Rolland 1990.
| Study characteristics | ||
| Methods | Trial design: parallel, randomised, double‐blind, double‐placebo study | |
| Participants | Participants: 194 women were randomised; 170 were analysed. Mean age: between 18 and 45 years Inclusion criteria:
Exclusion criteria:
Setting: 13 medical centres in seven European countries Timing: not stated |
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| Interventions | Nafarelin 200 μg twice daily IN + placebo PO twice daily for 6 months (n = 127) versus Danazol 200 mg twice daily PO + placebo IN twice daily for 6 months (n = 67) | |
| Outcomes |
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| Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Authors contacted regarding methods and data. Letter returned with author unknown at Department |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomised 2:1 nafarelin: danazol. 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 | Low risk | Double‐placebo, double‐blind study |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐placebo, double‐blind study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Details for attrition:
Nafarelin: 20/127 discontinued treatment. Danazol: 4/67 discontinued treatment. |
| 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 |