Dreno 1993.
Methods | Randomised, double‐blind Disease control = reduction of blisters, redness & itch > 50% Follow‐up: 10 days (= treatment period) |
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Participants | 57 participants with BP confirmed by IF studies | |
Interventions | A: 29/29 participants prednisolone (1.16 mg/kg/day). B: 28/28 participants methylprednisolone (1.17 mg/kg/day). |
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Outcomes |
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Notes | Problem: 'scale' for measuring symptoms & signs. Very short study duration | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The study was randomised. |
Allocation concealment (selection bias) | Unclear risk | Unclear. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Yes: double‐blind. Quote: "Taking into account the difference in presentation between the 2 products, the supply of the products to the participants was made by a person other than the investigator; additionally clinical follow‐up after the end of the study was done by a masked (blinded) investigator." (Translation, page 518) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 29/29 evaluated at both time points for prednisolone group. 27/28 evaluated at both times points for the methylprednisolone group. 1 participant dropped out (ceased treatment) after 8 days of treatment, due to a coma unrelated to the treatment (page 519). |
Selective reporting (reporting bias) | Low risk | All outcomes (number of blisters, itching, and redness) reported on at 5 and 10 days of treatment. |
Other bias | Unclear risk | Short study duration. Non‐validated assessment scales. |