Sesti 2012.

Study characteristics
Methods	Single centre parallel group RCT No. of women randomised: 72 No. of women analysed: 72 Power calculation for sample size ITT analysis Funding: not stated
Participants	Country: Italy Participants were women with HMB unresponsive to medical treatment with mean age 47 years Inclusion criteria Presence of HMB Reproductive age 35 to 50 years Completed family Failed appropriate first line oral medical therapy Normal Pap smear No pelvic pathology at ultrasound Normal endometrial biopsy PBAC ≥ 100 (average of 2 consecutive cycles) Exclusion criteria Previous endometrial resection/ablation Previous insertion of LNG‐IUS Any uterine pathology on scan or hysteroscopy Any pathology where hysterectomy was indicated Not fully investigated abnormal uterine bleeding Postmenopausal bleeding
Interventions	LNG‐IUS inserted within 7 days of onset of menstruation under paracervical block Laparoscopic supracervical hysterectomy (Both performed by the same surgeons using the same technique)
Outcomes	Primary PBAC score at 12 months Secondary Quality of life (SF‐36) Improvement in bleeding patterns Intensity of postoperative pain (VAS scale 0 to 100 in categories) Early postoperative complications requiring readmission Follow‐up at 3, 6, 12 and 24 months
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "computer generated list"
Allocation concealment (selection bias)	Low risk	Quote: "serially numbered opaque sealed envelopes"
Blinding of participants and personnel (performance bias) All outcomes	High risk	Blinding of patients until interventions were assigned, surgeons performing the procedures blinded
Blinding of participants and personnel (performance bias) Haematin alkaline, Haemoglobin All outcomes	Unclear risk	Alkaline haematin or haemoglobin were not measured
Blinding of outcome assessment (detection bias) All outcomes	High risk	Assessors blinded, but some outcomes based on patient self‐report, lack of blinding likely to influence outcome
Blinding of outcome assessment (detection bias) (Haematine alkaline and haemoglobin) All outcomes	Unclear risk	Alkaline haematin or haemoglobin were not measured
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up or exclusions
Selective reporting (reporting bias)	Low risk	All prespecified outcomes reported
Other bias	Low risk	Groups appeared balanced at baseline and no other potential bias