Kaaber 1983.
Methods | Randomised controlled, parallel‐group design This study was probably conducted in a secondary care setting at 2 Danish departments of dermatology |
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Participants | 30 female participants with pompholyx more than 6 months, and positive patch test to nickel
Dropouts: 6 Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Oral tetraethylthiuram disulphide (TETDS) 50 mg/d first week, increasing to 200 mg/d for at least 6 weeks in 11/15 participants for at least 6 weeks Control intervention • Placebo tablets in 13/15 The total duration of the study was probably 8 weeks (?); however run‐in time and total duration of treatment are not completely clear Both groups were allowed to use desoximetasone ointment and emollients Duration Probably 8 weeksIS |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | Study duration unclear. Timing of outcome assessments not clear. Comparison based on slopes of linear regression of scores. The secondary outcomes ‐ reduction in severity, investigator‐rated, and dose reduction ‐ were included but did not provide reproducible data Declarations of interest: not stated Funding: Hoechst Danmark and Dumex Ltd. Danmark supplied the study drugs 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: "referring to a system of random numbers, the patients received..." Comment: reference to a system of random numbers |
Allocation concealment (selection bias) | Unclear risk | Unclear if this concerned an open list and unclear how allocation was concealed |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the tablets were identical in appearance" Comment: study authors stated double‐blinded design; this is considered an adequate way to blind participants |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double‐blind design. No information is given about how observer blinding was achieved |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No intention‐to‐treat analysis but per protocol (24 of 30 = 80%) |
Selective reporting (reporting bias) | Unclear risk | No trial registration found. For observer‐rated severity score, the Results section states only that this was not statistically significant, only with regards to scaling and the frequency of flares. The Results section is very concise |
Other bias | Unclear risk | Baseline comparisons: not stated Diagnostic certainty: yes The study was completed |