Audebert 1997.
Study characteristics | ||
Methods | Trial design: Open, multi‐centre, central randomised study | |
Participants | Participants: 120 eligible women; 71 were randomised; 55 were analysed Mean age: 31 ± 5.9 years Inclusion criteria:
Exclusion criteria:
Setting: France Timing: January 1989 to February 1991 |
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Interventions | Leuprorelin 3.75 mg SC depot every 28 days for 24 weeks (n = 33) versus Danazol 600‐800 mg PO daily for 24 weeks (n = 22) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: yes Sample size calculation: not stated Funding: not stated Note previous version: Could not use data unless mean and SD specified; author contacted. Author replied that study was sponsored by a pharmaceutical company who hold the raw data. He is attempting to locate a contact for further information. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Central randomisation". 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 | Open‐label study. No details provided of blinding of participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Sufficient reporting of attrition:
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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 |