Hunter 1963.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind trial Date of study: not stated Location: 1 centre in London, UK |
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Participants |
Randomised: 41 participants (no description of the study population) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Methotrexate (n = 19), orally, 2.5 mg every day for 1 week and 1 week after Control intervention B. Placebo (n = 17), orally, every day for 1 week and 1 week after |
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Outcomes | Assessments not clearly stated (reported at 4 weeks) Primary outcomes of the trial
Outcomes of the trial
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Notes | Funding: not stated Declarations of interest: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | 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 random sequence generation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote (pp 1 and 2): “Control tablet of identical appearance... thus neither physician, patient nor pharmacist was aware whether drug or control had been dispensed” Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote (pp 1 and 2): “Control tablet of identical appearance... thus neither physician, patient nor pharmacist was aware whether drug or control had been dispensed” Comment: probably done |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 41 randomised participants and 38 analysed Comment: no description of the method used to manage missing data Not ITT analyses |
Selective reporting (reporting bias) | High risk | No pre‐specified outcomes mentioned in the Methods section |