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. 2013 Apr 30;2013(4):CD004416. doi: 10.1002/14651858.CD004416.pub2

Biagi 1994.

Study characteristics
Methods Design: double‐blind, placebo‐controlled using 2 different dosages
Duration: 8 weeks
Interval of assessment: start and end of study
Participants Number randomised: 48 (16 in each group)
Sex (M/F): 24/27 total (this applied to the whole group; there was no separation for the active and placebo groups)
Age of participants: children average 4.2 years (2.2 to 8.5 years)
Unit of allocation: whole person
Country and setting: Italy, single referral outpatient department
Inclusion criteria of the study
  • Diagnostic criteria: Hanifin and Rajka


Exclusion criteria of the study
  • Not specified

Interventions
  • 2 treatment groups:

    • first treatment group: high‐dose group, EPO capsules (dose = 0.5 mg/kg body weight)

    • second treatment group: low‐dose group, 50% EPO capsule and 50% placebo capsule (dose = 0.5 mg/kg body weight)

  • Placebo group: capsules of olive oil and vitamin E (0.5 mg/kg body weight)

Outcomes
  1. Severity of symptoms (method: clinical assessment by scoring 10 symptoms. Scoring from 0 to 3, 0 = absent, 1 = mild, 2 = moderate, 3 = severe)

  2. Red cell membrane fatty acid concentration

  3. Red cell membrane viscosity

Notes Concomittent treatment: allowed continued emollients and topical steroids
Compliance to treatment: unsure
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Children were randomised to receive either..."
Comment: The trial gave no method of generation
Allocation concealment (selection bias) High risk The trial gave no details
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 3/48 participants did not attend for follow up. The dropouts or losses to follow up by assignment group were unclear, as were the reasons
Selective reporting (reporting bias) Low risk The trial reported all prespecified outcomes
Other bias Low risk We contacted the author; there was no other bias
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "...all assessments were made double blind"
Comment: This was adequate, but details were not given of who was blinded and how. This was probably done