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 |
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Participants |
Number of participants
Inclusion criteria
Exclusion criteria
Baseline characteristics
High‐dose colchicine group (n = 22)
Placebo group (n = 21)
Pre‐treatment group differences: none |
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Interventions |
High‐dose colchicine
Control (placebo)
Co‐interventions
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Outcomes | Outcomes evaluated every 6 hours for 48 hours by a single assessor Primary outcome
Secondary outcomes
Outcomes used in this review
Time pointsused in this review
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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
Serious adverse events
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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 |