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. 2018 Apr 18;2018(4):CD006545. doi: 10.1002/14651858.CD006545.pub3

Jung 1977.

Methods

  • Design: parallel, 2 arms

  • Country: Germany

  • Method of randomisation: table

  • Blinding: participants

  • Location: outpatient clinic, Department of Dermatology, Heidelberg University

  • Length of follow‐up: 6 years
Participants

  • Diagnosis: haemangioma

  • Sex: female: 70; male: 30

  • Age: less than 9 months

  • Inclusion criteria: small children with planotuberous or tuberocavernous haemangiomas with growth tendency

  • Exclusion criteria: children older than 9 months, using active pretreatment, explicit therapy advice from referring physician, or haemangioma not accessible from radiation treatment

  • Number of randomised children: 100
Interventions

  • Intervention A (N = 51 children): soft X‐ray radiation, 400 rad (setting level 2, 29 kV, 0.3‐millimetre AL‐filter) 2 or 3 times per week for 4 to 7 weeks

  • Intervention B (N = 49 children): mock [sham] radiation 2 or 3 times per week for 4 to 7 weeks
Outcomes Outcomes were not classified as primary or secondary:

  • Clearance: proportion of children with lesions completely healed/minimal residual signs
Notes Translation of original publication (article in German)

  • Trial registration: not stated

  • Funder: not reported

  • Role of funder: not reported

  • A priori sample size estimation: no

  • Conducted: from January 1966 to December 1969

  • Declared conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Allocation was according to "table of chance".
Allocation concealment (selection bias) Unclear risk There was insufficient information to classify this item as high or low.
Blinding of participants (Performance bias) Low risk Participants were blinded by means of pseudo‐radiation intervention.
Blinding of personnel (performance bias) Unclear risk There was insufficient information to classify this item as high or low.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk There was insufficient information to classify this item as high or low.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Intention‐to‐treat analysis not used:

  • Intervention: 24 dropouts (47%; reasons not reported)

  • Control: 22 dropouts (44%; reasons not reported)
Selective reporting (reporting bias) High risk Adverse events were not reported in this trial.
Other bias Low risk No other biases were identified.