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) |
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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 |
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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 |
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Outcomes | MBL (alkaline haematin method) Adverse events |
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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Incomplete outcome data (attrition bias) All outcomes | High risk | 7/19 women withdrawn (postponed hysterectomy, fibroids at operation, postmenstrual phase, premenstrual phase, adverse effects of MFA) and 1 woman discontinuation because of adverse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 |