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Use of oral prednisolone or naproxen for the treatment of gout arthritis: A double-blind, randomised equivalence trial
The Lancet, 06/09/08

Janssens HJ et al. – These data suggest that oral prednisolone and naproxen are equally effective in the initial treatment of gout arthritis over 4 days.

Methods

A randomised clinical trial to test equivalence of prednisolone and naproxen for the treatment of monoarticular gout
Primary-care pts with gout confirmed by presence of monosodium urate crystals were eligible
120 pts 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 pts and physicians
The primary outcome was pain measured on a 100 mm VAS and the a priori margin for equivalence set at 10%
Analyses were done per protocol and by intention to treat

Results

Per-protocol analyses included 59 pts 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, suggesting equivalence
The difference in the size of change in pain was 1.57 mm
Adverse effects were similar between groups, minor, and resolved by 3 wks f/u

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