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

Cartwright 1987.

Methods Within‐participant, randomised controlled trial
This was a single‐centre study, conducted in the UK
Participants 30 participants with bilateral symmetrical constitutional hand eczema, resistant to previous treatment
 Dropouts: 12
Inclusion criteria of the trial
  • Resistant bilateral hand eczema


Exclusion criteria of the trial
  • Not defined


Study population
  • Gender: not stated

  • Age: not stated

Interventions Intervention
• Superficial X‐ray 300 Rad 10 kV 3 times with a 21‐day interval in 18/30 hands
Control intervention
• Placebo‐radiation in 18/30 contralateral hands 3 times with a 21‐day interval
Participants were followed up for 18 weeks after initial treatment
Participants continued application of tar paste or steroid ointments throughout the trial
Duration
21 weeks (3 weeks active treatment, 18 weeks follow‐up)
Outcomes Primary outcomes of the trial
Not defined.
Other outcomes
  • Participant‐rated severity score on scale 0 to 10 with increasing severity

  • Observer‐rated score 0 to 4 (0 = no eczema; 1 = eczema, mild scaling; 2 = erythema, scaling, fissures; 3 = erythema, severe scaling, bleeding fissures; 4 = active pompholyx)

  • Adverse events

Notes Secondary outcomes ‐ reduction in severity, investigator‐ and participant‐rated scoring ‐ were included but provided no reproducible data. Only graphic representation of outcome scores. Graphs in Figures 1 and 2 seem to have been exchanged.
High dropout: 12 out of 30. Reasons given for the 12 dropouts: unwilling to attend, mostly because eczema improved
Declarations of interest: not stated
Funding: not stated
Sample size rationale: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "according to a predetermined random code known by the radiographer..."
Reference to a predetermined random code known only by the radiographer
Allocation concealment (selection bias) Unclear risk No details about how allocation was concealed from participants and investigators, although the article states that only the radiographer knew the randomisation code
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "according to a predetermined random code known by the radiographer and unknown to patient and observer, one hand was irradiated with 300 rad (3 Gy) of Grenz rays (...) and the other hand treated in an exactly similar manner, except that sham therapy was given"
Comment: participants were truly blinded and received placebo‐radiation. The radiographer was the only one aware of the randomisation code in that he had to programme the radiation; however in our opinion, this study could not have been done in another fashion; therefore we judged this trial to have low risk, although not all staff were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "according to a predetermined random code known by the radiographer and unknown to patient and observer..."
Comment: the observer was unaware of the allocation; however no further details are provided
Incomplete outcome data (attrition bias) 
 All outcomes High risk No intention‐to‐treat analysis but per protocol (18 of 30 = less than 80%)
Selective reporting (reporting bias) Unclear risk No trial registration found. Outcomes mentioned in the Methods section are depicted in graphs and tables in the Results section; however participant‐ and observer‐rated graphs probably are switched because results in the participant section range from 0 to 3, and results for the observer range from 0 to 7
Other bias Low risk Baseline comparisons: within‐participant study was not applicable
Diagnostic certainty: yes
The study was completed