Lancet. 2008 May 31;371(9627):1854-60.

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

Janssens HJ, Janssen M, van de Lisdonk EH, van Riel PL, van Weel C.

Department of General Practice, Radboud University Nijmegen Medical Centre,
Nijmegen, Netherlands. h.janssens@hag.umcn.nl

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.