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. 2017 Mar 8;2017(3):CD011647. doi: 10.1002/14651858.CD011647.pub2

Sundic 2014.

Methods Randomised clinical trial.
Participants Country: Norway.
Number randomised: 62.
Post‐randomisation dropouts: 0 (0%).
Revised sample size: 62.
Mean age: 42 years.
Number of women: 6 (9.7%).
Symptomatic: not stated.
Asymptomatic: not stated.
Mean follow‐up period (for all groups): 3 months.
Target used for iron reduction: serum ferritin ≤ 50 μg/L.
Inclusion criteria:
  • Aged ≥ 18 years.

  • No previous treatment for haemochromatosis.

  • Diagnosis of haemochromatosis, defined as: presence of a homozygous genotype for C282Y or H63D or compound heterozygous genotype for C282Y and H63D and serum ferritin > 300 ng/mL or a transferrin saturation > 50% OR heterozygous C282Y genotype and ferritin levels > 500 ng/mL or transferrin saturation > 50%.


Exclusion criteria:
  • Atypical haemochromatosis without any documented genetic aberration or exclusively due to mutations other than C282Y and H63D.

  • Bodyweight < 65 kg.

  • Initial haemoglobin level < 13.5 g/dL.

Interventions Participants were randomly assigned to 2 groups.
Group 1: therapeutic erythrocytapheresis (n = 30).
Further details: 400 mL per single treatment bi‐weekly*.
Group 2: phlebotomy (n = 32).
Further details: 450 mL per single treatment weekly.
Treatment duration: 12 weeks.
Outcomes Adverse events.
Notes We attempted to contact the corresponding author in June 2015 to obtain additional information on risk of bias and outcomes. We did not receive any reply.
* It was unclear whether the authors meant 'bi‐weekly' to be once every two weeks or twice weekly.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomisation procedure was centralised to one of the participating centres, using a randomly generated sequence".
Allocation concealment (selection bias) Unclear risk Comment: this information was not available.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "different treatment".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: this information was not available.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: there were 6 dropouts/withdrawal but data regarding tolerance reported.
Selective reporting (reporting bias) High risk Comment: no data about mortality but just tolerability.
For‐profit bias Low risk Quote: "Grants from Helse Vest RHF and Helse Fonna HF (public hospital trusts)".
Other bias Low risk Comment: no other risk of bias.