Dubertret 1989.
Study characteristics | ||
Methods | RCT, active‐controlled Date of study: July 1987 ‐ January 1988 Location: Paris, France |
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Participants |
Randomised: 37 participants (mean age, sex ratio: not stated) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Cyclosporin (n = 18), orally, 2.5 mg/kg/d Control intervention B. Cyclosporin (n = 19), orally, 5 mg/kg/d |
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Outcomes | Time to assessment for the primary outcome: not stated Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Funding: not stated, but 1 out of 4 authors was a staff member of Sandoz pharmaceutical company 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 | Quote (p 136): "The patients were randomised..." Comment: no description of the method used to guarantee random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 136): "The patients were randomised..." Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not specified as blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: not specified as blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Randomly assigned 37, analysed 37 Dropouts and withdrawals Not stated Management of missing data: no description of the method used to guarantee management of 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 |