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. 2019 Sep 19;2019(9):CD000400. doi: 10.1002/14651858.CD000400.pub4

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)
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
Outcomes MBL (alkaline haematin method)
Notes No ITT analysis
Data made available by the author for the end of the first cross‐over period.
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