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. 2017 Aug 15;2017(8):CD007476. doi: 10.1002/14651858.CD007476.pub3

Sanjeeva 2015.

Methods Prospective randomised comparative study.
Participants 41 participants were randomised
38 participants reached end of study
Age (mean (SD)): DFX (n = 19): 5.23 (2.76) years; DFP (n = 19): 7.26 (2.42) years
Gender (male/female): 22/16
Setting: Thalassemia day care centre of Indira Gandhi Institute of child health, Bengaluru
Country: India
Inclusion criteria
  • Thalassemia diagnosis and regular blood transfusion

  • Serum ferritin > 1000 ng/mL

  • No chelation therapy


Exclusion criteria
  • Already on chelation therapy

  • Chronic liver or renal disease


Follow‐up: 12 months
Interventions 2 groups:
  • DFX (n = 19): dose of 20 mg/kg/day, once a day

  • DFP (n = 22): 75 mg/kg/day in 3 divided doses

Outcomes
  • Serum ferritin

  • WBC

  • Platelet count

  • Blood urea

  • Serum creatinine

  • Serum enzymes (AST, ALT)

  • Side effects

Notes No funding or conflict of interest mentioned
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "These children were randomly divided into two groups as group 1 and group 2 by computer generated randomisation."
Allocation concealment (selection bias) Unclear risk No details mentioned with regard to concealment of allocation.
Blinding (performance bias and detection bias) 
 All outcomes High risk No details given with regard to blinding.
Due to different application frequencies, blinding is not likely, in particular regarding performance bias.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 3 dropouts due to AEs in deferiprone group, per protocol analysis.
Selective reporting (reporting bias) High risk Measurements other than serum ferritin and AEs only given for 9 months (and only in the thesis document), but not for end of study (unsure whether not measured or not reported), although the author report measurements every 3 months.
In the thesis document, fundoscopy, growth harm and hearing were part of the evaluation sheet at 12‐month follow‐up, but no results were reported.
Other bias Low risk No other bias detected.