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

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
Participants 24 participants with chronic hand eczema (13 allergic, 5 atopic, 3 irritant, 2 tylotic, 1 pompholyx)
 Dropouts: 1
Inclusion criteria of the trial
  • Chronic symmetrical hand eczema unresponsive to topical steroids

  • Stable for at least 3 months


Exclusion criteria of the trial
  • Not defined


Study population
  • Gender: not stated

  • Age: not stated

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)
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
  • Observer‐rated severity score (0 = no symptoms, 4 = very severe symptoms for erythema, scaling, itching, vesicles, fissures, and distribution (size of area involved)) at week 5 and week 10

  • Comparison of number of participants who are better on the treated hand versus number of participants who are better on the placebo hand

  • Adverse events

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
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