5 days. Treatment was masked for both patients and physicians. The primary outcome was pain measured on a 100 mm visual analogue scale and the a priori margin for equivalence set at 10%. Analyses were done per protocol and by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN14648181. Findings: Data were incomplete for one patient in each treatment group, so per-protocol analyses included 59 patients in each group. After 90 h the reduction in the pain score was 44·7 mm and 46·0 mm for prednisolone and naproxen, respectively (difference 1·3 mm; 95% CI -9·8 to 7·1), suggesting equivalence. The difference in the size of change in pain was 1·57 mm (95% CI -8·65 to 11·78). Adverse effects were similar between groups, minor, and resolved by 3 week follow-up. Interpretation: Oral prednisolone and naproxen are equally effective in the initial treatment of gout arthritis over 4 days. Funding: Rheumatology Research Fund Arnhem, Netherlands.