Bonnar 1996.
Methods | RCT: computer‐generated randomization list to 1 of 3 groups No blinding mentioned | |
Participants | Country: UK No: 76 Age: 35 to 46 years Inclusion criteria: women reporting HMB confirmed to have > 80 mL per cycle loss, normal cervical smear 3 to 12 months before commencing the study Exclusion criteria: organic causes of menorrhagia found at hysteroscopy or endometrial biopsy, previous renal or hepatic impairment, VTE, inflammatory bowel disease, peptic or intestinal ulceration, coagulation or fibrinolytic disorders |
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Interventions | Ethamsylate 500 mg 4 times daily for days 1 to 5 of cycle (27 participants) TXA 1 g 4 times daily for days 1 to 5 of cycle (26 participants) MFA 500 mg 3 times daily for days 1 to 5 of cycle (23 participants) Duration: 3 placebo cycles and 3 treatment cycles |
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Outcomes | MBL: objective measurement (alkaline haematin method), duration of blood loss (days), participant's estimate of blood loss, number of sanitary towels used (end scores and change scores) Dysmenorrhoea Side effects |
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Notes | Clarification of data sought from authors and reply received Funded by the Health Research Board of Ireland and Pharmacia (a drug company) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized "by a computer generated randomization list" |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details; blinding not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 withdrew after randomization (2 in MFA group, 2 in ethamsylate group, 1 in TXA group) and lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All pre‐determined outcomes were reported and were relevant |
Other bias | Low risk | Groups appeared comparable at baseline |