Lawrence 1984.
Methods | Randomised, parallel‐arm trial One centre in the UK Period of inclusion not stated |
|
Participants |
Inclusion criteria
Exclusion criteria
Baseline data: randomised to PUVA therapy‐etretinate (1 mg/kg) (n = 10) or PUVA therapy‐placebo (n = 10)
Withdrawal: 1 dropout in the PUVA therapy‐placebo group (diverticulitis) |
|
Interventions |
Intervention 1 A: etretinate (1 mg/kg/d) (10 participants) Intervention 2 B: placebo (10 participants) Co‐interventions: oral PUVA therapy Duration of treatment: 20 weeks (2 weeks of etretinate or placebo alone and 18 weeks maximum of PUVA therapy‐etretinate or PUVA therapy‐placebo) |
|
Outcomes | No primary or secondary outcome pre‐specified
|
|
Notes | Roche Products Ltd supported the study and provided the etretinate. Dr Parker was supported by the Newcastle Health Authority Research Committee | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly allocated to either PUVA plus placebo (PUVA‐placebo) or PUVA plus etretinate (PUVA‐etretinate)" Comment: insufficient information about the sequence generation process to permit judgement |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on method to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "The trial was conducted as if double‐blind, although in most patients differences in side‐effects and patient response made a double‐blind assessment impossible" Comment: blinding probably broken |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "The trial was conducted as if double‐blind, although in most patients differences in side‐effects and patient response made a double‐blind assessment impossible" Comment: blinding probably broken |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "Nineteen patients completed the study. One patient, who was receiving placebo, was withdrawn during the sixth week of the study because she developed acute diverticulitis, presumably unrelated to treatment" Comment: 1 participant dropped out because of diverticulitis, but not mentioned whether she was included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |