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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

Nugteren‐Huying 1990.

Study characteristics
Methods RCT, active/placebo‐controlled, double‐blind
Date of study: not stated
Setting: multicentre in the Netherlands
Participants Randomised: 39 participants (mean age 44 years, 27 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (BSA ≥ 10)


Exclusion criteria
  • Pregnancy, kidney insufficiency, liver insufficiency

  • Had uncontrolled cardiovascular disorder


Dropouts and withdrawals
  • 5/39 (12.8%)

  • Time and reason: not stated

Interventions Intervention
A. Dimethylfumarate (n = 12), orally, 120 mg, gradual increase 1 ‐ 6 tablets, once a day, 16 weeks
Control intervention
B. Octyl hydrogen fumarate (n = 10), orally, 284 mg, gradual increase 1 ‐ 6 tablets, once a day, 16 weeks
C. Placebo (n = 12), orally, once a day, 16 weeks
Outcomes Assessments at 16 weeks
Primary outcomes of the trial
  • BSA


Secondary outcomes of the trial
  • Score of infiltration and scaling

  • Side effects

Notes Funding source: not stated
Declarations of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (p 331): "The patients were randomly assigned..."
Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias) Unclear risk Quote (p 331): "The patients were randomly assigned..."
Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 331): “The double‐blind treatment lasted 16 weeks for each patients... All tablets (provided by Fumapharm AG, Muri, Switzerland) had the same appearance, size and colour”
Comment: probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 331): “The double‐blind treatment lasted 16 weeks for each patients...All tablets (provided by Fumapharm AG, Muri, Switzerland) had the same appearance, size and color”
Comment: probably done
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Randomly assigned 39, analysed 34
Comment: no description of the method used to perform analyses of the primary outcome and to manage missing data
Selective reporting (reporting bias) Unclear risk Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported