Hurskainen 2001.

Study characteristics
Methods	Multicentre (n = 5), parallel group study. No. of women randomised: 236 No. of women analysed: 228 at 12 months, 232 at 5 years, 221 at 10 years Dropouts: LNG‐IUS group: 1.6% at 6 months' and 2.5% at 12 months' follow‐up; hysterectomy group: 9.4% at 6 months and 4.3% at 12 months' follow‐up. Power calculation for sample size and ITT analysis. Source of funding: Academy of Finland, STAKES and research funds of the University Hospitals in Finland. Mirena was provided free of charge by Leiras.
Participants	Country: Finland Women, aged 35 to 49 (mean age 43) referred by GPs or gynaecologists to 5 university hospitals Inclusion criteria Menorrhagia Still menstruating Family completed Eligible for hysterectomy Exclusion criteria Submucous fibroids Endometrial polyps Ovarian tumours or cysts Cervical disease Urinary or bowel symptoms or pain due to fibroids Lack of indication for hysterectomy History of cancer Menopause Severe depression Metrorrhagia as main complaint Previous treatment failure with LNG‐IUS Severe acne Uterine malformation
Interventions	LNG‐IUS Hysterectomy (either abdominal, vaginal or laparoscopy)
Outcomes	Primary Quality of life measured by EQ‐5D Secondary Quality of life measured by RAND 36, Anxiety scale, Becks Depression Scale, McCoy Sex Scale Costs Hospital services (operations, inpatient days, procedures, outpatient visits) Menstrual blood loss (measured by alkaline haematin method) Satisfaction Adverse effects (urinary symptoms, bone mineral density, cardiovascular risk factors, ovarian cysts, lower abdominal pain, back pain)
Notes	Results analysed at 1, 5 and 10 years' follow‐up.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation stratified by centre in clusters by drawing from a hat
Allocation concealment (selection bias)	Low risk	Quote: "numbered opaque sealed envelopes" ‐ physicians and other study personnel did not participate in allocation execution
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not blinded, lack of blinding likely to influence outcome
Blinding of participants and personnel (performance bias) Haematin alkaline, Haemoglobin All outcomes	Unclear risk	Haematin alkaline or haemoglobin were not measured
Blinding of outcome assessment (detection bias) All outcomes	High risk	Not blinded, lack of blinding likely to influence outcome
Blinding of outcome assessment (detection bias) (Haematine alkaline and haemoglobin) All outcomes	Unclear risk	Haematin alkaline or haemoglobin were not measured
Incomplete outcome data (attrition bias) All outcomes	Low risk	Minimal dropouts at 12 months (3/119 (2.5%) in LNG group and 5/117 (4.3%) in hysterectomy group). At 5‐year follow‐up, 2/119 (1.7%) lost to follow‐up in LNG group and 2/117 (1.7%) lost to follow‐up in hysterectomy group
Selective reporting (reporting bias)	Low risk	All prespecified outcomes reported
Other bias	Low risk	Groups appeared similar at baseline