Muro 2016.
Methods | Randomised, within‐patient study (left, right) One centre in Tokyo Period of inclusion: August 2010 to November 2012 |
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Participants |
Inclusion criteria
Exclusion criteria
Baseline data: treatment sites were randomised to maxacalcitol + betamethasone butyrate propionate ointments or betamethasone butyrate propionate ointment alone
Withdrawal: 2 participants did not return to our hospital after the start of the study; 4 did not visit at week 8; 2 changed therapeutic strategy |
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Interventions |
Intervention 1 A: maxacalcitol ointment (Oxarol ointment 25 mg/g; MXA) (27 participants, within‐participant design) Intervention 2 B: no treatment (27 participants, within‐participant design) Co‐interventions: betamethasone butyrate propionate ointment (Antebate ointment 0.05%; BBP). In addition, any phototherapy or systemic therapy begun before treatment would be continued without any change to the dosage regimen Duration of treatment: 8 weeks Seven out of 27 participants received a concomitant therapy during the study: ‐ Methotrexate (n = 2) ‐ Etretinate (n = 2) ‐ Local bath‐PUVA (n = 1) ‐ Etretinate, local bath‐PUVA (n = 1) ‐ Etretinate, methotrexate (n = 1) |
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Outcomes | No primary or secondary outcome pre‐specified
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Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The type of therapy was randomly assigned" Comment: no precision |
Allocation concealment (selection bias) | Low risk | Quote: "The type of therapy was randomly assigned via the sealed envelope method" Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "On one side two topical treatments were applied whereas on the other just one was applied making the blinding impossible " Comment: blinding impossible |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "No double blind" Comment: no blinding was done |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Twenty one patients were completed" Comment: 21 participants completed the study instead of 29, and study authors did not include 27 in the analysis ‐ only 21 |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |