Lindelöf 1987.
Methods | Within‐participant, randomised controlled study This study was carried out in a secondary care setting at a single centre. The study was conducted in Sweden |
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Participants | 24 participants with chronic hand eczema (13 allergic, 5 atopic, 3 irritant, 2 tylotic, 1 pompholyx)
Dropouts: 1 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Ionising radiation (Grenz rays, 300 rad) 1× weekly for 6 weeks in 23/24 hands Control intervention • Placebo radiation once a week for 6 weeks in 23/24 contralateral hands Participants were followed up to 10 weeks after initial treatment Duration 10 weeks (6 weeks active treatment, 4 weeks follow‐up) |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | The secondary outcome ‐ reduction in severity, investigator‐rated ‐ was included but provided no reproducible data. Total scores are only graphically presented, without statistical analysis Declarations of interest: not stated Funding: not stated Sample size rationale: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "the treatments were administered by a nurse according to a predetermined randomized code unknown to both patients and doctors" Comment: reference to a predetermined randomisation code |
Allocation concealment (selection bias) | Low risk | Quote: "the treatments were administered by a nurse according to a predetermined randomized code unknown to both patients and doctors" Comment: by including a third person, neither the physician/observer, nor the participants can be aware of the treatment allocation. Therefore we considered this as low risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the treatments were administered by a nurse according to a predetermined randomised code unknown to both patients and doctors" Comment: double‐blinded. Placebo therapy was achieved by "allowing the apparatus to hum without emitting radiation", which could be considered as adequate; however the treatments were administered by a nurse who was aware of the predetermined randomised code. Although one might argue that part of the staff was aware of the treatment allocation, we decided this is the best way to blind participants |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the treatments were administered by a nurse according to a predetermined randomized code unknown to both patients and doctors" Comment: the observer was blinded, and treatment was administered by someone else |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No intention‐to‐treat analysis but per protocol (23 of 24 = more than 80%) |
Selective reporting (reporting bias) | Low risk | No trial registration found. No major differences between the Methods and Results sections |
Other bias | Low risk | Baseline comparisons: as within‐participant study not applicable Diagnostic certainty: yes The study was completed |