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

Polat 2016.

Methods RCT.
 Parallel design.
 Location: Turkey.
 Multicentre.
 Carried out from October 2011 until April 2013.
Participants 90 children who were newly diagnosed with FMF according to the Yalçinkaya criteria or the Tel Hashomer criteria, and confirmed by genetic analysis with heterozygous or homozygous mutations.
45 participants each were randomised to colchicine twice daily (divided‐dose group) or once daily (single‐dose group).
Age, mean (SD): single‐dose group 7.90 (1.96) years; divided dose group 7.78 (2.00) years.
 Gender: 40 females, 39 males (79 participants completed study).
Interventions Single‐dose group: colchicine 1 mg/day once daily at 8:00 am.
Divided‐dose group: colchicine 1 mg/day divided into 2 doses one at 8:00 am and one at 8:00 pm.
Outcomes

  1. Disease symptoms and severity improvement.

  2. Duration of attacks.

  3. Acute phase response, including: ESR, CRP and SAA.

  4. Adverse events.


Outcomes measured at 3 and 6 months.
Notes Clinical Trials identifier: NCT02602028.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "It was a multicenter randomized controlled trial... The randomization was done at the baseline visit...Computer‐based block randomization algorithm was used with a block size of 2 and each patient was assigned to a treatment group with an equal chance of allocation."
Allocation concealment (selection bias) Low risk Central allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding. The review's secondary outcome of acute phase response was not influenced by lack of blinding, but the adverse events is likely to be influenced.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding. The review's secondary outcome of acute phase response was not influenced by lack of blinding, but the adverse events is likely to be influenced.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 3 people lost to follow‐up in the Divided dose group (6.67%), and 3 participants refused the treatment and 5 lost to follow‐up in Single‐dose group (17.78%), and no ITT analysis was performed.
Selective reporting (reporting bias) Low risk No selective reporting bias according to the protocol.
Other bias Low risk No other source of bias identified.
Sample size was calculated.