Skip to main content
. 2020 Jul 7;2020(7):CD008946. doi: 10.1002/14651858.CD008946.pub3

Thestrup‐Pedersen 1982.

Study characteristics
Methods This was a randomised, double‐blind, parallel‐group trial, which lasted 12 months.
Participants The study recruited 16 participants (8 in the intervention group and 8 in the control group) with histologically‐proven MF van Scott stage II to IV.
Demographics of the included participants
  • 8 men and 8 women

  • Mean age (range) in the intervention group = 67.4 years (53 to 83 years)

  • Mean age in the control group = 65.0 years (47 to 82 years)

  • Stages of disease: II: 14; III: 1; IV: 1

  • 0 participants were lost to follow‐up


Exclusion criteria of the trial
These were not reported.
Interventions
  • The intervention group was given 40 mg nitrogen mustard daily for 14 days followed by weekly/biweekly treatment 2 units transfer factor biweekly for 1 year. If participants had severe hypersensitivity towards HN₂ or relapse after previous HN₂ treatment, they were treated with PUVA.

  • The control group was given 40 mg nitrogen mustard daily for 14 days followed by weekly/biweekly treatment 2 units inactivated transfer factor biweekly for 1 year. If participants had severe hypersensitivity towards HN₂ or relapse after previous HN₂ treatment, they were treated with PUVA.

Outcomes Outcomes of the trial
  1. Common adverse effects of the treatments

  2. Percentage of participants demonstrating complete response

  3. Overall survival (assessed 1 year after the end of the intervention)

  4. Objective response rate

Notes The funding body was Landsforeningen til kraeftens bekaempelse (a grant came from the National Institution for Cancer Prevention of Danish Cancer Society). Conflicts of interest were not declared.
This study was conducted in the Department of Dermatology, University of Aarhus, Denmark.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study did not provide information about this. We sought information but got no response.
Allocation concealment (selection bias) High risk The corresponding trial author confirmed in an email response that the randomisation list was open.
Blinding of participants and personnel (performance bias)
All outcomes Low risk This was a double‐blind study.
Blinding of outcome assessment (detection bias)
All outcomes Low risk The corresponding trial author confirmed in an email response that the outcome assessors were blinded.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No losses to follow‐up were reported, but the number of participants randomised was not stated.
Selective reporting (reporting bias) Low risk This was unknown. We contacted the corresponding author for additional outcome data, and the author responded with a completed data extraction form.
Other bias High risk Concomitant treatment was permitted.