Table 1.
Consensus Statement | Rating | ||||||
---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | 5 | 6 | 5 or 6 | |
The study design will involve simple randomization to either spironolactone or the antibiotic comparator with no dose escalation | 0.0% | 0.0% | 0.0% | 0.0% | 25.0% | 75.0% | 100.0% |
Doxycycline will be the antibiotic comparator in the study | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% | 100.0% | 100.0% |
The dose of spironolactone will be 100mg/day | 0.0% | 0.0% | 0.0% | 12.5% | 0.0% | 87.5% | 87.5% |
The dose of doxycycline will be 100mg/day | 0.0% | 6.3% | 0.0% | 12.5% | 43.8% | 37.5% | 81.3% |
We will assess the primary endpoint at 16 weeks | 0.0% | 0.0% | 0.0% | 0.0% | 12.5% | 87.5% | 100.0% |
Study subjects will be required to attest to abstinence or some form of contraception, but they will be allowed to continue their current form of contraception when they enter the study. | 0.0% | 0.0% | 0.0% | 0.0% | 6.3% | 93.8% | 100.0% |
To be eligible for the study, subjects must not have changed their contraception (e.g. started new combined oral contraceptive) within 3 months of study randomization | 0.0% | 0.0% | 0.0% | 0.0% | 12.5% | 87.5% | 100.0% |
Study subjects should be allowed to continue their topical regimen that they were using prior to randomization | 6.3% | 6.3% | 6.3% | 12.5% | 31.3% | 37.5% | 68.8% |
Study subjects should not be allowed to use any topical therapies during the study | 43.8% | 12.5% | 0.0% | 12.5% | 6.3% | 25.0% | 31.3% |
1: I do not endorse this approach; 6: I think this approach is acceptable