Bonnar 1996.
Methods | Randomised controlled trial, parallel group, no evidence of blinding, randomisation by computer‐generated randomisation list 5 women withdrew during first cycle of treatment (2 from MFA group, 2 from ethamsylate group and 1 from tranexamic acid group) ITT analysis on remaining 76 women (18 of whom withdrew during the study) Power calculation for sample size made No loss to follow‐up |
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Participants | Dublin, Ireland 81 women, mean age 39 years (range 35–46 years) with a mean MBL > 80 mL/cycle measured over 3 consecutive menstrual periods. Exclusions: "Organic" causes of menorrhagia by gynaecological investigation (hysteroscopy, endometrial biopsy and cervical smear). History of renal or hepatic impairment, previous thromboembolic disease, inflammatory bowel disease, peptic or intestinal ulceration or coagulation or fibrinolytic disorders |
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Interventions | Group 1: tranexamic acid: 1 g 4 times daily for 5 days from day 1 of menses, n = 26 Group 2: ethamsylate: 500 mg 4 times daily for 5 days from day 1 of menses, n = 27 Group 3: MFA: 500 mg 3 times daily for 5 days from day 1 of menses, n = 23 Duration: 3 menstrual cycles |
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Outcomes | MBL (by alkaline haematin method) Duration of bleeding (days) Patient's estimation of blood loss (less, same, greater) Quality of life (dysmenorrhoea) Adverse events (type, incidence) Patient acceptability of treatment (would you be prepared to continue with this treatment?) |
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Notes | No ITT analysis Baseline comparability done Additional data provided by the author |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated list |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5/81 women withdrew (2 from MFA group, 2 from ethamsylate group and 1 from tranexamic acid group) |
Other bias | Low risk | Groups similar at baseline |