Burry 1992.
Study characteristics | ||
Methods | Trial design: "Multi‐centre, double‐blind study" | |
Participants | Participants: 169 women eligible; 169 were randomised and 147 analysed for efficacy. Mean age: not stated Inclusion criteria:
Exclusion criteria: not stated Setting: United States of America Timing: not stated |
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Interventions | Nafarelin 400 μg daily IN for 6 months (n = 111) versus Danazol 600 mg daily PO for 6 months (n = 58) | |
Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Note previous version: Need more info on randomisation and participants and raw data for quality of life. Authors contacted, awaiting response |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The randomisation procedure assigned two of every three patients to receive nafarelin, 400 μg daily (n = 111), and one of three patients to danazol, 600 mg daily (n = 58). No further details were provided of method used to generate the randomisation sequence. |
Allocation concealment (selection bias) | Unclear risk | No details were provided of method used to conceal treatment group allocation. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The study was "double‐blind". No further details were provided on the method of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The study was "double‐blind". No further details were provided on the method of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Sufficient details for 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 |