White 1986.
| Methods | Randomised, parallel‐arm trial One centre in Newcastle, UK Period of inclusion not stated |
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| Participants |
Inclusion criteria
Exclusion criteria
Baseline data: randomised to etretinate 30 mg/d (n = 10) or placebo (n = 10)
Withdrawal: 2 in each group were lost (1 for an episode of chest pain and the other who felt treatment was not controlling the disease in the etretinate group; 1 for cellulitis of the leg and the other for poor compliance in the placebo group) |
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| Interventions |
Intervention 1 A: etretinate 30 mg/d (10 participants) Intervention 2 B: placebo (10 participants) Co‐interventions: none Duration of treatment: 12 weeks |
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| Outcomes | No primary or secondary outcome pre‐specified
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| Notes | Quote: "Thanks to Dr Alan Miller and Miss Sandy Jones and to Roche Products Limited for support" Comment: it appears that the study had industry support. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "After an initial 4‐week period of taking 70 mg etretinate per day, patients were allocated at random to one of two treatment regimens, receiving either 30 mg etretinate per day or identical placebo capsules" 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: "Neither patient nor doctor knew which patients were allocated to which group" Comment: however, blinding was likely broken because of obvious side effects in the etretinate group, mainly mucocutaneous side effects |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "Neither patient nor doctor knew which patients were allocated to which group" Comment: however, blinding was likely broken because of obvious side effects in the etretinate group, mainly mucocutaneous side effects |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Eight patients in the etretinate group completed the trial. Of the others, one had an episode of chest pain 2 weeks after starting the maintenance dose and was advised by her general practitioner to stop the tablets. Data from this patient were not included in subsequent analyses. Another patient withdrew after 4 weeks on the low‐dose regimen because she felt the treatment was not controlling her condition. Eight patients in the placebo group completed the trial. The two who did not were one with poor compliance and one who was withdrawn when she developed cellulitis of her leg after 4 weeks. This settled with antibiotics. Her data were not included in the analyses from that point" Comment: 2 of the 4 dropouts were not included in subsequent analyses, but unsure if the other 2 were included |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |
AE: adverse event.
BBP: betamethasone butyrate propionate.
DLQI: Dermatology Life Quality Index.
FAS: full analysis set.
IL: interleukin.
ITT: intention‐to‐treat.
LOCF: last observation carried forward.
mPASI: modified Psoriasis Area and Severity Index.
NB‐UVB: narrowband ultraviolet B.
PAO: pustulotic arthro‐osteitis.
PGA: physicians' global assessment.
PPP: palmoplantar pustulosis.
PPPASI: Palmo‐Plantar Pustular Area and Severity Index.
PPPGA: Palmo‐Plantar Physician Global Assessment.
PPQoLI: Palmoplantar Quality of Life Index.
PPSI: Palmo‐Plantar Severity Index.
PUVA: combination of psoralens and long‐wave ultraviolet radiation.
RCT: randomised controlled trial.
SD: standard deviation.
TAA: triamcinolone acetonide.
UVA: ultraviolet A.
UVA1: ultraviolet A1.
WPAI:PSO: Work Productivity and Activity Impairment questionnaire:Psoriasis.