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. 2020 Jul 7;2020(7):CD008946. doi: 10.1002/14651858.CD008946.pub3

Stadler 2006.

Study characteristics
Methods This was a randomised parallel‐group trial, which lasted 52 weeks.
Participants The study recruited 124 participants with cutaneous T‐cell lymphoma (stages lA to IIA) ‐ type mycosis fungoides or small to medium cellular pleomorphic type. The principle investigator (Stadler) stated on author contact that all participants had histologically‐proven mycosis fungoides.
Demographics of the included participants
  • The male/female ratio was not reported

  • The mean age (range) was not reported

  • The stages of disease was not reported

  • 31/124 (25%) participants were lost to follow‐up, resulting in 93 participants evaluated (50 in the intervention group and 43 in the control group)


Exclusion criteria of the trial
These were not reported.
Interventions
  • The intervention group was given IFN‐α 3 x weekly 9 MU and PUVA: 8‐methoxypsoralen (0.6 mg/kg), 5 x weekly in weeks 1 to 4, 3 x weekly in weeks 5 to 23, 2 x weekly in weeks 24 to 48, with escalating doses beginning with 0.25 J/cm².

  • The control group was given PUVA as described above.

Outcomes Outcomes of the trial
  1. Percentage of participants demonstrating clearance (defined by clearance of at least 90% of all lesion surfaces, lesions, or tumour size)

Notes The funding body was not declared. The disclosure in Stadler 2006 stated: "No significant financial relationships to disclose."
This study was conducted in 26 tertiary care centres in Germany and Switzerland.
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) Unclear risk The study did not provide information about this. We sought information but got no response.
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding was unlikely since no placebo injections were described.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk The study did not provide information about this. We sought information but got no response.
Incomplete outcome data (attrition bias)
All outcomes High risk 31/124 (25%) randomised participants were not evaluable, and no reasons for this were stated.
Selective reporting (reporting bias) High risk The only outcome reported was complete remission; there was no report on adverse effects.
We contacted the corresponding author for additional outcome data, but we received no reply within 4 weeks.
Other bias Unclear risk It was unclear if previous treatment was stopped and if concomitant medication was permitted.