Fraser 1991.
Methods | Randomisation technique not stated. 8‐cycle cross‐over treatment trial without blinding or placebo. 7 lost to follow‐up. Not ITT and no power calculation made. Women randomised into 3 treatment groups. All women received MFA and 1 of 3 other treatments: naproxen, oral contraceptive and danazol in a random order. 2 control cycles prior to first Rx, 2 Rx cycles, 2 control cycles prior to second Rx, 2 Rx cycles. | |
Participants | Australia 45 women with a convincing clinical history of menorrhagia, regular periods, no hormonal therapy in the previous 3 months and with no evidence of pelvic and systemic causes of menorrhagia Inclusion criteria: subjectively defined menorrhagia (37% had MBL < 80 mL/cycle) |
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Interventions | MFA 500 mg every 6–8 hours from onset of menstruation until 1 day after (maximum 5 days), n = 20 Naproxen 500 mg at onset followed by 250 mg every 6–8 hours until 1 day after (maximum 5 days), n = 6 Oral contraceptive (low dose): 30 μg ethinyl and 150 μg levonorgestrel daily for 21 days out of 28, n = 6 Danazol (low dose): 200 mg daily from day 5 of the second control cycle for 8 weeks, n = 6 Group 1: MFA + naproxen, n = 14 Group 2: MFA + combined low‐dose contraceptive pill, n = 12 Group 3: MFA + danazol, n = 12 8 cycle design: 2 untreated cycles, 2 cycles with first treatment, 2 untreated cycles, 2 cycles with second treatment |
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Outcomes | MBL (alkaline haematin method) | |
Notes | No ITT analysis Data made available by the author for the end of the first cross‐over period. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
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 | High risk | 7/45 women lost to follow‐up, no ITT analysis |
Other bias | Unclear risk | Nothing detected |