Beissert 2007.
Study characteristics | ||
Methods | Multicentre study in Germany; central randomisation; not masked Two 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 on page 1537 of study report). 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 Mean age in the azathioprine group was 76 years (12 males, 26 females), and in the MMF group 75 years (15 males, 20 females). Disease severity was variable, mild to severe. Inclusion criteria
Exclusion criteria
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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 of study report). |
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Outcomes | Primary
Secondary
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Notes | Registered trial: NCT00431119 Cumulative corticosteroid dose: described as primary outcome until complete healing was achieved (page 1537); on page 1539, the cumulative corticosteroid dose was defined as corticosteroid dose until the end of the documentation period (> 720 days) (Table 11, Table 14). We presumed that calculated cumulative corticosteroid dose was calculated until the end of the documentation period. This trial was supported by an unrestricted grant from Hoffmann‐La Roche AG, producers and providers of the mycophenolate mofetil (CellCept) used in the study. |
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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 of participants and personnel (performance bias) All outcomes | High risk | Study design: "non blinded clinical trial" (Page 1448). |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were not masked. 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: 1 participant was lost, 2 died of non‐treatment‐related 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: complete healing Secondary: cumulative corticosteroid doses used |
Other bias | Unclear risk | ‐ |