Skip to main content
. 2010 Oct 6;2010(10):CD002292. doi: 10.1002/14651858.CD002292.pub3

Dreno 1993.

Methods Randomised, double‐blind
Disease control = reduction of blisters, redness & itch > 50%
Follow‐up: 10 days (= treatment period)
Participants 57 participants with BP confirmed by IF studies
Interventions A: 29/29 participants prednisolone (1.16 mg/kg/day).
B: 28/28 participants methylprednisolone (1.17 mg/kg/day).
Outcomes
  1. Number of blisters

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

  3. The 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 (performance bias and detection bias) 
 All outcomes Low risk Yes: double‐blind.
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. 1 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.