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

Asawanonda 2006.

Study characteristics
Methods RCT, active placebo‐controlled, double‐blind
Date of study: not reported
Location: Bangkok, Thailand, Asia
Participants Randomised: 24 participants (mean age 40 years (methotrexate) 48 years (placebo), 15 male)
Inclusion criteria
  • Participants with moderate‐severe plaque type psoriasis (BSA ≥ 20)


Exclusion criteria
  • Pregnancy, immunosuppression, alcohol abuse


Dropouts and withdrawals
  • 4 (17%)

  • Time and reasons: conflicts in schedule (1 methotrexate group, 3 placebo group)

Interventions Intervention
A. Methotrexate (n = 11), 15 mg/week, orally
Control
B. Placebo (n = 13), orally
Co‐intervention: phototherapy UVB
Outcomes Assessment at 24 weeks
Primary outcomes of the trial
  • PASI 90


Secondary outcomes of the trial
  • Time to relapse after clearance

Notes Funding: (quote p 1013) no funding source
Declarations of interest: (quote p 1013) "None identified"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p 1014): "randomized by way of randomization cards"
Comment: probably done
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 Low risk Quote (p 1014): "to receive either MTX or placebo, which were identical in appearance"
Comment: probably done, placebo‐controlled
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 1015): "PASI scores were given by a investigator blinded to the treatment assignment"
Comment: probably done, placebo‐controlled
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Randomly assigned 24, analysed 24
Management of missing data:
Comment: no more precision regarding methods for dealing with missing data
Selective reporting (reporting bias) Unclear risk Comment: no protocol available. The outcomes mentioned in the Methods section appeared to have been reported.