Guillaume 1993.
Methods | Randomised, not blind Disease control = no new blisters for 4 weeks, prednisolone dose decreased gradually to 0.5 mg/kg at 3 months and 0.2 mg/kg at 6 months Follow‐up: 6 months ( = treatment period) |
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Participants | 100 participants with BP confirmed by IF studies | |
Interventions | 31/32 participants prednisolone 1 mg/kg/day versus 36/36 participants azathioprine + prednisolone 1 mg/kg/day versus 31/32 participants plasma exchange + prednisolone 1 mg/kg/day. | |
Outcomes |
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Notes | Trial stopped at interim period due to no appreciable benefit | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised. Quote: "According to pre‐established randomisation lists equilibrated in blocks of 3 for each center." (Page 50) |
Allocation concealment (selection bias) | Unclear risk | Unclear. No details given about how the allocation was concealed from the study investigator. Quote: "After determining a patient's eligibility, the attending physician telephoned the study co‐ordinator who assigned the patient." (Page 50) |
Blinding (performance bias and detection bias) All outcomes | High risk | The study was not blind. See "Treatment Groups", page 50. "Techinically difficult and theoretically debatable to perform 'sham' plasma exchanges". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reasons for 2 dropouts not clear. Quote: "unavailable for follow‐up after having withdrawn their consent" (page 51) (not clear if this was before or after starting treatment). Dropouts not included in the analysis. |
Selective reporting (reporting bias) | Unclear risk | Controlled disease was stated to be no more than 1 new blister occurring 4 weeks after starting treatment, resolution of erythema, and no more than minimal pruritis. Only the composite measure of controlled disease was reported (Table 2, page 52). |
Other bias | Unclear risk | Trial stopped early. Quote: "Our trial was interrupted after the interim analysis showed no appreciable benefit resulting from the addition of azathioprine or plasma exchange to prednisolone in the initial (at 4 weeks) and maintenance (at 6 months) treatments of BP" (page 52). |