Palagiano 1994.
Study characteristics | ||
Methods | Trial design: Randomised, open study | |
Participants | Participants: 50 women were randomised, 47 were analysed Age: 20‐40 Inclusion criteria:
Exclusion criteria: Setting: Italy Timing: |
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Interventions | Leuprolide acetate 3.75mg IM monthly for 6 months (n=30) versus Danazol 600mg OD PO for 6 months (n=20) | |
Outcomes | Dysmenorrhoea, dyspareunia, pelvic pain Adverse effects | |
Notes | Intention‐to‐treat analysis: Sample size calculation: Funding: Authors contacted regarding methods and replied |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly allocated" |
Allocation concealment (selection bias) | Low risk | Randomisation done by a pharmacy |
Blinding (performance bias and detection bias) All outcomes | High risk | Open study |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals after randomisation <10% "drop out patients without M.D. consultation" |
Selective reporting (reporting bias) | Low risk | All primary outcomes stated were reported on |