Chamberlain 1991.

Methods	Randomisation by Taves method of minimisation Double‐blind randomised trial with parallel groups and double‐dummy technique Exclusions postrandomisation: 6 (5 fibroids, 1 IUCD) Not ITT, no power calculation made
Participants	UK 42 women, aged 18–55 years, with menorrhagia, MBL > 80 mL/cycle and regular menstrual cycles Exclusions: taking oral contraceptives, antacids, anticoagulants or protein bound drugs; hepatic impairment, inflammatory bowel disease or endocrine disorders; wish to become pregnant during trial; known allergies to prostaglandin inhibitors; anaemic (haemoglobin < 9 g/dL); IUCD fitted, uterine enlargement due to fibroids
Interventions	Group 1: MFA 500 mg 3 times daily for duration of menses, n = 19 Group 2: ethamsylate 500 mg 4 times daily for duration of menses, n = 17 Duration: 3 cycles + 1 cycle post‐Rx
Outcomes	MBL (mean of 3 Rx cycles measured by alkaline haematin method) MBL (during 1 post‐Rx cycle measured by alkaline haematin method) Adverse events
Notes	No ITT analysis Detailed data from published study not available from authors. Lorex Synthélabo was able to provide data from the same study but numbers in the groups were different from the published study. Results analysed from the unpublished data. Pretreatment MBL not comparable between the 2 groups. Adverse effects data not available from unpublished data.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Taves method of minimisation
Allocation concealment (selection bias)	Unclear risk	Unclear risk
Blinding (performance bias and detection bias) All outcomes	Low risk	Double blind
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	6/42 women excluded (not clear from which group: 5 for fibroids and 1 because of IUCD)
Other bias	High risk	Detailed data from published study not available from authors. Lorex Synthélabo was able to provide data from the same study but numbers in the groups were different from the published study. Results analysed from the unpublished data. Pretreatment MBL not comparable between the 2 groups. Adverse effects data not available from unpublished data.