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

van Eijkeren 1992.

Methods Randomisation list controlled by pharmacy
Double‐blind, placebo‐controlled, parallel group
No ITT and no power calculation made
7 withdrawals (postponed hysterectomy, fibroids at operation, postmenstrual phase, premenstrual phase). 1 discontinuation because of adverse effects of MFA (rash and itching)
Participants Netherlands
19 women, mean age 40 years
Inclusion criteria: aged < 45 years, MBL > 80 mL/cycle, regular menstrual cycle
Exclusion criteria: IUD, use of NSAIDs or other medication that could affect haemostasis, contraindications against NSAIDs, use of hormonal medication
Interventions Group 1: MFA 500 mg 3 times daily from 5 days prior to menses to cessation of bleeding, n = 6
Group 2: placebo 3 times daily from 5 days prior to menses to cessation of bleeding, n = 5
Duration: 1 menstrual cycle
Outcomes MBL (alkaline haematin method)
Adverse events
Notes 19 women randomised but 7 dropped out after the treatment cycle (this high dropout rate reduced the quality of the study). Data reported only for the 11 women that went on to have a hysterectomy. Requested data from the 7 withdrawals but received no answer from author.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation list controlled by pharmacy
Allocation concealment (selection bias) Low risk Outside control of randomisation list
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double blind
Incomplete outcome data (attrition bias) 
 All outcomes High risk 7/19 women withdrawn (postponed hysterectomy, fibroids at operation, postmenstrual phase, premenstrual phase, adverse effects of MFA) and 1 woman discontinuation because of adverse effects; no ITT analysis
Other bias Unclear risk Nothing detected