Guitart 2002.
Study characteristics | ||
Methods | This was a randomised, open‐label, parallel‐group trial, which lasted 24 weeks. | |
Participants | The study recruited 43 participants (20 in the high‐dose group and 23 in the low‐dose group) with histologically‐proven mycosis fungoides stages IB and IIA, with lymph node biopsies negative for MF involvement. 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 | Data were abstracted from the manuscript sent by the corresponding author; the sample size was smaller than planned according to the author. Dose reduction was necessary in 14/39 participants because of hyperlipidaemic side‐effects, although antilipidaemic therapy was prescribed for each participant. This study was conducted in 12 tertiary care centres in the USA. This study was funded by Ligan Pharmaceutical (San Diego, CA). Several authors have participated in the speakers bureau and/or received research grants from Ligand Pharmaceuticals. | |
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 | This was an open‐label trial. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No separate outcome assessor was mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis was carried out: 4 participants (10%) dropped out after randomisation without receiving a single treatment; 1 person (5%) in the 300 mg/day bexarotene group dropped out for "other" reason. |
Selective reporting (reporting bias) | Low risk | We contacted the corresponding author for additional outcome data, and we had an email response. We were sent a manuscript of unpublished data, and we had further confirmation by email that all outcomes were reported. |
Other bias | High risk | The study had a smaller sample size than planned; dose reduction was necessary in 14/39 participants due to hypertriglyceridaemia, although preventive antilipidaemic therapy was prescribed for each participant. |