Thestrup‐Pedersen 1984.
Methods | Cross‐over trial Number of centres not stated Period of inclusion not stated |
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Participants |
Inclusion criteria
Exclusion criteria
Clinical evaluation was performed before and after 4 and after 8 weeks Baseline data: colchicine 0.5 mg 3 to 4 times per day according to weight vs placebo (n = 27)
Withdrawal: 1 dropout (reason not mentioned) |
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Interventions |
Intervention 1 A: colchicine 0.5 mg (3 to 4 times per day according to weight) (27 participants, cross‐over design) Intervention 2 B: placebo (3 to 4 times per day) (27 participants, cross‐over design) Co‐interventions: none Duration of treatment: 8 weeks |
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Outcomes | No primary or secondary outcome pre‐specified
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Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The patients received Tablet A for four weeks and Tablet B for another four weeks" Comment: insufficient information about the sequence generation process to permit judgement |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on method to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double‐blind placebo‐controlled. Drugs were added to placebo to give a bitter taste equal to tablets with colchicine" Comment: we consider blinding at low risk for trial vs placebo with no obvious clinical adverse events or known specific taste of experimental drug |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "double‐blind placebo‐controlled" Comment: we consider blinding at low risk for trial vs placebo with no obvious clinical adverse events or known specific taste of experimental drug |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "One patient received colchicine, but not placebo" Comment: only 1 dropout in the placebo group |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |