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Prednisolone plus paracetamol (acetaminophen) was as effective as indomethacin plus paracetamol but had fewer adverse effects in acute gout-like arthritis

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In patients with acute gout-like arthritis, what is the analgesic efficacy of prednisolone plus paracetamol compared with indomethacin plus paracetamol?

Man CY, Cheung IT, Cameron PA, et al. Comparison of oral prednisolone/paracetamol and oral indomethacin/paracetamol combination therapy in the treatment of acute goutlike arthritis: a double-blind, randomized, controlled trial. Ann Emerg Med 2007;49:670–7.

Clinical impact ratings GP/FP/Primary care ★★★★★★⋆ IM/Ambulatory care ★★★★★★★ Emergency medicine ★★★★★★⋆ Rheumatology ★★★★★⋆⋆

METHODS

Embedded ImageDesign:

randomised placebo controlled trial.

Embedded ImageAllocation:

{concealed}*.†

Embedded ImageBlinding:

blinded (patients and {healthcare providers}*).†

Embedded ImageFollow-up period:

14 days.

Embedded ImageSetting:

an emergency department (ED) of a large teaching hospital in Hong Kong, China.

Embedded ImagePatients:

90 patients >17 years of age (mean age 65 y, 82% men) with acute gouty arthritis who presented to the ED within 3 days of pain onset and had ⩾1 of the following: metatarsal-phalangeal joint involvement; knee or ankle joint involvement and aspirate containing crystals; or typical gouty arthritis, with either gouty tophi or previous joint aspiration confirming the diagnosis of gout. Exclusion criteria included clinical suspicion of sepsis or other joint disease, significant comorbidity, renal insufficiency, bleeding disorder, dementia or confusion, active gastrointestinal symptoms, warfarin use, and allergy to study drug.

Embedded ImageIntervention:

patients in the prednisolone group (n = 44) initially received an intramuscular placebo (IM) injection (3 ml), six 5 mg tablets of prednisolone, indomethacin placebo, and paracetamol, 1 g. Patients were then given a prescription for 5 days of oral therapy with prednisolone (30 mg/d), paracetamol (1 g every 6 h as required), and indomethacin placebo. In the indomethacin group (n = 46), patients initially received an IM injection of diclofenac, 3 ml, 75 mg; oral indomethacin, 50 mg; paracetamol, 1 g; and placebo. Patients were then given a prescription for indomethacin (50 mg orally every 8 h for 2 d and 25 mg every 8 h for another 3 d), prednisolone placebo, and paracetamol (1 g every 6 h) as required. Other analgesics were given as required.

Embedded ImageOutcomes:

pain relief at rest and with activity, and adverse events.

Embedded ImagePatient follow-up:

100% (intention to treat).

*Information provided by author.

†See glossary.

MAIN RESULTS

During the ED phase, groups did not differ for mean pain scores. During follow-up, the prednisolone group had a slightly greater decrease in mean pain scores than the indomethacin group (table), but these differences were small. More patients in the indomethacin group experienced adverse effects (table).

CONCLUSION

In relieving the pain of acute gout-like arthritis, oral prednisolone plus paracetamol was as effective as indomethacin plus paracetamol but had fewer adverse effects.

Prednisolone (pred) v indomethacin (ind) each added to paracetamol for acute gout-like arthritis*

Commentary

The study by Man et al is a well designed, randomised, double-blind study comparing oral prednisolone plus paracetamol with indomethacin plus paracetamol in an ED setting. The authors concluded that the 2 treatment modalities were equally effective in relieving pain, but the prednisolone regimen caused fewer side effects. A limitation of the study is that the authors looked only at short-term acute side effects and did not follow the patients long enough to determine if they developed long-term toxicity from the drugs (eg, steroid-induced avascular necrosis of the femoral head). In addition, the prednisolone group required significantly more acetaminophen than the indomethacin group, an average of 10.3 g compared with 6.4 g, respectively. One would, therefore, be concerned about possible acetaminophen toxicity.

It is unclear why the authors decided to use indomethacin as comparison drug. Although it is used in the treatment of gout, indomethacin is known to produce significant toxicity,1 and a different non-steroidal anti-inflammatory drug (NSAID) may have been a better choice. Along these lines, etoricoxib, a new cyclooxygenase-2 inhibitor, has been shown to be as effective as indomethacin and less toxic in treating acute gouty attacks.2 In conclusion, oral prednisolone appears to be superior to indomethacin in treating acute gout, but whether it is superior to other NSAIDs still needs to be determined.

References

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Footnotes

  • Source of funding: no external funding.