Sjövall 1987.
Methods | Parallel‐group, randomised controlled trial (3 groups) This study was carried out in a secondary care setting and was probably a single‐centre study in Sweden |
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Participants | 18 participants (3 male, 15 female) with chronic hand eczema of different types resistant to conventional therapy (11 patch test‐proven relevant allergy, 4 atopic, 3 endogenous)
Dropouts: 3 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • UVB irradiation only on hands 4 times a week for 8 weeks in 6 participants • Filtered light (placebo UVB, no UVB) on the hands 4 times a week for 8 weeks in 6 participants • Hand UVB followed by whole‐body UVB + UVA 4 times a week during 8 weeks in 6 participants Their 'ordinary topical treatment' was permitted in all groups Three months after end of treatment, participants were mailed a questionnaire regarding the course of their hand eczema and their opinions on treatment Duration 8 weeks with an email follow‐up after 3 months |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | Small number of participants. Main table unclear: results at 8 weeks or at 20 weeks? Follow‐up at 3 months presented in a descriptive way, without exact details Declarations of interest: not stated Funding: the study was supported by grants from Alfred Österlund and Finsen Foundations Sample size rationale: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the patients were randomly divided..." Comment: no further details |
Allocation concealment (selection bias) | Unclear risk | No details about how allocation was concealed from participants and clinicians |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "the whole device was covered by green clothes, thus making it possible to perform a double blind trial between the patients in group 1 and 2" Comment: the investigators covered the machine with green clothes; by this method, 2 groups (A and B) were blinded; however the third group of participants was not blinded because they received whole‐body irradiation. Staff probably was not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The investigators state a partly double‐blind design; however it is unclear how observers were blinded, and if they were independent observers |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No intention‐to‐treat analysis but per protocol (15 of 18 = more than 80%) |
Selective reporting (reporting bias) | Low risk | No trial registration found. No major differences between Materials and Methods sections |
Other bias | Unclear risk | Baseline comparisons: no baseline comparisons Diagnostic certainty: yes The study was completed |