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

Sheehan‐Dare 1989.

Methods Within‐participant, randomised controlled trial. Hands were unit of randomisation and analysis
This study was conducted at a single department of dermatology in the UK
Participants 25 participants with chronic constitutional hand eczema; participants with irritant or allergic contact dermatitis were excluded
 Dropouts: 4
Inclusion criteria of the trial
  • Bilateral and symmetrical chronic, constitutional vesicular palmar eczema for at least 6 months with continued or episodic vesiculation

  • Resistant to topical emollients, steroid and tar preparations


Exclusion criteria of the trial
  • Irritant and allergic dermatitis


Study population
  • Gender: 14 female, 7 male

  • Age: mean 52.3 years, range 19 to 79 years

Interventions Intervention
• Topical PUVA thrice weekly for 6 weeks in 21/24 hands
• Radiotherapy 90 Rad 50 KV 3 times with 21‐day interval in 21/24 contralateral hands for 6 weeks
Participants were followed up until 18 weeks after initial treatment
Duration
18 weeks (6 weeks of active treatment, 12 weeks of follow‐up)
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
  • Participant‐rated severity on linear analogue scale of 10 cm

  • Observer‐rated severity score 0 to 4 (0 = normal skin; 1 = eczema, mild scaling, and erythema; 2 = moderate scaling, erythema, and shallow fissures; 3 = severe scaling, erythema, and deep bleeding fissures; 4 = active pompholyx) at baseline and at weeks 6, 9, and 18

  • Adverse events

Notes The primary outcome adverse events and the secondary outcomes reduction in severity, participant‐rated and investigator‐rated, were included but did not provide reproducible data. Means of outcome scores were not given as exact figures but in a graphical presentation
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: "patients were randomly allocated topical PUVA to one hand and superficial radiotherapy to the other using a pre‐determined code"
Comment: participants were randomly allocated using a predetermined code
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 Low risk Quote: "the procedure was carried out in such a way that patients were unable to tell which hand had received active treatment"
Quote: "the topical PUVA treated hand received sham radiotherapy during which the X‐ray machine appeared to function normally but the power supply to the tube was interrupted such that no X‐rays were received by the patient"
Quote: "the superficial radiotherapy treated hand was treated with a sham PUVA procedure. This consisted of an application of the organic solvent base without psoralen 5 min prior to exposure to the light source"
Comment: participant blinding. We consider this an adequate way to blind participants, although personnel probably were not blinded to perform the procedures
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "patients were assessed by 2 observers (R.S‐D and M.G) who were unaware of the treatment status of each hand until the codes were broken at the end of the study"
Comment: observer blinding; independent observers are considered an adequate method for detection bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No intention‐to‐treat analysis but per protocol (21 of 25 = more than 80%)
Selective reporting (reporting bias) Low risk No trial registration found. No discrepancies between the Materials and Results sections
Other bias Low risk Baseline comparisons: within‐participant design not applicable
Diagnostic certainty: yes
The study was completed