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 |
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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). |
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Outcomes | Primary:
Secondary:
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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:
Secondary:
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Other bias | Low risk | No other bias. |