Methods | RCT, active‐controlled Date of study: July 1987‐January 1988 Location: Paris |
|
Participants |
Randomised: 37 participants (mean age, sex ratio: not stated) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
|
|
Interventions |
Intervention A. Cyclosporin (n = 18), orally, 2.5 mg/kg/d Control intervention B. Cyclosporin (n = 19), orally, 5 mg/kg/d |
|
Outcomes | Time to Assessment for the primary outcome: not stated Primary outcomes of the trial
Secondary outcomes of the trial
|
|
Notes | Funding: not stated however one out of four authors was a staff member of Sandoz pharmaceutical company Declarations of interest: not stated |
|
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 pre‐specified outcomes mentioned in the methods section appeared to have been reported |