Lowe 1991.
Study characteristics | ||
Methods | RCT, placebo‐controlled, double‐blind trial Date of study: not stated Location: 2 centres in Santa Monica and New York City, USA |
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Participants |
Randomised: 34 participants, age range 20 ‐ 75 years, 24 male Inclusion criteria
Exclusion criteria
Dropouts and withdrawals
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Interventions |
Intervention A. Acitretin (n = 16), orally, 50 mg, daily, 12 weeks Control intervention B. Placebo (n = 18), orally, daily, 12 weeks Co‐intervention: UVB (phototherapy) |
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Outcomes | Assessments at 12 weeks Primary outcomes of the trial
Secondary outcomes of the trial
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Notes | Funding source (p 591): Quote: "Supported by Roche dermatologics, Nutley, New Jersey and the Skin Research Foundation of California, Santa Monica, California" 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 592): "Patients receiving UVB phototherapy were randomly assigned" Comment: no description of the method used to guarantee random sequence generation |
Allocation concealment (selection bias) | Unclear risk | Quote (p 592): "Patients receiving UVB phototherapy were randomly assigned" Comment: no description of the method used to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote (p 592): "were randomly assigned to either acitretin or placebo" Comment: no more precision however adverse effects of acitretin such as cheilitis are visible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote (p 592): "were randomly assigned to either acitretin or placebo... the same observer who was unaware of patient group examined the patients throughout the investigation" Comment: no more precision but adverse effects of acitretin such as cheilitis are visible |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 34 included / 34 analysed (Table 2) Comment: no description of the method used to manage the missing data or to perform the 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 |