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
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 | 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. |
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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. |