Burry 1989.
Study characteristics | ||
Methods | Trial design: Parallel, double‐blind, double‐dummy randomised trial | |
Participants | Participants: 53 women were randomised; 51 were analysed. Mean age: 23‐38 years Inclusion criteria:
Exclusion criteria:
Setting: United States of America Timing: Not stated |
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Interventions | Group I: danazol, 800 mg/day (400 mg twice daily) (n = 10) Group II: danazol, 600 mg/day (200 mg three times a day) (n = 8) Group III: intranasal nafarelin, 800 μg/day (400 μg twice a day) (n = 10) Group IV: intranasal nafarelin, 400 μg/day (200 μg two times a day) (n = 25) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: No Sample size calculation: not stated Funding: not stated Included in this review, but did not contribute any data Not possible to contact leading author; unfortunately had passed away. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | 'Randomly allocated'. 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 had a parallel, double‐blind, double‐dummy design. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The study had a parallel, double‐blind, double‐dummy design. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Group I: Danazol, 800 mg/day (400 mg twice a day): Nine of the 10 patients included in this group completed the study; one withdrew because of severe headaches. Group II: Danazol, 600 mg/day (200 mg three times a day). All eight patients completed the study. Group III: Nafarelin acetate, 800 μg/day (400 μg twice a day). Nine of 10 patients included in this group completed the study: one withdrew because of mood swings. Group IV: Nafarelin acetate, 400 μg/day (200 μg twice a day). All 25 patients included in this group completed the study. |
Selective reporting (reporting bias) | High risk | Change in symptoms was asked for, but not reported in published article. |
Other bias | Low risk | No other risk of bias detected |