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

Kosan 2004.

Methods RCT.
Parallel design.
 Location: Turkey.
 Single centre.
Participants 39 pediatric outpatients with the diagnosis of FMF, diagnosed based on Tel Hashomer criteria.
 20 participants randomised to colchicine 2 or 3 times per day (divided‐dose group) and 19 to colchicine once daily (single‐dose group).
 Age, mean (SD): single‐dose group 9.8 (4.3) years; divided‐dose group 10.2 (4.0) years.
 Gender: 21 females, 18 males.
Interventions Single‐dose group: colchicine 0.97 ± 0.35 mg/day once daily.
Divided‐dose group: colchicine 0.95 ± 0.30 mg/day, dose divided into 2 or 3 times daily.
NB not stated if mean and SD or mean and SE reported.
Outcomes
  1. Number of attacks in the study period.

  2. Acute phase response, including: ESR, CRP, fibrinogen, WBC, platelets and ferritin concentration.

  3. Adverse events.


Outcomes measured at 8 months.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were randomly divided in two groups", however, the exactly randomization method was unclear.
Allocation concealment (selection bias) Unclear risk The exact method of allocation concealment was unclear.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk No blinding, however, the review's secondary outcome of acute phase response was not influenced by lack of blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk No blinding, however, the review's secondary outcome of acute phase response was not influenced by lack of blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No incomplete outcome data reported.
Selective reporting (reporting bias) Unclear risk Protocol could not be reviewed; moreover, the methods section did not predefine outcome measurements.
Other bias High risk Differences of FMF severity between groups were not described.