NEET 1992.
Study characteristics | ||
Methods | Trial design: Multi‐centre, parallel, randomised, double‐blind, double‐dummy study | |
Participants | Participants: 315 women were randomised, 307 were analysed for safety and 263 were analysed for efficacy. Mean age: not stated Inclusion criteria:
Exclusion criteria:
Setting: Multiple sites within Europe Timing: not stated |
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Interventions | Nafarelin 200 mcg twice daily intranasal + placebo per os for 6 months (n = 206) versus Danazol 200 mg three times a day per os + placebo intranasal for 6 months (n = 101) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: no Sample size calculation: not stated Funding: Supported in part by Syntex Research, Palo Alto, California, US Note previous version: 8 participants who were randomised never took the study medication. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "patients were randomised so that 2 were assigned to receive nafarelin for every 1 assigned to receive danazol". No further information was provided on method used to generate random 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 | Double‐blind study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind study |
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 |