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. 2010 Oct 6;2010(10):CD002292. doi: 10.1002/14651858.CD002292.pub3

Beissert 2007.

Methods Multicentre in Germany, central randomisation, not blinded
2 parallel groups; initial dose was maintained until blister formation ceased and re‐epithelialisation started. Corticosteroid dose was then reduced every 2 weeks; after discontinuation of corticosteroid, azathioprine, or mycophenolate mofetil (MMF) dose was maintained for 4 more weeks, then reduced (see taper regimen page 1537)
Follow‐up of 720 days
Participants 73 participants with bullous pemphigoid, confirmed by direct and indirect immunofluorescence on salt split skin
Interventions A: 38/38 oral methylprednisolone 0.5 mg/kg/day plus azathioprine sodium 2 mg/kg/day.
B: 35/35 oral methylprednisolone 0.5 mg/kg/day plus mycophenolate mofetil 2000 mg/day (tapering described on page 1537).
Outcomes Primary:
  1. Complete healing (complete reepithelialisation of all lesions)

  2. Cumulative steroid dose (until end of documentation > 720 days) (Table 2)


Secondary:
  1. Duration of remission (disease‐free interval)

  2. Safety profiles

Notes Cumulative corticosteroid dose: described as primary outcome until complete healing was achieved (page 1537); on page1539 the cumulative corticosteroid dose was defined as corticosteroid dose until the end of the documentation period (> 720 days) (Table 2, Table 3). We presumed that calculated cumulative corticosteroid dose is calculated until the end of the documentation period.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomisation was stratified according to the clinical centre and performed centrally with the use of random number of three for each stratum." (Page 1537)
Allocation concealment (selection bias) Unclear risk Allocation concealment is not well described.
Blinding (performance bias and detection bias) 
 All outcomes High risk Intentionally not blinded by trial investigators.
Quote: "Since complete healing was a primary outcome measure, blinding was not considered necessary." (Page 1537)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Yes. In Beissert 2007 1 participant was lost, 2 died of treatment unrelated causes ‐ they were included in the intention‐to‐treat analysis.
The same number of participants who started the trial were analysed at the end of the trial. (Figure 1, page 1538)
Selective reporting (reporting bias) Low risk Outcomes reported for both outcome measures.
Primary:
  1. Complete healing


Secondary:
  1. Cumulative corticosteroid doses used

Other bias Low risk No other bias.