Goldfarb 1988.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind Date of study: not stated Location: not stated |
|
Participants |
Randomised: 38 participants (mean age 45 ‐ 48 years, 31 male) Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
|
|
Interventions |
Intervention A. Acitretin (n = 10), orally, 10 ‐ 25 mg/day, 8 weeks B. Acitretin (n = 16), orally, 50 ‐ 75 mg/day, 8 weeks Control intervention C. Placebo (n = 12), orally, daily, 8 weeks |
|
Outcomes | Assessments at 8 weeks Primary outcomes of the trial
Outcomes of the trial
|
|
Notes | Funding sources, quote (p 655): "Supported in part by Hoffman‐La Roche Inc., Nutley, NJ, and the Babcock Dermatologic Endowment" Declarations of interest: not stated |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote (p 656): "21 patients were randomly and equally divided into 4 groups" Comment: no description of the method used to generate the sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 656): "21 patients were randomly and equally divided into 4 groups" Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote (p 656): "we have studied 38 patients in a double‐blind fashion" Comment: visible side effect of acitretin |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote (p 656): "we have studied 38 patients in a double‐blind fashion" Comment: visible side effect of acitretin |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Randomly assigned 38, analysed 38 No mention of how the missing data were managed |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported |