Meffert 1997.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind Date of study: not stated Location: 17 centres in Germany |
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Participants |
Randomised: 128 participants Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Ciclosporin (n = 43), orally, 1.25 mg/kg/d, 10 weeks Control intervention B. Ciclosporin (n = 41), orally, 2.5 mg/kg/d, 10 weeks C. Placebo (n = 44), orally, 10 weeks |
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Outcomes | Assessments at 10 weeks Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Funding source not stated but 3 out of 4 authors from Sandoz pharmaceuticals 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 77): "patients were randomised" 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 | Unclear risk | Quote (p 77): "double blind study period" Comment: no description of the method used to guarantee blinding regarding the need of hypertension and renal function surveillance and modification in ciclosporin groups |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote (p 77): "double blind study period" Comment: no description of the method used to guarantee blinding, regarding the need of hypertension and renal function surveillance and modification in ciclosporin groups |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 128 included/120 analysed Comment: methods for dealing with missing data not specified, not ITT analyses |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported |