Methods | RCT, active‐placebo controlled, open‐label trial Date of study: February 2010‐October 2011 Location: Baghdad, Iraq (1 centre) |
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Participants |
Randomised: 120 participants (mean age 41 years, 41 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
No more statements regarding time and reasons of follow‐up |
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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 |
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Outcomes | Assessment at 6 months Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Funding: not stated Declarations of interest: none |
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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. |