Fivenson 1994.
Methods | Randomised open‐label, but randomisation method not stated, not blind Disease control after 8 weeks Rx: complete response = 100% clearing of all lesions, partial response ≥ 50%, no response < 25%. Pruritus and physician's global assessment were also recorded. Disease recurrence in the follow up period was recorded if: new blisters, urticarial lesions and/or crusts were noted. Follow‐up: 10 months (= treatment period) |
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Participants | 20 participants with BP confirmed by IF studies | |
Interventions | A: 6/6 participants prednisone 40 to 80 mg/day. B: 14/14 participants nicotinamide 1500 mg/day in 3 divided doses + tetracycline 2 g/day 4 divided doses. |
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Outcomes |
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Notes | Not clear how the prednisone dose was decided or number of participants on higher or lower dose | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No details given. |
Allocation concealment (selection bias) | Unclear risk | Unclear; no details given. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not blind, described as "open‐label" (page 753). |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 20 were randomised, 18 were treated. 2 were unavailable for follow up within the initial 8 weeks, both from the tetracycline/nicotinamide group. There was 1 death in the prednisone group due to sepsis complicated by aspiration pneumonia, the time point was not given but the participant was available for follow up at week 8 as the results for all 8 participants who received prednisolone is given in Table 1 (page 755). At longer term follow‐up, only n = 3 in the prednisolone group and n = 5 in the tetracycline/nicotinamide group are reported, no detail of the reasons for loss to follow up at this later follow‐up were reported. |
Selective reporting (reporting bias) | Low risk | All outcomes reported at each time point. |
Other bias | Unclear risk | Unclear if the participant groups were equivalent with respect to disease severity or demographics at the start of the therapy. |