Initiation of allopurinol at first medical contact for acute attacks of gout: a randomized clinical trial

Am J Med. 2012 Nov;125(11):1126-1134.e7. doi: 10.1016/j.amjmed.2012.05.025.


Objective: Streamlining the initiation of allopurinol could result in a cost benefit for a common medical problem and obviate the perception that no treatment is required once acute attacks have resolved. Our objective was to test the hypothesis that there is no difference in patient daily pain or subsequent attacks with early versus delayed initiation of allopurinol for an acute gout attack.

Methods: A total of 57 men with crystal-proven gout were randomized to allopurinol 300 mg daily or matching placebo for 10 days. All subjects received indomethacin 50 mg 3 times per day for 10 days, a prophylactic dose of colchicine 0.6 mg 2 times per day for 90 days, and open-label allopurinol starting at day 11. Primary outcome measures were pain on visual analogue scale (VAS) for the primary joint on days 1 to 10 and self-reported flares in any joint through day 30.

Results: On the basis of 51 evaluable subjects (allopurinol in 26, placebo in 25), mean daily VAS pain scores did not differ significantly between study groups at any point between days 1 and 10. Initial VAS pain scores for allopurinol and placebo arms were 6.72 versus 6.28 (P=.37), declining to 0.18 versus 0.27 (P=.54) at day 10, with neither group consistently having more daily pain. Subsequent flares occurred in 2 subjects taking allopurinol and 3 subjects taking placebo (P=.60). Although urate levels decreased rapidly in the allopurinol group (from 7.8 mg/dL at baseline to 5.9 mg/dL at day 3), sedimentation rates and C-reactive protein levels did not differ between groups at any point.

Conclusions: Allopurinol initiation during an acute gout attack caused no significant difference in daily pain, recurrent flares, or inflammatory markers.

Trial registration: NCT01310673.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acute Disease
  • Allopurinol / adverse effects
  • Allopurinol / therapeutic use*
  • Colchicine / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Gout / complications
  • Gout / drug therapy*
  • Gout Suppressants / adverse effects
  • Gout Suppressants / therapeutic use*
  • Humans
  • Indomethacin / therapeutic use*
  • Male
  • Pain Management / methods*
  • Pain Measurement
  • Recurrence
  • Severity of Illness Index
  • Treatment Outcome


  • Gout Suppressants
  • Allopurinol
  • Colchicine
  • Indomethacin

Associated data