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. 2017 Dec 22;2017(12):CD011535. doi: 10.1002/14651858.CD011535.pub2
Methods RCT, active‐placebo controlled, open‐label trial
Date of study: February 2010‐October 2011
Location: Baghdad, Iraq (1 centre)
Participants Randomised: 120 participants (mean age 41 years, 41 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (BSA > 10%)

  • Age ≥ 18 and ≤ 60 years


Exclusion criteria
  • Pregnancy, kidney insufficiency, liver insufficiency, past history of malignant tumours

  • Had received conventional systemic treatments in the 4 past weeks

  • Had received biologics (anti‐TNFα)

  • Had uncontrolled diabetes


Dropouts and withdrawals
  • 7 (6%)


No more statements regarding time and reasons of follow‐up
Interventions Intervention
A. Methotrexate + NBUVB (n = 38), 20 mg/week + 45 mJ/cm2, 3 times/week
Control intervention
B. NBUVB (n = 38), 45 mJ/cm2, 3 times/week
C. Methotrexate (n = 37), 20 mg/week
Outcomes Assessment at 6 months
Primary outcomes of the trial
  • PASI 90


Secondary outcomes of the trial
  • Number of weeks for achieving clearance

  • Total cumulative dose of UVB

  • Relapses (PASI returning at 50% of original score for 1 year)

Notes Funding: not stated
Declarations of interest: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (page 1531): "three groups randomly...”
Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias) Unclear risk Comment: No description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias) All outcomes High risk Comment: not stated that it was a blind trial, probably not blind
Blinding of outcome assessment (detection bias) All outcomes High risk Comment: no independent assessor. Not stated that it was a blind trial, probably not blind
Incomplete outcome data (attrition bias) All outcomes Unclear risk Randomly assigned 120, analysed 113
Management of missing data: not stated
Selective reporting (reporting bias) Unclear risk Comment: no protocol available. The outcomes mentioned in the methods section appeared to have been reported.