Dockeray 1989.
Methods | Women randomised according to a randomisation code without blinding into 2 treatment groups, MFA and danazol. 1 woman (from MFA group) was withdrawn because of adverse effects. No loss to follow‐up. The duration of the study was 4 menstrual cycles, 2 untreated (control) and 2 with treatment. No power calculation made or ITT analysis |
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Participants | Ireland 40 women, mean age 37.8 years (range 23–48 years) with normal pelvic organs and no endometrial pathology Inclusion criteria: objective unexplained MBL > 80 mL/cycle (alkaline haematin method), history of excessive menstrual bleeding |
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Interventions | Group 1: MFA 500 mg 3 times daily for 3–5 days for 2 cycles, n = 19 Group 2: danazol 100 mg twice daily for 60 days for 2 cycles, n = 20 |
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Outcomes | MBL (alkaline haematin method) Number of days bleeding Quality of life (dysmenorrhoea) Adverse events (incidence, severity) Patient acceptability of treatment (prepared to continue Rx?) |
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Notes | No ITT analysis Baseline comparability done |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation code |
Allocation concealment (selection bias) | Unclear risk | Unclear risk |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts reported; 1 woman was withdrawn because of adverse effects. |
Other bias | Low risk | Similar at baseline |