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
Exclusion criteria of the trial These were not reported. |
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Interventions |
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Outcomes |
Outcomes of the trial
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Notes | Funding body and conflict of interests not declared. This study was conducted in 21 tertiary care centres in Germany, Austria, and Switzerland. |
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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. |