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

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
  • 25 men and 18 women

  • Mean age (range) = 57.5 years

  • Stages of disease: IB: 36, IIA 7

  • 4 participants were lost to follow‐up (1/20 = 5% in the high‐dose group; 3/23 = 13% in the control group), resulting in 39 participants evaluated (19 in the high‐dose group and 20 in the low‐dose group)


Exclusion criteria of the trial
These were not reported.
Interventions
  • The high‐dose group was given bexarotene 300 mg/day (starting week 1) and PUVA (starting week 2) and fenofibrate 54 mg/day (starting week 0).

  • The low‐dose group was given bexarotene 150 mg/day (starting week 1) and PUVA (starting week 2) and fenofibrate 54 mg/day (starting week 0).

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

  2. Percentage of participants demonstrating complete response

  3. Relapse defined as the time period after remission when the eruption reappears after short‐term clearance (assessed 6 months after the end of the intervention)

  4. Overall survival

  5. Objective response rate

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.