Prednisolon, een geschikte eerste keus voor pijnbehandeling bij jicht: een gerandomiseerde dubbelblinde equivalentietrial met naproxen als referentie*

Objective

To study whether prednisolone is equivalent to naproxen as a treatment for pain in gouty arthritis.

Design

Randomised, double-blind equivalence trial.

Method

120 primary care patients with gouty arthritis confirmed by the presence of monosodium urate crystals were included. They were randomised by computer to receive either prednisolone (35 mg once a day, n = 60) or naproxen (500 mg twice a day, n = 60) for 5 days. Blinding was used for patients and investigators for drug assignment, including analyses during the complete trial period. The primary endpoint was pain measured on a visual analogue scale of 100 mm. The margin of equivalence was arbitrarily set at 10% beforehand. Analyses took place per protocol and per intention-to-treat. This study was registered as an international trial (www.controlled-trials.com/ISRCTN14648181).

Results

Data were incomplete for one patient in each treatment group, so the 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 extent of change in pain in 90 h was 1.57 mm (95% CI: –8.7 to 11.8). Adverse effects were similar in both groups, were minor, and disappeared after 3 weeks.

Conclusion

Prednisolone and naproxen were equally effective in the initial treatment of gouty arthritis in this study. For patient safety reasons, prednisolone is suitable as a first-choice treatment in gout, instead of NSAIDs and colchicine, which have been accepted up to now.