Joly 2002.
Methods | Randomised, not blinded Disease control = number of new blisters after 3 weeks (21 days) of treatment. (Not clear if participant kept record of new blisters daily or if all new blisters since previous visit were averaged out to get a daily rate) |
|
Participants | 341 participants with BP confirmed by IF studies | |
Interventions | Moderate disease: A: 40 g topical clobetasol propionate cream twice daily to entire body 77/77 versus 0.5 mg/kg/day oral prednisone 76/76. Extensive disease: A: topical clobetasol 93/93 versus prednisone 1 mg/kg/day 95/95. |
|
Outcomes |
|
|
Notes | Originally there were 364 participants recruited: 14 did not meet the inclusion criteria, 8 did not give consent, 1 withdrew his consent in the beginning of the study: left with 341 study participants | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed centrally with the use of random numbers in permuted blocks of four within each stratum." (Page 322) |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment is not well described. Probably adequate as it was done centrally. |
Blinding (performance bias and detection bias) All outcomes | High risk | The study was not blinded. A nurse not otherwise associated with the study assessed the number of new bullae, daily. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants and outcomes adequately reported. |
Selective reporting (reporting bias) | Low risk | Adequately reported. |
Other bias | Unclear risk | Quote: "In accordance with the study protocol, the investigators switched three patients with moderate bullous pemphigoid and four with extensive bullous pemphigoid from the oral‐prednisone group to the topical‐corticosteroid group because of side‐effects of treatment." (Page 324) 'Compliance with treatment and adverse effects'. |