Jelley 1986.
Study characteristics | ||
Methods | Trial design: "Open, prospective, randomised, parallel study", multi‐centre | |
Participants | Participants: 80 women were randomised; 68 were analysed. Median age: Buserelin = 28 and danazol = 30 Inclusion criteria:
Exclusion criteria:
Setting: UK Timing: not stated |
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Interventions | Buserelin 300 mcg three times a day intranasally for 7 months (n = 34) versus Danazol 600 mg once daily per OS for 7 months (n = 34) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Note previous version: Preliminary findings for the first 68 women treated only. Attempted to contact author regarding data. Author not contactable |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The code was derived from random number tables". No further details were provided of method used to generate the randomisation sequence. |
Allocation concealment (selection bias) | Low risk | "A sealed envelope was provided for each patient, and opened only after the patient's name had been entered on it". |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open study, no blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Open study, no blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Detail 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 |