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

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)
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.
Outcomes
  1. Number of bullous, crusted, urticarial lesions as follows: none = 0, 1 to 5 = 1+, 6 to 10 = 2+, 11 to 20 = 3+, 20 to 40 = 4+, more than 40 lesions = 5+. All three of these recorded as less than or more than 1 cm in size. Total highest score possible on each visit per participant. Mean scores for each group used to calculate P values

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.