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. 2023 Aug 11;2023(8):CD002292. doi: 10.1002/14651858.CD002292.pub4

Dreno 1993.

Study characteristics
Methods Randomised, investigator masked.
Disease control = reduction of blisters, redness, and itch > 50%
Follow‐up: 10 days (= treatment period)
Participants 57 participants with bullous pemphigoid confirmed by immunofluorescence studies
Mean age in the methylprednisolone group was 77 years (11 males, 17 females) and in the prednisolone group 77 years (14 males, 15 females). Disease severity was not stated. The numbers of blisters when people were included in the study were 67 +/‐ 34 in the methylprednisolone group and 56 +/‐ 85 in the prednisolone group on average.
Inclusion criteria: people with immunologically‐confirmed pemphigoid
Exclusion criteria
  • Paraneoplastic pemphigoid

  • People treated with corticosteroids during the last month before potential inclusion in the study or who received medication that potentially influenced their course of pemphigoid (immunosuppressant, plasmaphaeresis, erythromycin, dapsone, cyclosporine)

Interventions A) 29/29 participants prednisolone (1.16 mg/kg/day)
B) 28/28 participants methylprednisolone (1.17 mg/kg/day)
Outcomes
  • Number of blisters

  • Extent of erythema scale: 0 (absent) to 3 (severe)

  • Intensity of pruritus (itch), scale 0 (absent) to 3 (severe), at days 5 and 10

Notes Problem: 'scale' for measuring symptoms & signs. Very short study duration
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study was randomised.
Allocation concealment (selection bias) Unclear risk Unclear
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "Taking into account the difference in presentation between the 2 products, the supply of the products to the participants was made by a person other than the investigator; additionally clinical follow‐up after the end of the study was done by a masked (blinded) investigator" (Translation, page 518).
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Taking into account the difference in presentation between the 2 products, the supply of the products to the participants was made by a person other than the investigator; additionally clinical follow‐up after the end of the study was done by a masked (blinded) investigator" (Translation, page 518).
Incomplete outcome data (attrition bias)
All outcomes Low risk 29/29 evaluated at both time points for prednisolone group. 27/28 evaluated at both times points for the methylprednisolone group. One participant dropped out (ceased treatment) after 8 days of treatment, due to a coma unrelated to the treatment (page 519).
Selective reporting (reporting bias) Low risk All outcomes (number of blisters, itching, and redness) reported on at 5 and 10 days of treatment.
Other bias Unclear risk Short study duration. Non‐validated assessment scales.