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. 2019 Apr 26;2019(4):CD004055. doi: 10.1002/14651858.CD004055.pub2

Kaaber 1983.

Methods Randomised controlled, parallel‐group design
This study was probably conducted in a secondary care setting at 2 Danish departments of dermatology
Participants 30 female participants with pompholyx more than 6 months, and positive patch test to nickel
 Dropouts: 6
Inclusion criteria of the trial
  • Pompholyx of the hands of more than 6 months' duration

  • At least 1 flare every 2 weeks

  • A positive patch test to nickel


Exclusion criteria of the trial
  • Not defined


Study population
  • Gender: 30 female, no male

  • Age: median 25 years, range 19 to 67 years

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
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
  • Participant‐rated (?) number of flares at each 2‐ to 3‐week visit

  • Observer‐rated score of severity: area involved 0 to 4, erythema 0 to 3, number of vesicles 0 to 3, scaling 0 to 3

  • Number of participants healed (not specified in Methods)

  • Amount of corticosteroid ointment used since last visit

  • Adverse events

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
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