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. 2021 Aug 26;2021(8):CD006190. doi: 10.1002/14651858.CD006190.pub3

Ahern 1987.

Study characteristics
Methods Study design: randomised, double‐blind, two‐arm, parallel placebo‐controlled trial
Setting: Repatriation General Hospital, Daw Park, South Australia
Time period: not reported
Intervention: oral colchicine taken at baseline (1 mg) and every 2 hours (0.5 mg) until complete response or adverse events versus matched placebo given in the same way
Sample size: not described in the published report
Analysis: not described whether ITT or per protocol analysis
Participants Number of participants
  • Enrolled: 45 participants

  • Randomised: 43 (22 in colchicine and 21 in placebo group) (2 participants were excluded due to their inability to understand VAS)

  • Analysed: 43 (22 in colchicine and 21 in placebo group)


Inclusion criteria
  • Acute gout, confirmed by identification of monosodium urate crystals in synovial fluid


Exclusion criteria
  • Not described


Baseline characteristics
  • Gender: 40/43 (93%) were male across both groups


High‐dose colchicine group (n = 22)
  • No. of joints involved in group: 22 (8 large (ankle, knee or wrist) joints, 14 small (MTP, MCP or PIP) joints)

  • Age: mean (SD) 69 (8)

  • Age: range (in years) 55 to 85

  • Duration of symptoms (hours): mean (SD) 38 (51)

  • Weight (kg): mean (SD) 71 (9)

  • Serum uric acid (mmol/L): mean (SD) 0.55 (0.16); (normal range for serum uric acid is 0.12 to 0.45)

  • Serum creatine (mmol/L): mean (SD) 0.14 (0.08); (normal range for serum creatine is 0.06 to 0.13)

  • Clinical score: mean (SD) 9.5 (2.8)

  • Pain score: mean (SD) 56 (21)


Placebo group (n = 21)
  • No. of joints involved in group: 22 (6 large (ankle, knee or wrist) joints, 16 small (MTP, MCP or PIP) joints)

  • Age: mean (SD) 70 (8)

  • Age range (in years): 56 to 91

  • Duration of symptoms (hours): mean (SD) 38 (29)

  • Weight (kg): mean (SD) 74 (11)

  • Serum uric acid (mmol/L): mean (SD) 0.50 (0.15); (normal range for serum uric acid is 0.12 to 0.45)

  • Serum creatine (mmol/L): mean (SD) 0.12 (0.03); (normal range for serum creatine is 0.06 to 0.13)

  • Clinical score: mean (SD) 10.3 (2.4)

  • Pain score: mean (SD) 68 (21)


Pre‐treatment group differences: none
Interventions High‐dose colchicine
  • Oral colchicine 1 mg followed by 0.5 mg every 2 hours until complete response (number of doses and total dose not specified) or adverse events (nausea, vomiting or diarrhoea) occurred


Control (placebo)
  • Matching placebo given in the same way


Co‐interventions
  • No NSAIDs or analgesics were allowed 48 hours before trial entry or during the trial

Outcomes Outcomes evaluated every 6 hours for 48 hours by a single assessor
Primary outcome
  • Number of responders, defined as number who had a 50% decrease in pain from baseline: pain was measured on a VAS (type of VAS not described)


Secondary outcomes
  • Number of responders, defined as number who had a 50% decrease in the compounded clinical score comprising pain, tenderness on palpation, swelling and redness, each graded on a 4‐point scale (none 0, mild 1, moderate 2, severe 3) (range 0 to 12 for each affected joint)


Outcomes used in this review
  • Number of responders, defined as number who had a 50% decrease in VAS pain


Time pointsused in this review
  • 12, 24, 36 and 48 hours postintervention

Source of funding Not reported
Notes Trial registration: not done as the trial was conducted prior to establishment of trial registries.
Competing interests: the authors declared no competing interests for this study.
Withdrawals: 2 participants withdrew but their treatment groups were not specified
Total adverse events
  • High‐dose colchicine group: 22/22 (100%); the design of this study involved participants taking 0.5 mg of colchicine every two hours until complete response or adverse events (nausea, vomiting, or diarrhoea) occurred.

  • Placebo group: 5/21 (23.8%); nausea = 5


Serious adverse events
  • There were no serious adverse events reported in either study arm.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers (information received after communication with authors)
Allocation concealment (selection bias) Low risk Allocation was concealed and held in pharmacy (information received after communication with authors)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Matching placebo control was used, implying that participants were blinded. It was not stated in the report whether or not study personnel were blinded, however in fact both study personnel and participants were blinded (information received after communication with authors)
Blinding of outcome assessment (detection bias) Self‐reported outcomes (pain, treatment success, reduction of inflammation, function, serious adverse events, total adverse events, withdrawals due to adverse events) Low risk Participants were blinded for this trial (information received after communication with authors)
Blinding of outcome assessment (detection bias) Assessor‐reported outcomes (reduction of inflammation, function) Low risk Outcome assessors were blinded (information received after communication with authors)
Incomplete outcome data (attrition bias)
All outcomes Low risk 2 participants were excluded because of inability to understand VAS ‐ it is not clear whether or not these participants were randomised but it is unlikely that this would have affected the study outcome
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported although it is not clear if the criterion for improvement (50% reduction from baseline score) was prespecified
Other bias Low risk No other potential sources of bias identified