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

Borrek 1997.

Study characteristics
Methods Design: randomised by draw, double‐blind, placebo‐controlled, cross‐over
Duration: 20 to 24 weeks
Interval of assessment: 4 to 3 weeks
Participants Number randomised: 24 children and teenagers from 3 to 17 years of age
Sex (M/F): 14/10 total
Age of participants: 3 to 17 years (mean age = 10 years)
Unit of allocation: single person
Country and setting: Germany, 1 university pediatric clinic
Inclusion criteria of the study
  • Chronic recurrent atopic dermatitis at the time of enrolment in the study

  • Was clinically symptomatic within the last 6 months

  • Diagnostic criteria: Hanifin Rajka's criteria

  • Severity of condition: mild to moderate


Exclusion criteria of the study
  • Epilepsy

  • Fat storage disease

  • Participating in another study

Interventions
  • Treatment group: 3 capsules daily, each with 60 mg borage seed oil and 5 mg vitamin E

  • Placebo group: 3 capsules daily, each with 60 mg corn oil and 5 mg vitamin E

Outcomes
  1. Costa (Costa 1989) score by clinician (method: this simple scoring system (SSS) scores 10 severity criteria (0 to 7) and 10 topographic sites (0 to 3) giving a maximum score of 100)

  2. Acute, chronic, and subjective symptoms by participants (method: diaries)

  3. Use of steroidal creme and antihistamines (method: questionnaires)

Notes Concommitant treatment: permitted
Assessment of compliance: unsure
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was by draw (entrance to study)
Allocation concealment (selection bias) Unclear risk The trial did not specify this
Incomplete outcome data (attrition bias)
All outcomes Low risk 2 participants from each group withdrew due to non‐compliance
Selective reporting (reporting bias) Low risk The trial reported all prespecified outcomes
Other bias Low risk Quote (page 101): "No difference between the two groups in the most important variables"
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (page 101): "Patient and examiner were blinded with respect to after completion of the capsule contents"
Comment: This was adequate (both blinded)