Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial

Ann Intern Med. 2016 Apr 5;164(7):464-71. doi: 10.7326/M14-2070. Epub 2016 Feb 23.


Background: Two recent double-blind, randomized, controlled trials (RCTs) showed that oral steroids and nonsteroidal anti-inflammatory drugs have similar analgesic effectiveness for management of gout, but the trials had small sample sizes and other methodological limitations.

Objective: To compare the effectiveness and safety of oral prednisolone versus oral indomethacin in patients presenting to emergency departments (EDs) with acute gout.

Design: Multicenter, double-blind, randomized equivalence trial. Patients were randomly assigned (1:1 ratio) to receive either indomethacin or prednisolone. (ISRCTN registry number: ISRCTN45724113).

Setting: Four EDs in Hong Kong.

Participants: 416 patients aged 18 years or older.

Measurements: Analgesic effectiveness was defined as changes in pain (at rest or with activity) greater than 13 mm on a 100-mm visual analogue scale. Outcomes were measured during the first 2 hours in the ED and from days 1 to 14.

Results: 376 patients completed the study. Equivalent and clinically significant within-group reductions in mean pain score were observed with indomethacin and prednisolone in the ED (approximately 10 mm [rest] and 20 mm [activity]) and from days 1 to 14 (approximately 25 mm [rest] and 45 mm [activity]). No major adverse events occurred during the study. During the ED phase, patients in the indomethacin group had more minor adverse events than those in the prednisolone group (19% vs. 6%; P < 0.001). During days 1 to 14, 37% of patients in each group had minor adverse events.

Limitation: Diagnosis of gout was usually based on clinical criteria rather than examination of joint fluid.

Conclusion: Oral prednisolone and indomethacin had similar analgesic effectiveness among patients with acute gout. Prednisolone is a safe, effective first-line option for treatment of acute gout.

Primary funding source: Health and Health Services Research Grant Committee of the Hong Kong Government.

Publication types

  • Multicenter Study
  • Pragmatic Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Double-Blind Method
  • Emergency Service, Hospital
  • Female
  • Gout / drug therapy*
  • Gout / physiopathology
  • Hong Kong
  • Humans
  • Indomethacin / therapeutic use
  • Male
  • Middle Aged
  • Pain / etiology
  • Pain / prevention & control
  • Prednisolone / administration & dosage*
  • Prednisolone / adverse effects


  • Anti-Inflammatory Agents
  • Anti-Inflammatory Agents, Non-Steroidal
  • Prednisolone
  • Indomethacin