Vercellini 1994.
Study characteristics | ||
Methods | Trial design: Open‐label, randomised study | |
Participants | Participants: 42 women were randomised and analysed. Mean age: Group 1: 29 ± 6 years Group 2: 31 ± 6 years Inclusion criteria:
Exclusion criteria:
Setting: Italy Timing: not stated |
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Interventions | Group 1: Danazol only, oraly 50 mg/day for 9 months (n = 21) versus Group 2: Leuprolide 3.75 mg in a 28‐day IM depot for 3 months, followed by oral danazol 50 mg/day for 6 months + danazol (n = 21) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Computer‐generated randomisation list". No further details of method used to generate the randomisation sequence were provided. |
Allocation concealment (selection bias) | Unclear risk | No details of method used to conceal allocation were provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details provided of blinding of participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided of blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5/42 withdrew from this study, one in each group at the fifth month of treatment (for persistent pain) and one in each group during follow‐up (they requested additional therapy). One women in the Danazol group was lost to follow‐up. Group 1: 18/21 completed follow‐up. Group 2: 19/21 completed follow‐up. |
Selective reporting (reporting bias) | Low risk | The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | No other risk of bias detected |