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

Buslau 1996.

Study characteristics
Methods Design: randomised, double‐blind, placebo‐controlled, parallel
Duration: 12 weeks
Interval of assessment: daily by participant
Participants Number randomised: 50 (25 each in the active and placebo groups)
Sex (M/F): 18/32 total (8/17 in the active group and 10/15 in the placebo group)
Age of participants: not mentioned
Unit of allocation: whole person
Country and setting: Germany, not noted
Inclusion criteria of the study
  • Severity of condition: mild to moderate

  • Diagnostic criteria: Hanifin Rajka's criteria


Exclusion criteria of the study
  • Not specified

Interventions
  • Treatment group: 2 capsules daily each with 500 mg of BO

  • Placebo group: 2 capsules daily each with 500 mg of palm kernel oil

Outcomes
  1. ADASI score (method of assessment: mapping with the help of coloured markers)

Notes Concomitant treatment: not permitted
Compliance to treatment: not undertaken
Previous treatment: unsure
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk The trial did not specify the method of sequence generation
Allocation concealment (selection bias) High risk The trial did not specify the method of allocation concealment
Incomplete outcome data (attrition bias)
All outcomes High risk 7/25 participants in the active group withdrew, and 11/25 in the placebo group withdrew. The trial undertook ITT analysis, but dropouts were not balanced between the groups
Selective reporting (reporting bias) Low risk The trial reported all prespecified outcomes
Other bias Unclear risk No detail of funding or support was listed
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk This was adequate for participants, but it was unclear if they blinded the clinician outcome assessor