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

Stadler 1998.

Study characteristics
Methods This was a randomised, open‐label, parallel‐group trial, which lasted 48 weeks.
Participants The study recruited 82 participants (40 in the IFN‐α + PUVA group and 42 in the IFN‐α + acitretin group) with small‐ to medium‐sized pleomorphic T‐cell lymphoma or mycosis fungoides stage I or II. The principle investigator (Stadler) stated on author contact that all participants had histologically‐proven mycosis fungoides.
Demographics of the included participants
  • 62 men and 20 women

  • Mean age (range) = 58 years (26 to 82 years)

  • Stages of disease: IA: 36; IB: 28; IIA: 10; IIB: 8

  • 16/98 (16.3%) participants were lost to follow‐up (distribution in groups not reported)


Exclusion criteria of the trial
These were not reported.
Interventions
  • The IFN‐α + PUVA group were given IFN‐α at a starting dose of 3‐6‐9 MU in week 1 followed by 3 x weekly 9 MU in weeks 2 to 48 and 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 until minimal erythema dose was reached.

  • The IFN‐α + acitretin group were given IFN‐α as described above and acitretin, 25 mg daily in week 1 and 50 mg daily in weeks 2 to 48.

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

  2. Percentage of participants demonstrating complete response

  3. Objective response rate

Notes Funding body and conflict of interests not declared.
This study was conducted in 21 tertiary care centres in Germany, Austria, and Switzerland.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was by a central institution/third party (Estimate GmbH, Augsburg/Germany) and stratified by pretreatment.
Allocation concealment (selection bias) Low risk Randomisation was by central institution/third party (Estimate GmbH, Augsburg/Germany) and stratified by pretreatment.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk This was not possible because of different interventions (PUVA vs capsules).
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 The primary analysis was per‐protocol. ITT analysis was also carried out for comparison between study groups regarding complete remission: 16/98 (16%) participants dropped out (6 participants did not receive any treatment; 6 participants had insufficient data monitored; and 4 participants had wrong staging at enrolment); there was no distribution between groups reported. 40/49 participants in the PUVA group and 42/49 participants in the acitretin group were evaluable.
Selective reporting (reporting bias) Unclear risk This was unknown. 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.