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. 2018 Oct 19;2018(10):CD010893. doi: 10.1002/14651858.CD010893.pub3

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
  1. Frequency of attacks.

  2. Timing of FMF attacks.

  3. Adverse events.


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.