Dinarello 1974.
Methods | RCT: separate course of colchicine and placebo were administrated in random order, 28 days for a course with a total of 60 courses. Cross‐over design. Location: USA. 2 centres. | |
Participants | 11 adults with a history of frequent attacks and characteristics of FMF. Age: unclear. Gender: unclear. | |
Interventions | Intervention: 0.6 mg colchicine 3 times daily for 28 days (1 course). Control: matching placebo. | |
Outcomes |
Outcomes measured at 11 months. |
|
Notes | The outcome data could not be distinguished among each phase. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Separate courses of colchicine, 0.6‐mg tablets, and placebo were administered in random order", however, the exactly randomization method was unclear. |
Allocation concealment (selection bias) | Unclear risk | The exactly allocation method was unclear. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The tablets were bottled, coded and dispensed by the Pharmaceutical Development Service at the National Institutes of Health." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Whether outcome assessment was blinded was unclear. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Six of the 11 patients had completed the study at the time it was terminated, whereas none of the remaining five patients had experienced a sufficient number of attacks for therapy to be considered either a success or a failure." |
Selective reporting (reporting bias) | Unclear risk | Protocol could not be reviewed; moreover, the methods section did not predefine outcome measurements. |
Other bias | High risk | The baseline characteristics of each participant were not described. |