Objectives & Background To compare oral prednisolone with oral indomethacin in patients presenting to emergency departments (ED) with acute gout firstly for analgesic effectiveness, and secondly for safety.

Methods Pragmatic, multi-centre, double-blind, randomized, equivalence trial. Each patient received either oral indomethacin plus placebo or prednisolone plus placebo for 5 days. Data were analysed in the first two hours in the ED, and from days 1 to 14.

Results 416 patients were recruited (208 patients in each arm), and 376 patients completed the study. Clinically significant reductions in mean pain score were observed within two hours of treatment with both indomethacin and prednisolone both at rest and with activity, and also over the subsequent 14 days. The margin of equivalence set a priori at 13% between the two arms was not breached. There were no major adverse events during the ED or later phases of the study. In the first two hours, there were minor adverse events affecting 34 (18%) patients in the indomethacin group and 10 (5.3%) patients in the prednisolone group (P<0.001). From day 1 to day 14, 75 (39%) patients in the indomethacin group and 75 (40%) patients in the prednisolone group suffered from mild side effects (P=0.50).

Conclusion Prednisolone and Indomethacin are equally effective first line treatments for acute gout in ED patients. There were no serious adverse event rates during a follow-up period of 14 days.