Summary of findings 1. Clobetasol propionate cream compared to oral prednisone for bullous pemphigoid.
| Clobetasol propionate cream compared to oral prednisone for bullous pemphigoid (Joly 2002) | ||||||
| Patient or population: bullous pemphigoid Setting: in‐patient, multicenter (20 dermatologic centres in France) Intervention: clobetasol propionate cream (40 grams daily, subsequently tapered) Comparison: oral prednisone (0.5 mg/kg for moderate disease and 1 mg/kg for extensive disease) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) |
Comments NNTB/H (95% CI) |
|
| Risk with oral prednisone | Risk with clobetasol propionate cream | |||||
| Disease control (healing of skin lesions) at day 21 | Study population | RR 1.08 (1.03 to 1.13) | 341 (1 RCT) | ⊕⊕⊕⊝ Moderatea | NNTB = 14 (11.0 to 17.4) for complete healing of skin lesions over 21 days | |
| 924 per 1000 | 998 per 1000 (952 to 1000) |
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| Mortality at 1 year | Study population | RR 0.73 (0.53 to 1.01) | 341 (1 RCT) | ⊕⊕⊝⊝ Lowb | NNTB = 11 (7.2 to 17.4) for mortality at 1 year Mortality at 1 year ‐ prednisone 1 mg/kg for extensive disease: RR 0.58 (0.37 to 0.89); moderatec‐certainty evidence |
|
| 363 per 1000 | 265 per 1000 (192 to 366) |
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| Quality of life ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | ‐ |
| Adverse events: severe complications at day 21 |
Study population | RR 0.65 (0.50 to 0.86) |
341 (1 RCT) |
⊕⊕⊝⊝ Lowb | NNTB = 7 (4.9 to 8.2) for severe complications at day 21d | |
| 468 per 1000 | 304 per 1000 (234 to 402) |
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| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OR: odds ratio; NNTB/H: number needed to treat for an additional beneficial/harmful outcome; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded by one level for risk of bias (detection/performance). bDowngraded by two levels for imprecision (CI includes null effect and wide CI) and risk of bias (detection/performance). cDowngraded by one level for imprecision (low number of events). dAdverse events were very heterogeneously reported in the various studies. The number of deaths was the only reliable and comparable figure; we therefore decided to report adverse events only descriptively in most studies.